Shilajit fulvic acid information

www.rudramani.com SHILAJIT Anti ageing elixir from
Himalayan Mountains
60% Fulvic acid. $9/- Only
The invention to be protected consists of a synergic composition to be used in the prevention and treatment of neurodegenerative diseases such as Alzheimer
and other dementias associated to aging. The composition contains Shilajit extract, folic acid, vitamin B6 and B12. Shilajit is a millenary sacred plant with a
large quantity of healing properties, it is very effective in reducing fatigue and works as a natural energizer. This herb growing in the Himalayas mountains
contains fulvic acid and humic acid, natural antioxidant substances that help to delay cell aging, they attack tumor generation, help to neutralize toxins and to
improve the availability of minerals in the body making them bioactive and bioavailable for our body. We have recently found this plant in the Andean sector of
the north of Chile (Andean Shilajit). Shilajit contains roughly 85 types of minerals in their ionic form which are vital to maintain energetic metabolism balanced in
the body. Shilajit's minerals are not similar to the ones normally sold in the market as food supplements because these have ionic form and have been
previously absorbed by plants and have returned to the soil, so they are easily absorbed by human cells. A few patents exist associated to the Shilajit
nutraceutic around the world vindicating the advantages and qualities of the individual product. U.S. Pat. No. 5,405,613 refers to the use of Shilajit or its
extracts in vitamin or mineral compositions and methods to restore the energetic balance or to increase the bioenergetic field in mammals. Inventors found that
Shilajit,“has a vibrational field substantially stronger than that of any other vitamin, mineral, alimentary substance or herb”. They also discovered that when
adding small quantities of Shilajit to a vitamin or mineral formulation the energetic properties increased. U.S. Pat. No. 6,440,436 describes a Shilajit
composition having an abundance of bioactive components useful for countering toxic agents, as well as for personal, pharmaceutical and nutritional care.

Below is a description of the main characteristics and attributes of the components of this invention using Andean Shilajit in addition to other food supplements:
Fulvic Acid. It is a Shilajit component, a completely natural and organic extract rising from the deposit of a plant 75 million years ago and corresponding to the
higher cretaceous period. It contains a large quantity of photochemicals, biochemicals, antioxidants, free radicals suppressors, nutrient substances, enzymes,
hormones, aminoacids, antibiotics, antivirals, antimycotic substances, among other elements. Fulvic acid contains about 74 essential organic and mineral
compounds dissolved with 42% of solid acid food. It improves mineral availability in the body, regenerates and extends residence time of essential nutrients in
the cells, diminishes the damage produced by toxic compounds, heavy metals, free radicals and its consumption improves permeability for the digestive and
circulatory systems and cell membranes. In the 15th century, during the Ming Dinasty, Li Shi Zhen registered, in the pharmacologic abridgement of Medical
Matters, the incidents of the use of “Wujinsan” (golden medicine) which contained fulvic acid as an active ingredient in the treatment of infectious ulcerous
diseases, thus involving fulvic acid as an agent for anti-inflammatory coagulation and for efficient blood.
Before 1978, fulvic acid had been used in hospitals and on population in general to treat successfully a wide range of diseases; nonetheless, there was very
scarce research on its therapeutic mechanism. Due to lack of clinical data and absence of clinical trials, there were still doubts as to the therapeutic use of
fulvic acid. From that time onwards, a group of medical schools and hospitals in China have begun to carry out comprehensive studies on the toxicology and
pathology of fulvic acid and its clinical uses. Hundreds of studies have been published in China, some of them appearing in international newspapers, in
addition to some reports presented in various meetings outside China. The pharmaceutic companies in the hands of Dr. Shanxi in Gongxian, Henan and in
Kunming, Yunnan produced the fulvic acid that was then approved by the Chinese drug administration due to its non-toxicity, for oral as well as external uses.
The pharmaceutic use of fulvic acid has been approved by the provincial drug administration on the basis of its efficacy and safety, both internally and
externally. At present, it is recognized that fulvic acid acts as an important protective agent and a powerful natural electrolyte that can restore the electric
balance of damaged cells, neutralize toxins and eliminate food intoxication in a matter of minutes. It is created in the soil by microorganisms with the aim of
transporting minerals and nutrients from there to the plants. Then, complex photosynthesis reactions produce the components from different zones of the plant.
Sugars coming from complex carbohydrates flow along the whole plant for nutrition. Some return to the roots where microorganisms are fed, producing fulvic
acids as a complex with minerals and nutrients, and the cycle begins again. In plants, fulvic acid stimulates metabolism, provides breathing, increases proteins
and the activity of multiple enzymes, improves permeability of cell membranes, their division and elongation, it facilitates chlorophyl synthesis, drought
tolerance, protects soil pH and from microbe attacks, contributes to electrochemical balance as a donor or acceptor, disintegrates silicone in order to release
essential nutrient substances, detoxificates contaminants such as pesticides and herbicides.
When minerals contact with fulvic acid, in an aqueous environment, they dissolve naturally in an ionic manner and, literally, they become a part of it. Once
minerals are in the fulvic acid complex, they become bioactive, bioavailable and organic. For that reason, when elemental minerals are transformed into an
organic state through a natural chemical process implying fulvic acid and photosynthesis, they are safe to be used both in human beings and animals. Fulvic
acid is found and extracted, preferentially, in the Himalayas, but it was recently discovered in the northern region of Chile (Andean Shilajit). The latter is richer
in fulvic acid than the Shilajit from the Himalayas. It has been scientifically demonstrated that among its multiple benefits it helps human tissue to grow and
regenerate, it lowers strain, stress, general weakness and fatigue, acting as an antioxidant. Its use as medication helps to slow down cell aging.
Another important aspect of the use of fulvic acid consists in a general health improvement through the fight against several diseases associated to mineral
deficiency in the body. Organic fulvic acids are created precisely by microorganisms in the soil with the goal of transporting minerals and nutrients from the soil
up to the plant, which would help to perform the same function in the human body. In ancestral medicine it was considered a panacea and used to increase
sexual and spiritual energy, the same vigor that tension and anxiety wither. In India the indigenous medicine system uses it to combat various illnesses such
as: kidney and bladder affections, anaemia, asthma, chronic bronchitis, nervous weakness, diabetes, fermentative dyspepsia, hepatosplenomegaly, hysteria,
sexual neurasthenia, digestive disorders, etc.

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Pharmacologic Studies Achieved with Fulvic Acid:
1. As an antiinflammatory agent: The efficacy of hydrogenated cortisone with respect to fulvic acid changes according to the site of its origin and the extraction
method used. (i) Fulvic acid inhibits an enzyme discharged in the infected area and moreover regulates the zinc and copper levels of the trace elements, thus
activating the dismutase that contain zinc and copper.
2. Stimulates blood circulation and enhances coagulation: Many diseases are caused by the malfunctioning of circulation in the blood's capillary system. The
therapeutical effect of fulvic acid is a result of its capacity to restore and improve circulation in the blood's capillary system. On the other hand, fulvic acid also
serves as a blood coagulant when there is tapping or blood filtrating from the vascular layer.
3. Digestive ulcers: The healing effects of fulvic acid are the result of its capacity to stimulate blood circulation in the stomach wall and its ability to inhibit the
secretion of acid-producing cells. It also stimulates the secretion of glands that have the capacity to protect the stomach's inner wall, thus preventing ulcers.
4. Immune System: There is reason to believe that if fulvic acid is injected in the abdominal area, the size of the thymus increases in animals under testing,
together with the augmentation of macrophage activity. A dosification of 5 mg/kg of weight injected in the abdominal area is beneficial. Nonetheless, doses over
50 mg/kg showed the opposite effect, that is, the size of the thymus is reduced.
5. Endocrine System: Fulvic acid regulates the abnormal secretion of the thyroid hormone as a result of its power to regulate cyclic at the cell level.
6. Cancer: Fulvic acid, in general, does not kill tumor cells; nonetheless, it serves as a regulator agent in the immune system and can be used jointly with
other antineoplastic medicines.
Clinical Uses of Fulvic Acid
1. Antiinflammatory and blood coagulant: In many clinical cases infections were accompanied by blood filtering into the area or bleeding ulcers. Fulvic acid
moderates ulcerous conditions on the basis of its antiinflammatory nature, acting at the coagulation level and the whole body.
2. Infection of the cornea: Fifty-three cases were studied and treated with fulvic acid eye drops and intramuscular injections, obtaining a rate of success of
94.2%. The study was carried out in an eye clinic at the Shaoxin hospital, Zhejiang province, China.
3. Acute gastrointestinal hemorraghe: 160 cases were studied and treated with fulvic acid in oral and injectable form, with a rate of success of 95.6%. The
studies were carried out at Internal Medicine at the Tongren Hospital, Beijing, China.
4. Skin ulcers: Fifty-one cases were studied and treated with a fulvic acid bath and minerals with a rate of success of 92.2%. The studies were carried out at
Internal Medicine at the Tongren Hospital, Beijing, China.
5. Rheumatoid arthritis: A large number of cases were studied and treated with the fulvic acid bath mixed with minerals and in oral form (capsules), with a rate
of success of 92%. de éxito. The studies were carried out at the Haidian Hospital, Beijing, China.
6. Hemorrhoids: Several thousands of cases were studied and treated with the fulvic acid preparation. The rate of success was so high that the Chinese
medical authorities developed an over-the-counter (OTC) medicine for its national distribution. The studies were carried out at the hospitals of Erlonglu in Beijing
and Kunming in Yunnan, China.
7. Esophageal Cancer: disease's incubation period: 27 cases were studied and treated using a solution of fulvic acid in water during two years. The hit rate was
100% in the progression of the prevention of the tumor in its cancerous state. The studies were carried out by Hongji Xie, et al.
8. Overactive thyroid: 33 cases studied and treated during 6 months with fulvic acid in oral form (capsules) with a rate of success of 0.9%. The studies were
carried out at the Tongren Hospital, Beijing, China.

In short, as a result of common efforts contributed by researchers and their basic clinical studies on science, the fulvic acid component, originating from humic
acid, has proven to be an effective and safe remedy for a wide variety of illnesses. This contribution has raised the curiosity and interest of foreign scientists, as
stated in “The recent progress in Chinese medicine” published in Singapore and in “Fulvic Acid” published in Germany.

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The difference between Shilajit-based fulvic acid (FAs) and alluvial soil-derived fulvic acids lies in the core structures of the fulvic acids (FAs) in these
compositions. Shilajit-FAs contains 3,8-oxygenated dibenzo-?-pyrone as the core nucleus, which, upon repeated oxidation, and Michael addition reactions by
nucleophile-containing oxygen, nitrogen and carbon ions, in association with various lipid moieties, produce a multiplayer micellar structure. In contrast, alluvial
soil-FAs are composed essentially of aromatic hydroxy acids and polyphenols derived from phenolic oxidations. Both these FAs contain different metal ions,
especially Fe, Co, Zn, Ca, etc., associated with the FAs. The metals in Shilajit-FAs are well-organized, multicentered, metal-ion associated products which, in
the case of iron, maintains the metal in the reduced state and produce different iron-containing enzymes. Such trace ion-metal associations are not possible for
soil-FAs because they have a much less organized heteropolycondensate structure whose micellar structure is irregular.

Another unique feature of Shilajit-FAs is that it is of endogenous origin produced by animal systems. These systems meet the essential need of bioavailability
of trace metals and minerals, which serve as a carrier of essential nutrients in the living animal body. By contrast, soil-FAs, being exogenous in origin, do not
contribute to those essential needs of animals.

Shilajit-FAs also contains oligomeric (di, tri, tetra) dibenzo-?-pyrones, which scavenge free radicals and free metal ions, to become a soft-spin radical. In
contrast, soil-FAs contain only esters of phenolic acids which do not have the antioxidant activity possessed by Shilajit-FAs.

Significantly, acylated DBP, with a lipid chain, are present in Shilajit-FAs; these actives behave like a liposome (polymicellar structure) which can act as an
efficient carrier molecule. The phenolic acid esters present in soil-FAs do not possess these characteristics.

Thus, in accordance with the invention, the purified fulvic acid carrier constituent of native Shilajit, without toxic components, and substantially without bioactive
constituents in the voids of the carrier, is provided by a defined extraction procedure from native Shilajit.

The purified Shilajit composition containing the purified fulvic acid carrier is obtained by an extraction procedure from native Shilajit rock exdudate, according to
the following steps:
(a) powdering native Shilajit exdudate and dissolving it in water as solvent,

(b) filtering the mixture to remove insoluble substances,

(c) evaporating water from the filtrate to obtain a brown viscous residue,

(d) extracting the residue with a hot organic solvent, e.g. methanol, to obtain both a soluble fraction and an insoluble Shilajit-humic fraction,
(e) adding dilute aqueous NaOH to the insoluble Shilajit-humic fraction to precipitate polymeric quinones,

(f) acidifying the alkaline filtrate to a pH below about 3 to precipitate humic acids, leaving a brown acidic solution of fulvic acids,

(g) fractionating the acidic solution by passing it over activated carbon to provide a solution of low-to-medium Mw fulvic acids,

(h) passing the fulvic acid solution through a H+ ion-exchange resin to concentrate the fulvic acids in solution, and
(i) evaporating the solution.

The thus-obtained extraction product is a purified Shilajit composition preferable containing at least 40% by weight of purified fulvic acid carrier, and it is
substantially without bioactive components therein. The fulvic acid has a sponge-like structure punctuated by voids of about 200-1000 ? in diameter and an
{overscore (M)}n of about 700-2500. The active material then is added to the carrier to fill voids in its structure, thus-forming the desired delivery system. Upon
dissolution in water, the active ingredient is released to perform its intended active function, e.g. a pharmaceutical, nutritional or cosmetic function.

Himalayan Mountains

www.alzheimer-herbs.com: Memory boosting & cognition
enhancing herbs. Protects against degenerative brain
diseases Try it if AD runs in your family.
A potent antioxidant neuroprotective nutraceutical composition that comprises blending extract of Shilajit (250 to 500 mg) and folic acid (200 to 400 ?g),
together with small amounts of vitamins B6 (20 to 40 ?g) and B12 (4 to 8 ?g) consumed per day. This composition can be used to prevent and to treat
neurodegenerative diseases or episodes of cognitive deterioration arising from various pathological conditions. The use thereof is indicated in the treatment of
Alzheimer's disease and senile dementia as the pathological conditions preferably to be treated. The composition is suitable for direct human consumption by
mouth, either in solid form as a powder or as a suspension of the extract, as a food additive or as a nutraceutical agent. It may be formulated as a nutraceutical
agent to be included as an ingredient in beverages or as a drug in conjunction with permitted excipients.

t has been estimated that the USA invests more than $178 billion dollars annually in direct and indirect costs to control Alzheimer Disease (AD). With a
percentage of the population over 65 years old (in Chile it is over 12%), the number of people with AD will increase rapidly and proportionally. If early diagnosis
technologies for AD are not found soon, as well as interventions for its treatment, the number of people who will develop the disease will surpass health
systems. Since our group has conducted research for more than 30 years in this field and we have made some of the most relevant discoveries in the world, we
are in the best position to innovate and find effective solutions for its prevention, early detection and treatment. Thus our findings contribute to AD prevention, to
its diagnosis (molecular markers and neuroimage technologies), and now to its treatment. We are developing new drugs for controlling the disease, in addition
to cognitive stimulation technologies through software designed to improve patients' quality of life and to correct memory disorders. We now offer a
pharmaceutical formulation that, according to our previous research, helps to prevent and control brain disorders leading to AD and other neurodegenerative
diseases, among them oxidative stress, neuroinflammation and the gradual loss of neurons.

At present the FDA has approved only 5 drugs for AD treatment, and the use of some of them has been extended to other dementias (vascular dementia, Lewy
bodies dementia, frontotemporal dementia due to taupathies, etc.) (Maccioni & Perry, 2009).

Four of them inhibit AChE enzyme (acetil colinesterasa) and their pharmacologic activity is aimed at compensating the cholinergic loss taking place in AD.
None of them succeeds in healing this pathology and their action is rather palliative, diminishing the progress of symptoms, as they do not control AD's
etiopathogenesis. These drugs are: Tacrine® (almost not used any more due to its hepatotoxic condition), Donepecil, Rivastigmine and Galantamine. The last
three cover more than 80% of the markets and in spite of their very low effectiveness their sales amount to billions of dollars around the world.

Each one of them is sold in pharmaceutic forms under commercial names given by different laboratories which produce and put them on the market. They are
highly expensive but have not managed to stop the disease's progression. The other drug is Memantine, which acts at another level, on NMDA receptors
blocking exitotoxicity processes and the entrance of calcium into brain cells. Its market is still reduced as it has been commercialized for a shorter period of
time. Its use is reserved essentially for advanced stages of the disease, but it is also palliative as it does not heal AD due to its incapacity to control
endogenous mechanisms leading to the pathogenesis of this disease. On the other hand, other molecules are undergoing research and clinical testing, for
example: (i) growth factors such as Cerebrolysin® which could be promising if the action—not yet demonstrated—of neurotrophic factors can be proven, and (ii)
inhibitors of gamma secretase and vaccines guided towards senile plaques, definitively not effective due to the fact that senile plaques, neuropathological
alterations formed by beta amiloid, are not responsible for AD and recent studies strongly disprove the amiloid hypothesis. These drugs, in which several
pharmaceutic industries have invested billions of dollars, have not been successful because they do not respond to modern hypothesis of the pathology, as the
tau and neuroimmunomodulation hypotheses (Maccioni & Perry, 2009).

AD's pathogenesis is directly related to the self aggregation of tau as the common final path for altered mechanisms of signal transduction between glial and
neuronal cells, as a result of a series of danger signals in which innate immunity phenomena are involved (Maccioni et al., 2009). Therefore two types of the
latest generation drugs would be the most promising for an effective AD treatment and could in the future replace the five first-generation molecules that have
not proven to be effective. These new molecules are:
a) Inhibitors of the tau pathologic autoagregation in PHF-type filaments and finally in neurofibrillary tangles (NFTs), among which the drugs of our patent are
present, the “quinolines”, and exert an effective action at this level.
b) Modern antiinflammatories that control over activation of TNF a proinflammatory cytokine, including etanercept.
The significant progress in the knowledge of the molecular aspects promoting neurodegeneration in relation to cognitive deterioration, including the changes in
the functioning of the tau protein, inflammatory processes and oxidative stress, among others (Maccioni et al., 2001, 2006, 2009, Quintanilla et al., 2004;
Orellana et al., 2005; Fernández et al., 2008; Farias 2010), is contributing nowadays to a more open-minded attitude in the search of new tools to treat these
disorders. In Chile the prevalence of cognitive deterioration in the population, based for this diagnosis on a MiniMental<13 score is 7.9% in the age between 60-
69 years, 18% between 70-79 years and 48% at 80 or more. It is estimated that the population with this kind of deterioration is over 280,000 people (Ministry of
Health). This same study revealed a significant greater prevalence according to the literacy level: for people with only primary studies, the prevalence was
20.3%, for those with high school studies, 3.7% and for those with university studies, 2.6% (Ministry of Health, First Health Survey, 2003).

Neurodegenerative disorders are linked to an extensive and gradual neuronal loss, and associated to the ethiopathogenesis of this illness are the tau neurotoxic
aggregates as well as the neurofibrillary tangles (NFTs). These are formed by a protein associated to the neuronal cytoskeleton named tau, which is
hyperphosphorylated in the brains of AD patients (Kurt et al., 1997; Maccioni et al., 2001; Maccioni et al., 2004). Via unknown mechanisms, tau undergoes
important modifications such as abnormal phosphorylation due to the deregulated activity of various kinases and phosphatases affecting their normal biological
function (Zambrano et al., 2004). Under these circumstances tau begins to aggregate itself and produces NTFs, which are structures constituting a
hystopathological marker, characteristic of AD (Maccioni et al., 2003).
The product of our neuroprotective formulation blocks the neuroinflammatory processes where the hyperphosphorylation of the tau protein takes place
(Maccioni et al., 2009). On the basis of our hypothesis of the presence of tau in the ethiopathogenesis of AD, we have been researching on the disaggregating
action of different molecules on NFTs, the main hystopathological injury found in brains of individuals presenting this pathology. After several attempts with
drugs that disassemble amyloid's senile plaques, most of the efforts made worldwide to control cognitive disorders are being directed at present towards
molecules with antiinflammatory activity and neuroprotectors.
In this context, and due to the dramatic increase in life expectancy at the global level, to find viable solutions for the treatment of cognitive disorders constitutes
one of the greatest challenges faced by the pharmaceutical and biotechnological industry. There exist very few effective pharmaceutical formulations that act as
neuroprotectors or cognitive function restorers; among them the most recent is Memory XLR, which contains essentially vitamins and S-adenosylmetionin and
has shown relatively promising results at the clinical level (Chan and Shea, 2007). This confirms the enormous importance of generating natural products with
nutraceutical activity that stimulate brain function, with no adverse effects for human beings, and with a tested efficiency and safety. This is the foundation of

our effort to generate a formulation containing a nutraceutic with a highly antioxidant potential. Our nutraceutical formulae contains more than 96 times the
antioxidant power present in cranberry concentrates and Noni, among others, measured by the TAR index, the Total Antioxidant Reactivity and evaluated in
TROLOX equivalents. Thus our nutraceutic combines its high potency antioxidant effects with vitamins B6 and B12 plus folic acid, all of them key
neuroprotective elements for brain activity and also for avoiding cognitive deterioration. The nutraceutic belonging to this formulation is a 100% native product,
the “Andean Shilajit”, obtained from millenarian organic concentrates derived from bryophyt plants from the north of Chile, found in the subsoil of arid zones,
with a high acid fulvic content, a product with a proven antioxidant power in addition to an anti-inflammatory activity. Besides these characteristics favoring brain
health, folic acid jointly with vitamin B12 are key components to halt metabolic processes generating homocysteine, a neurotoxic activity. High homocysteine
anaemia in patients is an important risk factor for cognitive deterioration. Moreover, vitamin B12 has a synthesis which decreases in the brain as people begin
to age so it is advisable to supplement it.

www.alzheimer-herbs.com: Memory boosting & cognition
enhancing herbs. Protects against degenerative brain
diseases Try it if AD runs in your family.

Himalayan Mountains
This invention relates to shilajit compositions, and particularly to purified shilajit compositions obtained from native shilajit, which compositions have an
abundance of defined bio-active constituents and are devoid of toxic components, and to personal care, pharmaceutical and nutritional use formulations thereof.

2. Description of the Prior Art
Rejuvenating changes in one's body can be initiated and effected by nutrition, herbs and herbo-minerals. Aging and its associated problems are a degenerative
disease, which, however, is preventable and treatable. The aging process involves the action of highly reactive free radicals, produced systemically, which
interact with other cellular compounds and produce oxidative damages and eventually kills cells and tissues and impairs the immune function of the organism.
Such free radical damage accumulates and increases with age, creating degenerative diseases, such as Alzheimer's, cardiovascular, arthritis, cancer and over
a hundred other diseases.
DNA, the cellular building block of the body, is very sensitive to oxidative stress. Although repairs to damaged DNA are constantly being made, the cell's
mechanism cannot keep up with the number of mutations that occur in the organism, particularly in the aged. Mitochondria, the part of the cell that is
responsible for producing cellular energy, has its own DNA, but it does not have a repair mechanism to give it protection against free radical induced damage.
The mutation of mitochondrial DNA therefore produces a greater adverse effect than DNA mutation elsewhere in the system. Researchers in recent years have
shown that certain individual natural supplements, such as omega-3-polyunsaturated fatty acids and metabolites thereof, oxygenated dibenzo-?-pyrones, and
their O-acylesters, as well as hydroxyacetophenones and (?-lipoic acids, can protect against oxidative damage to mitochondrial DNA.

Accordingly, it is desired in this invention to provide a purified composition of bioactive agents to protect the body against free radical damage.

Native shilajit is a blackish-brown exudation, of variable consistencies, obtained from steep rocks of different formations found in the Himalayas at altitudes
between 1000-5000 m, from Arunachal Pradesh in the East, to Kashmir in the West. Shilajit also is found in other mountain ranges of the world, e.g.
Afganisthan (Hindukush, Badakh-Shan), Australia (Northern Pollock Ranges), and in the former USSR (Tien-Shan, Pamir, Caucasus, Ural). Native shilajit is
believed to arrest aging and also produce rejuvenation, two important attributes of an Ayurvedic rasayan medicine. Considerable controversy, however, has
existed in the literature concerning the nature and chemical character of shilajit. It has been variously described as a bitumen (asphalt), a mineral resin, a plant
fossil, a substance of mixed plant and animal origin, or an inorganic substance.
Generally, native shilajit contains two classes of organic compounds, namely, (a) humic substances and (b) non-humic organic metabolites. Humic substances
are the the major organic constituents of native shilajit, present in an amount of about 80-85% therein, and have molecular weights ranging from several
thousands for humic acids (HAs), and up to several million for polymeric humins (HMs), to only a few hundred for its fulvic acid (FAs) component. These
substances also are found in soils and sediments distributed over the earth's surface, occurring in almost all terrestrial and aquatic environments. Humic
substances are produced by the interactions of plants, algae, and mosses (bryophtes), with microorganisms, by a process known as humification. Humification
of latex- and resin-bearing plants is primarily responsible for the production of the water-soluble humic substances.

The non-humic substances of shilajit are low molecular weight (Mw) compounds of plant and microbial origin, occurring in and around shilajit bearing rocks. The
remaining non-humic organic masses in shilajit comprise a mixture of low Mw aromatic, aliphatic alicyclic, and heterocyclic (N- and S-containing) compounds.
Of particular biological interest are low Mw oxygenated dibenzo-?-pyrones (DBP) and hydroxyacetophenones (HAPs).

The biological effects of shilajit are believed to be due to the two distinct classes of bioactive compounds: (i) DBPs, both mono- and bis-compounds thereof, in
free and metal-ion conjugated forms; and (ii) fulvic acids (FAs) from shilajit-humic substances, which function as a carrier for the bioactive DBPs. However,
native shilajit rhizospheres from different origins suffer from the presence of only small amounts of (i) and (ii) therein. Large amounts of contaminants, e.g. high
Mw polymeric quinones, humins (HMs), and inorganic substances are present. Furthermore, shilajit rhizospheres are always heavily infested at its periphery
with a large array of microorganisms, some of which are producers of mycotoxins. Thus, the potential risk of ingesting shilajit in its native form, or only after
rudimentary purification, with no control or defined standards, is quite apparent.

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Preparing purified shilajit composition from native shilajit. A purified shilajit composition is provided herein from native shilajit. The composition has an
abundance of bioactive components, particularly, at least 0.3%, preferably 0.4-1%, by weight, oxygenated dibenzo-pyrones and at least 60%, preferably 65-
70%, by weight of fulvic acids of low-to-medium molecular weight ({overscore (M)}n of 700-2000) with an E4/E6 ratio of 8-10 at ?465-665 nm, and whose 2%
aqueous solution has a pH of 7.

1. A purified shilajit composition comprising: (a) at least 0.3% by weight of bioactive oxygenated dibenzo-?-pyrones (DBPs), or their esters; present as
monomer, dimer and/or tetramers, including free and metal-ion conjugate forms thereof, and (b) fulvic acids of low-to-medium molecular weight, Mn 700-2000,
having an E4/E6 absorption ratio of 8 to 10 at ?465/665 nm which ensure the bioavailability of DBPs by acting as an efficient carrier for the DBPs.

2. A composition according to claim 1 further including about 0.1 to 0.4% of ?-polyunsaturated fatty acids; 0.1-0.4 of a mono- or di-hydroxyacetophenone, or
C16-C22 acid esters thereof, and 0.05 to 0.3% of ?-lipoic acid.
3. A composition according to claim 1 further including about 3-12% of benzoic acid, or m-hydroxy benzoic acid, or C16-C22 alcohol esters thereof, and about
0.5-1% of —N and —S heterocyclic and other aromatic compounds.
4. A composition according to claim 1 wherein: (a) is a methanol soluble 3-OH or 3, 8 (OH)2 DBP derivative, or a C16-C22 ester thereof; and (b) is a water
soluble fulvic acid.
5. A composition according to claim 1 whose 2% aqueous solution has a pH of >7.

6. A composition according to claim 1 wherein (a) is present in an amount of about 0.4 to 1%, and (b) is present in an amount of about at least 60%.

7. A personal care, pharmaceutical or nutritional formulation comprising the composition of claim 1 present therein in an amount of about 0.1 to 60% by weight.

8. A skin care or protection formulation according to claim 7 in the form of a lotion, cream or gel, wherein said composition is present in an amount of about
0.1-5%.

9. A pharmaceutical formulation according to claim 7 in the form of a tablet, syrup, elixir or capsule.
10. A nutritional formulation according to claim 7 which contains about 0.5 to 30% of said composition.

11. A skin care or protection formulation according to claim 7 which additionally contains a cosmetically acceptable carrier and at least one cosmetic adjuvant
selected from the group of sunscreens, antioxidants, preservatives, perfumes, oils, waxes, propellants, waterproofing agents, emulsifiers, thickeners,
humectants and emollients.

12. A composition according to claim 1 in which humic acid, humins and polymeric quinones are substantially absent therein.

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Purified shilajit composition, without toxic components, obtained by extraction of native shilajit whose biologically active components are present in weight
amounts of:

(a) at least 0.3%, preferably 0.4-1%, of an oxygenated dibenzo-?-pryone (DBP), its di- and/or tetramers, and their esters; and
(b) at least 60%, preferably 65-70%, of low-to-medium molecular weight Mw(Mn) fulvic acids (FAs), ({overscore (M)}n is a number average molecular weight),
having an E4/E6 absorption ratio of 8 to 10 at ?465/665 nm.

The purified shilajit of the invention includes (a) mono- or di-hydroxy or tetrameric dibenzo-?-pyrones (DBP) and (b) fulvic acids (FAs) which repeat units having
the formula: embedded image
The methanol soluble portion of the purified shilajit composition also includes 0.1-0.5% 3-OH dibenzo-?-pyrone; 0.3-1.5% 3,8-diOH dibenzo-?-pyrone; 0.001-
0.1% eicosapentaenoic acid; 0.005-0.01% docosapentaenoic acid; 0.01-0.3% docosahexaenoic acid; 0.1-0.2% 2-hydroxyacetophenone; 0.01-0.2% 2,4-
dihydroxyacetophenone and 0.05-0.3% ?-lipoic acid.

The composition of the invention finds particular application in personal care, pharmaceutical and nutritional use formulations, suitably at a use level of 0.1 to
60% by weight of the composition, preferably about 0.2 to 10% in personal care formulations.

The purified shilajit compositions of the invention are obtained by an extraction procedure from native shilajit rock exdudate, as follows:

(a) powdering native shilajit exdudate and dissolving it in water as solvent,
(b) filtering the mixture to remove insoluble substances,
(c) evaporating water from the filtrate to obtain a brown viscous residue,
(d) extracting the residue with a hot organic solvent, e.g. methanol, to obtain both a soluble fraction which includes low Mw bioactive phenolic compounds
particularly oxygenated dibenzo-?-pyrones, and insoluble shilajit humic substances,
(e) adding dilute aqueous NaOH to the insoluble shilajit humic portion to precipitate polymeric quinones,
(f) acidifying the filtrate below a pH of about 3 to precipitate humic acids leaving a brown acidic solution of fulvic acids,
(g) fractionating said acidic solution by passing it over activated carbon to provide a solution of low-to-medium Mw fulvic acids,
(h) passing the fulvic acid solution through a H+ ion-exchange resin to concentrate the fulvic acids in solution,
(i) evaporating the solution, and
(j) combining the low-to-medium Mwfulvic acids Mw 700-2000, with the low Mw bioactive phenolic compounds in a suitable proportion, e.g. 9:1 by weight.

Standardization of purified shilajit compositions is controlled analytically so that the composition contains (a) at least 0.3%, preferably 0.4-1%, of oxygenated
dibenzo-?-pyrones including mono- and dimers of 3,8-dihydroxydibenzo-?-pyrones (in free and metal ion conjugated forms) (by HPLC analysis, chemical
analysis); (b) low-to-medium Mw fulvic acids (Mw 700-2000) in an amount of at least 60%, preferably 65-70% (HPTLC E4/E6 analysis at different pH levels;
range 8-10, preferably 9-10; and electron spin resonance spectroscopy); and with metal ions (Fe (II/III), Cu(II) and Zn (II) and Mg(II) ions in conjugated forms of
(3-5%).

The 2% aqueous solution of the composition of the invention has a pH ?7. A low pH indicates the presence of substantial amounts of humic acid, humins and
polymeric humus, which, accordingly, are essentially absent herein.

The thus-obtained purified shilajit composition according to the invention has the relative abundance of bioactive constituents

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Russian mumie for improving bone-growth and treating osteoporosis. The extract of Russian Mumie may be used alone as an active ingredient or in
appropriate association, as well as in combination with other pharmaceutically active compounds or pharmaceutically acceptable additives. The inventive
composition for improving bone-growth and treating osteoporosis can be prepared with the mixture of the extract of Russian mumie and pharmaceutically
acceptable inactive carrier in clinical treatment and used for therapeutics and health care food. Russian mumie can be classified with Indian mumie found in
Afghanistan, Bhutan, China, Nepal, Pakistan, Tibet etc. and Russian mumie found in Kirgysia, Tajikistan, Uzbekistan, Kazakhstan, Norway and the former
USSR area i. e. , Ural, Baykal, Sayan, Caucasus and Altai Mountains regions, and found in a small quantities from steep rock faces at altitude between 1000
to 5000 meters (Ghosal et al., The core structure of Shiajet humus, Soil Biology Biochem., 23, pp673-680,1991 ; The need for formulation of Shilajit by its
isolated active constituents, Phytother Res., 5, pp211-216, 1991).
Russian mumie is a semi-hard, brownish black to dark, greasy, black resin that has a distinctive coniferous smell and bitter taste and formed due to the long-
term humification of Euphorbia and Triforium (clover) plants
Mumie has been used to treat dermatitis, nervous system disease, inflammation, scar and facial paralysis as a folk medicine. Mumie are the medicine means
of Tibetan medicine, Med. G. Uzbek., 8, pp80- 84, 1964) and known to be useful as a rejuvenator. H. , Mumie and its medicinal properties, ppl-220 Dushanbe,
Russia, 1997).There is experimental evidence that active chemical constituents of Mumie consist of organic components and inorganic components, in which
exemplary organic components are fulvic acid and humic acid frequently found in humus genus plants together with resinous acids and naphthenic acids and
inorganic components are Ca, K, Mg, Fe and etc (Kozlovskaia V. I. Treatment of peripheral nervous system disease with Caucasian Mumie, Vrach Delo, 6,
pp88-92, 1968).However, there has been no report on the osteoporosis treating effects of Russian Mumie till now.
Accordingly, present inventors have endeavored to study on the function of Russian Mumie in osteoblast, finally found their effects on bone growth stimulation
and accomplished present invention.
DISCLOSURE OF THE INVENTION Accordingly, it is object of the present invention to provide a pharmaceutical composition comprising Russian Mumie
extract and a pharmaceutically acceptable carrier for stimulating bone growth, preventing and treating osteoporosis.Inventive present composition for stimulating
bone growth, preventing and treating osteoporosis, contains 0.5 to 50 w/w% dried Russian Mumie extract among the total weight of present composition.It is
another object of the present invention to provide a use of above Russian Mumie extract for the preparation of pharmaceutical composition for stimulating bone
growth, preventing and treating osteoporosis.
An inventive Russian Mumie extract may be prepared in accordance with the following procedure.
For example, dried Russian Mumie is pulverized or crushed by various pulverizer to obtain the extracting material thereof. The material is mixed with 1 to 5-fold
volume of water, lower alcohols such as methanol, ethanol and the like, or the mixtures thereof, preferably, with an mix ratio of 1: 1 to 3: 1; and is subjected to
sonification extraction, reflux extraction or extraction at R. T. or a temperature ranging from 60 to 90°C to obtain a crude extract; the crude extract is
centrifuged, filtered and then lyophilized to obtain an extract powder.The extract prepared by above process can be subject to various sephadex column
chromatography using porous resin column chromatography such as Sephacryl S-300, Sephadex G-50, Sephadex G-5 and the like to obtain further purified
fractions and if necessary, to additional fractionation process by conventional fractionation methods known in the art (Harborne J. B.
It is another object of the present study is to to provide a pharmaceutical composition comprising the purified fractions prepared by above described additional
purification method and a pharmaceutically acceptable carrier for stimulating bone growth, preventing and treating osteoporosis.
Above described extract promotes the proliferation and differentiation of osteoblast and collagen synthesis, which shows the stimulating effect of bone growth,
preventing and treating effect of osteoporosis.

It is another object of the present study to provide a method for promoting of bone growth or preventing and treating osteoporosis in human or
mammal comprising administering a pharmaceutically effective amount of above described extract for treating said human or mammal disease.
It is still another object of the present study to provide health care food comprising above described extract and a sitologically acceptable additive for
stimulating bone growth, preventing and treating osteoporosis.
It is an object of the present invention to provide a use of Russian Mumie extract for the preparation of pharmaceutical composition for stimulating bone growth,
preventing and treating osteoporosis.
Inventive composition can contains not only above-described extract but also other substances or their derivatives having similar function to the extract, and
additionally contains other active ingredients if necessary.
A pharmaceutical formulation may be prepared by using the composition in accordance with any of the conventional procedures. In preparing the formulation,
the active ingredient is preferably admixed or diluted with a carrier or enclosed within a carrier, which may be in the form of a capsule, sachet or other
container. When the carrier serves as a diluent, it may be a solid, semi-solid or liquid material acting as a vehicle, excipient or medium for the active ingredient.

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Shilajit extract obtained by purifying the bioactive fractions of Shilajit. The bioactive fractions of Shilajit include 0. 3% by weight of oxygenated dibenzo-a-
pyrones and 60% by weight of low-molecular weight fulvic acid. A method of obtaining such bioactive fractions of Shilajit is disclosed in US Patent No. 6,440,
436 in detail. The inventive composition has the activity of enhancing the metabolic function of the entire human body so as to improve sexual function and to
enhance reproductive function. The administration of the inventive composition to adult men for a given period increases erection number and lengthens erection
maintenance time. Thus, the inventive composition will be useful as foods or drugs for the improvement of sexual function or the strengthening of reproductive
function. Also, the inventive composition is derived from natural substances, used in Himalayan region encompassing India, China, Tibet and parts of Central
Asia for a long time and thus, advantageous in that it has secured safety and little or no side effects. Generally, the causes of male infertility include semen or
sperm abnormalities, sperm transport disorders, and aspermia. Among such causes, more than a half are spermatogenesis disorder caused by the disorder of
testis function of making sperms, and the abnormality of sperm components. The causes of female infertility are very various, and it is not easy to find these
causes. Typical causes include the interruption of tubal patency, and ovulation disorders, such as amenorrhoea, anovulatory menstruation, and sporadic
anovulatory disorders. The administration of the inventive composition to white rats causes a remarkable increase in the sperm number of the testes and
epididymides of the white rats for males, and shortens the diestrus stage in estrous cycles of the white rats for females. Thus, the inventive composition may
be effectively used to treat male infertility caused by sperm deficiency or to treat female infertility caused by ovulation abnormalities. The inventive composition
may be contained in the desired product at 1-100 parts by weight based on the total weight of the desired product. The composition may additionally contain at
least one hygienically or pharmaceutically acceptable carrier and may be formulated with the carrier into foods or drugs. Examples of the carrier include, but
are not limited to, saline, buffered saline, water, glycerol and ethanol. In addition, any carrier known in the art may be used. The inventive pharmaceutical
composition prepared by the conventional method as described above may be orally administered, and used in the form of general medicine formulations. The
inventive composition may be formulated with generally used diluents or excipients, such as fillers, extenders, binders, wetting agents, disintegrants and
surfactants. The dose of the pharmaceutical composition may vary depending on the age, sex and condition of a subject, the in vivo absorption rate, inactivation
rate and excretion rate of the active ingredient, and the kind of a drug used in combination. The composition may be orally administered at a daily dose of, for
example, but not limited to, 1-10 g. Solid formulations for oral administration include tablets, pills, powders, granules and capsules, and liquid formulations for
oral administration include suspensions, internal solutions, emulsions, and syrups. These liquid formulations may contain various excipients such as wetting
agents, sweeteners, aromatics, and preservatives in addition to generally used simple diluents such as water and liquid paraffin.
[Preferred Embodiments) The present invention will hereinafter be described in further detail by examples.

It will however be obvious to a person skilled in the art that the present invention is not limited to or by the examples, and various variations and modifications to
these examples are possible within the scope of the present invention as set forth in the claims.

Example 1 1.25 g of Shilajit (Ayurvedic industry, Dolpa, Nepal) was dissolved in 100 ml of purified water so as to prepare an aqueous suspension.

Example 2 2.50 g of Shilajit was dissolved in 100 ml of purified water so as to prepare an aqueous suspension.

Example 3 5.00 g of Shilajit was dissolved in 100 ml of purified water so as to prepare an aqueous suspension.
Test Example 1: Measurement of change in organ weight of male white rats Six-weeks-old Sprague Dawley male white rats (Samyook Animal, Kyungki
province, Korea) were divided into a control group, group 1, group 2 and group 3, each group consisting of 6 animals and administered Shilajit after adaptation
to circumstance for a week. The aqueous suspensions prepared in Examples 1-3 were administered to the animal groups at doses of 0 mg Shilajit/kg body
weight (control group), 25 mg Shilajit/kg body weight (group 1), 50 mg Shilajit/kg body weight (group 2) and 100 mg Shilajit/kg body weight (group 3), for 6
weeks.
After 6 weeks of the administration, the white rats were anesthetized with ether, and each of the animal organs (i. e. , heart, kidneys, spleen, liver, brain, testes
and epididymides) was taken out and weighed. The weight of each of the organs was calculated as a weight percentage to body weight, and the results are
shown in Table 1 below.
Table 1: Weight of each organ of white rats (weight percentage; g (%)) g (%) Body Liver SpIeen Kidney Heart Brain Left Right Left Right weighttestis testis
epididymisepididymis Control Mean 445. 670 4.418 0.279 0.876 0.350 0.507 0.422 0.423 0. 130 0.127 group SD. (i) 27. 330 0.598 0.024 0.098 0.043 0.051
0.034 0.031 0.009 0.009 Group I Mean 440.750 4.105 0.248 0.791 0.300 0.464 0.388 0.395 0.128 0.127 S. D. (i) 24.076 0.447 0.028 0.091 0.015 0.037 0.030
0.036 0.013 0. 012 Group 2 Mean 457. 857 4.226 0. 209 0. 785 0.314 0.459 0.372 0. 377 0.121 0.127 S. D. () 22.520 0. 391 0.015 0.083 0.027 0.020 0.029
0.023 0.008 0.012 Group 3 Mean 445.000 3.955 0.249 0.743 0.332 0.464 0.390 0.399 0.131 0.134 S. D. (). 31. 282 0. 352 0. 043 0.089 0.049 0.025 0.040
0.037 0.018 0.012
As can be seen in Table 1, all the test groups administered with Shilajit did not show a significant difference in the weight of each organ.

Test Example 2: Measurement of sperm number of male white rats Testes and epididymides obtained in Test Example 1 were collected separately and
measured for sperm number. For the testes, tunica albuginea was removed and the remaining tissue was put in a 50-ml centrifuge tube into which 5 ml of 0.9%
saline was put. Then, the tissue was homogenized with a homogenizer two times for 30 seconds each time and treated with an ultrasonic cleaner for 3
minutes.

Then, the homogenate was diluted to a suitable concentration, and 10 PI of the dilution was placed on hemocytometer, and covered with a cover glass, and
then measured for sperm number with an optical microscope.
For the epididymides, they were cut into small pieces with scissors and placed in a 50-ml centrifuge tube, and 3 ml of 0.9% saline was added to the tissue.
The tissue solution was homogenized with a homogenizer three or four times for 30 seconds each time, and the homogenate was diluted to a suitable
concentration. 10 ptl of the dilution was measured for sperm number in the same manner as described above.
Table 2: Measurement of sperm number of testes Testis weight (g) Sperm number/g Sperm number/day /rat Control group 3.428 15490536 4518826 740791
Group 1 3. 445 15665179 4547222 745446 Group 2 3. 421 18153365 5306450 869910 Group 3 3. 496 20156693 5765645 945188 Table 3: Measurement of
sperm number of epididymides Epididymis weight Total sperm number Sperm number/g Sperm number/day (g) /rat Control group 1. 173 19677159 16775072
2750012 Group 1 1. 121 22131046 19742236 3236432 Group 2 1. 138 48476455 42597940 6983269 roup 3 1.175 74201330 63150068 10352470 As can be
seen in Tables 2 and 3, all the animal groups administered with Shilajit showed an increase in the sperm number of both the testes and the epididymides in
proportion to the dose of Shilajit, as compared with the control group. Particularly, the animal group administered with 100 mg of Shilajit showed a significant

increase in sperm number as compared with the control group (P<0.05, ANOVA test).

Test Example 3: Test on ovulation effect in female white rats In this test, 27 female white rats (Samyook Animal, Kyungkido, Korea) were divided into a control
group and two test groups, each group consisting of 9 animals.
The aqueous suspensions of Examples 1 and 3 were administered to the animal groups at doses of 0 mg Shilajit/kg body weight (control group), 25 mg
Shilajit/kg body weight, and 100 mg Shilajit/kg body weight.
After 6 weeks of the administration, the estrous cycle of each of the test animals was checked, and the oviducts of white rats showing estrus stage were
detatched and counted the ova number. The results are shown in Table 5 below. The estrous cycle was determined according to the Rugh's method, the vaginal
smears of female white rats were collected with cotton swabs, and applied on a slide glass, and then observed under an optical microscope (Nikon YS 100,
Japan). The classification of estrous cycles was determined by three main cell types, i. e., leukocytes, epithelial cells and comified epithelial cells, and the
characteristic of each estrous cycle, as shown in Table 4 below.
Table 4: Microscopic characteristics of vaginal smears according to estrous cycles of female white rats Cycle Period (day) Microscopic characteristics of
vaginal smears Diestrus 1-3 Only leukocytes are observed Proestrus Leukocytes and nucleated epithelial cells are observed Early estrus 0. 5-1 Epithelial cells
and slightly comified cells also exist Estrus 0. 5-1 Only cornified cells are observed Metestms l Leukocytes and cornified cells are observed Table 5: Number of
ovulation-induced white rats and ova number thereof Shilajit dose Day I Day 2 Day 3 Day 4 Day 5 Number of ovulation-induced Control 019 1/9 ln 1J6 O16
animals (per number of test 25 mg 1/9 1/8 0/7 0/6 0/6 animals) 100 mg 4/9 2/5 113 0/2 0/2 Control 0 9 10 15 0 Ova number (per rat) 25 mg 12 8 0 0 0 100 m
11. 75 14 16 0 0 As can be seen in Table 5, the 25-mg dose group showed no significant difference in the number of ovulation-induced rat from the control
group, but the 1 00-mg dose group showed a significant increase in the number of white rats in estrus. In the test results of this Test Example, for each of the
control group and the low- dose group, the number of white rats in estrus stage at least a day of 5 days was only 2-3 of 9 animals. However, for the 100-mg
dose group, the number of white rats in estrus stage at least a day of 5 days was 7, which is two to three times more than that of the control group. Thus, it
was considered that the administration of Shilajit shortens the diestrus stage, thus increasing ovulation frequency. In the results of actual observation, the
number of ovulation-induced rat in the 100-mg dose group was more than those of the control group and the low-dose group. Test Example 4: Test on sexual
function improvement Seven 30-to 50-year-old male volunteers were collected and administered orally with the composition of Example 3 for 3 weeks. Then, a
five-question survey relating to sexual desire cycle, erection degree, erection maintenance time, erection number and ejaculation success was conducted on
the volunteers. The results are shown in Table 6 below.
Table 6: Effects on sexual function of adult men Individual 1 2 3 4 5 6 7 Drugdosage Be AfBe Af Be Af Be Af Be Af Be Af Be Af Sexual desire Everyday o o o o
cycle 1-3 days o o o 0 0 One week # # # 0Complete erection # # # Erection Moderate o o o o o o o o o o o Not complete Erection Remarkabl im roved o
maintenance improved 0 0 # 0 0 time Similar to before dosage # Complete Yes # # # # # # # # ejaculation No # # # # # # Erection Less than one time # # # # #
# # number (in Two times # # # # # # ejaculation No 0 0 0 0 0 o Erection Less than one time # # # # # # # number (in Two times # # # # # # one sexual More
than three times o intercourse) Be: before Af After
As can be seen in Table 6,6 of 7 volunteers answered that the erection maintenance time lengthened and the erection number in one sexual intercourse
increased.
This indicates that the erection maintenance time and the erection number were generally increased. In the results of the answer survey on erection degree, 2
of 7 volunteers answered that the erection degree was improved. Also, 2 of 5 persons who have not reached complete ejaculation answered that ejaculation
was improved.
In the question on sexual desire cycle, there was no discrimination, since persons showing a shortening in the sexual desire cycle, persons showing a slight
lengthening, and persons showing little or no change, were present together. Such results suggest that there is no linear correlation between sexual function
and sexual desire.
Accordingly, the results of this Test Example showed that the inventive composition had at least some effects on the improvement of sexual function in all the 7
test volunteers, although there was a difference in the degree of the effects. From such results, it is believed that the long-term application of the composition
will induce complete ejaculation, thus increasing sexual satisfaction.
[Industrial Applicabilityl As described above, the composition according to the present invention has the activity of enhancing the metabolic function of the
entire human body so as to improve sexual function and to strengthen reproductive function. Thus, the inventive composition will be useful as health foods or
drugs for improving sexual function.

Moreover, the Shilajit composition significantly increases the sperm number of testes and epididymides without having any special effects on other organs, so
that the inventive composition will be useful as an agent for the treatment of male infertility. For women, the inventive composition may increase ovulation
induction so that it will be useful as an agent for treating the infertility of patients with reduced ovulation rate.

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Novel use of Shilajit or the extract thereof. Composition containing Shilajit or the extract thereof, which has the activity of enhancing the metabolic function of
the entire body, resulting in an improvement in sexual function and an increase in reproductive function, and thus has effects on nutritional tonic, sexual
function improvement, infertility treatment, and the like. Shilajit (botanical name: Asphaltum), also known as mineral pitch, is a natural exudate oozed from
rocks during hot weather in the lower Himalayas, Vindhya and other mountain tracts. Shilajit is a compact mass of vegetable organic matter, composed of a
gummy matrix interspersed with vegetable fibers and minerals. Shilajit is known to include moisture, gums, albuminoids, calcium, potassium, nitrogen, silica,
resin, vegetable matter, magnesium, sulphur, iron, chloride, phosphorous, iodine, glycosides, tannic acid, benzoic acid, vitamins and enzymes.

Meanwhile, in countries around the Himalayas, Shilajit has been traditionally used for general physical strengthening, anti-aging, blood sugar stabilization,
injury healing, enhanced brain functioning potency, bone density increase, immune system strengthening, arthritis treatment, and hypertension treatment.
Research reports discloses that the addition of Shilajit or the extract thereof to a vitamin/mineral preparation has the effect of increasing the energetic
properties of the vitamin/mineral preparation. More research reports disclose a method of purifying bioactive components of Shilajit. Also, this report discloses
that the Shilajit extract purified by this method may be used as a skin care and protection formulation or a pharmaceutical or nutritional formulation. The Shilajit
composition disclosed in the patent contains, as biologically active components, 0.3% by weight of oxygenated dibenzo-a-pyrone and 60% by weight of low-
molecular weight fulvic acid. The literatures mentioned in this specification is incorporated herein by reference in its entirety.

The present inventors have conducted studies on screening of natural substances having the effects of restoring physical reproductive function and treating
impotency, infertility, etc. , without side effects, and consequently found that the administration of Shilajit to human beings shows an improvement in sexual
function, and the administration of Shilajit to white rats shows an increase in sperm number for males and a shortening the diestrus stage in estrous cycle for
females, thereby completing the present invention.

Shilajit composition containing natural substances, which can be used in restoring physical reproductive function and treating infertility, etc., without side
effects.
To achieve the above object, the present invention provides a composition for the improvement of sexual function or the strengthening of reproductive function,
which contains Silajit or the extract thereof.
Also, the present invention provides a composition for the treatment of infertility, which contains Shilajit or the extract thereof Hereinafter, the present invention
will be described in detail.
The present invention provides a composition containing Shilajit or the extract thereof.
Specifically, Shilajit, which is a natural exudate oozed from rocks in the lower Himalayas, etc. , is a blackish-brown liquid. Thus, it is commercially available in
a liquid form or a blackish-brown solid form resulted from drying of the liquid form. The composition according to the present invention may contain
commercially available solid Shilajit in the form of powders or granules or in the form of a dilution in water. Moreover, the inventive composition may contain a
Shilajit extract. The extract according to the present invention may be a conventional water extract or a crude extract prepared by a solvent extract method
using alcohol as a solvent. Also, the extract may be fraction extracts purified by column chromatography. The extract preparation method according to the
present invention may be any extraction method known to a person having ordinary skill in the art. Examples of the extraction method include, but art not
limited to, extraction with water, alcohol or mixed solvent, extraction with a bath or at ambient temperature.

Preferably, the inventive composition contains a Shilajit extract obtained by purifying the bioactive fractions of Shilajit. The bioactive fractions of Shilajit include
0. 3% by weight of oxygenated dibenzo-a-pyrones and 60% by weight of low-molecular weight fulvic acid.

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What is Shilajit? Where it is found?
Shilajit which is sometimes also pronounced as shilajeet or silajit or shilajitu is a thick mineral pitch found in the higher altitudes of mountains. Shilajit is a pale
brownish to blackish brownish exudation of varying constituents found worldwide in sedimentary rocks of mountains. During summer months when the weather
is hot in the mountains shilajit oozes out of the rocks. In India shilajeet is found in Himalayan mountains bordering Arunachal Pradesh to Kashmir and from
Tibet and to Nepal. In Russia this mineral pitch is found in caucasian mountains, Ural mountains, Altai mountains (bordering Mongolia and Kazakhstan) and in
China Shilajith is found in Yunann mountains and Kunming stone forest. The name Shilajit in sanskrit is split as "shila' meaning rock and "jeet" meaning
victory literally meaning "winner of the rocks". In other local terms it is known as "Mountain sweat" "mountain blood" "shilaras - rock juice", "vajikaran -
aphrodisiac" etc. In scientific texts it is known as Asphaltum Punjabinum. The yogis of India say that Shilajit makes the human body like a rock making it
withstand the decay and destruction that comes with time and disease.

How is shilajeet formed?
Shilajeet is basically a concentration of plant life. The mountains around the world and particularly Himalayan mountain were home to rich vegetation and plant
life. After their time the vegetation died and the nutrients were returned back to earth. These decayed plant life under the specific climatic conditions of the
mountains and over hundreds of years formed the thick mineral pitch which is known as shilajit. the source of Shilajith is historic plant life. The formation of
various nutrients in shilajit particularly fulvic acid and the ionic minerals (which are easily absorbed by body cells) make silajit truly a wonder health
supplement.

Discovery of Shilajit
In modern times Shilajit was discovered by British explorers in Himalayan mountains sometime around 1860's. They found the monkeys in the Himalayan
regions eating some substance from the rocks. It was later found to be shilajit. It was also noted that the monkeys in the Himalayan region seemed to age very
slowly as was noted from their skin texture and hair as compared to normal monkeys.

Purification of Silajit
The raw shilajit mined form the rocks cannot be taken as such. Traditional purification of shilajit as done by ayurvedic doctors was to water wash the raw shilajit
several times and filtered to remove the water insoluble impurities. the filtrate is concentrated by direct heating by fire or by keeping the filtrate under direct
sunlight. The creamy layer which is thus formed in the heating process is skimmed several times to get pure shilajit. However modern methods of shilajit
purification used advanced techniques of pulsated water cleansing, reverse osmosis (separating shilajit through semi permeable membrane) , vaccum filtration
and freeze drying. In free drying the moisture and water contents are separated from shilajit at a lower temperature itself. Subjecting shilajit to higher
temperature during purification process could destroy some of the nutrients. the modern purification methods take this into consideration and uses freeze
drying process.

Shilajits odor and taste
Raw Shilajit as such does not seem to have any fixed taste or odor. It depends on the place where it is harvested. Raw shilajit could have salty or pungent
taste. However when purified could be odorless and tasteless.

Shilajits constituents
Shilajit was found to contain fulvic acid, humic acid, albuminoids, Di benzo alpha pyrones, chemo proteins, macro minerals like potassium, chlorine, sodium,
calcium, phosphorous, magnesium, zinc, iron, manganese, copper iodine, selenium, moybdenum, sulfur, cobalt, nickel, chromium, fluorine, boron, strontium,
silicon, vanadium etc. These minerals are in ionic form. These minerals have already been absorbed and assimilated by rich vegetation and plant life. They
have been returned back to earth after their time. These minerals in shilajit have high bio availability and are easily absorbable by body cells. Many of these
minerals are found in trace quantities in parts per billion range. Though these trace minerals like chromium, vanadium etc. are not used directly by the body
they are vital for many biochemical processes in the body. They act as a catalysts for various types of enzyme formation. Fulvic acid is another major
constant of shilajit. It is found in humus in the soil. It's main function is to transport the nutrients particular minerals to the plants from the soil. In mammals
fulvic acid plays the main role of transporting the minerals deep into the cells. Fulvic acid seems to have that unique capacity to dilate and permeate the thick
cell walls so as to transmit the minerals into the cells.

Benefits of Shilajeet
Shilajit is traditionally used as a panacea for many illnesses in the Ayurvedic system of medicines. It is specifically advised by the traditional ayurvedic and
yogic practitioners to boost stamina, vigor, energy levels, vitality, immunity and to prolong life. The Ayurvedic medical practitioners called shilajit as the
Maharasa or super vitalizer. The yogis of India attributed Shilajit to many magical and mystical properties. On seeing the way shilajit helped people they termed
it as an Amrit or nectar (elixir) of long and healthy life. Ancient Indian texts as old as 2000 years mention of shilajit. Some of the ailments where Shilajit was
recommended by ayurvedic doctors for the treatment of diabetes, anemia, wound healing, allergic disorders, hemorrhoids, spleen enlargement, liver diseases,
epilepsy, renal calculi, gastro intestinal disorders, sexual dysfunction, prostate hypertrophy, genito urinary disorders, debility (physical and cerebral) and
geriatric problems. There has been a couple research reports done as recent as 2010 which shows that Shilajit could be beneficial in the management of
Alzheimer's disease and even HIV infection.

Shilajit as Mumiyo or Moomio
Though Shilajit was predominately used by Indian ayurvedic practitioners and yogis there are many substances which are similar to shilajit (i.e.) mineral
pitches found in mountains. Such substance was Myemu in Russia, mummie in Germany, mumio or momio in Persia (Iran) and Hajar -ul- musa in Arabic. It
was said that the legendary invader Chengiz Khan used to take mumio for himself and the top leaders of his army used it. In Russia it is known as Mumiyo or
Mumijo. It is found in the Altai mountains, parts of ural mountains and mountains bordering Iran Technically mumiyo and Shilajit could be similar. Mumiyo was
widely used by Russian army operating in extreme climates. Worldwide the popular name for this mountain mineral pitch is Shilajit. By Shilajit we refer to the
the mineral pitch found in Himalayan mountains.

Fulvic acid
Silajit has evoked great interest among scientists as many of the beneficial properties do seem to be true to some extent. Studies were done as early as
1920's to analyze the contents of Silajit. Shilajeet was found to contain as much as 80+ minerals in highly bioavailable ionic form, di benzo alpha pyrones and
Fulvic acid. The fulvic acid in shilajeet has evoked a lot of interest. Fulvic acid is a type of humic acid. Humic acid is a principal component of humic
substances, which are the major organic constituents of soil. It is formed by the bio degradation of dead organic matter. Humic acid is not a single acid but it is
a complex mixture of many different acids containing carboxyl and phenolate groups. While humic acid is the general term fulvic acids are essentially those

humic acids which are of lower molecular weight and higher oxygen content. Fulvic acids are poly-electrolytes and have an unique property to diffuse easily
through membranes. This property of fulvic acid is important as a nutrient because they are able to penetrate easily through the thick cell walls and transport
the nutrients. Fulvic acid is available only in nature and many attempts to artificially synthesise fulvic acid have failed.

Humic substances in soils and sediments can be divided into three main fractions: humic acids, fulvic acids, and humin. Humic substances are formed by the
microbial degradation of dead plant matter, such as lignin. They are very resistant to further bio degradation. The precise properties and structure of a given
humic substance sample depend on variety of conditions including location, climate, altitude, age, method of extraction etc.. Nevertheless, the average
properties of humic substances from different sources are remarkably similar. There are functional differences between humic acids, humins and fulvic acids.
Humin is insoluble in dilute alkali. Gray humic acids (GHA) are soluble in low-ionic-strength alkaline media; brown humic acids (BHA) are soluble in alkaline
conditions independent of ionic strength. But fulvic acids (FA) are soluble in all conditions independent of pH and I. This is another property of fulvic acid that
makes it very useful in mammals.

While fulvic acids can be extracted from various natural resources the fulvic acid in Himalayan shilajit is considered the best. It is because of several reasons
including the clean climatic conditions of himalayas, freezing low temperature, high altitudes, formation of humic substance over centuries, rich vegetation etc.
The processing of raw shilajeet to increase the concentration of fulvic acid is also very vital. Raw silajit when harvested could contain as little as 10% fulvic
acid. Modern processing methods are capable of increasing this concentration to as much as 60% using various chemical engineering techniques like water jet
pulsation, vacuum filtration, reverse osmosis, freeze drying (whereas water/moisture is evaporated at a much lower temperature itself), pulverizing etc. Shilajeet
is highly hygroscopic (i.e.) it will absorb large amount of moisture from air. Hence the processed shilajit which is in powdered is normally encapsulated. This
ensures the preservation of fulvic acid concentration.
While shilajit fulvic acid can be taken in any form taking it after meals along with milk seems to be the option. Milk can be cow or soy.

Himalayan Mountains

Himalayan Mountains
Shilajit is a compact mass of vegetable organic matter, composed of a gummy matrix interspersed with vegetable fibres and minerals. Substances which have
been identified in Shilajit include moisture, gums, albuminoids, calcium, potassium, nitrogen, silica, resin, vegetable matter, magnesium, sulphur, iron,
chloride, phosphorous, iodine, glycosides, tannic acid, benzoic acid and a number of vitamins and enzymes. The invention further relates to a method to
restore energetic balance or intensity, or to support or enhance a bioenergetic field in a mammal comprising administering to a mammal an effective amount of
Shilajit or an extract thereof. In the Eastern world, a compound known as Shilajit (silajit) has a history of use as a folk remedy for various disorders, including
genito-urinary diseases, diabetes, gall stones, jaundice, enlarged spleen, fermentative dyspepsia, worms, digestive disorders, piles, epilepsy, nervous
disorders, eczema, anaemia, anorexia, asthma etc. Shilajit has also been used as a tonic to help retain youthful vigour. Shilajit has been administered either
by itself or in combination with certain other ayurvedic (herbal) medicines.
Shilajit is a natural exudate ejected from rocks during hot weather in the lower Himalayas, Vindhya and other mountain tracts and Nepal, or it may be a tar
formed in the earth from the decomposition of vegetable substances. (See the Indian Materia Medica, pages 23 to 32 for a detailed discussion of the
composition and properties of Shilajit). It is a compact mass of vegetable organic matter, composed of a gummy matrix interspersed with vegetable fibres and
minerals. Substances which have been identified in Shilajit include moisture, gums, albuminoids, calcium, potassium, nitrogen, silica, resin, vegetable matter,
magnesium, sulphur, iron, chloride, phosphorous, iodine, glycosides, tannic acid, and a number of vitamins and enzymes. Shilajit also contains benzoic acid, a
compound which, along with its derivatives, has been used as a component of nutritional vitamin and mineral preparations.
The present study has found that Shilajit over and above its nutritional and herbal content has novel energetic properties. Measurement of subtle energy
changes indicate that Shilajit has a vibratory field that is substantially stronger than any vitamin, mineral, food substance or herb. Its vibratory field is also
stronger than the vibratory fields of any of the known ingredients which make up Shilajit, when these ingredients are tested as pure substances from non-
Shilajit sources. The present study has also surprisingly found that when a small amount of Shilajit is added to a vitamin or mineral preparation, the energetic
properties of the vitamin or mineral preparation are enhanced. In particular, the present study has found that the addition of a small amount of Shilajit to a
vitamin or mineral preparation increases the energy field of the entire preparation to at or near the vibratory level of pure Shilajit.
The addition of Shilajit to vitamin or mineral preparations imparts to the preparations an energetic quality above and beyond their nutritional content. As well, the
energetic quality of Shilajit-fortified vitamin and mineral preparations support or enhance a user's bioenergetic field. The present study therfore relates to the use
of Shilajit or extracts thereof in a vitamin and/or mineral preparation to enhance the energy properties of the preparation.
The study also relates to a composition comprising Shilajit or extracts thereof in a vitamin and/or mineral preparation. The study further relates to a method to
restore energetic balance or intensity, or to support or enhance a bioenergetic field in a mammal comprising administering to a mammal an effective amount of
Shilajit or extracts thereof. Preferably, the Shilajit or extract thereof is administered in a vitamin and/or mineral preparation.

Himalayan Mountains

Shilajit fulvic acid information

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