This document discusses herbal formulations and the challenges encountered in their development, including issues with safety, standardization, and quality control. It explores the detoxification process in Ayurveda, detailing methods to purify toxic substances while enhancing the medicinal properties of herbal ingredients. Various types of Ayurvedic formulations and their preparation methods, such as asava and arishta, are explained, emphasizing the historical context and traditional practices involved.

1. Herbal formulations
Ravish Yadav

2. Content
• Herbal formulation
• Challenges in herbal formulation
• Constrain in herbal formulation
• Ayurvedic formulations
• Concept of detoxification

3. Herbal formulation
• Herbal formulation shall mean a dosage form consisting of one or
more herbs or processed herb(s) in specified quantities to provide
specific nutritional, cosmetic benefits, and/or other benefits meant
for use to diagnose treat, mitigate diseases of human beings or
animals and/or to alter the structure or physiology of human beings
or animals.

4. Herbal formulation
• Herbal preparations are obtained by subjecting herbal substances to
treatments such as extraction, distillation, expression, fractionation,
purification, concentration or fermentation.
• These include comminuted or powdered herbal substances,
tinctures, extracts, essential oils, expressed juices and processed
exudates.

5. Challenges in Herbal formulation
• A key challenge is to objectively assess conflicting toxicological,
epidemiological, and other data and the verification of herbal
materials used.
• Management within ranges of risk
• Communication of uncertainty
• Pharmacological, toxicological, and clinical documentation
• Pharmacovigilance

6. Challenges in Herbal formulation
• Understanding why addition of harmful additives works evaluating
“drug” interactions
• Constraints with clinical trials and
• Standardization
• Safety and efficacy assessment

7. Factors affecting safety and Quality
• Quality of starting materials
• Complexity of nomenclature of herbal ingredients
• Chemical contamination by Heavy metals
• Choice of chemical markers
• Adulteration with synthetic chemical drugs

8. Constrains of herbal formulation
• Indiscriminate harvesting and poor post-harvest treatment practices.
• Lack of research on the development of high-yielding varieties,
domestication etc.
• Poor agriculture and propagation methods.
• Inefficient processing techniques leading to low yields and poor
quality products.
• Poor quality control procedures.

9. Constrains of herbal formulation
• Lack of current good manufacturing practices.
• Lack of R & D on product and process development.
• Difficulties in marketing.
• Lack of trained personnel and equipment.
• Lack of facilities to fabricate equipment locally.
• Lack of access to latest technological and market information

10. Factors affecting herbal formulation
• Drug adulteration
• Faulty collection
• Imperfect preparation
• Incorrect storage
• Gross substitution with plant material
• Substitution with exhausted drugs

11. Ayurvedic formulations
• Ayurvedic medicine originated in the early evolution of India about
3,000-5,000 years ago.
• These formulations are taken from the ancient Vedic text or Vedas
(books of Ayurveda), the ancient religious and philosophical texts
that are the oldest surviving literature in the world, which makes
Ayurvedic medicine the oldest surviving healing system.

12. Type of Ayurvedic formulations
1. CLASSICAL AYURVEDIC MEDICINES
• These medicines are present in traditional Ayurvedic text books such
as Charaka Samhita, Sushruta Samhita etc. The manufacturing
company follows the same formula and prepares medicines. For e.g
bhasmas, asavas, arishtas, taila etc.

13. Type of Ayurvedic formulations
2. PROPRIETARY MEDICINES
• These are also known as patent medicines or modern
Ayurvedic medicines. Their formula, dosage form are
decided by the manufacturing company and ingredients
used in these preparation are not found in traditional
Ayurvedic text books. Every company has its own formula
and conducts clinical trial, research on the medicine about
its efficacy. For e.g. capsules, syrups etc.

14. Types and Forms
of Ayuvedic formulations
• Solid dosage forms:
• Gutika & Chruna
• Semi solid forms:
• Avaleha & Ghrita
• Liquid dosage forms:
• Asava , Arista & Tai;la

15. Asava & Arishta
Natural fermented liquid medicines
• Medicinal preparations processed by soaking drugs in the
powdered forms or in the form of their decoction (known
as kasaya in Ayurveda), in a solution of sugar or jiggery
(gur), for a specified period of time.
• During soaking, it undergoes fermentation generating
alcohol and in process facilitating extraction of active
constituents contained in the drugs.

16. Asava & Arishta
• Alcohol so generated also serves as preservative in the
product.
• Absolute cleanliness is maintained during the preparation
of arishta and asava.
• The wooden pots (vessels) are fumigated with pippali (long
pepper) churna and also smeared with ghee before the
fermentation liquids are poured into them.
• They can be kept indefinitely, should be stored in well
stoppered bottles or jars.

17. Dhoopana
Why fumigation?
• The fermentation vessels are subjected to dhoopana, a
process of fumigation to prevent the growth of naturally
occurring microorganisms that may contaminate or hamper
the process of fermentation. Molasses or powders of crude
drugs like Indian valerian, agaru (Aquilaria agallocha), chandan
(Santalum album), marich (Piper negrum, Black pepper) and
such are sprinkled on hot embers and burnt to fumigate.
• These crude drugs may contain volatile oils that have
antibacterial, antiseptic action thereby providing a specific
eco-system similar to present day sterilization procedures.

18. Lepana –
Why Smearing and Coating Process?
• The fermentation vessels are porous to outside air that may
affect fermentation process.
• Process to smear and coat the inner surface of the
fermentation vessel is prescribed to edge out such adverse
effects.
• Ghee, honey or cow‟s urine are used as base with herbs like
Pippali (long pepper) Chavya (Piper retrofractum), Priyangu
(Callicarpa macrophylla) made into the form of paste that is
smeared evenly to provide a coat on the inner surface of the
fermentation vessel.
• Such a coat forms protective layer to prevent any
unwarranted interaction between the fermentation material
and outside air. Most ingredients used for smear have
pungent or sharp attributes.

19. Asava (Definition by Sushruta)
• The medication which is prepared by mixing together different kinds
of medicinal juices, decoction, jaggery (molasses) and flowers of
dhataki (Woodfordia fruticosa) in an earthen vessel buried deep into
a heap of grains for flavoring and to initiate fermentation.

20. Asava
(Fermented infusion)
• Required quantity of water and jaggery or sugar is taken,
boiled, cooled and transferred to fermentation vessel or
barrel.
• Finely powdered crude drugs and other ingredients as
mentioned in the formula are then added to it
• The container is covered with the lid and edges are sealed
with clay smeared cloth, wrapped in seven consecutive
layers. Normally the vessels used for processing of asava
are placed in cellar(basement) of a specific period in order
to facilitate sadhana (fermentation) process.

21. Asava
(Fermented infusion)
• The contents are examined for completion of sandhana process and
asava is filtered and bottled.
• Filtered asava should be clear and without any froth (foam) at the
top.
• It should not become sour on standing.
• It has characteristic, aromatic and alcoholic odour.
• Examples: Kumariasava, Punarnavasava, Chandanasava, Arvindasava,
Kanakasava, Madhukasava

22. Arishta
(definition by Bhavprakash samhita)
• The formulations which are prepared with the use of pakvaushadha
siddha; earlier prepared (cooked) medications like herbal infusions or
decoctions

23. Arishta
(Fermented decoction)
• The crude drugs mentioned in the formula (patha), are coarsely
powdered and decoction (Kashaya) is prepared, filtered and
transferred to wooden vats.
• Sugar, honey or jaggery is added to it, dissolved and boiled.
• Dravyas, other finely powdered ingredients and Dhataki pushpa
(Woodfordica fruticose) are added to it to trigger the fermentation
process.

24. Arishta
(Fermented decoction)
• The container is covered with the lid and edges are sealed with clay
smeared cloth, wrapped in seven consecutive layers. Normally the
vessels used for processing of arishta are placed in cellar(basement)
of a specific period in order to facilitate sadhana (fermentation)
process.
• The contents are examined for completion of sadhana process and
arishta is filtered and bottled.

25. Arishta
(Fermented decoction)
• Filtered arishta should be clear and without any froth (foam) at the
top.
• It should not become sour on standing.
• It has characteristic, aromatic and alcoholic odour.
• Examples: Ashokarishta, Kutarishta, Dashmularishta, Vidangarista,
Arjunarishta, Ashwagandharishta

26. Avaleha
(Jam/Paste like products)
• Avaleha or leha is a semi solid preparation of drugs prepared by
addition of sugar, jiggery(gur) or sugar candy and boiled with
prescribed drug juice or decoction.
• Jaggery-gur or sugar candy is dissolved in liquid, boiled and strained.
• The powdered drugs in small quantities are added and stirred
continuously to form homogenous mass.

27. Avaleha
• Ghee or oil is added when preparation is hot.
• Examples:
• Chyawanprash, Kutakabaleha, Drakshavaleha, Vasavaleha,
Bilvadileha, Surnava leha

28. Ghrita
(Medicated clarified butters)
• The preparation in which ghee is boiled with the prescribed quantity
of the decoction (kasaya) and fine paste (kalka) of the drug as
specified in the formula.
• The process of preparation of ghrita ensures the absorption of the
therapeutically active constituents of the drugs used in the
preparation.
• Ghrita solifies when cooled. It has colour, odour and taste of the
ingredients used in the preparation.

29. Ghrita
(Medicated clarified butters)
• Ghrita are preparation for internal consumption and are stable for
about 16 months.
• Normally they are taken along with warm vehicle (water or milk).
• Examples: Asokaghrita, Nirgundi ghrita, Brahmi ghrita, Sukumara
ghrita, Pippalyadi ghrita
• It can be preserved in glass, polythene or aluminium containers.

30. Churna (Powders)
• Fine powder of drug or drugs is known as churna.
• Drugs mentioned in patha, are cleaned properly, dried thoroughly,
pulverised and the sieved.
• The churna is free flowing and retains potency for one year, if
preserved in air-tight containers.
• Examples: Triphala churna, Sudarshan churna, Trikatu churna,
Drakshadi churna, Sitopatadi churna

31. Taila (Medicated Oils)
• They are called sneha kalpa/paka and prepared by cooking oil with
the juice or the decoction and paste of drugs.
• Unless otherwise specified, paste of drug should be 1/4th part of the
oil and the liquid (drava) should be 4 times of oil.
• If no liquid is specified in recipe, water should be used.

32. Taila (Medicated Oils)
• For preparing medicated oil, the fine paste of drug, liquid and oil
together, cooked, stirred constantly to the paste at the bottom and
prevented from getting charred.
• When medicated taila gets properly cooked, large amount of foam
appears at the surface of the oil.
• Therefore the formulation should be strained prior to packing.

33. Taila (Medicated Oils)
• If salt or any alkali preparation is added to the recipe, it should be
after the oil is strained and mixed thoroughly.
• Tailas can be used internally and topically.
• They retain potency for about 16 months.
• They are taken internally with warm water or warm milk.
• Examples: Bhrinraj taila, Mahanarayan Taila, Anu taila, Jyotismati taila

34. Gutika (Pills)
• It is in the form of pills. They are made by using single or
combinations of vegetable, mineral or animal drugs.
• These preparations can be used up to 2 years. Pills with minerals can
be used indefinitely.
• These formulations should not loose their original colour, odour,
taste and form on standing.

35. Gutika (Pills)
• They should be kept away from moisture, if they contain salt, ksara or
sugar.
• Examples: Lasunadi gutika, Pranda gutika, Khadiradi gutika

36. Detoxification of Formulation
• Ayurveda involves the use of drugs obtained from plants,
animals, and mineral origin.
• All the three sources of drugs can be divided under
poisonous and non-poisonous category.
• There are various crude drugs, which generally possess
unwanted impurities and toxic substances, which can lead
to harmful health problems.
• These poisonous/toxic plants are categorized as vis
(poison) and upavis (toxic but not lethal for human health)
in Ayurvedic texts and also listed in the schedule-E of Drugs
and Cosmetics Act 1940.

37. Detoxification of Formulation
• The detoxification or purification process of any toxic
material used for medicinal purposes is termed as
“Śodhana”.
• Śodhana (detoxification/purification) involves the
conversion of any poisonous drug into beneficial, non-
poisonous/nontoxic ones.
• It is cited in the treatises of Ayurveda that by proper
processing, vis can be converted into amrita (nectar) and
on other hand on adoption of inappropriate methods,
nontoxic materials become a toxic.

38. Detoxification of Formulation
• Aconitum species, Strychnos nux-vomica, Acorus calamus,
Abrus precatorius etc., are some of the interesting
examples of toxic plants, which are still used in the Indian
system of medicine.
• Aconitine, strychnine, β–asarone, abrin are some of the
toxic components present in these plants and are relatively
toxic in nature.
• Śodhana process involves the purification as well as
reduction in the levels of toxic principles which sometimes
results in an enhanced therapeutic efficacy.

39. Detoxification of Formulation
• Various sodhana process includes
1. Simple boiling with water or lemon juice
2. Triturating with borax
3. Swedana (heat treatment with liquids)
4. Treating with cows urine
5. Treating with cow milk
6. Frying with cow ghee or castor oil

40. Detoxification of Formulation
Objectives of Sodhana
1. To prepare herbomineral preparations
2. To enhance safety
3. To enhance Potency
4. To decrease the toxicity
5. To produce synergistic effects with other plant materials.

41. Shodhana-Abrus
• Guñjā (Abrus precatorius Linn., Family: Fabaceae) roots, seeds, and
leaves have been used traditionally for their purgative, emetic, tonic,
aphrodisiac, and hair growth promoting properties after being
processed through Śodhana.
• Since ancient times, it has been used as fish poison, arrow poison
and also for criminal purposes of poisoning both humans and cattle.

42. Shodhana-Abrus
• Abrus seeds contain a toxic lectin, abrin (an albumotoxin), a fat-
splitting enzyme, a glucoside (abrussic acid), urease, abarnin,
trigonelline, choline, hypaphorine, and steroidal oil that have
abortive effects.
• Abrin has a fatal dose of 0.1–1 μg/kg in humans and it is reported
that boiling renders the seed harmless.
• In Śodhana of Guñjā seeds, they are subjected to the svedana in dolā
yantra with Godugdha or Kāñji for 3–6 h.

43. • It consists of a pot half filled
with specified liquid with a
horizontal rod placed on the rim
from which the bundle of
material to be treated will be
immersed and heated.
• Swedana is a steam treatment
• Godugdha: Cow milk
• Gomutra: Cow urine
• Goghrita: Cow ghee
• Kanji: Sour gruel

45. Shodhana-Abrus
• The Śodhita material is then subjected to washing with hot water and
drying under shade.
• During the Śodhana process, color of the media changes due to the
removal of colored materials from the endosperm of the seeds and
subsequently there is loss in weight.
• According to Singh et al. High performance liquid chromatography
(HPLC) study of the Guñjā extract before and after the Śodhana
process showed that the level of toxic hypaphorine decreases,
whereas the less toxic alkaloid abrine increases.

46. Shodhana-Abrus
• Perhaps during Śodhana process, a major part of hypaphorine might
have undergone transformation into abrine by reduction of its
tertiary amino group into the primary amino group.
• Percentage of protein present in Guñjā also reduces after Śodhana.

47. Shodhana-Abrus
• In another study, chromatographic evaluation confirms the absence
of the steroidal oil in Śodhita Guñjā seed, which is responsible for the
abortifacient effect. The LD50 dose of Guñjā was reported to increase
from 2 to 5 g/kg (aśodhita) to ≥5 g/kg (Śodhita).
• The efficacy studies on hair growth and antibacterial effect of the
Śodhita Guñjā show significant result.

48. Shodhana-Aconite
• Many species of the genus Aconitum viz., Aconitum ferox Wall.,
Aconitum napellus Linn., and Aconitum chasmanthum Holmes ex.
Stapf. are known under the common name “Vatsanābha” in Sanskrit
and “Aconite” in English.
• The roots of all the three plants are extremely poisonous but useful
in the treatment of various diseases such as fever, rheumatoid
arthritis, sciatica, hypertension, and acts as “rasāyana”
(immunomodulators) after their detoxification.

49. Shodhana-Aconite
• Most of the alkaloids present in the root of Aconitum species at
higher doses are reported to have cardiotoxic and neurotoxic effects.
Severe Aconite poisoning results mainly due to the accidental
ingestion of wild plant or excess consumption of herbal decoction
made from the Aconite roots.
• Isolated compound (Aconite) from Vatsanābha at a dose of 2 mg can
cause death, while 1 g of Vatsanābha is fatal for human being.

50. Shodhana-Aconite
• The root of Vatsanābha was used as poison for hunting animals in
ancient times by tribals.
• Overdosing of traditional Ayurvedic formulations of Vatsanābha may
cause hypotension, bradycardia or bidirectional tachycardia.
• Due to such reasons, the therapeutic dose of Vatsanābha mentioned
in Ayurvedic system of medicine is 8 mg to 16 mg/day.

51. Shodhana-Aconite
• Its purification process includes svedana (boiling) in dola yantra using
Godugdha (cow milk) for 3 h daily for three continuous days,
followed by washing with water thrice and drying under sun light.
• After Śodhana process, the total alkaloid content decreases, but the
contents of less toxic substances such as aconine, hypoaconine, and
benzylhypoaconine increases possibly due to conversion of the toxic
aconitine into aconine or hydrolysis of the alkaloids to their
respective amino alcohols after Śodhana process.

52. Shodhana-Aconite
• In another study, it has been reported that the purified form of A.
carmichaeli produces cholinergic stimulation which prevents the
cold-stress-induced hypothermia and immuno–suppression.
• Moreover, the unpurified root of A. napellus has been reported to
cause a significant rise in heart rate and changes in electrocardiogram
as compared to purified Aconite. It has been reported that Gomūtra
(cow urine) converts Aconite to a compound with cardiac stimulant
property, whereas, raw Aconite showed cardiac depressant
properties.

53. Shodhana-Aconite
• Śodhana by both Gomūtra and Godugdha makes Aconite devoid of
cardiac and neuro–muscular toxic effects without affecting its
antipyretic activity.
• A. chasmanthum is another species which is well known for its
cardiac and neuro-toxicity.

54. Shodhana-Aconite
• A. chasmanthum showed toxic effects, which leads to the impairment
in kidney and liver functions. Śodhana with Gomūtra reduces the
toxic effects of Aconite significantly.
• In vivo and in vitro studies on frog heart showed that A. ferox has
potential effect to depress the heart rate by its positive inotropic and
negative chronotropic effects and these effects may be mediated
through cholinergic stimulation or by direct action on the heart
muscle.

55. Shodhana- Nuxvomica
• Kupīlu (Strychnos nux-vomica Linn., Family: Loganiaceae) is
extensively used in various conditions such as nervous debility,
paralysis, and weakness of limbs, sexual weakness, dyspepsia,
dysentery, and rheumatism after proper Śodhana.
• Kupīlu has been reported to contain active alkaloids (strychnine and
brucine), which are highly poisonous.
• There are several specific Śodhana procedures, which have been
adopted to purify the toxic materials from the seeds of Kupīlu.

56. Shodhana- Nuxvomica
• Classical method of purification includes soaking of Kupīlu seeds in
liquid media (one after another) for 3–20 days. The liquid media
include kāñji (soaking for 3 days), Godugdha (boiling for 3 h),
Gomūtra (7 days soaking) and Goghrita (cow ghee) (fried till brownish
red in color and swollen) After Śodhana process, the seeds are
washed with lukewarm water where the outer seed coat and embryo
are removed from the cotyledons.
• Similarly in Chinese system of medicine, nux-vomica is fried with
sesame oil for detoxification.

57. Shodhana- Nuxvomica
• Kupīlu after Śodhana exhibits low percentage of total alkaloid content
(strychnine and brucine); and the toxic loganin glycoside is
eliminated. Detoxification of Kupīlu might be due to the chemical
changes that causes the enhance N–oxidation and conversion of
strychnine and brucine into less toxic derivatives such as
isostrychnine, isobrucine, strychnine N–oxide, brucine N–oxide, and
reduced level of loganic acid content of the seed.

58. Shodhana- Nuxvomica
• Being acidic in nature, kāñji is a better extraction medium because it
may facilitate the extraction of alkaloids and other phytochemicals.
• Though larger doses of strychnine are known to be lethal, in lower
doses it is known to be a stimulator.
• Gomūtra Śodhita Kupīlu shows better pharmacological potency than
the raw seeds. Śodhana enhances its hepatoprotective potency.

59. Shodhana process-Datura
• Dhattūra (Datura metel Linn., Family: Solanaceae) seeds are highly
toxic and may be fatal, due to the presence of alkaloids in them.
• Most of the side-effects (dryness of the mouth, excessive thirst,
cramps, unconsciousness, and giddiness) are due to anticholinergic
property of the alkaloids present in this plant.
• In the purification process of Dhattūra, seeds are soaked in freshly
collected Gomūtra and kept aside for 12 h.

60. Shodhana process-Datura
• After washing, the seeds are transferred to the dolā yantra
for svedana process for 3 h.
• The seeds are again washed with lukewarm water, allowed
to dry and the seeds testa are removed.
• Reduction in total alkaloid content and increase in total
protein content of seed were observed after Śodhana.
• Complete removal of scopolamine and partial removal of
hyosciamine reflects the importance of Śodhana of
Dhattūra by means of which the toxic effects are removed

61. Shodhana-Cannabis
• Leaves of Cannabis seativa Linn. are bitter, astringent, tonic,
aphrodisiac, alterative, intoxicating, stomachic, analgesic, and
abortifacient.
• It is used for the treatment of convulsions, otalgia, abdominal
disorders, malarial fever, dysentery, diarrhea, skin diseases, hysteria,
insomnia, gonorrhea, colic, tetanus, and hydrophobia.
• Its excessive use causes dyspepsia, cough, impotence, melancholy,
dropsy, restlessness, and insanity.

62. Shodhana-Cannabis
• In order to reduce these toxic effects, Bhangā is boiled with Babbula
Tvak kvātha for 3 h and the powder obtained is triturated with
Godugdha.
• Toxic effects of Bhangā can also be reduced by triturating with
Babbula Tvak kvātha and frying the powder obtained in Cow Ghee.

63. Sodhana-Papaver
• The opium obtained from the fruits of Papaver somniferum Linn. is
bitter, astringent, sweet, constipating, aphrodisiac, sedative,
somniferous, narcotic, myotic, and antispasmodic.
• It is used for the treatment of cough, fever, inflammatory affections
of eye, proctalgia and low back pain due to diarrhea and dysentery,
migraine, malaria, dysmenorrhea, cystitis, menorrhagia, and other
painful conditions.
• Major constituents of opium are morphine and papavarine.
• Large dose of opium exhibited toxic effects of central nervous
system, induces sleep, relieves pain and develops euphoria.
• Toxic effects of opium can be reduced by steeping in cold water for
5–6 h. After this process, the insoluble brown latex obtained is used
in the Ayurvedic medicine.
• Severe toxicity of opium can also be reduced by triturating with
ginger juice. This process is repeated 21 times.

64. Sodhana-Papaver
• Large dose of opium exhibited toxic effects of central nervous
system, induces sleep, relieves pain and develops euphoria.
• Toxic effects of opium can be reduced by steeping in cold water for
5–6 h. After this process, the insoluble brown latex obtained is used
in the Ayurvedic medicine.
• Severe toxicity of opium can also be reduced by triturating with
ginger juice. This process is repeated 21 times.