This document discusses herbs and herbal medicines. It covers the history of herbal medicine use dating back thousands of years, outlines quality control standards for herbal medicines, and describes methods used to authenticate herbal raw materials and ensure product quality. Key points include the importance of using standardized herbal extracts and validated production processes, as well as following guidelines from organizations like the WHO, EMEA and pharmacopoeias. Authentication of herbal drugs involves taxonomic, microscopic, physicochemical, spectral and molecular analysis to verify identity.

1. HERBS AS RAW MATERIALS & PROCESSING OF RAW MATERIALS & HERBAL DRUGS
K SUDHEER KUMAR
Assoc.Professor
MAK COLLEGE OF PHARMACY , HYDERABAD

3. The use of medicinal plants is old as the existence of mankind. According to
World Health Organization (WHO) data, about 80% of world population are
using products based on medicinal herbs.
Phytotherapy is based on the use of herbal drugs and medicinal products for
the purpose of prevention and treatment.
Rational phytotherapy is a modern concept of herbal medicines using, which
are made of standardized herbal extracts.
The quality of each final product is guaranteed by the use of raw materials of
a standard quality, defined process of production, and validated equipment.
Quality control of herbal drugs and herbal isolates (tinctures, extracts, and
essential oils) is done according to the requirements of Pharmacopoeia and
other relevant regulations.

4. The Pharmacopoeia monographs
Monographs European Medicinal Evaluation Agency (EMEA),
World Health Organization (WHO),
European Scientific Cooperative on Phythotherapy (ESCOP),
Commission E (The German Commission E is a scientific advisory board )

5. The process of drafting a new herbal remedies is very complex and strictly
defined phase.
Each step in the process is important, from the initial idea, market
analysis, selecting high-quality plant material and ancillary
pharmaceutical raw materials, recipe formulation, production
preparation, quality control of product, preparation of documentation,
protection of intellectual property rights, to the introduction of herbal
drug in regular production.
The drafting process must be validated and secure documentation.

6. Prehistoric men have dared to use particular medicinal plants, based on careful
observation of the behavior of animals who have been using them .
Over time, the use of herbal medicines and other natural products has developed
on the basis of both positive and negative experiences.
The collected rich experiences have gradually developed into folk medicine, such
as traditional European medicine, traditional Chinese medicine, Indian Ayurveda,
Japanese Kampo, or traditional Arabic and Islamic medicine.
They consist, not only of herbal remedies but also of other types of drugs, for
example, from minerals or animals, or physical procedures
The oldest of these sources are clay tables, discovered in Mesopotamia (2600
BC),

7. which in addition to the description showed also therapeutic application and
galenical form in which the plants were to be used. In those ancient times,
medical plants mentioned were castor oil, grapes, coffee, oils of cedar and
cypress, licorice, myrrh, and poppy juice.
The ancient Egyptian papyrus, Ebers Papyrus (1550 BC), represented some kind
of first Pharmacopoeia. Egyptians were known for their skill of embalming,
distilling scented water, and making perfume of aromatic plants, and for those
they were using many medicinal plants that are still in use today (aloe,
peppermint, plantain, poppy seeds, and coriander).

8. The Indian holy books provide many examples of the treatments using medical
plants, widespread in that country. A large number of aromatic herbs and spices
that are still in use nowadays throughout the world, such as pepper, cloves,
nutmeg, originate from India.
With comprehensive development of science in ancient Greece, the pharmacy
also receives a special place.
The most famous doctor of ancient Greece, which is considered to be the
"father of medicine," is Hippocrates (460–377 BC). He was the first to
systematize overall medical and pharmaceutical experience and publish them in
the capital work Corpus Hyppocraticum.
The most ancient botanist Theophrastus (371–286 BC) together with his
students founded the first botanical garden in Athens. He described more than
500 most important medicinal plants.

9. The founder of the European pharmacognosy, a Roman doctor of Greek origin,
Dioscorides, who lived in the first century BC., described medicinal plants which
were used in the ancient world, in his capital work De Materia Medica.
Dioscorides' most appreciated domestic plants were as follows: willow,
camomile, garlic, onion, marsh mallow, ivy, nettle, sage, common centaury,
coriander, parsley, sea onion,

10. Herbal medicines have been an extremely important source for the discovery of
many drugs. Morphine, which was the first purely natural product to be
isolated, was introduced in pharmacotherapy in 1826 (Merck).
The first semisynthetic pure substance of aspirin, salicylic acid-based, was
isolated from the bark of Salix alba produced in 1899 (Bayer).
This was followed by the isolation of active compounds from old herbal drugs,
such as digitoxin, codeine, pilocarpine, quinine, and many others, some of
which are still in use today.

11. In recent years, many herbal medicines have found their way into the official
medicine. Some of them are Dronabinol and Cannabidiol isolated from Cannabis
sativa,
Tiotropium derivative of atropine from Atropa belladonna for combating
obstructive and chronic bronchitis,
Galantamine, alkaloid from Galanthus nivalis which is used to relieve symptoms
of Alzheimer's disease, and Apomorphine, which is a semisynthetic compound
based on morphine from Papaver somniferum and is intended for people
suffering from Parkinson's disease

12. Phytotherapy, as a complementary part of pharmacotherapy, has an important
place in many areas of modern medicine. It represents a system of treatments
based on the use of natural medicinal resources (drugs) and herbal remedies
(herbal remedies) in the purposes of prevention and treatment.
Herbal drug is the whole or grained, dried part of a plant, algae, fungi, or lichen,
which is used for its medicinal properties. In addition to the plant organs
(above-ground part of the blooming plant as flower, leaf, root, bark, fruit, and
seed), plant exudates can also be considered as a drug (resins, balsams, and
rubber). Herbal medicines, herbal remedies, or herbal medicinal products
(HMPs) contain as active ingredients exclusively herbal drugs or herbal drug
preparations. Herbal drug preparations are obtained from drugs, with the
procedures of distillation, extraction, filtration, and so on.

13. Extractive isolates of herbal medicines and herbal preparations are extremely
complex multicomponent mixtures, as opposed to synthetic drugs that are most
commonly a single pure compound.
 In the production of herbal remedies, certain actions and procedures are
needed to be undertaken (collecting medicinal plants from spontaneous flora and
plantation cultivation, obtaining extractive isolates, and their characterization),
which do not precede the production of synthetic drugs.
the procedures of making herbal medicines are largely modernized and defined
in all segments.
There are a number of guidelines that prescribe standards in all aspects of
making herbal medicines:
The European Medicines Agency guidelines for the quality of herbal medicines,
the WHO guidelines provide standards and guidelines for good agricultural
practices, good laboratory practices, and so on

14. The quality of each final product is ensured by the standard quality of raw
materials, the application of validated production processes and procedures on
validated equipment. It is similar with herbal remedies, which are made of high-
quality herbal raw materials, extractive preparations (extracts and tinctures) and
isolates (essential oil and fatty oil).
The basis of high-quality herbal remedies is the plant material of a standard
quality. Many factors affect the quality of plant material. Regardless of whether
the medicinal plants are grown or collected from the wild, biogenetic factors are
certainly important (species, variety, chemotype.

15. The following are the conditions in which a plant grows as air, climate, land,
then agro-technical measures that are applied during the large-scale production
(proper sowing, irrigation, fertilization, control against weed and pests), and
then collection from the wild or harvest of the plantation, transport, proper
storage, drying, and grinding. It is very important to educate people how to deal
with the collection of herbal raw materials from spontaneous flora, as well as
those who grow the plants, whether they are doing so in the conventional
conditions or organic conditions of medicinal plants production. Quality control
of herbal raw materials is strictly defined and traceable.

16. Definition includes
biological source of drug, the Latin name of the genus and species, and the
minimum amount of essential oil in the case of aromatic drugs or the minimum
quantities of active substances to which the drug is declared.
Characteristics define appearance, odor, taste, and solubility.
Identification in addition to macroscopic analysis (organoleptic inspection), which
includes appearance, color, odor, and microscopic analysis, is carried out for
certain herbal drugs, followed by chemical analysis (specific chemical reactions
and thin-layer chromatography (TLC)).

17. Predicted tests include water, loss on drying, total ash, foreign matter, swelling
index, microbiological purity, bitterness value, starch, and broken drug. Assay
includes essential oils, tannins, declared active substance (gas
chromatography (GC), GC/mass spectrometry (GC/MS), liquid chromatography
(LC), and UV-VIS spectroscopy).
For the evaluation of herbal raw materials quality, in addition to the
determination of microbiological safety, complete analysis of the health safety
is often performed, according to the current regulations (which includes not
only the results of physical, physicochemical, and chemical tests but also
organoleptic findings, preservatives, sweeteners, mycotoxins, metals and
metalloids, pesticide residue, microbiological tests, and radioactivity).

18. AUTHENTICATION METHODS FOR DRUGS
The traditional systems of medicine have become significantly more popular all
over the globe because of the curative property, less toxic and minimal side
effects.
The mode of preparation and plant used in traditional medicine varies from
place to place. In addition acceptance of traditional medicines, especially herbal
medicines in the developed world is sharply increasing.
ASU drugs may vary in composition and properties, unlike conventional
pharmaceutical products, which are usually prepared from synthetic, chemically
pure materials by means of reproducible manufacturing techniques and
procedures. Correct identification and quality assurance of the starting material
is therefore an essential prerequisite to ensure reproducible quality of these
medicines which contribute to its safety and efficacy.
Thus authentication is a critical step for successful and reliable clinical
applications and for further experimental studies on Herbal drugs.

19. Authentication is especially useful in cases of drugs that are frequently substituted or
adulterated with other varieties which are morphologically and chemically
indistinguishable. Several herbal drugs in the market still cannot be identified or
authenticated based on their morphological or histological characteristics. Use of wrong
drugs may be ineffective or it may worsen the condition.
Authentication of Herbal Drugs: Authenticated raw material is the basic starting point in
developing a botanical product. In addition, each step of harvest, storage, processing and
formulation may dramatically alter the quality and consistency of final product. Therefore
methods to ensure quality control in manufacturing and storage are requisite tools to
ensure optimal efficacy and safety of these products. Furthermore, such controls are
critical for the evaluation of pharmacological, toxicological or clinical studies involving
botanical products.

20. Taxonomic method The botanical origin of the drug is identified and its scientific Latin
binomial (i.e. genus species) name is determined based on this method. It is the first step
for authentication.
Herbarium voucher sample: The sample of collected material should be kept as a voucher
sample in a herbarium or a research institute for future references.
Macroscopic method: Macroscopic identity of botanical materials is based on parameters
like shape, size, color, texture, surface characteristics, fracture characteristics, odor, taste
and such organoleptic properties that are compared to a standard reference material.
Microscopic method: Microscopy is used to determine the structural, cellular and internal
tissue features of botanicals. It is usually used to identify and differentiate two herbals that
are similar.
Fluorescence Microscope Besides the ordinary light microscope, polarized and fluorescence
microscopes can also be used to enhance the accuracy of authentication. For example, it has
been found that starch grains, crystals of calcium oxalate, stone cells, vessels and fibers have
stable and special polariscopic characteristics

21. Physicochemical methods: Physicochemical parameters include total ash, water soluble
ash, acid insoluble ash and sulphated ash. These values of the individual drugs or the
proprietary medicines can be compared with the standard values of Indian pharmacopoeia
and thus the identity can be ascertained.
Chemometric and Spectral methods Initially the use of infrared (IR) spectroscopic method
is restricted only for structural elucidation of isolated compounds from the herbal
matrices. It is also found useful in phytochemical studies as a “fingerprinting” device, for
comparing a natural with synthetic sample .
Chromatographic methods: High Performance Liquid Chromatography (HPLC), Capillary
Electrophoresis (CE) and Thin Layer Chromatography (TLC) are the most commonly used
analytical methods for herbal products The analysis of volatile compounds by gas
chromatography is very important in chemical analysis of herbal medicines .
Thin Layer Chromatography (TLC): TLC was the common choice for the analysis of herbs
before instrumental chromatography methods like GC and HPLC were established. Even
nowadays, TLC is still frequently used for the analysis of herbal medicines since various
pharmacopoeias still use TLC to provide first characteristic fingerprints of herbs

22. High Performance Liquid Chromatography (HPLC): HPLC is a popular method for the
analysis of herbal medicines, because it is easy to learn and use and is not limited by the
volatility or stability of the sample compound. In general HPLC can be used to analyze
almost all the compounds in herbal medicines.
Molecular markers: Molecular markers generally refer to biochemical constituents,
including primary and secondary metabolites and other macromolecules such as nucleic
acids. DNA markers are reliable for informative polymorphisms as the genetic composition
is unique for each species and is not affected by age, physiological conditions as well as
environmental factors.

23. Authentication of Minerals: The use of minerals as source of drugs is largely used in
Indian systems of medicine next to herbals,
Physical properties: The physical properties of individual minerals will be a powerful tool
for identification. These properties include nature, colour, streak, tenacity, transparency,
luster, hardness, fracture, cleavage or parting, magnetism and specific gravity. These unique
physical characteristics of minerals can be used for the authentication.
Optical properties: Optical properties include application of optical crystallography in
identification of minerals that are crystalline and transparent irrespective of their chemical
composition. This can be determined within limits by means of polarizing microscope.
Refractive Index (RI): It is defined as ratio of velocity of light in media to that in vacuum.
It varies with wavelength. Immersion method is used to determine the RI.
Chemical properties: The Chemical properties include effect on heat, solubility, reaction
with acids like HCl, HNO3, H2 SO4, assays which include Volumetric/ Gravimetric/ AAS/ ICPA/
Flame photometry for Na, K, qualitative test for carbonate and sulphate, analysis of heavy
metals like Arsenic and other elements.

24. In spite of all these factors, the microbial contamination, pesticide residue and
heavy metal analysis should be considered before processing the raw material
for drug preparation. This is regarding the safety issue of drugs. This type of
analysis is required when evaluating the authenticity of botanicals because
these extraneous contaminants can cause undesired physiological effects.

25. Herbal drug (or substance)
Herbal drug is the part of the medicinal plant used for therapeutic purposes.
According to the European Pharmacopoeia (and the EU Directives) herbal drugs
(substances) are mainly whole, fragmented or cut plants, plant parts, algae, fungi,
lichens in an unprocessed state, usually in dried form but sometimes fresh. Certain
exudates that have not been subjected to a specific treatment are also considered to
be herbal drugs (substances). Herbal drugs (substances) are precisely defined by the
plant part used and the botanical name according to the binomial system (genus,
species, variety and author). From an herbal substance, different herbal preparations
can be made. They can represent the active ingredient in an individual herbal
medicinal product.

26. Herbal medicinal product
Any medicinal product, exclusively containing as active substances one or more herbal
substances or one or more herbal preparations, or one or more such herbal substances in
combination with one or more such herbal preparations.
Herbal (drug) preparation
Preparations obtained by subjecting herbal substances to treatments such as extraction,
distillation, expression, fractionation, purification, concentration or fermentation. These
include comminuted powdered herbal substances, tinctures, extracts, essential oils,
expressed juices and processed exudates.
Herbal remedy Any herbal product used with therapeutic purposes. The meaning of herbal
remedy is very close to that of herbal medicinal product, but differs from the last in the fact
that the term is not subjected to drug regulations.
Herbal Teas Consist exclusively of one or more herbal substance(s) intended for oral
aqueous preparations by means of decoction, infusion or maceration. This preparation is
prepared immediately before use. Herbal teas are usually supplied in bulk form or in
sachets.

27. Soft extracts are semi-solid preparations obtained by evaporation or partial evaporation of
the solvent used for preparation.
Dry extracts are solid preparations obtained by evaporation of the solvent used for their
production. Dry extracts usually have a loss on drying or water content not greater than 5
per cent m/m.
Liquid extracts are liquid preparations of which, in general, 1 part by mass or volume is
equivalent to 1 part by mass of the herbal drug or animal matter. These preparations are
adjusted, if necessary, so that they satisfy the requirements for the content of the solvent
and, where applicable, for the constituents.
Tinctures are liquid preparations which are usually obtained using either 1 part of herbal
drug or animal matter and 10 parts of extraction solvent or 1 part of herbal drug or animal
matter and 5 parts of extraction solvent.

28. Markers are chemically defined constituents or groups of constituents of an herbal
substance, herbal preparation or herbal medicinal product, which are of interest for
control purposes independent of whether they have any therapeutic activity. Markers
serve to calculate the quantity of herbal substance(s) or herbal preparation(s) in the
herbal medicinal product if the marker has been quantitatively determined in the herbal
substance or herbal preparation.
Standardization Means adjusting the herbal drug preparation to a defined content of a
constituent or a group of substances with known therapeutic activity respectively by
adding excipients or by mixing herbal drugs or herbal drug preparations (e.g. standardized
extract from the European Pharmacopoeia)
Traditional Herbal Medicinal Product (THMP)
THMP are medicinal products for human use that fulfill the conditions laid down in Article
16a (1) of EU Directive 2001/83/EC as amended. Traditional herbal medicinal product may
also contain vitamins and minerals, provided that the actions of the vitamins and minerals
are ancillary to that of the active ingredients.

29. Lack of appropriate standards is one of the key factors that limits wider acceptance of
herbal drugs. The main reason advanced for the difficulty in developing quality control
standards is that most of these products use whole herbs, or parts of plants or their
total extracts, and in many cases a mixture of number of plants. These drugs often
contain a varied number and quantity of chemical constituents. It is challenging to
develop suitable standards because a plant drug or its preparation is regarded as one
active entity in its entirety, whether or not the active constituents with therapeutic
activity are known.

30. Quality control of raw material
Consistent quality of herbal medicinal products can only be assured if the starting
materials are defined in an explicit and rigorous manner. Each plant used for processing
should be taxonomically identified and checked using its pharmacognostic and
chemotaxonomic characteristics. Comparison of a sample from raw material with
herbariumspecimens maintained in amanufacturing house repository can prove useful.
The geographical source, season of collection, method of drying, parts of the plant used,
whether fresh or dried, should be recorded.

31. The lack of scientific identification, or misidentification, will compromise the rest of the
scientific work on the plant. So, for medicinal plant research, we should perform a
harvesting for botanical identification and another one for phytochemical and
pharmacological studies, each one with specific recommendations. From an anatomical
standpoint, medicinal plants have aroused interest due to their abundance of secretory
structures such as idioblasts, cavities, channels, laticifers and glandular trichomes, among
others (Fahn, 1979; Evert, 2006), and the chemical diversity of their secretions which are
rich in terpenes, alkaloids and phenolic compounds (Harbone, 1997). These secretions can
be identified by conventional chemical analysis or by histochemical methods, which
identify the compounds in situ, such as tests for lipids and terpenic substances, tests for
phenolic compounds,tests for proteins, tests for alkaloids , tests for carbohydrates and
tests for
crystals.

32. Harvest
For each medicinal plant there is an appropriate time for harvesting the crop. The
phytochemical monitoring of the active compounds allows the establishment of the right
time to harvest.
However, for plants whose active principles are not known yet, there are some general
rules which can be applied.
The bark should be harvested in spring, early summer and autumn. The humid
environment facilitates the detachment of the bark.
The bark should be carefully removed by cutting vertical segments. Care must be taken
not to "roulette" the trunk, that is, to remove peels in horizontal cotes surrounding the
trunk. This procedure prevents the circulation of the sap, resulting in the plant’s death.
The underground organs: roots, rhizomes, tubers, bulbs of perennial plants should be
harvested during winter, the dormant period, when the concentration of active principles
reaches its maximum in these organs.

33. The herbaceous plants and leaves are harvested when they start flowering. Some
plants allow more than one cut. Sometimes, when there are well defined rainy and dry
periods, the harvesting of the leaves is done during the dry season, allowing the plant to
regenerate them during the rainy season. The shoot tips are harvested in full bloom and
before seed formation.
The flowers are cut before opening up completely,
but sometimes the open inflorescences are harvested. The fruits are harvest "at once",
i.e. before reaching the mature state. The seeds are harvested when ripe. If they are
from fleshy fruits, the leftover pulp which surrounds them should be removed and the
seeds dried.
Periods of drought and rainfall influence the content of active principles. Thus, the
alkaloid content decreases after the rain whereas the content of essential oils increases.
The content of essential oils decreases after the drought.
The concentration of active principles varies according to the time of the day. In
general, glycosides reach their highest concentration in the afternoon, while essential
oils reach their maximum level around noon

34. Post-harvest processing
The post-harvest processing aims at the conservation of the physical, chemical,
organoleptic and pharmacological characteristics of the plant drug. The inadequate post-
harvest processing results in low quality raw material, with loss of active ingredients,
increased microbial load and bad commercial presentation.
The loss of active ingredients involve: degradation by metabolic processes; active
principles hydrolysis; decomposition by light; enzymatic decomposition; degradation of
thermolabile substances by heat ; volatilization of essential oils and contamination by
bacteria and fungi.
The first stage of post-harvest processing involves examination and manual separation of
parts which are damaged, stained and with signs of attacks by insects and / or fungi. The
next recommended step, is to wash the drug in running water.

35. The moisture content in fresh plants varies from 60% to 80%. The drying process
reduces the moisture content to 5% - 12%. According to the plant organ, the weight
losses during drying are:
- Leaves: 20% to 75% - Bark: 40% to 65% - Wood: 30% to 70% - Roots: 25% to 80%
- Flowers: 15% to 80%
Most medicinal plants can be dried at temperatures between 30°C and 60°C. Plants
containing essential oils or volatile substances should be dried at temperatures below
40°C. In all cases good air circulation should be ensured, favoring the process.
The method of drying must be experimentally determined for each plant drug. The slow
drying may cause harmful changes, by the action of enzymes, fungi and bacteria, before
the process is completed. A very quick drying hardens the superficial layer of the cells
and prevents the evaporation of water inside the organ, which also results in the action
of enzymes

36. Storage However great care has been taken during harvesting and drying, the plants
lose active ingredients by degradation during storage. Although the recommended time
limit for storing leaves and shoot tips is from12 to 18 months, and for bark and roots
from 12 to 36 months, some plants lose active ingredients soon.
The conservation of vegetable raw material for a longer period of time depends on
storage conditions. Appropriate conditions prevent the product from having contact
with the sun, dust, rodents and insects and other degradation factors, thereby,
impeding the loss of volatile principles.
The material can be wrapped in burlap sacks or bales. The use of plastic bags should be
avoided as it does not allow adequate ventilation. The bags should be labeled with the
scientific name of the plant and the part used entry date, supplier name origin and
approval of quality control.

37. Grinding The grinding is intended to reduce the particle size of the plant drug, making it
suitable for the next step of the process which is extraction.
The extraction of a drug as a whole or divided into coarse fragments will be incomplete
due to poor penetration of the solvent in the plant tissue.
It will also be very slow, since the cell membranes act as real barriers hindering the
extraction procedure. In the case of previously divided drugs, such membranes are
partially destroyed, making the dissolution of the cellular components in the outer liquid
easier and more efficient.
However, the excessive division and the formation of very fine dust may cause problems
during the extraction process.
In the percolation process there is a powder compaction, which impedes the passage of
the solvent, resulting in an incomplete extraction of the drug.
In the maceration process the very fine particles might pass to the extract and bring it to
a cloudy appearance. The milling process is preceded by screening to remove impurities.
In this operation strange material, such as large pieces of wood, other types of metal are
removed manually.

38. MICROBIOLOGICAL QUALITY CONTROL OF DRUG PLANTS AND THEIR DERIVATIVES
The microbiological quality assurance of herbal medicines must necessarily involve a
proper stance regarding the Good Agricultural Practice.
Researchers have even recommended the cultivation indoors, with full control over the
climate and the presence of pathogens, and the possibility of genetic enhancement
combined with biotechnological studies, indicating a tendency to domestication instead of
harvesting from the wild.
Regulatory aspects
Heterogeneity exists not only between countries but even within the same country in
relation to the maximum microbial limits which are acceptable for herbal products.
In some countries, herbal drugs for oral, topical or episodic use, produced by infusions,
decoctions and maceration, have different laws when compared to plant drugs presented
as capsules, tinctures, tablets, extracts and syrups. However, in general, the tests used to
verify the presence of microorganisms in plant drugs show no significant variation and
follow the recommendations used for non-sterile pharmaceutical products

39. Physical, chemical and physico-chemical controls of quality of herbal drugs and/or their
derivatives: Tinctures and extracts To ensure quality for vegetable raw material, the WHO, 1992
recommends that the pharmacopoeia specifications for the plant material must include: -
Botanical name, with reference to the authors; -
Specification of the part used; -
Morphological description,
macro and microscopic examination; -
Determination of particle size distribution; -
 Determination of total ash or sulfated ash (residue on ignition) and acid insoluble ash;
Determination of extractable matter; -
Determination of water and loss on drying; -
 Determination of essential oils; -
Identification by thin layer chromatography;
Quantitative determination of active constituents; -
 Limit tests for heavy metals; -
Determination of pesticide residues

40. The development of herbal medicines, as a rule, involves planning and obtaining intermediate
preparations as required steps for processing vegetable raw material into a
finished product, which will provide the desired pharmaceutical presentation. Among the available
intermediate preparations, Pharmacopoeias recommend the tincture or fluid extract. These liquid
presentations can be utilized to obtain standardized dried extracts, which can be used in the
production of various pharmaceutical forms. It is important that the starting material is stabilized in
order to ensure the reproducibility of the process. It also has to be sufficiently pulverized so as to
achieve optimum performance in the process of extracting the chemical constituents of
pharmaceutical interest. To obtain a derivative of any medicinal plant, being it herbal medicine in any
form, quality
control is required from the cultivation, management and harvesting of the plant species;
passing through the production of intermediate product up to the final formulation. Therefore, for
the technological development of herbal medicines according to the requirements and specifications
of the countries’ laws, it is essential to establish protocols that ensure quality control of raw
materials, vegetable products and ingredients used in their production, as well as validation of
qualitative and quantitative techniques appropriate to the chemical markers chosen.