Standardization of herbal drugs

Topics: Herbalism, Chinese herbology, Pharmacology Pages: 18 (5089 words) Published: September 23, 2013
Archana A. Bele et al. IRJP 2011, 2 (12), 56-60
Available online

ISSN 2230 – 8407
Review Article

Archana A. Bele*, Anubha Khale
H.K College of Pharmacy, Jogeshwari (W), M.S., India
Article Received on: 19/10/11 Revised on: 22/11/11 Approved for publication: 13/12/11

Herbal drugs have been used since ancient times as medicines for the treatment of a range of diseases. Medicinal plants have played a key role in world health. There is a growing focus on the importance of medicinal plants in the traditional health care system (viz. Ayurveda, Unani, Homoeopathy, Yoga) in solving health care problems. Systematic approach and well-designed methodologies for the standardization of herbal raw materials and herbal formulations are developed. In view of the growing interest in herbal medicines, methods for standardization of herbal drugs are developed and used in different formulation. Keywords: Herbal drugs, herbal raw material, herbal formulation, standardization.

Standardization of drugs means confirmation of its identity and determination of its quality and purity. Phytotherapeutic agents or phytomedicines are standardized herbal preparations consisting of complex mixtures of one or more plants which are used in most countries for the management of various diseases. According to the WHO definition, herbal drugs contain as active ingredients plant parts or plant materials in the crude or processed state plus certain excipients, i.e., solvents, diluents or preservatives.3

There are problems which may influence the quality of herbals · Herbal drugs are usually mixtures of many constituents
· The active principles are, in most cases unknown
· Selective analytical methods or reference compounds may not be available commercially
· Plant materials are chemically and naturally variable
· The methods of harvesting, drying, storage, transportation, and processing have an effect
(ex. mode of extraction & polarity of the extracting solvent, instability of constituents,etc.)
Factors influencing phyto-chemical Profile of
medicinal plants:
· Genetic variants (gene level) leading to the variability in the chemical composition.
· Geographical and nutritional factors-altitude, soil composition, microbial load, climate, temperature, etc.
· Seasonal changes (rainfall, drought, water stress, etc.)
· Seasonal variations alkaloid composition in the leaves of Adhatoda vasica is low in Feb and March and highest in
· Association patterns including animals and insects.
Need for standardization:
· Modern system of medicine is based on sound experimental data, toxicity studies and human clinical studies.
· But, pharmacopoeial standards on raw material\finished products are not available.
· cGMP for the herbal industry are not well defined nor the barest minimum standards of medicinal plant products are maintained or regulated.
· The lack of quality standards has resulted in mild to serious adverse effects ranging from hepatotoxicity to death. Hence, herbal ingredients require tools for determining identity, purity and quality and tools have to be technically sufficient, rapid and cost effective with GMP requirements.

World Health Organization has set specific guidelines for the assessment of the safety, efficacy, and quality of herbal medicines.

Standardization of herbal drugs is not an easy task as numerous factors influence the bio efficacy and reproducible therapeutic effect. In order to obtain quality oriented herbal products, care should be taken right from the proper identification of plants, season and area of collection and their extraction and purification process and rationalizing the combination in case of polyherbal drugs.7

In recent years, there has been great demand for plant derived products in developed...

References: 1. Ansari S.H, “Standardization of crude drugs”, Essentials of Pharmacognosy, Ist
edition, 2005;06:.14, 581.
Tech. Oct.-Dec. 2008; 1(4) :310-312.
10. Sapna Shrikumar*, M. Uma Maheswari, A. Suganthi, T.K. Ravi, Pharma infonet
vol 2, 2004.
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