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About Authors:
R.C. Gedar1*, Rakesh Sharma2, Sanjeev Sharma2
1Seth G. L. Bihani S. D. college of technical education, IPSDR, Sriganganagar (Raj.)
2J. C. D. M. Pharmacy College, Sirsa (Hry.)

This review highlights the current advances in knowledge about the safety, efficacy and quality control of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and hasthus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false.

Reference Id: PHARMATUTOR-ART-1551

Since ancient times, mankind has used plants to cure disease and relive physical sufferings. His understanding of herbal drugs was very innovative and critical from earliest times and usually was restricted to the medicine men of the tribe. Knowledge regarding sources and uses of different parts of medicinal plants was inherited through generations. Several developing countries have at present well organised and deep rooted traditional systems of medicine, namely, Ayurveda, Sidha, and Unani, have been in existence here for several centuries. In traditional medicine, more than one thousand plants are regularly used which are mostly collected in their wild form. Traditional herbal medicine plays an important role side by side with modern medicine in health care of people, particularly in poorer sections, as western medicine is unavailable to many for economic and other reasons. (Wyk B. V. 2004, Bhattacharjee S.K. 2005)

Quality control of herbal drugs
Quality control for efficacy and safety of herbal products is of paramount importance. Quality can be defined as the status of a drug that is determined by identity, purity, content and other chemical, physical, or biological properties or by the manufacturing processes. Quality control is a term that refers to processes involved in maintains the quality and validity of manufactured products. (Mukherjee P. K. 2002)

In general, quality control is based on three important pharmacopoeial terminology:
·  Identity: Is the herb the one it should be?

· Purity: Are there contaminants, e.g., in the form of other herbs which should not be there?

· Content or assay: Is the content of active constituents within the defined limits? It is obvious that the content is the most difficult one to assess, since in most herbal drugs the active constituents are unknown. Sometimes markers can be used which are, by definition, chemically defined constituents that are of interest for control purposes, independent of whether they have any therapeutic activity or not.

· Quality control and the standardization of herbal medicines involve several steps. The source and quality of raw materials, good agricultural practices and manufacturing processes are certainly essential steps for the quality control of herbal medicines and play a pivotal role in guaranteeing the quality and stability of herbal preparations. The quality of a plant product is determined by the prevailing conditions during growth, and accepted Good Agricultural Practices (GAP) can control this. These include seed selection, growth conditions, use of fertilizers, harvesting, drying and storage. In fact, GAP procedures are, and will be, an integral part of quality control. Factors such as the use of fresh plants, age and part of plant collected, period, time and method of collection, temperature of processing, exposure to light, availability of water, nutrients, drying, packing, transportation of raw material and storage, can greatly affect the quality, and hence the therapeutic value of herbal medicines. Apart from these criteria, factors such as the method of extraction, contamination with microorganisms, heavy metals, and pesticides can alter the quality, safety, and efficacy of herbal drugs. Thus proper standardization and quality control of both the raw material and the herbal preparations should be conducted. Standardization involves adjusting the herbal drug preparation to a defined content of a constituent or a group of substances with known therapeutic activity by adding excipients or by mixing herbal drugs or herbal drug preparations. Botanical extracts made directly from crude plant material show substantial variation in composition, quality, and therapeutic effects. Standardized extracts are highquality extracts containing consistent levels of specified compounds, and they are subjected to rigorous quality controls during all phases of the growing, harvesting, and manufacturing processes. (Bhattacharjee S. K. 2005, Bandaranayake W.M, 2006)

Fig. 1 Steps for Quality Control of Herbal Drugs



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