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Medicinal plants have played an important role in a world health. Herbal drugs have been used since earliest times as medicines for the treatment of a variety of diseases. There is a growing focus on the importance of medicinal plants in the traditional health care systems. Phytotherapeutic agents or Phytomedicines are standardized herbal preparations consisting of complex mixtures of one or more plants which are used in most of the countries for the management of various diseases. Eighty percent of the world’s population depends on herbal drugs and to either global it is vital to maintain its quality.
The quality of herbal drugs is the sum of all the factors which contribute directly or indirectly to the safety. Standardization of drugs means confirmation of its identity and determination of its quality and purity. It is an important measurement for ensuring the quality control of the herbal drugs. It is a process of evaluating the quality and purity of herbal drug on the basis of various parameters like morphological, microscopical, physical, chemical and biological parameters.
Standardization of herbal raw drugs contain passport data of raw plant drugs, botanical authentication, which contain microscopic and molecular examination, physical parameters like moisture content, ash value, extractive values etc. At the present due to advances in the crude drugs in the addition to its physical contants. A system to ensure that every packet of medicines that is being sold has the correct substances in the correct amount and will induce its therapeutic effect this is known as standardization.
The quality control of the plant products is a general requirements to be fulfilled. A good quality assurance is necessary when dealing with the plant products, intended to be released in market as drugs should be made to obtain and maintain the high quality of these plant products. To check any adulteration or non- deliberate mixing in the commercial batches, the specification must be laid down for each herb.
It is accepted worldwide that the standardization of herbal drugs is wide and deep. According to WHO, the herbal drug standardization is the process involved in the physicochemical evaluation of crude drugs that covers various aspects like the selection and handling of crude drug material, safety, efficacy and stability assessment of finished product formulation. The guidelines set by WHO for herbal drug standardization can be summarized as follows:
There are so many evaluation tools for the standardization of herbal drugs and their formulations. The following tools are used for evaluation:
Fingerprinting analysis is the advance technique for standardization. The Fingerprint analysis is the most powerful tool for quality control and standardization of herbal drugs. Fingerprinting is the process that determines the concentration of a set of characteristic chemical substances in the herbs. Advanced techniques for standardization include Chromatographic fingerprinting and DNA fingerprinting. The Chromatographic fingerprinting includes Thin layer chromatography (TLC), High Performance Thin Layer Chromatography (HPTLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), etc., while DNA fingerprinting techniques includes Hybridization Based Methods, PCR Based Methods and Sequence Based Methods.
GMP for herbal industry is not well defined nor barest minimum standards of herbal product are maintained or regulated because modern system of medicine based on the sound experimental data, toxicity studies and human trails and pharmacopoeial standards on raw material or end products are available.
Pharmacognosy has been developed rapidly due to this improvement made in the technology of isolation process which include the development of techniques such as column, paper, thin layer, gas liquid, HPLC and droplet counter current chromatography procedure. These methods have allowed the rapid isolation of substance which was previously difficult to obtain by classical procedure. The most important factor has been the development of the new spectroscopic techniques, which has opened up whole new vistas in the exciting field.
Simultaneous advancement in the field of chemistry, biochemistry, biosynthesis and pharmacology has developed. Various active constituents have been isolated from the plant, which are used in modern medicine. With the advancement in synthetic organic chemistry, most of the active constituents of the plants used in medicine have been synthesized. However, in spite of phenomenal progress and appearance of antibiotics as major therapeutic agents, plants continue to provide basic raw material for some of the most important drug.
Since the indiscriminate use of synthetic drug and antibiotics has resulted in serious symptoms all over the world, the demand of the plant based raw materials for pharmaceuticals have increased enormously. Moreover, the synthetic drug and intermediary chemicals are extremely expensive. The World Health Organization (WHO) has emphasized the utilization of indigenous system of medicine based on the locally available raw materials that is a medicinal plant. Furthermore, approximately one third of all the drugs are plant-based and if bacteria and fungi are also included, nearly 60% of the pharmaceuticals are of plant origin. Our country is rich in large number of such plants that are either used directly or as a source of active principles in formulation of drug curing dreaded diseases. India is a rich source of medicinal plants which are distributed in almost all parts of the country. The herb collector and small traders collect the drug for manufacturing of Ayurvedic and Unani medicines. But there is a shortage of these materials for maintaining the sustained supply of the plant based drug industries.
It is also not dependent only on natural resources to keep the wheel of industries running all the time in view of fast depleting natural wealth and this call for the domestication and cultivation of these plants as well as an increment in the drug production with uniformly high potency.
Inspire of the tremendous advancement in medicines, there are a number of diseases for which modern medicines have no cure. In such conditions, it treated only symptoms to provide relief to the patients. These include arthritic diseases, liver disorders, cancer, AIDS, etc. In recent trends have shown that plant drugs have the answer to such cases. Recently a number of formulations based on Ayurvedic medicines have come to the market for control of liver disorders and some of these have been found effective against these diseases. There is a considerable scope to screen such a plant for active constituent, which may be used in future for the treatment of such incurable diseases.
Control and monitor on growing conditions, harvesting time, part of plant harvested, absence of toxins, pesticides or other contaminants, drying methods, freshness and storage, processing, extraction solvents, whole extraction processes and analytical controls.
The Process Of Standardization Of Herbal Raw Drugs. (2024, Feb 20). Retrieved from https://studymoose.com/the-process-of-standardization-of-herbal-raw-drugs-essay
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