Chinese plant extract market needs standardized management
June 25, 2012As a new emerging industry in nearly 10 years, Chinese plant extracts industry lacks of a complete set of policies and regulations. The entire industry lacks of supports from scientific research strength. The majority of plant extracts products do not have uniform quality standards. Meanwhile, the national pharmacopoeia and industry standards have not yet been equivalent with developed countries. The plant extract manufacturer has an unclear understanding of quality standards. They are mainly reflected in unclear understanding of standard in effectiveness composition and content standard. Simply use index components as the standing while ignoring the other index components result in the imbalance among the compositions of various indicators.
GEP’s literally meaning is good drug extraction standard. It has become the management practices to ensure the quality of herbal medicine and Chinese medicine extraction production, involving extraction, concentration, chromatography, crystallization, filtration, drying unit operation. The main target of the Chinese plant extract is an herbal medicine, plant extracts, to some extent can also be known as the Chinese herb extracts. Quality standardization of plant extracts has been a controversial topic. Broad standardization should be involved in the management and operation of the production process of herbal plant extracts every aspect in order to ensure product consistency.
Plant extracts in the quality of the initial raw materials and therefore should be stressed that the origin of raw materials, species selection and research, and strive to do the linking with GAP from the source control of toxic and hazardous substances. Should also strengthen the research and application of the fingerprint pattern on the effectiveness of the composition of raw materials. In short, tube production, learning the various fields, actively coordinate with the establishment of GEP, it is bound to effectively promote the standardization and regulation of quality control for plant extracts.
Botanicals often complex composition, the pharmacodynamic material basis and mechanism of action blur, often in the process of extraction and separation of functional components into degradation and interaction is different from the chemical drug extraction and separation, and the current lack of quality control standards. Chinese plant extracts in all aspects of the development, production, circulation, from macro to micro, yet lack the necessary management practices, products and miscellaneous specifications, small manufacturing enterprises operating channels chaos, product quality varied. The establishment of the GEP, from the hardware and software technology sectors for enterprise, higher demands, improve industry access threshold, which play to clean up the market, standardize enterprise behavior, eliminate fake and shoddy products and inferior role of enterprises, so that the limited social resources concentrated flows to some enterprises in the competition. The pattern of plant extract industry will change.
The Chinese plant extracts is the emerging field differentiated from the traditional Chinese medicine industry in recent years. The GEP establishment promotes the standardization and industrialization of the whole plant extract industry, thus contributing to the production and differentiation of proprietary Chinese medicines for the production of raw materials and preparations production. Through this specialization, it will promote the level of concentration and standardization for traditional Chinese pharmaceutical raw materials suppliers.
At present, Chinese plant extract industry is still short of appropriate policies and regulations. The establishment of GEP is still in the research and exploration stage. The product quality standardization has a long way to go. It is believed that, with the gradually implementations of relating regulations and policies, and development of research and technology, GEP is bound to link with GAP and GMP regulations. It will become the bridge for herbal medicines importing and exporting. At that time, modernization and internationalization of Chinese medicine in real sense will be acheived.Source:http://www.cospcn.com
Posted by tracy ma. Posted In : pharmaceutical raw materials