The concept of traditional Chinese medicine extraction, please, 3Q.

Traditional Chinese medicine extract is a new field differentiated from traditional Chinese medicine industry, which is the deep processing of traditional Chinese medicine. Standardized traditional Chinese medicine extract refers to the extract that reaches a certain quality standard according to the standardized production process, including the standardization of the production process and quality of the original medicinal materials and extracts. Some experts have doubts about "standardization". I think it is a broad concept of "model", which can be enriched and modified in continuous research and development. 1, the development of traditional Chinese medicine extract for thousands of years, traditional Chinese medicine is mainly made of raw materials or decoction pieces, and patients make their own decoction to take, and this method is still widely used at present. The disadvantages of this traditional medication method are obvious, such as inconvenient administration, unstable curative effect and uncontrollable quality. Plant extract is a new product form in the international natural medicine and health care products market, and it is the carrier of modern plant medicine advanced technology. This kind of products are produced according to the requirements of GAP and good manufacturing practices. At the same time, advanced technology and quality inspection technology, such as macroporous resin separation technology, are widely used in domestic extract production enterprises, but less used in Chinese patent medicine production. The application of analytical instruments and technologies such as high-pressure liquid chromatography, high-performance thin-layer chromatography, gas chromatography, gas chromatography-mass spectrometry and high-pressure liquid chromatography-mass spectrometry in traditional Chinese medicine extracts reflects the technological progress of traditional Chinese medicine industry and the requirements of modernization of traditional Chinese medicine. 2. Present situation of traditional Chinese medicine extracts at home and abroad At present, China's traditional Chinese medicine extract industry has formed a certain scale, with more than 200 professional production enterprises, and many Chinese patent medicines, fine chemicals and other production enterprises also produce extracts. There are 200-300 operating enterprises, and the scale of operation is generally small, with the maximum not exceeding $10 million. In foreign countries, extraction is an important link and way in the application of botanical drugs. 1993 gave a speech at the 4 1 World Annual Conference on Medicinal Plants held at Heine University in Dü sseldorf, Germany. The lecture 10 introduced the activity research of plant extracts and components. In the late 1970s, Chinese medicine was made into extractum in Japan, and it was also developed and widely used in Singapore and other places. 25% prescriptions in Europe and America contain at least 1 higher plant extract or compound. In the United States, plant extracts account for more than 95% of the herbal medicine market, while raw materials and other products account for less than 5%. In Germany, herbal products mainly in the form of extracts account for 65,438+00% of the national drug market and nearly 30% of the national OTC market, and their herbal products are regarded as drugs rather than food supplements, and have been included in medical insurance coverage. It can be seen that plant medicine extracts have a good application foundation and a broad market abroad. The main varieties of Chinese medicine extracts exported from China are: Ginkgo biloba, Hypericum perforatum, Acanthopanax senticosus, Angelica sinensis, Ginseng and other extracts. 3. Policies of Europe, America and other countries and regions on traditional Chinese medicine extracts. American herbal medicine management is relatively backward. In the Dietary Supplement Health Education Law, the definition of "dietary supplement" includes "herbs or other plants" and "any concentrate", which undoubtedly determines the legal status of plant extracts as dietary supplements. There are 20 kinds of extracts (including vegetable oil and aromatic oil). ) in the United States Pharmacopoeia 2000 edition. In the legislative process in Germany, plant extracts are allowed to be registered as prescription drugs. About 60 thousand drugs registered in Germany contain herbal ingredients, most of which are herbal extracts. These drugs are based on 600-700 kinds of plants and made into about 5,000 kinds of extracts or preparations. There are strict examination and approval procedures for Chinese medicine to enter Germany as a plant medicine. First, you need to fill out the application form. The quality of products shall conform to the German translation of China Pharmacopoeia. Heavy metal content should not exceed the standard. The pesticide residue is less than 0. 1- 1.0mg/kg. The results of chemical and microbiological tests meet the standards. There must also be proof materials such as production license of origin and German expert certificate. Traditional Chinese medicine generally enters Germany in the form of health care products and is applied in the form of food management. The EU classifies drugs into eight categories, namely, patented drugs, generic drugs, over-the-counter drugs, natural botanical drugs, vaccine products, blood products, biological products and antidepressants. In addition to Britain and the Netherlands, Germany, France, Italy and other countries list natural plant medicines as prescription drugs or OTC drugs for control. From June 5438 to 10, 2003, the European Parliament adopted the revision opinion of the Directive on the Registration Procedure of European Botanical Medicines, stipulating that traditional botanical medicines can contain non-botanical ingredients, which partially relaxed the requirements for the clinical use of traditional botanical medicines. After the directive comes into effect, the traditional herbal medicine products originally governed by the relevant food laws and regulations will still be governed by the relevant food laws and regulations if the content of natural herbal medicine substances or natural herbal medicine extracts is lower than the medical dose. The European Pharmacopoeia lists the general rules of extracts, and the 2000 supplementary edition contains three standardized extracts: aloe, senna and belladonna leaves. Further standardization and classification of extracts are under discussion. According to the intrinsic quality, it can be divided into quantitative extract, standardized extract and purified extract. Europe has produced standardized extracts of various medicinal plants: Echinacea purpurea, Valeriana officinalis, Palmetto and Ginkgo biloba. Although Japan was deeply influenced by China culture in history and was the largest export market of traditional Chinese medicine in China, the use of traditional Chinese medicine was also greatly restricted. At present, in addition to the 265,438+00 approved prescriptions, the Ministry of Health and Welfare is extremely strict in approving new prescriptions of traditional Chinese medicine. Treating Chinese medicine prescriptions like new compound medicines is almost equivalent to closing the door, and there are many restrictive measures for the examination and approval of imported Chinese patent medicines. However, in recent years, the Japanese government has obviously relaxed the control of health food, such as canceling the restrictions on dosage forms and relaxing the restrictions on the types of natural botanical drugs that can be used in health food. Japan will introduce a new pharmaceutical law next year, with the basic principle of "deregulation". The implementation of the "responsibility system for selling yuan" will further move closer to Europe and the United States in the management of pharmaceutical production and circulation, and will relax the previous strict restrictions. 4. Veterinary medicine field of traditional Chinese medicine extract At present, the use of western medicine in veterinary medicine field is increasingly restricted, while traditional Chinese medicine extract has strong antibacterial and antiviral effects, and has no tolerance and side effects, so it has been paid more and more attention in veterinary medicine production field. Summary: With the development of medical science and technology, more and more scientific research departments will attach importance to refining Chinese herbal medicine extracts, and the state will also issue relevant production and sales regulations to standardize the Chinese herbal medicine extract market.