More than 40 kinds of Chinese herbal extracts can still be purchased

Guide: on May 20, the State Food and Drug Administration issued the notice of the State Food and Drug Administration on the special treatment of Ginkgo biloba drugs Later, Wu Zhen, deputy director of the State Administration, revealed a major message in the special video conference on Ginkgo biloba drugs: since January 1, 2016, the production of traditional Chinese medicine can no longer be entrusted for extraction Any Chinese patent medicine production enterprise that does not have the ability to extract traditional Chinese medicine will stop the production of corresponding varieties, and the purchased extracts must be in accordance with the law According to the documents mentioned by Wu Zhen in his speech, the author browsed the specific requirements and regulations of the documents, and found that there are more than 40 varieties available for the plant extraction industry to record Chinese herbal extracts In addition to the more than 40 varieties, the non recordable Chinese herbal extracts must be extracted by themselves and not purchased Ginkgo biloba extract reflects the strange current situation of the industry Let's review the Ginkgo biloba event first
Ginkgo biloba extract was originally developed by a German pharmaceutical manufacturer, and was sold in China before the 1990s It is loved by patients because of its efficacy The main place of origin of Ginkgo biloba in China is Xuzhou, Shandong and other places in Jiangsu Province Ginkgo biloba preparation has been researched and developed in China since the 1990s At present, there is an injection manufacturer under the management of chemicals Yuekang Pharmaceutical Group Co., Ltd., with the approval number of Guoyao Zhun Zi h20070226, has nearly 100 other 117 specifications (dosage forms) of product manufacturers, all of which are managed according to the approval number of traditional Chinese medicine Ginkgo biloba extract was published in the 2002 supplement, 2005 edition and 2010 edition of Chinese Pharmacopoeia respectively According to the data retrieval and inquiry on the website of the State Administration, there are 13 extracts with approval number in China at present, and no management information of approval number of Ginkgo biloba extract has been searched The search results are shown in the following screenshot: At the same time, the author also searched the product number information of Guilin Xingda Pharmaceutical Co., Ltd and showed that the enterprise only had one approval number of ginkgo leaf: gyzz0055191 Wanbangde (Hunan) Natural Medicine Co., Ltd only has two approval numbers of ginkgo leaf and ginkgo leaf capsule: gyzz027946 and gyzz026290; none of the above two enterprises has the approval number of ginkgo leaf extract The results showed that: Ginkgo biloba extract has been included in the national drug legal standard for at least 13 years Although it has been revised at least three times and the pharmacopoeia standard version has been updated, the State Administration has not implemented the approval number control on Ginkgo biloba extract Article 7 of sfjyhj [2014] No 135 notice of the food and Drug Administration on strengthening the supervision and administration of extraction and extraction in the production of traditional Chinese medicine stipulates that the Chinese patent medicine national drug standard prescription items shall be downloaded clearly, and the extraction of traditional Chinese medicine with separate national drug standards shall be subject to filing management And for the extracts that have been under the management of approval number before, the application for re registration will not be accepted after the expiration of the registration period All of them shall be included in the record management of extracts according to this notice All pharmaceutical manufacturers that produce or use the above-mentioned Chinese herbal extracts shall file with the Provincial Bureau in accordance with the detailed rules for the implementation of the filing management of Chinese herbal extracts It can be seen that Ginkgo biloba extract can completely go the way of filing to legalize its production and operation, but what the author knows is that there is no information disclosure of extract filing enterprises permitted by policies at present At present, in China, there is a three regardless industry - planting and lifting industry The industry is mainly engaged in the production and sales of plant extracts Most of its production products are exported abroad, used as health products or food additives abroad, and some as raw materials of domestic health products The internal information of the industry shows that: after more than 20 years of accumulation and development, the current scale of the industry has grown from more than 5 billion yuan in 2005 to more than 16 billion yuan in 2013; the number of enterprises engaged in the industry has also grown from more than 200 in 2005 to more than 3000 now
The Ginkgo biloba extract incident has found that Hunan and Guangxi, two illegal enterprises, are purchased from unqualified plant extract enterprises in Jiangsu Province These enterprises have been in the state of "three regardless" and allowed to develop In recent years, the National Bureau and provincial bureaus have repeatedly launched actions to combat illegal additives of traditional Chinese medicine preparations, which are also repeatedly related to the plant extract industry Therefore, the boundary of plant extraction has become the pain that must be eliminated in the production environment standard and purification of traditional Chinese medicine! More than 40 varieties can also be purchased On July 29, 2014, sfjyhj [2014] No 135 notice of the food and Drug Administration on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese medicine was issued by the State Administration According to the requirements of the filing, the successful planting and extracting enterprises shall organize production in accordance with the GMP requirements to ensure the quality of their products, and their daily supervision shall be in the charge of the provincial (District, city) food and drug administration This requirement puts forward higher requirements for plant extraction at present The field of planting and lifting has always been in the field of "three regardless", with uneven production technology, quality management and hardware settings In particular, the key process parameters, facilities and conditions, purification requirements, process layout, quality inspection center, storage conditions and other aspects related to metering, mixing uniformity, paste collection, drying, crushing, etc are far from the requirements of GMP, and do not have the basic hardware conditions to separate the flow of people and logistics, prevent pollution, cross contamination and error accidents, which must be carried out to meet the filing requirements of the State Administration All round improvement If the filing system of traditional Chinese medicine extracts is implemented, only 47 traditional Chinese medicine extracts can be filed for management, that is, the enterprise can produce by itself or purchase, and the other must be extracted by the enterprise itself Because there is no Pharmacopoeia around the author for the time being, the following varieties that can be temporarily purchased are not all varieties, but they have basically covered most of the main varieties
Total ginsenoside of ginseng stem and leaf, total ginsenoside of ginseng, total saponin of Panax notoginseng, rhubarb extract, total phenolic acid extract of Salvia miltiorrhiza, tanshinone extract, hawthorn leaf extract, Beidou root extract, scutellarin, Notoginsenoside, total saponin of notoginseng, sarcophagus extract, Yinchen extract, andrographolide, zhebailu extract, huangteng, forsythia extract, Scutellaria extract, peony Vitex oil, patchouli oil, acanthopanax senticosus extract, Ginkgo biloba extract, mangrove oil, menthol, menthol oil, belladonna flow extract, belladonna flow extract, angelica flow extract, cinnamon oil, turpentine oil, zedoary oil, ginger flow extract, castor oil, asiaticoside, buffalo horn concentrated powder, star anise oil, liquorice extract, liquorice flow extract, cinnamon oil, etc Although the above varieties can be purchased, considering that there is still a large gap between the current plant extraction industry and the national requirements, it is suggested that the best way for pharmaceutical companies is to extract by themselves, otherwise, if the supplier's products are not qualified, it is easy to suffer