Introduction: on May 20, national food drug safety administration issued the food and drug supervision bureau about special notice in ginkgo biloba drugs.

    Later national bureau deputy director wu in ginkgo biloba drugs revealed a significant special TV telephone conference information: since January 1, 2016, Chinese medicine extract production shall not entrust, whoever does not have the ability to Chinese traditional medicine extraction of proprietary Chinese medicine production enterprises, the corresponding varieties shall stop production, outsourcing extract must be in accordance with the rules in accordance with the law.

    According to wu mentioned in his speech at the file, browse the file specific requirements and regulations, the writer found for plant extract of Chinese medicine extract for record more than 40 varieties, which more than 40 varieties, not for the record of Chinese medicine extract must own extraction, shall not be purchased.

    Ginkgo biloba extract reflects the industry status quo to blame

    Let's review the ginkgo biloba events.

    Ginkgo biloba extract was originally a German pharmaceutical production enterprise product development, until the 1990 s into the domestic sales, due to the curative effect is really loved by patients, domestic producers from ginkgo biloba leaves in xuzhou, jiangsu, shandong and other places, domestic research and development of ginkgo leaf preparation since the 1990 s, there are produced according to the injection of drugs management enterprise a: yue kang pharmaceutical group co., LTD., approval number H20070226 approved by the state and the rest of the specifications (form) of 117 products nearly hundred enterprises, all in accordance with the approval document number of traditional Chinese medicine (TCM) management.

    Ginkgo biloba extract respectively by an expanded 2000 edition of Chinese pharmacopoeia 2002, 2005 a, 2010 a records, after the country site data retrieval query, at present the approval document number of countries have extract, a total of 13, there is no search to the document of approval for ginkgo biloba extract management information, the search results to see the following screenshot:

    At the same time the author also can search guilin xingda pharmaceutical co., LTD. Product approval document information, according to the enterprise only has the ginkgo leaves an approval number: Z20055191 approved by the state. Wan bond (hunan) natural products co., LTD. Leaves only with ginkgo leaf and ginkgo leaf capsules two approval number: Z20027946 approved by the state and Z20026290 approved by the state; The two companies are not ginkgo biloba extract approval number.

    Results show that: ginkgo biloba extract was national drug standard legal income at least 13 years, although after at least three times pharmacopoeia standard edition and revision updates, country did not conduct approval number control of ginkgo biloba extract.

    Eating drug safety medicine digesting the prison [2014] no. 135 the food and drug supervision administration on strengthening in the production of traditional Chinese medicine extraction and extract the supervision and administration of notice stipulated in article 7: the download Ming of proprietary Chinese medicine prescription items national drug standards, and has a separate national drug standards of traditional Chinese medicine extract for the record management. And shall manage the approval number of previously extract after the expiration of the approval document registration no longer accept its application for registration again. This circular into extract filing management. All production or use of the above should be the record of Chinese medicine extract pharmaceutical producing enterprises, shall be in accordance with the record management detailed rules for the implementation of a Chinese medicine extract on ShengJu for the record.

    Visible, ginkgo biloba extract can go for the record the road and make the legalization of its production and operation, but I know is that there is no policy allows extract for the record the enterprise information disclosure.

    At present in China, there is a phytochemistry industry - across the industry. The industry is mainly engaged in production and sales of plant extracts, the production of most products for export, foreign used as a health food or food additive, part used as domestic health care products of raw materials.

    Its industry internal data shows: phytochemistry industry after 20 years of accumulation and development, the scale from more than 50 in 2005 has grown to 2013, more than 160 160 yuan; Phytochemistry enterprise also engaged in the development from 2005 to more than 200 to more than 3000 today.

    Ginkgo biloba extract event has been found in hunan and guangxi both illegal enterprises from jiangsu phytochemistry enterprise no qualification purchases of ginkgo biloba extract, these enterprises has been in a state of "no man", let its development; Country in recent years, the provincial bureau carried out many times on Chinese native medicine preparation and illegal additives, also repeatedly and phytochemistry can't get away. Phytochemistry community, therefore, has become Chinese medicine production specification and purification have to erase the pain!

    More than 40 varieties can also be purchased

    On July 29, 2014, the country issued by the food drug safety medicine the prison [2014] no. 135 the food and drug supervision bureau about strengthen supervision and management in the production of traditional Chinese medicine extraction and extract the notice. For the record, the record of successful phytochemistry enterprises shall, in accordance with requirements of the pharmaceutical GMP production, ensure the quality of its products, its daily supervision by provinces, autonomous regions and municipalities directly under the food and drug administration is responsible for.

    The requirement for plant extract put forward higher requirements. Phytochemistry industry has been in a "no man", its production technology, quality management, hardware setup is uneven. Especially relevant measuring, mixing uniformity, extract, drying, crushing and other key process parameters, infrastructure conditions, purification requirements, process layout, quality inspection center, the storage conditions and so on various aspects and GMP requirements gap is bigger, does not have considered separately, prevent pollution, cross contamination and error accident basic hardware conditions, to satisfy the requirement of the country for the record must improve in all directions.

    If shall practise a system of traditional Chinese medicine extract for the record, only 47 Chinese medicine extract can be put on record management, in which companies can produce, can also be purchased, the other must be extracted enterprises themselves. Because the author side had not pharmacopoeia, the following can temporarily not all varieties of outsourcing of variety, but most basically have covered the main varieties.

    Ginseng stem leaf total saponins, ginseng total saponins, notoginseng total saponin, rhubarb extract, red sage root total phenolic acid extract, tanshinone extract, hawthorn leaf extract, north bean root extract, lamps, and the 373 alcohol saponins, notoginseng total saponin, swollen section wind extract, wormwood extract, andrographis lactone, zhejiang shell liquid extract, daemonorops margaritae element, st John's wort extract, scutellaria baicalensis extract, vitex oil, patchouli oil, acanthopanax extract, ginkgo biloba extract, full mountain red oil, menthol, peppermint oil dementholized, belladonna liquid extract, belladonna extract, angelica liquid extract, cinnamon oil, turpentine, zedoary turmeric oil, Jiang Liu extract, castor oil extract, centella asiatica extract total glycosides, buffalo horn powder concentrate, star anise oil, licorice extract, licorice extract, cassia oil, etc.

    These varieties can be purchased, but given the current plant extract industry from the national requirements, there is still a large gap so the best way to suggest that drug companies or their extraction, otherwise, if supplier product is unqualified, easily.