"Ginkgo biloba leaf" reveals the inside story of the industry

"Ginkgo leaf incident" is still in continuous fermentation, the State Food and Drug Administration recently issued "three gold medals", emphasizing the special treatment of ginkgo leaf For this reason, some enterprises involved have also started recall Behind the storm, the reporter learned that the change of technology can greatly reduce the cost, making the relevant enterprises dare to take risks At the same time, it also reflects the lack of regulatory standards of plant extract industry The State Food and Drug Administration reiterated on May 31 that it would recall all ginkgo leaf related drugs before June 3 We will not only investigate the drug market, but also the health care market, and the scope of rectification will continue to expand Up to now, the "Ginkgo biloba" disturbance involves at least 48 Ginkgo biloba preparation manufacturers and Ginkgo biloba extract manufacturers The main problem to investigate and deal with is to use 3% hydrochloric acid instead of dilute ethanol to prepare Ginkgo biloba extract The State Food and Drug Administration reported that there was a risk of "decomposing the effective ingredients of drugs and affecting the efficacy of drugs" by changing the extraction process without authorization Yu Zhibin, the Ministry of traditional Chinese medicine of China Chamber of Commerce for the import and export of medical and health care products (hereinafter referred to as the chamber), told the daily economic news that with 3% hydrochloric acid extraction, 4000 yuan per ton of cost can be saved Industry insiders of Ginkgo biloba extract enterprises say that this can not only reduce costs, but also improve the yield and shorten the basic process time Behind the process change, the standard of Ginkgo biloba extract needs to be improved At present, only Pharmacopoeia of the people's Republic of China is the only standard, and only "effective ingredients" are detected in the industry, and the non effective or harmful ingredients will not be detected actively In order to save cost, the "Ginkgo biloba" process was changed because of a flight inspection From May 9 to 11, the State Food and Drug Administration found that Guilin Xingda Industry Co., Ltd "changed the extraction process to produce Ginkgo biloba extract from dilute ethanol to 3% hydrochloric acid without authorization; never qualified enterprises purchased Ginkgo biloba extract illegally, and its extraction process was also 3% salt acid extraction", and also used the illegal Ginkgo biloba extract for Ginkgo biloba production and sales The illegal Ginkgo biloba extract logistics has entered Yunnan Baiyao, Kangenbei, Qianyuan pharmaceutical, Fangsheng pharmaceutical and other listed companies Ningbo Lihua Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Longsheng Pharmaceutical Co., Ltd., a Hong Kong listed company, also has the same situation The State Food and Drug Administration found that changing the process of illegal production of Ginkgo biloba extract is not a case, "the current problems in the production of Ginkgo biloba drugs may be systemic risks." "I didn't expect this supervision in the industry." The head of sales of a Ginkgo biloba extract company in Xi'an told the daily economic news that some illegal enterprises in the industry have been extracting with hydrochloric acid for not a day or two The person in charge said that dilute ethanol should be used for extraction according to the current production standards Some people in the pharmaceutical industry have previously told the media that the cost of hydrochloric acid is only about one sixth of that of dilute ethanol "Changing the process can reduce the cost," Yu Zhibin, the Ministry of traditional Chinese medicine of the chamber of Commerce for medical insurance, told reporters By using hydrochloric acid to extract, each ton of Ginkgo biloba extract can save 4000 yuan in cost The reporter saw from Alibaba that the price of Ginkgo biloba extract was different in different specifications, but most of them were priced at 400-700 yuan per kilogram and 400000-700000 yuan per ton The head of another plant extraction company told reporters that the price in the industry is generally 10% higher than the cost The price of anhydrous ethanol is 6000-8000 yuan per ton, and the price of hydrochloric acid is 300-600 yuan per ton Ethanol can be recycled or recycled in the extraction process, but the low price of hydrochloric acid is more attractive According to the heads of several plant extraction enterprises, cost reduction is only one aspect, and hydrochloric acid extraction is more efficient A person in charge of an enterprise told reporters that it takes small enterprises about a week to produce a ton of Ginkgo biloba extract, and a few tons of output a year According to her understanding, hydrochloric acid extraction can shorten the basic process time "Hydrochloric acid extraction rate is higher, and more things are extracted." According to the above-mentioned person in charge of sales in Xi'an, the flavonoids in Ginkgo biloba leaves are easily lost when the temperature is a little higher during the extraction process, and the requirements for the extraction environment are very strict "If hydrochloric acid is used, some environmental requirements are relatively loose during the extraction process, so it is easy to extract flavonoids, with a higher yield." According to the State Food and drug administration, hydrochloric acid is used to extract "effective ingredients of drugs, which will affect the efficacy of drugs" Although Xi'an Sales Director has a high rate and a short time, it is not safe The industrial standard of Guilin Xingda Pharmaceutical Co., Ltd., which needs to be improved in this notice, has "serious illegal acts" In addition to being suspected of violating the provisions of the drug administration law, it also violates the requirements of the standard of Ginkgo biloba extract in the Pharmacopoeia of the people's Republic of China "Drug Administration Law" stipulates that "Pharmacopoeia" is the national drug standard, industry insiders said, Ginkgo biloba extract "now only Pharmacopoeia this standard." Yu Zhibin told reporters that if the extract is used for medicinal purposes, it must be produced according to the Pharmacopoeia; if it is used for health products and dietary supplements, it must be carried out by reference; if it is to be exported, it needs to be done according to customer requirements and standards Concerning the specific extraction process standards, a pharmaceutical industry person in Sichuan told the reporter of daily economic news that the enterprise first applied for the process, and then carried out the preparation and extraction The problem exposed this time was that "the enterprise changed the application process, and changed it without permission" "There has always been such a situation (process change) in the ginkgo leaf extraction industry" Yu Zhibin recalled that in 2013, the chamber of Commerce for medical insurance thought that the standards at that time were not enough to play a role in identifying and defending the fake, so it invited some domestic enterprises to participate in the launch of "international commercial standards for ginkgo leaf extract", but it was only a recommended standard Some enterprises tested according to the Pharmacopoeia and exported according to the According to "international business standards", "no one has to test according to which standard, there is no unity." To test whether hydrochloric acid process is used, it is proposed to test solvent residue In this regard, Yu Zhibin said that the residue is difficult to determine, and the main reason for the change of the process is that the composition has been changed Therefore, three free components are added to the international business standard, and "if it is abnormal production, these three indicators will change" "According to the means of adulteration, more and more strict production and inspection standards are customized." Person in charge of sales in Xi'an According to China business daily, in the procurement process, the involved Yunnan Xitao green Pharmaceutical Co., Ltd (hereinafter referred to as Xitao pharmaceutical) will test the raw materials, including the content of acid substances, effective ingredients, etc why "qualified" medicinal materials have this problem? According to the person in charge of Xitao pharmaceutical, "some ingredients cannot be tested" Shi lichen, head of Beijing Dingchen pharmaceutical consulting, previously said that because the relevant industry outline only requires the detection of "effective ingredients" and does not require the detection of non effective or harmful ingredients, pharmaceutical companies usually do not take the initiative to detect in order to save costs We should learn from the mistakes in the revision of standards According to a reporter from a pharmaceutical industry in Sichuan Province, there is a new test method for hydrochloric acid process "Before, we looked at the effective ingredients, and now we may check if there are any residues that should not appear." The reporter of "daily economic news" noted that at least 48 companies were involved in the "Ginkgo biloba leaf" storm, most of which were due to the purchase of illegal Ginkgo biloba leaf extract, so the outsourcing risk was obvious Xitao Pharmaceutical Co., Ltd has "one of the largest extraction production bases in Yunnan Province" Its annual production capacity of Ginkgo biloba extract is more than 100 tons, and it also purchased 6.9 tons from Guilin Xingda Pharmaceutical Co., Ltd Besides self delivery and outsourcing, what is the demand of the whole industry? According to incomplete statistics, at present, domestic demand and international export of Ginkgo biloba extract are about 400 tons, Yu said According to the analysis of the directors of many plant extraction enterprises, the first step is to reduce the cost of the extraction by pharmaceutical enterprises The demand of pharmaceutical enterprises is large If the whole process of self extraction goes down, the cycle is long and the cost is high, it is not as cheap as the extraction The second step is the process problem, for example, if some extracts want to get 99% purity, if pharmaceutical enterprises want to produce, the process can not reach, and the investment will be more Due to insufficient self capacity, the enterprise has to take risks in outsourcing At present, the plant extract industry has gradually become a "sunrise industry" The market scale has grown from more than 5 billion yuan in 2005 to more than 16 billion yuan in 2013 From January to November 2014, the total export volume of traditional Chinese medicine products reached 3.004 billion US dollars, including 1.592 billion US dollars of plant extract Industry insiders said that after the storm, the plant extraction industry will face a major reorganization The reporter found a notice of the food and Drug Administration on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese medicine (hereinafter referred to as the notice) issued in 2014, which clearly stated that: from January 1, 2016, any Chinese patent medicine manufacturing enterprises that do not have the ability of extraction of traditional Chinese medicine will stop the production of corresponding varieties The notice also puts forward the filing requirements: the successful planting and extracting enterprises shall organize production in accordance with the requirements of GMP At the same time, further supervision should be carried out on the outsourcing of Chinese patent medicine manufacturers, "for the Chinese herbal extracts that belong to the record management, they can be extracted by themselves or purchased and used; for the Chinese herbal extracts that do not belong to the record management, they should be extracted by themselves." The reporter inquired in the State Food and drug administration that up to now, there are four approval numbers in the "record publicity of Chinese herbal extracts" and 57 approval documents related to "extracts" in the "GMP certification" "Ginkgo biloba event related enterprises Guilin Xingda Pharmaceutical Co., Ltd wanbond (Hunan) Natural Medicine Co., Ltd Qianyuan pharmaceutical, Fangsheng pharmaceutical, Yunnan Baiyao, Haiwang biological, Kangenbei, Hansen pharmaceutical, Yibai pharmaceutical, Xinbang pharmaceutical, etc