Ginkgo leaf storm uncovers insider pharmaceuticals to change craftsmanship

"Ginkgo biloba event" is still continuing to ferment, and the State Food and Drug Administration has issued "three gold medals" in succession, emphasizing that Ginkgo biloba should be specially treated. To this end, some companies involved have also started the recall. After the turmoil, the reporter learned that due to changes in technology can greatly reduce the cost, making related companies dare to take the risk. At the same time, it also reflects the lack of regulatory standards for plant extracts.

The State Administration of Food and Drug Administration reiterated on May 31 that all Ginkgo biloba problem drugs should be recalled before June 3rd. Not only the drug market but also the health product market was investigated, and the scope of rectification continued to expand.

Up to now, the "Ginkgo biloba" controversy has involved at least 48 Ginkgo biloba preparation companies and Ginkgo biloba extract production enterprises. The problem of investigation and disposal is mainly to prepare Ginkgo biloba extract with 3% hydrochloric acid instead of dilute ethanol. The State Food and Drug Administration reported that the unauthorized removal of the extraction process had the risk of "decomposing the active ingredients of drugs and affecting the efficacy of drugs."

The Chinese Medicine and Health Products Import and Export Chamber of Commerce (hereinafter referred to as the Medicare Chamber of Commerce) Chinese Medicine Department Yu Zhibin told the "Daily Economic News" reporter that extracting with 3% hydrochloric acid would save 4,000 yuan per ton. According to industry insiders of Ginkgo biloba extract, this will not only reduce costs, but also increase the yield and shorten the basic process time.

Behind the process change, the standard for extracts of Ginkgo biloba leaves needs to be improved. At present, only the "Pharmacopoeia of the People's Republic of China" is the only standard, and only "active ingredients" are tested in the industry, and active or harmful ingredients are not actively detected.

Change the process for cost savings

The "Ginkgo biloba" winds originate from a flight inspection. From May 9 to 11, the State Food and Drug Administration found that Guilin Xingda Industry Co., Ltd. “changed the extracting process to produce Ginkgo biloba extract without authorization and changed it from dilute ethanol extraction to 3% hydrochloric acid extraction; it never purchased a qualified company. Ginkgo biloba extract, and its extraction process is also extracted with 3% hydrochloric acid, and the illegal Ginkgo biloba extract is used for the production and sale of Ginkgo biloba leaves. Illegal Ginkgo biloba extract was imported into listed companies such as Yunnan Baiyao, Connba, Wuyuan Pharmaceutical and Fangsheng Pharmaceutical. The same situation exists for Ningbo Lihua Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Hong Kong-listed company Langsheng Pharmaceuticals.

The State Food and Drug Administration found that changing the illegal production process of Ginkgo biloba extract is not a case. "The current problems in the production of Ginkgo biloba leaves may be systemic risks." "The industry appears to have this supervision, I really did not expect." Xi'an production The person in charge of sales of the Ginkgo biloba extract company told the “Daily Economic News” reporter that some unscrupulous companies in the industry did not extract it with hydrochloric acid for a day or two. The responsible person introduced that current production should use standard ethanol extraction.

Some people in the pharmaceutical industry told the media earlier that the cost of hydrochloric acid is only about one-sixth that of diluted ethanol. “Changing the process can reduce costs,” said Yu Zhibin, a member of the Chinese Medicinal Insurance Association’s Department of Traditional Chinese Medicine. Using hydrochloric acid extraction, a ton of Ginkgo biloba extract can save 4,000 yuan in cost.

The reporter saw from the Internet, Ginkgo biloba extract specifications vary in price, but most of the price of 400 yuan to 700 yuan a kilogram, a ton price of 400,000 to 700,000 yuan. Another plant extract company official told reporters that the industry's selling price is generally 10% higher than the cost.

One ton of anhydrous ethanol is priced from 6000 to 8,000 yuan, and one ton of hydrochloric acid is commonly used at prices ranging from 300 to 600 yuan. Ethanol can be recycled during the extraction process and can be recovered at the end, but the low price of hydrochloric acid is more temptation.

In the eyes of several plant extracts business owners, reducing costs is only one aspect. The use of hydrochloric acid extraction will increase efficiency. A person in charge of the company told reporters that it takes about a week for a small company to produce a ton of Ginkgo biloba extract, and a few tons of output a year. According to her understanding, the use of hydrochloric acid extraction can shorten the basic process time.

"The extraction rate of hydrochloric acid is higher, and more things are extracted." According to the sales person in Xi'an mentioned above, the temperature of the flavonoids in Ginkgo biloba leaves is slightly higher during the extraction process, and it is very easy to lose. The requirements for the extraction environment are very strict. . "If hydrochloric acid is used, some environmental requirements during the extraction process are relatively relaxed, and it is very easy to extract flavonoids and have a higher yield."

The State Food and Drug Administration notified that hydrochloric acid extraction "decomposes active ingredients of drugs and affects the efficacy of drugs." Xi'an sales responsible person said that although the rate is high and time is short, it is not safe.

Industry standards need to be improved

The notified Guilin Xingda Pharmaceutical Co., Ltd. "has a serious violation of law", in addition to alleged violations of the "Pharmaceutical Administration Law," the provisions of the relevant drug management, but also in violation of the "People's Republic of China Pharmacopoeia" on Ginkgo biloba extract standard requirements.

The "Drug Administration Law" stipulates that "Pharmacopoeia" is a national drug standard, and people in the industry have stated that Ginkgo biloba extract "is now only a standard for pharmacopoeia". Yu Zhibin told reporters that if the extract is medicinal, it must be produced in accordance with the Pharmacopoeia; if it is used for health products and dietary supplements, it should be referred to; if it is exported, it needs to be done according to customer requirements and standards.

When it comes to specific extraction process standards, a pharmacist from Sichuan told a reporter of the “Daily Economic News” that companies must first declare the technology and then carry out the system. This time, the exposed problem is that “companies have changed the declared process and have not been allowed to do so. , change without permission".

“In the Ginkgo biloba extraction industry, there has been a (process change) situation.” Yu Zhibin recalled that in 2013, the Medical Insurance Association considered that the standards at that time were not enough to play a role in falsifying and arguing, thus inviting some domestic enterprises to participate. The “International Business Standard for Extracts of Ginkgo Biloba Extract” has been introduced, but it is only a recommended standard. Some companies have tested according to the Pharmacopoeia and exported according to the “International Business Standards”. “No one has to check according to which standard and there is no unity.”

To test the use of the hydrochloric acid process, it was proposed to test the residual solvent. In this regard, Yu Zhibin said that the residue is unpredictable, and the process is mainly changed in composition. As a result, three free components were added to the "International Business Standards". "If it is abnormal, these three indicators will change." "According to adulteration measures, more and more stringent production and inspection standards have been customized."

According to the China Business Report, during the procurement process, Yunnan Xitao Green Pharmaceutical Co., Ltd. (referred to as XiTao Pharmaceutical Co., Ltd.) involved in the inspection will examine the raw materials, including the content of acidic substances, active ingredients, etc. "This problem has arisen in herbal medicine. The person in charge of XiTao Pharmaceutical stated that "some ingredients cannot be tested." Shi Lichen, head of Beijing Dingson Medical Consulting, said earlier that because the relevant industry program only requires the detection of “active ingredients” and does not require the detection of non-effective or harmful ingredients, pharmaceutical companies will not actively detect them in order to save costs.

The standard changes to eat a bite, a long wisdom. The reporter learned from a pharmaceutical company in Sichuan that there is now a new method of detection that is specific to the hydrochloric acid process. “Looking at the active ingredients before, we may now check whether there are residues that should not appear.”

Extraction of extracts is tightened

The reporter noted that the “Ginkgo biloba” affair involved at least 48 companies, most of them because of the illegal ginko leaf extract, and the risk of outsourcing was obvious.

XiTao Pharmaceutical has “one of the largest extraction and production bases in Yunnan Province” and has an annual production capacity of more than 100 tons of Ginkgo biloba extract. This time, it also purchased 6.9 tons from Guilin Xingda Pharmaceutical.

What is the demand for the industry as a whole, apart from mentioning it outsourcing? Yu Zhibin said that according to incomplete statistics, at present, domestic demand for Ginkgo biloba extract and international exports are all around 400 tons.

According to the analysis of the heads of a number of plant extracting companies, the first step is to reduce the cost of extracting extracts from pharmaceutical companies, and the demand for pharmaceutical companies is relatively large. If the entire process is followed, the cycle is long and the cost is high, it is not as good as mining; Process problems, such as the purity of 99% for some extracts, and more if the pharmaceutical companies want to produce, the process can not reach.

Since there is not enough capacity, companies only venture out. At present, the plant extracts 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 was 3.004 billion US dollars, of which, Plant extracts amounted to $1.592 billion.

Industry sources said that after the storm, the plant extraction industry will face a major reorganization. The reporter found a "Notice on Strengthening the Supervision and Administration of Extracts and Extracts from Traditional Chinese Medicine Production" issued by the Food and Drug Administration in 2014 (hereinafter referred to as "Notice"), which explicitly states: Since January 1, 2016, no The Chinese patent medicine manufacturing enterprises that have the ability to extract Chinese medicines will stop production of the corresponding varieties.

The "Notice" also puts forward filing requirements: Successfully filed planting companies should organize production in accordance with the requirements of the "Pharmaceutical Production Quality Management Practice" (GMP). At the same time, to further supervise the outsourcing of Chinese patent medicine manufacturing enterprises, “for extracts of Chinese medicines that belong to the record management, they can be extracted on their own, or they can purchase and use already-registered extracts of Chinese medicine; for Chinese herbal extracts that do not belong to record management, they should Extract.” The reporter consulted with the National Food and Drug Administration. As of now, there are 4 approval numbers for the “Publishing of Traditional Chinese Medicine Extracts” and 57 approvals related to “Extracts” in the “GMP Certification”.