【直报网5月22日讯】（21世纪经济报道）5月20日，食药监总局通报了26家问题药品企业名单，并将在全国范围内组织开展银杏叶药品专项治理。

CNDSN may 22 news (21st Century Business Herald) on May 20, the food and Drug Administration informed the 26 drugs list of enterprises, and in the nationwide organize Ginkgo biloba drugs special governance.

据悉，食药监总局在对低价销售银杏叶药品企业的飞行检查中发现，桂林兴达药业有限公司和万邦德（湖南）天然药物有限公司违规改变银杏叶提取生产工艺、非法生产提取物，并将这些产品销售给包括云南白药(000538,股吧)、仟源医药(300254,股吧)、方盛制药(603998,股吧)三家上市公司在内的24家医药企业。

It is reported that the food and Drug Administration in flight inspection of low-priced sales of Ginkgo biloba drugs firms found, Guilin Xingda Pharmaceutical Co., Ltd. and Wan Bangde (Hunan) Natural Medicine Co., Ltd. illegal change of production process, illegal production of extract of Ginkgo biloba extract and these products are sold to including Yunnan Baiyao (000538, stock it), Qian source pharmaceutical (300254, stock it), Fangsheng pharmacy (603998, Guba) three listed companies, including 24 pharmaceutical enterprises.

对此，仟源医药证券事务代表薛媛媛向21世纪经济报道记者表示，双方合作之前有考察过公司资质，并通过了备案审查，但是后期为什么出现这一产品质量问题，还需要进一步的调查。

In this regard, Yuan Yuan Xue thousand source medical securities affairs representative to the 21st Century Business Herald reporter said before the cooperation between the two sides have the inspection of the qualification of the company, and through the review of the record, but later why this product quality problems, but also the need for further investigation.

“企业改变加工工艺，主要是为了节约成本，同时形成价格优势。”卓创资讯中药行业分析师张斌认为：“中药提取物目前也没有明确的行业标准。之前在中药提取物行业并没有强制进行GMP改造，加上委托代加工现象比较多，行业监管难以展开。”

"Enterprises change the processing technology, mainly to save costs, while the formation of price advantage." Www medicine industry analyst Zhang Bin said: "traditional Chinese medicine extract is also not clear industry standards. Before the extract of the Chinese medicine industry has not forced GMP transformation, and the Commission of the phenomenon of the generation of more, industry regulation difficult to start."

26家药企中招

26 companies caught

根据通报，桂林兴达药业将银杏叶提取生产工艺由稀乙醇提取改为3%盐酸提取，同时从不具备资质的企业购进以盐酸工艺生产的银杏叶提取物，用于生产银杏叶片，并将外购的提取物销售给其他的药品生产企业，伪造原料购进台账和生产检验记录。

According to the bulletin, Guilin Xingda pharmaceutical will Ginkgo biloba extract production process from dilute ethanol extract changed to 3% hydrochloric acid extraction and never have qualified enterprises to purchase by hydrochloric acid process for the production of Ginkgo biloba extract for production of gingko leaf and will extract sales outsourcing to other pharmaceutical producing enterprises, forged raw material purchase ledger and production inspection records.

而万邦德（湖南）天然药物有限公司则是用购进的银杏叶提取物生产银杏叶片和银杏叶胶囊等制剂，伪造原料购进台账和生产检验记录。

And limited company of natural drug Wan Bangde (Hunan) is purchased ginkgo leaf extract production of gingko leaf and Ginkgo Ye Jiaonang etc. preparation forged raw material purchase ledger and production inspection records.

“银杏片的主要药效成分是黄酮，黄酮是属于脂类，不是溶性物质，所以在提取过程中必须使用醇类物质。因为使用甲醇提取的成品毒性会比较大，所以主要使用稀乙醇。”张斌告诉21世纪经济报道记者，该企业使用盐酸来提取会不会导致酸性超标，是一个比较重要的检测方向，需要看企业的用量和使用方式。

"The main active ingredient of the ginkgo tablet is the flavone, the flavonoid belongs to the lipid, is not the soluble substance, therefore must use the alcohol substance in the extraction process.. Because the use of methanol extraction of the toxicity of the more large, so the main use of dilute ethanol." Zhang Bin, told 21st Century Business Herald reporter, the enterprise use hydrochloric acid to extract will not lead to acidic exceeded, is a more important direction detection, need to look at the amount of enterprises and use.

据了解，银杏叶提取物的化学成分中含有银杏酸这一有害成分，可引起严重的过敏反应，还会引起基因突变、神经损伤等。鉴于此，2010年版《中国药典》对银杏叶制剂规定，银杏酸含量应在10ug/g以下。而市场上银杏叶提取物的质量参差不齐，主要表现在银杏酸含量的控制的不同，其价格亦相差悬殊。

It is understood that the chemical constituents of Ginkgo biloba extract contains a harmful ingredient of ginkgo acid, can cause serious allergic reaction, but also cause mutations, nerve damage, etc.. In view of this, the 2010 edition of the Chinese pharmacopoeia for Ginkgo biloba leaves preparation, ginkgo acid content should be below 10ug/g. The quality of the extracts of Ginkgo biloba leaves is different, and the price of the Ginkgo biloba leaves is different from the control of the content of the Ginkgo biloba..

“相比较稀乙醇，盐酸成本便宜很多，价格大概是稀乙醇的六分之一。但是盐酸是强酸，按照制作的过程中加入的比重，对最后成品的影响会不同，酸含量超标也是很有可能的。”医药行业分析师赵镇说道。

"Relatively dilute ethanol, hydrochloric acid cost much cheaper, the price is probably 1/6 of dilute ethanol. But hydrochloric acid is strong, according to the proportion of added in the process of making, impact on the final product will different acid content exceeded is very likely. " Pharmaceutical industry analyst Zhao Zhen said.

不过，云南白药对这一通报予以否认。21日午间，云南白药发布澄清公告称：“云南白药集团股份有限公司及其所属生产单位以前不生产含银杏叶提取物的任何制剂产品，也从未使用过通告中所提及的"银杏叶提取物"。”

However, Yunnan Baiyao denied the report. 21 afternoon, Yunnan Baiyao issued to clarify the notice said: "Yunnan Baiyao Group Co., Ltd. and its affiliated production unit before does not produce containing ginkgo biloba extract any drug product, also never used the notice referred to in the" ginkgo leaf extract "."

同日，方盛制药亦发布公告称，已成立了由质量部、生产技术部、采购部等相关部门组成的调查小组，对桂林兴达供应的银杏叶提取物展开全面的内部调查。“公司已终止与桂林兴达的所有业务往来，并将依法向其索赔。”

On the same day, Fangsheng pharmacy also announced that has established the investigation team composed of quality department, production technology department, purchasing department and other relevant departments, launched a comprehensive internal investigation of Guilin Xingda supplies of Ginkgo biloba extract. "The company has terminated all business dealings with Guilin, Xingda and will be legally its claim."

Regulatory challenges

“中药行业所有的标准和行业规范，都是针对原料、饮片和中成药，在中药提取物和制剂领域并没有明确的法律法规和行业标准。提取物在中国药典里面有提到相关的限定和检测，以及生产检测工艺的要求，但也只是一个指导性的大纲。”张斌说道。

"All the standards and industry norms of the Chinese medicine industry are aimed at raw materials, pieces and proprietary Chinese medicine, and there are no clear laws and regulations and industry standards in the field of Chinese herbal extracts and preparation. The extract has the relevant limits and testing in the Pharmacopoeia of China, as well as the requirements of the production testing process, but it is only a directive outline.." Zhang Bin said.

据国家食药监总局（CFDA）数据库资料显示：截至2015年1月，国内生产和进口的银杏叶提取物生产销售厂商已有113家，其中注射剂13家，口服制剂100家。据不完全统计，全国现在银杏加工产业链上的生产经营厂商有300多家，主要生产银杏叶提取物及下游产品，包括药品、保健品、化妆品、食品和饮料等系列产品。

According to the State Food and Drug Administration (CFDA) data showed: as of January 2015, Ginkgo biloba extract production and sales companies in domestic production and imports has 113, including 13 injection, oral preparation of 100. According to incomplete statistics, the country now gingko processing industry chain of production companies have more than 300, mainly the production of ginkgo leaf extract and its downstream products, including medicines, health products, cosmetics, food and beverage products.

“虽然生产加工的企业并不多，但是监管还是比较难。”张斌告诉记者，一方面，长期以来中药的加工环节凭借自身的经验，许多加工企业就钻监管的漏洞，按照自己的古方子或者自己比较擅长和习惯的加工流程来操作。另一方面，中药加工企业的整体规模都比较小，在市场竞争中，尤其是面对外资这些外来竞争者，主要还是选择降低成本来获得价格优势。

Although the production and processing of the enterprise is not much, but the supervision is still difficult." Zhang Bin, told reporters, on the one hand, for a long time the process of traditional Chinese medicine by virtue of their own experience, many processing enterprises drill regulatory loopholes, in accordance with their ancient prescription or more adept and habits of the process to operate. On the other hand, the overall size of the Chinese herbal medicine processing enterprises are relatively small, in the market competition, especially in the face of these exotic foreign competitors, the main thing is to choose to reduce costs to get the price advantage.

而北京鼎臣医药咨询负责人史立臣则认为：“银杏叶提取物行业算不上价格战，厂家转变加工工艺更多的是为了获得更高的利润，因为银杏叶应用领域很多，所以下游的需求也很大。”

Beijing Dingchen medical consultation, which is responsible for Shi lichen said: "Ginkgo biloba extract industry not price war, manufacturers to shift process more is in order to obtain higher profits, because Ginkgo biloba has been applied in many areas, so the downstream demand is also very strong."

据了解，中国是全球第一大银杏叶提取物生产国。由于有效成分含量较多、应用较广，银杏叶提取物制剂早已载入2009年《国家医保药目录》的药物，并牢牢占据了脑血管疾病及抗痴呆中药提取类药物的市场平台。据不完全统计，截至2013年，国内医院脑血管及抗痴呆药物市场达到225亿元，其中银杏叶制剂市场占据了20%，国内银杏叶制剂市场约为45亿元。

It is understood that China is the world's first major Ginkgo biloba extract producer. Because the content of effective components in more and more extensive, ginkgo leaf extract preparation has been recorded in 2009 the national medical insurance medicine catalogue of drugs, and firmly occupy the cerebral vascular disease and extraction of traditional Chinese medicine of anti dementia drugs market platform. According to incomplete statistics, as of 2013, the domestic hospital cerebrovascular and anti dementia drug market reached 225 million yuan, the ginkgo leaf preparation market accounted for 20%, domestic ginkgo leaf preparation market is about 45 billion yuan.

另据博思数据显示，目前全球银杏叶提取物生产主要集中在中国、德国和法国。2013年，上述三国年度产量占全球总产量的78.3%。其中，中国银杏叶提取物产量为348.6吨，占同期全球产量的48.52%；德国产量为107.3吨，占比为14.93%；法国产量为106.8吨，占比为14.86%。

According to Booz data, the current global production of Ginkgo biloba extract mainly concentrated in Chinese, Germany and france. In 2013, the annual output of the three countries accounted for 78.3% of total global output. Among them, the output of Ginkgo biloba extract of China was 348.6 tons, accounting for 48.52% of the global output; German output was 107.3 tons, accounting for 14.93%; French output was 106.8 tons, accounting for 14.86%.

“之前在中药提取物并没有强制进行GMP改造，如果该生产车间是严格按照GMP标准生产的话，那么后期还可以查出问题主要出现在哪个环节。但是如果没有按照GMP改造的话，那很难去追查。”赵镇补充说道。

"Before in the extract of traditional Chinese medicine and there is no mandatory GMP transformation, if the production workshop is strictly in accordance with the GMP standard production, then the latter can also be found mainly in which links. But if there is no change according to the GMP, it is difficult to pursue." Zhao added, said.

值得一提的是，银杏叶提取物行业迎来整顿潮。国家食药监总局表示，将组织对市场销售的银杏叶制剂进行全面抽验，并对部分企业进行飞行检查，及时向社会公布检验和检查结果。

It is worth mentioning that Ginkgo biloba extract industry usher in the tide of rectification. The State Food and Drug Administration said that will organize the market sales of Ginkgo biloba extract to conduct a comprehensive testing, and flight inspection on the part of the enterprise, timely publication of the inspection and examination results to the society.