Improve the quality standard of traditional Chinese medicine to motorists

China's traditional Chinese medicine ZhangDongFeng news reporter

Not long ago the "shu pharmaceutical event" by the media exposure, again lead the topic of traditional Chinese medicine standard, some media sword "TCM standard absence," to lead to "qualified" fake drugs. To this, the expert also have words to say, Chinese traditional medicine quality depend mainly on process management, if all standard management, must rely on the bad.

Standard why there are always loopholes

Traditional Chinese medicine and a single component of chemical medicine are different, often by many kinds of medicine, traditional Chinese medicine composition of the most complex, effective component is not clear. In the test index, the content determination of general just detection one to two kinds of medicinal. And, the standard is for the qualified for drugs. That is to say, the standard reflect is the product you should have what, how many, not what shouldn't have. This makes some "smart" enterprise have a loophole.

Reporters in the interview, he heard the drug testing department experts to have a number of such reflection. Some enterprise will plant some extracted from the similar components for release as medicinal materials. For example, using the ginseng extract in leaves of ginseng saponins medicinal ginseng, pretend to be release to reduce costs, and test, the ginseng saponins high content, the products completely "qualified".

Again with "shu pharmaceutical products DanCanPian compound as an example, at present only a pharmacopoeia DanCanTong content determination, including sanqi (panax notoginseng) and other standard components only testing with or without. Similar this kind of situation medicines, some "smart" enterprise is likely to cheat on labor and material, in order to reduce the cost for no less content determination standards to drill medicinal herbs, taking advantage of the pharmacopoeia.

For such behavior, experts are also very helpless, "no way."

Drug testing department for false medicine, is only to later, because don't know in advance what ingredients will join fraudsters. "And," a bigger problem of prepared Chinese food and drug verification research institute experts told a reporter, "at present the basic inspection prepared every day is qualified, and use of genuine traditional Chinese drugs but very few, because of the low standard of prepared."

According to information, the food and drug administration for years through the implementation of "the national drug standards improve action plan", further improve the Chinese herbal medicine, Chinese medicine yinpian and proprietary Chinese medicine standards. By the end of 2009, a total of 2433 a variety of traditional Chinese medicines standards have improved.

However, despite the chemical composition of the traditional Chinese medicine research has been developing for nearly a century, but so far most effective ingredients of traditional Chinese medicine is still not to clarify. "pharmacopoeia 2010 edition of the 663 kinds of Chinese medicinal materials posted a (including yinpian and extract), only 20% of the breed more system based on the chemical composition of the research, and now has to elucidate the varieties of effective ingredients of less than 5%". China's food and drug verification research institute traditional Chinese medicine experts LinRuiChao chief told reporters.

Therefore, a few false enterprise and drill loophole pharmacopoeia of the enterprise, we also is not surprising. And Chinese medicine quality standards increase will is an eternal topic.

Traditional Chinese medicine is urgent measures to improve the injection

Traditional Chinese medicine injection since 2006 "was called" later, the standard question has become a hot social concern. In 2009, in order to improve the safety of tcmi, effectiveness, and quality control, the food and drug administration launched the safety evaluation of tcmi again.

The pharmacopoeia committee chief national Chinese medicine experts ZhongZhi money has held "in jiangsu province lianyungang tcmi improve quality standards and testing method conference on points out, we carry on the traditional Chinese medicine injection, and international practice to evaluate the curative effect of the evaluation is different, we again the evaluation standard and is again foothold internal components, etc. Because tcmi many varieties is the s and s, was developed by the scientific research, production conditions, not perfect, and the lack of standards that a need to make up a missed lesson. He stressed that, Chinese traditional medicine injection now is higher standard. Some basic work good varieties can improve, "first standard evaluation" after.

And set up the "scientific, reasonable and economic, practical, environmental protection" tcmi quality standard, is the consensus of the expert.

Money ZhongZhi introduced in the 2015 edition of the pharmacopoeia outline, said tcmi improvement ideas to the standard is, first, safeguarding the drug use security; Second, the method must be science, relative now standard level should be advanced, operation must be practical. Third, in the innovation also want to consider inherited, not blindly pursuing high, do not easily knocked out, to introduce the concept of drugs, can use simple economics method of quality control, and no need to pursue advanced and complex method.

His special hints enterprise, Chinese traditional medicine injection measures to improve the process, the source and producing area is key point; But also pay attention to the process and process control connected. Traditional Chinese medicine injection raw material is medicinal herbs, end products, stable it is difficult to do, no uniform standard enterprise, semi-finished products must build a semi-finished products standards. Traditional Chinese medicine injection to speak of process control, on-line monitoring actual only half done, want to have a loop, want to have the means to solve.

Establish standard must speak the scientific nature

For some enterprise reflect, the release of standard in practical work often appear even if the good medicine also short of money, ZhongZhi gives the following interpretation.

Drug standard, according to their own physical and chemical is drugs and biological characteristics, in accordance with approved prescription source, production process and storage transport process each link for the possible effects of the drugs used to test whether the quality requirements and measure to drug use its quality is stable technical regulations uniform.

And researchers in the draft standards, often ignore is the storage, transportation process each link impact. For example, for research of medicinal materials is often fresh, sample is also produced in research data, when is so a. But in fact, the enterprise of medicinal materials is often a put two years, then go to feeding, do out of the drug may not qualified. So make standard must take all of these factors into consideration.

A standard on why after several years, is to fully consider the process.

"National standard" is the market access standard. The enterprise standard should be considered to ensure that the products from the production come out to the public, to the effective period of not less than ", "national standard, so, the enterprise must be higher than the standard factory" gb ".

Money ZhongZhi also talked about a point of view, Chinese traditional medicine quality depend mainly on process management. Standard position, in fact is the final supervision and market.

He thinks, at present, our country of medicine management idea is standardized management. But, the standard to carry the thing is limited, loading not so much responsibility. The quality of the Chinese traditional medicine is production comes out, and not out of the inspection. Think about it, it's the first workshop in the fields and production process, there are so many link, the standard knows how? So, Chinese traditional medicine quality by standard to management, all must be bad. The This concept is to gradually change.