Traditional Chinese medicine and western medicine low standard of traditional Chinese medicine

Our correspondent ZhangDongFeng

China's traditional Chinese medicine reported

        "Now management concept some not clear, even HuangLianSu, camphor these traditional Chinese medicine was as the western medicine, artesunate and batch of western medicine. Management with western go, so their limitations and living. A wrong idea, often can disrupt the vision, once the chemical composition clear becomes the western medicine, so, traditional Chinese medicine research were all clear into the western medicine, Chinese traditional medicine development how?

        "Now, the results of varieties are the last century 50 s to eighty s by local (provincial) approved. 1985 years after the implementation of the pharmaceutical administration law, the unified national examination and approval over new drugs, these varieties by landmark to gb, through the local standards to rectify, expert evaluation, transition to come over. Now in the market and 60 kinds.

        "The existing traditional compound preparations basic research of the weak originally, if the enterprise can't improve quality standards, and accordingly the efficacy and safety of the research, the hard to avoid in the future will be eliminated.

        Recently, the guangzhou baiyun mountain cold clear capsule is Hong Kong department of health detection contain western medicine ingredient "acetaminophen" and recalled, news cause for mainland China and Hong Kong Chinese medicine is under the lower high standard of talk, the reporter has visited the relevant Chinese medicine management and new drug evaluation experts, of this question about reading.

        Drug management concept are different

        ZhangShiChen professor, served as deputy director of the health YaoZhengJu, state food and drug administration registration division of priests, should the Hong Kong government department of health YaoPin helped boost to visit Hong Kong Chinese medicine such as Chinese medicine registered management related work. Mainland China and Hong Kong Chinese medicine standard is what tall what is low, his most say.

        In view of "Hong Kong not allowed in Chinese medicine to join the western medicine composition, Hong Kong is far higher than the mainland Chinese standard standard" view, ZhangShiChen said, 1997 Hong Kong did not return before, british-era of TCM in Hong Kong has no legal status, not legal, so, Hong Kong no legal management of traditional Chinese medicine, no approval said Monday. Doctor of traditional Chinese medicine, Chinese medicine shop open nobody tube, Hong Kong is from the mainland of traditional Chinese medicine of the past. What about the strict management! I to Hong Kong is to help make Chinese medicine management regulations. Hong Kong 1999 issued regulations of Chinese medicine, equal to the legislation.

        But, Hong Kong or commonwealth management concept, and claims that can't mix with traditional and western medicine of traditional Chinese medicine containing ingredients not allowed into. And in the mainland, traditional Chinese medicine and western medicine prescription drug use is legal, but will speak the truth, must go through the state food and drug administration for approval. "I think it is two different management idea, let's management idea than their strong." ZhangShiChen said.

        In mainland China, traditional Chinese medicine and western medicine formula can be why together? ZhangShiChen think three reasons, first, a traditional Chinese traditional formula, in Chinese medicine has many is a single chemical composition of medicine, traditional Chinese medicine it as for Chinese traditional medicine, also be the sexual flavour, major functions, such as synthetic borneol, camphor, borax, light powder, red pink, arsenic. But western thought these are chemical medicine. This is the idea of the difference.

        2 it is the western medicine in China, the traditional Chinese medicine with western medicine to use in, and to increase the curative effect of traditional Chinese medicine, a republic. If ZhangXiChun "aspirin gesso soup", and not just a liberation.

        Three is the "drug administration law after coming on stage strict management, the traditional formula that combined to truth, what role, what are the characteristics.

        ZhangShiChen also told reporters that a view, "now management concept some not clear, even HuangLianSu, camphor these traditional Chinese medicine, western medicine to the artemisinin is batch of western medicine. Management, so that they go with western their thumbs and limited live. A wrong idea, often would disrupt the vision, once the chemical composition becomes the western medicine, so clearly, Chinese traditional medicine are clearly all the research into the western medicine, Chinese traditional medicine development how?"

        High threshold for examination and approval,

        "Equal to three new difficulty"

        In Hong Kong Chinese medicine in western medicine composition ban added, but in the mainland, in accordance with the new drug approval method "is legal. Traditional varieties in China joint formula called traditional compound preparations, has strict examination and approval requirement.

        State pharmacopoeia committee executive committee members extraordinary week professor told reporters, traditional Chinese medicine and western medicine according to the compound preparations of, basically see to what medicine give priority to. Such as traditional Chinese medicine is given priority to, add some vitamin and so on, should be in Chinese traditional medicine group; Such as the western medicine is given priority to, add a little Chinese medicine, western medicine should be according to the batch. "If the curative effect of traditional Chinese medicine, western medicine has a 30% 40% of the curative effect of traditional Chinese medicine, in this way also."

        "1 + 1 must be greater than 2." Weeks extraordinary insisted. If the role of Chinese traditional medicine is 1, the role of western medicine is 1, so, 1 plus 1 must be greater than 2, that is to join the western medicine to help increase after the curative effect of traditional Chinese medicine, Chinese medicine will not be allowed to add in western medicine. If 1 + 1 = 2, you'll certainly not, not be approved. But also to do the positive control, including the curative effect of traditional Chinese medicine, western medicine, the curative effect of traditional Chinese medicine and western medicine the curative effect, and placebo-controlled, four controls are to have the same cases.

        "Traditional compound preparations to do the Chinese traditional medicine respectively pharmacodynamics experiment, western medicine, and pharmacodynamics experiment of Chinese medicine for the traditional Chinese medicine of the test synergia from western medicine. So, make a traditional compound preparations, equal to three new drugs. The difficulty of pure Chinese herbal medicine is much more difficult than make." State pharmacopoeia committee GaoXueMin senior member of professor told reporters that point of view.

        Still in use of formal variety

        Only 60 kinds

        Traditional compound preparations were designed to enhance the curative effect, reduce adverse reactions, achieve the purpose of the specimen. In fact, this kind of to traditional Chinese medicine composition is given priority to, complementary with right amount square of western medicine composition in the treatment of many diseases indeed, played good curative effect. In an interview with reporters heard the affirmation of the experts.

        According to expert introduction, now, the results of varieties are the last century 50 s to eighty s by local (provincial) approved. 1985 years after the implementation of the pharmaceutical administration law, the unified national examination and approval over new drugs, these varieties by landmark to gb, through the local standards to rectify, expert evaluation, transition to come over. In those days the examination and approval policy is more comfortable, but now more and more strictly.

        This kind of varieties, the most common is cold remedies, cough PingChuanYao, transdermal of external use, and was a small amount. Such as, cold medicine and vitamin C, caffeine, massacre, such as acetaminophen, sensitive, cough PingChuanYao and ammonium chloride and aminophylline, absorbed through skin external use and salicylic acid methyl ester, individual oral glucose-lowering with optimal, etc. Now in the market and 60 kinds.

        Traditional compound preparations

        Adverse reactions cannot be neglected

        Traditional compound preparations adverse reaction of the problem is of particular concern you, weeks extraordinary told reporters, this kind of medicine all the pharmacopoeia, should be very standard. But to not enter pharmacopoeia varieties, we couldn't tube.

        According to zhou extraordinary introduces, at present, the traditional Chinese medicine in China pharmacopoeia posted there only a few part of varieties, only 30% of the total approved drugs. And the United States is 70% of the approved drug income pharmacopoeia, another 30% didn't belong to the variety of patent protection.

        Now, the traditional compound preparations in security hidden danger a lot. Such as though state food and drug administration has repeatedly requirements production enterprise product manual and perfect packaging, labels, but there will still be some enterprise in the manual "DaMaiFu", not labeled with western medicine composition; Some doctors prescription medicine pharmacy or sell not fulfill the tip obligation; Some patients don't know its composition, it will be as a pure Chinese herbal medicine preparation, think more to eat it doesn't matter, any dose or for long-term use, may cause repeated drug use or exceed dosage drug use. Such as clinical use extensive d C YinQiao piece, just because of adverse reactions high-risk, appeared in the last year the national adverse drug reaction monitoring center issued 32 of the issue of the adverse drug reaction information bulletin ", the main reason is the combination of the use and its composition similar to the other drugs.

        Another such as lowering blood sugar medicine, fall blood pressure medicine, if the dose can lead to serious side effects. "Nearly pills, over the age of 60 patients use is easy to cause hypoglycemia, risk." Special done/drug alert research weeks shot extraordinary said.

        The increase of the standard will be eliminated

        Because of this, the industry of the traditional views of compound preparations have been not unified. The drug agency in China for its future development hold what attitude? Reporters from the mouth of the experts, roughly know some.

        "Traditional compound preparations have its characteristics. China absolutely can't say no to allow and banned. But national policies did not lead." ZhangShiChen said.

        "Policy allows, but the threshold is very high, great input, difficulty, and nobody called the equal to cancel in disguised form." Weeks that extraordinary.

        GaoXueMin words more certain, "don't support, not destroyed."

        According to reporter understanding, the food and drug administration in the "eleventh five-year plan" period has started to implement "the national drug standards improve action plan", backward standard and variety. Don't improve the standard of the varieties by natural selection to market. While the existing traditional compound preparations basic research of the weak originally, if the enterprise can't improve quality standards, and accordingly the efficacy and safety of the research, the hard to avoid in the future will be eliminated.