The traditional Chinese medicine quality evaluation system is not yet complete

The traditional Chinese medicine quality evaluation system is not yet complete
Li Wei, cub reporter of this newspaper, bank up reporter with earth money red one engaged in standard research of traditional Chinese medicine expert tell such a thing at medical the intersection of quality control and international forum a few days ago forever: Once he goes to a factory that make traditional Chinese medicine, see the workshop stopping a small-scale way rolling machine. He wonders very much, just understands, unexpectedly this machine is used for grinding and rolling traditional Chinese medicine dreg after asking to the person in the factory. Originally, factory as garbage disposal, never expect after peripheral peasant pick up, mix, mix, boil, dry by any new cow bezoar come out, directly dregs of a decoction cow bezoar in the dregs of a decoction in the past, sell for, answer in the factory also. For some time, the quality of medicines containing cow bezoar that this pharmaceutical factory produces does not always pass, it is found that later " Processed " Cow bezoar get into trouble. This pharmaceutical factory have to buy the way rolling machine, has pulverized and dealt with dregs of a decoction. A word spreads in the traditional Chinese medicine circle: Export the best crude drugs, the better one is in hospital, pharmacy of giving a bit more again, the worst one is handed over to the pharmaceutical factory. Therefore the problem of how to promote traditional Chinese medicine quality initiated has aroused the attention from every personage on this forum. Exceed the introduction according to Lin Rui, researcher of Nat'l Pharmaceutical Biological Products Control Inst, the past 20 years, our country has made sure progress in the analysis and research of the complicated system drug effect material base of traditional Chinese medicine, have made very great progress on new technology and application in traditional Chinese medicine is analysed and researched of the new method. In the past 10 years, workers are mainly as follows, in the traditional Chinese medicine analytical method and technology that adopts that the medicine of our country is analyzed High-efficient liquid phase chromatogram law, gaseous phase chromatogram, high-efficient capillary electric swimming, high-efficient thin layer chromatogram law and chromatogram mass spectrum unite and use technology. Among them analyze technical application presents the trend that rises year by year, has reflected traditional Chinese medicine of our country to analyze competence and international repercussions are promoting progressively. The expert participating in the conference proposes, the country has strengthened the management of the quality of medicines in recent years, but medicines quality testing and situation controlled still allow of no optimist. Traditional Chinese medicine is studied, ignored the further investigation of the effective material base of traditional Chinese medicine for a long time, especially it is studied that main drug effect material to the complicated system of traditional Chinese medicine is basic, lack new thinking and effective method, it is basically unable to expound the function mechanism of traditional Chinese medicine from the molecule level, therefore has formed inherent quality and security that the current quality criteria of traditional Chinese medicine can't really reflect traditional Chinese medicine, cause quality and security difficult commenting on and control of traditional Chinese medicine. Traditional Chinese medicine quality evaluation and four following problems of controlling technology system badly in need of solution: The scientific traditional Chinese medicine quality evaluation system needs setting up and improving, comparing with chemical medicine badly, traditional Chinese medicine is one not to set up a set of effectual quantitative appraisal methods and standards yet at present by multicomponent, multifactor complicated system that forms. Solve the quality evaluation of the complicated system of traditional Chinese medicine and control the problem to be already not merely been a application problem of advanced analytical technique, the innovation of thinking of research and research approach will be that traditional Chinese medicine in 21st century analyze primary task faced. The traditional Chinese medicine quality standard system needs improving and improving because of the technological reason badly, our country has a lot of daily traditional Chinese medicine at present ' Chinese medicinal materials and Chinese medicine) It is not complete to still lack the quality criteria or standard, restive its inherent quality, the potential safety hazard of using medicine exists. Only Israel " Chinese pharmacopoeia " ' 2005 version) 500 multi-type Chinese medicinal materials standard recorded are an example, there are nearly half the varieties besides morphological characteristics such as properties,etc., not having or lacking the detection method of special attribute, have influenced the quality evaluation of Chinese medicinal materials and preparation and security and effective of clinical practice seriously. In addition national medicine and import traditional Chinese medicine or natural quality criteria of medicine, exist a lot of much-needed improve and that raise problem too. Our country issue Tibetan medicine of " standard of medicines of Ministry of Public Health ", is covered with medicine, links the medicine fascicle separately 1995, 1998, 1999, but lack the normal quality criteria, has restricted application and passing on of national medicine seriously. Importing traditional Chinese medicine partly has qualities that accuses of the problem not complete of the standard too. The standard, basically rely on the experience to distinguish as it is joined and is still carried out and issued in 1988 now that imported North Korea is red, lack objective detection and control the index. National medicine and the intersection of part and scope of application to import crude drugs expand, once the safe problem appears, influence is enormous. The key detection technique needs setting up and improving in recent years badly, new analysis and detecting instruments introduce medicines to analyze in monitoring in a large amount, for instance quality control and production process that high-efficient liquid phase chromatograph, near infrared fingerprint technology of vltrahigh voltage,etc. have been already used in traditional Chinese medicine extensively are controlled. But, medicines supervise test being different from general scientific research, science, rationality, feasibility systematic appraisal and verification like not carrying on in the course of carrying out medicines standardly to these instruments, will cause medicines analyze measure the intersection of result and the intersection of person who differ greatly and question in the the whole country, influence the quality control of medicines and supervise. In addition, compared with developed country, the micro- composition analysis detection technique still lags behind in traditional Chinese medicine of our country, some of the compositions are effective composition, some are poisonous harmful to the composition, some is the violated medicine or chemical medicine added illegally. Our country does not have universal standard and method used for measuring and adding chemical medicines in the health food at present, it is one of the main reasons too to lack essential detection technical support. Traditional Chinese medicine bad reaction mechanism inquire after and relevant detection technique need badly, set up and improve experts, think, the complexity of the traditional Chinese medicine base source and variety of composition have caused its security to be very difficult and got the basic guarantee, have caused a lot of making it clear, an unidentified bad reaction and bad incident. Demand mechanism and corresponding control technology of the bad reaction of traditional Chinese medicine urgently to strengthen, need to set up a set of control modes and detection techniques progressively. It is reported separately, the harmful residue problems of traditional Chinese medicine influence the international image of traditional Chinese medicine seriously too, heavy metal, yellow aspergillus toxin and residues of pesticides measure and already become the most important technological barrier which has influenced international trade of traditional Chinese medicine with the standard with a limit on quantity, become and restrain traditional Chinese medicine from moving towards the internationalized, modernized bottleneck. At the meeting of Chinese People's Political Consultative Conference(CPPCC) in 2007, over 30 committee member's motions demand to pay attention to the medicine quality control of mineral, carry on the case study to the medical security of cinnabar, Realgar, national medicines examine and comment the centre to solicit the opinion to this subject many times too. Control the harmful element in this kind of medicine rationally, guarantee Chinese medicine uses the safe important respect clinically. The expert thinks, on the basis of fully inheriting the fine tradition of traditional Chinese medicine, set up mineral medicines as soon as possible and set prescription in preparation the quality of the mineral composition accuses of the method, set up relative science, feasible limit to measure the index and standard with a limit on quantity in including toxic medicines such as cinnabar, Realgar,etc., there are great realistic meanings on advancing traditional Chinese medicine modernization, internationalization.

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