How does traditional Chinese medicine injectable preparation extricate oneself from a plight
The research and development of traditional Chinese medicine injectable preparation receives the increasingly a lot of concern in recent years, the market is developing fast too. From 1999 to 2005, the average growth rate of the market of national traditional Chinese medicine injectable preparation is up to 35%, by 2005, the market scale of traditional Chinese medicine injectable preparation has already been close to 250 million yuan. Traditional Chinese medicine injectable preparation is favored day by day by the medical enterprise, develop traditional Chinese medicine injectable preparation variety, not merely a factory that make traditional Chinese medicine is interested, more Western medicine factories even foreign capitals, joint-venture pharmaceutical factory are very interested in. Meanwhile, traditional Chinese medicine injectable preparation is considered as developing direction of traditional Chinese medicine modernization and breach exploring world market for a time too. Some pharmacy enterprises are " changing medicine dosage form, can apply for new medicine " Drive under,one after another march into traditional Chinese medicine injectable preparation market. Up till now, about 400 national enterprises producing traditional Chinese medicine injectable preparation, traditional Chinese medicine injectable preparation produced with the approval of country has 100 multi-type. It is reported, among 2000- 2005 years, while purchasing the list in every large hospital Chinese medicine, rank the top several, it is nearly all traditional Chinese medicine injectable preparation. However, with the increase of the consumption, the question of traditional Chinese medicine injectable preparation floats above the surface of water quickly. Since 2001, before the national medicines bad reaction monitoring center in " the bad reaction information of medicines is notified " in 10 periods, involve 12 kinds of Chinese medicine bad reactions together, among them traditional Chinese medicine injectable preparation accounts for 8 kinds. It is 702 that these 8 kinds of traditional Chinese medicine injectable preparation are counted by the bad reaction example notified, and cause 6 people death. And the thorn five plus injectable preparation and Zhi's yellow injectable preparation incident of mattress that happens recently pushes traditional Chinese medicine injectable preparation to the teeth of the storm again. Solving the problem existing in the injectable preparation development of traditional Chinese medicine reaches the very urgent stage. First of all, the security of traditional Chinese medicine injectable preparation should be guaranteed by its quality. The extreme professor pays close attention to the security of traditional Chinese medicine injectable preparation for many years week in the academy of sciences of Chinese Chinese medicine, he and colleagues once carried on research to the differentiation method included in 109 kinds of traditional Chinese medicine injectable preparation of the national standard. The result of study is: The differentiation method of some traditional Chinese medicine injectable preparation is difficult to confirm the true and false at present, can't reach the requirement for controlling quality. Indeed, because traditional Chinese medicine injectable preparation mix preparations, it is more complicated to require composition and production technology, if the purity is not high, it is apt to cause the bad reaction that there is impurity slightly, this is the main reason causing the traditional Chinese medicine injectable preparation question to happen frequently. So, from the raw materials screening, producing, processing, storing, transporting the course of traditional Chinese medicine injectable preparation, every step needs to strictly control quality. And the government should encourage, lead having the pharmacy enterprises which researches and develops the capability to strengthen the efforts researched and developed to traditional Chinese medicine injectable preparation, heighten the level of whole trade and compete for the capability. Secondly, should strengthen, supervise and improve examination and approval system, have seeking unity of standard strictly scientific. December 6, 2007, " traditional Chinese medicine, basic technical requirement of natural medicine injectable preparation" which national Bureau of Drugs Supervision releases formally, improve the quality requirement to traditional Chinese medicine injectable preparation. After this traditional Chinese medicine injectable preparation goes wrong, the national food medicines supervision bureau says especially, will adopt the action next, will further strengthen traditional Chinese medicine injectable preparation quality to supervise, stopping production that the manufacturing enterprise that can't guarantee to traditional Chinese medicine injectable preparation quality should stop production, the cancellation that should be cancelled, strengthen the efforts inspected to main injectable preparation on the market by random samples, discover the problems to deal with in time. Meanwhile, Bureau of Drugs Supervision will announce too the bad reaction to traditional Chinese medicine will be monitored in time. Whether however, traditional Chinese medicine injectable preparation should draw lessons from the quality control standard of Western medicine, can not reach the unified opinion in the educational circles of Chinese medicine yet so far. In supervision, such pressures in many aspectses as it is safe that national Bureau of Drugs Supervision faces coming from history and culture, industry development, people's livelihood too. To that it seems still at one stage of fumbling how traditional Chinese medicine injectable preparation supervise. As to traditional Chinese medicine the examining, commenting of injectable preparation, should also go on according to the scientific standard of the law. However, no matter supervise, or examine and approve, should all have a scientific strict unified standard, there is no such a standard up till now in traditional Chinese medicine injectable preparation, so it is the task of top priority to set up and seek unity of standard. Third, the intersection of application and in need of Chinese medicine basic theory of traditional Chinese medicine come, instruct, traditional Chinese medicine injectable preparation should like this also. And have clinically, high-level Chinese medicine doctors are fewer and fewer, so someone points out, the question of traditional Chinese medicine is not its one's own question, but a question of Chinese medicine. Original traditional Chinese medicine injectable preparation should be traditional according to Chinese medicine " Eight key links " Use dialectically, just deserve to be called real " traditional Chinese medicine " ; But in present much clinical airline, " have a fever with clear to turn on fairy, cold take pairs of the rhizome of Chinese goldthread, cardiovascular vessel disease uses the fragrant red needle " Western medicine pithy formula but prevailing very,it increase by risks that uses medicine been unreasonable undoubtedly this. Clinical the intersection of department and Professor often the intersection of chapter and rich introduction according to the intersection of Beijing University of Trad. Chinese Medicine and traditional Chinese medicine, traditional Chinese medicine injectable preparation face " the inadequate natural endowment " in theory : As to single injectable preparation, a lot of old docters of TCM do not think it distinguish with chemical medicine at all in the composition, do not pay attention to and construct and manage assisting and enabling with the monarch and his subjects while using dialectically either, has already totally deviated from the tradition of traditional Chinese medicine, should not even call it " Traditional Chinese medicine injectable preparation " . Finally, medicines recall and come into the open with information wanting in time accurately. As to problematic traditional Chinese medicine injectable preparation, Ministry of Public Health, Bureau of Drugs Supervision should strengthen every province, district, market food pharmaceuticals administration department and supervise enterprises recalling the situation, and pay close attention to its medicines bad reaction of injectable preparation, there is something special to report immediately, handle properly. As to the bad reaction of traditional Chinese medicine injectable preparation, should announce to clinician, the public and patient in time. Until variety, quality criteria that notify owe complete variety, the intersection of composition and the intersection of flavour of a drug and more variety,etc. in " whether the intersection of medicine and the intersection of bad reaction and information notify ", need to pay close attention. Lee in Beijing is brave
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