Traditional Chinese medicine injectable preparation save oneself: Only " review it with the improvement "

Traditional Chinese medicine injectable preparation save oneself: Only " review it with the improvement "
Staff reporter Wang LeMin 13 patient use the intersection of Tin Shui and fragrant red parenteral solution that medicine company produce appear the shiver with cold, generate heat etc. uncomfortable. Medicine supervises department's test to find, the fragrant red parenteral solution heat source project that this lot number is 080524 is not up to standard. On March 24, Ministry of Public Health, national food medicines supervise an urgent notice of administration bureau, have stopped use and sale of fragrant red parenteral solution of this lot number. In recent years, after bad incidents recured, traditional Chinese medicine injectable preparation is bearing the public's unprecedented trust crisis of coming from. An insider comments: "The moment that traditional Chinese medicine injectable preparation has already faced reviewing, not a bit by sheer good luck, there is not any leeway. " The bad incident was expedited the emergence of and made a thorough review on consciousness 1941, the initiative of Radix Bupleuri parenteral solution succeeded in marking the birth of traditional Chinese medicine parenteral solution. But it is during recent 10 years that traditional Chinese medicine injectable preparation really gets swift and violent development. Deputy to the National People's Congress, martial prowess Li ZhenJiang, Chairman of Pharmaceutcal Co., Ltd. in Hebei introduce, as one of industry's development and modernized direction of traditional Chinese medicine of traditional Chinese medicine, developing traditional Chinese medicine injectable preparation becomes a stream of upsurge gradually, various products project start in all parts one after another. The statistics show, from 1999 to 2006, the average growth rate of the market of national traditional Chinese medicine injectable preparation exceeded 30%. At present, industry's annual sales amount of traditional Chinese medicine injectable preparation has already exceeded 20 billion yuan. Will it be June 2006, have serious bad reaction, the intersection of Herba Houttuyniae and parenteral solution, compound the intersection of dandelion and the intersection of parenteral solution,etc. and 7 including Herba Houttuyniae or plain sodium of new Herba Houttuyniae injectable preparation, supervised the administration bureau delaying using and examining and approving by national food medicines. In that periods of time, get national the intersection of food and medicines supervise the intersection of administration bureau and medicines appraise the intersection of person and " a gang of continue a gang of " that place visit ,Come from the personnel of big and small 195 of Herba Houttuyniae parenteral solution manufacturer in the whole country, hope to ask about Herba Houttuyniae " Live again " News. Hereafter, although variety of some intramuscular injection was resumed using, the intravenous variety has been laid aside and neglected all the time. A few years hereafter, stung five plus parenteral solution, mattress Zhi yellow parenteral solution, parenteral solution of a pair of the rhizome of Chinese goldthread, bad incident of fragrant red parenteral solution and happened in succession. Though the reason why the bad incident happens is not the same, are full of products quality problem, full of medicines bad reactions, among them exist and use the unreasonable reason too, but the security of traditional Chinese medicine injectable preparation receives the public's unprecedented query. General view of insider, traditional Chinese medicine injectable preparation era of the great prosperity stop to " Herba Houttuyniae incident " in 2006 the most . Since then, the security question of traditional Chinese medicine injectable preparation has been repeatly paid close attention to. Hard wound all linked with one another in the face of predicament, traditional Chinese medicine the intersection of injectable preparation and industrial circle begin, face traditional Chinese medicine straightly injectable preparation hard to injure. Study a great deal of bosses fewer than the injectable preparation manufacturing enterprise of a traditional Chinese medicine and say before clinic, " Chinese pharmacopoeia's " 2005 version appendix was hit " Check the law and employ the guideline in traditional Chinese medicine injectable preparation security " ,Unusual toxicity, step down material, irritated response, haemolysis and condense, hot original, the intersection of bacterium and the intersection of endotoxin,etc. and inspection method. , if the one that use the above-mentioned " Chinese pharmacopoeia " " The guideline " Go on again if appraising, I'm afraid every kind of injectable preparation needs supplementary a large amount of research work. Chinese medicinal materials source and adjuvants pharmacopoeia committee's committee member, health reason group's Chairman of medicine company Xiao Wei of loud country of quality problem are said for example, honeysuckle base Radix Ophiopogonis originally, mountain silver flower base gray the intersection of felt and maos of Radix Ophiopogonis, red the intersection of gland and Radix Ophiopogonis or Radix Ophiopogonis of South China originally, these makes composition that mountain silver flower and honeysuckle suck not the same, lower and greener former sour content of the glucoside content of the mountain silver flowers and trees rhinoceros grass is relatively high, if use instead of the honeysuckle, may cause and cause quick function. Meanwhile, the place of production of Chinese medicinal materials is different to lead to the fact Chinese medicinal materials quality are unstable, cause the injectable preparation composition of traditional Chinese medicine to be different. The not yet fixed place of production of a lot of Chinese medicinal materials at present, Chinese medicinal materials GAP (good agricultural norm) already set up The planting base, can't totally fit injectable preparation manufacturing enterprise of traditional Chinese medicine's requirement yet in such aspects as quality, output. In addition, some adjuvants lack the parenteral standard again, quality is difficult to control, such as Twain - 80, inferior hydrogen sodium sulfic acid,etc.. Phenomenon of different crafts of the same variety still more for example fragrant red parenteral solution have 169 codes in all, Herba Houttuyniae parenteral solution has 196 codes in all. In addition some the intersection of traditional Chinese medicine and the intersection of injectable preparation and production technology lag behind, result in, it tans quality, protein, resin macromolecule to be impurity difficult except that in the preparation relatively. Lack the chemical expert of plant of military academy of medical sciences of China of long-term clinical observation data researcher Qiao ShanYi and say, traditional Chinese medicine injectable preparation was transferred from oral traditional Chinese medicine to injection, lack long-term clinical observation and experiment, the controllable quality criteria is far from setting up. Its each link of researching and developing, examining and approving, producing and using clinically etc. has improved places of a need. How to minimize the risk in the face of the trust crisis, a lot of insiders call upon to protect traditional Chinese medicine injectable preparation well. The reason is the injectable preparation representatives of traditional Chinese medicine " The modernized breach of traditional Chinese medicine " ," China initiates " " whether is it independent to have industry it is national the intellectual property right one " ,It is " an important component inside the culture of traditional Chinese medicine " . But the fact is, in the bad incident of traditional Chinese medicine injectable preparation recuring in recent years, the public has not suspected on curative effect of traditional Chinese medicine injectable preparation, that was cared about is not whether it is finally a part of culture of traditional Chinese medicine, and is querying its security. What if to these questions? National food medicines supervise Wu Zhen, Deputy Bureau Director of administration bureau, saying, from this year, medicines supervision department according to " Place people's administration on the highest position safely " Principle,spend it last traditional Chinese medicine injectable preparation quality by strength - -Strengthen the supervision of the injectable preparation production ink of traditional Chinese medicine, check with the strictest standard, so long as the hidden danger exists, stop production firmly; Implement the improvement performance plan of the injectable preparation standard of traditional Chinese medicine, solve the inadequate natural endowment of traditional Chinese medicine injectable preparation; Appraise traditional Chinese medicine injectable preparation again in an all-round way; Strengthen the guidance to traditional Chinese medicine injectable preparation in using the course. It is reported, at present, medicine supervises security, control method of the quality and index that the department is improving 123 kinds of already listing traditional Chinese medicine injectable preparation in an all-round way, supervise the injectable preparation manufacturing enterprise of traditional Chinese medicine to fix the place of production of crude drugs, control raw materials crude drugs, intermediate and finished quality strictly, realize the whole quality control that is produced and processed correctly. The insider thinks, some basic rules which the supervision department issued recently, will help the whole traditional Chinese medicine injectable preparation field to move towards the reason, norm, serve clinical application more safely. The insider briefs on, the good rule of supervision department is made Degree is due to initiative participation of enterprises. "Who can rescue traditional Chinese medicine injectable preparation? " Say, only " review with the improvement " as enterprises .

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