Traditional Chinese medicine injectable preparation " The fault " Where

Traditional Chinese medicine injectable preparation " The fault " Where
Staff reporter Wang LeMin "And a traditional Chinese medicine injectable preparation meets accident! " In the afternoon of October 19, head of the department says to reporters medicine of a hospital while having a meeting in Shijiazhuang. This time what met accident is yellow parenteral solution of Zhi of mattress. This medicine head of the department says, the notice that he received is, in the morning of October 19, Ministry of Public Health holds the urgent video-and teleconference, notify Shaanxi Province the intersection of Yanan and the intersection of city and the intersection of Zhidan and county people's hospital use the intersection of Shanxi and too competent the intersection of medicine company and yellow parenteral solution of Zhi of mattress that Co., Ltd. produce ' The lot number is 071001) And then, have bad reaction take place to 4 neonates, a neonatal death of 9 days of birth among them. Ministry of Public Health requires all parts to stop the clinic use of yellow parenteral solution of Zhi of mattress of this lot number immediately. Because have a meeting outside, this medicine head of the department contacts personnel of pharmacy dept. in a hurry, advice constantly: "Seal yellow parenteral solution of Zhi of mattress of this factory up for safekeeping as soon as possible, can't send medicines. " Injectable preparation bad reaction high to take place traditional Chinese medicine 5 thorn plus bad incident of medicines of will it be the beginning October have final result, Zhi's yellow parenteral solution incident of the mattress is thereupon emergence. In some insider eyes, this is not coincidence, because they worry for a long time. In 2007, national food medicines supervised the administration bureau announcing 25 kinds of traditional Chinese medicine injectable preparation with serious bad reaction. In the list, serious quantity of bad reaction rank more or less according to take place 2006, the yellow injectable preparation of Zhi of mattress meeting accident this time ranks the 17th, stings five plus injectable preparation and ranks the fourth. The bad incident of traditional Chinese medicine injectable preparation which medicine director of department of the Chinese Academy of Sciences Hu Xin of BJ Hospital has enumerated to the reporter in recent years: In June of 2006, the national medicines bad reaction monitoring center received the parenteral solution bad reaction of Herba Houttuyniae and reported 5488 together, serious medicines bad reaction (ADR) 258, 44 people die, Herba Houttuyniae parenteral solution is delayed selling and using. In 2005, the lotus must manage parenteral solution, would rather wear the amber varieties such as parenteral solution,etc. were revised the medicines manual because of the serious bad reaction. In 2004, parenteral solution of Puerarin caused the haemolysis, had the manual revised immediately. Hu Xin says, in 2001 - 2003, the bad reaction of traditional Chinese medicine reported the quantity accounted for 13.5% that ADR reported the total number, the injectable preparation bad reaction report of traditional Chinese medicine accounts for 77.2% of the total number of case report of bad reaction of traditional Chinese medicine. The medicines bad reaction report that the reporter has consulted 2004 - 2007 counts finding, this proportion all maintained at about 80%. The manifesting, offering as a gift high of the proportion of the bad reaction takes place in traditional Chinese medicine injectable preparation. The differentiation method can not reach the quality and accuse of requiring a reporter to consult medicine supervises department's latest medicines quality and inspects the announcement by random samples to find, the intersection of Shanxi and too competent the intersection of medicine company and yellow parenteral solution of Zhi of mattress that Co., Ltd. produce, have entered medicines not up to standard before this incident " The blacklist " . Supervise the administration bureau in Hubei food medicines in Hubei medicines' list not up to standard of quality announcement of third quarter of 2007 released, the intersection of Shanxi and too competent the intersection of medicine company and the intersection of mattress and the intersection of Zhi and yellow parenteral solution (10 ml / one that Co., Ltd. produce, lot number: 70404),Because " can be seen foreign matter " Judged medicines not up to standard. Yellow parenteral solution of Zhi of mattress which the health general Pharmaceutcal Co., Ltd. of Changzhou produces (10 ml / one, lot number: 702038, 704063),Also because " can see foreign matter " Judged medicines not up to standard. In Henan Province food medicines supervise the medicines list not up to standard of the second half of 2007 that the administration bureau releases, yellow parenteral solution of Zhi of mattress which the health general Pharmaceutcal Co., Ltd. of Changzhou produces (10 ml / one, lot number: 0706052),Because " can be seen foreign matter " Rank medicines not up to standard " The blacklist " . If is the medicines bad reaction difficult to avoid, then how will traditional Chinese medicine injectable preparation reduce the danger by quality control? 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. Zhou ChaoFan says, the chemical composition of traditional Chinese medicine of single flavor has been already complicated enough, there is much flavour of a drug of compound traditional Chinese medicine injectable preparation, there is no flavour of a drug distinguished to increase too, bring very great difficulty to affirmation of the products. China Medicine University Professor Wang GuangJi points out, as to the fast analysis of the unknown composition included in traditional Chinese medicine preparation, still lack corresponding tactics and technology at present. Researching and developing can't have rushed on like a swarm of hornets all the time, traditional Chinese medicine injectable preparation has been considered to represent a modernized developing direction of traditional Chinese medicine, as the points of growth of profit of enterprises, are undoubtedly favored by the medical enterprise. On October 19, Chinese Chinese medicine chief researcher of academy of sciences academician Li LianDa says while reviewing the new medicine research of traditional Chinese medicine, during these years, it is " out of control " that quality and level of declaring traditional Chinese medicine new medicine of medicine enterprise are in State. He enumerates figures to say, from 1985 to 2007, it reaches 22094 kinds to declare traditional Chinese medicine new medicine, among them, changed reaching 11839 kinds of dosage form specification, accounts for about 54%. The person in charge of a medicine enterprise tells reporters, develop traditional Chinese medicine injectable preparation variety now, 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. Professor Zhou ChaoFan has mentioned one and woken up for the research and development of traditional Chinese medicine injectable preparation: Injectable preparation pours into the body directly, its quality must adhere to the high standard and strict requirement. Each kind of medicine of injectable preparation makes up there must be reliable differentiation method. Without differentiation method or variety not reliable of the differentiation method, should be on the basis of appraising again, improve the science of the differentiation method, otherwise should eliminate this variety. Traditional Chinese medicine injectable preparation makes up medicines should not too much, try hard to choose a flavor carefully, should not exceed three medicines. Zhou ChaoFan says, should strengthen the injectable preparation management of traditional Chinese medicine, the particularity of the medicine route that give in view of injectable preparation, not only should emphasize that determines the project in content, but also the method wants the advanced person, the index (including index composition, composition quantity, composition content etc.) It should be rational, revise the standard in right time. To have the intersection of content and standard the intersection of project and unsatisfactory variety now, should in time through appraise according to the circumstances punishing again. Meanwhile, traditional Chinese medicine injectable preparation is new dosage form of the original creation of our country, though development is very fast, but there are many problems, should strengthen basic research and application study of traditional Chinese medicine injectable preparation. Finish in October 20 ' 2008 Chinese medicine learn annual meeting and during the meeting the eighth week such as pharmacist, referring to the problem that traditional Chinese medicine injectable preparation faces at present, a lot of experts say, what is it no matter sting the final reason why five plus Zhi's yellow incident of incident and mattress happen, everybody should review traditional Chinese medicine injectable preparation together How to develop, OK question of management. This has been already very urgent.

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