Traditional Chinese medicine injectable preparation meets the safe crisis to endure to the fullest extent query And then appraise and shuffle the market

Traditional Chinese medicine injectable preparation meets the safe crisis to endure to the fullest extent, query And then appraise and shuffle the market
On September 17, national food medicines supervise the administration bureau giving notice on their websites, require all parts delay, sell, use for how pairs of the intersection of the rhizome of Chinese goldthread and parenteral solution that much Pharmaceutcal Co., Ltd. produce does it label. Traditional Chinese medicine injectable preparation is safe to calculate from traditional Chinese medicine injectable preparation Radix Bupleuri of first, the traditional Chinese medicine injectable preparation family already with a history of more than 60 years, has never encountered the security to query like today. Only sting five plus parenteral solution, mattress Zhi yellow parenteral solution, parenteral solution of a pair of the rhizome of Chinese goldthread and use the incident of causing death in succession from the year 2008 till now. Would rather add Herba Houttuyniae parenteral solution several years ago, easy blood injectable preparation incidents of traditional Chinese medicine such as parenteral solution,etc., traditional Chinese medicine parenteral solution has already been queried. At present, over 20 billion yuan, 400 million persons use traditional Chinese medicine injectable preparation every year in industry's annual sales amount of traditional Chinese medicine injectable preparation. Attentive brain vascular disease, therapeutic field of antitumor, antiviral and some acute disease, it is even not replacable function that it is being important that traditional Chinese medicine injectable preparation is being produced. However, " in Beijing, some large-scale general hospitals have already cleared traditional Chinese medicine injectable preparation out of the dispensary. " In a copy of materials that Dongzhimen hospital offers of Beijing University of Trad. Chinese Medicine, the reporter has seen such a content. The problem concentrates on using statistics of the situation take place according to Beijing medicines' bad reaction in links, in 2007, in all medicines bad reactions appearing in the newspaper, chemical medicines account for 86.7%, Chinese medicine accounts for 11.9%, the bio-pharmaceuticals accounts for 1. 4% . In 2008, in the medicines bad reaction will be counted, chemical medicines account for 86.1%, Chinese medicine accounts for 13.2%, the bio-pharmaceuticals accounts for 0. 74% . In view of data, the proportion of the bad reaction takes place and is well below chemical medicines in Chinese medicine; As the proportion of the bad reaction of traditional Chinese medicine injectable preparation of a part of Chinese medicine, lower than chemical medicines especially. In the clinical use of the hospital of Dongzhimen of Beijing University of Trad. Chinese Medicine, history for many years of use of traditional Chinese medicine injectable preparation, assortment and quantity rise year by year. Offer the introduction according to president Wang Yao, this institute has 26 pieces of traditional Chinese medicine injectable preparation variety in all at present, traditional Chinese medicine injectable preparation rate of utilization in the patient account for 51%, even up to 90% in specific departments such as respiratory medicine,etc. in in hospital by institute this, but the bad reaction related to traditional Chinese medicine injectable preparation of every year of the whole institute, about 40 examples, and mostly slight allergic response. Wang Yao offers providing for reporter the parallel table of the situation takes place in daily traditional Chinese medicine injectable preparation and bad reaction of Dongzhimen hospital. This statistics reveal, in 2007, this institute uses clearly and makes parenteral solution No. 27200 Branch of fairy for 1300 patients, 1 bad reaction; It is clear to use and make parenteral solution No. 29440 Branch of fairy, 3 bad reactions in 2008. In 2007, 2008, it is No. 7800 Branch, No. 10799 Branch respectively that Dongzhimen hospital will use and join parenteral solution of wheat, no bad reaction takes place. Vice President of Beijing University of Trad. Chinese Medicine Dongzhimen hospital Liu QingQuan has participated in the investigation of the bad incident of numerous traditional Chinese medicine injectable preparation. In his view, the appearance of the bad incident of parenteral solution of traditional Chinese medicine, does not have too great relation with medicine. Except relate to the patient's idiosyncrasy partly, the most important reason, lie in it is used that the clinical one is unreasonable. "For example the incident of causing death of parenteral solution of a pair of the rhizome of Chinese goldthread appearing in Qinghai this year, the patient has just got cold, hospital to use heads of spore, the intersection of forest and many kinds of antibiotic such as being mould and plain to it very first, use parenteral solution of a pair of the rhizome of Chinese goldthread finally, cause patient death. " QingQuan Liu say, pairs of the intersection of the rhizome of Chinese goldthread and issue of parenteral solution in fact, Western medicine and the intersection of traditional Chinese medicine and the intersection of injectable preparation and unreasonable question that use jointly. In the first half of this year, Hebei food medicines supervise the administration bureau receiving the report, Henan one patient whom Pharmaceutcal Co., Ltd. produce clear to die turn on parenteral solution of fairy, in martial prowess of using. After Ann of this office supervises and in checking Pharmaceutcal Co., Ltd. of the martial prowess, have not found the production ink goes wrong. "The ones that have seen the patient have used medicine the situation discovers the problems. " Division chief Li Xun say, the patient is that cold has a fever, but within two and a half hours, through having an intravenous drip, doctors have used including clear and made more than ten kinds of medicines such as fairy, very beginning spore, moroxydine, insulin to him, it causes the death to jointly use medicine no as. Rich in a dramatic one, this patient is a Vice President of the hospital where one stays, it is the medicine that he prescribed for oneself. In the bad incident of traditional Chinese medicine injectable preparation happening in recent years, the general method of the government is, require the pharmaceutical factory to stop production immediately. But what let a lot of pharmaceutical factories be unable to understand is, the responsibility for the incident is asserted and does not announce even after stalling for a long time, the date that enterprises resume production is not within the foreseeable future. "I object to stopping the pharmaceutical factory once going wrong. " Li ZhenJiang, president of Pharmaceutcal Co., Ltd. of the martial prowess says, it is the responsibility of enterprises that should be dealt with in accordance with the law, it is not the responsibility of enterprises that can't always close the pharmaceutical factory. The doctor at the basic level needs training according to bad incident of traditional Chinese medicine injectable preparation in recent years more, mostly happen in the basic unit, medical organization of villages and towns. Because of the horizontal question of medical treatment of medical organization at the basic level, after presenting the serious bad reaction, do not often have a better rescue method. "We have on traditional Chinese medicine injectable preparation and support the attitude, but in using, need to clear up condition, use to the ill. " National food medicines supervise the mao of check commissioner of administration bureau shaken guests and said. Just because a large number of products were used in the basic unit, Pharmaceutcal Co., Ltd. of the martial prowess has made the leaflet that medicines used, taken to the medical organization at the basic level by the sales force, propagate to the medical personnel. "At at use of medicines,it is can for external use don't take orally,is it can oral need intramuscular injection, can intramuscular injection does not need the intravenous injection, traditional Chinese medicine and Western medicine should follow such a principle. " Liu QingQuan says, traditional Chinese medicine injectable preparation is usually used for the urgent critical patient, generally can't use at will; If use rationally, its security is secure. But does not know who misleads the patient, cause a lot of patients to demand to have an intravenous drip only catching a cold. In the materials that the hospital offer of Dongzhimen, the injectable preparation composition of traditional Chinese medicine is complicated, try hard to avoid jointly using with other medicines in clinic, should avoid exceeding the long term administration of the dosage too. In addition, should be according to the regulation strictly on disposing time, instilling the speed, using the temperature, storing the condition, different use which dissolve the matchmaker. Dialectical administration the intersection of traditional Chinese medicine and one principle that injectable preparation use too, for example clear to turn on the intersection of fairy and parenteral solution, use for hot disease generate heat, can't be used in sympotoms caused by cold factors and generate heat. If use it by mistake, will increase the possibility taking place in bad reaction greatly. However, such Chinese medicine uses medicine dialectically the principle can not get complete implementation in clinic. According to the statistics made by the departments concerned, in the clinical use of traditional Chinese medicine injectable preparation, the consumption of Western medicine should be far greater than Chinese medicine, and Western medicine often lacks enough Chinese medicine knowledge. Wang Yao offers and tells reporters, the dialectical administration method with basic Chinese medicine is not too profound to be understood, Western medicine can be basically mastered after corresponding training, especially use of traditional Chinese medicine injectable preparation? �� old Yu Neglect and select? "Western medicine need, train with Western medicine with traditional Chinese medicine, Chinese medicine, can't confused so and then to go down. " Wang Yao offers and says, the manual of traditional Chinese medicine injectable preparation needs the improvement too, all listed what side effects, taboos are there in detail, use the guidance of medicine for the doctor. And then appraise and pull open shuffling the curtain supervise administration bureau Ann supervising Li Xun, division chief of place and to Hebei food medicines, traditional Chinese medicine injectable preparation is a variety making him constantly nervous. Because as to varieties such as traditional Chinese medicine decoction, tablet,etc., own risk of traditional Chinese medicine injectable preparation of entering blood directly is very high. Though relatively chemical medicines, the bad reaction of Chinese medicine is not high, in the bad reaction of Chinese medicine, traditional Chinese medicine injectable preparation has occupied the largest proportion. While counting in Beijing 2007 medicines bad reaction, the bad reaction of traditional Chinese medicine injectable preparation accounts for 71.9% of the bad reaction of Chinese medicine. Li Xun finds after surveying traditional Chinese medicine injectable preparation manufacturing enterprise of Hebei, in Hebei, there are 7 pharmaceutical factories producing traditional Chinese medicine injectable preparation, involve 17 varieties and 41 product rules. In 2008, the traditional Chinese medicine injectable preparation sales amount of these 7 enterprises is 8. 200 million yuan, but 800 million yuan among them concentrates on an enterprise of Pharmaceutcal Co., Ltd. of martial prowess, there is only 20 million yuan in other 6 of sales amount which enterprises add up. "According to our imagination, manufacturing enterprises with a traditional Chinese medicine injectable preparation of Hebei are enough, it is unnecessary for the enterprises of too small scale to set foot in this field. " Li Xun says. A large number of situations for producing traditional Chinese medicine injectable preparation of small enterprise that Li Xun said are very general in the whole country. Such as the intersection of Herba Houttuyniae and parenteral solution, the whole country have more thanth enterprise produce, traditional Chinese medicine composition a complicated one clear to turn on the intersection of fairy and the intersection of parenteral solution and the whole country, have a dozen enterprise produce too most in the injectable preparation. The technological level of these enterprises differs greatly, the quality of medicines has obvious differences too. In the first half of this year, national food medicines supervise the administration bureau starting traditional Chinese medicine injectable preparation and appraising, require enterprises to arrange and look into production and risk of quality control link in an all-round way, control the injectable preparation potential safety hazard of traditional Chinese medicine. National food medicines supervise the administration bureau to the key variety, the quality control of traditional Chinese medicine injectable preparation launches appraising with risk benefit synthetically in batches, stage by stage. This job in the field of business is known as the shuffling big of traditional Chinese medicine injectable preparation. According to the introduction of Li Xun, Hebei food medicines supervise the administration bureau requiring 6 enterprises besides Pharmaceutcal Co., Ltd. of the martial prowess to delay producing traditional Chinese medicine injectable preparation, resume production after checking, improving the standard by oneself. Because traditional Chinese medicine injectable preparation appraise, need enterprise raise the standard raw materials, production technology, the intersection of medicines and standard, the intersection of fingerprint and the intersection of atlas,etc. and each detail again, it can be produced that the products are qualified, the input that enterprises need is very great. Li Xun, for those 6 estimation which enterprises producing traditional Chinese medicine injectable preparations have appraised in Hebei, traditional Chinese medicine injectable preparation of a product rule needs input of about 5 million yuan. The figure let these irresolute enterprise, because two enterprise put into enormous to give up, appraise already in that, "after they give up, we cancel their authentication codes of medicines. " To martial prowess Pharmaceutcal Co., Ltd. with highest level and still producing at present, Li Xun does not dare to adopt a casual attitude either, will go to enterprises to see the situation every week, warn enterprises to pay attention to safely. "It is not enough yet for our country to study about chemical composition of traditional Chinese medicine, traditional Chinese medicine injectable preparation is even more like this. " National food medicines supervise the mao of check commissioner of administration bureau shaking guests to tell reporters, national food medicines improved production in the threshold of traditional Chinese medicine injectable preparation once supervising the administration bureau last year, strictly control examining and approving, has not criticized these two years. To the composition question of traditional Chinese medicine injectable preparation, national Bureau of Drugs Supervision requires in a situation that the composition can't be totally clear, know 60% composition of its at least. In these 60% of the compositions, should know 80% effective composition; In the valid composition, 90% should be controllable. This standard is called 689 principles, but according to the introduction of insider, such a standard is too high, most enterprises can not do at present. "We agree to the appraisal again of traditional Chinese medicine injectable preparation, this field needs to improve the threshold, only by improving the threshold can it raise the quality. " Li ZhenJiang, president of Pharmaceutcal Co., Ltd. of the martial prowess says, the competition of the Chinese products is often price competition, cause many enterprises to regard sacrificing quality as the cost. According to Li ZhenJiang's introduction, Pharmaceutcal Co., Ltd. of the martial prowess has already occupied the market share above domestic traditional Chinese medicine injectable preparation 30% at present, accomplish this intensity, to quality, the safe concern is stricter. With clear to make the intersection of fairy and parenteral solution as example, martial prowess fingerprint atlas Pharmaceutcal Co., Ltd. act as can already define their 85.79% compositions. In this way, can guarantee one on quality medicines of the batch of each one. "We adopt flying to check to the raw materials supplier, do not notify and check by surprise in advance. " Li ZhenJiang says, the quality of medicines concerns patient's life, is concerning the lives of enterprises too. Traditional Chinese medicine the intersection of injectable preparation and the intersection of bad reaction and incident review, take place bad reaction case report to amount to 1006 while being new about the intersection of Puerarin and injectable preparation January 1 to will it be June 30 2005, 2003, among them 11 die. November of 2004, serious bad reactions such as haemolysis,etc. have been released in national food medicines can cause acute blood vessel because of injectable preparation of Puerarin while supervising the administration bureau " The notice on revising the Puerarin injectable preparation manual " . 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 June of 2006, the national medicines bad reaction monitoring center received the parenteral solution bad reaction of Herba Houttuyniae and reported 5488 together, 258 bad reactions of serious medicines, 44 people die, Herba Houttuyniae parenteral solution is delayed selling and using. In 2007, national food medicines supervised the administration bureau announcing 25 kinds of traditional Chinese medicine injectable preparation with serious bad reaction. October 5, 2008, 6 patients in Yunnan Province Red River state have used and labelled and presented the serious bad reaction for two batches of thorns five plus parenteral solution that the pharmaceutical factory of Wanda Mountain of Heilongjiang Province produces, thereafter 3 patients die. The morning of October 19, 2008, Ministry of Public Health notify Shaanxi Province the intersection of Zhidan and county people's hospital use the intersection of Shanxi and too competent the intersection of medicine company and the intersection of mattress and Zhi that Co., Ltd. produce behind the yellow parenteral solution promptly, 4 neonates bad reaction take place, a neonatal death of 9 days of birth among them. 9 - 10 of February of 2009, 3 patient's veins are infused and annotated in order that after the parenteral solution of a pair of the rhizome of Chinese goldthread which pharmacy Co., Ltd. Jiamusi Branch of river produces in Usu of Heilongjiang in Datong County of Qinghai Province, the suspected bad reaction takes place. On February 10, because a 62 -year-old woman patient among them died after all rescue measures proved ineffectual. (put in order according to the materials)

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