Three hundred kinds of South medicine will be selected into the quality standard of national pharmacopoeia
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Last Update: 2010-04-12
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Source: Internet
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Author: User
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On September 9, the "2010 Pharmacopoeia quality standard seminar" held by the provincial food and Drug Administration in Luofushan revealed that at present, our province is undertaking the drafting of 304 national pharmacopoeia standard varieties, of which Luofushan national drug alone undertakes the drafting of 19 varieties of standards According to the meeting, Guangdong Province is a major province of traditional Chinese medicine in China The status of a major province of traditional Chinese medicine comes from the output of traditional Chinese medicine products, and more from the quality of traditional Chinese medicine products Since the national action plan for improving the standard of Chinese patent medicine was launched in 2006, Guangdong Southern medicine has continuously improved its own quality, overcome the prejudice of North and south medicine, become an important base for formulating the national standard of Southern medicine, and laid a foundation for the improvement of the status of Guangdong Province as a strong province of traditional Chinese medicine It is not the first time that Zhou Fucheng, Deputy Secretary General of the national pharmacopoeia committee, introduced the draft of 2010 Pharmacopoeia He said that 2010 Pharmacopoeia has been prepared and officially implemented on July 1 Chinese pharmacopoeia is a drug code formulated by the state in accordance with the law to ensure the quality control of drugs and the safety and effectiveness of people's drug use It is the legal basis for drug development, production, operation, use and management, and the core of the national drug standard system The 2010 edition of Chinese pharmacopoeia is the ninth edition of Pharmacopoeia organized and compiled in the 60 years since the founding of new China On the basis of summarizing the Pharmacopoeia of calendar edition, the new pharmacopoeia makes full use of the standard resources of drugs at home and abroad in recent years, pays attention to innovation and development, and practically reflects the development status of China's pharmaceutical industry and clinical drug use level, which provides powerful technology for further strengthening drug supervision and management Surgical support The reporter learned from the meeting that it was not the first time that "Xiaoyan Lidan tablet" was included in the Pharmacopoeia "Anti inflammatory and cholagogic tablets" made by Luofushan Pharmaceutical Co., Ltd consist of Andrographis paniculata and Xihuangcao, which can be traced back to 1969 when the Ministry of health of the Logistics Department of Guangzhou army compiled the manual of commonly used Chinese herbal medicines; the Guangzhou army stationed in Luofushan area of Guangdong Province took local herbal medicines for disease prevention and treatment It is also recorded in the selected materials of Guangxi new Chinese herbal medicine exhibition Due to the early effect of listing, Xiaoyan Lidan tablet was selected into the category of basic medicine catalogue and the national medical insurance catalogue in August 2009 However, the quality standard of the drug is relatively low and the quality control is poor For example, the original standards of Xihuangcao and kumuyuan have no specific thin-layer identification items, and the manufacturer's feeding and the accuracy of the basic source of the raw materials cannot pass the effective evaluation of the drug standards Therefore, although Xiaoyan Lidan tablet was once included in supplement 97 of Pharmacopoeia 95, it was not included in Pharmacopoeia 2000 and 2005 Luofushan national medicine has been committed to the R & D and manufacturing of Chinese patent medicines represented by "Xiaoyan Lidan tablet" since its establishment In this process, we should clarify the basic sources of medicinal materials, stabilize the pharmaceutical technology and improve the quality standards Through standard review, the production quality control and standard of "Xiaoyan Lidan tablet" drafted by Luofushan national medicine was finally included in Pharmacopoeia 2010 The 16 character policy of "standard improvement, government leading, enterprise main body, typical demonstration" drafted by Luofushan Guoyao was included in the successful model of 2010 Pharmacopoeia and highly affirmed by the State Pharmacopoeia Committee and Guangdong food and drug administration Why Luofushan national medicine was selected as the new standard drafter? According to Liao Zhizhong, R & D director of Luofushan national medicine, the original standard of Xiaoyan Lidan tablets was that the content of andrographolide in small tablets was 1mg, and the content of andrographolide in large tablets was 3mg In the past production process, the quality control standard of Luofushan national medicine was higher than the original standard, reaching the content of 3mg in small tablets and 15mg in large tablets Therefore, the therapeutic effect of Luofushan Xiaoyan Lidan tablet is more excellent, which is widely recognized by doctors, patients and drug supervision departments, and has achieved the first performance in production and sales in China Zhou Chaofan, executive member of the National Pharmacopoeia Committee and drug evaluation expert of the State Food and drug administration, highly praised this He believed that enterprises actively participated in the drafting process, actively assumed social responsibility, and set a series of highly targeted technical indicators, which could restrict enterprises to strictly control the prescription process of the Pharmacopoeia to the greatest extent, and prevent production enterprises from stealing work and cutting materials The limited guarantee product curative effect, satisfies the sick patient's treatment demand Some experts pointed out at the meeting that at present, the bidding documents for essential drugs in some provinces have a prominent feature: under the government led bidding procurement system, the preferential policies for differential pricing of original research drugs and high-quality standard drugs have shifted, and the quality stratification has been cancelled At present, there are two misunderstandings in the use of basic drugs One is to choose the use with the lowest price, whose purpose is to benefit the patients as much as possible But have you made a comprehensive evaluation on the content standard, production scale and efficacy performance of the same drugs? The second is to choose the product with the highest price and high price, which has a large margin and can still get a certain sales rebate in the use process Other factors are ignored Therefore, the improvement of the quality standard of the basic drug catalogue provides the selection standard for the grass-roots use of drugs, and ensures the high standard of domestic drugs from the system, guides enterprises to produce high-quality varieties, guides the grass-roots use of high-quality domestic drugs, and ensures the revitalization of national drugs from the system It is reported that the Luo Fu Shan pharmaceutical industry, which was built in 1970, has continuously excavated and inherited the essence of ancient medicine by using the southern medicine resources of the Luo Fu mountain In recent years, more than 150 kinds of products have been developed by utilizing the rich resources of Chinese herbal medicine Among them, 84 species have entered the national health insurance catalogue and 30 have entered the national basic drug list "Luofushan" trademark was awarded as "Guangdong famous trademark".
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