维吾尔药质量标准现状分析及发展建议

Investigation on Quality Standards for Uygur Medicine

目的:调研国家维吾尔药标准现状,分析并提出发展建议。方法:检索近20年相关维吾尔药标准报道的科技文献,统计国家与新疆维吾尔自治区颁布的维吾尔药标准,向新疆维吾尔自治区境内维吾尔药制药企业、维吾尔医医疗机构发放调查表,对维吾尔医临床实际应用的国药准字维吾尔成药、院内制剂进行调查,对制剂处方中药材品种、基源及其标准状况进行统计分析。结果:国家标准收载维吾尔药材123种,维吾尔药成方制剂85种,实际批准生产45种;维吾尔医医院制剂标准204种;维吾尔医成药和医院制剂处方所使用的维吾尔药材总数达800种。涉及维吾尔药制药企业9家、维吾尔医医疗机构12家。维吾尔药材与《中国药典》2010年版收载中药材交叉使用的品种151个,与《卫生部药品标准-藏药分册》收载藏药交叉使用的药材品种12个,与《卫生部药品标准-蒙药分册》收载蒙药交叉使用的药材品种8个。70%的维吾尔药材品种均产自于新疆,20%产于外省区,10%依靠进口。结论:维吾尔药国家和地方标准体系初建轮廓,74.8%药材已经纳入国家和自治区标准。80%维吾尔成药在维吾尔医疗机构作为医院制剂生产,25.2%的维吾尔药材没有质量标准。建议进一步加强部分维吾尔药材品种基源调查、化学物质基础研究、药材名称的维吾尔语和汉语一致性规范化研究。

Objective： To investigate the current quality standards of Uygur medicines in China, and provide suggestions for further development. Methods： Scientific literatures that reported relevant standards of Uygur medicine in nearly 20 years were retrieved and Uygur medicine standards issued by the government of Xinjiang Uygur autonomous region were statistically summarized. Questionnaires were sent to the pharmaceutical enterprises and medical institutes in Xinjiang to investigate the actual clinical application status of Uygur medicine approved by the nation and hospital preparations. The varieties of traditional Chinese medicine in the preparations, the foundation and the conditions of standards of the preparation prescriptions were statistically analyzed. Results： There were 123 Uygur ethnic medicinal crud drugs and 85 herbal formulations in the volume of National Drug Standards, and 45 kinds of them were approved for production. There were 204 hospital herbal preparations made of 800 kinds of Uyghur herbs in the volume of Xinjiang Uygur Ethnic Medicine Standards, involving 9 Uyghur pharmaceutical enterprises and 12 Uyghur medical institutes. There were 151 crud drugs overlapped with medicines listed in Chinese Pharmacopoeia（2010 edition） and 12 overlapped with Tibetan medicines listed in Drug Standards-Volume of Tibetan Medicines, and 8 with Mongolian medicines in Drug Standards-Volume of Mongolian Medicines issued by Minister of Health. 70% of the Uygur herbal drugs were from Xinjiang Uygur Autonomous Region, 20% from the other provinces of China, and 10% were imported from foreign countries. Conclusion： The structure of standard systems for Uygur herbal drug has been established both in national and local level which already covered 74.8% of the medicine. 80% of Uyghur patent medicines are produced as hospital preparations in Uyghur medical institutes and 25.2% of Uyghur herbs are still not been studied for standardization. It is suggested to further enhance the investigation of the herbal origin of Uygur ethnic medicine, the research of chemical foundation and the consistency and standardization of Uygur and Chinese names of Uygur herbs.