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青海省医疗机构中藏药制剂备案常见问题及分析OA

Common Problems and Analysis of Tibetan Medicine Preparation Filing in Medical Institutions in Qinghai Province

中文摘要英文摘要

目的:对青海省民族医疗机构制剂备案资料中存在的问题进行汇总与分析,在鼓励民族医药发展与保障公众用药安全并重的新形势下,提出可能的解决方案和思路,为药品监管部门今后制定与实施引导政策提供参考.方法:对青海省2018-2022年申报的中藏药制剂的备案情况进行调研,收集汇总医疗机构应用传统工艺配制中藏药制剂备案的申报资料中存在的问题.结果:医疗机构制剂申报需在制剂名称、功能主治、说明书、工艺及质量标准研究等方面予以完善.结论:医疗机构需强化制剂立题审查,立足临床需求开展研究;监管部门应加快制定多单位备案、临床用量大的制剂品种及处方内非标准药材的质量标准,以促进民族医疗机构制剂健康发展,繁荣民族医药事业.

Objective:To summarize and analyze the problems found in the preparation record data of ethnic medical institutions in our province,and to explore the possible solutions and ideas under the new situation of encouraging the development of ethnic medicine and ensuring the safety of public drug use,so as to provide reference for the formulation and introduction of guiding policies.Methods:The filing situation of Chinese and Tibetan medicine preparations declared in our province from 2018 to 2022 was investiga-ted,and the filing data of Chinese and Tibetan medicine preparations prepared by traditional technology in medical institutions were collected and analyzed.Results The declaration of preparations for medical institutions needs to be improved in terms of preparation name,functional indications,instructions,process and quality standard research.Conclusion:Medical institutions should strengthen the examination of the scientificity and necessity of the research and development of preparations,and carry out research based on the actual needs of clinical and patients;the regulatory authorities need to speed up the formulation of preparations with multi-unit records and large clinical dosage,and the quality standards of medicinal materials without national standards in the prescriptions,so as to promote the standardized development of preparations in ethnic medical institutions and prosper the cause of ethnic medicine.

石春兰;年永琪;汪永明;刘学良;程小平;王永晶;祁彦凯;韩达斌

青海省药品审评核查中心,青海西宁 810000青海省药品审评核查中心,青海西宁 810000青海省药品审评核查中心,青海西宁 810000青海省药品审评核查中心,青海西宁 810000青海省药品审评核查中心,青海西宁 810000青海省药品审评核查中心,青海西宁 810000青海省药品审评核查中心,青海西宁 810000青海省药品审评核查中心,青海西宁 810000

医药卫生

医疗机构制剂备案中藏药制剂传统工艺申报资料

Medical institution preparationsRecordingTibetan medicine preparationsTraditional crafts

《中国药物评价》 2026 (2)

86-89,4

青海省基础研究项目(2025-ZJ-603)

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