山东省医疗机构中药制剂技术审评常见问题及分析

目的 对我省医疗机构中药制剂技术审评中发现的问题进行汇总分析,探讨在既要鼓励中医药发展,又要保障公众用药安全的新形势下,对“医疗机构应用传统工艺配制中药制剂实施备案管理”工作提供参考。方法 对我省2015～2018年申报的中药制剂的审评情况进行了调研,汇总分析医疗机构制剂申报资料中存在的主要问题。结果 医疗机构制剂的申报需要在制剂名称、功能主治、说明书、工艺及质量标准研究、临床研究资料等方面进行完善。结论 建议相关医疗机构加强前期的立题科学性和必要性审查,做好相关研究工作,充分考虑医院和患者的实际需求,以促进医疗机构中药制剂的健康发展,繁荣中医药事业。

Common problems and analysis of evaluation of traditional Chinese medicine preparations in Shandong medical institutions

Objective This paper summarized and analysed the problems found in the evaluation of traditional Chinese medicine preparations in medical institutions of our province, and explores the reference for our province''s "record management of traditional Chinese medicine preparations prepared by medical institutions using traditional techniques" under the new situation of encouraging the development of traditional Chinese medicine and ensuring the safety of drug use by the public.Methods The review of Chinese medicine preparations submitted for approval in our province from 2015 to 2018 was investigated,and the main problems in the application data of Chinese medicine preparations in medical institutions were summarized and analyzed.Results The declaration data of preparations in medical institutions need to be improved in terms of name, function, instruction, process and quality standards, and clinical research data.Conclusion It is suggested that the relevant medical institutions should strengthen the scientific and necessary examination of the previous topics, do a good job in relevant research work, fully consider the actual needs of hospitals and patients, so as to promote the healthy development of traditional Chinese medicine preparations in medical institutions and prosper the cause of traditional Chinese medicine.