山东省医疗机构中药制剂质量标准现状及标准提高问题分析  

Analysis on the current situation and improvement of TCM preparation quality standard in Shandong Province medical institutions

作　　者：徐兴燕 许丽丽 于雅萌 林林 汪冰 刘传民 林永强 XU Xingyan;XU Lili;YU Yameng;LIN Lin;WANG Bing;LIU Chuanmin;LIN Yongqiang(Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM,Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong University of Traditional Chinese Medicine,Jinan 250355,China;Shandong Drug Administration,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,中药标准创新与质量评价工程实验室,山东济南250101 [2]山东中医药大学,山东济南250355 [3]山东省药品监督管理局,山东济南250101

出　　处：《药学研究》2021年第2期134-137,共4页Journal of Pharmaceutical Research

基　　金：重大新药创制专项(中药新药丹皮酚滴丸、紫芍皂苷软胶囊和贞芍醇苷胶囊的研发与其关键创新技术)(子课题编号:2017ZX09301064010);山东省药品监督管理局委托《山东省医疗制剂规范》结集出版项目。

摘　　要：目的规范山东省医疗机构中药制剂质量标准,保障医疗机构中药制剂的安全、有效和质量可控。方法基于山东省医疗机构中药制剂质量标准现状,通过对《山东省医疗机构制剂规范》(第一版第一册)和标准提高品种的整理和归纳,总结医疗机构中药制剂质量标准存在的问题。结果《山东省医疗机构制剂规范》(第一版第一册)收载的780个品种的质量标准项目设置相对简单,质量控制指标单一,对比标准提高任务中310个品种提高前后质量标准发现,标准整体控制大幅提高,在今后的工作中,应加强质量标准的安全性、完整性和适用性,提高制剂质量,保障人民临床用药安全、有效。结论《山东省医疗机构制剂规范》作为山东省医疗机构制剂的法定标准,颁布实施后山东省的医疗机构制剂标准水平将得到大幅提高。Objective To standardize the quality standards of TCM preparations in medical institutions of Shandong Province and ensure the safety,effectiveness and quality control of TCM preparation in medical institutions.Methods Based on the status of TCM preparation quality standards of medical institutions in Shandong Province,this paper summarized the existing problems of TCM preparation quality standards of medical institutions in Shandong Province by sorting out and summarizing Shandong Provincial Medical Institution Preparation Specification(volume 1,first edition)and the improved varieties.Results The quality standard items of 780 varieties collected in Shandong Provincial Medical Institution Preparation Specification(Volume I,first edition)are relatively simple,and the quality control index is single,comparing the quality standards of 310 varieties in the standard improvement task before and after the improvement,the overall standard control was significantly improved.In the future work,we should strengthen the quality standard of security,integrity and applicability,and improve the quality of preparations to ensure the safe and effective clinical application.Conclusion As the legal standard of Shandong Provincial medical institution preparation,medical institution preparation standard in Shandong Province will be greatly improved after the promulgation and implementation of Shandong Provincial Medical Institution Preparation Specification.

关 键 词：《山东省医疗机构制剂规范》 医疗机构 中药制剂 质量标准 标准提高 

分 类 号：R95[医药卫生—药学]