某医疗机构中药制剂质量标准存在的问题及修正对策  

Problems Existing in the Quality Standard of Traditional Chinese Medicine Preparation in a Medical Institution and Correction Countermeasures

作　　者：刘敏 田佳懿[1,3] 年宏蕾 陈丽芳 刘炜 Liu Min;Tian Jiayi;Nian Honglei;Cheng Lifang;Liu Wei(Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China;Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use,Beijing 100038,china)

机构地区：[1]首都医科大学附属北京世纪坛医院,北京100038 [2]首都医科大学附属北京佑安医院,北京100069 [3]临床合理用药评价北京市重点实验室,北京100038

出　　处：《中国药事》2021年第9期1060-1065,共6页Chinese Pharmaceutical Affairs

基　　金：国家自然科学基金面上基金资助项目(编号82073741);北京市属医院科研培育计划(编号PZ20190701);首都医科大学附属北京世纪坛医院青年基金(编号2017q-45);银丹解毒颗粒医疗机构制剂备案研究(编号2020-B06)。

摘　　要：目的:规范某医疗机构中药制剂质量标准,为医疗机构中药制剂质量标准的规范化发展提供参考。方法:对某医疗机构中药制剂质量标准进行梳理,分析中药制剂质量标准中存在的问题,并提出修正对策。结果:某医疗机构中药制剂的质量标准,主要存在制剂名称、处方书写不规范、缺少配制工艺参数、薄层鉴别数量不够、检查项目不全、功能主治表达不规范等问题。结论:通过中药制剂的质量标准修正,建立了科学性强、灵敏度高、专属性强、重现性好、技术较先进而又不脱离生产实际的中药制剂质量标准,进一步保障了制剂的安全性、有效性和稳定性。Objective:To standardize the quality standards of traditional Chinese medicine preparations in the medical institution,and provide references for the standardized development of quality standards of traditional Chinese medicine preparations in medical institutions.Methods:The quality standard of traditional Chinese medicine preparation in the medical institution was sorted,the problems existing in the quality standard of traditional Chinese medicine preparation in the medical institution were analyzed,and the correction countermeasures were put forward.Results:The quality standards of traditional Chinese medicine preparations in the medical institution mainly have some problems,such as non-standard names of preparations and prescription writing,lack of preparation process parameters,insufficient number of thin layer identification,incomplete inspection items,and non-standard expressions of functional indications.Conclusion:Through the revision of the quality standard of traditional Chinese medicine preparations,the quality standard of traditional Chinese medicine preparations with strong scientific nature,high sensitivity,strong specificity,good reproducibility,relatively advanced technology and not being separated from the actual production has been established,which further guarantees the safety,effectiveness and stability of the preparations.

关 键 词：医疗机构制剂 中药制剂 质量标准 标准提高 问题与对策 

分 类 号：R95[医药卫生—药学]