统计过程控制在医疗机构制剂质量回顾分析中的应用  

Role of statistical process control in retrospective analysis of the quality of preparations in medical institutions

作　　者：岳凤芹 杨思成 黄菊 陈思迪 彭伟 陈树和 周从辉 孙婉瑾 段雪云 YUE Feng-qin;YANG Si-cheng;HUANG Ju;CHEN Si-di;PENG Wei;CHEN Shu-he;ZHOU Cong-hui;SUN Wan-jin;DUAN Xue-yun(College of Pharmacy,Hubei University of Chinese Medicine,Wuhan 430065;Department of Pharmacy,Affiliated Hospital of Hubei University of Chinese Medicine/Hubei Hospital of Traditional Chinese Medicine/Institute of Chinese Medicine,Hubei Academy of Chinese Medicine,Wuhan 430061;Hubei Shizhen Laborary,Wuhan 430061)

机构地区：[1]湖北中医药大学药学院,武汉430065 [2]湖北中医药大学附属医院/湖北省中医院/湖北省中医药研究院药事部,武汉430061 [3]湖北时珍实验室,武汉430061

出　　处：《中南药学》2025年第1期252-257,共6页Central South Pharmacy

基　　金：全国中药特色技术传承人才培训项目(国中医药人教函[2023]96号);国家中医药管理局“十二五”重点专科培育项目(国中医药医政发[2012]2号)。

摘　　要：目的以地五养肝胶囊为例,探讨统计过程控制在医疗机构制剂质量回顾分析中的应用。方法运用Minitab 18软件中具有能力分析的“Capability Sixpack”功能,以地五养肝胶囊中所含有效性成分五味子醇甲的含量为评判指标,判断该制剂在生产过程中是否处于受控状态及配制工艺是否稳定。结果2018年12月至2021年12月生产的地五养肝胶囊中所有批次产品质量均符合所拟订标准,但是配制工艺、过程能力尚不稳定,需采取改进措施。在采取改进措施后,其生产能力有所提高,生产状态稳定,达到控制状态,可满足生产所需。结论能力六合图在医疗机构制剂生产的质量分析中可以起到很好的警示作用,在质量控制中发挥重要作用,及时提醒操作人员对生产过程自查自纠,有利于医疗机构制剂的持续、稳定发展。Objective To determine the role of statistical process control in the retrospective analysis of the quality of preparations in medical institutions with Diwu Yanggan capsules as an example.Methods The Capability Sixpack function for capability analysis in Minitab 18 software was used.The content of schisandrin A in Diwu Yanggan capsules was used as the evaluation index to determine whether the preparation was under control during the production and whether the configuration was stable.Results The quality of all batches of Diwu Yanggan capsules produced from December 2018 to December 2021 met the proposed standards,but the preparation and process capability remained unstable,and improvement was needed.After the improvement,the production capacity was enhanced,the production was stable and met the requirements.Conclusion Capability Sixpack plays a warning role in the quality analysis of preparations in medical institutions,also plays an important role in quality control,and can timely remind operators to double-check the production of preparations in medical institutions.

关 键 词：质量回顾分析 医疗机构制剂 统计过程控制 质量分析 地五养肝胶囊 

分 类 号：R95[医药卫生—药学]