PDCA循环法用于黑膏药制剂生产质量管控效果分析  

Effect of PDCA Cycle Method on Production Quality Control of Black Plaster Preparation

作　　者：马依林[1] 张虹[1] MA Yilin;ZHANG Hong(Isoyang Onthopedic Hospital of Henan Prorince,Onthopedic Hospital of Henan Protince,Lsoyang.Hemain,China 471002)

机构地区：[1]河南省洛阳正骨医院·河南省骨科医院,河南洛阳471002

出　　处：《中国药业》2021年第21期18-20,共3页China Pharmaceuticals

基　　金：河南省中医药管理局项目[TCM2018021]。

摘　　要：目的探讨PDCA循环法用于黑膏药制剂生产质量管控的效果。方法应用PDCA(计划-实施-检查-处理)循环管理模式,以制剂半成品不合格率为评价指标,运用鱼骨图法、头脑风暴法、"5why"分析法等分析影响制剂质量的原因,并制订计划、实施执行、反馈效果,最后进行总结。以黑膏药制剂半成品为研究对象,医院制剂科除检测黑膏药成品的标准外,主要从黑膏药基质软化点、未包装前的性状、装量差异等方面进行质量控制。统计2018年8月至10月(实施PDCA循环前)和2018年11月至2019年1月、2019年2月至4月、2019年5月至7月(分别实施3轮PDCA循环后)的不合格率,采用SPSS 19.0统计学软件分析。结果 1,2,3轮PDCA循环后黑膏药制剂半成品不合格率分别为0.13%,0.07%,0.03%,均显著低于实施PDCA循环前的0.32%(P <0.01)。结论 PDCA循环法用于黑膏药制剂的生产全流程质量管理,降低了黑膏药制剂的不合格率,提高了制剂质量,可广泛应用于传统剂型生产的质量管控。Objective To investigate the effect of PDCA cycle on the production quality control of black plaster preparation.Methods PDCA(plan-do-check-action)cycle method was applied.Taking the unqualified rate of semi-finished products of the preparation as the evaluation index,the causes affecting the quality of the preparation were analyzed by the fishbone diagram method,brainstorming method,and"5 why"analysis method.The plan was formulated and implemented,and the effect was feedback and summarized.Taking the semi-finished products of black plaster preparation as the research object,in addition to detecting the standards of the finished products of black plaster,the preparation department of our hospital mainly controlled the quality of the preparation from the aspects of the softening point of black plaster matrix,the properties before unpacking and the difference of loading capacity.The unqualified rates of the preparation from August to October 2018(before the implementation of PDCA cycle),from November 2018 to January 2019,from February to April 2019 and from May to July 2019(after the first,second,third rounds of PDCA cycle)were counted and analyzed by the SPSS 19.0 statistical software.Results After the first,second,third rounds of PDCA cycle,the unqualified rates of semi-finished products of black plaster preparation were 0.13%,0.07%and 0.03%,respectively,which were significantly lower than 0.32%of that before the implementation of PDCA cycle(P<0.01).Conclusion The implementation of PDCA cycle method in the whole process of quality management of black plaster preparation can effectively reduce the unqualified rate of black plaster preparation and improve the preparation quality of black plaster,which can be widely used in the quality control of the production of the traditional dosage forms.

关 键 词：PDCA循环法 黑膏药 质量管理 药事管理 

分 类 号：R95[医药卫生—药学]