济南战区医疗机构制剂抽验质量评价

Quality Assessment of Preparations Sampled in the pre-Jinan Military Region

目的分析评价"十二五"期间济南军区联勤部药品仪器检验所对济南战区辖区内医疗机构配制的制剂抽验发现的质量问题,为促进制剂质量的提高提供参考。方法对"十二五"期间济南战区医疗机构制剂监督抽验检验结果和数据进行统计处理,并对发现的质量问题进行分析,讨论其形成的原因。结果统计分析了医疗机构制剂1416批,其中不合格制剂33批,不合格涉及的剂型有13种;不合格涉及的检验项目有6项,最常见的不合格项目是微生物限度检查(占不合格总数的42.42%),其次为含量测定(18.19%)、装量(15.15%)等。结论梳理不合格项目产生的原因,要求配制单位严格遵守药品配制管理规范,提高制剂质量,确保人民群众和官兵用药安全有效。

Objective To analyse the problems with the quality of preparations made in medical institutions of Jinan Military Region.Methods Inspection records and test results of preparations made in medical institutions of Jinan Mititary Region during the 12 th Five-Year Plan Period statistically analyzed.The main quality problems of the preparations and the causes were investigated.Results A total of 1416 batches of preparations were inspected,33 of which were unqualified,involving 13 formulations.Among the 6unqualified items of inspection,the microbe limit test took the first place（42.42% of the total）,followed by assay（18.19%）and loading capacity（15.15%）.Conclusion Medical institutions should further optimize the technology and processes in strict compliance with Good Manufacturing Practice in order to improve the quality standards of preparations and guarantee safe and effective medication.