影响抗生素微生物检定法(管碟法)测定准确性的常见原因分析
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摘要
目的总结抗生素微生物检定法(管碟法)中影响测定结果准确性的常见系统误差并加以控制。方法梳理10余年来中检院仲裁复验的案例,对共性问题进行整理,找出可能原因,并采用单一变量实验设计的方式加以确证。结果估计效价和浓度比的错误计算、点样顺序和点样时间规范性和熟练程度、试验标准菌株的变异均会对管碟法测定结果产生影响。结论通过细化实验操作规范,可以避免或尽量消除此类系统误差的影响。
Objective The common system deviations which affect the measuring accuracy of the microbiological assay(the agar diffusion method) were summarized and methods to control them were identified. Methods The cases in the last decade were collected. These cases had a common feature that is a large gap between results of the arbitration or reexamination and the first inspection. We found out the possible common factors for this phenomenon through analysis, and confirmed the causes by a single variable confirmatory experiment. Results The common system deviations that affect the measuring accuracy of the agar diffusion method mainly include the erroneous calculation of the estimated potency and the concentration ratio, the standardization and proficiency in operation, and the mutation of reference culture. Conclusion It is possible to avoid or eliminate these system deviations on the measuring accuracy of the agar diffusion method by means of detailed experimental operations.
Objective The common system deviations which affect the measuring accuracy of the microbiological assay(the agar diffusion method) were summarized and methods to control them were identified. Methods The cases in the last decade were collected. These cases had a common feature that is a large gap between results of the arbitration or reexamination and the first inspection. We found out the possible common factors for this phenomenon through analysis, and confirmed the causes by a single variable confirmatory experiment. Results The common system deviations that affect the measuring accuracy of the agar diffusion method mainly include the erroneous calculation of the estimated potency and the concentration ratio, the standardization and proficiency in operation, and the mutation of reference culture. Conclusion It is possible to avoid or eliminate these system deviations on the measuring accuracy of the agar diffusion method by means of detailed experimental operations.
引文
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[3]The European Pharmacopoeia Commission.The European Pharmacopoeia[S].(9.0).Strasbourg:Council of Europe,2017.
[4]The British Pharmacopoeia Commission.The British Pharmacopoeia[S].(2017).British Pharmacopoeia Commission Laboratory,2017.
[5]The United States Pharmacopoeia Commission Inc.The United States Pharmacopeia[S].(USP41).Rockville,Md:the United States Pharmacopeia Convention,Inc,2018:NF36,2018.
[6]The Ministry of Health,Labour and Welfare.The Japanese pharmacopoeia[S].(17th Ed).Tokyo:Society of Japanese Pharmacopoeia,2016.
[7]张治锬.抗生素药品检验[M].北京:人民卫生出版社,1987:12-18.
[8]胡昌勤,刘炜.抗生素微生物检定法及其标准操作[M].北京:气象出版社,2004:4-19.
[9]国家食品药品监督管理局人事司.药品检验技术[M].北京:中国医药科技出版社,2013.
[10]国家药典委员会.中国药典分析检测技术指南[S].北京:中国医药科技出版社,2017.
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