《中国药典》中重量差异检查、含量均匀度检查和含量测定方法的统计抽样原理解读  

Interpretations of Statistical Sampling Principles of Weight Difference Examination,Content Uniformity Examination and Assay in Chinese Pharmacopoeia

作　　者：冯铮铮 付绍华 祝天毅 FENG Zheng-zheng;FU Shao-hua;ZHU Tian-yi(Beijing Union Pharmaceutical Factory Ltd.,Beijing 102600,China;Xi'an Taikomed Pharmaceutical Technology Co.,Ltd.,Xi'an 710064,China)

机构地区：[1]北京协和药厂有限公司,北京102600 [2]西安泰科迈医药科技股份有限公司,陕西西安710064

出　　处：《解放军药学学报》2023年第4期301-304,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的探讨《中国药典》中重量差异检查、含量均匀度检查和含量测定方法的统计抽样原理,帮助质量工作人员更清楚地了解《中国药典》标准的质量保证水平。方法使用抽样特性曲线分析批不合格品率与接收概率的关系,明确检查方法对质量风险控制水平和质量保证水平的控制情况。结果通过分析,明确了3个方法的抽样检验方案类型和质量保证水平,其中重量差异检查法是以不合格品率为质量指标的计数型抽样检验方案,含量均匀度检查法是以不合格品率为质量指标的二次抽样的计量型抽样检验方案,含量测定方法是以均值为质量指标的一次抽样的计量型抽样检验方案,3个抽样检验方案均是同时考虑生产方风险和使用方风险的标准型抽样方案。结论《中国药典》科学地应用统计抽样原理来制定检查方法和标准限度,对生产方风险和使用方风险均有较好的控制。企业在制定内控标准时,也应当通过分析抽样特性曲线,根据风险选择抽取样本的数量和判定方法,并应注意到各指标间的关系,制定统一的控制标准。Objective To give the quality-related staff a better idea about the quality assurance level of pharmacopoeial standards by presenting the statistical sampling principles of three inspection methods:weight variance inspection,content uniformity inspection and assay specified in the Chinese Pharmacopoeia.Methods The sampling characteristic curve was used to analyze the relationships between the rate of nonconforming products and the acceptance probability.The intensity of control over the quality risk control level and quality assurance level by these inspection methods was determined.Results Based on analysis,the types of sampling and testing schemes and quality assurance levels of the three inspection methods were clarified.In which the Weight Variance Inspection method is a sampling inspection by attributes with the rate of non-conforming products as the quality indicator.The Content Uniformity Inspection method is a sampling inspection by variables of double sampling with the rate of non-conforming products as the quality indicator,and the Assay Method is a sampling inspection by variables of single sampling with the mean value as the quality indicator.All the three sampling strategies were standard sampling schemes that took into account both Producer's Risk and Consumer's Risk.Conclusion The Chinese Pharmacopoeia has effectively used the principles of statistical sampling to specify inspection methods and standard limits,which leads to better control over both Producer's Risk and Consumer's Risk.When formulating internal control standards,enterprises should also choose the amount of sampling and determination methods according to the risk by analyzing the OC curve.The relationships between indicators should be considered to ensure uniform control standards.

关 键 词：重量差异 含量均匀度 含量测定 抽样特性曲线 计数型抽样检验 计量型抽样检验 

分 类 号：R917[医药卫生—药物分析学]