《中国药典》与《美国药典》《欧洲药典》《日本药典》中聚合酶链式反应法的比较研究  

Comparative Study of Polymerase Chain Reaction among Chinese Pharmacopeia,United States Pharmacopeia,European Pharmacopeia,and Japanese Pharmacopeia

作　　者：安春艳 井良义 陈卓 刘文杰 牛振东 AN Chunyan;JING Liangyi;CHEN Zhuo;LIU Wenjie;NIU Zhendong(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《生命科学仪器》2022年第5期46-52,共7页Life Science Instruments

摘　　要：目的:《中国药典》2020年版四部通则1001提供了聚合酶链式反应(Polymerase chain reaction,PCR)法的基本内容,对规范使用该方法具有重要作用。随着生物技术进步、药品生产实践的发展、以及国际药典的更新,该分析方法的内容有待不断完善。本文比较研究了中国药典和国外主流药典现行版本中关于PCR法的内容,为我国药典中相关内容的修订和完善提供理论参考。方法:比较《中国药典》(2020年版)与《美国药典》(2022年版)、《欧洲药典》(10.0版)和《日本药典》(第18版)中涉及到PCR方法的内容。结果:我国药典在PCR法的适用对象、产物检测、分析方法验证和和质量控制等多个方面与国外药典存有差异。在此基础上,本文提出了在现有药典内容基础上进行PCR分析方法的质量控制进行修订的建议。结论:通过对各国药典的比较研究,为药典中PCR法的修订提供了参考。Objective:The general chapter 1001 in Chinese Pharmacopeia(ChP,Edition 2020)provides the fundamental contents on the polymerase chain reaction(PCR)method,which acts as an important guidance for the use of PCR method.With the progress of biological technology and drug production,together with the update of the international pharmacopeia,PCR method in ChP 2020 needs improvement.Herein,the authors aim to provide theoretic references for the future revise of PCR method in Chinese Pharmacopeia by comparing the major international pharmacopeia.Methods:Compare the PCR-related contents in ChP 2020,United States Pharmacopeia(Edition 2022),European Pharmacopeia(Editon 10.0),and Japanese Pharmacopeia(Editon 18),and assess the need of revising PCR method.Results:The differences exist in various aspects including suitable scope,product detection,analytical method validation,and quality control of PCR method between ChP 2020 and the other three pharmacopeia.Thus,the revise on the quality control of PCR method was suggested based on the existing contents.Conclusion:The comparative study provided the reference for the amendment of PCR method.

关 键 词：聚合酶链式反应 分析方法 质量控制 药典 比较研究 

分 类 号：R95[医药卫生—药学]