《中国药典》聚合酶链式反应法的建立

Establishment of polymerase chain reaction method in Chinese Pharmacopoeia(2020 edition)

随着聚合酶链式反应(PCR)在药物质量控制的应用普及,2020年版《中国药典》增订了PCR法通则。该通则规定了采用PCR技术对中药和生化药种属进行鉴别及其他药品质量控制的基本要求,包括对仪器的一般要求、对PCR体系的一般要求、方法适用性试验、测定法(供试品前处理、模板制备、引物、核酸扩增、反应产物检测、结果判定)、附注等。该文介绍了PCR法通则及其起草说明,并对该检测技术在中药、生化药等应用前景进行展望。

With the application and popularization of PCR(polymerase chain reaction)technology in drug quality control,the ge-neral rule of PCR has been approved to be listed in the Chinese Pharmacopoeia(2020 edition).This rule has set general quality stan-dards for species identification in Chinese herbal medicine and biochemical medicine,as well as quality control of other medicines.The general rule is composed of general requirements for instruments,general requirements for PCR system,operational suitability test,measurement procedure(sample pretreatment,templates preparation,primers,nucleic acid amplification,reaction products detection,result judgment)and notes,etc.In this article,we introduced the general rule of PCR and its drafting instructions.Furthermore,its application perspective in Chinese herbal medicine and biochemical medicine was discussed.