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

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.