Abstract:
OBJECTIVE To introduce the main revision situation about antimicrobial effectiveness testing of the Chinese Pharmacopoeia(ChP) 2020 Edition.
METHODS Compared antimicrobial effectiveness testing of ChP 2020 Edition to the relevant content of the ChP 2015 Edition, the differences and links between the main pharmacopoeias such as ChP, US Pharmacopoeia(USP), European Pharmacopoeia(EP), British Pharmacopoeia(BP), and Japanese Pharmacopoeia(JP) were analyzed at the same time.
RESULTS The antimicrobial effectiveness testing of ChP 2020 Edition had been revised in the culture system, test strains, and so on, it was more suitable to guide the screening of antibacterial agents and the establishment of antibacterial systems in the pharmaceutical preparations.
CONCLUSION The antimicrobial effectiveness testing has been further improved to become a more complete method, which can be used to guide the screening of bacteriostatic agents in the drug development stage, and can also be used for the scientific and reasonable evaluation of the addition of bacteriostatic agents for listed drugs, which is conducive to ensuring drug safety and effective.