Comparative Study of Microbial Limit Test and Criteria of TCM Decoction Pieces among United States Pharma- copeia，European Pharmacopeia ，Japanese Pharmacopeia and Chinese Pharmacopeia / 中国药房

ABSTRACT

OBJECTIVE：To compare the difference of microbiological limit test and criteria of TCM decoction pieces among 43 edition of United States Pharmacopeia （USP43），10.0 edition of European Pharmacopeia （EP10.0），17 edition of Japanese Pharmacopeia （JP17）and 2020 edition of Chinese Pharmacopeia （ChP2020），and to provide refernce for the revision and improvement of microbiological standards for TCM decoction pieces in China. METHODS ：The differences in the microbial enumeration tests method （including sampling and sample preparation ，selection of bacteria and culture medium ，count of microorganisms and heat-resistant bacteria ，etc.），tests for specified microorganisms （including sample pretreatment ，enrichment， separation and identification ，etc.）and microbial related limit criteria were compared among USP 43，EP10.0，JP17 and ChP 2020. RESULTS & CONCLUSIONS ：In terms of microbiological examination of TCM decoction pieces ，USP43，EP10.0，JP17 had their own independent provisions. Chp 2020 added“general rule 1108”. In terms of inspection items ，in addition to the total aerobic bacteria count and total combined yeasts and molds count ，ChP2020 and EP 10.0 provided three methods for the inspection of control bacteria （bile-resistant Gram-negative bacteria ， Escherichia coli ， Salmonella）. On the basis ， JP17 supplemented Staphylococcus aureus test；However，USP43 added Clostridium test method and put forward the concept of objectionable microorganisms risk assessment ；ChP2020 also added a new method for counting heat-resistant bacteria. In terms of microbial limit criteria，USP43 was the most detailed in the classification of TCM decoction pieces ，which was more strict than EP 10.0 and JP 17； ChP2020 had not set up a unified limit for the inspection of control bacteria of TCM decoction pieces. ChP 2020 revised the “microbial limit standard for TCM extracts and TCM decoction pieces ”，but it was not perfect compared with the Pharmacopoeia of the United States ，Europe and Japan. It is suggested that according to the current situation of microbial contamination and control of TCM decoction pieces ，the microbial limit test and criteria of TCM related products in Pharmacopoeia should be gradually improved ，and the microbial limit level of corresponding products should be reasonably refined.