摘要
Abstract
Objective To provide reference for the improvement of microbial identification standards.Methods Focusing on the general chapter 1021 ″Bacterial DNA signature sequence identification method″ in the 2020 edition of Chinese Pharmacopoeia,problems in practical use were analyzed and suggestions were provided by comparing domestic and foreign pharmacopoeias(USP 2024,EP 11.0,JP 18)and corresponding standards for nucleic acid-based microbial identification methods.Results In domestic and foreign pharmacopoeias and standards,nucleic acid-based microbial identification content was divided into two categories:guiding principles and specific methods.Problems were identified in the practical application of current standards,such as overly strict limitations on DNA signature sequence types,insufficient clarity in standard databases and result determinationand,and lack of nucleic acid identification methods related to fungi.It is suggested to increase flexibility and inclusiveness in the language description of methods in current standards,promote the construction of standard databases,clarify result determination standards,and add fungal-related methods appropriately.Conclusion The current standards can provide specific guidance for microbial contamination control,but there is a gap compared to the actual needs of pharmaceutical microbial identification,and the relevant standard system needs to be further improved.关键词
药品/药典/细菌/微生物鉴定/核酸/DNA特征序列Key words
pharmaceutical/pharmacopoeia/bacteria/microbial identification/nucleic acid/DNA signature sequence分类
医药卫生
