含抑菌成分中药片剂的微生物限度检查方法学研究OA

To establish a microbial limit test method for traditional Chinese medicine tablets containing antibacterial ingredients,the article evaluated the applicability of the method and the recovery ratio of aerobic bacteria based on the 2020 edition of the Pharmacopoeia of the People's Republic of China.By using a 1∶10 test solution and the petri dish method for counting,the recovery ratio of aerobic bacteria count for Staphylococcus aureus was less than 0.5,while the recovery ratios for mold and yeast counts for Candida albicans and Aspergillus niger were both between 0.5 and 2.To eliminate the antibacterial effect,aerobic bacteria were counted using the plate method with 1∶20 and 1∶50 test solutions,respectively.The recovery ratio of Staphylococcus aureus in the 1∶20 test solution was still less than 0.5,while the recovery ratios of each 1∶50 test solution were between 0.5 and 2.Conventional methods were used for bacterial control testing,and corresponding positive bacteria were detected in both the experimental group and the positive control group.The petri dish method was used for counting experiments,with a dilution ratio of 1∶50 for aerobic bacterial count and 1∶10 for mold and yeast count.Conventional methods were used for controlling bacterial detection,thus establishing an effective microbial limit test method for traditional Chinese medicine tablets containing antibacterial ingredients.