关键词: font-size:medium, ">国家药品抽检；心宁片；微生物限度检查；方法适用性；结果分析

Abstract: Objective： According to the 2025 national drug sampling inspection plan of the National Medical Products Administration， microbial limit tests were conducted on 75 batches of Xinning Tablets from 5 manufacturers and the results were analyzed. Methods： Based on the relevant provisions of General Chapters 1105 and 1106 of the Chinese Pharmacopoeia 2020 Edition， applicable microbial limit test methods for Xinning Tablets from different manufacturers were established. All the sampled products were tested using the conventional method and the method with additional dilution solution. Results： For the 2025 national drug sampling inspection， all Xinning Tablets from 5 manufacturers could pass the aerobic bacteria limit test using the method with additional dilution solution， and the control bacteria limit test using the conventional method. Four manufacturers′ samples could pass the mold and yeast limit test using the conventional method， while the samples from one manufacturer needed to use 1∶20 as the lowest dilution level for the mold and yeast limit test. The microbial limit test results of all 75 batches of Xinning Tablets were in compliance with the regulations. Conclusion： Different manufacturers have different production processes for Xinning Tablets. When conducting microbial limit tests on drugs， various factors that may affect the test results should be fully considered， and appropriate microbial limit test methods should be established to ensure the safety of drug use for the public.

Key words: font-size:medium, ">National drug sampling inspection； Xinning tablets； Microbial limit test； Method applicability； Analysis of the results