Abstract：Objective To establish the microbial limit test method for Qingshen Pills, and analyze the results of the microbiological tests, and provide reference for actual production. Methods With reference to the method in the 2015 edition of the Chinese Pharmacopoeia, a method for microbial counting of 8 kinds of traditional Chinese medicine in Qingshen Pills and Qingshen Pills was established. The microbial limit tests of 30 batches of Qingshen Pills were tested to investigate the correlation between the content of aerobic bacteria and the moisture of the pill, and the correlation between the microbial content and the baking time. And the microbiological contents of 8 kinds of traditional Chinese medicine in Qingshen Pills were analyzed. Results The microbial contamination of Qingshen Pills is mainly aerobic bacteria. The higher the water content of Qingshen Pills was, the higher the microbial contamination level was. The longer the baking time, the less the moisture of the pills and the less the total number of aerobic bacteria. Dandelion had the most serious microbial contamination in 8 kinds of traditional Chinese medicine. Conclusion The water content and baking time of Qingshen Pills should be strictly controlled, and microbial limit standards for traditional Chinese medicine should be established to guide actual production and gradually improve the quality of Qingshen Pills.
易伟 李思 吴晶晶 苏华 龚光明. 清肾丸的微生物限度检查及影响因素分析[J]. 中国医药导报, 2020, 17(30): 138-141.
YI Wei LI Si WU Jingjing SU Hua GONG Guangming. Microbial limit test and influence factor analysis of Qingshen Pills. 中国医药导报, 2020, 17(30): 138-141.
2020, Vol. 17 
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