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Applicability test and result analysis of microbial limit test for Sanqi Powder of traditional Chinese medicine |
LIU Kanglian1 PANG Yunjuan2 LIANG Xiaoling2 PANG Lanying2 LAI Fuxi2 LIANG Jie1 |
1.College of Pharmacy, Guangxi University of Chinese Medicine, Guangxi Zhuang Autonomous Region, Nangning 530222, China;
2.YuLin Food and Drug Inspection and Testing Center, Yulin Engineering Technology Center for Quality Inspection and Evaluation of Chinese Medicinal Materials (Including Spices), Guangxi Zhuang Autonomous Region, Yulin 537000, China
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Abstract Objective To establish a microbial limit test and the applicability test for Sanqi Powder from three manufacturers based on Chinese Pharmacopoeia in 2020, and to provide reference for the study of the microbial limit test method of powdered traditional Chinese medicine. Methods According to the four general rules 1108 of Chinese Pharmacopoeia in 2020, the plate method was used to determine the total number of aerobic, mold, and yeast. The applicability of methods for Sabouraud Dextrose Agar, Sabouraud Agar (containing chloramphenicol), and Rose Bengal Agar was studied. The conventional method and dilution method were used to test the applicability of control bacteria. Results The total number of aerobic bacteria in Sanqi Powder from three manufacturers were 1∶100, 1∶50, 1∶20 by plate method, the total number of molds and yeasts were 1∶20, 1∶10, 1∶10 by plate method. Escherichia coli and Gram-negative bacteria were both detected by conventional method, and the maximum volume of Salmonella enrichment liquid tryptophan soybean peptone liquid medium was 200 ml. Conclusion The microbial limit test methods of Sanqi Powder from three manufacturers conforms to the relevant provisions of the fourth general rule of Chinese Pharmacopoeia in 2020, and the method is feasible. Sanqi Powder has a certain inhibitory effect on bacteria. The microbial limit test methods of Sanqi Powder from different manufacturers are not identical.
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