GONG Ya, LI Min, CAO Jian, et al. Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder[J]. 2020,20(10):1197-1199.
GONG Ya, LI Min, CAO Jian, et al. Establishment of Microbial Limit Test Method for 4 Kinds of Hospital Chinese Medicine Preparations Containing Traditional Chinese Medicine Powder[J]. 2020,20(10):1197-1199. DOI: 10.14009/j.issn.1672-2124.2020.10.012.
OBJECTIVE: To establish microbial limit test method for 4 kinds of hospital Chinese medicine preparations( Yanshao Weikang capsules
Ruling tablets
Zhikeping capsules and Yanshen capsules) containing TCM powder. METHODS: According to specific rules of the four general rules 1105
1106 and 1107 of Pharmacopoeia of the People’s Republic of China( 2015 edition) for testing basis. Plating method was adopted to process the test sample and explore the dilution level. RESULTS: In the applicability test for the total count of aerobic bacteria
molds and yeasts
within the allowable dilution level
the plating dilution method can eliminate antibacterial effect
and the recovery rate of each test bacteria was 0. 5-2. 0. All the 4 preparations were tested for bacteria control by direct inoculation method
none of which had antibacterial effect. CONCLUSIONS: Yanshao Weikang capsules
Ruling tablets
Zhikeping capsules and Yanshen capsules can all be tested for the total count of aerobic bacteria
molds and yeasts by plating method
and the control bacteria inspections can be conducted by direct inoculation.
关键词
中药原粉医院中药制剂微生物限度检查方法适用性
Keywords
Traditional Chinese medicine powderHospital Chinese medicine preparationMicrobial limit testMethod applicability