| 夏天,崔迎,任文鑫,等.清火片(胶囊)微生物限度检查方法适用性试验[J].安徽医药,2021,25(6):1114-1117. |
| 清火片(胶囊)微生物限度检查方法适用性试验 |
| Research on applicability test of microbial limit test for Qinghuo tablets (capsules) |
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| DOI：10.3969/j.issn.1009-6469.2021.06.012 |
| 中文关键词: 细菌载量 集落计数，微生物 清火片(胶囊) 微生物限度 检查方法 金黄色葡萄球菌 |
| 英文关键词: Bacterial load Colony count, microbial Qinghuo tablets (capsules) Microbial limit Test method Staphylococ |
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| 中文摘要: |
| 目的对国内 22家企业生产的清火片(胶囊)的微生物限度方法学进行研究比对，确定适合每家企业的微生物限度检查方法。方法按照《中国药典》 2015版四部微生物限度检查法(通则 1105、通则 1106)对清火片(胶囊)，进行方法适用性试验。结果 266批清火片(胶囊)微生物限度检查结果全部符合规定，其中 207批需氧菌总数结果 <10 CFU/g，263批样品霉菌和酵母菌总数结果 <10 CFU/g。清火片(胶囊)需氧菌总数计数采用薄膜过滤法，各个厂家的样品冲洗程度略有不同，霉菌和酵母菌总数计数采用平皿法，控制菌检查采用常规法。结论本实验室确认的清火片(胶囊)的微生物限度检查方法与企业提供的方法有差异，然而，现有的微生物限度检查结果全部符合《中国药典》的标准规定。 |
| 英文摘要: |
| Objective To confirm suitable microbial limit test method of every manufacturer by researching, and to determine themicrobial limit test method of Qinghuo tablets (capsules) produced by 22 domestic manufacturers.Methods Qinghuo tablets (capsules) were tested for the applicability of the method according to the microbial limit test method in Pharmacopoeia of the People's Re? public of China (ChP) 2015 edition volume Ⅳ (general principles 1105 and 1106).Results The microbial limit test results of 266 batches of Qinghuo tablets (capsules) were all in line with the requirements, including 207 batches of aerobic bacteria less than 10CFU/g, 263 batches of samples of moulds and yeasts less than 10 CFU/g. Membrane filtration method can be used to determine the totalnumber of aerobic bacteria in Qinghuo tablets (capsules). The degree of sample flushing varied slightly in different manufacturers. Theplate method can be used to determine the total number of moulds and yeasts, and the routine method can be used to examine controlbacteria.Conclusions There are some differences between the microbial limit test method of Qinghuo tablets (capsules) confirmed byour laboratory and the method provided by manufacturers. However, the existing microbial limit inspection results all conform to thestandard provisions in ChP. |
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