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肠炎宁片2015年版药典微生物限度检查法验证与评价 被引量:4

Verification and Evaluation on Microbial Limit Test of Methodology for Changyanning Tablets in ChP 2015
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摘要 目的:建立肠炎宁片微生物限度检查方法,并对方法进行验证和评价。方法:需氧菌总数计数法及霉菌和酵母菌总数计数法均采用平皿法,供试液浓度分别为1∶100和1∶10。大肠埃希菌检查、耐胆盐革兰阴性菌检查和沙门菌检查均为常规法。结果:5种试验菌的回收试验结果均在0.5~2.0之间。结论:该方法适用于肠炎宁片的微生物限度检查。 Objective: To provide a method of microbial limit test for Changyanning tablets and carry out the verification of the mothod. Methods: A plate method was used in the total aerobic microbial count and the concentration of the test liquid was 1 : 100. A plate method was used in the total yeast and mold count while the concentration of the test liquid was 1 : 10. The direct inoculation method was used for the detection of Escherichia coli, bile-tolerant gram -negative bacteria and Salmonella enterica subsp. Results: The recoveries of the five strains were from 0.5 to 2.0. Conclusion: The method is suitable for the microbial limit examination of Changyanning tablets.
出处 《中国药师》 CAS 2017年第5期946-948,共3页 China Pharmacist
关键词 肠炎宁片 微生物限度检查 方法验证 Changyanning tablets Microbial limit Verification and evaluation of methodology
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