论文部分内容阅读
目的对八珍胶囊和八珍片微生物限度检查进行方法学验证并对检验结果和污染菌进行分析。方法八珍胶囊和八珍片采用中国药典2015年版微生物限度检查法进行方法验证,对6家31批次的八珍胶囊和八珍片进行微生物限度检查,细菌和酵母菌鉴定采用VITEK2全自动微生物鉴定系统。结果需氧菌总数、真菌和酵母菌总数验证中各菌的回收率均>0.5,大肠埃希菌检查、耐胆盐革兰阴性菌检查沙门菌检查各验证组均可检出阳性菌。污染的微生物主要是芽孢杆菌等药材原料和环境中常见的细菌和酵母菌。结论建立满足中国药典2015年版要求的八珍胶囊和八珍片的微生物限度检查方法,需氧菌总数采用培养基稀释法、真菌和酵母菌总数采用常规法,大肠埃希菌检查、耐胆盐革兰阴性菌检查和沙门菌检查(针对八珍胶囊)都采用直接接种法。31批样品的微生物限度检查结果均符合规定,污染的微生物主要为药材原料和环境中常见的芽孢杆菌等。
Objective To validate the method of microbial limit test of Bazhen capsule and Bazhen tablet and analyze the test results and the contamination bacteria. Methods Bazhen capsule and Bazhen tablets were verified by the Chinese Pharmacopoeia 2015 edition microbial limit test method. The microbial test of Bazhen capsule and Bazhen tablets in 6 batches of 31 batches was carried out. The identification of bacteria and yeast was carried out by using VITEK2 automatic microbe Identification system. Results The total number of aerobic bacteria, the total number of fungi and yeast validation of the recovery rate of each bacteria were> 0.5, Escherichia coli test, bile-resistant saline-gram-negative bacteria check Salmonella test can be detected in each positive group of bacteria. Polluted microorganisms are mainly Bacillus and other medicinal materials and environment common bacteria and yeasts. Conclusion The microbial limit test method of Bazhen capsule and Bazhen tablet, which meet the requirements of the Chinese Pharmacopoeia 2015 edition, was established. The total number of aerobic bacteria was determined by the medium dilution method. The total number of fungi and yeast was determined by conventional method, Escherichia coli test, Gram-negative bacteria and Salmonella examination (for Bazhen capsules) are used direct inoculation. 31 batches of samples of microbial limit test results are in line with the provisions of the main microbial contamination of raw materials and the environment of Bacillus and other common.