柴芩清热口服液微生物限度检查方法适用性试验

目的:建立柴芩清热口服液微生物限度检查方法,并对5个不同批次柴芩清热口服液微生物限度进行适用性试验。方法:根据2015版《中华人民共和国药典》制备金黄色葡萄球菌菌液、枯草芽孢杆菌菌液、大肠埃希菌菌液、白色念珠菌菌液、黑曲霉菌液和铜绿假单胞菌菌液;而后采用氯化钠胰蛋白胨稀释液制得1∶10的柴芩清热口服液供试品溶液;根据药典中微生物限度检查法,一步一步建立方法学,即进行计数方法适用性试验和控制菌检查试验,并重复3次进行反复验证,对柴芩清热口服液中微生物的含量进行检测。结果:1)需氧菌总数的计数中:采用薄膜过滤法微生物限度适用性试验研究,柴芩清热口服液需氧菌的菌株回收率计数试验结果显示:金黄色葡萄球菌、白色念球菌、枯草芽孢杆菌、黑曲霉、铜绿假单胞菌的菌株回收率计数分别为1. 02、0. 99、0. 84、0. 96、0. 99。2)霉菌和酵母菌计数中结果显示,白色念珠菌和黑曲霉的菌株回收率分别是0. 89和0. 89。3)柴芩清热口服液在常规法检测控制菌适用性试验结果中显示,每1 g柴芩清热口服液供试品中可能的菌数(10~2N 10~3) cfu。4) 5批柴芩清热口服液的微生物计数结果显示需氧菌总数、霉菌总数和酵母菌总数均10 cfu/m L,而在控制菌检查试验结果中5批柴芩清热口服液中大肠埃希菌均未检出。结论:本研究中柴芩清热口服液微生物限度检查结果均符合我国2015版《中华人民共和国药典》的规定。

Applicability Test of Microbiological Limit Test Method for Chaiqin Qingre Oral Liquid

To establish a microbiological limit test method of Chaiqin Qingre Oral Liquid and to test the applicability of 5 different batches of Chaiqin Qingre Oral Liquid.Methods:Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Candida albicans, Aspergillus Niger and Pseudomonas aeruginosa were prepared according to the 2015 edition of Chinese Pharmacopoeia.Then the sample solution of Chaiqin Qingre oral liquid was prepared by sodium chloride tryptone dilution solution at 1:10.According to the microbial limit test method in Pharmacopoeia, the methodology was established step by step, that is, the applicability test of counting method and the test of control bacteria.The content of microorganism in Chaiqin Qingre oral liquid was detected by repeated verification for 3 times.Results:1)In the count of aerobic bacteria, the applicability test of microbial limit by membrane filtration was carried out.The results showed that the recovery rates of Staphylococcus aureus, Candida albicans, Bacillus subtilis, Aspergillus Niger and Pseudomonas aeruginosa were 1.02, 0.99, 0.84, 0.96, 0.99, respectively.2)The recovery rates of Candida albicans and Aspergillus Niger were 0.89 and 0.89, respectively.3)The results of the applicability test of Chaiqin Qingre oral liquid in the routine method showed that the possible number of bacteria per 1 g of Chaiqin Qingre oral liquid was(102