四黄软膏微生物限度检验方法的验证

Verification Experiment on Microbial Limit Test Method of Sihuang Ointment

目的:建立科学有效的实验方法适用于四黄软膏微生物限度的检查,确保方法学验证结果准确、可靠。方法:按照《中国药典》2015年版四部附录1105、1106非无菌产品微生物限度检查的规定对其微生物计数及控制菌进行检查,通过5种试验菌的回收率确认检验方法的有效性。结果:在3次独立的平行实验中,需氧菌总数、霉菌和酵母菌总数验证中5种试验菌每次试验的回收率比值菌落在0.5~2的范围内;在控制菌检查中,试验组均可检出金黄色葡萄球菌和铜绿假单胞菌。结论:需氧菌总数、霉菌和酵母菌总数检查采用薄膜过滤法,控制菌检查采用薄膜过滤法。

Objective:To establish a scientific and effective test method for the detection of microbial limit of Sihuang ointment,and to ensure that the results of methodological verification are accurate and reliable.Methods:The microbial count and control bacteria of 1106 aseptic products were examined according to the provisions of appendix 1105 and 1106 of the 2015 edition of Chinese Pharmacopoeia,and the validity of the test method was confirmed by the recovery rate of five kinds of test bacteria.Results:In three independent parallel experiments,the recovery ratio of the five tested bacteria was within the range of 0.5-2 in the verification of the total number of aerobic bacteria and the total number of mold and yeast,and Staphylococcus aureus and Pseudomonas aeruginosa could be detected in these three independent parallel experiments.Conclusion:Membrane filtration was used to detect the total number of aerobic bacteria,mold and yeast,and membrane filtration was used to control the bacteria.