阿奇霉素颗粒(Ⅱ)微生物限度检查方法学验证

Azithromycin Granules (Ⅱ) Microbial Limit Inspection Methodology Verification

目的:建立阿奇霉素颗粒(Ⅱ)的微生物限度检查方法。方法:根据《中国药典》2015年版四部通则1105微生物计数法、1106控制菌检查法,对阿奇霉素颗粒(Ⅱ)微生物限度检查法进行验证,计算5株阳性菌的回收率,并检查3批样品的微生物限度。结果:采用薄膜过滤法(1∶100)测定需氧菌总数,回收率比值为0.8~1.1;采用平皿法(1∶10)测定霉菌和酵母菌总数,回收率比值为0.9~1.1;采用薄膜过滤法检查大肠埃希菌,阳性对照菌生长良好,阴性对照未检出;3批样品按照建立的方法检测微生物限度,均符合规定。结论:建立的方法能有效去除阿奇霉素颗粒(Ⅱ)中的抑菌成分,不影响污染微生物的生长,可作为阿奇霉素颗粒(Ⅱ)微生物限度的检查方法,并用于产品的质量控制。

Objective:To establish a microbial limit inspection method for azithromycin granules (Ⅱ).Methods:According to the 2015 edition of the "Chinese Pharmacopoeia",of the four general principles 1105 microbial counting method and 1106 control bacteria inspection method,the azithromycin granule (Ⅱ) microbial limit inspection method was verified,and the recovery rate of 5 positive bacteria was calculated,and three batches of samples were inspected the microbial limit.Results:Membrane filtration method (1∶100) was used to determine the total number of aerobic bacteria,and the recovery ratio was 0.8-1.1;the plate method (1∶10) was used to determine the total number of molds and yeasts,and the recovery ratio was 0.9-1.1;the filter method was used to check Escherichia coli.The positive control bacteria grew well,while the negative control was not detected.Three batches of samples were tested for microbial limits according to the established method,and all met the regulations.Conclusion:The established method can effectively remove the antibacterial components in azithromycin granules (Ⅱ) without affecting the growth of contaminating microorganisms.It can be used as a method for checking the microbial limit of azithromycin granules (Ⅱ) and used for product quality control.