药用辅料黑氧化铁、硬脂酸镁和糊精的微生物限度检查方法适用性研究

Validation on Microbial Limit Test Method of Pharmaceutical Excipientblack Ferric Oxide and Magnesium Stearate and Dextrin

目的:建立药用辅料黑氧化铁、硬脂酸镁和糊精的微生物限度检查法并进行方法适用性试验。方法:按照《中国药典》2020年版四部通则1105和1106项下要求进行试验。需氧菌总数、霉菌和酵母菌总数检查采用常规平皿法,控制菌检查采用常规法、100mL胰酪大豆胨液体培养基,各实验菌进行回收率试验,并对控制菌进行适用性实验。结果:需氧菌总数、霉菌和酵母菌总数试验中各菌的回收比值均符合《中国药典》2020年版规定,控制菌检查方法可行。结论:该方法适用于药用辅料糊精、黑氧化铁和硬脂酸镁的微生物限度检查。

Objective:To establish the microbial limit test method for pharmaceutical excipients such as ferric black oxide,magnesium stearate and dextrin,and to carry out the applicability test of the method.Methods:The results were determined according to general rules 1105 and 1106 of the Chinese Pharmacopoeia(2020 edition).The total number of aerobic bacteria,molds and yeasts was checked by conventional plate method,and the control bacteria was checked by conventional method,100mL tryptic soy peptone liquid medium.The recovery rate test was conducted for each experimental bacteria,and the applicability test was conducted for the control bacteria.Results:The total number of aerobic bacteria,fungi and yeasts of black ferric oxide,magnesium stearate and dextrin were all collected by conventional method,and the microbial recovery ratio was between 0.5 and 2.0.Escherichia coli was examined by conventional method,and the volume of pancreatic soy meal liquid medium was 100 mL.Conclusion:The established method can be used to detect the microbial limit of black ferric oxide,magnesium stearate and dextrin.