摘要
目的改进水杨酸硫软膏微生物限度检查方法。方法根据《中国药典》2020年版的规定,采用平皿法和薄膜过滤法进行方法学验证。结果用无菌液体石蜡萃取样品,全幅过滤无菌均质袋制备供试液,霉菌和酵母菌总数计数采用培养基稀释法,需氧菌总数计数采用薄膜过滤法(冲洗300 ml/膜),各试验菌回收比值可达到《中国药典》要求;控制菌采用薄膜过滤法进行检查。结论改进后的方法可用于水杨酸硫软膏的微生物限度检查,新方法克服了传统方法操作复杂、经济成本高等缺点,更加简单、高效,结果可靠。
Objective To improve the microbial limit test methods for the salicylic acid and sulfur ointment.Methods The plate method and membrane filtration method were used for methodological verification of the salicylic acid and sulfur ointment according to the Chinese Pharmacopoeia(2020).Results The samples were extracted with sterile liquid paraffin and filtered with the sterile homogeneous bag.The total numbers of molds and yeasts were calculated with the plate method and the total number of aerobic bacteria with the membrane filtration method(300 ml/mem-brance).The recovery rate of each strain of test bacteria lived up to the standard of Chinese Pharmacopoeia(2020).The control bacteria were tested with the membrane filtration method.Conclusion This improved microbial test method can be used for microbial limit test of the salicylic acid and sulfur ointment.This method is more user-friendly,efficient,reliable and economical.
作者
贺康洪
巩伟
HE Kang-hong;GONG Wei(Institute for Drug and Instrument Control of Shenyang Joint Logistic Support Center,Shenyang 110026,China)
出处
《解放军药学学报》
CAS
2022年第5期405-407,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
水杨酸硫软膏
微生物限度
salicylic acid and sulfur ointment
microbial limit test
