大蒜素肠溶胶丸微生物计数方法的建立及结果分析

Establishment and Result Analysis of Microorganism Count Method of Allicin Enteric-coated Pellet

目的建立大蒜素肠溶胶丸计数方法。方法按2015年版《中国药典》四部通则进行大蒜素肠溶胶丸微生物计数法适应性试验,采用聚山梨酯80为乳化剂、pH 6.8磷酸盐缓冲液为稀释剂,需氧菌总数、霉菌和酵母菌总数均采用1∶50供试液按薄膜过滤法计数,用pH 7.0无菌氯化钠-蛋白胨缓冲液冲洗300mL/膜。结果需氧菌总数、霉菌和酵母菌总数各菌的回收率比值均大于0.5。结论该方法可作为大蒜素肠溶胶丸微生物计数检查方法。

OBJECTIVE To establish enumeration method for alltride enteric-coated soft capsule.METHODS According to the 2015 edition of Chinese pharmacopoeiafour general principles of allicin enteric capsule microbial counting method adaptability tests,used in yamanashi ester 80 as the emulsifier,pH 6.8 phosphate buffer as diluent,total aerobic bacteria,mould and yeast adopt 1:50 by membrane filtration method,Chinese herbs were tested with sterile sodium chloride-peptone pH 7.0 buffer flush 300 mL/film.RESULTS The recovery ratios of total aerobic bacteria,molds and yeasts were all greater than 0.5.CONCLUSION This method can be used to detect the microorganism of allicin enteric-coated pellets.