摘要
目的建立咳喘平颗粒的微生物限度检查方法。方法采用《中国药典》2015年版微生物限度检查法进行适用性试验,需氧菌总数计数、霉菌和酵母菌总数计数、大肠埃希菌检查均采用培养基稀释法。结果适用性试验各菌的收回均在0.5~2,验证组可检出大肠埃希菌,该方法可行。结论该方法确立了咳喘平颗粒微生物限度检查,为该品种制定微生物限度标准提供了科学依据。
Objective To established the method for microbial limit test of Kechuanping granules. Methods The total aerobic microbial count, total yeasts, mold count and tile detection ofEscherichia coli were tested by culture medium dilution method, which was conducted by using microbial limit Applicability test in Chinese Pharmacopoeia 2015. Results The recoveries of each validation strain of the total aerobic microbial count, total yeasts and mold count ranged 0.5- 2. This method could detect Escherichia coli and was practical. Conclusion This method has established the scientific basis for developing standards test for microbial limits.
出处
《北京医学》
CAS
2016年第8期837-840,共4页
Beijing Medical Journal
关键词
咳喘平颗粒
微生物限度
质量分析
Kechuanping granules
microbial limit test method
quality analysis