摘要
比较复方青黛胶囊《中国药典》2015年版与2010年版微生物限度检查法的验证研究。按照《中国药典》2010年版附录[1]及2015年版四部[2]通则1105非无菌产品微生物限度检查进行方法学建立和验证。复方青黛胶囊试验按《中国药典》2010年版方法检查可采用培养基稀释法进行细菌检查,平皿法进行霉菌和酵母菌检查;按《中国药典》2015年版方法检查可采用平皿倾注法进行需氧菌总数及霉菌和酵母菌总数的测定。2015年版《中国药典》所用培养基广谱性强,有助于所有存活微生物生长;同时新版药典的微生物计数法与2010年版相比,更科学、严谨、操作性更强,达到了与国际接轨的目的。
In order to compare the compound indigo naturalis capsule in Chinese pharmacopoeia 2015 edition and 2010 edition of microbial limit test of validation studies according to Chinese pharmacopoeia 2010 version of the appendix,four 2015 of sterile goods microbial limit inspection,we establish and verify the methodology. Compound indigo naturalis capsule test according to the 2010 edition of Chinese pharmacopoeia we check that bacteria culture medium dilution method can be used to perform inspections,AGAR method can be used to mold and yeast. According to the 2015 edition of China pharmacopoeia we check that AGAR pouring method can be used for the total number of aerobe and determination of the total number of mold and yeast. 2015 edition of Chinese pharmacopoeia medium used broad-spectrum strong sex,helping all living microbial growth. At the same time,the new pharmacopoeia microbial counting method compared with the 2010 version was more scientific,rigorous and practical stronger and achieved the goal of the in line with international standards.
出处
《药物生物技术》
CAS
2017年第5期402-405,共4页
Pharmaceutical Biotechnology
关键词
复方青黛胶囊
复方制剂
微生物限度
中国药典
验证方法
回收比值
Compound indigo naturalis capsule, Compound preparations, Microbial limit, Chinese pharmacopoeia, Pharmacopoeia,Validation method, Recycling ratio
