摘要
目的建立小儿氨酚黄那敏颗粒微生物限度检查方法。方法按《中国药典》2010年版附录微生物限度检查法规定的方法验证进行试验。结果小儿氨酚黄那敏颗粒以常规法检查细菌、霉菌、酵母菌、大肠埃希菌、大肠菌群和沙门菌,回收率均大于70%。结论小儿氨酚黄那敏颗粒细菌、霉菌和酵母菌的计数方法采用常规法,控制菌可采用常规法检验,结果有效可行。
OBJECTIVE To establish microbial limit test for children Paracetamol Min Huang Granules METHODS The methods were according to Chinese Pharmacopoeia 2010 Edition Appendix microbial limit test method. CONCLUSION It is effective and feasible that bacteria,filamentons fungi and yeast count were detected with routine method; Control bacteria can be tested by using the conventional method.
出处
《海峡药学》
2015年第6期63-65,共3页
Strait Pharmaceutical Journal
关键词
小儿氨酚黄那敏颗粒
微生物限度检验法
方法验证
回收率
Children Paracetamol Min Huang Granules
Microbial limits test
Method validation
Recovery
