维生素E乳膏微生物限度检查方法验证  

Research on the Determination of Validation Method for Microbial Limits Test in Vitamin E Cream

作　　者：翁一玲[1] 张黎莉 陈松旺 

机构地区：[1]福建中医药大学附属第二人民医院,福州350003 [2]福建省福州市药品检验所,福州350007 [3]福建省药品技术审评中心,福州350003

出　　处：《海峡药学》2014年第9期53-55,共3页Strait Pharmaceutical Journal

摘　　要：目的建立维生素E乳膏的微生物限度检查方法并对其进行验证,保证微生物限度检查方法的科学性以及检验结果的正确性和可靠性。方法采用《中国药典》2010年版二部附录微生物限度检查法项下方法进行方法验证。结果确认了维生素E乳膏的微生物限度的检查方法。结论维生素E乳膏的细菌、霉菌、酵母菌计数,控制菌检查均可采用常规法,结果可靠。OBJECTIVE To establish a microbial limits test of Vitamin E cream and to ensure the scientificity of the test and the accuracy and reliability of the reault. METHODS The methods were validated according to Chinese Pharmacopoeia 2010 Edition 2 Appendix microbial limits test. RESULTS The microbial limit test methods were confirmed for Vitamin E cream. CONCLUSION The bacteria,mildew and yeast counting bacteria controlling both can be tested by using the conventional method ,which is reliable.

关 键 词：维生素E乳膏 微生物限度检查法 回收率 研究 

分 类 号：R927.12[医药卫生—药学]