摘要
目的建立白斑膏的微生物限度检验方法。方法采用中国药典2005年版二部附录微生物限度检查方法项下方法的验证。结果确定了白斑膏微生物限度检查的操作方法,试验组及稀释剂对照组的菌数回收率均大于70%,符合制剂质量控制要求。结论本研究为白斑膏的微生物限度检查提供了依据,对药品质量控制有实际作用。
Objective To establish a method of sterility test for Baiban ointment.Methods The test was used according to the pharmacopeia of china 2005 verification test item.Results The result of verification test showed that the bacteria were growing well and control tubes showed positive.The recovery rate of bacteria of both two groups were more than 70%.Conclusion The sterility test method is feasible and simple.
出处
《实用药物与临床》
CAS
2008年第2期126-127,共2页
Practical Pharmacy and Clinical Remedies
关键词
白斑膏
微生物限度
验证试验
Baiban ointment
Sterility test
Verification test
