摘要
目的建立复方苯甲酸软膏和10%硫软膏的微生物限度检查方法。方法依据2010年版《中国药典(二部)》附录微生物限度检查法对样品进行方法学验证,测定阳性菌的回收率。结果在适宜的供试液制备条件下,复方苯甲酸软膏和10%硫软膏均可采用培养基稀释法消除其抑菌作用。结论经验证,培养基稀释法可用于复方苯甲酸软膏和10%硫软膏的质量监控及检测研究。
Objective To establish the microbial limit test method for 2 kinds of hospital ointment Compound Benzoic Acid Ointment and 10% Sulfur Ointment. Methods According to the microbial limit test method in the appendix of the Chinese Pharmacopoeia （edition 2010）,the samples were performed the methodological validation for detecting the recovery rate of positive bacteria. Results Under the proper preparing condition of the test solution,Compound Benzoic Acid Ointment and 10% Sulfur Ointment all adopted the culture medi- um dilution Methods to eliminate the bacteriostasis action. Conclusion The established microbial limit test method after validation can be used in the quality monitoring and detection research of Compound Benzoic Acid Ointment and 10% Sulfur Ointment.
出处
《中国药业》
CAS
2012年第18期47-49,共3页
China Pharmaceuticals
关键词
医院制剂
软膏
微生物限度
方法验证
hospital preparation
ointment
microbial limit
methodological validation
