百宝丹喷雾剂微生物限度检查方法学验证  

Validation of Microbial Limit Tests of Baibaodan Spray

作　　者：赵加强[1] 周荣光[1,2] 杨兆祥[1] 李翠娥[2] 高宏涛[1] 

机构地区：[1]昆明制药集团股份有限公司,云南昆明650100 [2]昆明医科大学,云南昆明650500

出　　处：《亚太传统医药》2015年第21期23-25,共3页Asia-Pacific Traditional Medicine

基　　金：云南省科技计划项目(2013FZ260)

摘　　要：目的:建立百宝丹喷雾剂的微生物限度检查方法。方法:按照《中国药典》2010版要求,采用常规法和培养基稀释法对具有代表性的细菌、霉菌、酵母菌进行回收率测定,并对控制菌检查法进行方法学验证。结果:采用培养基稀释法(0.2mL/皿),5种试验菌的回收率均大于70%;采用培养基稀释法(供试液10mL+增菌培养基800mL)检查金黄色葡萄球菌、铜绿假单胞菌,试验组和阳性对照组呈阳性反应,阴性菌对照组呈阴性反应。结论:可采用培养基稀释法对百宝丹喷雾剂进行微生物限度检查。Objective：To establish a microbial limits testing methods for Baibaodan spray.Methods：Referring to Chinese Pharmacopoeia（2010edition）,the validation of counting method of bacteria,mold and yeast,and the validation of control bacteria check method was done in accordance with the conventional method and the medium dilution method.Results：Using the culture medium dilution method（0.2mL/dish）,the recovery rates of 5test microorganisms were all more than 70%.Staphylococcus aureus andPseudomonas aeruginosa can be detected by the medium dilution method（testing solution 10 mL plus culture medium 800mL）.Conclusion：The medium dilution method could be used for microbial llimit tests of Baibaodan spray.

关 键 词：百宝丹喷雾剂 微生物限度检查 方法学验证 

分 类 号：R284.1[医药卫生—中药学]