感冒退热颗粒微生物限度检查方法学验证  

Validation method for the microbial limit test of ganmao tuire keli

作　　者：蒋小云 张先文 陶俊钰 

机构地区：[1]上海海虹实业(集团)巢湖中辰药业有限公司 [2]安徽省巢湖市药品检验所,安徽巢湖238000

出　　处：《安徽医药》2008年第2期123-125,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的对感冒退热颗粒微生物限度检查方法进行方法学验证。方法采用平皿计数法,分组分别使用5种试验菌验证。试验组供试液加菌液注入培养基中培养,菌液组分别取各试验菌液注入培养基中培养,稀释剂对照组取稀释剂加菌液注入培养基中培养,供试品对照组取供试液注入培养基中培养。通过3次独立的平行试验,分别计算各试验菌每次试验的回收率。采用观察大肠埃希菌、大肠菌群与阴性金黄色葡萄球菌在相同环境下的培养基来验证控制菌的检查方法。结果各试验菌的回收率高于70%,稀释剂对5种试验菌的回收率均高于70%。结论采用常规法可以进行本品的微生物限度检查。Aim To validate the microbial limit test of ganmao tuire keli. Methods Plate counting method was used to count. Trail liquid and bacterial liquid, five bacterial liquids, dilute liquid and bacterial liquid, trail liquid were respectively injected into culture medium of trial group, bacterial liquid group, dilution bilingual group, trail liquid control group. Every trail recovery rate was calculated in three independent trails. The control bacteria checking method was validated by observing cultivation of escheriachia coli, coliform and positive staphybococcus aureus under the same environment. Results The rate of every trail bacteria was higher than 70% , and the rates of five diluted trail bacterias were higher than 70%. Conclusion The microbial limit test of Ganmao Tuire Keli can be used.

关 键 词：感冒退热颗粒 微生物限度检查方法 验证 

分 类 号：R286[医药卫生—中药学]