阿莫西林胶囊微生物限度检查方法学验证  

The Validation of the Microorganism Limited Inspecting Method of Amoxicillin Capsule

作　　者：陈妍[1] 李朝庆[1] 

机构地区：[1]哈药集团制药总厂,150086

出　　处：《黑龙江医药》2009年第2期137-139,共3页Heilongjiang Medicine journal

摘　　要：目的:对阿莫西林胶囊微生物限度检查方法进行方法学验证。方法:采用平皿记数法,分组分别使用5种实验菌验证。试验组取供试液加菌液注入培养基中培养。菌液组分别取各实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与阴性金黄色葡萄球菌在相同环境下的培养来验证控制菌的检查方法。结果:各试验菌的回收率均高于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。Objective： To verify the microorganism limited inspecting method of Amoxicillin Capsules. 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. mtritive edium of trial group,bacterial liquid group, dilution bilingual group,trail liquid control group. The revovery rate of every trial was calculated in three independent trails. The control bacteria checking method was verified by observing cultivation of Escherichia coli and negative staphybococcus aureus under the same environment. Results：The recovery rate of every trail bacteria was higher than 70%,and the rates of five diluted trail bacterias were higher than 70%. Conclusion：The microorganism limited inspecting of Amoxicillin Capsule can be used.

关 键 词：阿莫西林胶囊 微生物限度检查方法 验证 

分 类 号：R927.1[医药卫生—药学]