文档介绍：黄连上清丸微生物限度检查方法学验证
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【摘要】目的:对黄连上清丸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、大肠菌群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。
【关键词】黄连上清丸微生物限度检查方法验证
Abstract Objective:To verify the anism limited inspecting method of Huanglian Shangqing pill. Method: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 verified by observing cultivation of Escherichia coli,coliform and positive us aureus under the same environment. Result:The rate of every trail bacteria was higher than 70%,and the rates of five diluted trail bacterias were higher than 70%. Conclusion:The anism limited inspecting of Huanglian Shangqing pill can be used.
Key words Huanglian Shangqing pill; anism limited inspecting method; verification
黄连上清丸具有散风清热、泻火止痛的功效,用于治疗风热上攻、肺胃热盛所致的头晕目眩、牙齿疼痛、口舌生疮等。其疗效确切,患者认可,并为中国药典(2005年版)收载。生产企业为了适应市场需要和方便患者服用,申请将大蜜丸改变为水丸。现根据中国药典(2005年版)要