阿莫西林-克拉维酸钾干混悬剂(8∶1)的质量标准控制  

The study of quality standards on Amoxicillin and Clavulanate Potassium for Suspension(8∶1)

作　　者：劳乔莲 邱文涛[1] 劳秋立 

机构地区：[1]广东省中医院西药房,广州510000 [2]广州白云山医药集团股份有限公司白云山制药总厂,广州510400

出　　处：《中国处方药》2017年第8期29-31,共3页Journal of China Prescription Drug

摘　　要：目的考察阿莫西林-克拉维酸钾干混悬剂(8∶1)的质量标准。方法依据药典标准对3批样品的外观性状、有关物质测定、水分、溶液pH值、装量差异、沉降体积比、微生物限度进行检查,从而确定该复方制剂的质量控制内容和贮存运输条件的要求。结果与结论阿莫西林-克拉维酸钾干混悬剂(8∶1)的贮存条件为凉暗、干燥处密封,阿莫西林-克拉维酸钾干混悬剂(8∶1)能较稳定保存,此条件下其他要求均能达到干混悬剂制剂药典标准。Objective To study the quality standards of amoxicillin and clavulanate Potassium for Suspension(8∶1).Methods Quality standards,quality control of all aspects of a complete investigation to determine the save method of preparation and quality control indicators.Results and conclusion Amoxicillin and clavulanate Potassium for Suspension(8∶1)should be stored with cool,dry,sealed conditions,then the drug would be stable.And under these conditions,other requirements can reach the pharmacopoeia standard for dry suspension preparations.

关 键 词：阿莫西林 克拉维酸钾 干混悬剂 质量标准研究 

分 类 号：R927.1[医药卫生—药学]