国产注射用法莫替丁的质量分析研究

Analysis Study of the Quality of Domestic Famotidine for Injection

目的:评价国内注射用法莫替丁的质量状况及存在的问题。方法:通过对27个厂家生产的53批次注射用法莫替丁的性状、鉴别、溶液澄清度与颜色、酸度、有关物质、干燥失重、细菌内毒素、无菌和含量测定等项目的标准化检验和探索性研究,考察其质量状况和含水量、酸度、贮藏温度等因素对产品质量的影响。结果:依据现行标准检验,该产品合格率仅为34%。通过探索性研究发现,含水量、酸度对产品质量有较大影响。国内产品目前尚未建立统一的较为完善的标准,而是存在多个水平参差不齐的质量标准。结论:该品种质量状况较差,现行标准亟待修订;生产工艺与质量密切相关,工艺亟需改进。

OBJECTIVE：To evaluate the quality and problems of domestic Famotidine for injection.METHODS：53 batches of Famotidine for injection from 27 manufacturers were tested in terms of property,identification,clarity and color of solution,acidity,related substance,loss on drying,bacterial endotoxin,asepsis and content determination according to official standards and the exploratory research method,to investigate their quality and the influencing factor of quality as water content,pH and storage temperature.RESULTS：Through the test with current standards,we found that its passing rate is 34%.Through the exploratory study,we found that water and pH had great impact on quality.Uniform perfect standard is absent in China at present,while there are many quality standards at different levels.CONCLUSIONS：The quality is poor and current standards need to be revised.The production technology is closely related with the quality,so that the technology needs to be improved urgently.