红霉素肠溶片质量分析  

Study on the quality of erythromycin enteric-coated tablets

作　　者：洪建文[1] 刘振龙[1] 彭洁[1] 黄文静[1] 肖慧[1] 胡音[1] 

机构地区：[1]广东省药品检验所抗生素室,广州510180

出　　处：《药物分析杂志》2012年第4期729-731,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对国内不同厂家生产的红霉素肠溶片的质量进行对比研究。方法:采用释放曲线测定、有关物质、含量测定等检测方法,综合评价不同工艺的制剂产品。结果:释放曲线测定结果显示目前国内的红霉素肠溶片厂家间质量差异较大,同一厂家不同批次的质量均一性不好。数据同时还显示存在低限投料和用不合格原料投料的情况。结论:结果表明国内红霉素肠溶片质量参差不齐,应引导企业进行制剂工艺改进,提高质量。Objective：To study the quality of different manufactures of erythromycin enteric-coated tablets.Methods：By using stripping curves of dissolution,related substances determination and determination of erythromycin,accelerated samples were analyzed.Results：The cumulative dissolutions of tablets of different manufactures were shown different dissolution process respectively.The dissolutions curves of different lots from same manufacture were different.There are low batch and unqualified raw materials in drug production.Conclusion：Studies have shown that differences among the quality of erythromycin enteric-coated tablets from different manufactures.The quality of domestic-made preparations needs to be improved.

关 键 词：红霉素 肠溶片 释放曲线 有关物质 含量测定 药品标准 质量对比 

分 类 号：R917[医药卫生—药物分析学]