溶出度评价不同厂家拉米夫定片的内在质量  

Intrinsic Quality Evaluation of Lamivudine Tablets from Different Manufacturers by Real-time Dissolution Test

作　　者：阚微娜[1] 隗笑[1] 杨宏伟[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药师》2013年第9期1347-1350,共4页China Pharmacist

摘　　要：目的:考察不同厂家拉米夫定片体外溶出度曲线,比较不同厂家药品的内在质量,为药品质量控制和临床用药提供参考。方法:采用光纤药物溶出度实时测定仪,测定4个厂家拉米夫定片在水、0.1 mol·L^(-1)盐酸溶液、pH4.0醋酸盐缓冲液和pH 6.8磷酸盐缓冲液4种溶出介质中的溶出过程,并对溶出曲线进行了比较分析。结果:原研企业样品均一性良好,国内仿制样品均一性较差。在4种溶出介质中,有2个厂家与原研制剂溶出曲线相似,1个厂家相似性较差。结论:不同pH介质中的实时溶出度可全面反映药物在不同体内环境下的溶出行为,能更有效地评价制剂的内在质量。Objective： To investigate the dissolution curves and compare the intrinsic quality of lamivudine tablets from different manufacturers to provide the reference for the drug quality control and clinical medication. Method： The dissolution test was carried out in water, 0.1 mol · L- 1 hydroehilorlde acid solution, pH 4.0 and pH 6.8 PBS with fiber-optic dissolution test system. Result： The quality uniformity of the original manufacturer was better than that of the imitation manufacturers. In the 4 mediums, the dissolu tion profiles of 2 imitaion inanufacturers were similar to that of the original manufacturer. Conclusion ： The dissolution profiles in differ ent mediums can comprehensively reflect dissolution process in vivo. It can provide a better way for the evaluation of the intrinsic quali ty of medicines.

关 键 词：拉米夫定片 光纤药物溶出度测定 不同介质溶出度 仿制药-致性评价 

分 类 号：R927.1[医药卫生—药学]