摘要
目的考察复方烟酸辛伐他汀双层片中缓释层烟酸与速释层辛伐他汀的体外释放度。方法以国内上市的烟酸缓释片（商品名本悦）作为对照片，用UV法比较了本院自制的复方烟酸辛伐他汀双层片缓释层中烟酸在水、0．1mol／L盐酸及pH6．8磷酸盐缓冲液三种介质中的释放情况，同时以含0．5％十二烷基硫酸钠（SiS）的0．01mol／L磷酸盐缓冲液（pH7．0）为溶出介质，采用HPLC法测定了速释层中辛伐他汀的释放情况。结果自制复方烟酸辛伐他汀双层片中烟酸在3、9和16h的累积百分释放度在10％～30％、40％～60％和75％以上，符合规定。复方烟酸辛伐他汀双层自制片和对照片中烟酸的释放曲线均符合Higuchi方程，相关系数大于0．99，相似因子f2值在规定的50-100之内。速释层中辛伐他汀在45min内溶出80％以上。结论自制复方烟酸辛伐他汀双层片与对照片中烟酸的释放性能相似，辛伐他汀溶出度亦符合要求。
Objective To investigate in vitro release profile of extended-release layer containing niacin and immediate-release layer containing simvastatin in compound tablets. Methods Extended-release layer of the tablets were subjected to an in vitro release in different dissolution media （water, 0.1 mol/L HCl, pH6.8 phosphate buffer） for determining niacin by UV, and niacin extended-release tablets BENYUE on sale served as the control. 0.01 mol/L phosphate buffer （pH7.0, containing 0.5% SIS） was used as the dissolution meditan for determining simvastatin by HPLC. Results Release rate of niacin in an extended-release layer ranged from 10% to 30% in 3h, 40% to 60% in 9 h, and over 75% in 16 h, which could accord with quality. Release curves of the two products could accord with the Higuchi equation （ r 〉 0.99）. The similarity factor f2 was between 50 and 100. Release rate of simvastatin in an immaediate-release layer was up to 80% in 45 minutes. Conclusion Release rates of niacin in the experimental formulation and reference product BENYUE are similar. Simvastatin in an immediate-release layer accords with quality in release rate.
出处
《山东大学学报（医学版）》
CAS
北大核心
2009年第6期109-113,共5页
Journal of Shandong University:Health Sciences
关键词
烟酸
辛伐他汀
双层片
体外释放
Niacin
Simvastatin
Double-layer Tablets
In Vitro Release
