复方烟酸辛伐他汀双层片体外释放度的研究

山东大学学报(医学版) ›› 2209, Vol. 47 ›› Issue (6): 109-113.

复方烟酸辛伐他汀双层片体外释放度的研究

高秀蕊臧恒昌

1. 山东大学药学院制药工程系，济南 250012； 2. 山东食品药品职业学院教务科，山东淄博 255011

收稿日期:2008-12-09 出版日期:2009-06-16 发布日期:2209-06-25
通讯作者: 臧恒昌（1964- ），男，教授，主要从事制药工艺优化与在线控制的研究。 E-mail:zanghcw@126.com
作者简介:高秀蕊（1970- ），女，高级工程师，主要从事药物分析的研究。

In vitro release of compound niacin extended-release and simvastatin immediaterelease double-layer tablets

GAO Xiu-Rui, ZANG Heng-Chang

1． Department of Pharmaceutical Engineering, School of Pharmacy, Shandong University， Jinan 250012, China；
2． Education Study Section, Shandong Drug and Food Vocational College, Zibo 255011, Shandong, China

Received:2008-12-09 Online:2009-06-16 Published:2209-06-25

摘要/Abstract

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pH 6.8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（SLS）的0.01?mol/L磷酸盐缓冲液（pH 7.0）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。

关键词: 烟酸；辛伐他汀；双层片；体外释放

Abstract:

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, 0.1mol/L HCl, pH6.8 phosphate buffer) for determining niacin by UV, and niacin extended-release tablets BENYUE on sale served as the control. 0.01mol/L phosphate buffer (pH7.0, containing 0.5% SLS) was used as the dissolution medium for determining simvastatin by HPLC. ResultsRelease 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 16h, 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 immediate-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.

Key words: Niacin； Simvastatin； Doublelayer Tablets； In Vitro Release

中图分类号:

R917

高秀蕊臧恒昌. 复方烟酸辛伐他汀双层片体外释放度的研究[J]. 山东大学学报(医学版), 2209, 47(6): 109-113.

GAO Xiu-Rui, ZANG Heng-Chang. In vitro release of compound niacin extended-release and simvastatin immediaterelease double-layer tablets[J]. JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES), 2209, 47(6): 109-113.

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[1]	高秀蕊臧恒昌. 复方烟酸辛伐他汀双层片体外释放度的研究[J]. 山东大学学报(医学版), 2009, 47(6): 109-.
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