Objective To study the release rate of niacin for Niacin extended-release and Simvastatin tablets in different media, and analyze their release behavior in vitro. Methods The release of Niacin for self~prepared and imported compound preparation in four different media were determined by UV, the kinetics model and similarity factor(f2 value) were compared. Results Self-made and imported sustained-release tablets in vitro release of nicotinic acid were complied with the Ritger-Peppas equation, the n values of the equation in the four media were from 0.45 to 0.89, indicating that the drug release was caused by the interaction of the skeleton of drug diffusion and dissolution. Comparing with the value of the reference formulation, the f2 value of the self extended-release tablets which were in water, 0.lmol/L HC1, pH 4.5 acetate buffer and pH 6.8 phosphate buffer release medium were 67.59, 80.24, 67.27 and 65.57 respectively, which were greater than 50. Conclusion Niacin release behavior of self-prepared was consistent with the imported extended-release tablets in vitro.%目的 研究辛伐他汀烟酸缓释片在不同释放介质中烟酸的释放度,分析其在体外的释放行为.方法 用UV法 测定自制与进口辛伐他汀烟酸缓释片在四种不同介质中的烟酸释放情况,并对其释放模型和f2相似因子进行比较.结果 自制和进口缓释片的烟酸体外释放度符合Ritger-Peppas方程,在四种介质中方程拟合的n值均在0.45～0.89之间,说明该药物释放是药物扩散和骨架溶蚀共同作用的.与参比制剂相比,自制缓释片在水、0.1 mol/L盐酸、pH4.5醋酸盐缓冲液及pH 6.8磷酸盐缓冲液释放介质中,f2值分别为67.59、80.24、67.27和65.57,均大于50.结论 自制制剂与进口制剂的缓释部分体外释放行为相似.
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