阿克他利缓释片的研制及释放度考察

Preparation and release characteristics of actarit sustained-release tablets

目的研究处方的组成和制备因素对阿克他利体外释放度的影响。方法以羟丙甲基纤维素(HPMC)为缓释材料,建立阿克他利缓释片的体外分析方法,通过测定累积溶出百分率对各种处方及工艺因素进行比较。结果 HPMC的黏度和用量、微晶纤维素的用量以及湿颗粒的粒径等因素均对主药的释放产生一定影响。对释药机制的考察表明,释药机制为混合机制,即扩散和溶蚀协同作用的结果。结论经处方筛选可以获得缓释效果较好的阿克他利缓释片。

Objective To study the effect of composition and preparation procedure of actarit sustained-release tablets on its release rate in vitro. Methods The analytical method in vitro of actarit sustained-release tablets with HPMC as the matrix material was set up and the effect of different formulation and preparation procedure on drug release was studied by determining the cumulative release. Results The release of actarit was affected by the viscosity and content of HPMC,the content of MCC and diameters of granules had effect on. The sustainedrelease mechanism of the tablets was also studied. It was showed that both diffusion and erosion had effects on the drug release. Conclusion Actarit sustained-release tablets with appropriate release rate can be obtained through formulation optimzation.