盐酸恩丹西酮缓释片的研制及体外释药特性

Preparation of Ondansetron Hydrochloride Sustained-release Tablet Evaluation of Its and Drug Release Behavior in Vitro

制备盐酸恩丹西酮缓释片并对影响释药的因素进行考察。以羟丙甲纤维素(HPM C)为骨架材料制备了盐酸恩丹西酮缓释片,通过正交设计试验优选最佳处方和工艺。对影响释药的因素,如HPM C的黏度和用量、填充剂的种类、制片工艺、润湿剂及释放介质pH等进行了考察。盐酸恩丹西酮缓释片体外释药符合H iguch i方程,HPM C的黏度、填充剂的种类及测定释放度的转速对该缓释片的释药几乎无影响,而制片工艺、润湿剂及释放介质pH值对缓释片释药影响较大。盐酸恩丹西酮缓释片在体外12 h缓释效果较好。

For the purpose of preparing the ondansetron hydrochloride sustained-release tablets and studying the influencing factors, we prepared the ondansetron hydrochloride sustained-release tablets, using hydroxypropylmethylcellose （HPMC） as the matrix material. Then we investigated the effects of the viscosity and amount of HPMC, the sort of fillers, the preparation methods,the alcohol content in adhesives, and the pH of the dissolving solution on the release of ondansetron hydrochloride from sustained-release tablets. On the basis of pharmaceutical preformulation studies,the best formulation and preparation methods were screened out according to orthogonal experiment design method. The release behavior of the tablets followed the Higuchi equation. The viscosity of HPMC,the sort of fillers and the rotation speed had no significant effects on the release of ondansetron hydrochloride sustained-release tablets,while the preparation methods,the alcohol content in adhesives and the pH of the dissolving solution influcenced the release of ondansetron hydrochloride sustained-release tablets significantly. Ondansetron hydrochloride sustained-release tablets had good drug relase behavior for in 12 h in vitro.