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目的:制备盐酸雷诺嗪缓释片并对释药因素进行考察。方法:采用HPMC、EC和Eudragit RL100组成的混合型骨架材料制备了盐酸雷诺嗪缓释片,对影响释药的因素,如HPMC的黏度、制粒用乙醇的体积分数、片形、片重、压片压力、包衣、释放介质、转速等进行了考察,并在此基础上通过正交设计试验优选最佳处方和工艺。结果:盐酸雷诺嗪缓释片的体外释药行为符合Higuchi方程;制粒用乙醇的体积分数、片形、片重、压片压力、测定转速对RH缓释片的释放速率有明显影响;而HPMC的黏度、释放介质的pH值和包衣对药物的释放速率没有明显影响。结论:采用HPMC、EC和Eudragit RL100组成的混合型骨架材料,制备了日服2次的盐酸雷诺嗪缓释片。
OBJECTIVE: To prepare ranolazine hydrochloride sustained-release tablets and investigate the factors of drug release. Methods: The ranolazine hydrochloride sustained-release tablets were prepared by using mixed framework materials composed of HPMC, EC and Eudragit RL100. The influence factors of drug release, such as the viscosity of HPMC, the volume fraction of ethanol by pellet, the tablet shape, Tableting pressure, coating, release medium, speed and so on were investigated, and on this basis through orthogonal design test to optimize the best prescription and process. Results: The release behavior of ranolazine hydrochloride sustained-release tablets in vitro was in accordance with Higuchi’s equation. The volume fraction of ethanol, tablet shape, tablet weight, tabletting pressure and the measured rotational speed had significant effects on the release rate of RH sustained-release tablets; The viscosity of HPMC, the pH of the release medium, and the coating did not have a significant effect on the drug release rate. CONCLUSION: The ranolazine hydrochloride sustained-release tablets were prepared twice daily with a mixture of HPMC, EC and Eudragit RL100.