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目的:制备盐酸倍他司汀缓释骨架片。方法:采用亲水性高分子材料HPMC为骨架,制备盐酸倍他司汀缓释片,并用单因素试验考察其释药特征。正交试验优化处方工艺。结果:以60% HPMC K15M为骨架材料,磷酸氢钙为填充剂,用10% PVP的90%乙醇溶液为黏合剂,湿法制粒压片为最佳工艺,片重为500 mg。药物体外释放接近Higuchi模型,能实现药物12 h内缓慢释放。结论:本品制备工艺简便,具有缓解特性。
Objective: Preparation of betahistine hydrochloride sustained release matrix tablets. Methods: The sustained-release tablets of betahistine hydrochloride were prepared by hydrophilic polymer HPMC. The release characteristics of betahistine hydrochloride sustained-release tablets were investigated by single factor test. Orthogonal test to optimize prescription process. RESULTS: 60% HPMC K15M was used as the matrix material and calcium hydrogen phosphate was used as the filler, and 90% ethanol solution of 10% PVP was used as the binder. Wet granulation was the best process and the weight was 500 mg. Drug release in vitro close to Higuchi model, the drug can be released slowly within 12 h. Conclusion: The preparation process is simple, with ease characteristics.