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目的采用亲水凝胶骨架材料制备盐酸多奈哌齐缓释片,并对其质量进行评价。方法采用亲水凝胶骨架材料HPMC K100LV和K4M联用通过干法制粒工艺制备盐酸多奈哌齐缓释片,以溶出曲线相似性f2值作为评价指标,通过正交设计进行处方优化,用高效液相色谱法进行含量和杂质检测,通过加速和长期试验考察片剂稳定性。结果以该方法制备的盐酸多奈哌齐缓释片质量稳定,具有与原研制剂一致的溶出特征。结论以该方法制备盐酸多奈哌齐缓释片具有可行性。
OBJECTIVE To prepare donepezil hydrochloride sustained-release tablets by hydrophilic gel matrix and to evaluate its quality. Methods Donepezil hydrochloride sustained-release tablets were prepared by dry-granulation process using hydrophilic gel matrix materials HPMC K100LV and K4M. The f2 value of dissolution curve was used as evaluation index, and the prescription was optimized by orthogonal design. High performance liquid chromatography Method for content and impurity testing, tablet stability by accelerated and long-term tests. Results The donepezil hydrochloride sustained-release tablets prepared by this method had stable quality and consistent dissolution characteristics with the original preparations. Conclusion The preparation of donepezil hydrochloride sustained-release tablets is feasible.