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目的制备藤甲酰苷双层片,优化其处方及制备工艺并探讨其药物释放机制。方法用水溶性载体材料聚乙二醇制备固体分散体,制成藤甲酰苷速释层,选择羟丙基甲基纤维素(HPMC)作为主要的缓释材料,制成藤甲酰苷缓释片层,通过单因素考察确定了藤甲酰苷双层片缓释层的处方。使用DDslover软件拟合缓释层释放曲线。结果本方法制备的藤甲酰苷双层片符合体外释放度要求。其中缓释层的体外释药行为符合Higuchi模型,相关系数r=0.998 3,释放机制为扩散和骨架溶蚀协同作用。结论本方法制备的藤甲酰苷双层片达到既快速起效,又缓释长效的目的。
OBJECTIVE To prepare niacin glycoside bilayer tablets and optimize its formulation and preparation process and to explore its drug release mechanism. Methods The solid dispersions were prepared by using polyethylene glycol as the water-soluble carrier material, and the quick release layer of noggin was prepared. HPMC was selected as the main sustained release material to make the sustained release of nogoodtyl Laminar layer. The prescription of the sustained-release layer of twoflavin was established by single factor investigation. Use DDslover software to fit the release profile. Results The niacin-containing bilayer tablets prepared by this method met the requirements of in vitro release. The release behavior of sustained-release layer in vitro was consistent with Higuchi model, the correlation coefficient was 0.998 3, and the release mechanism was the synergistic effect of diffusion and skeleton dissolution. Conclusion This method of preparation of the double-slice vine to achieve both rapid onset of action, but also the purpose of sustained-release long-acting.