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目的:制备多巴丝肼控释胶囊并建立质量控制方法。方法:采用盐酸苄丝肼和左旋多巴为主药,羟丙基甲基纤维素(HPMC)为基本骨架材料,湿法制粒,分别制备2种主药的控释颗粒,按处方量混合制成多巴丝肼控释胶囊。用正交试验优化处方,用HPLC法测定含量及体外释放度并对2种主药进行释放行为分析。结果:HPMC的用量对药物的释放影响显著,多巴丝肼控释胶囊的体外释药可持续12h,盐酸苄丝肼和左旋多巴的平均回收率分别为99.5%和99.6%,RSD均<1%(n=9)。左旋多巴和盐酸苄丝肼的释放曲线均符合零级释药方程。结论:所制多巴丝肼控释胶囊释放缓慢、平稳,具有控释性。
OBJECTIVE: To prepare doxazosin controlled release capsules and to establish a quality control method. Methods: The controlled release granules of two kinds of main drugs were prepared respectively by taking benserazide hydrochloride and levodopa as the main drugs, hydroxypropyl methylcellulose (HPMC) as the basic skeleton material and wet granulation. Into the multi-channel silk hydrazine controlled release capsules. The orthogonal test was used to optimize the prescription, the content and the release in vitro were determined by HPLC, and the release behaviors of the two main drugs were analyzed. Results: The release of HPMC was significantly affected by the release of HPMC. The sustained release of dobesilazin sustained release capsules for 12h, the average recoveries of benserazide hydrochloride and levodopa were 99.5% and 99.6%, respectively, and the RSDs were < 1% (n = 9). Levodopa and benserazide hydrochloride release curves are in line with the zero-order release equation. Conclusion: The produced dobesilate controlled release capsule is slow, steady and controlled release.