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目的:制备盐酸雷尼替丁控释微丸并研究其释放机理。方法:用单因素实验方法考察了包衣液中溶媒系统的组成、膜材的浓度、致孔剂和增塑剂量对药物释放的影响。结果:膜材浓度增加、水比例增大,释药速度加快;加入PVPK_(30),可加快释药,这些与包衣厚度共同决定衣膜的控释能力。结论:体外释放度表明本微丸属于包衣骨架控释微丸,随包衣厚度的改变而释放机理有所不同。
OBJECTIVE: To prepare ranitidine hydrochloride controlled-release pellets and study its mechanism of release. Methods: The influence of the composition of the solvent system, the concentration of membrane material, the amount of porogen and the amount of plasticizer on drug release were investigated by single factor experiment. Results: The membrane concentration increased, the proportion of water increased, and the drug release rate accelerated. The addition of PVPK_ (30) accelerated the release of drug, which together with the thickness of the coating determined the release ability of the membrane. CONCLUSION: In vitro release indicates that the pellets belong to the controlled release coated pellets and have different release mechanisms with varying coating thickness.