马来酸罗托沙敏缓释混悬液的制备及质量评价

发布时间：2018-03-18 07:17

  本文选题：马来酸罗托沙敏　切入点：缓释混悬液　出处：《中国药房》2017年07期 　论文类型：期刊论文

【摘要】：目的:制备马来酸罗托沙敏缓释混悬液并评价其质量。方法:以马来酸罗托沙敏为原料,采用阳离子交换树脂制备载药树脂;并通过表面包衣法,以Eudragit RS100为包衣材料制备缓释微粒,最终制成缓释混悬液。采用高效液相色谱法测定马来酸罗托沙敏的含量,计算载药量,比较原研制剂与自制混悬液的释放度。结果:载药树脂制备时药物用量为2%、反应温度为25℃、反应时间为4 h,表面包衣时载药量为35%、包衣材料的用量为10%、反应温度为40℃。缓释微粒包衣前、后的载药量分别为35.23%和32.72%,收率为96.82%;所制缓释混悬液中马来酸罗托沙敏占标示量的98.76%,10 h的累积释放度达80%左右,与原研制剂比较的相似因子f2为65.73。结论:成功制得马来酸罗托沙敏缓释混悬液,其释放特性与原研制剂相似。
[Abstract]:Objective: to prepare rotorsalamine maleate sustained-release suspension and evaluate its quality. Methods: using rotorsalamine maleate as raw material, cationic exchange resin was used to prepare drug-carrying resin, and drug carrying resin was prepared by surface coating method. Eudragit RS100 was used as coating material to prepare slow-release particles, and finally sustained release suspension was prepared. The content of rotosamine maleate was determined by high performance liquid chromatography (HPLC), and the amount of drug loaded was calculated. Results: the amount of drug used in the preparation of drug-loaded resin was 2%, and the reaction temperature was 25 鈩，

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