马来酸罗托沙敏缓释混悬液的制备及质量评价
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篇名: 马来酸罗托沙敏缓释混悬液的制备及质量评价
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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 Carbinoxamine maleate sustained-release suspension, and evaluate its quality. METHODS: Using carbinoxamine maleate as raw material, drug-loaded resin was prepared by cation exchange resin; surface coating method was used to finally prepare sustained-release suspension, using Eudragit RS100 as sustained-release coating material to prepare sustained-release microparticles. HPLC was conducted to determine the content of carbinoxamine maleate, release degree of original preparations and self-made suspensions was compared, drug-loading capacity was calculated. RESULTS: The drug amount in preparing drug-loaded resin was 2%, reaction temperature was 25 ℃, and reaction time was 4 h; the drug-loading capacity in surface coating was 35%, amount of coating material was 10%, and reaction temperature was 40 ℃. The drug-loading capacities of sustained particles before and after coating were 35.23%, 32.72%, respectively; the yield was 96.82%. The carbinoxamine maleate in prepared sustained-release suspension accounted for 98.76% of the labeled amount; release degree in 10 h reached about 80%, f2 was 65.73. CONCLUSIONS: Carbinoxamine maleate sustained-release suspension is prepared successfully, and its release is similar to the original preparation.
期刊: 2017年第28卷第7期
作者: 王伊凡,楼姝含,王永禄,顾晓彤,李学明
AUTHORS: WANG Yifan,LOU Shuhan,WANG Yonglu,GU Xiaotong,LI Xueming
关键字: 马来酸罗托沙敏;缓释混悬液;阳离子交换树脂;表面包衣;高效液相色谱法
KEYWORDS: Carbinoxamine maleate; Sustained-release suspension; Cation exchange resin; Surface coating; HPLC
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