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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 |
| TITLE： | |
| 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 |
| 阅读数： | 426 次 |
| 本月下载数： | 5 次 |
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