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正交试验优化枸橼酸莫沙比利胃漂浮缓释微丸的辅料处方
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| 篇名： | 正交试验优化枸橼酸莫沙比利胃漂浮缓释微丸的辅料处方 |
| TITLE： | |
| 摘要： | 目的：优化枸橼酸莫沙比利胃漂浮缓释微丸的辅料处方。方法：采用单因素试验考察不同助漂剂、黏合剂、泡腾剂对微丸8 h漂浮率的影响；以十八醇、羟丙基甲基纤维素（HPMC）、碳酸氢钠用量为考察因素，以微丸8 h漂浮率、圆整度和收率的综合评分为指标，设计正交试验法优选辅料处方，并进行验证试验。结果：优化的辅料处方中十八醇、HPMC、碳酸氢钠用量分别为13.0、3.7、3.4 g。验证试验结果显示，按该辅料处方制备的微丸所得综合评分较高，与正交试验结果一致。结论：优化的辅料处方稳定可靠，可用于枸橼酸莫沙比利胃漂浮缓释微丸的制备。 |
| ABSTRACT： | OBJECTIVE： To optimize the excipient formulation of Mosapride citrate gastric floating sustained-release pellets.METHODS： Single factor test was used to investigate the effects of different floating assistants， adhesives and effervescent agents on floating rate of pellets within 8 h. The excipient formulation was optimized by orthogonal test with the amount of octadecanol， HPMC and sodium bicarbonate as factors using comprehensive score of 8 h floating rate， roundness and recovery rate as indexes. Validation test was also conducted. RESULTS： The optimal excipient formulation included the weight of octadecanol， HPMC and sodium bicarbonate were 13.0， 3.7 g， 3.4 g. The results of validation test showed that comprehensive indexes of the pellets prepared by excipient formulation were high， which were consistent with the orthogonal test results. CONCLUSIONS： The optimal excipient formulation is stable and reliable，and is suitable for the preparation of Mosapride citrate gastric floating sustained-release pellets. |
| 期刊： | 2018年第29卷第24期 |
| 作者： | 江尚飞，何静，邱妍川，李芝，邢于政，张露 |
| AUTHORS： | JIANG Shangfei，HE Jing，QIU Yanchuan，LI Zhi，XING Yuzheng，ZHANG Lu |
| 关键字： | 正交试验；枸橼酸莫沙比利；胃漂浮缓释微丸；辅料；处方 |
| KEYWORDS： | Orthogonal test； Mosapride citrate； Gastric floating sustained-release pellets； Excipient； Formulation |
| 阅读数： | 386 次 |
| 本月下载数： | 5 次 |
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