| 盐酸恩丹西酮缓释胶囊质量标准研究 |
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| 引用本文： | 邵曼莉,陈爽,杜智敏.盐酸恩丹西酮缓释胶囊质量标准研究[J].药物分析杂志,2007,27(2):234-237. |
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| 作者姓名： | 邵曼莉 陈爽 杜智敏 |
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| 作者单位： | 哈尔滨医科大学附属二院临床药物研究所 |
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| 摘 要： | 目的:制定盐酸恩丹西酮缓释胶囊的质量标准。方法:采用 HPLC 法测定盐酸恩丹西酮的含量和溶出度。结果:盐酸恩丹西酮缓释胶囊含量在90.0%～110.0%范围内;体外释放曲线符合一级动力学方程和 Higuchi 方程;有关物质检查未见。结论:本法简便、准确,专属性强,可用于盐酸恩丹西酮缓释胶囊的质量标准研究。
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| 关 键 词： | 高效液相色谱 盐酸恩丹西酮缓释胶囊 溶出度 含量 有关物质 |
| 文章编号： | 0254-1793（2007）02-0234-04 |
| 修稿时间： | 2006-01-18 |
Study on the quality standard of ondansetron hydrochloride sustained release capsules |
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| SHAO Man - li, CHEN Shuang, DU Zhi - min.Study on the quality standard of ondansetron hydrochloride sustained release capsules[J].Chinese Journal of Pharmaceutical Analysis,2007,27(2):234-237. |
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| Authors: | SHAO Man - li CHEN Shuang DU Zhi - min |
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| Institution: | The Clinical Pharmacy Institute,the Second Affiliated Hospital of Harbin Medical University,Harbin 150086 ,China |
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| Abstract: | Objective:To develop the quality standard of ondansetron hydrochloride sustained release capsules. Methods:The determinated on the content and the dissolution of ondansetron hydrochloride by HPLC.Results:The content of ondansetron hydrochloride sustained release capsules was the range of 90.0%-110.0%.The release profile of ondansetron hydrochoride from the capsules followed the first-order dynamics equation and Higuchi ki- netics equation;related substance of which was not found.Conclusion:This method is simple,accurate,specific and may be used for the quality standard of ondansetron hydrochloride sustained release capsules. |
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| Keywords: | HPLC ondansetron hydrochloride sustained release capsules dissolution content related substances |
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