| 巴戟甲素亲水凝胶骨架肠溶缓释片的质量研究 |
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| 引用本文： | 陈地灵,庄满贤,林励,陈永刚,邓瑞云.巴戟甲素亲水凝胶骨架肠溶缓释片的质量研究[J].中国新药杂志,2011(10). |
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| 作者姓名： | 陈地灵 庄满贤 林励 陈永刚 邓瑞云 |
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| 作者单位： | 广州中医药大学中药学院; |
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| 基金项目： | 海南省重点科技计划项目(090603) |
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| 摘 要： | 目的:建立巴戟甲素亲水凝胶骨架肠溶缓释片质量控制方法。方法:按中国药典附录ⅠA片剂项下要求依次检查片重,采用转篮法检查制剂的释放度;采用薄层色谱法鉴别制剂中巴戟甲素,采用高效液相-蒸发光色谱法(HPLC-ELSD)测定巴戟甲素含量。结果:制剂片重和释放度均符合制剂通则标准;制剂巴戟甲素薄层行为良好,且阴性对照无干扰;测得5批制剂中巴戟甲素含量在38.33～40.89 m.g片-1之间,为标示量的93.0%～107.0%。结论:制剂指标检查符合制剂通则标准;所建立的薄层色谱法可准确鉴别制剂中的巴戟甲素;制剂中巴戟甲素含量符合规格要求,研制的骨架肠溶包衣缓释片质量可控、稳定。本方法准确、可靠、重复性好,可用于巴戟甲素亲水凝胶骨架肠溶缓释片的质量控制。
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| 关 键 词： | 巴戟甲素 质量研究 薄层色谱法 高效液相-蒸发光色谱法 |
Quality of Bajijiasu enteric coated sustained-release tablets with hydrogel matrix |
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| CHEN Di-ling,ZHUANG Man-xian,LIN Li,CHEN Yong-gang,DENG Rui-yun.Quality of Bajijiasu enteric coated sustained-release tablets with hydrogel matrix[J].Chinese Journal of New Drugs,2011(10). |
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| Authors: | CHEN Di-ling ZHUANG Man-xian LIN Li CHEN Yong-gang DENG Rui-yun |
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| Institution: | CHEN Di-ling,ZHUANG Man-xian,LIN Li,CHEN Yong-gang,DENG Rui-yun(College of Chinese Materia Medica,Guangzhou University of TCM,Guangzhou 510006,China) |
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| Abstract: | Objective: To establish the methods to control the quality of Bajijiasu enteric coated sustained-release tablets with hydrogel matrix.Methods: The weight variation of the tablets was measured,and the release rate was detected by ameliorated rotating basket method according to the requirements of Chinese Pharmacopoeia(Appendix IA),the spot of Bajijiasu was identified by thin-layer chromatography(TLC),the content of Bajijiasu was detected by liquid-evaporative light chromatography(HPLC-ELSD).Results: The tabl... |
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| Keywords: | Bajijiasu quality study TLC HPLC-ELSD |
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