玉夏胶囊质量标准研究
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安徽省芜湖市科技计划2009年度科技项目(编号:卫生5—1)


Research of Quality Standard of Yuxia Capsule
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    摘要:

    目的:建立医疗机构制剂玉夏胶囊的质量控制标准。方法:采用薄层色谱(TLC)法对玉夏胶囊中防己、莱菔子进行定性鉴别研究;采用高效液相色谱(HPLC)法对玉夏胶囊中的粉防己碱和防己诺林碱进行定量研究。结果:薄层色谱中阴性样品均无干扰,专属性强;防己诺林碱在24~84 μg/mL范围内峰面积与浓度呈现良好的线性关系,r=0.9992,平均回收率为102.3%,RSD=2.57%;粉防己碱在34.5~207.0 μg/mL范围内峰面积与浓度呈现良好的线性关系,r=0.9999,平均回收率为102.3%,RSD=2.57%。结论:本实验建立的方法简便、快捷、准确、重现性好,可用于玉夏胶囊的质量控制。

    Abstract:

    To establish the quality standard of Yuxia capsules. Methods: Radix stephaniae tetrandrae(Fang Ji)and Radish Seed(Laifuzi) were identified by TLC and the contents of Tetrandrine and Fangchinoline were detremined by HPLC. Results: The TLC chromatography was exclusive and the blank test showed no interference. The detremination of fangchinoline kept good linear relation in the content ranges of 24~84 μg/mL r =0.9992. The average recovery test of fangchinoline was 102.3%, RSD=2.57%.The detremination of tetrandrine kept good linear relation in the content ranges of 34.5~207.0 μg/mL, r =0.9999. The average recovery test of tetrandrine was 102.3%, RSD=2.57%. Conclusion:The established qualitative methods are simple, fast, accurate and with good reproducibility which can be used for the quality control of Yuxia capsules.

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周娟娟,祁俊,秦亚东.玉夏胶囊质量标准研究[J].世界中医药,2016,(01).

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  • 收稿日期:2015-03-19
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  • 在线发布日期: 2016-02-01
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