益气通痹胶囊质量标准研究

杨玉华; 韩世龙; 孙裕; 封士兰

益气通痹胶囊质量标准研究

1.
兰州大学药学院, 甘肃兰州 730000;兰州佛慈制药股份有限公司, 甘肃兰州 730000
2.
兰州大学药学院, 甘肃兰州 730000

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出版历程
- 收稿日期: 2013-04-15
- 修回日期: 2013-05-24

Quality Standard of Yiqi-Tongbi Capsule

1.
Pharmacy Department of Lanzhou University, Lanzhou 730000, China;Lanzhou Foci Pharmaceutical Ltd., Lanzhou 730000, China
2.
Pharmacy Department of Lanzhou University, Lanzhou 730000, China

摘要

摘要: 采用薄层色谱法对益气通痹胶囊中黄芪、何首乌、五味子、赤芍、延胡索进行定性鉴别,采用高效液相色谱法测定了制剂中淫羊藿苷的含量. 所用薄层色谱具有鉴别特征,色谱斑点清晰,专属性强. 淫羊藿苷在0.55~3.30 μg范围内呈良好的线性关系(r =0.99996),平均回收率为98.4%,RSD为0.62 %. 所建立的定性和定量方法,操作简便可靠,专属性强,重现性好,能较全面反映该制剂内在质量,可作为益气通痹胶囊新药研发质量控制标准.
- 益气通痹胶囊 /
- 薄层色谱法 /
- 淫羊藿苷 /
- 高效液相色谱法
Abstract: A thin layer chromatographic method has been developed for the identification of Astragali Radix, Polygoni Multiflori Radix, Schisandrae Chinensis Fructus, Paeoniae Radix Rubra, and Corydalis Rhizoma in Yiqi-tongbi capsule. The content of epimedium glycoside in the preparation is determined by HPLC. The established TLC has obvious characteristics with clear spots and strong specificity. Epimedium glycoside showed good linearity in the range of 0.55-3.30 μg (r =0.99996). The average recovery rate was 98.4% with a RSD of 0.62%. The developed qualitative and quantitative analysis methods are simple, reliable, specific and reproducible and can be applied for the comprehensive quality control of Yiqi-tongbi capsule.
- Yiqi-tongbi capsule /
- TLC /
- epimedium glycoside /
- HPLC

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