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目的:建立心脑康胶囊的质量标准。方法:采用薄层色谱法鉴别制剂中的制何首乌、川芎、红花、甘草;高效液相色谱法测定制剂中芍药苷的含量。色谱柱:Shim-pack VP-ODS(250 mm×4.6 mm,5μm);流动相为乙腈和1%磷酸水溶液(15:85);流速:1 ml·min~(-1);柱温:30℃;检测波长为230 nm。结果:薄层色谱法能对制何首乌、川芎、红花、甘草进行专属性定性分析;高效液相色谱法测定芍药苷的线性范围为0.276~1.380μg(r=0.999 8);平均回收率为97.88%,RSD为1.63%(n=5)。结论:本文方法简便、快速、准确,可用于心脑康胶囊的质量控制。
Objective: To establish the quality standard of Xinnaokang capsule. Methods: The preparation of Polygonum multiflorum Thunb, Rhizoma Chuanxiong, Honghua and Licorice was identified by TLC. The content of paeoniflorin in the preparation was determined by HPLC. Column: Shim-pack VP-ODS (250 mm×4.6 mm, 5 μm); mobile phase of acetonitrile and 1% aqueous phosphoric acid (15:85); flow rate: 1 ml·min-1; column temperature: 30 °C; detection wavelength is 230 nm. RESULTS: The specific qualitative analysis of Polygonum multiflorum Thunb, Rhizoma Chuanxiong, Honghua and Licorice was carried out by TLC. The linear range of the determination of paeoniflorin by HPLC was 0.276-1.380 μg (r=0.999 8); the average recovery was 97.88%, RSD 1.63% (n=5). Conclusion: This method is simple, rapid, accurate and can be used for quality control of Xinnaokang capsule.