化生平胶囊的质量标准研究

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目的::建立化生平胶囊的质量标准。方法:采用TLC法对黄芪、白花蛇舌草、丹参进行鉴别;用HPLC法测定黄芪甲苷的含量,色谱柱为Kromasil C18(250 mm ×4.6 mm,5μm),流动相为乙腈-水(32∶68),流速:1.0 ml·min-1,检测波长:203 nm柱温:25℃,进样量:20μl。结果:TLC色谱斑点清晰;黄芪甲苷在进样量为2.000~10.000μg 范围内线性关系良好( r=0.9996),平均回收率为100.8%,RSD为1.9%(n=6)。结论:该方法简便、准确、可靠,可用于化生平胶囊的质量控制。“,”Objective:To establish the quality standard for Huashengping capsules. Methods: Milkvetch Root, Hedyotis diffusa Willd and Salvia miltiorrhiza were identified by TLC. The content of astragaloside A was detected by HPLC. The column was Kormasil C18(250 mm ×4.6 mm, 5 μm) and the flow rate was 1.0 ml·min-1. The mobile phases was a mixture of acetonitrile-water (32∶68 ) . The detection wavelength was 203 nm. The column temperature was 25℃ and the sample size was 20μl. Results:The TLC chro-matography spots were clear. Astragaloside A was linear within the range of 2. 000-10. 000 μg(r=0. 999 6) and the average recovery was 100. 8%(RSD=1. 9%,n=6). Conclusion:The method is simple, accurate and reliable, which can be used in the quality con-trol of Huashengping capsules.
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