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目的:建立控制老年咳喘胶囊的质量标准。方法:采用TLC法对老年咳喘胶囊中淫羊藿、黄精及甘草进行了定性鉴别;采用HPLC-ELSD法对老年咳喘胶囊中黄芪甲苷进行定量分析。色谱柱为C18柱(250 mm×4.6mm,5μm),流动相为乙腈-水(32∶68),流速0.8 mL/min,ELSD参数中漂移管温度为100℃,氮气流速为2.5 L/min。结果:薄层斑点清晰,阴性对照无干扰;黄芪甲苷对照品在4.03～40.30μg范围内,进样量与峰面积呈良好线性关系,平均加样回收率为98.60%,RSD=1.02%(n=6)。结论:方法简便可行,结果准确可靠,重现性好,可作为本产品的质量控制方法。
Objective: To establish the quality control of senile Kechuan capsule. Methods: Ephedra, Polygonatum sibiricum and Glycyrrhiza uralensis were identified qualitatively by TLC in Elder Kechuan Capsule. Astragaloside IV in elderly Kechuan capsule was quantitatively analyzed by HPLC-ELSD. The column was C18 (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-water (32:68) at a flow rate of 0.8 mL / min. The drift tube temperature was 100 ° C in ELSD and the flow rate of nitrogen was 2.5 L / min . Results: TLC spots were clear and no interference was found in the negative control. Astragaloside reference standard was in the range of 4.03-40.30μg with a good linear relationship between injection volume and peak area. The average recoveries were 98.60% and RSD = 1.02% n = 6). Conclusion: The method is simple and feasible, the results are accurate and reliable, reproducible, and can be used as the quality control method of this product.