藏骨宝胶囊的质量标准研究

Study on the quality standard of Zanggubao Capsules

目的建立藏骨宝胶囊的质量标准。方法采用TLC法鉴别制剂中的土木香内酯和齐墩果酸;建立HPLC法测定制剂中秦皮甲素和秦皮乙素的含量。色谱柱为Kromasi1C18(150mm×4.6mm,5μm);流动相为乙腈-1mL·L^(-1)磷酸溶液(12∶88);检测波长:334nm;流速:1.0mL·min-1;柱温:25℃;进样量:20μL。结果土木香内酯和齐墩果酸的TLC图斑点清晰、分离良好,阴性样品无干扰。秦皮甲素质量浓度在5.42~54.2μg·mL^(-1)范围内呈良好的线性关系(r=0.999 3),其平均加样回收率为100.06%,RSD值为1.14%(n=9);秦皮乙素的质量浓度在3.28~32.8μg·mL^(-1)范围内呈良好的线性关系(r=0.999 5),其平均加样回收率为100.80%,RSD值为1.68%(n=9)。结论该方法操作简便、快速、准确,可作为藏骨宝胶囊质量控制的方法。

To establish a quality standard for Zanggubao Capsules.TLC was adopted to identify alantolactone and oleanic acid in the preparation;HPLC was adopted to determine the content of aesculin and esculetin in the preparation;the column was Kromasil Ci8(150mm X4.6mm,5 jum)with mobil phase of acetonitrile-1 mL.L 1 phosphoric acid solution(12:88)at a flow rate of 1.0 mL.min 1,the detection wavelength was 334 nm,column temperature was 25°C,the injection volume was 20 juL.TLC showed clear spots and good separation.The linear range of aesculin concentration was 5.42-54.2μg.mL 1(r=0.999 3),the linear range of esculetin concentration was 3.28-32.8μg.mL 1(r=0.999 5);recovery of aesculin was 100.06%(RSD=1.14%,n=9),and recovery of esculetin was 100.80%(RSD=1.6 8%,n=9).The method was convenient,rapid and accurate,and can be used for the quality control of Zanggubao Capsules.