摘要
目的建立降压抗栓胶囊的质量标准。方法采用TLC法对处方中丹参、川芎、甘草和酸枣仁进行定性鉴别;采用HPLC法测定丹参酮ⅡA的含量。色谱柱:Inertsil ODS-3色谱柱(250 mm×4.6 mm,5μm);流动相:甲醇-水(75∶25);检测波长:270 nm;流速:1.0 mL·min~(—1);柱温:25℃;进样量:5μL。结果 TLC图斑点清晰,分离度好,阴性无干扰;HPLC法中,丹参酮ⅡA的线性范围为10.375～166.000μg·mL~(—1)(r=0.999 9),平均回收率为100.6%,RSD值为0.9%(n=9)。结论该方法操作简便、专属性高,可作为降压抗栓胶囊质量控制的常用方法。
Objective To establish the quality standard for Jiangyakangshuan Capsules.Methods Salvia Miltiorrhizae Radix,Chuanxiong Rhizoma,Glycyrrhizae Radix and Ziziphi Spinosae Semen were identified by TLC qualitatively.Tanshinone ⅡA was determined by HPLC.The chromatographic separation was carried out on an Inertsil ODS-3 column(250 mm×4.6 mm,5 μm) using methanol-water(75∶25) as a mobile phase with gradient elution at a flow rate of 1.0 mL·min~(—1);the injection volume was 5 μL;the column temperature was 25 ℃;the detection wavelength was 270 nm.Results The characteristics under a microscope were obvious.The TLC spots were clear and well-separated without any negative interference.The linear range of tanshinone ⅡA was 10.375-166.000 μg·mL~(—1)(r=0.999 9).The average recovery was 100.6%,with RSD was 0.9%(n=9).Conclusion The method is simple with high specificity,which can be used as the quality control method of Jiangyakangshuan Capsules.
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