彝心康胶囊中虎杖的鉴别与含量测定方法研究

Investigation on identification and assay of polygonum cuspidatum in Yixinkang capsules

目的:提升完善彝心康胶囊的质量标准。方法:采用薄层色谱法对彝心康胶囊中的虎杖进行鉴别,以高效液相色谱法对其主药虎杖中的虎杖苷进行含量测定,采用Agilent Eclipse XDB-C 18色谱柱(4.6 mm×150 mm,5μm);流动相为乙腈-水(15∶85);流速1.0 mL·min^(-1);检测波长306 nm;柱温35℃。结果:彝心康胶囊的虎杖薄层色谱中,在与对照品和对照药材色谱相应的位置上,显相同颜色的斑点,阴性无干扰。含量测定中虎杖苷进样量在3.994~79.896μg·mL^(-1)范围内与峰面积呈良好的线性关系(r^(2)=1.0000);平均加样回收率(n=6)为101.2%(RSD=0.64%);采用外标法计算10批样品中的虎杖苷含量测定结果为1.386~1.522 mg·粒^(-1)。结论:本法可用于彝心康胶囊的质量控制。

Objective:To improve the specification of yixinkang capsules.Methods:Thin layer chromatography(TLC)method was used for identification of Polygonum cuspidatum in Yixinkang Capsules,and high performance Liquid chromatography(HPLC)method was used for assay of polydatin in Polygonum cuspidatum in Yixinkang Capsules.The test was performed in Agilent Elipse XDB-C 18 column(4.6 mm×150 mm,5μm)with acetonitrile and water(15∶85).The flow rate was 1.0 mL·min^(-1),the detection wavelength was 306 nm,and the column temperature was 35℃.Results:The chromatogram of polygonum cuspidatum obtained through TLC presented the same colors spots corresponding to that of the reference substance and control medicine material without negative interference.The linearity between the concentrations and peak areas of polydatin was shown in the range of 3.994-79.896μg·mL^(-1)(r^(2)=1.0000),and the average spiked recovery was 101.2%with RSD as 0.64%(n=6).The contents of polydatin in 10 batches of samples were 1.386^(-1).522 mg per capsule.Conclusion:The established methods are simple,reliable and accurate.They can be applied to the quality control of Yixinkang capsules.