彝心康胶囊质量标准提升研究

Improvement of Quality Standard of Yixinkang Capsules

目的提升彝心康胶囊的质量标准。方法采用薄层色谱(TLC)法对彝心康胶囊中的鸡血藤、灯盏细辛进行定性鉴别;采用高效液相色谱(HPLC)法同时测定虎杖中虎杖苷和灯盏细辛中野黄芩苷的含量,色谱柱为Agilent Zorbax SB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.2%磷酸溶液(14∶86,V/V),流速为1.0 m L/min,检测波长为335 nm,柱温为35℃,进样量为10μL。结果鸡血藤、灯盏细辛的TLC图特征斑点显色清晰,分离度好,阴性对照无干扰。虎杖苷、野黄芩苷质量浓度分别在0.112~1.676μg(R^(2)=0.9992,n=6)和0.040~0.605μg(R^(2)=0.9995,n=6)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于2%;平均加样回收率分别为98.30%和99.48%,RSD分别为0.68%和0.66%(n=6)。结论所建立的TLC法专属性强、灵敏度高,HPLC法简便可行,结果准确、可靠,重复性、稳定性好,可用于彝心康胶囊的质量控制。

Objective To improve the quality standard of Yixinkang Capsules.Methods Spatholobus suberectus and Erigeron breviscapus in Yixinkang Capsules were identified by the thin-layer chromatography(TLC)method.The contents of polydatin in Polygonum cuspidatum and scutellarin in Erigeron breviscapus were determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Agilent Zorbax SB-C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.2%phosphoric acid solution(14∶86,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 335 nm,the column temperature was 35℃,and the injection volume was 10μL.Results The TLC characteristic spots of Spatholobus suberectus and Erigeron breviscapus were clear with good separation,and the negative control had no interference.The linear ranges of polydatin and scutellarin were0.112-1.676μg(R^(2)=0.9992,n=6),0.040-0.605μg(R^(2)=0.9995,n=6).The RSDs of precision,stability and repeatability tests were less than 2%.The average recoveries of polydatin and scutellarin were 98.30%and 99.48%with RSDs of 0.68%and 0.66%(n=6),respectively.Conclusion The TLC method has strong specificity,high sensitivity,and the HPLC method is simple and feasible,accurate and reliable with good repeatability and stability,which can be used for the quality control of Yixinkang Capsules.