肾舒颗粒质量标准研究

Study on Quality Standard of ShenShu Granules

目的为肾舒颗粒建立质量标准方法。方法对肾舒颗粒中的白花蛇舌草、黄柏、大青叶、茯苓、甘草药材进行薄层色谱鉴别;采用高效液相色谱法对肾舒颗粒中盐酸小檗碱的含量进行测定。色谱柱为Kromasil C_(18),流动相为乙腈-0.1%磷酸溶液(48∶52,V/V)(每100 mL溶液中含十二烷基磺酸钠0.1 g),流速为1.0 mL·min^(-1),检测波长为265 nm,柱温为35℃。结果白花蛇舌草、黄柏、大青叶、茯苓、甘草的TLC图斑点清晰,分离度好,阴性无干扰。盐酸小檗碱进样量线性范围为0.06252~0.6252μg(r=1.0000);精密度、稳定性、重复性试验的RSD均小于2.0%;平均加样回收率为104.48%(RSD=1.71%,n=6)。结论所建质量标准方法准确、简便,为肾舒颗粒质量控制提供了参考。

OBJECTIVE To establish the quality standard method of ShenShu Granules.METHODS Identified the Hedyotis diffusa,Cortex phellodendri chinensis,Folium isatidis,Poria cocos and Licorice qualitatively in ShenShu Granules by TLC method.HPLC method was used to measure the content of berberine hydrochloride in ShenShu Granules.The determination was performed on Kromasil C_(18)column with mobile phase consisted of acetonitrile-0.1%phosphoric acid(48∶52,V/V)(0.1 g sodium dodecyl sulfonate per 100 mL solution)at the flow rate of 1.0 mL·min^(-1).The detection wavelength was 265 nm and column temperature was 35℃.RESULTS TLC chromatograms of Hedyotis diffusa,Cortex phellodendri chinensis,Folium isatidis,Poria cocos and Licorice had clear spots with good separation and no same spot from negative samples.The linear range of berberine hydrochloride was 0.06252-0.6252μg(r=1.0000).RSDs of precision,stability and reproducibility tests were all lower than 2.0%.The Average recovery rate was 104.48%(RSD=1.71%,n=6).CONCLUSION The established quality standard method is accurate and simple,which provides a reference for the quality control of ShenShu Granules.