山蜡梅颗粒的质量标准研究

Studies on Quality Standard of Shanlamei Granule

目的建立山蜡梅颗粒的质量控制标准。方法以山蜡梅药材为对照,采用薄层色谱法对该产品进行定性鉴别,并用高效液相色谱法对其中含有的槲皮素及山柰素进行含量测定。结果鉴别项下的阴性对照无干扰,重现性好;槲皮素在1.61μg/mL～25.72μg/mL范围内呈良好的线性关系(r=0.9999),平均回收率为98.89%,RSD为1.21%;山柰素在2.16μg/mL～34.60μg/mL范围内呈良好的线性关系(r=0.9999),平均回收率为97.75%,RSD为1.53%。结论该方法准确、简便、灵敏度高,结论可靠,可作为山蜡梅颗粒的质量控制标准。

Objective To establish the standard for the quality control of Shanlamei Granule.Method Chimonanthus nitens Oliver.was identified quantitativ ely by thin -layer chromatography(TLC),quercetin and kaempferol in Shanlamei Granule were determined by RP -HPLC.Results The TLC Spots were highly clear without the interference of negative control and were reproductive.The c alibration curve for quercetin was l inear(r =0.9999)in the range of 1.61～25.72μg /mL and the mean recovery was 98.89%,RSD being 1.21%(n=5);for Kaempferol ,the calibration cu rve was linear(r =0.9999)in the range of 2.16～34.60μg /mL and the mean recovery was 97.75%,RSD being 1.53%(n=5).Conclusion This method is accurate,simple,sensitive and reliable,and it can be used for the quality control of Shanlamei Granule.