大山楂颗粒质量标准提升研究

Improvement of Quality Standard for Dashanzha Granules

目的提升大山楂颗粒的质量标准。方法采用薄层色谱(TLC)法对样品中山楂进行定性鉴别;采用紫外-可见分光光度(UV)法在500 nm波长处测定样品中金丝桃苷的含量。结果山楂的TLC图特征斑点显色清晰,分离度好,且阴性对照无干扰。金丝桃苷质量浓度在0.0049~0.0490 mg/mL范围内与吸光度线性关系良好(R^(2)=0.9997,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为100.10%,RSD为0.64%(n=6)。样品中金丝桃苷平均含量为每袋38.26 mg。结论所建立的方法操作简便,结果准确可靠,可用于大山楂颗粒的质量控制。

Objective To improve the quality standard of Dashanzha Granules.Methods Crataegi Fructus in the samples was identified qualitatively by the thin-layer chromatography(TLC)method.The content of hyperoside in the samples was determined by the ultraviolet-visible spectrophotometry at a wavelength of 500 nm.Results The TLC chromatograms of Crataegi Fructus showed clear characteristic spots,good resolution,and there was no interference from the negative reference.The linear range of hyperoside was 0.0049-0.0490 mg/mL(R^(2)=0.9997,n=6).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rate of hyperoside was 100.10%with an RSD of 0.64%(n=6).The average content of hyperoside in the samples was 38.26 mg per bag.Conclusion The established method is simple,accurate and reliable,which can be used for quality control of Dashanzha Granules.