结石通片质量标准的研究

Studies on Qualitative and Quantitative Methods for Jieshitong Tablets

摘要:

目的 :研究建立结石通片质量标准。 方法 :采用TLC法分别对结石通片中广金钱草、车前草、石韦进行了定性鉴别,采用HPLC法对广金钱草中的槲皮素和山奈素进行了含量测定。 结果 :结石通片中广金钱草、车前草、石韦的的薄层色谱鉴别斑点清晰,分离较好;HPLC含量测定结果显示,槲皮素在0.128 4~0.342 4 μg呈线性关系,r=0.999 3(n=6),平均加样回收率97.7%,RSD 0.8％;山奈素在0.118 8~0.316 8 μg呈线性关系,r=0.999 5(n=6),平均加样回收率97.3%,RSD 0.7％。 结论 :所建立的方法简便准确,分离度高,专属性强,重复性好,可有效控制结石通片的质量。

Abstract:

Objective: To study the qualitative and quantitative methods for Jieshitong Tablets. Method: Desmodii Styracifolii Herba , Plantaginis Herba and Pyrrosiae Folium in Jieshitong Tablets were identified with the method of TLC. Quercetin and kaempferol were determined with the method of HPLC. Result: By TLC, the spots of three herbal drugs were well separated and without interference. Quantitative analysis of HPLC showed that the linear range of quercetin and kaempferol was 0.128 4~0.342 4 μg and 0.118 8~0.316 8 μg, respectively. The average recovery of uercetin and kaempferol was 97.7% and 97.3%, respectively. The RSD (n=6) was 0.7% and 0.8%, respectively. Conclusion: The method set up could effectively control the quality of Jieshitong Tablets.