公英解毒熏洗剂质量标准研究

Study on Quality Standard of Gongying Jiedu Xunxi Prescription

目的：测定苦参碱、绿原酸、氧化苦参碱在我院医院制剂公英解毒熏洗剂中的含量,同时建立起质量标准。方法：应用显微镜对处方中金银花、黄柏中主要特性的显微辨别;采用TLC法鉴别方内黄柏、赤芍、蒲公英、苦参;同时借助高效液相色谱对公英解毒熏洗剂中苦参碱、绿原酸、氧化苦参碱等成分实现了含量测定。结果：TLC图谱中呈现出这4种物质的特征性斑点;绿原酸线性关系在0.084~0.504μg间良好,r=1,平均加样回收率98.42%,RSD=1.32%（n=6）。苦参碱线性关系在0.092~0.552μg良好,r=1,平均加样回收率99.03%,RSD=0.62%（n=6）。氧化苦参碱线性关系在0.082~0.492μg良好,r=0.9999,平均加样回收率99.98%,RSD=1.19%（n=6）。结论：本实验方法可行、重复性好,可作为该制剂的质量控制方法,为公英解毒熏洗剂的质量标准研究提供了科学依据。

Objective：To determine the content of chlorogenic acid,sophocarpidine,oxymatrine in the Gongying Jiedu Xunxi Prescription,and establish a standard for the quality control. Methods：Using the microscope to identify the main microstructure of Cortex Phellodendri and honeysuckle,identify the quality of prescription of Cortex Phellodendri,Radix Paeoniae Rubra,dandelion,Sophora flavescens by thin Layer chromatography（TLC）,besides testing the main content of chlorogenic acid,sophocarpidine,oxymatrine in the Gongying Jiedu Xunxi Prescription by the high performance liquid chromatography（HPLC）. Results：The characteristic spots can be detected on the TLC atlas. The chlorogenic acid gained a good linear relationship within the range of 0.08~0.504 μg,r=1,while the average recovery were 98.42%,RSD=1.32%（n=6）. The sophocarpidine gained a good linear relationship within the range of 0.092~0.552 μg,r=1,while the average recovery were 99.03%,RSD=0.62%,The oxymatrine gained a good linear relationship within the range of 0.082~0.492 μg,r=0.9999,while the average recovery were 99.98%,RSD=1.19%（n=6）. Conclusion：The method demonstrated to perform well with regard to feasibility and good reproducibility,and can be used as a standard to control the quality of the preparation.