消渴通络胶囊的质量标准研究

目的:建立消渴通络胶囊的质量标准。方法:采用薄层色谱(TLC)法对制剂中三七、赤芍、丹参、女贞子、牛蒡子、苍术进行定性鉴别;采用高效液相色谱法测定三七皂苷R1和人参皂苷Rg1、Re、Rb1的含量。结果:TLC斑点清晰,分离度好,阴性对照无干扰;三七皂苷R1和人参皂苷Rg1、Re、Rb1进样量分别在0.376～2.256、1.506～9.036、0.294～1.764、1.408～8.448μg范围内与各自峰面积积分值呈良好线性关系,平均回收率分别为98.64%、101.51%、100.29%、100.58%,r分别为0.9996、0.9999、0.9995、0.9999,RSD分别为0.73%、0.75%、1.01%、0.46%(n均为6)。结论:所建标准可用于消渴通络胶囊的质量控制。

Study on Quality Standard of Xiaoke Tongluo Capsules

OBJECTIVE： To establish the quality standard for Xiaoke tongluo capsules. METHODS：Panax notoginseng,Paeoni- ae Radix Rubra, Radix miltiorrhiza, Ligustri Lucidi Fructus,Arctium lappa and Atractylodis Rhizoma were identified by TLC. The contents of notoginsenoside RI, ginsenoside Rgt, ginsenoside Re and ginsenoside Rbt were determined by HPLC. RESULTS： TLC spots were distinct and well-separated without interference from negative sample. The linear ranges of notoginsenoside R,, ginsen- oside Rg-, ginsenoside Re and ginsenoside Rbl were 0.376-2.256 -μg, 1.506-9.036μg,0.294-1.764 μg, and 1.408-8.448μg, respectively. The average recoveries were 98.64% （RSD=0.73% , r=0.999 6） , 101.51% （RSD=0.75% , r=0.999 9） , 100.29% （RSD= 1.01%, r=0.999 5） and 100.58% （RSD=0.46%, r=0.999 9）, respectively. CONCLUSION： Established standard can be used for the quality control of Xiaoke tongluo capsules.