妇血宁颗粒的质量标准研究

Quality Standards of Fuxuening Granules

目的:建立妇血宁颗粒的质量标准。方法:采用薄层色谱(TLC)法对方中三七、断血流进行定性鉴别;采用高效液相色谱法测定三七皂苷R1、人参皂苷Rb1、人参皂苷Rg1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、人参皂苷Rb1、人参皂苷Rg1的进样量分别在0.44～4.40(r=0.9998)、0.82～8.20(r=0.9999)、0.74～7.40(r=0.9997)μg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98.21%、98.52%、98.76%,RSD分别为0.81%、0.77%、0.91%(n均为6)。结论:所建标准可用于该制剂的质量控制。

OBJECTIVE： To establish the quality standards of Fuxuening granules. METHODS： Identification of Panax notoginseng and Clinopodium Herb was carded out by TLC; HPLC method was adopted for the content determination of notoginsenoside R1, ginsenoside Rb1 and ginsenoside RgL in Fuxuening granules. RESULTS： TLC sports developed were fairy clear and well-separated with no interference from negative control. The linear ranges were 0.44～4.40μg （r=0.999 8） for notoginsenoside R1,0.82～8.20μg（r=0.999 9）for ginsenoside Rb1,0.74～7.40μg（r=0.999 7）for ginsenoside Rgrespectively. The averages recovery were 98.21% （RSD：0.81% ,n=6）, 98.52% （RSD：0.77%, n=6）, 98.76% （RSD=0.91%, n=6）. CONCLUSION：Established standard is suitable for quality control of Fuxuening granules.