参芪养心丸质量标准的研究

Quality standard for Shenqiyangxin Pills

目的建立参芪养心丸（黄芪、丹参、苦参等）的质量标准。方法 TLC法定性鉴别黄芪、丹参和苦参,高效液相色谱-蒸发光散射检测器（HPLC-ELSD）法测定黄芪甲苷的含有量,高效液相色谱-紫外检测器（HPLC-UV）法同时测定苦参碱和氧化苦参碱的含有量。结果黄芪、丹参、苦参的分离度良好,斑点清晰。黄芪甲苷在0.995 0~31.84μg范围内线性关系良好（r=0.999 5）,平均回收率为99.4%,RSD为1.5%（n=6）。苦参碱和氧化苦参碱的线性范围分别为0.001 250~0.036 00 mg/m L（r=0.999 7）和0.000 898 4~0.028 75 mg/m L（r=0.999 6）,平均回收率分别为98.2%（RSD=1.6%）和98.4%（RSD=1.7%）。结论该标准能有效控制参芪养心丸的质量。

AIM To establish the quality standard for Shenqiyangxin Pills（ Astragalus membranaceus,Salvia miltiorrhiza,Sophora flavescens,etc.）. METHODS TLC was used for the qualitative analyses of Astragalus membranaceus,Salvia miltiorrhiza and Sophora flavescens,while high performance liquid chromatography-evaporative light scattering detector（ HPLC-ELSD） was applied to the quantitative analysis of astragaloside,and high performance liquid chromatography-ultroviolet（ HPLC-UV） was used for that of matrine and oxymatrine. RESULTS Clear spots from TLC verified the good separations of Astragalus membranaceus,Salvia miltiorrhiza and Sophora flavescens,Astragaloside showed a good linear relationship within the range of 0. 995 0-31. 84 μg（ r = 0. 999 5）,whose average recovery was 99. 4% with the RSD of 1. 5%（ n = 6）. The linear ranges of matrine and oxymatrine were 0. 001 250-0. 036 00 mg / m L（ r = 0. 999 7） and 0. 999 7-0. 028 75 mg / m L（ r = 0. 999 6）,whose average recoveries were 98. 2%（ RSD = 1. 6%） and 98. 4%（ RSD = 1. 7%）,respectively. CONCLUSION This standard can help to control the quality of Shenqiyangxin Pills effectively.