【摘要】 目的:建立复方黄芪注射液中黄芪甲苷含量的高效液相测定方法,制订复方黄芪注射液的质量标准。方法:水提醇沉法制备复方黄芪注射液并采用高效液相色谱法测定三批复方黄芪注射液中黄芪甲苷含量分别为2.46、2.49、2.20mg/mL。结果:复方制剂中黄芪甲苷浓度在0.114~0.456mg/mL呈良好的线形关系,回归方程:y=3E+06x-20156,r=0.999,精密度检测、重复性检测、稳定性检测和回收率的RSD%分别为1.18、2.14、0.89、1.25。结论:采用高效液相法测定复方中黄芪甲苷含量方法简单,结果准确,可以作为复方黄芪注射液质量控制的含量测定方法,确定复方黄芪注射液中黄芪甲苷含量应该在2.0mg/mL以上。更多还原

【Abstract】 Objective: To establish a HPLC determining method for Astragaloside in compound Huangqi Injection and study its quality standard.Methods: to extract with water and precipitate with ethanol to prepare compound Huangqi Injection,and evaluate the quality through determining the content of establishing Astragaloside.Results:When the content of Astragaloside varies between 0.114~0.456mg/mL,the work curve is linear and the formula is y=3E+06x-20156,r=0.999,with RSD% of precision 1.18%,of repetition 2.14%,of recovery 1.25% and of stability 0.89%.Conclusion:It was proved that these methods were accurate and reliable for the quality control of compound Huangqi Injection,and the content of Astragaloside in Compound Huangqi Injection should be above 2.0 mg/mL.更多还原