复方黄芪健脾口服液质量标准提升研究

Study on Quality Standard Improving of Compound HuangQi JianPi Oral Liquid

目的 进一步完善复方黄芪健脾口服液的质量标准,更好地控制其质量及品质。方法 采用高效液相色谱-蒸发光散射法(HPLC-ELSD)测定制剂中黄芪甲苷的含量。结果 在进样量1.6968~11.3120μg(r^(2)=0.9997)范围内,黄芪甲苷线性关系良好。平均加样回收率97.47%,RSD为2.26%(n=6)。结论 所建立的标准操作简便、准确,可以有效控制复方黄芪健脾口服液的质量。

OBJECTIVE To improve the quality standard of Compound HuangQi JianPi oral liquid and enhance its quality control level.METHODS Quantitative determination of astragaloside Ⅳ in Compound HuangQi JianPi oral liquid by HPLC-ELSD.RESULTS The calibration curve of Astragaloside IV had a good linear within the range of 1.6968-11.3120 μg(r^(2)=0.9997).The average recovery rate was 97.47% with RSD being 2.26%(n=6).CONCLUSION The established quality standard was convenient operation,high accuracy which can effectively control the quality of Compound HuangQi JianPi oral liquid.