摘要
目的：建立测定贞芪扶正制剂中8种生物活性化合物的高效液相色谱法。方法：应用Hypersil ODS柱,柱温30℃。色谱系统Ⅰ：以甲醇和水为流动相,流速1.0 mL·min^-1,梯度洗脱,用二极管阵列检测器检测,波长为254,275,328 nm。色谱系统Ⅱ：以甲醇-水-冰醋酸-三乙胺（90∶10∶0.03∶0.06）为流动相,流速0.6 mL·min^-1,用蒸发光散射检测器检测,漂移管温度75℃,载气流速2.0 L·min^-1。结果：8种成分的峰面积与浓度的线性关系良好（r〉0.999）,加样回收率为95.4%-103.2%。结论：本研究为贞芪扶正制剂的多组分定量测定和质量控制提供了一种简单、可靠的方法。同时在传统工艺生产的制剂中检测不到的有效成分齐墩果酸和熊果酸,经生产工艺改进后可以检测到。此改进为该制剂生产工艺的研究提供了理论基础。
Objective：A simple and accurate high-performance liquid chromatography was established for the determination of eight bioactive compounds in Zhenqi Fuzheng preparation（ZFP）.Methods：The quantification of the 8 components was performed on a C18 column with the column temperature 30 ℃.Chromatographic system I：the mobile phase consisted of methanol and water using a gradient elution with the flow rate of 1.0 mL·min^-1 and the optimum detection wavelength of DAD was 254,275,328 nm to detect compounds 1-5.Chromatographic system Ⅱ：the mobile phase consisted of methanol,water,glacial acetic acid,triethylamine using an elution（90∶10∶0.03∶0.06）with the flow rate of 0.6 mL·min^-1 and the drift tube temperature of ELSD was 75 ℃,and the gas flow rate was 2.0 L·min^-1 to detect compounds 6-8.Results：All the compounds showed good linearity（r 0.999）in the range of the test concentration,the average recoveries of the method were between 95.4% and 103.2%.Conclusion：The results indicated that the method could be used as a convenient and reliable method in the multi-component determination and quality control of ZFP.As active ingredients,oleanolic acid and ursolic acid could be detected in the preparation made in this production process that the study developed,while not in the traditional manufacture.It provides a theoretical foundation for the study of production process of the preparation.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第7期1185-1190,共6页
Chinese Journal of Pharmaceutical Analysis
