高效液相色谱法同时测定健康人口服加味逍遥散后血清阿魏酸和芍药苷含量及其药动学研究  

Simultaneous determination and pharmacokinetic studies of ferulic acid and paeoniflorin in human serum by high performance liquid chromatography after oral administration of Modified Xiao-yao Decoction

作　　者：李辉[1] 任平[2] 黄熙[1] 唐文富[1] 魏宏强[1] 

机构地区：[1]四川大学华西医院中西医结合科,四川成都610041 [2]四川大学华西医院全科病房,四川成都610041

出　　处：《中西医结合学报》2008年第11期1178-1183,共6页Journal of Chinese Integrative Medicine

基　　金：国家杰出青年基金项目(No.30325045);国家自然科学基金资助项目(No.30271648);国家中医药管理局基础研究课题(No.02-03JP45)

摘　　要：目的：研究高效液相色谱法（high performance liquid chromatography,HPLC）同时测定健康人口服加味逍遥散（Modified Xiao-Yao Decoction,MXYD）后血清中阿魏酸和芍药苷含量及其药动学。方法：水浴法预处理血样,HPLC法同时测定8名健康人在口服加味逍遥散浓缩汤剂后8个时间点各个血清样本中芍药苷与阿魏酸的血药浓度。应用3P97药动学分析软件对血药浓度-时间数据进行拟合。选用香豆精为内标,芍药苷和阿魏酸检测波长分别为：0-10min为230nm和10-25min为320nm。结果：8名健康志愿者口服MXYD浓缩汤剂后,在血清中检测到芍药苷和阿魏酸。两种化合物分离完全,未出现其他物质干扰峰,保留时间（retention ti me,Tr）分别为8.02min和13.32min,内标香豆素为19.14min。芍药苷和阿魏酸的平均回收率分别为100.9%和95.3%,平均相对标准偏差（relative standarddeviation,RSD）分别为3.4%和3.2%。用空白血清加标准品绘制标准曲线,芍药苷线性范围为40-1280ng/ml,信噪比为3时最低检测线为5ng/ml,最低检测浓度为15ng/ml（RSD=12.5%）;阿魏酸线性范围为10-320ng/ml,最低检测线为0.65ng/ml,最低检测浓度5ng/ml（RSD=9.7%）。成分日间与日内精密度及准确度在92.1%-109.9%,且RSD〈5%。结论：采用高效液相色谱法对人体服用加味逍遥散后血清中的芍药苷和阿魏酸进行同步测定,适用于临床试验中血清芍药苷和阿魏酸的定性定量研究。Objective： To simultaneously determine the contents and explore the pharmacokinetics of ferulic acid and paeoniflorin by high performance liquid chromatography （HPLC） after oral administration of Modified Xiao-yao Decoction （MXYD）, a compound of traditional Chinese herbal medicine. Methods： A total of 8 healthy men were enlisted in this study. The serum samples were preprocessed by immersion method. The HPLC system was used to determine the contents of ferulic acid and paeoniflorin in the blood samples of the 8 healthy volunteers, and the blood was collected through the ulnar vein at 5 min, 10 min, 15 min, 30 min, 45 min, 1 h, 2 h and 3 h after MXYD administration. The dates of serum concentration-time were fitted by using the 3P97 analytical program of pharmacokinetics. The internal standard （IS） was coumarin. The detection wavelengths of paeoniflorin and ferulic acid were 230 nm from 0 min to 10 min and 320 nm from 10 min to 25 min respectively. Results： After MXYD administration, paeoniflorin and ferulic acid were separated completely in the serum and no other interfering peaks were found in the spectrum of the chromatograms. The retention times of the paeoniflorin and ferulic acid were 8. 02 min and 13. 32 min respectively, and that of the coumarin was 19.14 min. The mean recovery rates of paeoniflorin and ferulic acid were 100.9% and 95.3% with relative standard deviation （RSD） of 3.2% and 3.4%, respectively. The calibration curve for paeoniflorin was linear over the concentration range 40-1 280 ng/ml. Itslow-detection limit based onasignal-to-noiseratioof3 was 5 ng/ml and low-concentration limit was 15 ng/ml with an RSD of 12. 5%. Ferulic acid was in the range 10-320 ng/ml; its low-detection limit was 0. 65 ng/ml and low-concentration limit was 5 ng/ml with an RSD of 9.7%. The method was found to be highly precise, with an RSD〈5% and interday and intraday variability in the range of 92. 1%-109.9% for each of the concentrations tested. Conclusion： This is a study on simultaneous

关 键 词：加味逍遥散 芍药苷 阿魏酸 高效液相色谱 药动学 

分 类 号：R286[医药卫生—中药学] R285[医药卫生—中医学]