64.0%. The pharmacokinetic parameters for vaginal administration were as follows: Tmax, 0.5 h; Cmax, 20.88 ng/mL; AUC0-t, 64.71 h·ng/mL and the residence time was 3.06 h. By using deconvolution calculation method, the cumulative absorption fraction of GRe was about 0.89%. Conclusion The systemic exposure of GRe was precious little after the vaginal administration of Xiaomi suppository."/>

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Archive > Volume 10 Issue 3 > 2018,10(3):304-309 Prev Next

超高效液相色譜-質譜聯(lián)用法測定消糜栓家兔陰道給藥后人參皂苷Re的藥代動力學研究

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Pharmacokinetic study of ginsenoside Re after vaginal administration in rabbits by UPLC-MS/MS determination

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    摘要:
    目的 采用選擇性強、靈敏度高的超高效液相色譜-串聯(lián)質譜（UPLC-MS/MS）方法，研究消糜栓經(jīng)家兔陰道給藥后體內人參皂苷Re（GRe）的藥代動力學，以評價該用于局部治療藥物的全身暴露量。方法 采用UPLC®BEH C18柱色譜分離，乙腈-0.1%甲酸水作為流動相梯度洗脫。血漿樣品經(jīng)乙腈脫蛋白，采用Winnonlin 6.4軟件計算相關的藥代動力學參數(shù)。結果 GRe的標準曲線在5 ng/mL-500 ng/mL質量濃度范圍內線性關系良好（r＝0.9999）。最低定量限為5 ng/mL且滿足實驗要求。低、中、高三個濃度下GRe的日間和日間精密度均小于1.96%，GRe的平均回收率＞64%。陰道給藥后人參皂苷Re的藥代動力學參數(shù)結果為：Tmax，0.5 h，Cmax，20.88 ng/mL；AUC0-t，64.71 h·ng/mL，MRT，3.06 h。采用反卷積計算方法，GRe的全身累積吸收百分數(shù)約為0.89%。結論 消糜栓陰道給藥后GRe的全身暴露極少。

    Abstract:
    Objective A selective and sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was employed to study the pharmacokinetics of ginsenoside Re (GRe) in rabbits after vaginal administration of Xiaomi suppository to evaluate the systemic exposure of the suppository for the local treatment. Methods Chromatographic separation was on an ACQUITY UPLC? BEH C18 column, and acetonitrile-0.1% formic acid was used as mobile phase in gradient elution. The plasma samples were deproteinized by acetonitrile, and the pharmacokinetic parameters were calculated by Winnonlin 6.4. Results Calibration curve of GRe showed a good linearity over the concentration range from 5 ng/mL to 500 ng/mL (r = 0.9999). The low limit of quantification of 5 ng/mL could satisfy the experimental requirement. The intra-day and inter-day precision of GRe at three concentrations were less than 1.96%, and the average recoveries of GRe were >64.0%. The pharmacokinetic parameters for vaginal administration were as follows: Tmax, 0.5 h; Cmax, 20.88 ng/mL; AUC0-t, 64.71 h·ng/mL and the residence time was 3.06 h. By using deconvolution calculation method, the cumulative absorption fraction of GRe was about 0.89%. Conclusion The systemic exposure of GRe was precious little after the vaginal administration of Xiaomi suppository.

    關鍵詞:
    人參皂苷Re;藥代動力學;陰道給藥;消糜栓

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