毛细管气相色谱-电子捕获法测定5-单硝酸异山梨酯血药浓度的研究

 目的：建立毛细管气相色谱-电子捕获法(GC-ECD)测定人血浆中的5-单硝酸异山梨酯(IS-5-MN)的浓度，为研究该药物在人体内的药动学和生物利用度提供依据。方法：以2-单硝酸异山梨酯(IS-2-MN)为内标，血样经正己烷-乙醚(1:4)提取液两次萃取后，分离有机相，氮气下浓缩，甲苯溶解进样。采用Altech SE-30毛细管柱(ECONO)，15m×0.25mm，程序升温测定血药浓度。结果：标准曲线在24ng·ml^-1～1200ng·ml^-1浓度内，r=0.9993，日内、日间变异RSD为3.29%～9.50%，平均回收率为(101.66±1.11)％。结论：该方法测定血浆中5-单硝酸异山梨酯浓度准确度高，专一性强，简便易行，可以满足血药浓度测定及药动学研究的需要。

Determination of isosorbide 5-mononitrate in human plasma by capillary GC-ECD

OBJECTIVE: To establish a capillary GC-ECD method for the determination of isosorbide-5-mononitrate in human plasma and study the pharmacokinetics of isosorbide-5-mononitrate in healthy volunteers. METHODS: Using isosorbide-2-mononitrate as the internal standard, plasma samples were extracted twice with a solvent of n-hexane and ether (1:4). The organic phase was separated and concentrated under nitrogen stream. RESULTS: The linear range of this method was 24ng·ml^-1～1200ng·ml^-1, and the average recovery was (101.66±1.11)%. The coefficients of variation for inter-run and intra-run was RSD=3.29%～9.50% (n=5). CONCLUSION: This method was simple, convenient, and sensitive. It could be used to determine isosorbide-5-mononitrate in vivo.