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目的：建立测定人血浆中尼莫地平的毛细管气相色谱电子捕获检测法，并用本法研究尼莫地平片剂在健康人体内的药代动力学及相对生物利用度。方法：色谱柱为２５ｍ×０２ｍｍＩＤＯＶ１０１熔融石英毛细管柱，检测器为６３Ｎｉ电子捕获检测器。内标为尼群地平，血浆样品在碱性条件下用正己烷—乙酸乙酯（１∶１）提取。结果：浓度在２０～１５００ｎｇ·ｍｌ－１与峰面积比呈良好线性关系，γ＝０９９９８９。人血浆中尼莫地平的最低检出浓度为０１ｎｇ·ｍｌ－１，方法重现性好，提取回收率大于８０％。１０名志愿者随机交叉口服单剂量１００ｍｇ二种国产尼莫地平片剂后，以本法测定其体内过程符合一室模型。二种片剂的ＡＵＣ０→∞。Ｃｍａｘ，Ｔｍａｘ均无显著差异。结论：尼莫地平血药浓度测定结果表明两种尼莫地平片剂生物等效，Ａ片剂对Ｂ片剂的相对生物利用度为１０２０％。
OBJECTIVE: To establish a capillary gas chromatography electron capture method for the determination of nimodipine in human plasma and to study the pharmacokinetics and relative bioavailability of nimodipine tablets in healthy volunteers by this method. Methods: The column was 25m × 0 2mmIDOV101 fused silica capillary column, the detector was 63Ni electron capture detector. The internal standard was nitrendipine and the plasma samples were extracted with n-hexane-ethyl acetate (1: 1) under basic conditions. Results: The concentration ranged from 2 150 ~ 0 ng · ml-1 and peak area ratio showed a good linear relationship, γ = 0 99989. The minimum detectable concentration of nimodipine in human plasma was 0.1 ng · ml-1. The method was reproducible and the extraction recovery was more than 80%. Ten volunteers randomized to a single oral dose of 100mg two domestic nimodipine tablets, measured by the method of in vivo process in line with the one-compartment model. AUC0 → ∞ for both tablets. Cmax, Tmax no significant difference. Conclusion: The result of nimodipine plasma concentration test shows that the two nimodipine tablets are bioequivalent, and the relative bioavailability of tablet A to tablet B is 102.0%.