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本实验选择１２名健康受试者，采用随机交叉四组试验，对分别口服 １２０ｍｇ采用固体分散技术生产的三种国产尼莫地平片与德国拜尔药石生产的尼莫通片后的体内过程进行了研究。血浆药物浓度由本实验室改进的高效液相色谱测定法获得，采用非房室模型分析法用ＰＣＮＯＮＬＩＮ程序（ＳＣＩ，ｖ４．２）获得个体生物利用度参数Ｔｍａｘ、Ｃｍａｘ和ＡＵＣ０－∞。根据被测不同尼莫地平片剂间ＡＵＣ０－∞ 之比得出相对生物利用度（ｆ）；并将ＡＵＣ 等参数对数转换进行方差分析，在方差分析基础上再行双单侧检验（ｔｗｏ ｏｎｅ ｓｉｄｅｄ ｔｅｓｔｓ）进行生物等效性评价。生物等效性判定标准是以试验制剂生物利用度参数ＡＵＣ平均值的 ９０％可信限，应落在标准参比制剂的８０％～１２５％置信区间之内。统计学意义在 ｐ＝０.０５显著性水平上判定。结果表明，Ａ，Ｂ，Ｃ和Ｄ四种片剂的达峰时间Ｔｍａｘ分别为０.６±０.２ｈ、１.１±１２ｈ、０.５±０.１ｈ和０.５±０.２ｈ；峰浓度Ｃｍａｘ分别为１０８．８±５９.５ｎｇ·ｍｌ~(－１)、５６.１±３０.７ｎｇ·ｍｌ~(－１)、７３.２±３４.９ｎｇ·ｍｌ~(－１)和９４.７±４１.１ｎｇ·ｍｌ~(－１)；血浆药物浓度-时间曲线下面积ＡＵＣ０－∞分别?
In this study, 12 healthy subjects were selected and randomly divided into four groups. The in vivo process of oral administration of 120mg nimodipine tablets produced by solid dispersion technique and nimotop pellucida produced by Bayer drug of Germany respectively Study. Plasma drug concentrations were obtained by our laboratory modified HPLC assay and individual bioavailability parameters Tmax, Cmax and AUC0-∞ were obtained using the non-compartmental model analysis using the PCNONLIN program (SCI, v4.2). The relative bioavailability (f) was calculated according to the AUC0-∞ ratio between different nimodipine tablets tested. The logarithmic conversion of AUC and other parameters were analyzed by ANOVA. Based on the analysis of variance, two-sided one-sided test one sided tests for bioequivalence assessment. The bioequivalence criterion is based on a 90% confidence limit for the mean AUC of the bioavailability of the test formulation and falls within the 80% to 125% confidence interval of the standard reference formulation. The statistical significance was judged at the significance level of p = 0.05. The results showed that the peak time Tmax of the four tablets A, B, C and D were 0.6 ± 0.2h, 1.1 ± 12h, 0.5 ± 0.1h and 0.5 ± 0.2h respectively ; Peak concentration Cmax were 108.8 ± 59.5ng · ml -1, 56.1 ± 30.7ng · ml -1, 73.2 ± 34.9ng · ml -1, And 94.7 ± 41.1ng · ml ~ (-1), respectively; AUC0-∞ of plasma drug concentration-time curve, respectively