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目的比较中国老年收缩期高血压（ＳＹＳＴ－Ｃｈｉｎａ）和欧洲老年收缩期高血压（ＳＹＳＴ－Ｅｕｒ）两个大规模临床试验的一线药物中国资寿尼群地平和德国拜尔尼群地平在体外溶解释放及其药代动力学、药效学、副作用的异同。方法分别将６片（１０ｍｇ／片）资寿尼群地平和拜尔尼群地平在体外溶解在０．１Ｎ的盐酸溶剂中，观察其完全溶解所需时间，用高效液相半自动测定溶解的尼群地平浓度，计算并比较两种片剂溶解速率相似性因子ｆ２。用随机、交叉比较方法，分别给９个男性健康志愿者口服４０ｍｇ资寿尼群地平或拜尔尼群地平，采用高效液相紫外荧光检测法测定服药前及服药后不同时点血清中尼群地平的浓度。结果９个健康志愿者服用上述药物后，各时点测定的平均血药浓度在两种药物之间无明显差别。其药代动力学参数ＡＵＣ、Ｃｍａｘ、Ｔｍａｘ均无明显差别，两药的９０％可信限平均比值为０．９８９；根据ＣＰＭＰ“生物利用度和生物等效”的概念，如果一种药物的两种产品服用后生物利用度近似，以致其效应及安全性是相同的，那么这两种产品被认为是“生物等效”的。两种产品的ＡＵＣ之比在９０％可信限为０．８０～１．２５，即可达到“生物等效”的要求。因此认为，中国资寿尼群地平和德国拜尔尼群?
OBJECTIVE: To compare the first-line drugs, China Life Gini and Landen Group, in two large-scale clinical trials of systolic hypertension (SYST-China) and European elderly systolic hypertension (SYST-Eur) Release and pharmacokinetics, pharmacodynamics, side effects of similarities and differences. Methods Six tablets (10mg / tablet) were dissolved in 0.1N hydrochloric acid solution in vitro and the time of complete dissolution was measured. The contents of dissolved ginsenoside Group ground level, calculated and compared two tablet dissolution rate similarity factor f2. A randomized, crossover comparison method was used to orally administrate 40 mg of ginaton or bernidi orbital to 9 healthy volunteers respectively. Serum CNG before and at different time points The concentration of the horizon. Results Nine healthy volunteers taking the above drugs, the average blood concentration measured at each time point between the two drugs no significant difference. The pharmacokinetic parameters AUC, Cmax, Tmax were no significant difference between the two drugs 90% confidence limits the average ratio of 0.989; according to CPMP “bioavailability and bioequivalence” concept, if a drug Both products are bioequivalent after administration so that their effects and safety are the same, then both products are considered “bioequivalent.” The AUC ratio of the two products is 90% confidence limit 0.80 to 1.25 to achieve “bioequivalence” requirements. Therefore, China Life Ginnun peace and Germany Byrne group?