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目的：考察国产田可与进口新山地明胶囊的生物利用度。方法：对６例健康志愿者进行自身交叉口服单剂量田可及新山地明胶囊，用ＦＰＩＡ法测其全血浓度。资料数据采用ｔ检验做统计学处理。结果：田可及新山地明胶囊的主要药代动力学参数分别为：ｔ１／２β（１０．７３±１４．５５）ｈ，ＡＵＣ（６．７６±１．８４）（ｍｇ·ｈ）／Ｌ，Ｔｍａｘ（２．８９±１．５６）ｈ，Ｃｍａｘ（６６９．５７±２１８．３６）ｍｇ／Ｌ，和ｔ１／２β（５．００±０．８２）ｈ，ＡＵＣ（７．０４±２．４８）（ｍｇ·ｈ）／Ｌ，Ｔｍａｘ（１．３５±０．２１）ｈ，Ｃｍａｘ（１３７２．０９±３５９．１２）ｍｇ／Ｌ。田可胶囊相对于新山地明胶囊的生物利用度为９６％。结论：国产田可及进口新山地明胶囊的生物利用度有显著性差异。
Objective: To investigate the bioavailability of domestically produced Tianshan capsules and imports. METHODS: Six healthy volunteers were given self-crossover oral single-dose Tian Ke Ke Xin Shan Di Ming capsules and the whole blood concentration was measured by FPIA method. Data data were analyzed statistically using t test. Results: The main pharmacokinetic parameters of Tiankang and Xinshandimin capsules were: t1/2β(10.73±14.55)h, AUC(6.76±1.84)(mg·h)/L. Tmax (2.89±1.56) h, Cmax (669.57±218.36) mg/L, and t1/2β (5.00±0.82) h, AUC (7.04±2. 48) (mg·h)/L, Tmax (1.35±0.21) h, Cmax (1372.09±359.12) mg/L. The bioavailability of Tian Ke capsule relative to Xin Shan Di Ming capsule is 96%. Conclusion: There is significant difference in bioavailability between domestically produced Tianshan capsule and imported Xinshandiming capsule.