国产力康结核片在健康人体内的药代动力学  

Studies on the pharmacokinetics of pasiniazide in human body

作　　者：谢红歌[1] 石瑞如[1] 张霞[1] 

机构地区：[1]河南省胸科医院临床药理室

出　　处：《河南医学研究》1999年第2期134-136,共3页Henan Medical Research

摘　　要：目的：采用高效液相色谱法（ＨＰＬＣ），对８名男性健康志愿者顿服国产力康结核片（ｐａｓｉｎｉａｚｉｄｅ）与进口力排肺疾片（ｄｉｐａｓｉｃ）１２００ｍｇ后的药代动力学进行研究。方法：采用ＨｙｐｅｒｓｉｌＢＤＳＣ１８（１０μｍ４６×２５０ｍｍ）色谱柱，甲醇∶００２ｍｏｌＮａ２ＨＰＯ４＝５∶９５（ｐＨ７．４Ｖ∶Ｖ）为流动相，流速０８ｍｌ／ｍｉｎ，检测波长２５４ｎｍ进行测定。结果：力康结核片和力排肺疾片的主要动力学参数分别为：消除半衰期：Ｔ１／２６８２±０２５ｈ和６６６±０１７ｈ；峰浓度Ｃｍａｘ：８０３±０２６ｍｇ／ｍｌ和８０８±０３ｍｇ／ｍｌ；达峰时间Ｔｍａｘ：３３９±０１０ｈ和３７７±０３１ｈ；血药浓度－时间曲线下面面积为：１１８８２±１０２８ｍｇ／Ｌ．ｈ和１２１０７±１１６８ｍｇ／Ｌ．ｈ。结论：国产力康结核片与进口力排肺疾片的主要药动学参数基本相似。两者的相对生物利用度为９８１４％，属生物等效。Objective: The pharmacokinetics of domestic pasiniazide and imported dipasic was studied in eight normal male volunteer by HPLC.A single oral dose of 1200 mg pasiniazide and dipasic tablets was given according to a cross over design. Methods: High perfomance liquid chromatograph model LC10A(Shimadzu Japan) with a 254 nm wavelength uvdetector and hypersil BDS C18 column (10 m,4.6250 mm).The mobile phase of methanol and 0.02 M Na2HPO4=595(VV pH7.4) was pumped at 0.8 ml/min through the column. Results: The main pharmacokinetics parameters of pasiniazide and dipasic were follows respectivey T1/2:6.820.25 h and 6.660.17 h,Cmax 8.030.26 mg/ml,and 8.080.35 mg/ml,Tmax 3.390.10 h and 3.770.31 h;Auc118.8210.28 mg/Lh and 121.0711.68 mg/Lh.The relative bioavailabilities of them was 98.14%. Conclusion: The main pharmacokinetics paramelers of pasiniazide were the same as dipasic,The relative bioavailabilities of them were equivalent.

关 键 词：力康结核片 力排肺疾 药代动力学 HPLC 

分 类 号：R978.3[医药卫生—药品]