复方卡托普利片的药代动力学及生物等效性评价  

Study on Pharmacokinetics and Bioequivalent Evaluation of Two Compound Captopril Tablets

作　　者：吴正中[1] 童荣生[1] 孙世明[1] 曾明辉[1] 谢玉琼[1] 

机构地区：[1]四川省人民医院,四川成都610072

出　　处：《中国药业》2002年第3期43-45,共3页China Pharmaceuticals

摘　　要：目的：研究两种复方卡托普利片的药代动力学及生物等效性。方法：采用柱前衍生化高效液相色谱法测定１０名志愿受试者单剂量口服５０ｍｇ两种复方卡托普利片后血中卡托普利血药浓度的变化情况，数据经 ３ｐ８７药代动力学程序处理结果：两种片剂药时曲线下面积分别是（８６４．３０±１６９．９９）（ｎｇ／ｍＬ）×ｈ与（８５３．３８±１６５．７７）（ｎｇ／ｍＬ）×ｈ，达峰时间分别为（０．９１ ±０．２７）ｈ与（０．９１ ±０．２６）ｈ，峰浓度分别是（２８５．００±３７．３６）ｎｇ／ｍＬ与（２７９．８０± ３２．７７）ｎｇ／ｍＬ结论：配对ｔ检验与双单侧ｔ检验结果表明：二者药时曲线下面积、峰浓度及达峰时间均无显著性差异（Ｐ＞０．０５），为生物等效制剂。Objective: Study Pharmacokinetics and Bioequivalence of two compound captopril tablets. Methods: Adopting post - column derivatization HPLC, the change of plasma concentration of captopril in 10 volunteers which took single dose of 50mg two compound captopril orally was determined, the data were processed with the roftware 3p87. Results: The pharmacokinetic parameters for two tablets were: AUC(864. 30 ± 169. 99) (ng/mL) × h and (853. 38 ± 165. 7) (ng/mL) ×h; tmax(0. 91 ± 0. 27) h and (0. 9 ± 0. 26) h; Cmax(285. 00 ± 37. 36) ng/mL and (279. 80 ± 32. 77) ng/mL, respectively. Conclusion: The result of pair t - test and double single t - test indicate, AUC, Cmax and tmax of two tablets had no significant difference(P > 0. 05), they are bioequivalent preparation.

关 键 词：复方卡托普利片 药代动力学 生物等效性 合理用药 高效液相色谱法 

分 类 号：R972.4[医药卫生—药品] R969.1[医药卫生—药学]