高效液相色谱法测定盐酸曲普利啶血浆浓度及药动学  

Studies on pharmacokinetics and bioavailability of triprolidine hydroch loride by means of HPLC assay

作　　者：曲福军[1] 孙华[1] 于景翠[1] 

机构地区：[1]哈尔滨医科大学附属二院临床药学药物研究所,黑龙江哈尔滨150086

出　　处：《中国药学杂志》2003年第12期945-947,共3页Chinese Pharmaceutical Journal

摘　　要：目的　对健康受试者进行盐酸曲普利啶的药物动力学研究 ,以评价胶囊剂的生物等效性。方法　 18名健康志愿受试者 ,随机分组 ,自身交叉口服盐酸曲普利啶胶囊和片剂。用反相高效液相色谱法测定盐酸曲普利啶血浆浓度 ,3P87拟合药动学参数 ,计算药动学参数 ,并以AUC0～∞ ,tmax,cmax为指标 ,用方差分析、双单侧t检验及 1 2α置信区间分析片剂与胶囊的生物等效性。结果　盐酸曲普利啶胶囊与片剂的主要药动学参数分别为cmax(4 2 .1± 6 .3)和 (4 0 .7± 6 .4 ) μg·L-1,tmax(1.8± 0 .3)和 (1.8± 0 .3)h ,AUC0～∞(15 6 .5± 2 8.4 )和 (16 0 .9± 2 6 .7) μg·h·L-1,胶囊剂的相对生物利用度为 (98.3± 5 .4 ) %。结论　两制剂均符合一房室模型 。OBJECTIVETo determine the plasma concentrations o f triprolidine hydrochloride and evaluate the bioavailability of triprolidine ca psule.METHODS18 healthy male volunteers were given triproli dine hydrochloride capsules and tablets in a randomized cross over design.The pl asma concentrations of triprolidine were determined with reverse-HPLC.The pharm acokinetic parameters of two preparations were calculated with the 3P87 software .The t max ,c max and AUC 0～∞ were used to evaluate the bioequivalence of capsule and tablet with analysis of variance,two one-sided t test and (1-2α) confidence intervals.RESULTSThe pharm acokinetic parameters of triprolidine hydrochloride capsules and tablets were as follow:t max (1.8± 0.3 ) and (1.8±0.3) h,c max (42.1±6.3) and (40.7±6.4) μg·L -1 ,AUC 0～∞ (156.5±28.4) and (160.9±26.7) μ g·h·L -1 ,respectively.The relative bioavailability of capsule was (98.3± 5.4)%.CONCLUSIONThe two preparations were coincident with t wo-compartment model and were bioequivalent.

关 键 词：高效液相色谱法 测定 盐酸曲普利啶 血浆浓度 药动学 

分 类 号：R969.1[医药卫生—药理学] R976[医药卫生—药学]