布洛伪麻分散片的生物等效性

Study on the bioequivalence of ibuprofen and pseudoephedrine dispersible tablets

目的:研究布洛伪麻分散片在健康人体内的生物等效性。方法:将22名健康男性志愿受试者,随机分为2组,分别于早晨一次空腹口服供试品(布洛伪麻分散片)或对照品(布洛伪麻片)4片(每片含布洛芬200mg和盐酸伪麻黄碱30mg)。建立高效液相色谱法,分别以萘普生、对硝基苯胺为内标,测定布洛芬和盐酸伪麻黄碱的血药浓度。药动学参数用3P97程序计算。结果:供试品和对照品均符合口服一级吸收一房室开放模型。以方差分析和双向单侧t检验方法检验两制剂的AUC(0-inf)、AUC(0-t)、Cp、和t1/2的生物等效性,结果表明2种制剂体内生物等效。结论:2种制剂在人体内的药效没有差异。

OBJECTIVE To study the bioequivalence of ibuprofen and pseudoxephedrine dispersible tablets. METHODS In the morning, four tablets of test product（ibuprofen and pseudoephedrine dispersible tablets, each tablet contains ibuprofen 200 mg pseudoephedrine hydrochloride 30 mg） or controlled product （ibuprofen and pseudoephedrine tablets ）were given to 22 fasted healthy volunteers in a randomized study, ibuprofen and pseudoephedrine hydrochloride concentrations in plasma were determined by HPLC and naproxen and para-nitroaniline were used as internal standards respectively. The pharmacokinetic pa rameters of ibuprofen and pseudoephedrine hydrochloride were calculated by 3P97. RESULTS Ibuprofen and pseudoephedrine hydrochloride were fitted to the one compartment opened model with first-order absorption. The main pharmacokinetic parameters were analysed of variance, two sides t-test justified bioequivalence. The statistical results showed that two products were bioequivalent in vivo. CONCLUSION The statistical results shows that the test product is bioequivalent to the controlled product in vivo.