氢溴酸右美沙芬口腔崩解片的生物等效性研究

Bioequivalence of dextromethorphan hydrobromide after administration of orally disintegrating tablets(ODT)

目的：研究氢溴酸右美沙芬口腔崩解片和氢溴酸右美沙芬片的生物等效性。方法：采用两制剂双周期双交叉前后自身对照试验设计,20名健康男性志愿者分别口服单剂量氢溴酸右美沙芬口腔崩解片和氢溴酸右美沙芬片各60 mg（受试制剂和参比制剂）,用高效液相色谱（HPLC）-荧光检测法测定血浆中氧去甲右美沙芬的浓度,采用DAS2.0程序对药动学参数进行方差分析和双单侧t检验。结果：受试制剂和参比制剂在受试者体内的药动学参数分别为：t1/2（3.690±1.383）和（3.849±1.662）h,Cmax（989.200±232.444）和（950.149±208.194）ng.mL^-1,Tmax（1.850±0.462）和（1.950±0.426）h,AUC0-t（5 308.177±1 245.531）和（5 302.158±1 217.175）ng.h.mL^-1。以AUC0-t计算,与参比制剂相比受试制剂中氧去甲右美沙芬的平均相对生物利用度为（100.7±13.9）%。结论：统计结果表明,两种制剂在人体内具有生物等效性。

Objective：To study the bioequivalence of dextromethorphan hydrobromide after administration of orally disintegrating tablets and ods：20 healthy male volunteers were randomly dextromethorphan hydrobromide tablets in human. Methadministered with an oral single dose of dextromethorphan hydrobromide orally disintegrating tablets （test formulation ）and dextromethorphan hydrobromide tablets （reference formulation） 60 mg. The dextrophan concentration in plasma samples were determined by HPLC-FLD. The pharmacokinetic parameters of two preparations were analyzed using DAS 2.0 program , and the bioequivalence were evaluated by ANOVA and two-one-sided t-test. Results：The pharmacokinetic parameters of test and reference formulations were as follows： t1/2 （3. 690 ± 1. 383 ） vs. （ 3. 849 ± 1. 662） h, Cmax （989. 200 ± 232. 444） vs. （950. 149 ± 208. 194） ng· mL^-1, Tmax （ 1. 850 ± 0. 462） vs. （1.950±0.426）h,AUC0-t,（5 308.177±1 245. 531）vs. （5 302.158±1 217.175）ng· mL^-1. The relative bioavailability of the test formulation was （100.7 ± 13.9）%. Conclusion： Dextromethorphan hydrobromide orally disintegrating tablets were bioequivalent to dextromethorphan hydrobromide tablets.