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目的研究复方罗红霉素片在健康志愿者体内的药动学。方法 48名健康成年志愿者,男女各半,采用随机分组三制剂平行设计,分别单剂量口服复方罗红霉素片、300 mg罗红霉素片、60 mg盐酸氨溴索片、300 mg罗红霉素片合用60 mg盐酸氨溴索片后,用串联质谱法(LC-MS/MS)分别测定血浆中罗红霉素或氨溴索的浓度,采用DAS2.1程序分别计算各受试者的有关药动学参数,并用SPSS11.5对其单因素方差分析。结果复方罗红霉素片组与两单药合用组相比,罗红霉素和氨溴索的人体药动学参数无明显差异(P>0.05)。复方罗红霉素片与对照药罗红霉素片组相比,罗红霉素的人体药动学参数AUC、CLz/F、Vz/F、mρax经统计有显著差异(P<0.05),而其他参数无明显差异;复方罗红霉素片组与盐酸氨溴索片组相比,氨溴索的人体药动学参数AUC、MRT0-t、CLz/F、Vz/F经统计有显著差异(P<0.05),而其他参数无明显差异。结论复方罗红霉素片与两药合用的对照药相比,罗红霉素及氨溴索药动学参数均无明显差异,而与单药相比,罗红霉素及氨溴索的药动学参数有明显差异。
Objective To study the pharmacokinetics of compound roxithromycin tablets in healthy volunteers. METHODS: Forty-eight healthy adult volunteers were divided into male and female volunteers. Each group was randomized to receive three doses of compound roxithromycin tablets, 300 mg roxithromycin tablets, 60 mg ambroxol hydrochloride tablets, 300 mg Luo Erythromycin tablets were combined with 60 mg ambroxol hydrochloride tablets, the concentration of roxithromycin or ambroxol in plasma was determined by tandem mass spectrometry (LC-MS / MS), respectively. The pharmacokinetic parameters were analyzed using SPSS 11.5 for one-way ANOVA. Results There were no significant differences in the pharmacokinetic parameters of roxithromycin and ambroxol between compound roxithromycin group and two single drug combination groups (P> 0.05). Compound roxithromycin tablets compared with the control group roxithromycin tablets, roxithromycin human pharmacokinetic parameters AUC, CLz / F, Vz / F, mρax statistically significant differences (P <0.05) While the other parameters had no significant difference. Compared with ambroxol hydrochloride group, the pharmacokinetic parameters AMB, MRT0-t, CLz / F and Vz / F of ambroxol in compound roxithromycin group were statistically significant (P <0.05), while other parameters had no significant difference. Conclusions The roxithromycin and ambroxol have no significant difference in kinetic parameters when compared with those of the two drugs. However, compared with single drug, roxithromycin and ambroxol Pharmacokinetic parameters were significantly different.