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目的:比较盐酸氨溴索胶囊和片剂的药物动力学和生物利用度。方法:8名健康志愿者随机交叉单剂量口服90mg盐酸氨溴索胶囊和片剂,采用HPLC法测定氨溴索血药浓度,对2种制剂的药-时曲线下面积(AUC)进行方差分析和双向单侧t检验。结果:胶囊和片剂体内过程符合一室开放模型,Cmax、Lmax、T1/2(Ke)和AUC均无显著性差异。结论:盐酸氨溴索胶囊和片剂具有生物等效性,胶囊的相对生物利用度为99.76±1576%。
OBJECTIVE: To compare the pharmacokinetics and bioavailability of ambroxol capsules and tablets. Methods: Eight healthy volunteers were randomized crossover single oral dose of ambroxol hydrochloride capsules and tablets 90mg, HPLC determination of ambroxol blood concentration, the two formulations of the drug - time curve under the area (AUC) analysis of variance And two-way unilateral t test. RESULTS: The in vivo process of capsules and tablets conformed to the one-compartment open model with no significant difference in Cmax, Lmax, T1 / 2 (Ke) and AUC. Conclusion: Ambroxol hydrochloride capsules and tablets are bioequivalent, and the relative bioavailability of capsules is 99.76 ± 1576%.