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目的:比较盐酸氨溴索口服溶液和片剂的生物利用度与药代动力学。方法:志愿者随机交叉单剂量口服90mg盐酸氨溴索口服溶液和片剂,HPLC法测定血浆中的药物浓度,采用三因素方差分析和双向单侧t检验比较两种制剂的AUC。结果:口服溶液和片剂的cmax分别为(169.03±23.42)和(163.17±23.41)ng/ml;tmax分别为(1.20±0.22)和(1.44±0.23)h;t1/2β分别为(7.07±1.54)和(7.97±1.17)h;AUC分别为(1287.13±250.84)和(1317.85±151.31)h·ng/ml。结论:盐酸氨溴索口服溶液与片剂具有相同的生物利用度,口服溶液的相对生物利用度为(97.61±15.65)%。
OBJECTIVE: To compare the bioavailability and pharmacokinetics of ambroxol hydrochloride oral solution and tablets. Methods: 90 mg ambroxol hydrochloride oral solution and tablets were orally administered to volunteers in a randomized crossover single dose. The plasma concentration of the drug was determined by HPLC. The AUC of the two preparations was compared using three-way ANOVA and two-way one-sided t-test. Results: The cmax of oral solution and tablet were (169.03 ± 23.42) and (163.17 ± 23.41) ng / ml, respectively; the tmax were (1.20 ± 0.22) and 44 ± 0.23) h; t1 / 2β were (7.07 ± 1.54) and (7.97 ± 1.17) h respectively; AUC were (1287.13 ± 250.84) and 85 ± 151.31) h · ng / ml. Conclusion: Ambroxol hydrochloride oral solution has the same bioavailability as tablets, and the relative bioavailability of oral solution is (97.61 ± 15.65)%.