| 摘要: |
| 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 90 mg 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 (1 287.13± 250.84)和(1 317.85±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) ％。 |
| 关键词: 盐酸氨溴索、生物利用度、药物动力学、高效液相色谱法 |
| DOI： |
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| Pharmacokinetics and relative bioavailability of ambroxol hydrochloride oral solution |
| 胡晋红,王卓,宋洪杰,石晶,范国荣,沈意翔,徐学君,李珍 |
| () |
| Abstract: |
| Objective: To compare the pharmacokinetics and bioavailability between ambroxol hydrochloride oral solution and tablet. Methods: Volunteers were given oral solution or tablet with a single oral dose of 90 mg ambroxol hydrochloride in a randomized crossover study. The plasma concentrations of ambroxol were determined by HPLC method. Three factors analysis of variance and two one-side t test were adopted in the evaluation of the area under plasma drug concentrations-time curve (AUC ). Results: The maximum plasma concentration(cmax) of ambroxol oral solution and tablet were(169.03±23.42) and (163.17 ± 23.41) ng/ml; the time to reach cmax (tmax) were (1.20±0.22) and (1.44±0.23) h; elimination half-life(t1/2β) were(7.07±1.54) and (7.97 ± 1.17) h, AUC were (1 287.13±250.84) and (1 317.85 ± 151.31) h*ng/ml, respectively. Conclusion: The two preparations of ambroxol are of the same bioavailability. The relative bioavailability of oral solution of ambroxol is (97.61±15.65)%. |
| Key words: ambroxol hydrochloride bioavailability pharmacokinetics HPLC |
