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目的 :选择 10名男性健康志愿者 ,研究盐酸氨溴索口服溶液的相对生物利用度。方法 :采用反相高效液相色谱法 ,以紫外 2 42nm为检测波长 ,测定了单剂量口服 90mg盐酸氨溴索口服溶液和进口盐酸氨溴索片剂 (商品名Mucosolvan)在健康人体内的氨溴索浓度。结果 :盐酸氨溴索的体内动态过程呈一级吸收的一房室开放模型 ,国产口服溶液和进口Mucosolvan片剂的Cmax分别为 134.5 4± 43 .84ng·ml-1和 12 7.2 2± 36 .18ng·ml-1,tmax分别为 1.5 5± 0 .6 4h和 1.71± 0 .6 6h ,t1/ 2 Ke分别为 7.0 6± 0 .86h和 6 .79± 1.10h ,Auco -t分别为 1488.5 9± 419.13ng.g .ml-1和 140 6 .43± 36 0 .5 1ng·h·ml-1。结论 :盐酸氨溴索口服溶液的相对生物利用度为 10 5 .6 8%± 11.70 % ;选择Cmax和AUC0～τ进行三因素方差分析与双单侧t检验 ,结果表明国产口服溶液和进口Mucosolvan片剂两种制剂具有生物等效性。
Objective: To select ten male healthy volunteers to study the relative bioavailability of ambroxol hydrochloride oral solution. Methods: A reversed-phase high-performance liquid chromatography (HPLC) was developed with UV2 42nm as the detection wavelength. A single oral dose of ambroxol hydrochloride oral solution and imported ambroxol hydrochloride tablets (trade name: Mucosolvan) Bromine concentration. Results: Ambroxol hydrochloride showed a one-compartment open model with first-order absorption in vivo. The Cmax of domestic oral solution and imported Mucosolvan tablets were 134.5 4 ± 43 .84 ng · ml-1 and 12 7.2 2 ± 36, respectively. 18ng · ml-1, tmax were 1.55 ± 0.64h and 1.71 ± 0.66h, t1 / 2 Ke were 7.06 ± 0.86h and 6.79 ± 1.10h respectively, Auco-t was 1488.5 9 ± 419.13 ng.g. Ml-1 and 140 6 .43 ± 36 0 .5 1 ng · h · ml-1. CONCLUSION: The relative bioavailability of ambroxol hydrochloride oral solution is 105.68% ± 11.70%. Three-way ANOVA and two-sided one-tailed t-test were used to choose Cmax and AUC0 ~ τ. The results showed that domestic oral solution and imported Mucosolvan Tablets Both formulations are bioequivalent.