安普索口服液与片剂的药代动力学参数比较  

Comparison of the pharmacokinetics of ambroxol tablet and oral sulotion (Losolvan)

作　　者：宋维舒 程远远[2] 

机构地区：[1]177医院放射治疗科,广东广州510000 [2]暨南大学医学院第一附属医院临床药理室,广东广州510630

出　　处：《第一军医大学学报》2000年第5期420-421,共2页Journal of First Military Medical University

摘　　要：目的 测定8名健康志愿者单剂量口服30 ml乐舒痰口服液（含安普索3 mg/ml）或90 mg安普索片剂后的血药浓度变化情况。方法 采用反相高效液相色谱法。结果 安普索在体内的转运和分布呈一房室模型，口服液与片剂的Tmax分别为（1.95(0.66）和（2.03(0.98）h，Cmax分别为（161.7(39.3）和（166.9(35.5） ng/ml，t1/2分别为（5.89(1.48）和（5.32(1.57）h，AUC分别为（1 699.9(252.0）和（1637.7(262.4） ngh/ml。经统计学检验，差异均无显著性（P>0.05）。口服液与片剂的相对生物利用度为104.6%。结论 两药剂是生物等效制剂。Objective and Method To determine the changes of the plasma concentrations of ambroxol in 8 volunteers after the administration of single oral dose of 30 ml Losolvan solution (3 mg/ml) or 90 mg ambroxol tablets by using reverse phase high performance liquid chromatography (RP-HPLC). Results The pharmacokinetics of ambroxol conformed to one-compartment model. Tmax of the oral solution and tablets were (1.95(0.66) and (2.03(0.98) h respectively, Cmax were (161.7(39.3) and (166.9(35.5) ng/ml, t1/2 were (5.89(1.48) and (5.32(1.57) h , and the area under concentration-time curve (AUC) were (1 699.9( 252.0) and (1 637.7(262.4) ngh/ml, which all showed no significant difference by statistical analysis (P>0.05). The relative bioavailability of the solution was 104.6%. Conclusion These 2 preparations were bioequivalent.

关 键 词：高效液相色谱法 安普索 药代动力学 口服液 片剂 

分 类 号：R965[医药卫生—药理学]