盐酸氨溴索口腔崩解片的生物等效性研究  

Study of bioequivalence of Ambroxol Hydrochloride Orally Disintegrating Tablets

作　　者：薛洪源[1] 杨汉煜[2] 贺文涛[1] 王宇奇[1] 贾丽霞[1] 

机构地区：[1]白求恩国际和平医院临床药理室,石家庄050082 [2]石药集团中奇制药技术有限公司,石家庄050011

出　　处：《医药导报》2010年第1期27-30,共4页Herald of Medicine

摘　　要：目的研究盐酸氨溴索口腔崩解片的人体生物利用度和生物等效性。方法采用随机交叉试验设计,20例健康男性志愿者单剂量口服试验制剂盐酸氨溴索口腔崩解片和参比制剂盐酸氨溴索片各60mg,用高效液相色谱-串联质谱法测定血浆中氨溴索的浓度,计算两药的药动学参数。结果单剂量口服试验制剂和参比制剂后氨溴索的Cmax分别为(84.7±29.3)和(81.2±28.2)ng·mL-1,tmax分别为(1.7±0.5)和(1.8±0.4)h,t1/2分别为(7.9±0.9)和(8.3±1.0)h,AUC0～24h分别为(638.7±180.8)和(591.4±148.3)ng·h·mL-1,试验制剂的相对生物利用度为(108.2±16.5)%。结论试验制剂与参比制剂具有生物等效性。Objective To study the bioequivalence and relative bioavailability of ambroxol hydrochloride orally disintegrating tablets. Methods 20 healthy male volunteers were taken a single oral administration of 60 mg test and reference tablets, respectively, according to a randomized crossover design. The plasma concentrations of ambroxol were determined by a HPLC/MS/MS method. The pharmacokinetic parameters of the two tablets were calculated. Results C of a single dose of test and reference tablets were （84.7±29.3） and （81.2±28.2） ng·mL^-1,tmax were （1.7±0.5） and （1.8±0.4） h, t1/2 were （7.9 ± 0.9 ） and （ 8.3 ± 1.0） h, A UC0-24 h were （ 638.7 ± 180. 8 ） and （59 1. 4 ± 148.3 ） ng ·h· mL^-1 , respectively. The relative bioavailability of the test tablets was （ 108.2 ± 16.5 ） %. Conclusion The two preparations are bioequivalent.

关 键 词：氨溴索 盐酸 口腔崩解片 生物利用度 相对 生物等效性 药动学 液相色谱-串联质谱法 

分 类 号：R974[医药卫生—药品]