盐酸氨溴索口腔崩解片的人体生物等效性研究  

Study on Bioequivalence of Ambroxol Hydrochloride Oral Disintegrating Tablets in Healthy Volunteers

作　　者：陈白莹[1] 夏铮铮[2] 常宏[1] 

机构地区：[1]南方医科大学附属深圳市妇幼保健院药剂科,广东深圳518028 [2]香港大学深圳医院药学部,广东深圳518053

出　　处：《中国药房》2013年第22期2070-2072,共3页China Pharmacy

摘　　要：目的:对生产工艺重大改变前、后盐酸氨溴索口腔崩解片在健康人体的生物等效性进行对比研究。方法:20名健康男性受试者按交叉试验设计方案分别口服受试制剂和参比制剂各30mg,采集服药后48h内的动态血标本,以普拉克索为内标,采用液-质联用(LC-MS)法测定血浆中盐酸氨溴索的质量浓度,并用DAS2.0软件统计分析药动学参数。结果:参比制剂和受试制剂药动学参数分别为:cmax(84.96±32.46)、(90.86±44.81)ng/ml,tmax(1.7±0.7)、(1.4±0.3)h,AUC0-48h(678.85±235.17)、(663.87±214.37)ng.h/ml,t1/2(9.8±1.9)、(9.7±2.0)h,主要药动学参数无显著性差异。结论:生产工艺重大改变前、后生产的两种制剂生物等效。OBJECTIVE： To study the bioequivalence of Ambroxol hydrochloride oral disintegrating tablets in healthy volun- teers after significant change of manufacturing technology. METHODS ： Test preparation and reference preparation each 30 mg were given to 20 male healthy volunteers in randomized two-way crossover design. Blood samples were collected within 48 h after medi- cation using pramipexole as internal standard. Plasma concentrations of ambroxol hydrochloride were determined by LC-MS, and pharmacokinetic parameters were analyzed using DAS 2.0 software. RESULTS： The pharmaeokineties parameters of test prepara- tion and reference preparation were as follows： Cmax（84.96 ±32.46）ng/ml and （90.86 ± 44.81） ng/ml; tmx（1.7 ± 0.7） h and （1.4 ± 0.3） h; AUC0-48 b（678.85 ± 235.17） ng·h/ml and （663.87 ± 214.37）ng·h/ml;t1/2（9.8 ± 1.9） h and （9.7 ± 2.0）h, respectively. There was no significant difference in main pharmacokinetic parameters of them. CONCLUSIONS： Two preparations are bioequivalent af- ter significant change of manufacturing technology.

关 键 词：盐酸氨溴索 液-质联用法 药动学 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R378.2[医药卫生—药学]