摘要
目的比较溴吡斯的明分散片和市售普通片在兔体内的药动学参数,计算溴吡斯的明分散片的相对生物利用度。方法 12只新西兰大耳白兔采用随机交叉给药,单剂量口服60 mg溴吡斯的明分散片或普通片后,反相离子对色谱法测定血浆药物浓度,用DAS 2.1.1软件计算药动学参数及分散片相对生物利用度。结果溴吡斯的明分散片和普通片在兔体内的Cmax分别为(1.83±0.08)mg.L-1和(1.68±0.03)mg.L-1;tmax分别为(2.33±0.41)h和(2.58±0.20)h;AUC0-24分别为(15.50±0.62)mg.h.L-1和(15.14±0.30)mg.h.L-1;AUC0-∞分别为(15.82±0.70)mg.h.L-1和(15.57±0.32)mg.h.L-1;分散片相对生物利用度F0-24为102.38%和F0-∞为101.61%;经方差分析、双单侧t检验和非参数检验,两制剂在兔体内无显著性差异。结论溴吡斯的明分散片和普通片在兔体内生物等效。
Objective To compare the pharmacokinetic parameters of pyridostigmine bromide dispersible tablets and common tablets in rabbits.Methods Twelve rabbits were given an oral dose（60 mg） of pyridostigmine bromide dispersible tablets or common tablets in a randomized crossover study.The plasma concentration of pyridostigmine bromide was determined by reversed-phase ion pair chromatography.The pharmacokinetic parameters were calculated using DAS2.1.1 software.Results The pharmacokinetic parameters showed no significant differences in rabbit plasma between pyridostigmine bromide dispersible tablets and common tablets.The two tablets had a Cmax of 1.83±0.08 mg·L-1 and 1.68±0.03 mg·L-1,tmax of 2.33±0.41 h and 2.58±0.20 h,AUC0-24 of 15.50±0.62 mg·h·L-1 and 15.14±0.30 mg·h·L-1,AUC0-∞ of 15.82±0.70 mg·h·L-1 and 15.57±0.32 mg·h·L-1,respectively.The relative bioavailability F0-24 was 102.38% and F0-∞ was 101.61% for the dispersible tablets.Conclusion The two tablets are bioequivalent in rabbits.
出处
《南方医科大学学报》
CAS
CSCD
北大核心
2011年第10期1778-1780,共3页
Journal of Southern Medical University
基金
教育部博士点基金(20095503120008)
重庆市教育委员会资助项目(KJ090308)
关键词
溴吡斯的明
分散片
反相离子对色谱
生物等效性
pyridostigmine bromide
dispersible tablets
reversed-phase ion pair chromatography
bioequivalence
