摘要
目的:研究甲钴胺片在健康志愿者体内的相对生物利用度。方法:采用微生物法测定了20名健康受试者口服甲钴胺片和弥可保后不同时间血清中甲钴胺的浓度,采用面积法(△AUC0-72)估算了甲钴胺片相对生物利用度。结果:口服1500μg甲钴胺片和弥可保的tmax分别为(2.5±0.9),(2.4±1.2)h;Cmax分别为(322.1±198.9),(326.4±212.6)ng·L-1;t1/2分别为(21.0±5.2),(21.5±5.6)h。统计学处理结果,两剂型的药动学参数间差异均无显著性,受试制剂的相对生物利用度为(97.5±15.6)%。结论:两种制剂具有生物等效性。
OBJECTIVE To study the relative bioavailability of mecobalamin Tablets in healthy volunteers. METHODS An oral dose of 1 500 μg mecobalamin Tablets and 1 500μg methycobal were given to twenty healthy volunteers in a randomized crossover design, respectively. The drug concentrations were determined by the microbioassay method. RESULTS The main pharmacokinetic parameters were as follows：tmax were （2.5 ± 0. 9）, （2. 4 ± 1.2） h;Cmax were （322.1 ± 198.9）, （326. 4 ± 212. 6） ng·L^-1;t1/2 were （21.0 ± 5.2）, （21.5 ± 5.6） h, respectively. The statistic results showed no significant difference between the above two preparations. CONCLUSION The two preparations are bioequivalent.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2006年第4期393-394,共2页
Chinese Journal of Hospital Pharmacy
关键词
甲钴胺片
弥可保
生物利用度
mecobalamin tablets
methycobal
bloavailability
