摘要
目的研究司帕沙星分散片的人体内外相关性。方法应用RCZ-8A智能药物溶出仪测定司帕沙星分散片的溶出速率;用反相HPLC法测定人血清中的司帕沙星浓度,3P97软件计算药动学参数,并考察体内外参数之间的线性关系。结果18名健康志愿者单剂量口服司帕沙星分散400mg后,其体内过程符合一级吸收模型,其AUC0→∞,Cmax,tmax分别为(22.05±2.04)h.μg. ml-1,(1.51±0.16)μg.ml-1,(1.66±0.15)h;在4h内片剂平均累积溶出100%。结论将体外释放百分率即溶出度(F)对体内吸收分数(f)回归得回归方程为:f=1.0767F-9.2968,r=0.9892(P<0.05),其体内外存在显著相关性。
Objective To study the relationship between in vitro dissolution and in vivo absorption of Sparfloxacin dispersible tablets tablets. Methods rFhe dissolution of Sparfloxacin dispersible tablets was determined by RCZ - 8A dissolution tester. Spartloxacin concentration in serum was determined by HPLC and its pharmaeyokinetics parameters were obtained by 3P97 software. Results After a single dose of sparfloxacin tablets was given to each of 18 voltmteers,the pharmacyokinetics parameter, AUC0→∞ ,Cmax and tmax of Sparfloxacin dispersible tablets were （22.05 ± 2.04）h.μg.ml^-1 ,（1.51 ± 0.16） μg.ml^-1, （1.66 ± 0.15）h respectively. The dissolution of the tablets was 100% within 4h. Conclution The in vivo absorption of Sparfloxacin dispersible tablets is significantly positively related with its in vitro dissolution.
出处
《华南国防医学杂志》
CAS
2005年第4期9-11,共3页
Military Medical Journal of South China
关键词
司帕沙星分散片
溶出度
生物利用度
体内外相关性
Sparfloxacin dispersible tablet
HPLC
Bioavailability
in vivo- in vitro correlation
