摘要
目的对18名健康志愿者单剂量口服两种氟康唑胶囊后的血药浓度经时过程以及两者的生物等效性进行评价。方法采用LC/M S法测定人血浆中氟康唑浓度,18名健康受试者随机分组、自身交叉口服单剂量600m g氟康唑受试制剂和参比制剂进行生物等效性评价。结果采用3P 97计算两制剂的主要药动学参数:cm ax分别为(9315±1527)和(8928±1583)μg/L,Tm ax分别为(1.9±0.7)和(2.0±0.7)h,t1/2分别为(32.4±6.1)和(32.6±6.4)h,用梯形法计算,AUC0-t分别为(358749±75003)和(345997±78438)μg.h/L,AUC0-∞分别为(415346±101655)和(401636±100638)μg.h/L。结论两种氟康唑胶囊具有生物等效性。
Objective To observe the concentration-time process of fluconazole capsules in 18 healthy volunteers and evaluate the bioequivalence of two kinds of fluconazole capsules. Methods The plasma concentrations of fluconazole were determined by LC/MS method. Eighteen healthy human volunteers were randomly divided into two groups, and a cross-over single oral dose of 600 mg fluconazole of test capsule and reference one were delivered, respectively. Results The main pharmarcokinetic parameters of two preparations calculated by 3p97 software were as follows： cmax were （9315± 1527） and （8928±1583）μg/L, Tmax were （1.9±0.7） and （2.0±0.7）h, t1/2 were （32.4±6. 1） and （32.6±6.4）h, AUC0-1, were （358749±75003） and （345997±78438） μg · h/L, AUC0-∞ were （415346± 101655）and （401636± 100638） μg · h/L by using trapezoid method respectively. Conclusion The two preparations of fluconazole are bioeqivaient.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2007年第2期120-122,I0001,共4页
Chinese Journal of Antibiotics
基金
辽宁省"十一五"教育科学规划立项(编号为46-25)
