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目的建立人血浆中氟康唑含量测定的高效液相方法,并对供试制剂和参比制剂的生物等效性进行了评价。方法20名男性健康受试者,按双交叉设计,随机单剂量口服受试制剂和参比制剂氟康唑片300mg,分别于服药前和服药后多个时间点抽血测定。采用高效液相法测定血药浓度,并评价两种制剂的生物等效性。结果口服300mg氟康唑片受试和参比制剂后,t1/2分别为(29.98±4.79)h和(30.60±4.66)h,tmax分别为(1.9±0.3)h和(1.9±0.6)h;Cmax分别是(7.64±0.98)μg/ml和(7.93±0.78)μg/ml。用面积法AUC0-τ和AUC估算氟康唑片受试制剂的相对生物利用度F1和F2分别为(94.9±11.3)%和(94.8±11.9)%。结论试验制剂和参比制剂等效。
Objective To establish a high performance liquid phase method for the determination of fluconazole in human plasma and to evaluate the bioequivalence of test preparations and reference preparations. Methods Twenty healthy male subjects were randomized to receive a single oral dose of 300 mg fluconazole and a single oral dose of fluconazole. The blood samples were taken before and after taking the drug at different time points. The plasma concentration was determined by high performance liquid chromatography and the bioequivalence of the two preparations was evaluated. Results After oral administration of 300 mg fluconazole tablets and reference preparations, the t1 / 2 values were (29.98 ± 4.79) h and (30.60 ± 4.66) h, respectively, with tmax values of (1.9 ± 0.3) h and (1.9 ± 0.6) h ; Cmax were (7.64 ± 0.98) μg / ml and (7.93 ± 0.78) μg / ml, respectively. The relative bioavailabilities F1 and F2 of fluconazole tablets were estimated to be (94.9 ± 11.3)% and (94.8 ± 11.9)%, respectively, using the area method AUC0-τ and AUC. Conclusion The test preparation and the reference preparation are equivalent.