摘要
目的评价国内不同厂家左氧氟沙星片的相对生物利用度和生物等效性。方法18名男性健康受试者采用随机、自身对照、交叉法单剂量口服两个不同厂家的左氧氟沙星片后,采用荧光检测器RP-HPLC测定血浆中左氧氟沙星浓度。结果单剂量口服200 mg左氧氟沙星受试和比对制剂后的达峰时间Tm ax分别为(1.03±0.67)和(0.93±0.38)h;峰值血药浓度Cm ax分别为(2363.29±552.13)和(2499.25±573.31)ng/m l;T1/2β分别为(5.57±0.92)和(6.04±0.55)h;MRT分别为(7.77±1.14)和(8.02±0.68)h;药时曲线下面积AUC(0→t)分别为(13790.96±2171.28)和(13894.83±1873.47)ng.h.m l-1。受试制剂的相对生物利用度F为(99.40±9.70)%。两种片剂Cm ax及AUC(0→t)通过双单侧t检验,药物动力学参数均无显著性差异(P>0.05),且均落在等效范围。结论两种制剂生物等效。
Objective To evaluate the relative bioavailability and bioequivalence of test levofloxacin tablets from different manufactures. Methods 18 male healthy volunteers orally took a single dose of 200 mg tablets in randamized self-crossover ways. The plasma concentration of levofloxacin was determined by RP-HPLC with fluorescent detector. Results The pharmacokinetic parameters of reference and test drugs were as follow : Tmax (1.03 ± 0.67) and (0.93 ± 0.38 )h;Cmax ( 2363.29 ± 552.13 ) and (2499.25 ± 573.31 ) ng/ml;T1/2β(5. 57 ±0.92) and (6.04 ±0.55) h;MRT (7.77 ± l, 14) and( 8.02 ±0.68 ) h; AUC(0→1) ( 13790.96 ± 2171.28 ) and ( 13894.83 ±1873.47 ) ng · h · ml^-1, respectively. The relative bioavailability of levofloxacin tablet was (99.40 ± 9.70 ) %. There was no statistical difference between levofloxacin tablet in pharmacokinetic parameters (P 〉 0.05 ). Conclusion Two preparations of levofloxacin tablets are bioequivalence.
出处
《现代食品与药品杂志》
2006年第4期40-42,共3页
JOurnal of Modern Food and Pharmaceuticals