国产左氧氟沙星片的人体生物等效性研究Study on bioequivalence of levofloxacin tablets in healthy volunteers
张鹏,李小川,廉江平,丁元
ZHANG Peng,LI Xiao-Chuan,LIAN Jiang-Ping,Ding Yuan (Department of Pharmacy
摘要(Abstract)：
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 : T_(max)(1.03±0.67) and(0.93±0.38)h;C_(max)(2363.29±552.13) and(2499.25±573.31) ng/ml;T_(1/2β)(5.57±0.92) and(6.04±0.55)h;MRT(7.77±1.14) and(8.02±0.68)h;AUC_((0→t))(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.
关键词(KeyWords)：
左氧氟沙星;生物利用度;生物等效性;荧光;高效液相色谱法
levofloxacin;bioavailability;bioequivalence;fluorescent detector;HPLC
基金项目(Foundation):
作者(Author):
张鹏,李小川,廉江平,丁元
ZHANG Peng,LI Xiao-Chuan,LIAN Jiang-Ping,Ding Yuan (Department of Pharmacy
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