头孢克洛颗粒剂在男性健康志愿者体内的生物等效性评价  

Bioequivalence of cefaclor granula in healthy male volunteers

作　　者：李晋峰 沙莹 李佩琼[2] 王九辉[2] 林明琴[2] 

机构地区：[1]海口市制药厂有限公司,海南海口570311 [2]海南医学院药理学教研室,海南海口571101

出　　处：《中国医院药学杂志》2014年第5期353-355,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的:评价头孢克洛颗粒剂在男性健康志愿者体内的生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服给药。采用HPLC法测定给药前及给药后不同时间点头孢克洛的血清药物浓度。利用DAS 2.0软件计算药动学参数和进行统计分析。结果:参比制剂与试验制剂的主要药动学参数tmax、Cmax、AUC05和AUC0∞分别为(0.68±0.12)h和(0.68±0.12)h;(12.22±2.80)μg·ml-1和(11.70±2.65)μg·ml-1;(14.33±3.12)μg·ml-1·h和(13.65±2.72)μg·ml-1·h;(14.58±3.20)μg·ml-1·h和(13.88±2.79)μg·ml-1·h。两制剂主要药动学参数统计学分析无显著性差异。试验制剂AUC05、AUC0∞和Cmax的90%可信区间分别为88.3%-104.3%、88.1%-104.6%和90.1%-102.4%。结论:试验制剂与参比制剂生物学等效。OBJECTIVE To evaluate the bioequivalence of cefaclor granules in healthy male volunteers. METHODS In a randomized crossover study, 20 healthy male volunteers were given a single oral dose of cefaclor. The serum concentrations of cefaclor before and after administration at different time points were determined by HPLC. The pharmacokinetic parameters were calculated and a statistical analysis using DAS 2.0 software program. RESULTS The main pharmacokinetic parameters of reference and test preparation tmax ,Cmax, AUC0-5 and AUC0-∞ were （0. 68 ± 0. 12）h and （0.68 ± 0. 12） h, （12.21 ± 2. 80）μg. ml^1 and （ 11.70 ±2.65 ）μg. ml^1, （ 14. 33 ± 3. 12）μg. ml^1. h and （ 13.65 ± 2. 72 ） μg. ml^1 - 1 ~ h, （ 14. 58 ± 3. 20 ）μg. ml^1 - 1 . h and （13.88 ± 2. 79）μg. ml^1. h. The statistical analysis showed that the main pharmacokinetic parameters between test and refer ence preparations were no significant differences. The 90% confidence interval of tested preparations Cmax, AU0-∞ and AUC0-∞were 88.3%o - 104. 3% , 88. 1% - 104. 6% and 90. 1% - 102. 4%. CONCLUSION The test and reference prepara tions were bioequivalent.

关 键 词：头孢克洛 高效液相色谱法 生物等效性 

分 类 号：R969.1[医药卫生—药理学]