盐酸甲氯芬酯胶囊在健康受试者体内血药浓度测定及生物等效性研究

目的:建立对氯苯氧乙酸血药浓度的HPLC测定法,用于人体生物等效性研究.方法:采用随机双交叉实验设计,20名男性健康受试者分别单次口服受试制剂和参比制剂 200 mg,用HPLC法测定对氯苯氧乙酸的血药浓度.结果:受试制剂和参比制剂的AUC0-τ分别为(33.28±8.16) 和(33.08±7.87)μg·h·ml-1;AUC0-∞分别为(34.92±7.80)和(34.08±7.85)μg·h·ml-1;Cmax分别为(12.62±2.79)和(12.55±2.83)μg·ml-1;tmax分别为(2.11±0.37)和(2.07±0.32)h;t1/2分别为(6.01±2.86)和(6.12±2.74)h.受试制剂的相对生物利用度为(101.2±12.7)%.经统计学检验,两制剂的AUC0~∞、Cmax、tmax、t1/2差异无统计学意义(P>0.05).结论:受试制剂和参比制剂具有生物等效性.

Determination of Meclofenoxate Hydrochloride Capsules in Human Plasma by HPLC and Bioequivalence Study

Objective: To establish a method to study the relative bioavailability of chlorophenoxyacetic acid in Chinese healthy volunteers.Method: Twenty male healthy volunteers were received 200 mg meclofenoxate hydrochloride capsules orally in a random crossover design.Chlorophenoxyacetic acid concentrations in plasma were determined by HPLC.Result: The main pharmacokinetic parameters of test and reference capsules were as follows: AUC 0~τ of(33.28±8.16) and(33.08±7.87)μg·h·ml-1,AUC0~∞ of(34.92±7.80) and(34.08±7.85)μg·h·ml-1,Cmax of(12.62±2.79) and(12.55±2.83)μg·ml-1,tmax of(2.11±0.37) and(2.07±0.32) h,t1/2 of(6.01±2.86) and(6.12±2.74) h.The relative bioavailability of the test capsules was(101.2±12.7) %.Conclusion: The results demonstrate that the test and reference capsules are bioequivalent.