国产格列齐特片剂的生物利用度比较  

Relative bioavailability of gliclazide tablet in human

作　　者：陈妙英[1] 钟明康[1] 施孝金[1] 张静华[1] 

机构地区：[1]上海医科大学华山医院药剂科,上海200040

出　　处：《中国临床药学杂志》1999年第4期219-221,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的:研究不同厂家生产的两种格列齐特片剂在健康人体内的药物动力学和相对生物利用度.方法:采用HPLC测定10名志愿者单剂量po80mg格列齐特片剂后的血药浓度变化情况.结果:两种片剂的药物动力学参数:C_(max)分别为5.10和3.97μg/ml;t_(max)分别为3.55和3.97h;AUC分别为87.97和92.44(h·μg)/ml;T_(1/2).分别为10.74和10.76h.经统计学处理表明,两种片剂的AUC、C_(max)、T_(1/2)、t_(max)无差异.试验制剂对参比制剂的相对生物利用度为105.1%.结论:两种片剂具有生物等效.AIM: To study the relative bioavaiiabilities of 2 formulations (A and B) of gliclazide tablets in 10 healthy volunteers. METHODS: A single oral dose of 80 mggliclazide tablets was given orally according to an open randomized crossover test. The plasma concentration of gliclazide was determined by high performance liquid chromatography. RESULTS: The c_(max) of the tablet A and B were 5. 10 and 3. 97 μg/ml; the t_(max) 3. 55 and 3. 97 h; the AUC 87. 97 and 92. 44 (h · μg)/ml; the T1/2 10. 74 and 10. 76 h, respectively. There were no significant differences between A and B. The relative bioavailability of B was 105. 1%. CONCLUSION: The two formulations are bioequivalent.

关 键 词：格列齐特 高效液相色谱法 相对生物利用度 

分 类 号：R977.15[医药卫生—药品] R969.1[医药卫生—药学]