氨糖美辛肠溶片在健康志愿者的生物等效性研究  

Study on Bioequivalence of Glucosamine Indometacin Enteric-coated Tablets in Healthy Volunteers

作　　者：赵侠[1] 王惠珍[1] 周颖[1] 孙培红[1] 刘玉旺[1] 赵东方[1] 孙忠民[1] 仲卫华[2] 

机构地区：[1]北京大学第一医院药剂科,北京100034 [2]首都儿科研究院,北京100020

出　　处：《中国临床药理学杂志》2003年第2期121-124,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:研究po氨糖美辛肠溶片在20名健康志愿者体内的相对生物利用度和生物等效性。方法:20名健康男性志愿者按双周期、随机交叉口服单剂量含吲哚美辛75 mg的试验和对照氨糖美辛肠溶片两种制剂,用HPLC法测定血清中吲哚美辛的浓度,并用3P97对试验数据进行统计处理。结果:单剂量口服试验及对照氨糖美辛肠溶片的C_(max)分别为4.685±1.168mg·L^(-1)和4.888±1.414 mg·L^(-1);t_(max)分别为2.9±1.2 h和3.4±0.9 h;AUC_(0-24)分别为20.468±3.461 mg·h·L^(-1)和20.415±4.777 mg·h·L^(-1);AUC_(0-∞)分别为22.908±3.884 mg·h·L^(-1)和23.151±5.509 mg·h·L^(-1);试验氨糖美辛肠溶片的相对生物利用度为(102.24±2.98)％。结论:两种氨糖美辛肠溶片具有生物等效性。OBJECTIVE:To study the relative bioavailability and bioequivalence of glucosamine indometacin enteric-coated tablets in 20 healthy volunteers. METHODS: A single administration of 75 mg test and reference glucosamine indometacin enteric-coated tablets were given to 20 healthy male volunteers in randomized crossover study respectively. A high performance liquid chromatographic was developed to determine the concentration of indometacin in human serum. The data were analyzed by 3P97 program. RESULTS: The pharmacokinetics parameters after a single oral administration of 75 mg test and reference products were as follows: Cmax were 4.685 ± 1.168 mg-L-1 and 4.888±1.414 mg·L-1; tmax were 2.9 ± 1.2 h and 3.4 ± 0.9 h; AUC0-24 were 20.468 A 3.461 mg·h·L-1 and 20.415 ± 4.777 mg·h·L-1; AUC0-∞ were 2.908 ± 3.884 mg·h·L-1 and 23.151 ± 5.509 mg·h·L-1 The relative bioavailability of single oral administration group was ( 102.24±12.98 ) %. CONCLUSION: The tested and refered glucosamine indometacin enteric-coated tablets were bioequivalence.

关 键 词：氨糖美辛肠溶片 健康志愿者 生物等效性 相对生物利用度 药代动力学 

分 类 号：R971.1[医药卫生—药品] R969.1[医药卫生—药学]