国产与进口复方L-谷氨酰胺颗粒剂在健康人体的生物等效性  

Bioequivalence of domestic and imported compound L - glutamyl granules in healthy volunteers

作　　者：李豫[1] 刘蕾[1] 李璐[2] 李可欣[1] 孙春华[1] 

机构地区：[1]卫生部北京医院药学部 [2]中国医学科学院肿瘤医院

出　　处：《中国临床药理学杂志》2005年第5期359-362,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价国产与进口复方L-谷氨酰胺颗粒剂在健康人体的生物等效 性。方法健康受试者单剂量口服受试制剂或参比制剂2 g,用高效液相色谱 -紫外检测法测定血清中奠磺酸钠浓度。结果经BAPP2．0程序处理,受试 制剂与参比制剂的萸磺酸钠tmax分别为(3．3±1．0)和(3．5±O．9)h;Cmax分别 为(224．．07±58．44)和(247．98±80．45)ng·mL-1;AUC0-t分别为(2646.37± 736．08)和(2795．45±788．32)ng·h·mL-1;t1/2分别为(13．38±1．47)和 (13．69±1．45)h。国产复方L-谷氨酰胺颗粒中的奠磺酸钠相对生物利用度 为(95．5±11．5)％。结论2制剂中奠磺酸钠具有生物等效性。Objective To study the bioequivalence of domestic and imported compound L - glutamyl granules in 18 healthy male volunteers. Methods A single oral domestic and imported compound L - glutamyl granules were given according to a randomized 2 - way crossover design. Serum sodium azulene - sulfonate was determined by HPLC - UV. Results The pharmacokinetic parameters of sodium azulene - sulfonate were as follow： tmax were （3.3±1.0） and （3.5±0.9） h, Cmax were （224.07 ± 58.44） and （247.98±80.45）ng·mL^-1, AUC0-t were （2646.37±736.08） and （2795.45± 788.32） ng ·h ·mL^- 1. The relative bioavaiability of sodium azulene - sulfonate were （95.5 ± 11.5 ） %. Conclusion The result demonstrated that two formations of sodium azulene -sulfonate were bioequivalence.

关 键 词：复方L-谷氨酰胺 奠磺酸钠 生物等效性 高效液相色谱-紫外 

分 类 号：R969.1[医药卫生—药理学] R975.6[医药卫生—药学]