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《Journal of Shenyang Pharmaceutical University》 2015-06
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Phase I clinical research on pharmacokinetics of arginine ketoprofen injection

ZHAO Chun-yan;JIANG Chun-mei;ZHAO Li-li;XU Qiang;DENG Gang;LI Guo-xin;The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine;Yantai Justaware Pharmaceutical Co .;Suzhou Mac Well Bio-Med Sci & Tech Co .;  
Objective To observe the pharmacokinetic characteristics and the safety of arginine ketoprofen injection in healthy subjects,who were singly or successively intramuscular injected with arginine ketoprofen.Methods A three-doses,open,randomized,parallel and single center trials were adopted. Thirty. healthy subjects were singly injected with 50 mg,100 mg or 200 mg of arginine ketoprofen injection; the other 10 healthy subjects were injected with 50 mg of arginine ketoprofen injection,three times a day for 4 days.HPLC was used for testing the blood concentration. Results Main pharmacokinetic parameters( AUC0-24) after injected with 50 mg,100 mg or 200 mg of arginine ketoprofen injection were( 11. 796 ± 1. 713) mg·h·L- 1,( 21. 507 ± 4. 805) mg·h·L- 1and( 51. 802 ± 13. 537) mg·h·L- 1,respectively; t1 /2were( 1. 996 ± 0. 299) h,and( 3. 630 ± 1. 117) h,( 3. 147 ± 0. 919) h,respectively; tmaxwere( 0. 525 ± 0. 171) h,( 0. 533 ± 0. 125) h and( 0. 750 ± 0. 167) h,respectively; ρmaxwere( 6. 151 ± 1. 378) mg·L- 1,( 9. 961 ± 2. 549) mg·L- 1and( 20. 284 ± 4. 865) mg·L- 1,respectively. Pharmacokineticsparameters( AUCss) after successively injected with 50 mg of arginine ketoprofen injection was( 9. 572 ± 1. 958) mg·h·L- 1,Pharmacokinetic parameters( AUC0-24) was( 9. 984 ± 2. 067) mg·h·L- 1; t1 /2was( 2. 597 ± 0. 924) h,tmaxwas( 0. 417 ± 0. 088) h,ρmaxwas( 4. 994 ± 1. 252) mg·L- 1,accumulation factor R was( 1. 143 ± 0. 132). Conclusions The metabolism of ketoprofen shows linear phamacokinetics characteristics after singly injected with 50 mg,100 mg or 200 mg of arginine ketoprofen injection. No ketoprofen accumulation is observed in human body after successively injected with 50 mg of arginine ketoprofen injection.
【Fund】: 国家“十二五”重大新药创制项目:“中药新药临床评价研究技术平台”(2012ZX09303-017)
【CateGory Index】: R969.1
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