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재조합 사람 과립구 콜로니 자극인자인 CJ50001 의 중합체의 생물학적 활성과 급성독성에 관한 연구
하석훈(Suk Hoon Ha),이현수(Hyun Soo Lee),김기완(Ki Wan Kim),정종상(Jong Sang Sang),김달현(Dal Hyun Kim),임동문(Dong Moon Lim),김종호(Jong Ho Kim),조효진(Hyo Jin Cho),고형곤(Hyung Kon Ko) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.1
CJ50001 is a recombinant human granulocyte colony-stimulating factor (rHuG-CSF) that stimulates the formation of neutrophils from bone marrow stem cells. It was produced in E. coli and purified through refolding and several processes. We produced CS970125(300) using purified CJS0001 and additives in order to test the stability of CJ50001. When CS970125(300) was stored at 50℃ for more than 1 week, high molecular weight proteins were formed and those proteins were detected by non-reducing SDS-PAGE, gel filtration HPLC, and Western blot. Those proteins showed single band at the same position of CJ50001 in reducing SDS-PAGE. These data indicated that those high molecular weight proteins were the multimers of CJ50001. In biological assays, in vitro and in vivo, the multimers did not have biological activity and inhibitory action to that of CJ50001. The mutimers did not induce toxicity in mice and rats in acute toxicity test. These results suggest that if CS970125(300) containing CJ50001 is stored at 50℃, CJ50001 will be the multimers that do not have biological activity and inhibitory effect to CJ50001 and do not induce acute toxicity.
CJ-50001 (recombinant human granulocyte-colony stimulating factor) 의 흰주와 개에서의 약물동태학적 연구
김성남(Sung Nam Kim),신재규(Jae Kyu Shin),이수정(Soo Jung Lee),정용환(Yong Hwan Jung),하석훈(Suk Hoon Ha),김기완(Ki Wan Kim),고형곤(Hyung Kon Koh),김제학(Je Hak Kim) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.4
The pharmacokinetics of CJ-50001 (recombinant human granulocyte-colony stimulating factor, developed by R&D center of Cheil Jedang Corp.) were investigated in rats and dogs. The serum concentrations of CJ-50001 were measured by a sandwich enzyme immunoassay. After single intravenous (iv) administration of CJ-50001 to rats at a dose of 5 ㎍/kg, the mean terminal half-life and area under the concentration-time curve (AUC) were 0.96 h and 124.49 ㎍·/ml, respectively. After single subcutaneous (sc) administration at the same dose, maximum serum concentration was observed at about 2 hours after administration, and the mean terminal half-life, AUC and the bioavailability were 1.11 h, 63.58 ㎍·h/ml and 51.07%, respectively. In repeated dosing studies, CJ-50001 was administered iv and sc to rats at a daily dose of 5 ㎍/kg for 7 days. The pharmacokinetic parameters, such as mean AUC and terminal half-life, were not significantly different from those of single administration. Following single iv and sc administration of CJ50001 to dogs at a dose of 5 ㎍/kg, mean AUCs were much higher than those of rats, due to the decreased clearence (CL). After sc administration to dogs, maximum serum concentration was observed at 2∼4 hours after administration and the bioavailability was 54.60%.
유전자 재조합 B 형 간염 바이러스 표면 항원 , CJC-50100 의 일반약리작용
정성학(Seong Hak Jeong),최재묵(Jae Mook Choi),이남중(Nam Jung Lee),전형수(Hyung Soo Jeon),김연희(Yon Hee Kim),김재승(Jae Seung Kim),하석훈(Suk Hoon Ha),김영훈(Young Hoon Kim),이나경(Na Gyung Lee),김제학(Je Hak Kim),박완제(Wan Je Park 한국응용약물학회 2001 Biomolecules & Therapeutics(구 응용약물학회지) Vol.9 No.1
N/A CJC-50100 is a recombinant hepatitis B virus surface antigen (HBsAg) expressed in yeast. The general pharmacological properties of CJC-50100 were evaluated in mice, rats, dogs and isolated guinea pig ileum. The doses were 0.33∼33.3 ㎍/㎏ i.m. for mice and rats and 3.3∼9.9 ㎍/㎏ i.v. for dogs. The concentrations of 0.002∼0.02 ㎍/mlwere used for the assay with guinea pig ileum. Intramuscular administration of CJC-50100 at the doses did not alter general behavior and the responses for central nervous system, smooth muscle, gastrointestinal system, cardiovascular and respiratory system, and water and electrolytes excretion. In summary, CJC-50100 had no pharmacological effect in these studies even up to the 100-fold of the expected clinical dose, 20 ㎍/man/60 kg.