Toxicological Research
- 제14권3호
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- Pages.393-400
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- 1998
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- 1976-8257(pISSN)
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- 2234-2753(eISSN)
DA-3585(recombinant human erythropoietin)의 국소자극성에 관한 연구
Studies on Local Irritation of DA-3585, A Recombinant Human Erythropoietin, in Rabbits
- 조현 (동아제약(주) 연구소) ;
- 김동환 (동아제약(주) 연구소) ;
- 강경구 (동아제약(주) 연구소) ;
- 박장현 (동아제약(주) 연구소) ;
- 이성희 (동아제약(주) 연구소) ;
- 김원배 (동아제약(주) 연구소)
- Cho, Hyeon (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
- Kim, Dong-Hwan (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
- Kang, Kyung-Koo (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
- Park, Jang-Hyeon (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
- Lee, Sung-Hee (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
- Kim, Won-Bae (Research Laboratories, Dong-A Pharm. Co., Ltd.)
- 발행 : 1998.09.01
초록
As a series of safety studies on DA-3585, a recombinant human erythropoietin, its local irritancy was examined in rabbits after the following treatments; application into the conjunctival sac of the eye(single), subcutaneous injection (single and -day repeated)and intravenous injection (7-day repeated.)In addition, perivascular irritation of DA-3585 was investigated in mice. In the result of ocular irritation test, 10,000IU/ml solution of DA-3585 could be considered as a non-irritating material. The local irritation of DA-3585 by a single and 7-day repeated subcutaneous injection was negligible and not so much different from that of saline. In the vascular irritancy test, macro-and microscopic observations revealed that local irritation of DA-3585 was comparable to that of saline when injected into retroauricular vein of rabbits for 7 consecutive days. Furthermore the perivascular administration of DA-3585 upto the concentration of 10,000 IU/ml did not induce any morphological abnormalities at injection sites. The results obtained from the present study suggest that the local irritancy of DA-3585 is not different from that of saline when injected through intravenous or subcutaneous route for clinical practice.