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YHB6211(recombinant human granulocyte-colony stimulating factor)의 토끼에서 국소자극성에 관한연구
최연식(Yeon Shik Choi),안경규(Kyoung Kyu Ahn),전재현(Jae Hyeon Juhn),이종성(Jong Sung Lee),문병석(Byoung Seok Moon),유광현(Kwang Hyun You) 한국독성학회 1999 Toxicological Research Vol.15 No.2
Local irritation of YHB6211, a recombinant human granulocyte-colony stimulating factor, was assessed in male New Zealand White (NZW) rabbits by dermal and ocular application. In the skin irritation test, 0.5 ml of 0.03% YHB6211 aqueous solution was applied to the back skin of rabbits for 24 hours, and subsequent observation was performed. The solution did not induce any response after the treatment, and the primary irritation index (P.I.I.) of the compound was 0. In the eye irritation test, 0.1 ml of the same solution was instilled into the conjunctiva of the eye. No treatment related reactions were observed at the cornea, iris, and conjunctiva. Based on these results, 0.03% (w/v) YHB6211 solution could be considered as a non-irritating material.
YHB216 의 비글개에서 정맥내 단회 및 4 주 반복투여독성시험
장호송(Hu Song Zhang),정은용(Eun Yong Jung),신지순(Ji Soon Sin),안경규(Kyoung Kyu Ahn),최연식(Yeon Shik Choi),강종구(Jong Koo Kang),노용우(Yong Woo Roh),지형진(Hyeong Jin Ji),강민정(Min Joung Kang),이종욱(Jong Wook Lee) 한국응용약물학회 2002 Biomolecules & Therapeutics(구 응용약물학회지) Vol.10 No.1
N/A Recently, recombinant human erythropoietin (rHu-EPO) has been used to treat various types of anemia. YHB216 is a new rHu-EPO developed by Yuhan Research Institute. In this study, we investigated the single dose and 4-week repeated dose toxicity of YHB216 in Beagle dogs. In the single dose toxicity study, YHB216 was administered intravenously at single dose levels of 0 and 25,000 IU/㎏ to dogs (2 dogs/sex/ group). There were no treatment-related changes in survivals, clinical signs, body weight gain, hematological values, blood chemical values, and necropsy finding during experimental period. In the repeated dose toxicity study, YHB216 was administered intravenously to dogs for 4 weeks at the dose levels of 0, 100, 500, and 2,500 IU/㎏ (3 dogs/sex/group). There were no toxicologically significant changes in clinical signs, body weights, food and water consumptions, ophthalmoscopy, urinalysis and blood chemistry. There were increased values of red blood cell, hemoglobin, and hematocrit at all treated groups. Spleen revealed increased weight and extramedullary hematopoiesis at 500 IU/㎏ or more. These changes are all considered to be pharmacology-related effects and were recovered after 4-week recovery period. From these results, it is concluded that LD_50 value was above 25,000 IU/㎏ in the single dose toxicity study of YHB216 in dogs and the no observed adverse effect level (NOAEL) was 100 IU/㎏/day in the repeated dose toxicity study of YHB216 in dogs.
임신토끼에 있어서 새로운 Recombinant Human Granulocyte Colony - Stimulating Factor ( YHB6211 ) 의 배 , 태자 발생독성평가
황재식(Zai Zhi Huang),이수해(Su Hae Lee),신지순(Ji Soon Sin),신장우(Jang Woo Sin),최연식(Yeon Shik Choi),김대중(Dae Joong Kim),장호송(Hu Song Zhang),정은용(Eun Yong Jung),서동석(Dong Suk Seo),안경규(Kyoung Kyu Ahn),남상윤(Sang Yoon N 한국응용약물학회 2001 Biomolecules & Therapeutics(구 응용약물학회지) Vol.9 No.4
N/A YHB6211, a newly developed recombinant human granulocyte colonystimulating factor, was administered at dose levels of 0, 3, 15, and 75 ㎍/㎏/day intravenously to the pregnant New Zealand White rabbits (20 rabbits per group) during the organogenetic period, days 6 to 18 of gestation. All dams were subjected to Caesarian section on day 28 of gestation and their fetuses were examined for external, visceral, and skeletal abnormalities. No abnormalities in clinical signs, body weight changes, gross findings, mortality, and external appearance were found in all dams and fetuses exposed to 0, 3, and 15 ㎍/㎏/day of YHB6211. However, in the group treated with 75 ㎍/㎏/day of YHB6211, maternal body and uterine weights, fetal body weights and length, and the number of live fetuses were significantly decreased and further fetal mortality was remarkably increased. It is suggested that YHB6211 may have no side effect up to the dose level of 15 ㎍/㎏/day, and there would be no teratogenicity for fetuses of rabbits up to 75 ㎍/㎏/day even if it may have some toxic effects over 75 ㎍/㎏/day for dams and fetuses of rabbits.