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논문 상세정보

Abstract

LBD-001, a recombinant human interferon $\gamma$ produced by genetically engineered yeast as a host system, was intravenously administered to pregnant female rabbits (New Zealand White strain) from day 6 to 18 of gestation at dose levels of $0.35 \times 10^6$, $0. 69 \times 10^6$, and $1.38 \times 10^6$ I.U./kg/day. Hydrocortisone sodium succinate (0.3 mg/kg/day) was also given in the same way. Teratological effects of the test agents on the organogenesis of fetuses and the development of offsprings (F1 rabbits) were investigated. The results were as followings: (1) No significant changes by the treatment of LBD-001 or hydrocortisone sodium succinate were observed in the body weights, the food and water consumption, the lactating or nurshing behaviors, and the autopsy of the pregnant rabbits. (2) No significant changes in the resorption rate, the fetal organogenesis, and the normal develpoment of offsprings (F1) by the treatment of LBD-001 or hydrocortisone sodium succinate were detected. The results show that LBD-001 at the dose of $1.38 \times 10^6$ I.U./kg/day or less and hydrocortisone sodium succinate at the dose of 0.3 mg/kg/day are neither teratogenic in the organogensis of the fetuses and the development of the offsprings (F1) nor toxic to the mother rabbits.

참고문헌 (11)

  1. Teratological study of LBD-001, a recombinant interferon γ, in rats , Cho, S.I.;Lee, E.B. , J. Appl. Pharmacol / v.4,pp.301-309, 1996
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  4. Teratological studies on betamethasone 17-benzoate (MS-1112), Ⅱ. Teratogenecity and reproduction tests in rabbits , Ishimura, K.;Honda, Y.;Neda, K.;Ishikawa I.;Otawa, T.;Kawaguchi, Y.;Sato, H.;Henmi, Z. , Pharmacometrics / v.10,pp.685-694, 1975
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  6. Fertility study of LBD-001, a recombinant human interferon γ, in rats , Lee, E.B.;Cho, S.I. , J. Appl. Pharmacol / v.4,pp.297-300, 1996
  7. National Institute of Safety Research of Korea , Toxicity test guidelines for drugs / v.,pp.36, 1986
  8. Induction of cleft palate in rabbits by several glucocorticoids , Walker, B.E. , Pro. Soc. Exp. Biol. Med. / v.125,pp.1281-1284, 1967
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  10. Test methods for assessing female reproductive and developmental toxicology , Manson, J.M.;Zenick, H.;Costlow, R.D.;Hayes, A., W.(eds) , Principles and Methods of Toxicology(3rd edition) / v.,pp.989-1037, 1994
  11. Reproduction studies of prednisolone 17-valproate 21-acetate (2) Teratological study in rabbits , Koga, T.;Ota, T.;Aoki, Y.;Suganuma, Y. , Pharmacometrics / v.20,pp.87-98, 1980

이 논문을 인용한 문헌 (1)

  1. 1997. "" 한국독성학회지 = The Korean journal of toxicology, 13(1): 175~182 

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