Biomolecules & Therapeutics

The Korean Society of Applied Pharmacology (한국응용약물학회)
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Toxicity Study of a New PEG-hemoglobin SB1, a Red Blood Cell Substitute: Single Intravenous Administration in Beagle dogs

새로운 혈액대용제제 PEG-헤모글로빈 SB1의 개에 대한 단회정맥투여 독성시험

  • 한정희 (한국화학연구원 부설 안전성평가연구소) ;
  • 차신우 (한국화학연구원 부설 안전성평가연구소) ;
  • 김종춘 (한국화학연구원 부설 안전성평가연구소) ;
  • 기충용 (한국화학연구원 부설 안전성평가연구소) ;
  • 이미가엘 (한국화학연구원 부설 안전성평가연구소) ;
  • 노광 (선바이오(주))
  • Published : 2002.06.01
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Abstract

This study was performed to investigate the acute toxicity of PEG-hemoglobin SB1, a blood substitute, in beagle dogs. The male and female dogs were administered intravenously at the doses of 0.4375, 0.875 and 1.75 g/kg body weight, respectively. After a single intravenous administration of SB1 to dogs, we observed them daily for 2 weeks. SB1 did not induce any toxic signs in the mortalities, clinical signs, body weight changes, and gross necropsy findings of dogs. Based on these results, acute toxicity, dogs SB1 may have no side effect and its $LD_{50}$ value may be over 1.75 g/kg (25 ml/kg) of body weight in dogs.

Keywords

References

  1. Baldwin, A. L., Wilson, L. M. and Valeski, J. E. (1998). Ultra-strucural effects of intravascularly injected polyethylene glycol-hemoglobin in mtestinal mucosa. Am. J. Physiot., 275,H615-625
  2. Phillips, W. T., Klipper, R. W., Awasthi, V. D., Rudolph, A. S., Cliff, R., Kwasiborski, V. and Goins, B. A. (1999). Polyelh-ylene glycol-modified liposome-encapsulated hemoglobin:a long circulating red cell substitute. J. Pharmacol. Exp. Ther., 288, 665-670
  3. Sakaguchi, K., Miyauchi, Y., Suzuki, K. and Takahashi, A. (1991). A effects on the Neo Red Cell on the blood coagu-lation system and the complement system. Jpn. J. Artif. Oreans, 20, 620-625
  4. Sweeney, M. I., Yager, J. Y, Walz, W. and Juurlink, B. H (1995). Cellular mechanisms involved in brain ischemia. Can. J. Physiol. Pharmacol., 73, 1523-1535
  5. Shin, H., Shim, H., Yu, S., Kim J., Yang, S. and Chung, M. (2000). Pharmacokinetics of a New PEG-hemoglobin SBl for single intravenous administration to rats. Yakhak Hoeji, 44, 232-236
  6. Takahashi, A. (1995). Characterization of Neo Red CeIIs (NRCs), their function and safety in vivo tests. Artif. CeIIs Blood Substit. Immobil. Biotechnol., 23, 247-254
  7. Usuba, A., Motoki, R., Sakaguchi, K., Suzuki, K. and Kami-tani, T. (1994). Effect of neo red ceIIs on the hemodynam-ics and blood gas transport in canine hemorrhagic shock and its safety for vital organs. Artif. Cells Blood Substit. ImmobiI. BiotechnoI., 22, 503-506 https://doi.org/10.3109/10731199409117878
  8. Usuba, A., Motoki, R., Ogata, Y., Suzuki, K. and Kamitani, T. (1995). Effect and safety of liposome-encapsulated hemo-globin Neo Red CeIIs (NCRs) as a perfusate for total car-diovascular bypass. Artif. Cells BIood Substit. Immobil. Bio-technol., 23, 337-346 https://doi.org/10.3109/10731199509117950
  9. Yager, J. Y. and Thornhill, J. A. (1997). The effect of age on susceptibility to hypoxic-ischemic brain damage. Neurosci. Biobehav. Rev., 21, 167-174 https://doi.org/10.1016/S0149-7634(96)00006-1
  10. 식품의약품안전청고시 제1999-61호 의약품등의 독성시험기준, 식품의약품안전청 (1999. 12. 22.제정)