Subacute Transdermal Toxicity Study of Syndella gel, Topical Drug Containing Deproteinised Dialysate of Calf's Blood and Micronomicin sulfate, in Rats

흰쥐에서 신델라 겔 (송아지 제단백혈액추출물 : 황산미크로노마이신=20:1 복합제제)의 30일간 반복투여 경피독성시험

  • Nam, Suk-Woo (College of Pharmacy, Sung Kyun Kwan University) ;
  • Sung, Dae-Suk (College of Pharmacy, Sung Kyun Kwan University) ;
  • Yoo, Se-Keun (College of Pharmacy, Sung Kyun Kwan University) ;
  • Chang, Man-Sik (Central Research and Development Laboratories, Yungjin Pharmaceutical Co., Ltd.) ;
  • Choi, Wahn-Soo (Central Research and Development Laboratories, Yungjin Pharmaceutical Co., Ltd.) ;
  • Chung, Young-Kuk (Central Research and Development Laboratories, Yungjin Pharmaceutical Co., Ltd.) ;
  • Kim, Kyu-Bong (Central Research and Development Laboratories, Yungjin Pharmaceutical Co., Ltd.) ;
  • Han, Jeung-Whan (College of Pharmacy, Sung Kyun Kwan University) ;
  • Hong, Sung-Youl (Department of Genetic Engineering, Sung Kyun Kwan University) ;
  • Lee, Hyang-Woo (College of Pharmacy, Sung Kyun Kwan University)
  • 남석우 (성균관대학교 약학대학) ;
  • 성대석 (성균관대학교 약학대학) ;
  • 유세근 (성균관대학교 약학대학) ;
  • 장만식 (영진약품공업(주) 중앙연구소) ;
  • 최완수 (영진약품공업(주) 중앙연구소) ;
  • 정영국 (영진약품공업(주) 중앙연구소) ;
  • 김규봉 (영진약품공업(주) 중앙연구소) ;
  • 한정환 (성균관대학교 약학대학) ;
  • 홍성렬 (성균관대학교 유전공학과) ;
  • 이향우 (성균관대학교 약학대학)
  • Published : 1997.04.01

Abstract

This study was conducted to investigate the subacute transdermal toxicity of Syndella gel, a new topical drug containing deproteinized dialysate of calf's blood and micronomicin sulfate in Sprague-Dawley rats. Three doses (1.97, 3.94, 7.88 g/kg) of Syndella gel was daily treated transdermally to male and female rats for 30 days. No death was occurred in either control or treated rats. No significant toxic clinical signs and body weight change were not observed at any doses in the male or female rats treated. There were no significant alterations in hematologic and biochemical parameters in both sexes, however slight increase of potassium concentration was observed in 3.94g/kg and 7.88 g/kg female groups. No significant necrotic changes were not observed in examined organs. This study showed that up to 7.88g/kg Syndella gel did not induce subacute transdermal toxicity.

Keywords

References

  1. Arzneim. Forsch. v.15 The augmentative effect of a blood extract on cellular respiration Jaeger, K. H.;Leybold, K.;Mittenzwei, H.;Staudinger, H.;Waldstatten, L.
  2. VASA Band v.2 Wound healing and fibrinolytic activity Szekeres, L.;Torok, L.;Simon, N.
  3. Solcoseryl reactivate disturbed cellular energy metabolism and stimulates tissue regeneration Brochure of Solco Basle Ltd
  4. Praxis v.53 A contribution to clinical experimentation of solcoseryl in the treatment of decubitus and vascular ulcers and gangrene of the extremities Wyss, J. l.;Basti, H.
  5. Z. f. phys. Med. v.4 Investigations into the combination of physiotherapeutic training sessions with vaso-active drugs in intermittent claudication Krause, D.;Dittmar, K.
  6. Chemotherapy v.25 Comparison of antibacterial activity of KW-1062 with four aminoglycoside antibiotics in vitro and in vovo Goto, S.;Ogawa, M;Kaneko, Y.
  7. Chemotherapy v.25 Antibacterial activity of KW-1062, a new aminoglycoside antibiotic Sato, K.;Araki, Y.;Fukui, M.;Marumo. H.
  8. J. Applied Pharmacol. v.2 Evaluation of topical drug containing solcoseryl and micronomicin on surgical wound in mice Chung, K. J.;Chang, M. S.;Chun, J. O.;Chun, J. K.;Kim, S. C.;Choi, W. S.;Lee, H. W.
  9. Toxicity test guideline for safety evaluation of drugs for human use. No. 96-8 Korea KFDA
  10. Arch. Toxicol. v.54 A new approach to practical toxicity testing Lorke, D.
  11. Principles and methods of toxicology(3rd ed.) Statistics for toxicologists Gad, S. C.;Weil, C. S.