Journal of Oriental Neuropsychiatry (동의신경정신과학회지)

The Korean Society of Oriental Neuropsychiatry (대한한방신경정신과학회)
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13 weeks repeated oral dose toxicity studies with LMK02-Jangwonhwan in SD rats

LMK02의 Sprague-Dawley 랫드를 이용한 13 주간 반복 경구투여 독성시험

  • Kang, Hyung-Won (Department of Neuropsychiatry, College of Oriental Medicine, Wonkwang University) ;
  • Jang, Hyun-Ho (Department of Neuropsychiatry, College of Oriental Medicine, Wonkwang University) ;
  • Park, Jang-Ho (Department of Neuropsychiatry, College of Oriental Medicine, Wonkwang University) ;
  • Kim, Tae-Heon (Department of Neuropsychiatry, College of Oriental Medicine, Wonkwang University) ;
  • Lyu, Yeoung-Su (Department of Neuropsychiatry, College of Oriental Medicine, Wonkwang University)
  • 강형원 (원광대학교 한의과대학 한방신경정신과교실) ;
  • 장현호 (원광대학교 한의과대학 한방신경정신과교실) ;
  • 박장호 (원광대학교 한의과대학 한방신경정신과교실) ;
  • 김태헌 (원광대학교 한의과대학 한방신경정신과교실) ;
  • 류영수 (원광대학교 한의과대학 한방신경정신과교실)
  • Received : 2012.05.21
  • Accepted : 2012.05.29
  • Published : 2012.06.30
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Abstract

Objectives : The oriental medicine Jangwonhwan, a boiled extract of 12 medicinal herbs/mushrooms, has been prescribed to patients with cognitive dysfunction, as originally described in the Korean medical text, DonguiBogam(amnesia chapter). Recently, a modified formula of Jangwonhwan (LMK02-Jangwonhwan) consisting of seven medicinal plants/mushrooms, was shown to reduce the ${\beta}$-amyloid deposition in the brain of Tg-APPswe/PS1dE9 mouse model for Alzheimer's disease. The toxicity of LMK02-Jangwonhwan was investigated in SD rats, by a daily oral administration for 13 weeks and NOAEL(No observed adverse effect dose), a definite toxic dose and target organ, as well. Methods : Quality control of the tablet form of LMK02-Jangwonhwan was established by estimating the indicative components, Ginsenoside Rg3 of Red Ginseng and Decursin of Angelicagigas Nakai. The toxicity of LMK02-Jangwonhwan was investigated in 6 week old, specific pathogen free (SPF), Sprageu-Dawley rats by oral administration. Each test group consisted of 10 male and 10 female rats. The groups received doses of 500, 1,000 or 2,000 mg/kg/day of test substance for 13 weeks. The clinical signs, death rate, body weight, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemistry, organ weight and pathological changes were examined and compared with those of the control group. Results : The 13-week repeated oral treatment doses didn't result in any specific symptoms or death. There were no significant changes in the rat's weight and food consumption. Further, ophthalmic examination, urinalysis, hematological, serum biochemistry test and organ weight revealed no significant differences. Conclusions : The no-observed-adverse-effect level(NOAEL) of LMK02 for male and female Sprague-Dawley rats was determined as 2,000mg/kg/day and the target organ wasn't confirmed. Because no significant adverse effects were observed, the target organ could not be determined.

Keywords

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