Journal of Society of Preventive Korean Medicine (대한예방한의학회지)

Society of Preventive Korean Medicine (대한예방한의학회)
권호 표지

Single Oral Dose Toxicity Test of Bojungikkitang (Buzhongyiqi-tang) Aqueous Extract in ICR Mice

보중익기탕(補中益氣湯)의 마우스 경구 단회 투여 독성시험

  • Kim, Jong-Dae (College of Oriental Medicine, Daegu Haany University)
  • 김종대 (대구한의대학교 한의과대학 폐계내과학교실)
  • Received : 2011.07.04
  • Accepted : 2011.08.17
  • Published : 2011.08.31
Download PDF
⟨ Previous Next ⟩

Abstract

Objective : This study was to evaluate the single dose toxicity of Bojungikki-tang(Buzhongyiqi-tang, BJIKT) in male and female mice. Method : Aqueous extracts of BJIKT were administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy ; organ weight and histopathology of 12 principle organs were examined. Results : we could not find any mortality, clinical signs, and changes in the body and organ weight. In addition, no BJIKT-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Conclusion : The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of BJIKT aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines, and can be safety used in clinics.

Keywords

References

  1. Lee, J.E., Kim, H.J., Choi, E.K., Chai, H.Y., Yun, Y.W., Kim, D.J., Nam, S.Y., Lee, B.J., Ahn, B.W., Kang, H.G., Kim, Y.B. Four-week repeated-dose toxicity study on Pinellia Extract. Korean J. Lab. Anim. Sci., 19 : 127-141, 2003.
  2. 許浚. 東醫寶鑑. 서울 : 법인문화사. 2005 : 804.
  3. 道淵. 新訂對譯大方藥合編(全). 서울 : 행림출판사. 1986 : 117-120.
  4. 汪認庵. 醫方集解. 서울 : 成輔社. 1983 : 129.
  5. 한국식품의약품안전청. 의약품등의 독성시험기준. 한국식품의약품안전청 고시 제 2009- 116호. 2009.
  6. Irwin, S.. Comprehensive observational assessment : Ia. A systemic, quantitative procedure for assessing the behavioral and physiological state of the mouse. Psychopharmacology. 1968 : 13 : 222-257. https://doi.org/10.1007/BF00401402
  7. Dourish, C.T. Effects of drugs on spontaneous motor activity. In Experimental Psychopharmacology(A.J. Greenshaw and C.T. Dourish, Ed.). Clifton : Humana Press. 1987 : 325-334.
  8. 李東垣. 東垣十種醫書. 서울 : 대성문화사. 1983 : 87
  9. 鞠潤範, 金相贊, 朴宣東, 朴性奎, 徐富一, 徐榮培, 申舜植, 李尙仁, 李長泉, 李棣熙, 鄭宗佶, 朱榮丞, 崔湖榮. 方劑學. 서울 : 圖書出版 永林社. 2008 : 279-282.
  10. 田炳薰, 鄭遇悅. 補中益氣湯 및 四物湯加味 方이 白鼠 損傷肝의 回復에 미치는 影響. 동의병리학회지. 1991 : 6 : 27-61.
  11. 육창수, 김민선, 황영선, 류종훈. Elevated plus-maze를 이용한 신기환, 보중익기탕 및 사물탕의 항불안 효과. 응용약물학회지. 2001 : 9 : 125-130.
  12. 박성민, 임명현, 이준희, 박재현. 補中益氣湯과 六味地黃湯이 노화촉진생쥐(SAM)의 간장내 항산화작용에 미치는 영향. 大韓本草學會誌. 2003 : 18 : 175-191.
  13. 강대성, 감철우, 박동일. 보중익기탕이 알레르기반응에 미치는 영향에 대한 실험적연구. 생명과학회지. 2003 : 13 : 73-82.
  14. 은재순, 최훈, 송정모. 補中益氣湯이 생쥐의 특이적 면역반응에 미치는 영향. 동의병리학회지. 2002 : 16 : 943-947.
  15. 채수연, 신성해, 하미혜, 조성기, 김성호, 변명우, 이성태. 보중익기탕(補中益氣湯)의 T 세포 증식 유도 효과. 한국식품영양과학회지. 2004 : 33 : 1085-1091.
  16. 성익제. 보중익기탕이 비소세포 폐암세포 (NCI-H520) 이식마우스에서 항암 면역활성 및 악액질에 미치는 영향. 대구한의대학교 대학원. 2011
  17. 한성규, 최승훈, 안규석. 補中益氣湯, 手拈散 및 補中益氣湯 合手拈散의 抗癌과 免疫調節作用에 關한 實驗的 硏究. 경희한의대논문집. 1995 : 18 : 15-29.
  18. Plata, E.J., Murphy, W.H. Growth and haematologic properties of the BALB/wm strain of inbred mice. Lab. Anim. Sci.. 1972 : 22 : 712-720.
  19. Yamaguchi, C., Fujita, S., Obara, T., Ueda, T. Effects of room temperature on reproduction, body weight and organ weights, food and water intakes, and hematology in mice. Exp. Anim.. 1983 : 32 : 1-11.
  20. Lee, J.H., Yang, K.J., Shin, H.D., Park, B.R., Son, C.W., Jang, H.J., Park, D.C., Lee, H.S., Ku, S.K.. Single subcutaneous dose toxicity of Polycan${\circledR}$, a $\beta$-glucan originated from Aureobasidium in mice. Lab. Anim. Res.. 2005 : 21 : 299-305.
  21. Lee, H.S., Lee I.G., Ku S.K.. Single oral dose toxicity study of water extracts of Picrorrhiza Rhizoma in mice. J. Toxicol. Pub. Health, 2006 : 22 : 117-126.
  22. Banks, W.J.. Female reproductive system. In : Applied veterinary histology(W.J. Banks, Ed.), 2nd ed. Baltimore : Williams & Wilkins. 1986 : 506-526 .
  23. Pineda, M.H.. Female reproductive system. In : Veterinary endocrinology and reproduction( L.E. McDonald and M.H. Pineda, Eds.). Philadelphia : Lea & Febiger. 1989 : 303-354.
  24. U.S. Environmental Protection Agency. Health Effects Test Guidelines OPPTS 870.100, Acute Toxicity Testing Background. US EPA August, Washington, USA, 1998.