Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
권호 표지

Acute Oral Toxicity Study of Standardized Herbal Preparations(Gami-Samhwang-San, SH-21-B) in Rats

HPLC로 표준화한 가미삼황산(加味三黃散) 분획물(SH-21-B)의 랫드에 대한 단회경구투여독성시험

  • Yu, Young-Beob (Department of Medical Research, Korea Institute of Oriental Medicine) ;
  • Kim, Seon-Hyeong (Insoo Dang Oriental Clinic) ;
  • Yoon, Yoo-Sik (Department of Medical Research, Korea Institute of Oriental Medicine)
  • 유영법 (한국한의학연구원 의료연구부) ;
  • 김선형 (인수당 한의원) ;
  • 윤유식 (한국한의학연구원 의료연구부)
  • Published : 2005.09.01
Download PDF
⟨ Previous Next ⟩

Abstract

Gami-Samhwang-San, a herbal prescription for obesity treatment, is composed of seven crude herbs such as Rehmanniae Radix Preparata, Ephedrae Herba, Scutellariae Radix, Acori Gramineri Rhizoma, Polygalae Radix, Typhae Pollen, Armeniacae Semen, Menthae Herba. In this study, marker substances in n-butanol fraction (SH-21-B) from Gami-Samhwang-San were analyzed by high performance liquid chromatography (HPLC) and acute toxicity of standardized SH-21-B was evaluated by good laboratory practices (GLP) guideline of Korea Food and Drug Administration. Therefore we confirmed that there were baicalin of 15.92%, amygdalin of 6.57% and ephedrine of 2.49% in SH-21-B. SH-21-B was administered in rats at dose of 0 mg/kg, 2,000 mg/kg, and 5,000mg/kg. Clinical signs of both sexes of rats were observed daily for 14 days after single oral administration. Two female rats one administered at 2,000 mg/kg and the other administered at 5,000 mg/kg, died, but no dead animal was observed among male rats. Therefore $LD_{50}$ in the female rat is observed to be 8,710 mg/kg, and MLD (Minimun Lethal Dose) of the male rat is observed to be more than 5,000 mg/kg.

Keywords

References

  1. 김은정, 문귀임, 이문홍, 오현숙, 최종동, 정정순, 안경아, 김영림, 장문익, 김지연 (2001): Microwave를 이용한 생약재 잔류농약의 추출방법에 관한 연구. 식품의약품안전청보고서, 5, 278-290
  2. 손우찬 (2004): 안전성 평가의 평가 기법 및 최신동향 조사. 한국 과학기술정보연구원 보고서
  3. 식품의약품안전청 (1999): 의약품등의 독성시험기준. 식품의약품 안전청 고시 제 1999-61호
  4. 식품의약품안전청 (2000): 비임상시험관리기준 식품의약품안전청고시 제 2000-63호
  5. 안병민, 이동수, 백종태, 장성희, 장이선 (2002): 식물제제에 의한 간손상의 빈도. 식품의약품안전청연구보고서, 6, 1045-1046
  6. 유영법, 조성기 (2000): 감마선 조사 당귀(Angelica gigas Nakai) 의 유효성분 안정성 및 유전독성학적 안전성. 한국식품영양과학회지, 29, 300-306
  7. 이병철, 최기림, 이진신, 장원만, 안영민, 안세영, 두호경 (2000): Chinese Herb Nephropathy란 용어는 올바른 것인가? 대한 한방내과학회지, 21, 543-548
  8. 이영자, 김우성, 이창회, 허문회, 정지윤, 이선화, 김재이, 진종성, 김미경, 진선경, 이명자, 박영채, 홍기형 (2002): 유통 한약재의 잔류농약 및 잔류이산화황에 대한 모니터링 . 식품의약품안전청보고서, 6, 678-693
  9. 이지현, 류인열, 윤성준, 신원혁, 이정석, 최의혁, 홍수희, 유종훈, 김영묵, 이동윤, 이준상 (1998): 한약재 복용으로 인한 간염 17예에 대한 임상적 고찰. 대한소화기학회지, 32, 69-74
  10. 조성기, 유영법, 오헌, 곽연길, 변명우 (2000): 감마선 조사 생약재 (어성초,구기자)의 안전성에 관한 유전독성학적 평가. 한국식품저장유통학회지, 7, 68-73
  11. 허옥순, 이진하, 김세은, 주인선, 신동우, 이정호, 김지연, 강숙경, 이형규, 백승화, 문명우, 김진수 (2000): 유통 방기의 화학적 분석. 식품의약품안전청연구보고서 4. 111-118
  12. Farrar, P.L. (1997): Diagnostic exercise: Interstitial pneumonia in viral and mycoplasmal antibody-free sprague dawley rats. ACLAD NEWSLETTER (American Committee on Laboratory Animal Diseases), Fall Vol. 18, 5-9
  13. He, J.X., Akao, T. and Tani, T. (2002): Development of a simple HPLC method for determination of paeoniflorin-metabolizing activity of intestinal bacteria in rat feces. Chem. Pharm. Bull., 50,1233-1237 https://doi.org/10.1248/cpb.50.1233
  14. Jiang, Y., Lu, H.T. and Chen, F. (2004): Preparative purification of glycyrrhizin extracted from the root of liquorice using high-speed counter-current chromatography. J. Chromatogr. A., 1033, 183-186 https://doi.org/10.1016/j.chroma.2004.01.033
  15. Lee, J.H., Koh, J.A., Hwang, E.Y. and Hong, S.P. (2002): Quantitative determination of 5-hydroxymethyl-2-furaldehyde from rehmanniae radix preparata according to various processings. Kor. J. Herbology, 17, 145-149
  16. OECD (2002): Acute Oral Toxicity-OECD fixed dose method. 425
  17. Vanherweghem, J.L., Depierreux, M., Tielemans, C., Abramowicz, D., Dratwa, M., Jadoul, M., Richard, C., Vandervelde, D., Verbeelen, D., Vanhaelen-Fastre, R. and Vanhaelen, M. (1993): Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet, 341, 387-391 https://doi.org/10.1016/0140-6736(93)92984-2
  18. Wang, S.F., Chen, X.G, Hu, Z.D. and Ju, Y. (2003): Analysis of three effective components in Fructus corni and its preparations by micellar electrokinetic capillary chromatography. Biomed Chromatogr., 17, 306-311 https://doi.org/10.1002/bmc.247
  19. Yu, Y.B., Jeong, I.Y., Park, HR., Oh, H.H. and Jung, S.K. (2004): Toxicological safety and stability of the components of an irradiated Korean medicinal herb, Paeoniae Radix Job. Radiation Physics and Chemistry, 71, 115-119 https://doi.org/10.1016/j.radphyschem.2004.04.002
  20. Zhao, X. and Sun, Y. (2003): Analysis of Paeoniae Radix by high-performance liquid chromatography-electrospray ionization-mass spectrometry. Anal Sci., 19, 1313-1315 https://doi.org/10.2116/analsci.19.1313