대한본초학회지 (The Korea Journal of Herbology)

  • 제33권1호
  • /
  • Pages.71-76
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  • 2018
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  • 1229-1765(pISSN)
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  • 2288-7199(eISSN)
대한본초학회 (The Korea Association of Herbology)
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HBX-6의 Sprague-Dawley rat를 이용한 단회경구투여 독성시험

Single Oral Dose Toxicity Test of HBX-6 in Sprague-Dawley Rat

  • 진보람 (상지대학교 한의과대학 약리학교실) ;
  • 서동욱 (상지대학교 한의과대학 약리학교실) ;
  • 김명석 ((주)하원제약) ;
  • 이광호 ((주)하원제약) ;
  • 윤일주 ((주)하원제약) ;
  • 김창은 (상지대학교 한의과대학 약리학교실) ;
  • 안효진 (상지대학교 한의과대학 약리학교실)
  • Jin, Bo-Ram (Department of Pharmacology, College of Korean Medicine, Sangji University) ;
  • Seo, Dong-Wook (Department of Pharmacology, College of Korean Medicine, Sangji University) ;
  • Kim, Myoung-Seok (Central Research Institue of Hawon Pharmaceutical) ;
  • Lee, Kwang-Ho (Central Research Institue of Hawon Pharmaceutical) ;
  • Yoon, Il-Joo (Central Research Institue of Hawon Pharmaceutical) ;
  • Kim, Chang Eun (Department of Pharmacology, College of Korean Medicine, Sangji University) ;
  • An, Hyo-Jin (Department of Pharmacology, College of Korean Medicine, Sangji University)
  • 투고 : 2017.11.28
  • 심사 : 2018.01.15
  • 발행 : 2018.01.30
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초록

Objectives : This study was performed to investigate the single oral toxicity of HBX-6 in Sprague-Dawley (SD) rats. Methods : Twenty SD rats were randomly assigned to four groups of 5 rats each and were administrated singly to female and male SD rats, as an oral dose of 2000 mg/kg. HBX-6 is a newly combined Korean herbal medicine formula 30 % Ethanol extract derived from The Dongui Bogam. Now we are developing the prescription for the aim of improving benign prostatic hyperplasia (BPH) without undesirable side effects. HBX-6 is composed of nine medicinal herbs: Aconiti Lateralis Radix Preparata, Corni Fructus, Cistanchis Herba, Psoraleae Semen, Dendrobii Herba, Morindae Radix, Cuscutae Semen, Trigonellae Semen, Foeniculi Fructus. Animals were monitored for the mortality and changes in the body weight, clinical signs, gross observation and necropsy findings for the 14 days according to "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity - Fixed Dose Procedure" of OECD Test Guideline. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. After administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. Conclusions : Taken together, these results suggest that the approximate lethal dose of HBX-6 in both female and male SD rats were considered as over 2000 mg/kg.

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참고문헌

  1. Park H.m., Jang I.S., Lee S.D. Hepatotoxic Events Associated with Herbal Medicinal Products, Folk Remedies and Food Supplements in Korea, J Korean Oriental Med 2005;26(2):152-165.
  2. Lee J.E., Kim H.J., Choi E.K., Chai H.Y., Yun Y.W., Kim D.J. Four-week repeated-dose toxicity study on Pinellia Extract. The Korean journal of laboratory animal science. 2003;19:127-41.
  3. Kim S.R., Lee J.W., Lim S.Y., Jung Y.S., Choi H.Y., Kim J.D. Rat Single Oral Dose Toxicity Test of Armeniacae Semen, Korean J. Orient. Int. Med. 2012; 33(2)145-159.
  4. Theoharides T.C. Sudden death of a healthy college student related to ephedrine toxicity from a mahuang-containing drink, JCl in Psychopharmacol. 1997;17:437-9.
  5. Hwang S.Y., Kwon W., Chai H.Y., Cho Y.M., Ryu J.M., Kim D.K., Sin J.S., Kim T.K., Cho J.H., Shin S.H., Park J.H., Kang J.K., Kim Y.B. Four-Week Repeated-Dose Toxicity Study on Kamiguibitang. The Korean journal of laboratory animal science. 2004;20(3):267-73.
  6. Sung I.J., Park M.Y., Cheon W.H., Kim J.D. Mouse Single Oral Dose Toxicity Test and Bone Marrow Micronucleus Test of Mahwangbujaseshin-tang Extracts. Korean J. Oriental Physiology & Pathology. 2010;24(1):124-133.
  7. Bae Y.C., Choi B.H., Kim D.W., Hur J.I., Byun J.S., Kim D.J. Single Dose Toxicity Test of Bojungikkeehapdaechilkitang water extract in Male and Female ICR Mice. Korean J. Orient. Int. Med. 2005;26(2):369-378.
  8. Jeong H.R., Son B.W., Kim G.C., Shin S.S., Hwang W.D. Single Oral Dose Toxicity Study and Aconitine Content Analysis of Raw Aconiti Tuber and Sambutang. J. Int. Korean Med. 2016;37(3)427-441.
  9. Lepor, H., Kazzazi, A., Djavan, B. alpha-Blockers for benign prostatic hyperplasia: the new era. Curr Opin Urol. 2012;Jan;22(1):7-15. https://doi.org/10.1097/MOU.0b013e32834d9bfd
  10. Fagelman E, Lowe F.C. Herbal medications in the treatment of benign prostatic hyperplasia (BPH). Urol Clin North Am. 2002;Feb;29(1):23-9. https://doi.org/10.1016/S0094-0143(02)00015-0
  11. Jang I.S., Yang C.S., Lee S.D., Han C.H. A Review of Herbal Medicinal Products Associated with Toxic Events in Korea. J Korean Oriental Med. 2007;28(1)1-10
  12. Ministry of food and drug safety, Standard for Toxicity study of Pharmaceuticals, Korea National Institute of Health Notification No. 2014-136. 2014.
  13. Organization for Economic Co-Operation and Development(Ed.). OECD guideline (423) for testing of chemicals - acute oral toxicity-acute toxic class method. 2001.
  14. US Environmental Protection Agency. Health Effects Test Guidelines OPPTS 870.100, Acute Toxicity Testing Background. US EPA December-Washington, USA, 2002.