The Korea Journal of Herbology (대한본초학회지)

The Korea Association of Herbology (대한본초학회)
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Single Oral Dose Toxicity Test of Jeopgoltang Extracts in Sprague-Dawley Rat

접골탕(接骨湯) 2.0의 Sprague-Dawley 랫드를 이용한 단회경구투여 독성시험

  • YoungJin Choi (KyungHeeDaBok Korean medical clinic) ;
  • HyoJung Kim (National Institute for Korean Medicine Development) ;
  • Se-Jin Kim (National Institute for Korean Medicine Development) ;
  • JunSub Kim (National Institute for Korean Medicine Development) ;
  • Jiwoon Jeong (National Institute for Korean Medicine Development) ;
  • HyunHee Leem (National Institute for Korean Medicine Development) ;
  • BoGyung Jang (National Institute for Korean Medicine Development) ;
  • YuJin Park (National Institute for Korean Medicine Development) ;
  • Jungtae Leem (Hanbang Cardio‐Renal Syndrome Research Center, Wonkwang University) ;
  • Gi-Sang Bae (Hanbang Cardio‐Renal Syndrome Research Center, Wonkwang University) ;
  • Bitna Kweon (Hanbang Cardio‐Renal Syndrome Research Center, Wonkwang University) ;
  • Dong-Uk Kim (Hanbang Cardio‐Renal Syndrome Research Center, Wonkwang University)
  • 최영진 (경희 다복 한의원) ;
  • 김효정 (한국한의약진흥원) ;
  • 김세진 (한국한의약진흥원) ;
  • 김준섭 (한국한의약진흥원) ;
  • 정지운 (한국한의약진흥원) ;
  • 임현희 (한국한의약진흥원) ;
  • 장보경 (한국한의약진흥원) ;
  • 박유진 (한국한의약진흥원) ;
  • 임정태 (원광대학교 한방심신증후군연구센터) ;
  • 배기상 (원광대학교 한방심신증후군연구센터) ;
  • 권빛나 (원광대학교 한방심신증후군연구센터) ;
  • 김동욱 (원광대학교 한방심신증후군연구센터)
  • Received : 2024.02.22
  • Accepted : 2024.03.25
  • Published : 2024.03.30
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Abstract

Objectives : Jeopgoltang (JGT) is a new Korean herbal medicine formulation that is used to treat bone fractures. Although JGT is frequently used in clinical practice, there is a lack of scientific evidence on its safety. This study aimed to evaluate the preclinical toxicity of JGT using a single oral dose toxicity test in Sprague-Dawley (SD) rats. Methods : Five male and female rats per group were orally administered 1,250, 2,500, or 5,000 mg/kg of JGT after fasting for 12 h. Mortality and changes in clinical signs, body weight, and necropsy findings were monitored for 14 days according to the guidelines of the Korean Ministry of Food and Drug Safety and Organisation for Economic Co-operation and Development (OECD). Results : No significant clinical signs or mortality were observed after a single administration of up to 5,000 mg/kg. In addition, no significant necropsy findings related to JGT administration were observed. Conclusions: In conclusion, these results suggest that approximate Lethal Dose (ALD) of JGT on SD rats is over 5,000 mg/kg.

Keywords

Acknowledgement

본 연구는 한국한의약진흥원 '한의약 산업 선진화 지원 사업 (과제번호: 3234-302)' 지원으로 수행되었다.

References

  1. Gosselin RD. Guidelines on statistics for researchers using laboratory animals: the essentials. Lab Anim. 2019;53(1):28-42. [https://doi.org/10.1177/0023677218783223]
  2. Park HM, Jang IS, Lee SD. Hepatotoxic events associated with herbal medicinal products, folk remedies and food supplements in Korea. J Korean Med. 2005;26(2):152-65.
  3. Teschke R, Eickhoff A. Herbal hepatotoxicity in traditional and modern medicine: actual key issues and new encouraging steps. Front Pharmacol. 2015;6:72. [https://doi.org/10.3389/fphar.2015.00072]
  4. Fazzalari NL. Bone fracture and bone fracture repair. Osteoporos Int. 2011;22(6):2003-6. [https://doi.org/10.1007/s00198-011-1611-4]
  5. Association TKO. Orthopaedics Seoul: Choisin Medical Publishing; 2013.
  6. Gold T, Williams SA, Weiss RJ, Wang Y, Watkins C, Carroll J, et al. Impact of fractures on quality of life in patients with osteoporosis: a US cross-sectional survey. J Drug Assess. 2019;8(1):175-83. [https://doi.org/10.1080/21556660.2019.1677674]
  7. Bowring CE, Francis RM. National Osteoporosis Society's Position statement on hormone replacement therapy in the prevention and treatment of osteoporosis. Menopause Int. 2011;17(2):63-65. doi:10.1258/mi.2011.011012
  8. Won J, Choi Y, Yoon LS, Lee JH, Choi K, Lee H. Individualized herbal prescriptions for delayed union: A case series. Explore (NY). 2023;19(2):260-6. [https://doi.org/10.1016/j.explore.2022.03.001]
  9. Mosihuzzaman M. Herbal medicine in healthcare-an overview. Nat Prod Commun. 2012;7(6):807-12. [https://doi.org/10.1177/1934578X1200700628]
  10. Karimi A, Majlesi M, Rafieian-Kopaei M. Herbal versus synthetic drugs; beliefs and facts. J Nephropharmacology. 2015;4(1):27.
  11. Welfare MoHa. Herbal medicine CONSUMPTION SURVEY, 2020. In: Welfare MoHa, editor. Sejong: Ministry of Health and Welfare 2022.
  12. Rofiyati W, Hadi H, Rosyada RW, Putri TIYL, Putra MG, Ayuningtyas I, et al. Herbal Medicine on Response Immune Patient with COVID-19 Infection a Scoping Review. Open Access Maced J Med Sci. 2022;10(T8):155-9. [https://doi.org/10.3889/oamjms.2022.9489]
  13. Zhang HT, Huang MX, Liu X, Zheng XC, Li XH, Chen GQ, et al. Evaluation of the Adjuvant Efficacy of Natural Herbal Medicine on COVID-19: A Retrospective Matched Case-Control Study. Am J Chin Med. 2020;48(4):779-92. [https://doi.org/10.3889/oamjms.2022.9489]
  14. Jang S, Kim KH, Sun SH, Go HY, Lee EK, Jang BH, et al. Characteristics of Herbal Medicine Users and Adverse Events Experienced in South Korea: A Survey Study. Evid Based Complement Alternat Med. 2017;2017:4089019. [https://doi.org/10.1155/2017/4089019]
  15. Cho JH, Oh DS, Hong SH, Ko H, Lee NH, Park SE, et al. A nationwide study of the incidence rate of herb-induced liver injury in Korea. Arch Toxicol. 2017;91(12):4009-15. [https://doi.org/10.1007/s00204-017-2007-9]
  16. Jo J, Lee SH, Lee JM, Lee H, Kwack SJ, Kim DI. Use and safety of Korean herbal medicine during pregnancy: A Korean medicine literature review. Eur J Integr Med. 2016;8(1):4-11. [https://doi.org/10.1016/j.eujim.2015.10.008]
  17. Kim DG, Lee J, Kim W, An HJ, Lee JH, Chang J, et al. Assessment of General Toxicity of the Glycyrrhiza New Variety Extract in Rats. Plants (Basel). 2021;10(6):1126. [https://doi.org/10.3390/plants10061126]
  18. Lee JW, Jung YS, Jung TY, Kim JD, Choi HY. Mouse single oral dose toxicity test of Scutellariae radix aqueous extracts. Korean J Intern Med. 2013;34(1):46-58. [https://doi.org/10.5487/TR.2012.28.1.011]
  19. Yoo SR, Jeong SJ, Shin HK, Yoo SR, Jeong SJ, Shin HK. Single oral dose toxicity evaluation of Samultang, a traditional herbal formula, in Crl: CD (SD) rats. J Korean Med. 2014;35(2):28-33. [https://doi.org/10.13048/jkm.14019]
  20. Lee JW, Baek KM, Chang WS. Single-Dose Oral Toxicity Test of Woohwangchungshim-won in Mice. J Physiol & Pathol Korean Med. 2014;28(2):186-94. [https://doi.org/10.15188/kjopp.2014.04.28.2.186]
  21. Kim MJ, Lee MJ, Kim H. Repeated dose 90-day oral toxicity study of modified Samjung-Hwan in sprague-dawley rats. J Korean Med Obes Res. 2018;18(1):36-49. [https://doi.org/10.15429/jkomor.2018.18.1.36]
  22. Yi N, Mi Y, Xu X, et al. Nodakenin attenuates cartilage degradation and inflammatory responses in a mice model of knee osteoarthritis by regulating mitochondrial Drp1/ROS/NLRP3 axis. Int Immunopharmacol. 2022;113(Pt A):109349. doi:10.1016/j.intimp.2022.109349
  23. Hou T, Zhang L, Yang X. Ferulic acid, a natural polyphenol, protects against osteoporosis by activating SIRT1 and NF-κB in neonatal rats with glucocorticoid-induced osteoporosis. Biomed Pharmacother. 2019;120:109205. doi:10.1016/j.biopha.2019.109205
  24. Wu H, Lv Y, Wei F, Li C, Ge W, Du W. Comparative analysis of anti-osteoporosis efficacy in Radix Dipsaci before and after processing with salt based on spectrum-effect relationship. J Pharm Biomed Anal. 2022;221:115078. doi:10.1016/j.jpba.2022.115078
  25. Kim KM, Lee YJ, Hong YG, Kang JS. Oral Acute and Subacute Toxicity Studies of Decursin and Decursinol Angelate of Angelica gigas Nakai. Mol Cell Toxicol. 2009;5(2):153-9.
  26. Yun JW, Che JH, Kwon E, Kim YS, Kim SH, You JR, et al. Safety evaluation of Angelica gigas: Genotoxicity and 13-weeks oral subchronic toxicity in rats. Regul Toxicol Pharmacol. 2015;72(3):473-80. [https://doi.org/10.1016/j.yrtph.2015.05.025]
  27. Heo HY, Shin D-H, Lee JH, Seo Y-S, Kim Y-B, Shin I, et al. Two-weeks Oral Dose Toxicity Study of Dipsacus asperoides Extracts in C57BL/6 Mice. Kor J Herbology. 2021;36(5):101-8. [https://doi.org/10.6116/kjh.2021.36.5.101.]
  28. Hyun SW, Lee TG, Song SJ, Kim CS. Evaluation of oral toxicity and genotoxicity of Achyranthis Radix extract. J Ethnopharmacol. 2021;274:113944.