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Repeated Intramuscular-dose Toxicity Test of Water-soluble Carthami Flos (WCF) Pharmacopuncture in Sprague-Dawley Rats

  • Choi, Yoo-Min ;
  • Jung, Da-Jung ;
  • Kim, Seok-Hee ;
  • Kim, Jong-Uk ;
  • Yook, Tae-Han
  • Received : 2014.12.03
  • Accepted : 2014.12.22
  • Published : 2015.03.30

Abstract

Objectives: Water-soluble carthami flos (WCF) is a new mixture of Carthami flos (CF) pharmacopuncture. We conducted a 4-week toxicity test of repeated intramuscular injections of WCF in Sprague-Dawley rats. Methods: Forty male and 40 female rats were divided into 4 groups of 10 male and 10 female SD rats: The control group received 0.5 mL/animal/day of normal saline whereas the three experimental groups received WCF at doses of 0.125, 0.25, and 0.5 mL/animal/day, respectively. For 4 weeks, the solutions were injected into the femoral muscle of the rats alternating from side to side. Clinical signs, body weights, and food consumption were observed; opthalmological examinations and urinalyses were performed. On day 29, blood samples were taken for hematological and clinical chemistry analyses. Then, necropsy was conducted in all animals to observe weights and external and histopathological changes in the bodily organs. All data were tested using a statistical analysis system (SAS). Results: No deaths were observed. Temporary irregular respiration was observed in male rats of the experimental group for the first 10 days. Body weights, food consumptions, opthalmological examinations, urinalyses, clinical chemistry analyses, organ weights and necropsy produced no findings with toxicological meaning. In the hematological analysis, delay of prothrombin time (PT) was observed in male rats of the 0.25- and the 0.5-mL/animal/day groups. In the histopathological test, a dose-dependent inflammatory cell infiltration into the fascia and panniculitis in perimuscular tissues was observed in all animals of the experimental groups. However, those symptoms were limited to local injection points. No toxicological meanings, except localized changes, were noted. Conclusion: WCF solution has no significant toxicological meaning, but does produce localized symptoms. No observed adverse effect level (NOAEL) of WCF in male and female rats is expected for doses over 0.5 mL/animal/day.

Keywords

Carthamus tinctorious L. Carthami semen;intramuscular;toxicity tests;water-soluble carthami flos pharmacopuncture

References

  1. Korean Pharmacopuncture Institute. [Pharmacopuncturology: principles and clinical applications]. Seoul: Elsevier Korea LLC; 2012. Chapter 1, Definition and history; p. 3. Chaper 3, Types of pharmacopuncture; p. 9, 22-3, Chaper 7, Research trend; p. 93, 116-7, Chapter 8, Meridian field pharmacopuncture; p. 149, 159-62. Korean.
  2. Yook TH, Song BY, Sin MS, Kim BH, Park JJ, Yun JH. [Effects on the local thermal change following herbal acupuncture on D.I.T.I.]. The Acupuncture. 2000;17(3):57-68. Korean.
  3. Lee GM, Yeom SC, Kim DH, Ryu SW, Kim DJ, Cho NG, et al. [A clinical study of carthmi-flos herbal acupuncture treatment on cervical disc herniation patients]. The Acupuncture. 2006;23(3):21-35. Korean.
  4. Jeong DH, Ahn HJ, Hwang KS, Yun KB, Kim TW, Moon JH, et al. [Clinical study on effect of carthmi-flos herbal acupuncture therapy on shoulder pain]. The Acupuncture. 2002;19(6):184-92. Korean.
  5. Hur TY, Yun MY, Cho EH, Lee OJ, Kim KS, Cho NG. [Clinical study on effect of carthmi-flos herbal acupuncture therapy]. The Acupuncture. 2002;19(2):189-200. Korean.
  6. Kang KS, Lee JS, Kwon GR. [The clinical studies on the cases of side effect of CF herbal acupuncture]. J Pharmacopuncture. 2001;4(2):65-71. Korean.
  7. Lee JY, Kang HM, Lim CS, Kwon KR. [Report on the side-effects of pharmacopucture lubricants (CF, JsD)]. J Pharmacopuncture. 2007;10(3):137-42. Korean.
  8. Lee HG, Kim SC, Jung DJ, Choi YM, Sin MS, Choi SW, et al. Single intramuscular-dose toxicity of water soluble carthmi-flos herbal acupuncture (WCF) in sprague-dawley rats. J Pharmacopuncture. 2014;17(1):27-34.
  9. Jung DJ, Choi YM, Kim SH, Kim JU, Yook TH. Single intravenous-dose toxicity of water-soluble carthami-flos pharmacopuncture (WCF) in rats. J Pharmacopuncture. 2014;17(3):31-9 https://doi.org/10.3831/KPI.2014.17.024
  10. Korean Pharmacopuncture Institute. [Practice guide-line of pharmacopuncture]. Seoul: Elsevier Korea LLC; 1999. p. 13-4, 112-8, 138-203. Korean.
  11. Lee HJ, Koung FP, Kwon KR, Kang DI, Cohen L, Yang PY, et al. Comparative analysis of the bufonis venenum by using TLC, HPLC, and LC-MS for different extraction methods. J Pharmacopuncture. 2012;15(4):52-65. https://doi.org/10.3831/KPI.2012.15.012
  12. Song BK, Jeon YC, Kim SA, Shim AN, Seoung KM, Lee EJ. [The effect of intravenous injection of the water extract of Angelica gigas nakai on gliosis in the middle cerebral artery occlusion rats]. J Pharmacopuncture. 2011;14(3):5-17. Korean.
  13. Heo IH. [Toxicology]. Seoul: Shinil books; 1993. p. 9-10, 185-6. Korean.
  14. Ministy of Food and Drug Safety Notification No.2008-56 [internet] Seoul: Ministry of Food and Drug Safety; 2008. [cited 2014 Nov 25]. Available from: http://www.mfds.go.kr/index.do?x=0&searchkey=notice_number&mid=686&searchword=2008-56&y=0&division=&pageNo=1&seq=2545&cmd=v.

Cited by

  1. Carthami flos regulates gastrointestinal motility functions 2017, https://doi.org/10.1016/j.imr.2017.08.005

Acknowledgement

Supported by : Woosuk University