Korean Journal of Medicinal Crop Science (한국약용작물학회지)

The Korean Society of Medicinal Crop Science (한국약용작물학회)
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Safety Evaluation Test of Galgeun-tang Applied to Guidelines for the Testing of Chemicals

독성시험관리기준 적용 갈근탕의 안전성 평가

  • Nho, Jong Hyun (National Development Institute of Korean Medicine) ;
  • Jang, Ji Hun (National Development Institute of Korean Medicine) ;
  • Lee, Mu Jin (National Development Institute of Korean Medicine) ;
  • Yang, Beodul (National Development Institute of Korean Medicine) ;
  • Woo, Kyeong Wan (National Development Institute of Korean Medicine) ;
  • Lee, Hyun Joo (National Development Institute of Korean Medicine) ;
  • Kim, A Hyeon (National Development Institute of Korean Medicine) ;
  • Sim, Mi Ok (National Development Institute of Korean Medicine) ;
  • Cho, Hyun Woo (National Development Institute of Korean Medicine) ;
  • Jung, Ho Kyung (National Development Institute of Korean Medicine)
  • Received : 2019.04.11
  • Accepted : 2019.05.12
  • Published : 2019.06.30
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Abstract

Background: Galgeun-tang used in traditional Korean medicine, is a mixture of the medicinal plants Cinnamomi Ramulus, Ephedrae Herba and Puerariae Radix, and has been prescribed for the treatment of various ailments, including fever. Although the use of traditional medicinal herbs to treat diseases has recently increased, their safety and toxicity profiles incompletely elucidated. Thus, we evaluated Galgeun-tang's toxicity in male and female Sprague-Dawley rats. Methods and Results: Galgeun-tang (1,000, 2,000 and 4,000 mg/kg) was orally administered to rats for 13 weeks, and then, they were maintained for 4 weeks without administration (recovery period). Their clinical signs, and hematological and urinary properties, were monitored. The results showed that Galgeun-tang administeration slightly increased serum creatinine, urea nitrogen and, aspartate aminotransferase levels. Additionally, 2,000 and 4,000 mg/kg Galgeun-tang significantly increased urinary bilirubn and protein levels of male and female rats, which were restored during the recovery period. Conclusions: The no-observed-adverse-effect level of orally administered Galgeun-tang was 4,000 mg/kg in both female and male rats, and no target organs were identified. In addition, 400 mg/kg was found to be the no-observed-effect level for toxicity under the study conditions.

Keywords

Table 1. Composition of Galgeun-tang.

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Table 2. Summary of clinical signs of male and female rat administered with Galgeun-tang (GT).

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Table 3-1. Change in body weights of male and female rat administered with Galgeun-tang for 13-weeks.

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Table 3-2. Change in body weights of male and female rat administered with Galgeun-tang for 4-weeks of recovery evaluation.

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Table 3-3. Change in body weights of male and female rat administered with Galgeun-tang for 4-weeks of recovery evaluation.

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Table 4-1. Change in mean food consumption of male and female rat administered with Galgeun-tang for 13-weeks.

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Table 4-2. Change in mean food consumption of male and female rat administered with Galgeun-tang for 4-weeks of recovery evaluation.

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Table 5. Individual of urinalysis results in main groups.

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Table 5. continued.

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Table 5. continued.

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Table 6. Summary of hematological parameters in main and recovery groups.

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Table 7. Summary of biochemical parameters in main and recovery groups.

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Table 8. Summary of estrous cycle in main groups.

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Table 9. Summary of necropsy findings in male and female rats administered with Galgeun-tang.

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Table 10. Summary of absolute organ weights in male and female rats administered with Galgeun-tang.

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Table 11. Summary of relative organ weights in male and female rats administered with Galgeun-tang.

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