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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;Jang, Ji Hun;Lee, Mu Jin;Yang, Beodul;Woo, Kyeong Wan;Lee, Hyun Joo;Kim, A Hyeon;Sim, Mi Ok;Cho, Hyun Woo;Jung, Ho Kyung
노종현;장지훈;이무진;양버들;우경완;이현주;김아현;심미옥;조현우;정호경

  • Received : 2019.04.11
  • Accepted : 2019.05.12
  • Published : 2019.06.30

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

Galgeun-tang;Guidelines for the Testing of Chemicals;Herbal Medicine;Safety Evaluation

Acknowledgement

Supported by : 한국 토종자원