Sprague-Dawley계 흰쥐를 이용한 HT042의 14일 반복 경구투여 독성연구

• Published in: 大韓本草學會誌 Vol. 32; no. 1; pp. 63 - 68
• Main Authors: 송정빈, Jungbin Song, 이동헌, Donghun Lee, 김영식, Young-sik Kim, 이승경, Seunggyeong Lee, 배진숙, Jin-sook Bae, 김호철, Hocheol Kim
• Format: Journal Article
• Language: Korean
• Published: 대한본초학회 01.01.2017
• Subjects: Astragalus membranaceus; Eleutherococcus senticosus; HT042; Phlomis umbrosa; toxicity; 한의학; toxicity; Eleutherococcus senticosus; Phlomis umbrosa; HT042; Astragalus membranaceus
• ISSN: 1229-1765; 2288-7199
• DOI: 10.6116/kjh.2017.32.1.63.

Objectives : HT042 is a combination of three herbal extracts from the roots of Astragalus membranaceus , the stems of Eleutherococcus senticosus and the roots of Phlomis umbrosa, which has been demonstrated to increase longitudinal bone growth rate. The aim of this study was to assess the safety of HT042 after repeated oral administration. Methods : A 14-day repeated oral dose toxicity study was conducted using male and female Sprague-Dawley rats. HT042 was administered orally at repeated doses of 500, 1,000 and 2,000 ㎎/㎏/day for 14 days. Clinical signs and mortality were observed daily, whereas body weight and food consumption were recorded weekly throughout the experiment. At the end of the study, blood was taken from the posterior vena cava for hematology and serum biochemistry. All organs of the body surface, subcutis, head, thoracic cavity, and abdominal cavity were observed grossly. Then, the internal organs were removed and weighed. Results : No death occurred and no significant changes in clinical sign, body weight, food consumption and serum biochemistry parameters were observed in male and female rats over the study period. Although there were some alterations in hematologic and necropsy findings, and organ weights, these changes were not considered toxicologically significant. Conclusions : These results suggest that the 14-day repeated administration of HT042 does not produce any significant oral toxicity at doses of up to 2,000 ㎎/㎏/day in male and female rats under the present experimental conditions.