Oral acute and chronic toxicity studies of β, β-dimethylacrylalkannin in mice and rats

DOI Web Site 参考文献15件
  • Zhang Piao-Piao
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Yan Xiao-Dan
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Fan Xiao-Yu
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Ling Ya-Hao
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Li Chao
    Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., China
  • Lin Lin
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Qin Dan
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Liu Tian-Tian
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Li Ye
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Li Hui
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Zhang Qianqian
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China
  • Mu Wen-Bo
    Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., China
  • Wang Ai-Ping
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., China
  • Jin Hong-Tao
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., China
  • Wei Jin-Feng
    New Drug Safety Evaluation Center, Institute of Materia Medica, Peking Union Medical College, China Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., China

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<p>β, β-dimethylacrylalkannin is a major active chemical component extracted from Lithospermum erythrorhizon, a traditional Chinese medicine that exhibits strong antimicrobial, anti-cancer and anti-inflammatory activities. However, its potential toxicity has not been rigorously studied. To confirm its safety, the oral toxicity of β, β-dimethylacrylalkannin was evaluated in vivo. An acute oral toxicity study in mice demonstrated that β, β-dimethylacrylalkannin was practically nontoxic based on its high median lethal dose (LD50 > 10 g/kg). No deaths or abnormal responses were observed in the acute toxicity test using Wistar rats, suggesting that the maximum tolerated dose of β, β-dimethylacrylalkannin was greater than 10 g/kg. Chronic toxicity studies also revealed an absence of mortality and clinical symptoms, and no treatment-related adverse effects were detected by hematology, blood biochemistry and urinalysis examinations in all rats treated with 10-160 mg/kg/day β, β-dimethylacrylalkannin during a 6-month period. Increases in the relative organ weight of the lungs of females and the liver of males were observed at 160 mg/kg. Histopathological analyses revealed brown pigmentation in renal tubular epithelial cells at the middle and high doses (40-160 mg/kg/day). The no-observed-adverse-effect level (NOAEL) of β, β-dimethylacrylalkannin is 10 mg/kg/day. These results suggest that β, β-dimethylacrylalkannin is potentially safe for further development as a therapeutic agent in humans.</p>

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