Liver-Immune Research Center, Institute of Traditional Medicine and Bioscience of Daejeon University, 22-5, Daeheung-dong, Jung-gu, Daejeon 301-724, Republic of Korea.
Food Chem Toxicol. 2010 Feb;48(2):743-9. doi: 10.1016/j.fct.2009.12.008. Epub 2009 Dec 23.
CGX is a potential hepatoprotective herbal medicine used to treat various chronic liver disorders. The purpose of the study was to evaluate the pharmaceutical safety of CGX via a systemic 13-week repeated dose toxicity test in beagle dogs. Male and female beagle dogs were divided into four groups and two animals each from the control and high-dose group (400 mg/kg) were allocated into recovery groups. The dogs were administered with CGX (0, 100, 200, 400 mg/kg) for 13 weeks. During the experimental period, the dogs were observed for signs of gross toxicity and for behavioral changes; body weight and food consumption were measured. An ophthalmologic examination and urinalysis were performed at 0 and 13th week and blood biochemistry and hematological parameters analyses were performed at 0, 6th, and 13th week. A histopathological examination was also performed at the end of the experiment. There were no CGX-induced abnormalities in clinical signs, organ weights, food consumption, hematological, urine, and blood biochemical parameters, or histopathological findings in any of the groups during or after the 13 weeks. We demonstrated the safety of CGX for 13-week repeated dose and considered that it is safe for chronic clinical use.
CGX 是一种具有潜在保肝作用的草药,用于治疗各种慢性肝脏疾病。本研究的目的是通过对犬进行为期 13 周的重复剂量毒性试验,评估 CGX 的药物安全性。雄性和雌性比格犬分为四组,每组各有两只动物,对照组和高剂量组(400mg/kg)各有两只动物分配到恢复组。犬给予 CGX(0、100、200、400mg/kg)13 周。在实验期间,观察犬的大体毒性和行为变化;测量体重和食物消耗量。在第 0 和第 13 周进行眼科检查和尿液分析,在第 0、第 6 和第 13 周进行血液生化和血液参数分析。实验结束时还进行了组织病理学检查。在任何一组中,在 13 周的试验期间或之后,均未观察到 CGX 引起的临床症状、器官重量、食物消耗、血液学、尿液和血液生化参数或组织病理学异常。我们证明了 CGX 重复给药 13 周的安全性,并认为其可安全用于慢性临床应用。