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생약복합제 SKI306X 의 랫드에 대한 4 주 경구 반복투여 독성연구
김훈택(Hun Taek Kim),안재석(Jae Suk Ahn),정인호(In Ho Jeong),김택수(Taek Soo Kim),류근호(Keun Ho Ryu),임광진(Guang Jin Im),조용백(Yong Baik Cho),김대기(Dae Kee Kim),김환수(Hwan Su Kim),박광식(Kwang Sik Park),김기협(Key H . Kim),박병욱(P 한국응용약물학회 1996 Biomolecules & Therapeutics(구 응용약물학회지) Vol.4 No.1
This study was performed to determine the subacute toxicities of SKI306X, an antiinflammatory herbal extract, in rats. SKI306X was administered orally to rats once a day for 4 weeks at doses of 0.3, 1.0, and 3.0 g/㎏/ day. Each group consisted of 20 male and 20 female rats, including 5 male and 5 female rats per group for an interim study at the end of 2-week administration and for a 2-week recovery study, respectively. Throughout the study, all rats survived and no adverse clinical signs were observed. Although male rats treated with high dose (3.0 g/㎏/day) of SKI306X showed slight loss of body weight (approximately 5%) in comparison with control animals during the administration period, their body weight loss was normally restored during the recovery period. No significant change was found in all hematological parameters of SKI306X-treated groups except for the decreased number of red blood cells in all female groups at the interim study. Statistically significant changes were observed in several blood enzyme levels of SKI306X-treated groups; however, most of these significant changes were within normal range and statistically significant values did not show dose-related responses. In SKI306X-treated groups, the absolute and relative weights of liver, heart, and stomach were statistically different from those of control group, but these differences disappeared at the end of recovery period and also drug-related gross and histopathological findings in these organs were not found. No other drug-related gross and histopathological findings were observed. It is concluded from the results of this study that non-toxic dose of SKI306X was estimated to be between 0.3 and 1.0 g/㎏/day and the maximum tolerated dose of SKI306X was assumed to be higher than 3.0 g/㎏/day.
랫드에서 생약복합제 SKI306X 의 급성독성에 관한 연구
안재석(Jae Suk Ahn),김훈택(Hun Taek Kim),조용백(Yong Baik Cho),김환수(Hwan Su Kim),박광식(Kwang Sik Park),박병욱(Pyeong Uk Park) 한국응용약물학회 1996 Biomolecules & Therapeutics(구 응용약물학회지) Vol.4 No.1
SKI306X is a herbal extract prepared from three herbs Clematis mandshurica, Trichosanthes kirilowii and Prunella vulgaris. It showed strong antiinflammalory actions on carrageenan-induced edema, acetic acid-induced pain, adjuvant-induced arthritis, and oxygen radical-generated reactions. In this study, the acute toxicity of SKI306X was evaluated in rats by a single oral administration. Thirty male and thirty female rats were divided into 6 groups according to the dose levels, respectively. After oral administration of SKI306X with several doses (5.0 g/㎏, 3.3 g/㎏, 2.2 g/㎏, 1.5 g/㎏, 1.0 g/㎏), mortality, clinical signs, body weight, and gross findings in organs were examined. No toxic effect was shown in terms of mortality, clinical signs, body weight changes and gross findings. It is suggested the LD_(50) of SKI306X would be more than 5.0 g/㎏ in rats.