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A 90-day Repeated-Dosed Toxicity Study of Euphorbiae kansui radix Extract in Fischer 344/N Rats
Zhong-Ze Han,Hu-Song Zhang,Ki-Hyun Gil,Joo-Young Lee,Kwang-Han Kong,Myoung-Kyu Han,Hyun-Ju Yang,Hak-Soo Kim,Do-Hyung Kim,Tae-Hwan Ahn,Jin-Sook Bae,Hyun-Kyu Ko,Jung-Woon Lee,Moon-Soon Kim,Si-Whan Song 한국실험동물학회 2008 Laboratory Animal Research Vol.24 No.4
This study was performed to evaluate repeated-dose toxicities of Euphorbiae kansui radix extract in F344/N rats. Euphorbiae kansui radix extract was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 ㎎/㎏/day. Each group consisted of 10 rats of each gender. The Euphorbiae Kansui, Radix extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program (issued by National Institute of Toxicological Research) and The Standards of Toxicity Study for Medicinal Products (issued by Korea Food and Drug Administration). In the present study, there were no dose-related changes in mortality, clinical signs, body weights, ophthalmoscopy, urine analysis, hematological findings, estrus cycle and sperm examination of all animals treated with Euphorbiae kansui radix extract. There were increases of liver weights in 2,000 ㎎/㎏/day groups of males and in 333, 1,000 and 2,000 ㎎/㎏/day groups of females. There were decreases of alkaline phosphatase levels in 1,000 and 2,000 ㎎/㎏/day groups of both sexes. These results suggest that the oral no-observed-adverse-effect level (NOAEL) of the test item, Euphorbiae kansui radix extract, in rats is 2,000 ㎎/㎏/day in both genders; no-observed-effect level (NOEL) is 1,000 ㎎/㎏/day in male and 111 ㎎/㎏/day in female. The target organs were thought to be liver and thymus.
Zhong-Ze Han,Hong-De Xu,Kwang-Ho Kim,Tae-Hwan Ahn,Jin-Sook Bae,Ji-Young Lee,Ki-Hyun Gil,Joo-Young Lee,Su-Jung Woo,Hyun-Jung Yoo,Hyun-Kul Lee,Kap-Ho Kim,Chan-Koo Park,Hu-Song Zhang,Si-Whan Song 한국실험동물학회 2010 Laboratory Animal Research Vol.26 No.2
The purpose of this paper is to provide reference data related to the body weight, food & water consumptions, urinalysis, hematology and serum biochemistry parameters and absolute & relative organ weights obtained from control Sprague-Dawley rats, used in the 4-week and 13-week repeated-dose toxicity studies conducted in our laboratory between 2005 and 2008. The mean, standard deviation, minimum and maximum range values for hematology and serum biochemistry parameters, data of absolute & relative organ weights, and the difference between sexes and study duration of week 4 versus 13 week are presented. The studies were conducted according to “the standards of Toxicity Study for Medicinal Products” (2005) and The KFDA Notification No. 2000-63 ‘Good Laboratory Practice (GLP)’ (2000) issued by KFDA. These data could be used as reference material of Sprague-Dawley rats by conducting the studies to evaluate the toxicological profile of pre-clinical toxicity studies.
Kwang-Han Kong,Ju Young Jung,Kyo Hwan Koo,Si-Whan Song,Kap-Ho Kim,Zhong Ze Han,Seon-Hwa Lee,Ho-Chul Shin 한국실험동물학회 2010 Laboratory Animal Research Vol.26 No.4
Recent researches on clinically used triazole antifungal reagents are focused on their pharmacokinetic disadvantage which increases the probability of inducing adverse effects in patients. For this point, in the present laboratory, Chemon Inc., has investigated new antifungal reactive compounds, KAF-200522 and its chloride form, KAF-200522 · HCl, which has a modified triazole structure. Pharmacokinetic data were measured with LC-MS/MS in male mice which were orally treated with the above compounds at 10 ㎎/㎏. T<SUB>max</SUB> and t<SUB>½</SUB> of KAF-200522 · HCl were comparable to KAF-200522, but AUC and C<SUB>max</SUB> were 1.4 and 1.6 times higher than those of KAF-200522, respectively. In beagle dogs, AUC and C<SUB>max</SUB> of KAF-200522 · HCl were 2.7 and 1.4 times higher than those of KAF-200522, and t<SUB>½</SUB> was 3.5 times higher than that of KAF-200522. Moreover, in beagle dogs, the oral bioavailability value of KAF-200522 · HCl was revealed as 31.0% to contrast to 6.2% of KAF-200522. In 1-week repeated oral treatment toxicity study of KAF-200522 in male rats, inhibition of body weight gain was observed in 120 ㎎/㎏ treatment group, and loss of body weight was observed in 600 ㎎/㎏ treatment group. In the toxicokinetic study of KAF-200522, no accumulation after the systemic exposure was observed. In conclusion, as to the new antifungal drug development, KAF-200522 · HCl was considered to be advantageous in pharmacokinetic characteristics compared to KAF-200522.