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《Carcinogenesis,Teratogenesis & Mutagenesis》 2009-04
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Genotoxicity of Fructus Schisandrae Chinensis Concoction

HU Yan-ping,WANG Xin,SONG Jie,ZHANG Min,WANG Xiu-wen,LI Bo(National Center for Safety Evaluation of Drugs,National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100176,China)  
BACKGROUND AND AIM: To investigate the genotoxicity of Fructus Schisandrae Chinensis concoction using mouse lymphoma assay(MLA) and mouse bone marrow micronucleus test(MNT).MATERIALS AND METHODS: In MLA,four doses 0.97,1.94,3.88,7.77 mg/ml(crude drug)were used to treat L5178Y cells for 3 hours with and without metabolic activation,then expressed for 2 days.The mutation frequency plates were prepared and incubated for 12 days.Colony size in each plate was scored,and total mutation frequency and percentage of small colony mutants were calculated and assayed.In MNT,three dose levels of 3.13,6.25,12.50 g/kg(crude drug)were used.10 ICR mice(5 males/5 females) in each group were gavaged every 24 h twice and sacrificed after 24 hours of the last dosing.Both femur bones were collected to prepare bone marrow smear.For each mouse,the number of micronucleated polychromatic erythrocytes(MNPCE) in 2000 polychromatic erythrocytes(PCE) was counted,and the mean of rate of MNPCE of each group was calculated.RESULTS: MLA indicated that the total mutation frequency showed a dose-dependent increase with metabolic activation,and was statistically significant(P0.01) compared with negative control with and without metabolic activation.Percentage of small colony mutants was similar with positive control at high concentrations.MNT indicated the concoction did not show inhibitory effects on bone marrow,and the rate of MNPCE of each group induced did not show significant increase compared with negative control.CONCLUSION: Fructus Schisandrae Chinensis concoction induced tk gene mutation and chromosomal damage in L5178Y cells with and without metabolic activation.It indicated that the test article may have potential genotoxicity for humans.However Fructus Schisandrae Chinensis concoction did not show chromosomal damage of bone marrow in ICR mice,demonstrating no genotoxicity in vivo with metabolic activation under this study condition.
【Fund】: 国际科技合作项目:促进中药材在法国的注册和进入(2006DFB31690)
【CateGory Index】: R285
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