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作 者:熊明朋 刘宁 龚玮 刘波 XIONG Mingpeng;LIU Ning;GONG Wei;LIU Bo Jiangxi(Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)
机构地区:[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029
出 处:《药品评价》2022年第4期213-215,共3页Drug Evaluation
摘 要:目的:研究某中药育发液在体外哺乳动物微核试验中的遗传毒性。方法:采用MTT试验确定育发液的细胞毒性;采用中国仓鼠肺细胞株(CHL)细胞暴露在5.000μL/mL、2.500μL/mL、1.250μL/mL的育发液浓度下,分加S_(9)活化系统和无活化系统,培养3 h和24 h方案,进行体外微核试验。结果:MTT试验中,各剂量组在有活化系统和无活化系统的情况下,细胞毒性均小于10%;在体外微核试验中,供试品各剂量组在有活化系统和无活化系统情况下,与阴性对照相比差异无统计学意义(P>0.05),阳性对照组与阴性对照组相比差异有统计学意义(P<0.01),显示各剂量组的育发液对CHL细胞致突变性为阴性。结论:育发液在5.000μL/mL、2.500μL/mL、1.250μL/mL的情况下,对哺乳动物细胞没有致突变性,表明无遗传毒性。Objective:To study the genotoxicity of a traditional Chinese medicine hair growth liquid in mammalian micronucleus test in vitro.Methods:MTT assay was used to determine the cytotoxicity of hair growth liquid.CHL cells were exposed to 5.000 μg/mL,2.500 μg/mL,1.250 μg/mL hair growth culture solution,with and without S_(9) activation system,cultured for 3 hours and 24 hours,and micronucleus test was carried out in vitro.Results:In MTT test,the cytotoxicity of each dose group with and without activation system was less than 10%;the micronucleus test in vitro,there was no significant difference between the positive control group and the negative control group with and without activation system (P>0.05),and there was a very significant difference between the positive control group and the negative control group (P<0.01),which showed that the mutagenicity of hair growth hair culture liquid in each dose group to CHL cells was negative.Conclusion:At 5.000 μg/mL,2.500 μg/mL,1.250 μg/mL hair growth culture solution,hair growth liquid has no mutagenicity to mammalian cellsin vitro,indicating no genotoxicity.
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