世界中医药
文章摘要
引用本文:赵刚1,张寅静2,郭小娟1,杨艳霞1,夏纯1,黄志军1.健脾生血颗粒遗传毒性研究[J].世界中医药,2016,(12):.  
健脾生血颗粒遗传毒性研究
Genotoxicity evaluation of Jianpi Shengxue Granule
投稿时间:2016-12-05  
DOI:10.3969/j.issn.1673-7202.2016.12.061
中文关键词:  健脾生血颗粒  遗传毒性  微粒体回复突变试验  染色体畸变试验  微核试验
English Keywords:Jianpi Shengxue Granule  Genotoxicity  Ames test  Chromosomal aberration test  Micronucleus assay
基金项目:武汉市“汉阳英才计划”项目(编号:A3-17)
作者单位
赵刚1,张寅静2,郭小娟1,杨艳霞1,夏纯1,黄志军1 1 健民药业集团儿童药物研究院,武汉,430052
2 湖北省食品药品安全评价中心,武汉,430073 
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中文摘要:
      目的:考察健脾生血颗粒的遗传毒性。方法:分别采用组氨酸营养缺陷性鼠伤寒沙门氏菌TA97a、TA98、TA100、TA102、TA1535回复突变试验(Ames试验),CHO-K1细胞染色体畸变试验,以及小鼠骨髓细胞微核试验考察健脾生血颗粒的遗传毒性。结果:Ames试验结果显示,健脾生血颗粒无论在含有和不含有S9的条件下,在所有评估剂量水平的所有测试菌中均可观察到重复正常生长,且所有剂量的回复突变数与阴性对照组相比均无2倍或以上的显著上调,且无剂量反应关系;CHO-K1细胞染色体畸变试验结果显示,健脾生血颗粒650、130、26 μg/mL 3个剂量组的CHO-K1细胞染色体畸变率均小于5%;小鼠骨髓细胞微核试验结果显示,健脾生血颗粒3个剂量组[2 000、1 000和500 mg/(kg·d)]与阴性对照组间微核率差异均无统计学意义(P>0.05)。结论:在本试验条件下,健脾生血颗粒未见遗传毒性作用。
English Summary:
      To evaluate the genotoxicity of Jianpi Shengxue Granule.Methods:Genotoxicity of Jianpi Shengxue Granule was studied using Ames test,CHO-K1 cell chromosomal aberration test,and mouse bone marrow cell micronucleus assay,respectively.Results:The Ames test results indicated that Jianpi Shengxue Granule did not affect the normal growth of tested bacteriums at all dosages with or without S9.Compared with the negative control group,all number of reversion mutation had no significant up-regulation,and no dose-response relationship was found.Results of CHO-K1 cell chromosomal aberration test indicated that the aberration rates of Jianpi Shengxue Granule group(650,130,and 26 μg/mL)were all less than 5%.Results of micronucleus assay indicated that there was no statistical difference of micronucleus rate between the Jianpi Shengxue Granule group(2 000,1 000,and 500 μg/mL)and negative group(P>0.05).Conclusion:No genotoxicity of Jianpi Shengxue Granule was found under the conditions of this study.
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