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作 者:由振强[1] 宣尧仙[1] 蒋春红 陈晓 宋翼升[1] 谢宁 周国亮[1]
机构地区:[1]浙江省医学科学院安全性评价研究中心、国家新药安全评价研究重点实验室,杭州310013 [2]江西青峰药业有限公司,江西赣州341000
出 处:《中国临床药理学杂志》2013年第1期48-50,共3页The Chinese Journal of Clinical Pharmacology
基 金:国家重大新药创制科技重大专项基金资助项目(2012ZX09302001)
摘 要:目的研究喜炎平注射液的遗传毒性。方法用微生物回复突变试验、小鼠骨髓嗜多染红细胞微核试验、中国仓鼠肺成纤维细胞染色体畸变试验,检测喜炎平注射液遗传毒性。结果喜炎平注射液在每皿≤5 000μg内,代谢和非代谢活化条件下,对所测5种菌株的回变菌落数与阴性对照组比较均无统计学差异(P>0.05),对各菌株均未见致回复突变作用;亦未见诱发微核作用和染色体畸变诱发作用。结论喜炎平注射液在所测剂量范围内,未显示遗传毒性。Objective To study the genotoxicity of Xiyanping Injection in mice. Methods The Ames test, micronucleus test of mice bone marrow polychromatic erythrocytes and chromosomal abnormality test of Chinese hamster lung cells were used to assess the genotoxicity of Xiyanping Injection. Results Compared with the negative control group, no statis- tical difference ( P 〉 0. 05 ) was found in the number of colonies with back mutation pervessel in the five strains treated with Xiyanping Injection ( ≤ 5 000 ug/plate ) with or without S9 activation. And it also showed that Xiyanping Injection has no effect on chromosomal abnormality and micronuclei induced in all these studies. Conclusion Xiyanping Injection does not show its genetic toxicity within the dose range that was measured.
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