注射用左旋泮托拉唑钠的遗传毒性研究

Study on the Genetic Toxicity of S-(-)-pantoprazole Sodium for Injection

目的探讨注射用左旋泮托拉唑钠的遗传毒性。方法采用Ames试验、CHL细胞体外染色体畸变试验和体内微核试验3项试验组合,检测注射用左旋泮托拉唑钠的遗传毒性。结果Ames试验表明,注射用左旋泮托拉唑钠各剂量组回变菌落数与溶媒对照组比较,均无显著性升高;CHL细胞体外染色体畸变试验表明,各剂量组的染色体畸变率与溶媒对照组比较,差异无统计学意义;小鼠体内微核试验表明,各剂量组的微核率与溶媒对照组比较,差异无统计学意义;三项试验结果均为阴性。结论在本试验条件下,注射用左旋泮托拉唑钠未见遗传毒性作用。

Objective To study the genetic toxicity of S-(-)-pantoprazole sodium for injection.Methods The genetic toxicity of S-(-)-pantoprazole sodium for injection was evaluated by three experiments,including Ames test,CHL cell chromosome aberration test in vitro and micronucleus test in vitro.Results The results of Ames test showed that the number of bacterial colonies in each dose group of S-(-)-pantoprazole sodium for injection did not increase significantly compared with that of the solvent control group.The results of chromosome aberration test of CHL cells in vitro showed that the difference between chromosome aberration rates of S-(-)-pantoprazole sodium for injection treated groups and that of the solvent control group was not statistically significant.The results of micronucleus test in vitro showed that the difference between the micronucleus rate of S-(-)-pantoprazole sodium for injection treated groups and that of the solvent control group was not statistically significant.All the results of the three tests were negative.Conclusion Under the conditions of this test,S-(-)-pantoprazole sodium for injection has no genotoxic effect.