Study on Bacterial Reverse Mutation Test of Milk Calcium Chewable Tablets
Objective To evaluate the potential mutagenicity of Milk Calcium Chewable Tablets via bacterial reverse mutation assay,and explore the effect of the content of histidine in Milk Calcium Chewable Tablets on the number of spontaneous revertant colonies.Methods Salmonella typhimurium mutant strains TA97a,TA98,TA100 and TA102 were adopted for bacterial reverse mutation test,using liver homogenate as in vitro metabolic activation system(+/-s9).At the same time,blank control group,solvent control group and positive control group were set.For Milk Calcium Chewable Tablets,5 doses(50,10,2,0.4,0.08 mg/ml)were set and plate incorporation method was adopted.In addition,6 doses of histidine control group(1000,500,250,125,62.5,31.25 µg/ml)were also set.Results In a certain dose range of histidine,the number of spontaneous revertant colonies of four strains increased along with the increase of the histidine dose.As the histidine dose continued to increase,the number of revertant colonies decreased.The number of revertant colonies of each strain in each dose group of Milk Calcium Chewable Tablets,with or without S9,did not exceed twice the number of revertant colonies in the solvent control group,and there was no dose-response relationship was observed,indicating the result of Ames test was negative.Conclusion The results of Ames test of Milk Calcium Chewable Tablets are negative within the dose range of test in this study,indicating that Milk Calcium Chewable Tablets have no mutagenicity.Meanwhile,the influence of histidine component on the results of Ames test of Milk Calcium Chewable Tablets is excluded.
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