An Analysis of Significant Differences in Radioactive Uptake of Technetium[99Tcm]Phytate Injection at Different Radiolabeling Times in Targeted Organs
Objective To determine whether there is a significant difference in the radioactive uptake rate of[99Tcm]phytate injection in liver and thyroid of mice at 0 hour and 6 hours after labeling,and to provide a knowledge basis for establishing the product's shelf life.Methods Three batches of technetium[99Tcm]phytate injection and 9 mice were used as experimental objects,and these mice were divided into 3 groups with 3 mice in each group.Mice in groups 1-3 were injected with technetium[99Tcm]phytate injection 604-734 kBq at 0 hour after the labeling of batches 1-3 by tail vein injection,and the experimental data were statistically analyzed by one-way ANOVA to determine the significant differences among batches;The experiment involved 3 batches of[99Tcm]phytate injections and 18 mice,which were divided into 6 groups with 3 mice in each group.Groups 1-3 were injected via the tail vein with 440-584 kBq of[99Tcm]phytate injection from batches 1-3 at 0 hour after labeling,and groups 4-6 were injected in the same method with 440-584 kBq of[99Tcm]phytate injection from batches 1-3 at 6 hours after labeling.Statistical analysis of the experimental data was conducted using one-way ANOVA.Results The hypothesis test F-values of liver and thyroid uptake in groups 1-3 were 0.307 and 0.800,respectively,which were lower than F-crit value of 5.143,suggesting no significant difference in the radioactive uptake rates of liver and thyroid in these three batches of technetium[99Tcm]phytate injection;F-values for liver and thyroid uptake rates in groups 1-3 and 4-6 were 0.084 and 0.941,respectively,both less than F-critical value of 4.494.This indicated that there was no significant difference in the distribution of[99Tcm]phytate injection in mice between 0 hour and 6 hours after labeling.Conclusion The radioactive uptake rate of[99Tcm]phytate injection in liver and thyroid of mice at 6 hours after labeling meets the requirements of the pharmacopeia,indicating that the drug can still maintain good biodistribution characteristics.Therefore,the shelf life of[99Tcm]phytate injection can be set to no more than 6 hours.
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