不同标记时间的锝[^(99)Tc^(m)]植酸盐注射液在靶器官中放射性摄取量的显著性差异分析

An Analysis of Significant Differences in Radioactive Uptake of Technetium[^(99)Tc^(m)]Phytate Injection at Different Radiolabeling Times in Targeted Organs

目的判断在标记后第0小时和标记后第6小时锝[^(99)Tc^(m)]植酸盐注射液在小鼠肝脏和甲状腺中的放射性摄取率是否存在显著差异,为产品有效期的制定提供依据。方法以3批锝[^(99)Tc^(m)]植酸盐注射液和9只小鼠为实验对象,将小鼠分为3组,每组3只。通过尾静脉注射的方式向第1~3组小鼠体内注射第1~3批标记后第0小时的锝[^(99)Tc^(m)]植酸盐注射液604~734kBq,通过单因素方差分析(One-Way ANOVA)对实验数据进行统计分析,先行判断批间显著性差异;以3批锝[^(99)Tc^(m)]植酸盐注射液和18只小鼠为实验对象,将小鼠分为6组,每组3只。其中,通过尾静脉注射的方式向第1~3组小鼠体内注射第1~3批标记后第0小时的锝[^(99)Tc^(m)]植酸盐注射液440~584kBq,同法向第4~6组小鼠体内注射第1~3批标记后第6小时的锝[^(99)Tc^(m)]植酸盐注射液440~584kBq,通过单因素方差分析对实验数据进行统计分析。结果第1~3组小鼠肝脏和甲状腺摄取率的假设检验F值分别为0.307和0.800,均小于F-crit值5.143,即3批锝[^(99)Tc^(m)]植酸盐注射液的肝与甲状腺放射性摄取率差异没有统计学意义;第1~3组、4~6组小鼠肝脏和甲状腺摄取率的假设检验F值分别为0.084和0.941,均小于F-cirt值4.494,即标记后0h和标记后6h的锝[^(99)Tc^(m)]植酸盐注射液在小鼠体内的分布差异无统计学意义。结论标记6h后的锝[^(99)Tc^(m)]植酸盐注射液在小鼠肝脏和甲状腺的放射性摄取率均满足药典要求,且药物仍然可以保持良好的生物分布特性,锝[^(99)Tc^(m)]植酸盐注射液的有效期制定为不大于6h。

Objective To determine whether there is a significant difference in the radioactive uptake rate of[^(99)Tc^(m)]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[^(99)Tc^(m)]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[^(99)Tc^(m)]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[^(99)Tc^(m)]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[^(99)Tc^(m)]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[^(99)Tc^(m)]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[^(99)Tc^(m)]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[^(99)Tc^(m)]phytate injection in mice between 0 hour and 6 hours after labeling.Conclusion The radioactive uptake rate of[^(99)Tc^(m)]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[^(99)Tc^(m)]phytate injection can be set to no more than 6 hours.