The Liver Pills Irradiation Sterilization Dose Setting And Their Impact On The Long-term Toxicity Of Rats After Irradiation

Purpose：To explore the liver pills irradiation sterilization dose setting and theirpost-irradiation, long-term toxicity impact on rats. This study is to provide a scientificevidence for clinical safety applications of post-irradiation liver pills.Method：Determine the initial bioburden of the liver pills. After the cobaltirradiation sterilization, measure the D10and SD values. Gavage feeding the rats withpost-irradiation liver pills and make experiment observation for a long-term toxicity impacton the rats (120days). Determine the regular biochemical indices of the rats and observethe impact of the post-irradiation liver pills onto these indices. Determine the regular bloodand urine indices of the rats and observe the impact of post-irradiation liver pills to bloodindex and kidney function.Result：After applying linear regression and statistics calculation, a=7.1152,b=-0.5518, r=-0.9987; therefore, the linear regression equation is:1gy=7.1152-0.5518X. Since r (3)0.05, unilateral=0.988, so|r︳> r (3)0.05unilateral, P <0.05,suggesting that the irradiation dose and D-value of the biological indicator has significantlinear relationship. So, D10﹦1/︱b︱﹦1/|0.5518|=1.81kGy, SD=D101g(N0/N)﹦1.81x1g (1800/10-3)=11.322kGy.To sum up, the maximum initial bioburden of the liver pills was1800cfu/g. With D10value of1.81kGy and according to SAL for10-3, the minimum sterilization dose wasdetermined as11.322kGy. Therefore,11.32kGy was selected for this study. Thepost-irradiation liver pills have no obvious change or damage to the blood and kidneyfunction of the experimental rats. The post-irradiation liver pills have no obvious damageon liver function index of the experimental rats.Conclusion：The minimum60Co irradiation dosage that required sterilizing the liverpills is determined as11.322kGy. Based on the study, there was no obvious change or damage found in blood and kidney function of the experimental rats that fed with11.32kGy irradiated liver pills. The post-irradiation liver pills have no obvious damage onliver function index of the experimental rats.