舒肝丸辐照灭菌剂量的设定及辐照后其对大鼠肝功能的评价试验

The determination of absorbed doses for sterilization of shu-ganwan and evaluation for effects of irradiated shu-ganwan on liver function of rat

探索舒肝丸辐照灭菌剂量,及辐照后其对大鼠肝功能的影响,为辐照灭菌舒肝丸的临床安全应用提供实验依据。测定舒肝丸初始污染菌,经钴源辐照灭菌后,测定D10值及SD;用辐照灭菌后的舒肝丸对大鼠进行灌胃给药,测定大鼠血液生化指标,观察辐照的舒肝丸对大鼠生化指标的影响。本次实验舒肝丸初始污染菌范围在50-1800 CFU/g,D10值为1.81 kGy,经计算辐照灭菌剂量为11.322 kGy,确定灭菌保证水平为10-3,辐照后的舒肝丸对实验大鼠肝功能指标无明显损害作用。舒肝丸辐照灭菌剂量为11.322 kGy,经12 kGy辐照后的舒肝丸对实验大鼠肝功能指标无明显损害作用。

The absorbed dose of irradiation sterilization for Shu-Gan Wan and the effects of irradiated Shu-Gan Wan on rat liver function was investigated to provide the scientific basis for its clinical safety applications.The amount range of contaminating bacteria in original Shu-Gan Wan was determined before irradiation and the D10 SD were calculated after irradiation.The irradiated Shu-Gan Wan were given to the rats and the biochemical items of liver were measured before and after-irradiation.The experimental results show that the amount range of contaminat-ing bacteria count of the Shu-Gan Wan is 50-1800 CFU/g,the D10 value is 1.81 kGy and the minimum bactericidal dose has been calculated to be 11.322 kGy.The 60Co radiation dose for sterilization of Shu-Gan Wan has been sug-gested to be 11.322 kGy and irradiated Shu-Gan Wan has no significant damage to liver function of the rat.