^(60)Co-γ射线对盐酸四环素原料灭菌的研究

Impact of ^(60)Co-γ-ray Sterilization of Tetracycline Hydrochloride Raw Materials

采用不同剂量的60Co-γ射线对盐酸四环素原料进行辐射灭菌,结合稳定性考察数据,最终确定盐酸四环素原料的60Co-γ射线的辐射剂量为9 k Gy时,其理化检测指标符合USP的要求,且无菌检查符合要求。

Different doses of 60Co-γ rays were compared for radiation sterilization on raw materials of tetracycline hydrochloride. By checking stability data, the optimal radiation dose of 60Co-γ rays on tetracycline hydrochloride raw materials was 9 kGy, at which its physical and chemical detection indicators were in line with the requirements of USP, and the sterility test results met the requirements..