Study on irradiation sterilization of ceftiofur hydrochloride injection by 60Co-γ irradiation
The purpose of the study was to investigate the possibility of irradiation sterilization of ceftiofur hydrochloride injection.The samples of ceftiofur hydrochloride injection were irradiated with different radiation doses(8,16,24,32,40 kGy).The sedimentation volume ratio,content,related substances and sterility of the samples were tested before and after irradiation,and the irradiated samples were subjected to accelerated stability test at 40 ℃.The results showed that compared with before irradiation,the sedimentation volume ratio of the sample had no significant change,and the sterility of the product could be ensured after different irradiation doses.With the increase of irradiation dose,the sample content decreased and the impurity increased.When the radiation dose was 32 kGy and 40 kGy,the properties of the samples changed.Under the condition of acceleration at 40 ℃,with the extension of acceleration time,the content of samples with irradiation dose of 8～16 kGy decreased slightly,and the related substances increased slightly.After six months of acceleration,all the detected items were within the qualified range.The results showed that the samples of ceftiofur hydrochloride injection could be sterilized by irradiation.According to the results of accelerated stability of the product,the optimal irradiation dose was 8～16 kGy.
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