盐酸头孢噻呋注射液^(60)Co-γ辐照灭菌的研究

Study on irradiation sterilization of ceftiofur hydrochloride injection by ^(60)Co-γ irradiation

研究旨在探讨盐酸头孢噻呋注射液使用辐照灭菌的可能性。试验采用不同辐照剂量(8、16、24、32、40 kGy)对盐酸头孢噻呋注射液样品进行辐照,辐照前后样品进行沉降体积比、含量、有关物质及无菌等项目的检测,并将辐照后的样品进行40℃加速稳定性试验。结果显示,与辐照前相比,样品的沉降体积比无明显变化,不同的辐照剂量辐照后均能够保证产品无菌。随着辐照剂量的增加,样品的含量有所降低,杂质有所升高;当辐照剂量为32、40 kGy时,样品性状发生改变。在40℃加速条件下,随着加速时间延长,辐照剂量为8~16 kGy的样品含量略有降低,有关物质略有增加,加速6个月后各检测项均在合格范围内。研究表明,盐酸头孢噻呋注射液样品可采用辐照灭菌,根据产品的加速稳定性结果,初步筛选最佳辐照剂量为8~16 kGy。

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.