盐酸头孢替安吸湿性研究

Hygroscopicity Study of Cefotiam Hydrochloride

目的:对盐酸头孢替安进行吸湿性研究,为注射用盐酸头孢替安的分装工艺提供依据。方法:取盐酸头孢替安原料置于不同相对湿度(31%、43%、52%、60%、75%和92.5%)环境中,通过测定不同时间吸湿增重从而计算吸湿率,绘制吸湿曲线获得临界相对湿度。结果:盐酸头孢替安原料有较强吸湿性,其临界相对湿度为58%。结论:本研究为注射用盐酸头孢替安在工业化生产中控制合理的相对环境湿度及分装工艺条件提供了科学依据。

Objective： To study the hygroscopicity of Cefotiam Hydrochloride,and to provide reference for packaging Cefotiam Hydrochloride for Injection.Methodes：Take Cefotiam Hydrochloride raw material was placed in desiccators with different relative humidities（31%、43%、52%、60%、75%and 92.5%）,by measuring the different time to calculate the weight increasing rate of moisture absorption,and the moisture equilibrium curve was drawn to achieve critical relative humidity. Results：Cefotiam Hydrochloride raw material has strong moisture absorption,the critical relative humidity of Cefotiam Hydrochloride was 58%. Conclusion：The study provides scientific basis for reasonable relative humidity control of industrial production of Cefotiam Hydrochloride for Injection and the condition of loading technology.