头孢特仑新戊酯干混悬剂的制备工艺研究

Study on Two Different Preparation Technology of Cefteram Pivoxil Suspension

目的两种工艺制备头孢特仑新戊酯干混悬剂,对比产品质量。方法采用干法制粒和流化床制粒两种方法制备头孢特仑新戊酯干混悬剂,以沉降体积比、溶出度、含量、有关物质为评价指标对比产品质量,并分析两种制备工艺在生产上的可行性。结果经两种工艺制得的产品质量相当,相关评价指标均符合规定,但流化床制粒方式的操作工时明显缩短。结论采用流化床制粒方式制备头孢特仑新戊酯干混悬剂在生产上的可行性更高。

Objective Using two different processes to prepare cefteram pivoxil suspension, and compare the quality of product obtained. Methods Dry granulation and fluidized bed granulation were used to prepare the cefteram pivoxil suspension, the sedimentation volume ratio, dissolution, content and related substances were used as evaluation index to compare the quality of the products, and a brief analysis was made for the feasibility of the two kinds of preparation process on the production. Results The product＇ s related evaluation quality in the system of two processes complied with the provisions, but the period of fluidized bed granulation process was significantly shortened. Conclusion Fluidized bed granulation to prepare the cefteram pivoxil suspension was more feasible on production.