粉末综合性质表征在头孢呋辛酯批量变更中的应用  

Application of Powder Comprehensive Properties Characterization in Batch Changes of Cefuroxime Axetil

作　　者：胡瑞祥 赵万利 曾环想 

机构地区：[1]国药集团致君(深圳)制药有限公司,广东深圳518110

出　　处：《中国药师》2018年第1期164-168,共5页China Pharmacist

摘　　要：目的:研究头孢呋辛酯粉末综合性质表征在批量变更中的应用。方法:使用FT4多功能粉末流动性测试仪测试头孢呋辛酯批量变更前粉末的稳定性和变化流动速率、压缩率、剪切性质、充气性、透气性,制定相应的粉末指标,批量变更后测定结果是否符合要求。结果:变更批量后3批产品的粉体学指标值均介于最佳范围内。结论:头孢呋辛酯生产工艺未变而批量变更对头孢呋辛酯片生产工艺的顺利进行不产生影响,为制剂生产厂家提供一种新的快速验证方法。Objective： To study the application of powder comprehensive properties characterization of cefuroxime axetil in batch changes. Methods： The stability and change of the powder before the batch change of eefuroxime axetil were measured by an FT4 mul- tifunetional powder flow tester. The flow rate, compression rate, shear property, air inflation and air permeability were measured. The corresponding powder index was established. After the batch change, the above indices were detected to assess whether meeting the re- quirements. Results： The volume index of three batches of products after the batch change was within the optimal range. Conclusion： The batch changes of cefuroxime axetil have no effect on the smooth progress of cefuroxime axetil production, which provides a new rap- id verification method for preparation manufacturers.

关 键 词：头孢呋辛酯 稳定性和变化流动速率 压缩率 剪切性质 充气性 

分 类 号：R978.11[医药卫生—药品]