硫酸头孢匹罗结晶工艺的优化研究  

Optimization of cefpirome sulfate on crystallization process

作　　者：任峰 李庆伟 贾全 田洪年 刘树斌 Ren Feng;Li Qing-wei;Jia Quan;Tian Hong-nian;Liu Shu-bin(NCPC Hebei Huamin Pharmaceutical Co.,Ltd,Shijiazhuang 052165)

机构地区：[1]华北制药河北华民药业有限责任公司,石家庄052165

出　　处：《中国抗生素杂志》2020年第10期1000-1004,共5页Chinese Journal of Antibiotics

摘　　要：目的优化硫酸头孢匹罗结晶工艺,降低产品色级、提高含量。方法采用单因素试验考察脱色pH值、活性炭用量、硫酸头孢匹罗粗品流加速率、晶种用量对产品色级、含量的影响。通过正交试验优选最佳硫酸头孢匹罗结晶工艺条件,并进行3批试验验证,优化工艺。结果硫酸头孢匹罗结晶工艺的最佳条件为脱色pH4.0、活性炭用量为4%、硫酸头孢匹罗粗品流加速率1.5mL/min、晶种用量2%。3批验证试验与正交试验结果一致,产品质量均符合企业内控质量标准。结论优化后的工艺稳定可行,可以有效降低产品色级,提高含量,产生可观的经济效益。Objective To optimize the crystallization process of cefpirome sulfate,reduce the color level,and increase the content of the product.Methods The effects of decolorization pH value,the amount of activated carbon,acceleration rate of crude product flow,and the amount of crystal seed on the color grade and content of cefpirome sulfate were investigated by the single factor test.The crystallization conditions of cefpirome sulfate were optimized by the orthogonal test,and the process was verified by three batches of experiments.Results The optimized parameters for the crystallization process of cefpirome sulfate were decolorization pH4.0,the dosage of activated carbon 4%,the acceleration rate of crude product flow of cefpirome sulfate 1.5mL/min and the dosage of seed 2%.The results of three batches of validation tests were consistent with the orthogonal test results,and the product quality conformed to the internal control quality standards of enterprises.Conclusion The process is stable and feasible,which can effectively reduce the product color level,increase the content,and produce considerable economic benefits.

关 键 词：硫酸头孢匹罗 结晶 正交试验 

分 类 号：R978.1[医药卫生—药品] T0Q460.6[医药卫生—药学]