均匀设计在氟氯西林钠工艺优化中的应用  

Application of uniform design on the process optimization of flucloxacillin sodium

作　　者：刘慧勤 严正人 王利杰 吕冠芳 黄娟 Liu Hui-qin;Yan Zheng-ren;Wang Li-jie;LüGuan-fang;Huang Juan(North China Pharmaceutical Group Semisyntech Co.,Ltd,Shijiazhuang 052165)

机构地区：[1]华北制药集团先泰药业有限公司,石家庄052165

出　　处：《中国抗生素杂志》2018年第12期1514-1517,共4页Chinese Journal of Antibiotics

基　　金：河北省藁城区科学技术研究与发展计划(No.201411)

摘　　要：均匀设计适用于多因素多水平的实验设计。本文采用均匀设计对氟氯西林酰胺缩合单元工艺参数进行优化,运用U_(10)(10^(10))均匀设计表对反应温度、加入丙酮体积和反应pH值3个因素进行了10个水平的筛选,考察反应率、杂质1～3与因素水平之间的关系。运用SPSS软件对数据进行回归分析,得到反应率、杂质1～3与因素水平之间的线性回归方程,预测了氟氯西林酰胺缩合单元最佳工艺参数范围。最后对回归方程进行了试验验证,预测值与实测值有良好的吻合。Uniform design is suitable for multi-factor and multi-level experimental design.In this paper,the process parameters of the flucloxacillin amide condensation reaction unit were optimized using uniform design.The U10(10^10)uniform design table was used to screen the reaction temperature,the acetone volume,the pH value for 10 levels.In addition,the paper also detected the relationship between rate of reaction,impurity 1-3,and the levels of factors.By using SPSS software to regress the data,the linear regression equation between the rate of reaction, impurity 1-3,and the levels of factors was obtained.Then,the optimal process parameter range of flucloxacillin condensation unit was predicted.Finally,the regression equation was tested and verified.The predicted values and the measured values had good consistency.

关 键 词：氟氯西林 酰胺缩合 均匀设计 回归 

分 类 号：R978.11[医药卫生—药品] O213.1[医药卫生—药学]