【摘要】 考察了不同结晶体系对头孢拉定结晶过程的影响,通过正交试验优化了头孢拉定结晶工艺条件,即水量为头孢拉定质量的2倍,三乙胺和N,N-二甲基甲酰胺体积比为1.2,结晶初始温度30℃,结晶终了温度5℃。结果证明,在此条件下所得产品结晶收率可达92%左右。利用高效液相色谱、电子显微镜对产品进行检测证明产品纯度可达98%以上,粒度分布均匀,晶面完整;同时通过40℃储存条件下的化学稳定性试验表明产品稳定性符合药品质量要求。更多还原

【Abstract】 Cephradine crystallization in different kinds of precipitating systems was studied.An orthogonal design test with 4 factors showed that the best conditions were as follows: the volume of water was 2 times of cephradine weight,ratio of TEA and DMF was 1.2∶1,initial crystallization temperature was 30℃,cooling temperature was 5 ℃.The yield of cephradine crystallization is about 92% in this condition.The production in this crystallization process was analysised with HPLC and EM.It shows that the purity of product is over 98% and the model of crystal is good and well-distribted.By chemical stability test under 40 ℃,it shows that the stability of product meet criterion of drugs.更多还原