头孢克洛晶体粒度控制及应用  

Control and Application of Crystal Size of Cefaclor

作　　者：张立斌 贾全 田洪年 魏宝军 Zhang Libin;Jia Quan;Tian Hongnian;Wei Baojun(North China Pharmaceutical Hebei Huamin Pharmaceutical Co.,Ltd,Shijiazhuang 052165,China)

机构地区：[1]华北制药河北华民药业有限责任公司,河北石家庄052165

出　　处：《化工与医药工程》2022年第2期33-37,共5页Chemical and Pharmaceutical Engineering

摘　　要：为了有效控制头孢克洛原料药的粉体学指标,提高下游生产的适用性,对结晶过程控制进行了研究。采用单一变量对比试验,从搅拌转速、晶种加入时间和结晶温度等方面对头孢克洛的晶体粒径、形态及粒度分布进行了考察。试验结果显示300 r/min转速搅拌下,对晶体分散及成长较有利;在介稳区内高浓度出晶,产品粒径较小,粒度分布较窄;10℃结晶所得产品的晶形偏细长,晶体粒径小,且粒度分布范围较窄,随着温度的升高,产品晶体粒径增大,晶形趋于粗短,且粒度分布的范围增大。研究的粉体学影响因素可控性强,适用于产业化生产控制,产业化成品在头孢克洛口服制剂生产中适用性良好。In order to effectively control the powder index of cefaclor API and improve the applicability of downstream production,the control of crystallization process was studied.The particle size,morphology and particle size distribution of cefclone crystals were investigated by single variable contrast test from the aspects of stirring speed,seed adding time and crystallization temperature.The results showed that stirring at 300 r/min speed was favorable for crystal dispersion and growth.In the metastable zone,the high concentration of crystal growth leaded to small particle size and narrow particle size distribution.The product crystallized at 10℃ had elongated crystal shape,small crystal size and narrow particle size distribution range.With the increase of temperature,the crystal size of the product increased,the crystal shape tended to be coarser and shorter,and the particle size distribution range increased.The powder influencing factors studied were highly controllable and suitabled for industrial production control.The industrial finished products had good applicability in the production of cefaclor oral preparations.

关 键 词：酶法 头孢克洛 结晶 粒度 

分 类 号：TQ465.1[化学工程—制药化工]