摘要
在线颗粒度分析仪(FBRM)是专门为在线监测颗粒度相关参数设计的一种仪器,本文采用FBRM对美伐他汀药物结晶工艺进行在线监测。在现行生产工艺的基础上,从复合溶剂、养晶时间和溶解程度3个方面对美伐他汀工艺进行考察,得出以下结论:(1)在现行工艺的控制范围内,复合溶剂优化在美伐他汀粗品∶甲苯∶乙酸乙酯=1∶3∶0.5时,颗粒度总数最多,平均粒径较小,最适宜工业化生产;(2)养晶时间选择在25min左右为宜;(3)降温结晶前无需经过超滤等前处理,溶解40min左右后即可降温结晶,对产品质量和产量影响不大。
Focused Beam Reflectance Measurement （FBRM） is an equipment designed for on-line monitoring of the relevant parameters of particles. In this paper, we used FBRM to monitor the crystallization process of mevastatin. On the basis of production process, we discussed the influence of compound solvent, crystal growth time and the extent of dissolution to the mevastatiu crystallization process. Finally we reached to the following conclusions ： （ 1 ） In the proportion of crude mevastatin ： toluene ： ethyl acetate = 1 ： 3 ： 0.5, the process resulted in the largest total number of particles and the compatible average particle size, which were the most desired industrial production requirements; （2） 25min is the suitable crystal growth time; （3） There was no need of any pre-treatment such as ultrafihration before crystallization.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2009年第8期471-474,共4页
Chinese Journal of Antibiotics
