阿莫西林结晶工艺研究  

Crystallization Process of Amoxicillin

作　　者：冷凤[1] 赵静[1] 任风芝[1] 李晓露[1] 刘月[1] 张雪霞[1] 王秀英 LENG Feng;ZHAO Jing;REN Fengzhi;LI Xiaolu;LIU Yue;ZHANG Xuexia;WANG Xiuying(NCPC New Drug Research & Development Co.,Ltd.,National Engineering Research Center of Microbial Medicine,Hehei Industry Microbial Metabolic Engineering & Technology Research Center,Shijiazhuang 052165,China;North Best Branch Factory of North China Pharmaceutical Co.,Ltd.,Shijiazhuang 050015,China)

机构地区：[1]华北制药集团新药研究开发有限责任公司,微生物药物国家工程研究中心,河北省工业微生物代谢工程技术研究中心,河北石家庄052165 [2]华北制药股份有限公司北元分厂,河北石家庄050015

出　　处：《化学与生物工程》2022年第3期48-51,63,共5页Chemistry & Bioengineering

基　　金：河北省科技研发平台建设专项(199676154H)。

摘　　要：采用相似因子法考察了阿莫西林原料药粒度对阿莫西林胶囊溶出行为的影响,并对阿莫西林结晶工艺进行了优化。确定了阿莫西林原料药D[4,3](体积平均粒径)宜控制在40~65μm,最佳结晶工艺如下:结晶浓度为0.20 mg·mL^(-1),晶种加入量为4%~6%,投加晶种pH值为1.15~1.25,养晶时间为20~30 min。在此工艺条件下制备的阿莫西林晶体均匀规整、粒度分布窄,保证了阿莫西林相关制剂产品与参比制剂溶出行为的一致性。We investigated the effect of particle size of Amoxicillin bulk drug on dissolution behavior of Amoxicillin Capsules by a similarity factor method,and optimized the crystallization process of Amoxicillin.The results show that D[4,3](mean volume particle size)of Amoxicillin bulk drug should be controlled between 40μm and 65μm,and the optimal crystallization process can be determined as follows:the crystallization concentration is 0.20 mg·mL^(-1),the addition amount of crystal seed is 4%-6%,the pH value of adding crystal seed is 1.15-1.25,and the crystallization time is 20-30 min.Under above conditions,the Amoxicillin crystal is uniform and neat,and the particle size distribution is narrow,which ensure the consistency of the dissolution behavior of Amoxicillin related preparations and reference preparations.

关 键 词：阿莫西林 结晶工艺 晶型 粒度 溶出行为一致性 

分 类 号：TQ465.1[化学工程—制药化工]