摘要
通过赋形剂种类与用量、缓冲系统种类与浓度、成品pH值、活性炭用量、冻干曲线考察,确定了注射用醋酸卡泊芬净处方和制备工艺。为研制制定的处方及生产工艺能否生产出质量符合规定的产品,进行了中试放大生产,并对生产的成品进行质量检验。通过检测数据可知,我公司研制的注射用醋酸卡泊芬净处方工艺可行,成品质量均一可控,稳定性较好。
The formulation and preparation technology of caspofungin acetate for injection were confirmed by the research of types and dosages of vehicle,types and concentration of cache system,produce p H value selection,dosage of active carbon and freeze-drying process.We carried out the pilot-scale production and inspected the quality of finished produce in order to make sure that the quality of product which produced according to the formulation and preparation technology whether meet the quality standers.According to the inspection results,we confirm formulation and preparation of technology of caspofungin acetate for injection is feasible,quality of finished produce controllable and stable in quality.
作者
伏世建
赵砚荣
Fu ShiJian;Zhao YanRong(Jiangsu Aosaikang Pharmaceutical CO.,LTD,Jiangsu NanJing 211112)
出处
《化工时刊》
CAS
2018年第8期23-27,34,共6页
Chemical Industry Times
关键词
醋酸卡泊芬净
制备方法
检测方法
caspofungin acetate
preparation method
inspection method
