米卡芬净母核冻干工艺研究  

Study on the freeze-drying process of micafungin nucleus

作　　者：蔡喜田 邓佩佩[1] 仲伟潭[1] 刘素彦[1] 祝仕清 Cai Xitian;Deng Peipei;Zhong Weitan;Liu Suyan;Zhu Shiqing(National Engineering Research Center of Microbial Medicine,Hebei Industry Microbial Metabolic Engineering and Technology Research Center,New Drugs Research and Development of North China Pharmaceutical Grop Corporation Ltd.,Shijiazhuang 050015,China)

机构地区：[1]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,华北制药集团新药研究开发有限责任公司,河北石家庄050015

出　　处：《煤炭与化工》2018年第2期92-94,共3页Coal and Chemical Industry

摘　　要：研究了新一代棘白菌素类抗真菌药物米卡芬净母核的最佳冻干工艺条件。以水分、杂质含量、米卡芬净母核含量为指标优化冻干工艺,考察了冷冻温度、冷冻时间和干燥工艺参数对产品质量的影响。得到的米卡芬净母核最佳冻干工艺条件为:冷冻阶段温度为-30℃,时间为9 h;初级干燥阶段真空度为20 Pa,温度为-20℃,时间为18 h;解析干燥阶段真空度为2 Pa,温度为10℃,时间为3 h。在最优条件下进行了3批验证,结果表明,选定的冻干工艺稳定,重现性好。The freeze-drying process of the nucleus of micafungin,a new generation of echinocinomycin antifungal drug,was studied.The moisture and impurity content,micafungin nucleus content as the optimizing index of the freeze-drying process,the effects of freezing temperature,freezing time and drying parameters on product quality were invest igated.The optimal freeze-drying conditions:the temperature and the time in the freezing stage are respectively-30℃and 9 h,the vacuum temperature and the time in the primary drying stage are respectively 20 Pa,-20℃are and 18 h,the vacuum,temperature and time in analytical drying stage are respectively 2 Pa,10℃and 3 h.3 Batches of verifying test results under the optimal conditions show that,the freeze-drying process is stable and the reproducibility is good.

关 键 词：米卡芬净母核 棘白菌素类抗真菌药物 冻干工艺 优化 

分 类 号：Q936[生物学—微生物学] TQ465[化学工程—制药化工]