多糖类肝素湿品沉淀可保存时长的研究  

Research on the storage time of wet solid heparin

作　　者：田志鹏[1,2] 杜曦 王亮 兰舫 张灿 TIAN Zhi-peng;DU Xi;WANG Liang;LAN Fang;ZHANG Can(Hebei Changshan Biochemical Pharmaceutical Co.,Ltd,Shijiazhuang 050800;Hebei Research Center for Polysaccharide Drug Engineering Technology,Shijiazhuang 050800)

机构地区：[1]河北常山生化药业股份有限公司,石家庄050800 [2]河北省多糖类药物工程技术研究中心,石家庄050800

出　　处：《中南药学》2022年第7期1558-1563,共6页Central South Pharmacy

基　　金：国家发展和改革委2021年支持先进制造业和现代服务业发展专项;石家庄市科学技术研究与发展计划项目(No.211490132A)。

摘　　要：目的研究多糖类肝素湿品可允许的保存时长,以解决企业生产过程中遇到的产品因滞留和冻干设备故障中间产品无法保存的问题。方法以公司自产的肝素钠、达肝素钠、依诺肝素钠为原料,分别使用乙醇将产品从溶液中沉淀出来的湿样固体样品为样本,与对应干品进行对比,考察这几类肝素在湿样固体状态下保存10日、20日、30日、3个月、6个月、9个月、12个月产品质量是否产生变化。结果与固体粉末样品比,多糖类肝素湿品沉淀的分子量、效价、双糖等没有发生变化。结论肝素钠及低分子肝素在以湿样固体状态下存放12个月,其分子量、效价、双糖结果不发生变化。Objective To determine the permissible storage time for polysaccharide heparin to solve the problem that the intermediate products cannot be saved due to the product retention and freeze-drying equipment failure.Methods Heparin sodium,dalteparin sodium,and enoxaparin sodium produced by our company were used as raw materials.Wet solid samples separately precipitated from the solution by ethanol were used as samples and compared with solid powder samples to determine whether the qualities of the samples changed when heparins was stored in wet solid state after 10,20,and 30 days,3,6,and 9 months.Results The molecular weight,potency,disaccharide and other results of wet solid heparin didn’t change.Conclusion When heparin sodium and low molecular weight heparin are stored in wet solid state,their molecular weight,potency and disaccharide do not change within 12 months.

关 键 词：肝素钠 达肝素钠 依诺肝素钠 保存方式 存放时长 

分 类 号：TQ464[化学工程—制药化工] R94[医药卫生—药剂学]