毕业设计（论文）_荧光素钠注射液的制备及质量检查.docVIP

吉林省高等教育自学考试吉林大学生物制药专业 本科毕业设计 设计题目：荧光素钠注射液的制备及质量检查 设计作者: 准考证号： 8 通信地址： 联系电话： 吉林大学生命科学学院 2012年3月24日 摘要 本文研究了荧光素钠注射液的制备及质量检查。首先对荧光素钠进行提纯和检查，并对荧光素钠进行酸碱度，溶液的澄清度和颜色，氯化物，硫酸盐，锌盐，干燥失重等检查。采用重量测定法测定含量。对制备工艺中的活性炭用量筛选、pH值的选择、灭菌温度处方制备工艺99.5％，符合为标示含量的90.0％～110.0％的范围，符合要求。 关键词：荧光素钠；荧光素钠注射液；制备工艺；含量检查  目录 一、前言·····································································································1 ㈠试剂及仪器·······················································································2 1.原料与试剂··························································································2 2.仪器···································································································2 ㈡实验方法与步骤···················································································2 1.荧光素钠提纯························································································2 2.荧光素钠原料检查·················································································3 a.性状·····································································································3 b.鉴别·····································································································4 c.检查·····································································································5 d.含量测定······························································································7 3.荧光素钠注射液的制备···········································································8 a.荧光素钠注射液的配制···········································································8 b.制备工艺流程图···················································································8 c.处方依据······························································································8 d.工艺筛选······························································································9 e.影响因素试验处方中各成分的作用 对照品：系由原料药重结晶制得，纯度为99.6%，含量为99.7%(重量法)。市售样品：荧光素钠注射液20瓶（广州明兴制药有限公司生产，批号：031102，0.6g/3ml），合并后蒸出大部分水，剩余物