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毕业设计(论文)-荧光素钠注射液的制备及质量检查
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
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