一种注射用哌拉西林钠他唑巴坦钠中聚合物杂质的去除方法
- 专利权人:
- 江苏海宏制药有限公司
- 发明人:
- 许前辉,李文凯
- 申请号：
- CN202010350176.5
- 公开号：
- CN111514101A
- 申请日:
- 2020.04.28
- 申请国别(地区):
- CN
- 年份:
- 2020
- 代理人:
- 摘要：
- 本发明公开一种注射用哌拉西林钠他唑巴坦钠中聚合物杂质的去除方法，将注射用哌拉西林钠他唑巴坦钠冻干剂加入溶剂中强制降解，形成哌拉西林钠他唑巴坦钠强制降解溶液，放置一定时间后加入到高效凝胶色谱柱中，通入流动相进行梯度洗脱。通过控制洗脱液的浓度柱温、洗脱时间和流动相的比例将注射用哌拉西林钠他唑巴坦钠中的聚合物杂质去除，使哌拉西林钠他唑巴坦钠中得聚合物杂质得到有效控制，保证了注射用哌拉西林钠他唑巴坦钠的安全性。
- 来源网站：
- 中国工程科技知识中心
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