注射用头孢噻肟钠他唑巴坦钠(6∶1)的稳定性研究

Study on the Stability of Cefotaxime Sodium and Tazobactam Sodium(6∶1)for Injection

目的考察注射用头孢噻肟钠他唑巴坦钠制剂(6∶1)的稳定性,为确定产品有效期提供依据。方法本品经影响因素试验、加速试验和长期留样的稳定性试验,考察其性状、pH值、溶液的澄清度与颜色、有关物质、头孢噻肟聚合物、水分及含量等变化。结果稳定性试验结果表明,本品稳定性好,可推荐其有效期暂定为二年。

Objective To estimate the stability of cefotaxime sodium/tazobactam sodium（6 ： 1） for injection in store status.Methods ,Investigated the transformation for the appearance,pH clarity and color of solution, related substances, polymer, moisture and contents of cefotaxime sodiurn/tazobactam sodium with influencing factor testing,accelerated testing and long-term sample observation tests.Conclusion The combination is stability within two years.