硫酸奈替米星葡萄糖注射液稳定性研究

Study on stability of Netilmicin Sulfate Dextrose Injection

目的考察硫酸奈替米星葡萄糖注射液的稳定性。方法利用光照和高温、加速试验、长期试验测定对硫酸奈替米星葡萄糖注射液稳定性的影响。结果硫酸奈替米星葡萄糖注射液对光稳定性好,对于热在40℃稳定性良好,60℃稳定性稍差,加速试验,溶液外观颜色加深,降解产物5-羟甲基糠醛在3个月时已经超过规定,硫酸奈替米星的含量有所下降。长期试验,在室温放置九个月,产品外观、pH值、颜色、澄明度等项目没有显著变化。结论硫酸奈替米星葡萄糖注射液对光稳定,对热稳定性稍差但符合标准,加速试验和长期试验结果均符合要求。贮存时应置于阴凉干燥处。

OBJECTIVE To observe the stability of Netilmicin Sulfate Dextrose Injection. METHODS Determining the effect of light,heat,accelerating experiment,long-term experiment. RESULTS Netilmicin Sulfate Dextrose Injection was stable to light. Under 40℃ ,it is stable. However under 60℃ ,it is a little unstable. Accelerating experiment,the color of Netilmicin sulfate dextrose injection deepened and the content of the degradation product 5-hydroxymethyl furfurol increased to defined limit in three months. The content of Netilmicin sulfate decreased slightly. Long-term experiment, the appearance, pH, color, clarity of the product have no notable changes. CONCLUSION Netilmicin Sulfate Dextrose Injection was stable to light and little unstable to heat, but was acceptable. The results of accelerating experiment and long-term experiment were consistent with the satandard.