硫酸庆大霉素注射液处方和工艺研究

Study on Formulation and Preparation Process of Gentamycin Sulfate Injection

目的研究硫酸庆大霉素注射液的处方和工艺,提高其pH稳定性。方法考察了配制浓料的注射用水温度、抗氧剂用量及其加入顺序对pH稳定性的影响,按照最终确定的处方和工艺配制3批样品进行加速试验及长期稳定性试验。结果在硫酸庆大霉素注射液生产中,配制浓料的注射用水温度和抗氧剂的加入顺序对pH稳定性有影响,抗氧剂用量对pH稳定性几乎无影响。结论最终确定的处方和工艺比较合理,适用于大规模生产。

Objective To study the formulation and preparation process of Gentamycin Sulfate Injection and to improve its pH stability.Methods To investigate the impact of the injectable water temperature for preparing dense gentamycin sulfate,antioxidant dosage and its adding order on the pH stability.According to the finalized formulation and preparation process,3 batches of samples were prepared and performed the accelerated test and long-term stability experiment.Results In the production of Gentamycin Sulfate Injection,the injectable water temperature for preparing dense gentamycin sulfate and the adding order of antioxidant affected the pH stability,but the antioxidant dosage nearly had no influence on pH stability.Conclusion The finalized formulation and preparation process is more reasonable and suitable for mass production.