注射用地塞米松磷酸钠制备工艺研究

Study on the Preparation of Dexamethasone Sodium Phosphate for Injection

目的:研究注射用地塞米松磷酸钠的处方和生产工艺。方法:通过相关试验考察注射用地塞米松磷酸钠的性状、pH值、可见性异物、含量及有关物质,得到优选的处方及制备工艺。结果:本品在室温条件下进行长期稳定性试验18个月,各项质量指标均在合格范围内。结论:处方和工艺合理,利于生产操作,能保证产品质量。

Objective：To study the prescription and the preparation technique of dexamethasone sodium phosphate for injection.Methods：The character,pH value,visible impurity,contents and related substances of the titled product were investigated by a series of experiments to achieve the optimum prescription and preparation technique.Results：Various quality indicators of this product were in compliance within the qualified scope after the 18 months＇ long-term stability test under the room temperature.Conclusion：This prescription and preparation process is suitable for large scale preparation with the simplified operation and product quality assurance.