右倍他米松磷酸钠注射液的制备、质量控制及稳定性考察

Dexbetamethasone Sodium Phosphate Injection:Preparation,Quality Control and Stability Study

目的根据临床需要,研发右倍他米松磷酸钠注射液,考察其稳定性并建立质量控制方法。方法拟订处方组成与制备工艺,并进行性状、鉴别、pH值、有关物质检查等研究,采用高效液相色谱法测定右倍他米松磷酸钠含量,通过影响因素试验、恒温加速试验和长期留样试验考察其稳定性。结果按优化的最佳处方及工艺制备的3批中试样品均合格。结论该制剂处方工艺合理可行,质量可控,稳定性良好;含量测定方法重现性好,专属性强,测定结果在规定的限度内。

Objective To prepare Dexbetamethasone Sodium Phosphate Injection, and to investigate its stability and to set up the methods of quality control for meeting the clinical request. Methods The composition of fomula and manufacturing technique were designed. The property, identification, pH and related materials of the preparation were studied. The content of Dexbetamethasone Sodium Phosphate Injection was determined by the HPLC. The stability was investigated by influencing factor test, acceleration test and longterm test. Results According to the optimized fomula and manufacturing technique, the three batches of Dexbetamethasone Sodium Phosphate Injection were prepared and the quality of the products was investigated. It showed that the results were qualified. Conclusion The preparation is reasonable and feasible in techniques, controllable and stable in quality. The established method is repeatable and specific, and the determination results are within defined margin.