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目的:考察注射用阿魏酸钠制备工艺中的影响因素。方法:通过正交试验筛选阿魏酸钠的处方及制备工艺,考察支持剂、冻干机真空度及升华时间对制剂的影响。紫外分光光度法测定样品中阿魏酸钠的含量,采用高效液相色谱法对样品进行有关物质检查,经加速稳定性试验初步考察样品的稳定性。结果:注射用阿魏酸钠的最佳处方及工艺:支持剂为5%的氯化钠溶液,真空度为200Pa,升华时间为25h。所制得阿魏酸钠冻干粉针经加速试验3个月后,性状、pH、含量、水分等各指标无明显变化。结论:真空度对冻干产品成形的影响较大,这为冻干制剂的制备提供了参考依据。
Objective: To investigate the influencing factors in the preparation of sodium ferulate for injection. Methods: The orthogonal test was used to screen the preparation and preparation of sodium ferulate. The effects of support agent, vacuum degree and sublimation time on the preparation were investigated. The content of sodium ferulate in the sample was determined by UV spectrophotometry. The related substances were inspected by high performance liquid chromatography (HPLC), and the stability of the sample was examined by accelerated stability test. Results: The optimal formulation and process of sodium ferulate for injection were as follows: 5% sodium chloride solution as support agent, vacuum degree of 200Pa and sublimation time of 25h. The prepared sodium ferulate freeze-dried powder after 3 months accelerated test, traits, pH, content, moisture and other indicators no significant change. Conclusion: The degree of vacuum has a significant effect on the freeze-dried product formation, which provides a reference for the preparation of lyophilized preparation.