注射用福沙吡坦二甲葡胺的制备及质量对比研究

Study on Preparation and Quality Comparison of Fosaprepitant Dimeglumine for Injection

目的研究注射用福沙匹坦二甲葡胺的处方及制备工艺。方法通过相关试验考察样品的性状、pH值、含量及有关物质,筛选优化处方及制备工艺。结果样品经影响因素试验各项质量指标变化与原研产品基本一致。结论本品处方和制备工艺合理,产品质量与原研产品相当。

Objective To study the prescription and the preparation technology of fosaprepitant dimeglumine for injection. Methods The character, pH value, contents and related substances of the self-made product were investigated by a series of experiments to achieve the optimum prescription and preparation technology. Results The changes of all the quality indices of the self-made product are basically identical with those of original product. Conclusion The prescription and preparation technology are reasonable, and the quality of the product is in line with that of the original product.