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目的:考察注射用长春西汀亚微乳冻干制剂的影响因素及加速稳定性。方法:以外观性状、含量、有关物质以及复溶后的溶液pH、粒径为指标考察注射用长春西汀亚微乳冻干制剂在高温、强光影响因素以及加速试验条件下的稳定性。结果:长春西汀亚微乳冻干制剂在高温及强光条件下外观、含量及有关物质均有明显变化,加速条件下放置6个月后样品的各项检测指标无明显变化。结论:注射用长春西汀亚微乳冻干制剂对高温及强光照射较为敏感,但在加速条件下稳定性良好。
Objective: To investigate the influencing factors and accelerating stability of vinpocetine microemulsion injection for injection. Methods: The appearance, content, related substances and the pH and particle size of reconstituted solution were used as indexes to investigate the stability of the injection of Vinpocetin micro-emulsion freeze-dried preparation under the conditions of high temperature, high light and accelerating test. Results: The appearance, content and related substances of vinca cotyledon microemulsion freeze-dried preparations under high temperature and high light conditions all showed obvious changes. After 6 months of storage under accelerated conditions, there was no significant change in the detection indexes. Conclusion: The vinpocetine microemulsion freeze-dried preparations for injection are sensitive to high temperature and strong light irradiation, but have good stability under accelerated conditions.