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目的考察乳酸依沙吖啶溶液配方组成,研究溶液稳定性、筛选处方设计的合理性以及确定使用有效期,探讨其合理的贮存使用条件。方法选取配方不同并配制乳酸依沙吖啶溶液在贮存条件各异的稳定性做考察,以溶液外观性状、p H值、含量变化为考察指标,筛选最佳配方组成以及确定使用有效期。结果乳酸依沙吖啶溶液在不同配方不同贮存条件下稳定性各异。光照作用对乳酸依沙吖啶溶液影响较大,导致其颜色加深、含量下降;硫代硫酸钠可使溶液颜色加深,伴有不同程度片状红褐色沉淀生成,但对含量影响不大。结论不加硫代硫酸钠的乳酸依沙吖啶溶液配方,其在阴凉避光处贮存3个月,其含量符合规定,质量稳定,处方设计更合理。
Objective To investigate the composition of the solution of ethacridine lactate solution, study the stability of the solution, screen the rationality of the prescription design and determine the period of validity, and discuss its reasonable storage and use conditions. Methods The stability of different storage conditions with different formulations and formulation of Ethacridine lactate solution was investigated. The appearance and pH value of solution were taken as indexes to determine the optimum formulation and the effective period of application. Results The stability of ethacridine lactate solution under different storage conditions was different. The effect of illumination on the solution of ethacridine lactic acid has a greater impact, resulting in its color deepened, the content decreased; sodium thiosulfate solution can deepen the color, accompanied by varying degrees of flaky reddish brown precipitate formation, but little effect on the content. Conclusions Sodium thiosulfate lactic acid ethacridine solution without sodium thiosulfate solution was stored for 3 months in a cool and dark place. The content was in accordance with the regulations, the quality was stable and the prescription design was more reasonable.