原料药丹酚酸B粉末及其水溶液稳定性研究

目的:研究原料药丹酚酸B粉末及其水溶液的稳定性.方法:采用HPLC法测定粉末在强光照、高温、高湿条件下及水溶液在不同温度下的降解方程,用不同浓度的浓H2SO4测定其临界相对湿度.结果:10天内丹酚酸B粉末在强光照、高温条件下外观、含量基本无变化,常温条件下粉末易吸湿,其临界相对湿度为60%,水溶液降解Arrenius方程为IgK=-3.4529/T+7.6408 (r=0.9816),K25℃=1.132×104h-1,t0.9=38.80d.结论:原料药丹酚酸B粉末稳定性良好,水溶液稳定性较差.

Study on Raw Materials of Salvianolic Acid B for the Stability in Powder and Aqueous Solution

Objective:To study the stability of salvianolic acid B powder and aqueous solution.Methods:The determination to content variation in the strong light,high temperature,high humidity conditions and water solution at different temperatures degradation equation by HPLC method and using different concentration of concentrated H2SO4 determination of the critical relative humidity.Results:The appearance and content of salvianolic acid B powder did not change under high light,high temperature during the 10 days,and the critical relative humidity of salvianolic acid B powder is 60% under the normal temperature,the Arrenius equation of aqueous solution degradation is IgK=-3.4529/T+7.6408(r=0.9816),K25℃=1.132×104h-1,t0.9=38.80 days.Conclusion:The raw material of salvianolic acid B powder has good stability,water solution less stability.