双丹分散片的制剂处方前研究

Preformulation study on Shuangdan dispersible tablet

目的对双丹提取物的主要理化性质进行初步研究。方法测定了双丹提取物在水、0.1 mol/L盐酸溶液、p H6.8磷酸盐缓冲溶液中的表观溶解度,以丹酚酸B和芍药苷为指标成分,考察双丹提取物在光、湿、热中的稳定性,并测定双丹提取物的临界相对湿度。结果结果表明,双丹提取物在三种溶液中易溶;双丹提取物在强光、高湿度、高温度环境中不稳定,双丹提取物吸湿性强。结论提示双丹提取物在保存中应当尽量避免强光照射以及受潮、受热。

Objective The physicochemical property of Shuangdan extract were preliminarily studied. Methods The apparent solubility of Shuangdan extract in water, 0.1 mol/L HCl, pH6.8 buffer solution were determined. Salvianolic acid B and peoniflorin was used as index component to evaluate the stability of Shuangdan extract at the condition of high temperature, high humidity and strong light. Results The results showed that： Shuangdan extract is soluble in three kinds of solution and Shuangdan extract was instable at the condition of high temperature, high humidity and strong light. Conclusion It suggested that Shuangdan extract should avoid strong light, wet and heat when reserved.