双丹分散片中丹参素钠溶出度的研究

Dissolution of sodium danshensu in Shuangdan Dispersible Tablets

目的建立双丹分散片中丹参素钠溶出度的测定方法。方法参照《中国药典》2010年版第二部附录XC溶出度测定法第二法，以磷酸盐缓冲液（pH7．6）为溶出介质，温度控制在（37±0．5）℃，转速50r／min，采用高效液相色谱法检测，考察双丹分散片中丹参素钠的累积溶出率。结果丹参素钠在3．8～22．8μg／mL与峰面积有良好的线性关系（r=0．9999），双丹分散片在10min内丹参素钠平均累积溶出率达85％以上。结论本方法简便、精确高、重现性好，可用于双丹分散片中丹参素钠溶出度的测定。

Objective To establish a method for the dissolution of sodium danshensu in Shuangdan Dispersible Tablets. Methods According to the second method of stripping method in Chinese Pharmacopoeia 2010 Vol. II appendix XC,, using phosphate buffer solution （pH 7.6） as the solvent, temperature at （37 ± 0.5） ℃, and speed 50 r/min, the dissolution of sodium danshensu in Shuangdan Dispersible Tablets was determined by HPLC. Results Sodium danshensu showed a good linear relationship in the range of 3.8- 22.8μg/mL against peak area （r=0.999 9）. The dissolution of sodium danshensu in 10 min could reach more than 85%. Conclusion The method is simple, accurate, reliable, and can be used for the determination of Shuangdan Dispersible Tablets.