水飞蓟宾卵磷脂分散体胶囊剂溶出度测定方法的研究

Study on dissolution test method of Silybin Solid Dispersion Capsules

[目的]建立水飞蓟宾卵磷脂分散体胶囊剂中水飞蓟宾的溶出度测定方法。[方法]参照中国药典2000年版二部附录XC溶出度测定第2法 ,用紫外 -可见分光光度仪测定溶出度。[结果]确定了以pH7.8～8.0的磷酸缓冲液加0.5 %聚氧乙烯十二烷基醚为溶剂进行溶出度考察。测定方法和溶出方法的验证结果表明 ,本方法重现性较好。[结论]该法准确 ,可靠 。

To establish a method in determining the dissolution of silybin solid dispersion capsules. According to the description in Chp.2000.VolⅡ.Appendix XC, the dissolution of silybin solid dispersion capsules was determined by UV-VIS spectrophotometer. The selected media for dissolution test is phosphate buffer solution with 0.5%Brij35 (pH7.8～8.0).The dissolution of capsules has good reproducibility.[Conclusion] The method is considered to be a accurate and reliable dissolution determination for silybin capsules.