灯盏花素自乳化软胶囊溶出度研究

Study on Dissolution Rate of Breviscapine Self-emulsifying Soft Capsule

目的建立灯盏花自乳化软胶囊的溶出度测定方法。方法采用以十八烷基硅烷键合硅胶为色谱柱;以甲醇-0. 1%磷酸溶液(35:65)为流动相,流速1. 0 m L/min,检测波长335 nm。应用桨法,以磷酸盐缓冲液(pH6. 8)为溶出介质,转速为50 r·min-1,对灯盏花素软胶囊中野黄芩苷进行了溶出度测定。结果野黄芩苷的线性范围为17μg/m L^838μg/m L线性关系良好r=0. 9991,回收率97. 8%。采用试验确定的方法,灯盏花素软胶囊在40 min溶出达80%。结论研究灯盏花素自乳化软胶囊溶出度方法准确、可靠,可用于灯盏花素自乳化软胶囊的溶出度检测。

Objective： To establish a method for the determination of dissolution rate of Breviscapine self - emulsifying soft capsules. Methods：The octadecylsilane bonded silica gel was used as the column,the methanol -0. 1% phosphoric acid solution（ 35：65） as the mobile phase, 1.0 mL/min of flow rate and 335 nm of detection wavelength. The dissolution method was carried out on the Breviscapine soft capsule by using the paddle method with phosphate buffer（ pH6. 8）as the dissolution medium and the rotation speed was 50 r·min-1. Results ：The scutellarin had a linear range of 17 μg/mL to 838μg/mL, with a good t linear relationship, r = 0. 9991, and 97.8% of recovery rate. Though experiment determination method,greviscapine soft capsules were dissolved up to 80% at 40min. Conclusion：The method of dissolution rate of Breviscapine self -emulsitying soft capsule is accurate and reliable, and it can be used tbr the dissolution test of Breviscapine self- emulsifying soft capsule.