纳米制剂熊去氧胆酸片溶出度测定方法学研究

Determination of Dissolution of Ursodeoxycholic Acid for Ursodeoxycholic Acid Tablets in Nanoparticles

目的对自制纳米制剂熊去氧胆酸片进行溶出度考察,建立溶出度测定方法。方法考察了不同溶出介质及不同转速对熊去氧胆酸片溶出曲线的影响,确定溶出条件,通过HPLC分析对溶出度方法学进行验证,利用相似度值（f2因子）与熊去氧胆酸胶囊溶出曲线进行相似度比较。结果确定自制熊去氧胆酸片溶出条件为p H 7.5磷酸缓冲液,转速为75r·min-1;熊去氧胆酸浓度在0.08～0.18 mg·ml-1范围内与峰面积线性关系良好,r=0.9999;高、中、低3种剂量组的平均回收率分别为101.2%、100.2%、101.7%,RSD为0.7%、1.1%、1.2%（n=3）;自制熊去氧胆酸片与熊去氧胆酸胶囊在p H 7.5溶出介质中15 min溶出度大于85%。结论本研究建立的方法简便、准确、可靠,能有效监控自制熊去氧胆酸片的工艺水平和质量,可列入质量标准。

Objective To establish an HPLC method to determine the dissolution of ursodeoxycholic acid in self-made ursodeoxycholic acid nano-tablets for better quality control. Methods The difference in dissolution curves was observed via four media and different rotation speeds. The analytical method of dissolution was validated by HPLC. The dissolution rate of ursodeoxycholic acid capsules was compared to by f2 factor. Results It was established with paddle method that the dissolution medium was PBS（ p H 7. 5） at 75 r·min- 1. A linear correlation was observed when the concentration of ursodeoxycholic acid ranged from 0. 08 mg·ml- 1to 0. 18 mg·ml- 1,r =0. 9999. The average recovery was 101. 2%,100. 2% and 101. 7% respectively for three levels of ursodeoxycholic acid. The RSD was 0. 7%,1. 1% and 1. 2%（ n = 3）. Conclusion This dissolution method is simple,accurate and reliable,which can be used for quality control of ursodeoxycholic acid nano-tablets.