熊去氧胆酸胶囊溶出度测定方法研究

目的建立熊去氧胆酸胶囊溶出度的测定方法。方法依照2005年版《中国药典（二部）》附录溶出度测定项下第一法，以磷酸盐缓冲溶液（0．05mol／L磷酸二氢钾与0．05mol／L磷酸二氢钠等量混合，用1mol／L氢氧化钠溶液调节pH值至7．5）900mL为溶出介质，转速为75r／min，用高效液相色谱法测定，检测波长206nm。结果熊去氧胆酸质量浓度在0．1～2．0mg／mL范围内与峰面积线性关系良好（r=0．9999），高、中、低3种质量浓度的平均回收率为102．4％，99．4％，98．7％，RSD分别为0．97％，0．42％，1．2％（n=3）；3批样品的溶出度为85％～102％。结论该法操作简便、准确、可靠，适用于熊去氧胆酸胶囊的质量研究；

Research on Determination of Dissolution of Ursodeoxycholic Acid in Ursodeoxvcholic Acid Capsules

Objective To establish a method for the determination of the dissolution of ursodeoxycholic acid in Ursodeoxycholic Acid Capsules. Methods To carry out the dissolution test according to the method of appendix in the Chinese Pharmacopoeia （Edition 2005,Volum 2）,using 900 mL phosphate buffer （0.05 mol/L potassium dihydrogen orthophosphate and 0.05 mol/L sodium dihydrogen orthophosphate were mixed in the ratio of 1 ： 1,adjusting pH to 7.5 using 1 mol/L sodium hydroxide） as the solvent, with the rotation speed of 75 r/min,determination by HPLC, and the detection wavelength at 206 nm. Results There was a good linearity of Ursodeoxycholic Acid within the range of 0. 1 - 2.0 mg/mL （r=0. 999 9）,the average recovery rates were 102.4% ,99.4% and 98. 7% for three different levels of Ursodeoxycholic Acid, RSD were 0. 97% , 0.42% and 1.2% , respectively （ n = 3） ; the dissolution of Ursodeoxycholic Acid in Ursodeoxycholic Acid Capsules for three batches was from 85% -102%. Conclusion This method is simple, quick, accurate, and suitable for the quality control of Ursodeoxycholic Acid Capsules.