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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 study the dissolution of self-made ursodeoxycholic acid tablets and to establish a method for the determination of dissolution. Methods The dissolution kinetics of ursodeoxycholic acid tablets with different dissolution media and different rotational speeds were investigated. The dissolution conditions were determined. The dissolution method was validated by HPLC analysis. The similarity values (f2 factor) and ursodeoxycholic acid Capsule dissolution curve for similarity comparison. The results showed that the dissolution condition of homemade ursodeoxycholic acid tablets was p H 7.5 phosphate buffer at a rotational speed of 75 r · min -1 and the concentration of ursodeoxycholic acid was linear with the peak area in the range of 0.08-0.18 mg · ml -1 , r = 0.9999. The average recoveries of high, medium and low dosage groups were 101.2%, 100.2%, 101.7%, RSD 0.7%, 1.1% and 1.2% respectively (n = 3) Slices and ursodeoxycholic acid capsules eluted more than 85% in 15 min at pH 7.5 dissolution medium. Conclusion The method established in this study is simple, accurate and reliable, and can effectively monitor the process and quality of homemade ursodeoxycholic acid tablets, which can be included in the quality standard.