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目的:建立益肝灵分散片的质量标准。方法:采用薄层色谱法进行定性鉴别;采用紫外-可见分光光度法对水飞蓟素进行溶出度测定;采用高效液相色谱法对水飞蓟宾进行含量测定。结果:水飞蓟素薄层色谱清晰,分离度好。水飞蓟素溶出度测定在3.1~31.0μg.mL-1范围内线性良好,r=0.9995,平均回收率为99.07%(RSD=0.75%)。水飞蓟宾含量测定在0.128~1.280μg范围内线性良好,r=0.9997,平均回收率为100.12%(RSD=0.89%)。结论:该方法可较好地控制益肝灵分散片的质量。
Objective: To establish the quality standard of Yiganling dispersible tablets. Methods: TLC was used for qualitative identification. The dissolution of silymarin was determined by UV-Vis spectrophotometry. The content of silybin was determined by high performance liquid chromatography. Results: Silymarin thin layer chromatography is clear and the resolution is good. The dissolution of silybin was well within the range of 3.1~31.0μg.mL-1, r=0.9995, and the average recovery was 99.07% (RSD=0.75%). The content of silibinin was linear in the range of 0.128-1.280 μg, r=0.9997, and the average recovery was 100.12% (RSD=0.89%). Conclusion: This method can better control the quality of Yiganling dispersible tablets.