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目的:制定新工艺护肝片的质量标准,验证新工艺的可行性。方法:对五味子、柴胡、猪胆粉进行薄层鉴别,用高效液相色谱法测定五味子醇甲的含量。结果:在选定的薄层色谱条件下,五味子、柴胡、猪胆粉的特征斑点清晰,五味子醇甲的线性范围为20.5～184.5μg·ml~(-1),r=0.999 9,平均回收率为99.2%,RSD0.57%,n=9。结论:护肝片的新工艺稳定,其质量标准专属性好。
Objective: To develop the quality standard of new technology liver tablets, to verify the feasibility of new technology. Methods: Schisandra, Bupleurum, pig bile powder thin layer identification, determination of schisandrin content by high performance liquid chromatography. Results: Under the selected TLC conditions, the characteristic spots of Schisandra sphenanthera and pig gall powder were clear. The linear range of schisandrin was 20.5 ~ 184.5μg · ml ~ (-1), r = 0.999 9, the average The recovery was 99.2%, RSD 0.57%, n = 9. Conclusion: The new technology of Hugan tablet is stable and its quality standard is good.