健腰密骨片中丹酚酸B的质量控制方法建立

Establishment of a quality control method for the determination of salvianolic acid B in Jianyao Migu tablets

目的:建立健腰密骨片中丹酚酸B的质量控制方法。方法:通过条件摸索,建立复方健腰密骨片中丹酚酸B薄层色谱定性鉴别方法和高效液相色谱定量检测方法。结果:制剂中丹酚酸B在薄层层析板上显示一清晰斑点、且重现性好、专属性强、阴性对照无干扰。HPLC测定显示丹酚酸B在0.191~15.291 mg范围内呈良好线性关系,回归方程为Y=1190.30X-253.63,r=0.9999;平均加样回收率及RSD分别为96.72%和1.46%。结论:新建的检测方法简便、快速、准确,重复性好,可作为健腰密骨片中丹酚酸B的质量控制方法,可以更好地保证制剂的整体质量,具有很强的实用性。

Objective:To establish a quality control method of salvianolic acid B in Jianyao Migu tablets.Methods:A thin-layer chromatography(TLC)method for qualitative identification and an HPLC method for the quantitative determination of salvianolic acid B were established by condition tests.Results:Salvianolic acid B in the preparation showed a clear spot on TLC,which was reproducible and specific without the interference of negative control.The calibration curve of salvianolic acid B by HPLC was linear in the range of 0.191-15.291μg and regression equation was Y=1190.30X-253.63,r=0.9999.The average recovery ratio was 96.72%and the relative standard deviation was 1.46%.Conclusion:The established new methods are simple,rapid,accurate and reproducible and can be used as the quality control of salvianolic acid B in Jianyao Migu tablets and can better guarantee the overall quality of the preparation and has strong practicability.