香芍散结口服液质量标准研究

Quality Standard of Xiangshao Sanjie Oral Solution

目的建立香芍散结口服液的质量控制方法。方法采用薄层色谱法定性鉴别处方中当归、白芍、丹参、香附,采用高效液相色谱法测定白芍中主要成分芍药苷的含量。结果薄层色谱图斑点清晰,阴性对照无干扰。芍药苷进样质量浓度在0.007 482~0.249 4 mg/mL (n=7)范围内与峰面积线性关系良好,平均加样回收率为98.90%,RSD为1.29%(n=9)。结论该方法简单,专属性强,结果准确、可靠,可有效控制香芍散结口服液的质量。

Objective To establish a quality control method for Xiangshao Sanjie Oral Solution.Methods Thin layer chromatography( TLC) method was used for the identification of Radix Angelicae Sinensis,Radix Paeoniae Alba,Radix Salviae miltiorrhizae and Rhizoma Cyperi.High performance liquid chromatography( HPLC) method was used to determine the content of paeoniflorin from Radix Paeoniae Alba.Results The thin layer chromatogram had clear spots,and the negative control showed no interference.The mass concentration of paeoniflorin showed good linear relationship with the peak area in the range of 0.007 482-0.249 4 mg/mL( n = 7).The average recovery was 98.90%,and the RSD was 1.29%( n = 9).Conclusion The method is simple,specific,accurate and reliable,and can effectively control the quality of Xiangshao Sanjie Oral Solution.