固本化痰通脉颗粒的质量标准研究

Study on Quality Standard of Guben Huatan Tongmai Granules

目的建立固本化痰通脉颗粒的质量标准。方法采用薄层色谱法对该制剂中的白术、甘草、何首乌和山楂进行鉴别;采用高效液相色谱法测定制剂中二苯乙烯苷的含量:色谱柱为DiamonsilTMC18柱(4.6mm×250mm,5μm);甲醇∶水(30∶70)为流动相;流速:1.0ml/min;检测波长为320nm。结果薄层色谱斑点清晰,重现性好;二苯乙烯苷的平均加样回收率为98.83%,RSD=1.1%(n=6)。结论该方法准确可靠,重现性好,为固本化痰通脉颗粒的质量控制和评价提供了依据。

Objective： To establish the quality standard for Guben Huatan Tongmai Granules. Methods： The Rhizoma Atractylodis Macrocephalae,Radix Et Rhizoma Glycyrrhizae,Radix Polygoni Multiflori and Fructus Crataegi were identified by TLC, and the content of 2, 3, 5, 4＇ - teterahydroxystibene - 2 - O - β - D was determined by HPLC. The chromatographic procedure was carried out using DiamonsilTM Cls as an analytic column and a mixture of 30 volume of methanol and 70 volume of water as a mobile phase at a flow rate of 1.0 ml/min. The detection wavelength was set at 320 nm. Results： The TLC spots were clear and reproducible. The average recovery rate of 2, 3, 5, 4＇ - teterahydroxystibene- 2 - O - β- D was 98.83% and RSD was 1.1% （n = 6）. Conclusion：The method is reliable and accurate with high reproducibility. It can be used for quality control of Guben Huatan Tongmai Granules.