气滞胃痛颗粒质量标准研究

目的建立气滞胃痛颗粒的质量控制方法。方法采用薄层色谱(TLC)法对气滞胃痛颗粒中的香附、枳壳和甘草进行定性鉴别。采用高效液相色谱(HPLC)法对气滞胃痛颗粒中的延胡索乙素进行含量测定,色谱柱采用Alltima C18柱(250 mm×4.6 mm,5μm),以0.1%磷酸溶液(用三乙胺调pH至6.0)-乙腈(59∶41)为流动相,流速为1.0 mL/min,检测波长为280 nm,柱温为30℃。结果枳壳、香附和甘草薄层色谱法鉴别专属性强,延胡索乙素进样量在0.050 1～1.002μg范围内与峰面积呈良好线性关系(r=0.999 9,n=7),延胡索乙素平均回收率为99.94%,RSD=1.60%(n=6)。结论所用方法可准确地定性、定量,重现性好,可用于控制气滞胃痛颗粒的质量。

Study on the Quality Standard of Qizhi Weitong Granules

Objective To establish the quality control standard of Qizhi Weitong Granules.Methods Fructus Aurantii,Rhizome of Nutgrass Galingale,Radix et Rhizoma Glycyrrhizae were identified by TLC.The content of tetrahydropalmatine in Qizhi Weitong Granules was determined by HPLC.Alltima C18（250 mm×4.6 mm,5 μm） column was used.The mobile phase was 0.1%phosphoric acid（adjusted pH to 6.0 with triethylamine）-acetonitrile（59 ∶41） at a flow rate of 1.0 mL/min.The detection wavelength was at 280 nm,the column temperature was 30 ℃.Results The linear range was 0.050 1-1.002 μg for tetrahydropalmatine（r=0.999 9,n=7）.The mean recovery of tetrahydropalmatine was 99.94%,RSD=1.60%.Conclusion The method is simple,reliable,accurate and used to control the quality of Qizhi Weitong particle.