和血胶囊质量标准研究

Evaluation of the Quality of Hexue Capsules

目的:修订并提高和血胶囊质量标准。方法:采用薄层色谱法对和血胶囊中苍术、皂矾进行鉴别;采用高效液相色谱法对苍术素与5-羟甲基糠醛进行含量测定。结果:薄层鉴别法斑点清晰,专属性强;5-羟甲基糠醛的测定可区分苍术是否经过炮制,5-羟甲基糠醛浓度在0.595 2～17.85μg·mL-1范围内线性关系良好,r=0.999 9,平均回收率为102.6%,RSD为1.67%(n=6)。苍术素测定可有效控制苍术的投料量,苍术素浓度在1.076～32.29μg·mL-1范围内线性关系良好,r=0.999 9;苍术素的平均回收率为101.7%,RSD为1.39%(n=6)。结论:所建立的方法操作简单、结果准确,可为和血胶囊的质量控制提供参考。

Objective:To revise and improve the quality standard of Hexue capsules.Methods:Copperas and atractylodis rhizoma in Hexue capsules were discriminated by microscopy and TLC.The contents of atractydin and 5-hydroxymethylfural were determined by HPLC.Results:The TLC method identified the crude drugs with clear spots and strong specificity.The determination of 5-hydroxymethylfural distinguished whether the atractylodes were processed or not.The concentration of 5-hydroxymethylfural was linearly determined in the range of 0.595 2-17.85μg·mL^-1,r=0.999 9,the average recovery rate was 102.6% and the RSD was 1.67%(n=6).The determination of atractydin effectively controlled the dosage of atractylodis rhizoma.The concentration of atractydin was linearly determined in the range of 1.076-32.29μg·mL^-1,r=0.999 9,the average recovery rate of atractydin was 101.7% and the RSD was 1.39%(n=6).Conclusion:The method is simple in operation and accurate in results,which can be referred for the quality control of Hexue capsules.