复方黄栀颗粒的质量标准研究

Preliminary Study on the Quality Standard of Compound Huangzhi Granula

目的制定复方黄栀颗粒的质量标准。方法采用薄层色谱法(TLC)对处方中黄连、牡丹皮、栀子、升麻4味中药进行定性鉴别,采用高效液相色谱法(HPLC)对制剂中的盐酸小檗碱含量进行定量测定。结果 TLC法能定性检出黄连、栀子、牡丹皮、升麻,斑点清晰,且阴性对照无干扰;HPLC法测定盐酸小檗碱在6.1328～196.2500μg/ml范围内线性关系良好,r=0.999;平均加样回收率为98.34%,RSD=1.62%。结论本研究所建立的定性、定量检测方法操作简便、结果准确可靠、重现性好,能有效地控制复方黄栀颗粒的质量。

Objective To establish quality standard for Compound Huangzhi Granula.Methods The qualitative identification of Rhizoma Coptidis,Fructus Gardeniae,Cortex Moutan and Rhizoma Cimicifugae was carried out by thinlayer chromatography（TLC）,and the content of berberine hydrochloride was determined by HPLC.Results The results of TLC showed that the relevant spots were clear without interference in the blank reference.The content of berberine hydrochloride showed a good linearity in range of 6.1328～196.25μg/ml（R^2=0.999）.The average recovery rate was 98.34%and RSD was 1.62%.Conclusion The established qualitative and quantitative methods are simple,accurate,reliable and r eproducible,and can be effectively used for the quality control of Compound Huangzhi Granula.