曹富宁南宁市中医医：药学部，广西南宁530001

    HPLC法研究金黄膏的稳定性及其质控标准

    曹富宁

    南宁市中医医：药学部，广西南宁530001

    目的探讨HPLC法测定金黄膏中小檗碱和巴马丁含量尧稳定性与质控标准。方法通过色谱条件的优化，建立一种金黄膏测定方法，采用高效液相色谱法，色柱为：Apollo C18(250mm伊4.6mm，5滋m)，流动液相为乙腈-0.1豫磷酸(二元梯度洗脱)，检测波长346 nm，流速为1.0mL/min，柱温为30益，测定样品的精确度尧准确度尧稳定性尧重现性及专属性特性。结果将金黄膏按照上述方式进行，并且根据色谱检测方式判断，盐酸小檗碱为2.04%，巴马丁为1.95%，具有较好的稳定性曰盐酸小檗碱RSD为1.51%，巴马丁RSD为2.03%。巴马丁平均回收率为98.8%，RSD为1.85%，盐酸小檗碱平均回收率为100.9%，RSD为2.5%。由此说明，盐酸小檗碱和巴马丁在两种不同的药物成分在24 h内稳定性相对较好，且该检测方法具有较好的重现性。结论HPLC测定法分析金黄膏中小檗碱和巴马丁含量及稳定性与质控标准效果理想，该方法准确尧简便，重现性好，能够为制订质控标准提供依据，值得推广应用。

    HPLC测定法曰金黄膏曰小檗碱曰巴马丁曰稳定性曰质控标准

    [Abstract]Objective To investigate content and stability and quality control standard assays of berberine and golden cream palmatine by HPLC determination.M ethods Through the optimization of the chromatographic conditions,a gold—en pastedeterminationmethod established,high-performance liquid chromatographywasused:Apollo C18column(250mm伊4.6mm,5滋m),liquid phase was acetonitrile-0.1%phosphoric acid(binary gradient elution).The detection wavelength was 346 nm,velocity of flow was 1.0 mL/min.The column temperature was 30益,determination of accuracy,accuracy, stability and reproducibility and specificity characteristics were detected.Results The golden cream was conducted in accordance with the above-described manner and judged in accordance with chromatographic detection mode,berber—inewas 2.04%,palmatine was 1.95%,with good stability;berberine hydrochloride RSD was 1.51%,palmatine RSD was 2.03%.Average palmatine recovery was 98.8%,RSD was 1.85%,hydrochloric small firewood average recovery was 100.9%,RSD was 2.5%.It showed that berberine palmatine stability in two different pharmaceutical ingredientwithin 24 h was relatively good,and the detectionmethod had good reproducibility.Conclusion HPLC assay analysis of gold—en cream and palmatine content and stability and quality control standard of berberine is satisfactory,thismethod is accurate,simple,reproducible,and can provide the basis for the development of quality control standards,which should bewidely applied. ......