清炎洗剂的质量标准研究

Study on Quality Standards of Qingyan Lotion

目的:建立清炎洗剂的质量标准。方法:以蛇床子素为对照品,甲苯-乙酸乙酯(30∶1)为展开剂对其中的蛇床子药材进行薄层色谱鉴别;以苦参碱为对照品,甲苯-乙酸乙酯-丙酮-浓氨试液(2∶4∶3∶0.2)为展开剂对其中的苦参药材进行薄层色谱鉴别;采用反相高效液相色谱法测定主药蛇床子中蛇床子素含量。结果薄层色谱斑点清晰;蛇床子素在4.75～23.75μg/mL范围内有良好的线性关系,回归方程为C=0.0131A-0.322(r=0.9997),平均回收率为95.26%,RSD为1.55%。结论:方法简便、准确、重现性好,可用于本制剂的质量控制。

Objective： To establish the quality standards of Qingyan lotion.Methods：To use osthole as reference and toluene-ethylacetate（30：1） as developer for identify Fructus Cnidii by TLC.To use matrine as reference and toluene-ethylacetate-acetone-ammonia test solution（2：4：3：0.2）as developer for identify Radix Sophorae Flavescentis byTLC.RP-HPLC was used to determine osthole in Fructus cnidii.Results： The TLC spots were clear.The reference substance of osthole had a good linear relationship in the range of 4.75~23.75μg/mL,the regression equation was C=0.0131A-0.322,r=0.9997（n=5）,the average recovery rate was 95.26%,RSD=1.55%（n=9）.Conclusion： The method is simple and accurate with good reproducibility and can be applied to the quality control of Qingyan lotion.