苦参止痒洗剂的质量标准研究

Study on Quality Standard for Kushen Antipruritic Lotion

目的:建立苦参止痒洗剂质量标准的薄层色谱(TLC)和高压液相色谱(HPLC)测定法。方法:采用TLC法,对苦参止痒洗剂中苦参、甘草进行定性与鉴别;用高效液相色谱法(HPLC)对苦参止痒洗剂中金银花的主要成分绿原酸进行含量测定;色谱柱为Agi Lent Ec Lipse XDB-C_(18)柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.4%磷酸溶液(10∶90);检测波长为327 nm;流速为1 m L/min;色谱柱温度为30℃;气体压力为140 k Pa;理论塔板数按绿原酸峰计算不低于1 000。结果:薄层色谱中,斑点清晰,阴性对照无干扰,绿原酸的质量浓度在0.22~1.98μg/m L(r^2=0.999 7)范围内呈良好的线性关系,平均加样回收率为99.63%,RSD为0.12%(n=6)。结论:本试验所用方法简单、准确性高、重复性好,可用于苦参止痒洗剂的质量控制。

Objective： To establish the determination of the quality control of Kushen antipruritic lotion by TLC and HPLC.Methods： Radix sophorae flavescentis and Radix Glycyrrhizae were identified by TLC; HPLC was used to determinate chlorogenic acid that was contained in Honeysuckle flower.The column was Agi Lent Ec Lipse XDB-C18 column（250 mm×4.6 mm,5μm）,The mobile phase consisted of acetonitrile（A）,0.4% hosphoric acid-water（C）,isocratic elution（10：90）.The flow rate was 1.0 m L/min,the detection wavelength was 327 nm,the column temperature was at30 ℃ and the gaseous tension was 140 k Pa.Theoretical plate number calculated on chlorogenic acid peak shoμLd be not less than 1 000.ResμLts： The spots in the TLC were clear and distinguished well.The linear range of chlorogenic acid was between 0.22 μg/m L and 1.98 μg/m L（r^2=0.999 7）.The average recovery of chlorogenic acid was 99.63%,and RSD was 0.12%（n=6）.Conclusion： This method is simple,accurate,and reproducible which can be used for the quality control of Kushen antipruritic lotion.