消炎止痒浸膏质量标准研究

Study on the Quality Standard for Xiaoyan Zhiyang Lotion

目的建立消炎止痒浸膏的质量标准。方法采用薄层色谱(TLC)法定性鉴别消炎止痒浸膏制剂中的苦参碱和连翘苷;采用高效液相色谱(HPLC)法测定该制剂中蛇床子素含量,色谱柱为Topsil C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(63∶37,V/V),流速为1.0 m L/min,检测波长为322 nm,柱温为30℃,进样量为10μL。结果苦参碱、连翘苷的TLC图斑点清晰,分离度好,阴性对照无干扰;蛇床子素质量浓度在5.0~80.0μg/m L范围内与峰面积线性关系良好(r2=0.9996,n=5),平均加样回收率为100.84%,RSD为1.29%(n=6)。结论该方法操作简便,专属性强,样品分离度好,可用于消炎止痒浸膏的质量控制。

Objective To establish the quality standard for Xiaoyan Zhiyang Lotion.Methods Thin layer chromatography(TLC)method was used for qualitative identification of matrine and phillyrin in Xiaoyan Zhiyang Lotion.High performance liquid chromatography(HPLC)method was used for the content determination of osthole in this preparation;the chromatographic column was Topsil C18 column(250 mm×4.6 mm,5μm),the mobile phase was aectonitrile-water(63∶37,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 322 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC spots of matrine and phillyrin were clear,the separation was good,and the negative control had no interference.The osthole showed a good liner relationship in the range of 5.0-80.0μg/m L(r2=0.9996,n=5).The recovery was 100.84%,RSDwas 1.29%(n=6).Conclusion This method is easy to operate,has strong specificity and good sample resolution,which can be used for the quality control of Xiaoyan Zhiyang Lotion.