丹重搽剂质量标准研究

目的:建立丹重搽剂的质量标准。方法:采用薄层色谱(TLC)法定性鉴别方中牡丹皮、板蓝根、重楼、山楂和乌梅;采用高效液相色谱(HPLC)法测定丹皮酚的含量,色谱柱为Hypersil ODS C18(150mm×4.6mm,5μm),流动相为甲醇-水(45∶55),流速为1mL·min-1,检测波长为274nm,柱温为30℃。结果:TLC法可清晰鉴别出与牡丹皮、重楼、板蓝根、山楂和乌梅相对应的特征斑点;丹皮酚进样量在0.0482～0.4820μg范围内与峰面积积分值呈良好线性关系(r=0.9999),平均回收率为99.01%,RSD=1.60%(n=6)。结论:所建立的质量标准可用于丹重搽剂的质量控制。

Quality Standard of Danchong Liniment

OBJECTIVE:To establish the quality standard of Danchong liniment.METHODS:Cortex Moutan,Radix Isatidis,Rhizoma Paridis,Fructus Crataegi and Fructus Mume in the formula were identified qualitatively by TLC.The content of Paeonol was determined by HPLC in which Hypersil C18 column(150 mm×4.6 mm,5 μm)was used with mobile phase consisted of methanol-water(45∶55)at a flow rate of 1 mL·min-1.The detection wavelength was set at 274 nm and the column temperature was set at 30 ℃.RESULTS:Clear characteristic spots of Cortex Moutan,Radix Isatidis,Rhizoma Paridis,Fructus Crataegi and Fructus Mume were noted in TLC identification.The linearity of Paeonol was good in the range of 0.048 2～0.482 0 μg(r=0.999 9)with an average recovery of 99.01%(RSD=1.60%,n=6).CONCLUSION:The established quality standard can be used for the quality control of Danchong liniment.