复方柴胡袋泡茶的质量标准

摘要

目的 完善复方柴胡袋泡茶的质量控制标准,保障制剂质量. 方法 采用薄层色谱( TLC)法对制剂中的柴胡、葛根、连翘进行定性鉴别,用高效液相色谱( HPLC)法对制剂中的葛根素进行含量测定. 色谱条件:色谱柱为岛津VP-ODS-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.2%磷酸溶液(23:77),流速为1.0 mL·min-1,柱温为30℃,检测波长为250 nm. 结果 TLC斑点清晰,分离度良好,阴性对照无干扰;葛根素线性范围为1.340 8~56.632 8 μg·mL-1 ( r=0.999 9,n=6) ,平均加样回收率102.98%,RSD为1.48%( n=6). 结论 该方法简便易行,适用于复方柴胡袋泡茶的质量控制.%Objective To improve the quality standard of compound Chaihu tea. Methods Pupleuri Radix, Puerariae Lobatae Radix and Forsythiae Fructus were identified by thin layer chromatography (TLC).HPLC method was used to determine the content of puerarin.The determination was performed on a Shimadzu VP-ODS-C18column (250 mm×4.6 mm,5μm) with the mobile phase of methanol-0.2% H3PO4(23:77).The flow rate was 1.0 mL·min-1, the column temperature was set at 30 ℃ and the detection wavelength was 250 nm. Results The TLC spots were clear and well-separated without negative interference.The good linear correlation existed within the range of 1.340 8-56.632 8μg· mL-1 for puerarin (r=0.999 9, n=6) and the average recovery was 102.98% with RSD being 1.48% (n=6). Conclusion The method is simple and accurate.It can be used for quality control of compound Chaihu tea.