中满分消丸质量标准研究

Study on Quality Standard for Zhongmanfenxiao Pill

目的建立中满分消丸的质量标准。方法对厚朴、姜黄、白术、黄连进行薄层色谱(TLC)鉴别;用高效液相色谱(HPLC)法测定黄芩苷含量,色谱柱为瑞士Spherigel ODS柱(250mm×4.6mm,5μm),流动相为甲醇-水-磷酸(47∶53∶0.2),检测波长为280nm,柱温为40℃,流速为1.0mL/min。结果在TLC中能够检出厚朴、姜黄、白术、黄连,阴性对照无干扰;黄芩苷进样量在0.03851～0.77024μg范围内与峰面积线性关系良好,平均加样回收率为98.74%,RSD=1.57%。结论定性、定量方法简便、可靠、重现性好,可用于中满分消丸的质量控制。

Objective To establish the quality standard for Zhongmanfenxiao Pill. Methods The TLC method for identification of Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Rhizoma Atractylodis Macrocephalae, Rhizoma Coptidis in these pills were established, Baicalin was determined by HPLC. On Spherigel ODS column （250 mm × 4. 6 mm,5 μm）,the UV detector was set at 280 nm. The column temperature was at 40℃. The mobile phase was methanol- water-H3PO4 （47：53：0. 2） and the flow rate was 1.0 mL/min, Results Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Rhizoma Atractylodis Macrocephalae,Rhizoma Coptidis could be detected. The calibration curve showed good linearity. The average recovery rate of baicalin was 98.74%, RSD = 1.57%. Conclusion The method is simple,rapid and reproducible. It is suitable for the quality control of Zhongmanfenxiao Pill.