杜仲叶提取物滴丸质量控制及稳定性考察

Study on Quality Control and Stability of Folium Eucommiae Extract Dropping Pills

目的建立杜仲叶提取物滴丸的质量标准并考察其在室温和加速条件下的稳定性。方法采用薄层色谱（TLC）法定性鉴别滴丸中的绿原酸;采用高效液相色谱（HPLC）法测定滴丸中绿原酸的含量,色谱柱为Hypersic C18柱（250 mm×4.6 mm,5μm）,流动相为乙腈-0.4%磷酸溶液（13∶87）,流速为1.0 m L/min,检测波长为327 nm,柱温为室温。结果薄层色谱法色谱斑点清晰,专属性强,重复性好。绿原酸进样量在1.3~130μg/m L范围内与峰面积线性关系良好（r=0.999 9）,平均回收率为99.81%,RSD=1.28%（n=9）;3批滴丸中试样品经6个月加速试验和12个月长期试验考察,各项指标均符合质量标准要求。结论杜仲叶提取物滴丸稳定性好,建立的鉴别方法专属性强,定量方法简便、准确,可用于其质量控制。

Objective To establish the quality standard of Folium Eucommiae Extract Dropping Pills and to investigate the stability un-der the condition of the room temperature and accelerated testing. Methods Chlorogenic acid in Folium Eucommiae Extract Dropping Pills was qualitatively identified by TLC;its content was determined by adopting HPLC. The chromatographic column was the Hypersic C18（250 mm ＆#215; 4. 6 mm,5 μm）,acetonitrile-0. 4% phosphoric acid solution（13 ：87） was used as the mobile phase at the rate of 1. 0 mL/min. The detection wavelength was 327 nm and the column temperature was the room temperature. Results The chromato-graphic spots of samples were distinct with strong specificity and good reproducibility. The sample size of chlorogenic acid in the range of 1. 3 -130 μg/mL showed good linear relation with the peak area（ r=0. 999 9 ）;the average recovery rate was 99. 81%（ RSD=1. 28%,n=9）;after the accelerated testing and the long-term testing,the various indexes of 3 batches of pilot test samples accorded with the quality standard of Folium Eucommiae Extract Dropping Pills. Conclusion Folium Eucommiae Extract Dropping Pills is excellent in stability;the established identification method is simple,accurate and reliable,and can be used for quality control of Foli-um Eucommiae Extract Dropping Pills.