丁桂活络凝胶膏的质量标准研究  

Study on Quality Standard of Dinggui Huoluo Gel Paste

作　　者：郭宏彦[1] 涂禾[1] 刘中均 胡恒[1] 

机构地区：[1]四川省骨科医院,成都610041

出　　处：《中国药房》2014年第43期4076-4078,共3页China Pharmacy

基　　金：科技部科研院所技术开发研究专项资金项目(No.2012EG145135)

摘　　要：目的：建立丁桂活络凝胶膏的质量标准。方法：采用薄层色谱（TLC）法鉴别制剂中的木香、羌活、独活;采用高效液相色谱法测定制剂中延胡索乙素的含量：色谱柱为Waters Symmetry Shield C18（250 mm×4.6 mm,5μm）,流动相为甲醇-0.1%磷酸溶液（p H6.0,50∶50,V/V）,流速为1.0 ml/min,检测波长为280 nm,柱温为25℃,进样量为10μl。结果：木香、羌活、独活的TLC图斑点清晰、分离度好。延胡索乙素的质量浓度在10.58~52.90μg/ml范围内与峰面积积分值呈良好线性关系（r=0.999 9）;精密度、稳定性、重复性试验的RSD均≤0.72%,平均加样回收率为100.07%,RSD=0.65%（n=9）。结论：所建质量标准可用于丁桂活络凝胶膏的质量控制。OBJECTIVE： To establish the quality standard of Dinggui huoluo gel paste. METHODS：Aucklandiae lappa, Notop- terygium incisum and Heracleum hemsleyanum were identified by TLC. The content of tetrahydropalmatine was determined by HPLC. The determination was performed on Waters Symmetry Shield C18（250 mm×4.6 mm, 5μm）column with mobile phase con- sisted of methanol-0.1% phosphoric acid （pH6.0,50：50, V/V） at the flow rate of 1.0 ml/min. The detection wavelength was set at 280 nm. The column temperature was 25 ℃, and the sample size was 10μl. RESULTS： TLC spots ofA. lappa, N. incisum and H. hemsleyanum were clear and well-separated. The linear range of tetrahydropalmatine was 10.58-52.90μg/ml （r：0.999 9） o RSDs of precision, stability and reproducibility tests were all lower than 1.72%.The average recovery of 100.07% （RSD=0.65%, n=9）. CONCLUSIONS： The established quality standard can be used for the quality control of the preparation.

关 键 词：丁桂活络凝胶膏剂 延胡索乙素 木香 羌活 独活 薄层色谱法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]