速效牙痛宁酊质量标准的建立

Quality Standard for Suxiao Yatongning Tincture

目的：建立速效牙痛宁酊的质量标准。方法：采用薄层色谱法同时对速效牙痛宁酊中的芫花根和地骨皮进行定性鉴别;采用反相高效液相色谱法对7-羟基香豆素进行定量测定,色谱柱为Agilent ZORBAX SB-C18（250 mm×4.6 mm,5μm）,流动相为乙腈-四氢呋喃-0.8%醋酸溶液（12∶6∶82）,流速为1.0 ml·min-1,检测波长为324 nm,柱温为30℃。结果：薄层鉴别斑点清晰,阴性对照无干扰;定量测定中7-羟基香豆素分离度良好,进样在0.032～0.636μg范围内,与峰面积线性关系良好（r=0.999 9）,平均回收率为101.26%,RSD为1.32%（n=9）。结论：所建立方法操作准确度高、重复性好,可作为该制剂的质量控制方法之一。

Objective： To establish the quality standard for Suxiao Yatongning tincture. Methods： The roots of Daphne genkwa and Cortex Lycii were identified by TLC, and the content of 7-hydroxyl coumarin was determined by HPLC. An Agilent ZORBAX SB- C18 column（250 mm ×4.6 mm,5 μm） was used, the mobile phase consisted of acetonitrile-tetrabydrofuran-0.8% acetic acid（ 12： 6： 82）, the flow rate was 1.0 ml · rain-1 , the detection wavelength was set at 324 nm and the column temperature was 30℃. Results： The TLC sports were fairly clear without interference from the blank samples. 7-Hydroxyl eoumarin in the sample solution was well sep- arated, the linearity was good （r r-0.999 9） within the range of 0.032-0.636 μg, and the average recovery was 101.26% with RSD of 1.32% （ n = 9 ）. Conclusion： The method is rapid, simple, reliable and accurate, which can be applied as a quality control method for Suxiao Yatongning tincture.