五虎凝胶贴膏质量标准研究

Study on Quality Standard for Wuhu Gel Paste

关键词:  五虎凝胶贴膏  薄层色谱法  高效液相色谱法  质量标准

Key words:  Wuhu Gel Paste  TLC  HPLC  quality standard

摘要:

目的 建立五虎凝胶贴膏的质量标准。方法 采用薄层色谱法（TLC）对处方中白芷、当归、防风、红花、制天南星进行定性鉴别；采用HPLC同时测定处方中羟基红花黄色素A、阿魏酸、升麻素苷、5-O-甲基维斯阿米醇苷、欧前胡素、异欧前胡素的含量，色谱柱为Agilent Eclipse Plus C₁₈（250 mm×4.6 mm，5μm），流动相甲醇-0.025%磷酸，梯度洗脱，流速为1.0 mL·min^-1；柱温28℃；检测波长403，300，254 nm。结果 处方中所有药味薄层斑点清晰，分离度好，阴性无干扰；6种化合物在各自的范围内线性关系良好（r ≥ 0.999 5），平均加样回收率96.30%~100.56%，RSD为1.06%~1.65%。结论 建立的TLC鉴别方法专属性强、分离度好；HPLC测定方法准确稳定、重复性好，可用于五虎凝胶贴膏的质量控制。

Abstract:

OBJECTIVE To establish the quality standard for Wuhu Gel Paste. METHODS TLC was adopted to identify Angelica Dahurica, Angelicae Sinensis Radix, Saposhnikovia Divaricate, Carthamii Flos, Dried Ginger. HPLC was used to determine hydroxysafflor yellow A, ferulic acid, prim-O-glucosylcimifugin, 4-O-β-D-glucosyl-5-O-methylvisamminol, imperation and isoimperation. The analysis was performed on a 28℃ thermostatic Agilent Eclipse C₁₈ column(250 mm×4.6 mm, 5 μm), with the mobile phase comprising of methanol-0.025% phosphoric acid flowing at 1.0 mL·min^-1 in a gradient elution manner, and the detection wavelengths were set at 403, 300, 254 nm. RESULTS The medicinal flavours had clear thin spots, good separation and no negative interference. Six constituents showed good linear relationships within their own ranges(r ≥ 0.999 5), while the average recoveries were 96.30%-100.56% with the RSDs of 1.06%-1.65%. CONCLUSION The TLC method in this experiment has strong specificity and good separating degree. The HPLC method has high accuracy and repeatability. The established methods can be used to control quality of Wuhu Gel Paste.