三元乳癖消凝胶膏质量标准研究

摘要

Objective To establish the quality standard for Sanyuan Rupixiao Gel Paste. Methods Sparganii Rhizoma, Gleditsiae Sinensis Fructus, Cyperi Rhizoma and Impatientis Semen were identified by TLC method. The content of tetrahydropalmatine was determined by HPLC. Waters symmetry column was used with the mobile phase of acetonitrile-0.1% phosphatic acid in a gradient manner (pH was adjusted to 6.4 by triethylamine) (55:45) at the detection wavelength of 280 nm. The flow rate was 1.0 mL/min at the column temperature of 30 ℃. Results The spots in TLC were clear without any interference;tetrahydropalmatine showed a good linear relation in the range of 0.092–1.84 µg;the average recovery was 100.15%with RSD of 1.58%(n=6). Conclusion The method is simple and accurate with high reproducibility, which can be used for the quality control of Sanyuan Rupixiao Gel Paste.%目的：建立三元乳癖消凝胶膏的质量标准，增强该制剂的质量可控性。方法采用薄层色谱法对三元乳癖消凝胶膏中三棱、大皂角、香附和急性子进行定性鉴别，采用高效液相色谱法测定方中延胡索乙素含量。色谱柱：Waters symmetry柱（4.6 mm×250 mm，5µm）；流动相：乙腈∶0.1%磷酸溶液（三乙胺调节pH值至6.4）＝55∶45；流速：1.0 mL/min；柱温：30℃；检测波长：280 nm。结果制剂中三棱、大皂角、香附和急性子的薄层色谱斑点清晰，分离度好；延胡索乙素含量在0.092～1.84µg范围内具有良好的线性关系，平均加样回收率为100.15%，RSD＝1.58%（n＝6）。结论本研究所建立的方法简便、准确、重复性好，可用于三元乳癖消凝胶膏的质量控制。