论文部分内容阅读
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p H值至6.4)=55∶45;流速:1.0 m L/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。
Objective To establish the quality standard of San Yuan Rupi De Gel Gel and to enhance the quality controllability of the preparation. Methods The TLC, HPLC, HPLC method and HPLC method were used to identify the content of tetrahydropalmatine. Column: Waters symmetry column (4.6 mm × 250 mm, 5 μm); mobile phase: acetonitrile: 0.1% phosphoric acid solution (triethylamine adjusted pH value to 6.4) = 55:45; Temperature: 30 ℃; Detection wavelength: 280 nm. Results The TLC spots of Trigemina, Gleditsia, Cyperus rotundus and Acute were clear and the separation was good. The content of Tetrahydropalmatine was good in the range of 0.092-1.84 μg with the average recovery of 100.15% RSD = 1.58% (n = 6). Conclusion The method established in this study is simple, accurate and reproducible. It can be used for the quality control of San Yuan Routong Gel Gel.