三元乳癖消凝胶膏质量标准研究

Study on Quality Standard 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 for Sanyuan Rupixiao Gel Paste.Methods SparganiiRhizoma,Gleditsiae Sinensis Fructus,Cyperi Rhizoma and Impatientis Semen were identified by TLC method.Thecontent of tetrahydropalmatine was determined by HPLC.Waters symmetry column was used with the mobile phaseof acetonitrile-0.1%phosphatic acid in a gradient manner(pH was adjusted to6.4by triethylamine)(55:45)at thedetection wavelength of280nm.The flow rate was1.0mL/min at the column temperature of30℃.Results Thespots in TLC were clear without any interference;tetrahydropalmatine showed a good linear relation in the range of0.092–1.84μg;the average recovery was100.15%with RSD of1.58%(n=6).Conclusion The method is simple andaccurate with high reproducibility,which can be used for the quality control of Sanyuan Rupixiao Gel Paste.