关键词: font-size:medium, ">四黄栓；盐酸小檗碱；高效液相色谱；含量测定；成型工艺；正交试验

Abstract: Objective： To explore the method for determining the content of berberine hydrochloride in the extract of sihuang suppository， and to optimize the molding process of the suppository. Methods： HPLC quantitative determination was used to explore the method for determining the content of berberine hydrochloride in the extract. Orthogonal experiments were designed, and the melting temperature of the matrix， the filling temperature of the drug-containing matrix and the demolding time were used as the investigating factors. The appearance， properties， weight variation, melting time limit were used as comprehensive indicators， and the best molding process of sihuang suppository was selected. Results： The method for determining the content of berberine hydrochloride in sihuang suppository extract is as follows: Phenomenex C18 column (4.6 mm×250 mm， 5 μm)， acetonitrile- 0.05 mol·L-1 sodium dihydrogen phosphate solution (50∶50) as the mobile phase (add 0.4 g sodium dodecyl sulfate per 100 mL， and adjust the pH to 4.0 with phosphoric acid). The detection wavelength is 345 nm (VWD ultraviolet detector). The injection volume is 10 μL.The flow rate is 0.8 mL·min-1. The column temperature is 25 ℃. The best molding process is to heat the matrix in a water bath at 70 ℃ to completely melt it， add the finely ground extract powder that has passed through a 100-mesh sieve， and stir evenly. Cool to a temperature of about 40 ℃， pour it into the suppository mold， cure for 20 minutes， and release the mold to get it. Conclusion： A method for the determination of berberine hydrochloride content in sihuang suppository extract was preliminarily established， and the detection method has good stability and reproducibility. The molding process of sihuang suppository was optimized， which is simple， reasonable， stable and feasible.
 

Key words: font-size:medium, ">Sihuang suppository；Berberine hydrochloride；HPLC；Content determination；Molding process；Orthogonal test