关键词: font-size:medium, ">复方柏连灌肠剂；没食子酸；提取工艺；响应曲面法；高效液相色谱法

Abstract: Objective：To optimize the extraction process of compound bailian enema and to provide a reference for the application of preparations for medical institutions. Methods： Establish a HPLC method for the determination of gallic acid in compound bailian enema. The transfer rate of gallic acid was used as an evaluation indicator.Based on single factor experiments，the Box-Behnken response surface center combination method was used to design the factor level and investigate the effect of solid-liquid ratio， extraction time and extraction times on the extraction effect of gallic acid in the prescription.Results:The specificity， precision， repeatability， and stability of the established high performance liquid chromatography method met the requirements of the pharmacopoeia. The injection concentration of gallic acid in the range of 24-144 μg·mL-1 showed a good linear relationship with the chromatographic peak area. The regression equation is: y=27.794x+44.413， r2=0.999 9， and the average sample recovery rate is 99.6% (RSD=2.7%). The optimal extraction conditions for compound bailian enema are as follows extrant 3 times. 10 times the amount of water each time，extract for 1 h each time. The actual measurement and the response surface method regression model are highly fitted. Conclusion： The extraction process of compound bailian enema established in this study, which was optimized by response surface method is stable and reliable， and the quality is controllable.

Key words: Compound bailian enema;Gallic acid;Extraction process;Response surface method, High performance liquid chromatography