保健食品桂芍舒逸口服液的工艺优选与质量标准建立

目的 对桂芍舒逸口服液制作工艺进行优选, 并建立质量控制方法。方法 以芍药苷为测定指标, 利用正交试验优选出最佳制备工艺; 采用薄层色谱法对黄芪、白芍、炙甘草进行鉴别研究; 采用高效液相色谱法(high performance liquid chromatography, HPLC)测定芍药苷的含量。结果 最佳工艺为8倍量水煎煮3次, 每次1 h, 滤液8000 r/min, 离心20 min, 上清液加入饴糖、苯甲酸钠; 黄芪、白芍、炙甘草薄层定性鉴别。该方法斑点清晰、阴性无干扰、专属性好, 含量测定方法学验证良好, 测得芍药苷含量在190 mg/100 mL以上。结论 优化的提取工艺稳定可行, 建立的质量标准能够控制桂芍舒逸口服液质量, 保证其产品品质。

Optimization of process and establishment of quality standard of healthy food Guishao Shuyi oral liquid

Objective To optimize the process of Guishao Shuyi oral liquid and establish a quality control method. Methods The paeoniflorin was used as the determination index, and the preparation process was optimized by orthogonal test. Astragalus, Radix paeoniae alba and Radix glycyrrhizae was identified by thin layer chromatography. The content of paeoniflorin was determined by high performance liquid chromatography (HPLC). Result The best process was 8 times water decoction 3 times, each time 1 h, the filtrate was centrifuged by 8000 r/min for 20 min, and the supernatant was added with sucrose, sodium benzoate. Astragalus, Radix paeoniae alba and Radix glycyrrhizae were qualitative identified by thin layer chromatography. This method had clear spots, no negative interference, good specificity, good determination method of content determination, and the content of paeoniflorin was above 190 mg/100 mL. Conclusion The optimized extraction process is stable and feasible, and the established quality standards can control the quality of Guishao Shuyi oral liquid and ensure the quality of its products.