Qualitative and quantitative analysis of HPLC fingerprint of Wuji gastric floating sustained-release tablets

A qualitative and quantitative test method of fingerprint of Wuji gastric floating sustained-release tablets was established. High performance liquid chromatography （HPLC） was adopted, using Agilent ZORBAX SB-C18 column （250 mm×4.6 mm, 5 μm） as the chromatographic column, and acetonitrile-0.05 mol/L potassium dihydrogen phosphate solution as the mobile phase in a gradient elution with the flow rate of 1.0 mL/min. Sample solution （10 μL） was injected and was tested at the wavelength of 225 nm for 75 min at the column temperature of 30 ℃, Fingerprint similarity software （2004A version） was used to conduct data analysis. A total of 11 batches of Wuji gastric floating sustained-release tablets were tested and analyzed with HPLC fingerprint. Seventeen common peaks were found and the similarity of the 11 batches of agents was greater than 0.9, indicating that the production process of the agent is stable and feasible. The method is operable and could effectively control the quality of Wuji gastric floating sustained-release tablets.

左金胃漂浮缓释片多组分体内释放研究

目的:研究左金胃漂浮缓释片多组分的体内释放行为。方法:不同时间点取家兔胃内容物,处理并制备供试品溶液,采用高效液相色谱法建立各个时间点及全溶样品的图谱,计算体内累积释放度,采用相似因子法评价指标成分之间及指标成分与制剂之间的释放行为。结果:在10 h内,小檗碱与吴茱萸内酯、吴茱萸次碱的相似因子分别为52、61.5,与制剂的相似因子为66.4,吴茱萸内酯与吴茱萸次碱的相似因子为70,与制剂的相似因子分别为46.5、53.7。结论:在10 h内,小檗碱的释放行为与吴茱萸内酯、吴茱萸次碱及制剂相似;吴茱萸次碱与吴茱萸内酯及制剂的释放行为相似;而吴茱萸内酯与制剂的释放行为不一致。