复方茵陈保肝口服液的制备与提取工艺研究

Preparation and Extraction Process of Compound Yinchen Baogan Oral Liquid

关键词:  提取工艺 复方茵陈保肝口服液 质量标准

Key words:  Extraction process  compound Yin Chen Baogan oral liquid  quality standard

摘要:

［］ 目的：复方茵陈保肝口服液的制备工艺并建立质量标准。方法：1.采用紫外分光光度法,以滨蒿内酯为对照品,在340nm处测定按照不同工艺制备的口服液中香豆素含量,以香豆素含量高低作为优化标准。2.采用薄层色谱法对口服中茵陈、党参、淫羊藿进行定性鉴别。3.采用高效液相色谱法对口服液成品香豆素含量进行测定。结果：口服液在料液比为1：20,醇沉体积分数50%,煎煮时间2h条件时香豆素含量最高。薄层色谱中斑点清晰,阴性对照无干扰。高效液相色谱法中滨蒿内酯在6.8-136μg范围内具有良好的线性关系,平均加样回收率为98.79%,RSD为1.39%。结论：本实验优化制备工艺的方法简单可行,建立的质量标准适用于复方茵陈保肝口服液的质量控制。

Abstract:

Objective: To optimize the preparation process of compound Yinchenbao oral liquid and establish quality standard. Methods: 1. The content of coumarin in the oral liquid prepared by different process was determined by UV spectrophotometry, and the content of coumarin was determined as the optimized standard at 340 nm. 2. Thin-layer chromatography on the oral administration of capillaris, Codonopsis, Epimedium qualitative identification. The content of coumarin in oral liquid was determined by high performance liquid chromatography (HPLC). Results: The content of coumarin was the highest when the ratio of liquid to liquid was 1:20, the volume fraction of alcohol was 50%, and the boiling time was 2h. Thin layer chromatography clear spots, negative control without interference. The results showed that the average recoveries were 98.79% and the RSD was 1.39% in the range of 6.8-136μg. Conclusion: The method of optimizing the preparation process is simple and feasible. The quality standard is suitable for the quality control of compound Yinchenbao oral liquid.