疏清颗粒醇提工艺优化与质量标准提升

Study on Optimization of Ethanol Extraction Technology of Shuqing Granules and Improving the Quality Standard

目的 优化疏清颗粒制备方法中的醇提工艺,提高疏清颗粒的质量标准。方法 以靛玉红的含量作为指标,采用单因素试验,对提取时间、大青叶的粒度、提取温度、滤材目数进行优化,确定最佳提取工艺。建立疏清颗粒中水溶性成分阿魏酸的含量测定方法。结果 确定了醇提过程的工艺参数:大青叶的粉碎粒度为最粗粉,40℃温浸提取,浸渍时间为48 h,300目滤布过滤提取液,靛玉红的含量提高了4倍。薄层色谱鉴别和指纹图谱表明,工艺优化对疏清颗粒的物质基础无影响。建立的阿魏酸含量测定方法准确可靠,可以作为疏清颗粒水提工艺的评价标准。结论 工艺优化缩短了企业的生产周期,提高了生产效率,改善了药品的质量,增加水溶性成分的质量标准,以保证产品的一致性。

Objective To optimize the ethanol extraction technology of Shuqing granules and improve the quality standard.Methods The particle size of herbs,extraction temperature and time,and filter mesh were optimized by single-factor test to find the optimal extraction process using the content of indirubin as an indicator.To establish a method for the determination of water-soluble fraction of ferulic acid in Shuqing granules.Results The process variable of alcohol extraction process were determined:the crushing granularity was the coarsest powder,the extraction temperature was 40℃,the impregnation time was 48 h,and filtered by 300 mesh filter cloth.The content of indirubin had increased 4 times.Thin-layer chromatography and HPLC superimposed fingerprints indicated that technology optimization had no effect on the material basis of Shuqing Granules.The established method for the determination of ferulic acid was stable and accurate,and can be used as an index for the water extraction of Shuqing granules.Conclusion The optimized process shorten the production cycle of the company and improved the production efficiency the quality of granules.Quality standard for water-soluble fraction was established to ensure the consistency of production.