文献类型：期刊文献

中文题名：基于质量源于设计理念的白蕾复方浸膏干燥工艺研究

英文题名：Research on drying process of Bailei compound Extractum based on quality from design

作者：薄双琴[1];陈晖[1];柳娜[1];徐婕[1];王嘉鸣[1];景明[1]

第一作者：薄双琴

机构：[1]甘肃中医药大学,甘肃兰州730000

第一机构：甘肃中医药大学

年份：2023

卷号：34

期号：7

起止页码：1630

中文期刊名：时珍国医国药

外文期刊名：Lishizhen Medicine and Materia Medica Research

收录：北大核心:【北大核心2020】；CSCD:【CSCD_E2023_2024】；

基金：国家自然科学基金(81860788,82160854);甘肃省兰州市人才创新创业项目(2019-RC-101)。

语种：中文

中文关键词：质量源于设计;白蕾复方浸膏;粉体学性质;正交设计;指纹图谱

外文关键词：Quality by design;Bailei compound Extractum;Powder properties;Orthogonal design;Fingerprint

摘要：目的基于质量源于设计理念优化白蕾颗粒浸膏的干燥工艺,并对浸膏粉进行质量评价。方法以干膏率、指标性成分含量、粉体学性质研究对常压干燥和减压干燥所得的浸膏粉进行考察;采用正交设计以指标性成分转移率和干膏率为评价指标,优化减压干燥的工艺参数;对工艺优化后浸膏粉的性质通过重复试验、中药色谱指纹图谱相似度评价系统A版比较干燥前后的指纹图谱相似度、粉体学性质指标绘制物理指纹图谱进行综合表征,评价不同批次浸膏粉的质量一致性。结果浸膏减压干燥的最佳工艺条件为药液相对密度1.15~1.20(25℃),真空度-60Mpa,干燥温度70℃,优选干燥工艺的RSD值均不大于4.36%,浸膏干燥前后化学指纹谱相似度均大于0.92,3批浸膏粉的物理指纹谱相似度均大于0.99。结论优化的白蕾颗粒浸膏减压干燥工艺稳定可行,重复性好。
Objective To optimize the drying process of Bailei Granules extract based on quality from design and evaluate the quality of the extract powder.Methods The extractum powder obtained by atmospheric drying and vacuum drying were investigated by dry paste rate,index component content and powder properties.Orthogonal design was used to optimize the process parameters of vacuum drying with the index component transfer rate and dry paste rate as the evaluation indexes.The properties of the optimized extract powder were comprehensively characterized by repeated tests,comparison of fingerprint similarity before and after drying with the fingerprint similarity evaluation system VERSION A,and physical fingerprint mapping based on powder properties.The quality consistency of different batches of extract powder was evaluated.Results The optimum technological conditions for pressure-reducing drying of extract were as follows:relative density of liquid 1.15~1.20(25℃),vacuum degree-60Mpa,drying temperature 70℃.The RSD of the optimized drying process was not greater than 4.36%,the similarity of chemical fingerprint spectrum before and after drying of extract was greater than 0.92,and the similarity of physical fingerprint spectrum of three batches of extract powder was greater than 0.99.Conclusion The optimized vacuum drying process of Bailei granule extractum is stable,feasible and reproducible.