基于QbD理念的泽红胶囊中泽泻提取工艺研究  

Study on Extraction Technology of Alismatis Rhizoma from Zehong Capsule Based on QbD Concept

作　　者：夏裕发 林毅东 吴骅楷 王丽菊 Xia Yufa;Lin Yidong;Wu Huakai;Wang Liju(Zhangzhou Pien Tze Huang Pharmaceutical Co.,Ltd.,Zhangzhou 363000;Fujian Pien Tze Huang Enterprise Key Laboratory of Natural Medicine Research and Development,Zhangzhou 363000,China)

机构地区：[1]漳州片仔癀药业股份有限公司,福建漳州363000 [2]福建省片仔癀天然医药研发企业重点实验室,福建漳州363000

出　　处：《广东化工》2022年第23期50-53,共4页Guangdong Chemical Industry

基　　金：南平市科技计划项目(N2020Y007);中央引导地方科技发展专项(2019L3027)。

摘　　要：目的:优化泽红胶囊中泽泻提取工艺。方法:基于质量源于设计(QbD)理念,以干膏得率、23-乙酰泽泻醇B为泽泻提取过程中的关键质量属性(CQAs),以加水量,提取时间,提取次数为关键工艺参数(CPPs),通过单因素、正交实验考察CQAs与CPPs的交互作用,并进行工艺优化。结果:最佳工艺为用水提取2次,每次加水6倍量,提取1 h,首次提取前浸泡30 min。结论:优选的泽泻提取工艺稳定可行,可为后续产品的开发奠定基础。Objective: To optimize the extraction process of Alismatis Rhizoma from Zehong capsules. Methods: Based on quality by design(QbD), with the extract yield, content of alisol B 23-acetate as critical quality attributes(CQAs), with add water, extraction time, extraction times as critical process parameters(CPPs), through single factor and orthogonal experiment investigation CQAs interactions with CPPs, and process optimization. Results: The best process was to extract with water for 2 times, adding 6 times of water each time, extracting 1 h, soaking 30min before the first extraction. Conclusion: The optimized extraction process of Alismatis Rhizoma is stable and feasible, which can lay a foundation for the development of products.

关 键 词：质量源于设计 泽泻 失效模型与影响分析 正交试验 提取工艺 

分 类 号：TQ[化学工程]