[根据Box-Behnken设计-响应表面方法,标准关系和分析层次过程结合重法来优化经典处方Yihuang Decoction的提取过程]
Xin-Ying Lu1, Jia-Yao Bi1, Ming-Hui Li1
1School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102488, China.
概括
这项研究优化了利用设计质量 (QbD) 原则来提取义华脱. 优化过程确保了稳定,可靠的提取,产生与未来颗粒开发的参考样品相比的质量.
科学领域:
- 药理学和中国传统医学 (TCM) 提取优化.
- 在制药工艺开发中应用多变量统计方法.
背景情况:
- 经典的TCM处方需要强大的提取方法来保持一致的质量.
- 设计质量 (QbD) 原则对于现代化传统医药制造至关重要.
研究的目的:
- 优化利用QbD方法提取易黄的提取过程.
- 建立关键质量属性 (CQA) 和关键过程参数 (CPP) 以可靠提取.
- 开发一个预测模型,以获得最佳的开采条件.
主要方法:
- 盒子-Behnken设计响应表面方法结合标准关系 (SR) 和分析层次过程 (AHP) -重量方法 (EWM).
- 鉴定CQAs (基尼酸,菲洛登德林化物,柏柏林化物含量,提取产量,指纹相似性) 和CPPs (提取时间,添加水,提取时间).
- 开发一个功能模型,将CPP和CQA联系起来,用于全面的得分预测.
主要成果:
- 确定最优化的提取过程是:8倍的水量,1.5小时的提取时间和单次提取.
- 验证实验的平均综合得分为85.77,RSD为0.99%,符合质量控制标准.
- 优化的提取物表现出与参考样本相似的质量属性.
结论:
- 优化的提取过程为易华是稳定的,可靠的,和可重复的.
- 综合的QbD方法 (Box-Behnken,SR,AHP-EWM) 有效地优化了TCM的提取.
- 这种优化的工艺为开发易黄开颗粒提供了基础,并可以指导其他经典处方的研究.
关键词:
盒子-Behnken设计响应表面方法.义华 (Yihuang) 蒸煮剂 义华 (Yihuang) 蒸煮剂 义华 (Yihuang) 蒸煮剂 是一种消毒剂.分析层次的过程过程分析层次的过程.这是经典的处方药.重量方法的重方法.提取过程中的提取过程.从设计开始的质量.标准关系是标准关系.更多相关视频
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