基于过程分析技术和设计空间的金银花醇沉加醇过程终点检测

被引：21

作者：

徐冰 ^{[1
]}

罗赣 ^{[1
]}

林兆洲 ^{[1
]}

艾路 ^{[1
]}

史新元 ^{[1
,2
]}

乔延江 ^{[1
,2
]}

机构：

[1] 北京中医药大学中药信息工程研究中心

[2] 教育部中药制药与新药开发关键技术工程研究中心

来源：

高等学校化学学报 | 2013年 / 34卷 / 10期

关键词：

过程分析技术; 设计空间; 近红外光谱法; 醇沉过程; 终点检测;

D O I：

暂无

中图分类号：

TQ461 [中草药制剂的生产];

学科分类号：

091003 [林草生态工程学];

摘要：

建立了一种新的基于过程分析技术(PAT)和质量源于设计(QbD)设计空间的中药制药过程终点分析与控制方法.以近红外(NIR)光谱技术为PAT工具,采集正常操作条件下制药过程的多批次NIR光谱;采用主成分分析结合移动块相对标准偏差(PCA-MBRSD)法,确定每一批次过程的理想终点样本(DEPs),由多批DEPs的光谱信息构成过程终点设计空间;在过程终点设计空间确定的范围内,建立多变量统计过程控制(MSPC)模型,利用多变量Hotelling T2和SPE控制图对过程终点进行判断.应用上述方法,进行了金银花醇沉加醇过程终点检测研究,结果表明该方法灵敏、准确,适宜于中药制药过程终点检测.

引用

页码：2284 / 2289

页数：6

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