近红外光谱技术在注射用益气复脉（冻干）生产过程分析系统中的应用进展

尚献召，孟昭平，李德坤，张磊; SHANG Xianzhao; MENG Zhaoping; LI Dekun; ZHANG Lei

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2025年6月30日 3:30 星期一

首页 > 过刊浏览>2021年第44卷第11期 >2021,44(11):2314-2321. DOI:10.7501/j.issn.1674-6376.2021.11.004

近红外光谱技术在注射用益气复脉（冻干）生产过程分析系统中的应用进展

尚献召
尚献召
天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410
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孟昭平
孟昭平
天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410
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李德坤
李德坤
天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410
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张磊
张磊
天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410
通讯作者.
Email: zhanglei201312@tasly.com
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Research progress on NIRS-based process analytical system for production of Yiqi Fumai Lyophilized Injection

SHANG Xianzhao
SHANG Xianzhao
Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin, 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China
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MENG Zhaoping
MENG Zhaoping
Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin, 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China
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LI Dekun
LI Dekun
Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin, 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China
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ZHANG Lei
ZHANG Lei
Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin, 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China
Contact Author.
Email: zhanglei201312@tasly.com
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发布日期：2021-11-10

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[关键词]

注射用益气复脉（冻干） ; 近红外光谱技术 ; 过程分析技术 ; 分析方法 ; 中药制造 ; 质量标志物 ; 质量控制

[摘要]

近年来，近红外光谱技术在中药制造领域得到广泛应用，已经成为中药制造过程分析的重要技术手段。通过建立注射用益气复脉（冻干）的质量标志物的近红外光谱分析方法，并结合工艺特点与质量要求确定过程分析技术应用方式，介绍该制剂生产过程近红外光谱分析系统的构建，详细描述该系统建立过程工艺监测点的筛选原则、检测方式的选择依据。同时，结合笔者工作经验，提出了将近红外光谱分析技术运用于中药制造过程质量控制中需注意的问题（包括系统构建的前期准备、近红外光谱分析方法开发与运行管理体系完善等）并进行讨论。

[Key word]

Yiqi Fumai Lyophilized Injection (YQFM) ; near infrared spectroscopy ; process analytical technology ; analytical methods ; traditional Chinese medicine (TCM) product ; quality markers ; quality control

[Abstract]

In recent years, near infrared spectroscopy (NIRS) has been considered as an efficient tool for achieving process analytical technology (PAT) in the manufacture of traditional Chinese medicine (TCM) products. In this article, the NIRS based process analytical system for the production of Yiqi Fumai Lyophilized Injection (YQFM) was introduced. The design of the process analytical system was described in detail, including the selection of monitored processes and testing mode. Building the analytical methods of NIRS based on some of quality markers in YQFM, determining the application mode of PAT based on the process feature and quality requirement. Based on author's experience on PAT, some issues in the application of NIRS to the process monitoring and control in TCM production were raised and discussed. That include the preparation for production of PAT system, method development of NIRS, and improving the management of process analytical system. Finally, the prospect for the application of NIRS in the TCM industry was put forward.

[中图分类号]

R283.6;R286.0

[基金项目]

引用本文 / Get Citation

尚献召,孟昭平,李德坤,张磊.近红外光谱技术在注射用益气复脉（冻干）生产过程分析系统中的应用进展[J].药物评价研究,2021,44(11):2314-2321

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收稿日期: 2021-08-04

在线发布日期: 2021-11-10

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