张磊;岳洪水;鞠爱春;叶正良;
ZHANG Lei;YUE Hong-shui;JU Ai-chun;YE Zheng-liang;Tianjin Tasly Pride Pharmaceutical Co.,Ltd;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections;

• 1:天津天士力之骄药业有限公司
• 2:天津市中药注射剂安全性评价企业重点实验室

摘要(Abstract)：

目前,近红外光谱技术已经成为实施中药制造过程分析的重要技术手段。该文介绍了注射用丹参多酚酸生产全过程近红外光谱分析系统的构建,详细描述了该系统设计过程中监测工序的筛选原则、检测方式的选择依据以及应避免的潜在风险等核心问题。同时,阐述了注射用丹参多酚酸制造过程近红外光谱技术体系的开发,包括聚酰胺柱色谱和大孔树脂柱色谱洗脱过程监测方法的建立,以及成品质量快速检测方法的研究。此外,结合作者的科研及工作经验,讨论了将近红外光谱分析技术运用于中药制造过程质量监测及控制的潜在问题及解决思路,包括中药近红外光谱分析技术团队建设、生产过程近红外光谱分析系统的设计、近红外光谱分析方法的规范化以及过程分析系统管理制度的完善等,可为同行业其他企业生产过程分析系统的构建提供参考。最后,对近红外光谱技术在中药制造工业的发展前景进行了展望。
Currently,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 salvianolic acid for injection was introduced. The design of the process analytical system was described in detail,including the selection of monitored processes and testing mode,and potential risks that should be avoided. Moreover,the development of relative technologies was also presented,which contained the establishment of the monitoring methods for the elution of polyamide resin and macroporous resin chromatography processes,as well as the rapid analysis method for finished products. Based on author's experience of research and work,several issues in the application of NIRS to the process monitoring and control in TCM production were then raised,and some potential solutions were also discussed. The issues include building the technical team for process analytical system,the design of the process analytical system in the manufacture of TCM products,standardization of the NIRS-based analytical methods,and improving the management of process analytical system. Finally,the prospect for the application of NIRS in the TCM industry was put forward.

关键词(KeyWords)： 注射用丹参多酚酸;近红外光谱;过程分析技术
salvianolic acid for injection;near infrared spectroscopy;process analytical technology

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 张磊;岳洪水;鞠爱春;叶正良;
ZHANG Lei;YUE Hong-shui;JU Ai-chun;YE Zheng-liang;Tianjin Tasly Pride Pharmaceutical Co.,Ltd;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections;

Email:

DOI:

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