[在中国传统医药制造业中应用过程分析技术]
Wei-Feng Zhu1, Yu Shen1, Pan Deng2
1Key Laboratory of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Chinese Medicine Nanchang 330004, China.
概括
过程分析技术 (PAT) 通过实时的过程中监控来增强传统中医 (TCM) 制造质量控制. 这种方法确保了TCM产品的安全性,有效性和稳定性,超越了过时的离线测试方法.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程分析技术 (PAT) 是一种分析技术.
- 传统中国医学 (TCM) 是一种
背景情况:
- 在TCM制造中,传统的质量控制依赖于离线测试,这是耗时的,无法及时检测生产问题.
- 确保TCM产品的安全性,有效性和质量稳定性对于患者的治疗结果和监管合规性至关重要.
研究的目的:
- 审查过程分析技术 (PAT) 在传统中医制造业中的应用,优势和趋势.
- 突出PAT在实时质量控制和TCM制剂智能制造中的作用.
- 为加速PAT采用和升级TCM行业提供参考资料.
主要方法:
- 对国内和国际研究,政策,法规和与TCM中PAT相关的生产应用进行系统的文献分析.
- 审查常用的PAT工具,如近红外光谱,拉曼光谱和在线微波技术.
主要成果:
- PAT为TCM质量控制提供实时,系统,非破坏性,绿色和快速检测,确保产品质量的稳定性和提高效率.
- 使用PAT数据建立在线检测模型和闭环控制系统对于智能TCM制造至关重要.
- PAT有助于研究TCM中质量转移定律.
结论:
- 在TCM制造中,PAT代表了与传统质量控制方法相比的重大进步.
- 加快PAT实施对于TCM行业的智能转型,升级和高质量发展至关重要.
- 克服实时数据采集和闭环控制方面的技术挑战是实现PAT在TCM生产中的全部潜力的关键.
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