在中药(TCM)制造业,质量控制决定了安全,有效性,和最终产品的质量稳定性。传统的质量控制方法一般在批生产结束后对药品进行抽样离线检测,这是不全面的,未能及时发现生产过程中的问题。过程分析技术(PAT)使用过程测试,数学建模,数据分析,和其他技术来收集,分析,反馈,control,的关键质量属性(CQA),并实时不断提高中药制剂生产的各个环节。PAT在中药制造业中的应用是近年来的研究热点之一,它具有实时的优点,系统,非破坏性的,绿色,和快速检测,为中药制剂的生产质量控制提供依据。能有效保证中药制剂质量的稳定性,提高生产效率,并在研究中药的数量和质量转移规律中发挥关键作用。常用的PAT包括近红外光谱,拉曼光谱,在线微波,等。此外,通过PAT建立在线检测模型是实现中药生产智能制造的关键基础工作。通过PAT获取实时在线检测数据,并在此基础上建立闭环控制模型,是行业内关键的共性技术难点。本文采用系统的文献分析法,对国内外相关文献进行综述,政策法规,和生产应用,介绍了PAT的发展趋势和实际应用,从而为加快PAT在中药制造业的应用提供参考,智能化转型升级,和中药产业高质量发展。
In the traditional Chinese medicine(TCM) manufacturing industry, quality control determines the safety, effectiveness, and quality stability of the final product. The traditional quality control method generally carries out sampling off-line testing of drugs after the end of the batch production, which is incomprehensive, and it fails to find the problems in the production process in time. Process analysis technology(PAT) uses process testing, mathematical modeling, data analysis, and other technologies to collect, analyze, feedback, control, and continuously improve the critical quality attributes(CQA) in all aspects of the production of TCM preparations in real time. The application of PAT in the TCM manufacturing industry is one of the research hotspots in recent years, which has the advantages of real-time, systematic, non-destructive, green, and rapid detection for the production quality control of TCM preparations. It can effectively ensure the stability of the quality of TCM preparations, improve production efficiency, and play a key role in the study of the quantity and quality transfer law of TCM. Commonly used PAT includes near-infrared spectroscopy, Raman spectroscopy, online microwave, etc. In addition, the establishment of an online detection model by PAT is the key basic work to realize intelligent manufacturing in TCM production. Obtaining real-time online detection data through PAT and establishing a closed-loop control model on this basis are a key common technical difficulty in the industry. This paper adopted systematic literature analysis to summarize the relevant Chinese and foreign literature, policies and regulations, and production applications, and it introduced the development trend and practical application of PAT, so as to provide references for accelerating the application of PAT in the TCM manufacturing industry, the intelligent transformation and upgrading, and high-quality development of the TCM industry.