Enzyme-linked Immunosorbent Assay in Quality Control of Chinese Medicines： A Review / 中国实验方剂学杂志

In the quality control of Chinese medicine， the detection of active components and toxic and harmful components are two important links. Although conventional methods such as high performance liquid chromatography and liquid chromatography-mass spectrometry can accurately quantify the above substances， they have shortcomings such as complicated operation， high costs， inability of detection at any time， difficult detection of insoluble and macromolecular substances. Enzyme-linked immunosorbent assay （ELISA） can adsorb antigens or antibodies on the surface of solid carriers and realize qualitative or quantitative analysis of targets by using the specific reactions of antigens and antibodies. This method is praised for the simple operation， high sensitivity， strong specificity， simple requirements for experimental equipment， a wide application range， and low costs. In recent years， ELISA has been widely used in the quality control of Chinese medicine， especially in the content determination of mycotoxins represented by aflatoxin and the qualitative and quantitative analysis of active components. ELISA plays an increasingly important role with its unique advantages， providing new methods and ideas for the rapid quality examination of large quantities of Chinese medicines. This paper reviews the research progress in ELISA for the quality control of Chinese medicine in recent years and prospects its technical development and application prospects， aiming to provide reference and research ideas for further using this method to ensure the quality， safety， and controllability of Chinese medicine.

Studies on the methodology for quality control in Chinese medicine manufacturing process based on knowledge graph / 中国中药杂志

According to the requirements for developing the quality control technology in Chinese medicine( CM) manufacturing process and the practical scenarios in applying a new generation of artificial intelligence to CM industry,we present a method of constructing the knowledge graph( KG) for CM manufacture to solve key problems about quality control in CM manufacturing process.Based on the above,a " pharmaceutical industry brain" model for CM manufacture has been established. Further,we propose founding the KG-based methodology for quality control in CM manufacturing process,and briefly describe the design method,system architecture and main functions of the KG system. In this work,the KG for manufacturing Shuxuening Injection( SXNI) was developed as a demonstration study. The KG version 1. 0 platform for intelligent manufacturing SXNI has been built,which could realize technology leap of the quality control system in CM manufacturing process from perceptual intelligence to cognitive intelligence.

A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management / 中国中药杂志

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated.