Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

In the process of transforming and upgrading of traditional Chinese medicine( TCM) intelligent manufacturing,the TCM enterprises lack systematic and in-depth research on intelligent manufacturing of TCM,leading to insufficient understanding of relevant concepts,development direction,development content and other aspects,to some extent,causing fuzzy and chaotic phenomena. The theoretical model,as a higher expression level of scientific thinking,has the function of interpretation and prediction,and can provide theoretical basis as well as guide for scientific research. Therefore,this article aims to construct a theoretical model of TCM intelligent manufacturing based on the concept of flexible production and intelligent equipment for some unhealthy phenomena in the development process of TCM intelligent manufacturing. In the TCM intelligent manufacturing system,with theory model as the core,the new-generation information technology was integrated with the TCM manufacturing technology to realize the integration of informationization and industrilization as well as the landing of theoretical model. Then,a 3 D simulation model was established to provide a visual environment for intelligent manufacturing of TCM and simulate the virtual reality throughout the TCM intelligent manufacturing process. The new theoretical model in this paper,to a certain extent,can play a guiding role in the development of TCM intelligent manufacturing,and can also provide reference for the realization of TCM intelligent manufacturing.
Commerce ; Drug Industry ; standards ; Drugs, Chinese Herbal ; Medicine, Chinese Traditional ; Models, Theoretical ; Quality Control

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.
Artificial Intelligence ; Drug Industry/standards* ; Drugs, Chinese Herbal/standards* ; Medicine, Chinese Traditional/standards* ; Pattern Recognition, Automated ; Quality Control ; Technology, Pharmaceutical

The evolution of the quality control concepts of medical products within the global context and the development of the quality control technology of Chinese medicine are briefly described. Aimed at the bottlenecks in the regulation and quality control of Chinese medicine, using Big Data technology to address the significant challenges in Chinese medicine industry is proposed. For quality standard refinements and internationalization of Chinese medicine, a technological innovation strategy encompassing its methodology, and the R&D direction of the subsequent core technology are also presented.
Data Mining ; Databases, Factual ; Drug Industry ; organization & administration ; standards ; Drugs, Chinese Herbal ; analysis ; pharmacology ; standards ; Humans ; Quality Control

Small and medium-sized enterprises (SMEs) are important components in Chinese medicine industry. However, the lack of big brand is becoming an urgent problem which is critical to the survival of SMEs. This article discusses the concept and traits of Chinese medicine of big brand, from clinical, scientific and market value three aspects. Guided by market value, highlighting clinical value, aiming at the scientific value improvement of big brand cultivation, we put forward the key points in cultivation, aiming at obtaining branded Chinese medicine with widely recognized efficacy, good quality control system and mechanism well explained and meanwhile which can bring innovation improvement to theory of Chinese medicine. According to the characters of SMEs, we hold a view that to build multidisciplinary research union could be considered as basic path, and then, from top-level design, skill upgrading and application three stages to probe the implementation strategy.
China ; Drug Industry ; economics ; standards ; trends ; Drugs, Chinese Herbal ; economics ; standards ; Medicine, Chinese Traditional ; economics ; standards ; trends ; Plants, Medicinal ; growth & development ; Quality Control

Standards of commodity classes of Chinese materia medica is an important way to solve the "Lemons Problem" of traditional Chinese medicine market. Standards of commodity classes are also helpful to rebuild market mechanisms for "high price for good quality". The previous edition of commodity classes standards of Chinese materia medica was made 30 years ago. It is no longer adapted to the market demand. This article researched progress on standards of commodity classes of Chinese materia medica. It considered that biological activity is a better choice than chemical constituents for standards of commodity classes of Chinese materia medica. It is also considered that the key point to set standards of commodity classes is finding the influencing factors between "good quality" and "bad quality". The article also discussed the range of commodity classes of Chinese materia medica, and how to coordinate standards of pharmacopoeia and commodity classes. According to different demands, diversiform standards can be used in commodity classes of Chinese materia medica, but efficacy is considered the most important index of commodity standard. Decoction pieces can be included in standards of commodity classes of Chinese materia medica. The authors also formulated the standards of commodity classes of Notoginseng Radix as an example, and hope this study can make a positive and promotion effect on traditional Chinese medicine market related research.
China ; Drug Industry ; economics ; standards ; Drugs, Chinese Herbal ; economics ; standards ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; economics ; methods ; standards ; Panax notoginseng ; anatomy & histology ; chemistry ; Phytotherapy ; economics ; methods ; standards ; Plant Roots ; anatomy & histology ; chemistry ; Quality Control ; Reference Standards ; Research ; trends

In order to increase the yield and quality of the medicinal plant and enhance the competitive power of industry of medicinal plant in our country, this paper analyzed the status, problem and countermeasure of the tissue culture of medicinal plant on large scale. Although the biotechnology is one of the most efficient and promising means in production of medicinal plant, it still has problems such as stability of the material, safety of the transgenic medicinal plant and optimization of cultured condition. Establishing perfect evaluation system according to the characteristic of the medicinal plant is the key measures to assure the sustainable development of the tissue culture of medicinal plant on large scale.
Drug Industry ; methods ; standards ; Medicine, Chinese Traditional ; methods ; standards ; Plants, Genetically Modified ; Plants, Medicinal ; genetics ; growth & development ; Quality Control ; Tissue Culture Techniques ; methods ; standards

Chinese meteria medica (CMM) chain is a long-span chain covering agriculture which mainly depends on the forces of nature as well as high-tech CMM industry, CMM expertise industry and fast developing CMM circulation industry. Imbalance among the development of these industries produces bottlenecks and hinders the operation of the entire production chain. After analyzing the structure of Chinese meteria medica industrial chain from the perspective of national economy industry, three industry classifications and differentiation of factor intensity, we conclude that the complex structure of CMM industry chain is attributable to these three aspects. And the complexity is mainly shown at complex industry, varied product types, different coordination of various industrial sections and different technical growth speed of varied industry. We propose that structural complexity is the natural property of the chain, which is the main reason of industry sector development imbalance and bottleneck. Results of this research could provide theoretical analysis for future research on the coordination of industrial chain and the efficiency of resource allocation.
China ; Drug Industry ; economics ; standards ; Medicine, Chinese Traditional ; economics ; standards ; Plants, Medicinal ; chemistry

The authenticity and accuracy of data in clinical trials is extremely important. Any inauthentic data may affect the result of a clinical trial, and cause great loss. In our opinion, inauthentic data includes not only man-made spurious data, but also inaccurate data objectively formed. In this article, the features of inauthentic data are described, how to distinguish inauthentic data is discussed, and the causes of this kind of data are analyzed and concluded, which include: subjective intervention on the result of clinical trials, differentiation of the GCP knowledge level between different investigators, misunderstanding of the protocol, et al. And finally we propose that scientific training to investigators and other involved personnel and quality control during the course of data collection should be strengthened to prevent the occur of inauthentic data in clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Drug Evaluation ; Drug Industry ; Humans ; Quality Control

In recent years, with the continuous development of the industry of Dendrobium officinale, the technological alliance on CEEUSRO has been established. However, many problems also exposed with the rapid expansion of the industry, such as weak basic research, single species of the product, lack of in-depth studies and difficult to guarantee the quality. Industrial foam was gradually formed. To guard against the D. officinale becoming another "Puer Tea" , the authors believe that the key to sustainable development of the industry is enterprises and research institutes should strengthen basic research, speed up development of application of integrated innovations, government should strengthen guidance, regulate the operation of the market, then protect the quality of D. officinale in the market.
Dendrobium ; chemistry ; Drug Industry ; legislation & jurisprudence ; standards ; statistics & numerical data ; Drugs, Chinese Herbal ; standards ; Government Regulation ; Quality Control