Method and system for developing standardized traditional chinese medicine product based on component analysis, and medium

Abstract

The application provides a traditional Chinese medicine standardization product development method and system based on component analysis and a medium. The development method comprises the following steps: performing whole component analysis; establishing a dynamic component database; formulating quality standards for traditional Chinese medicinal materials and / or traditional Chinese medicine products; determining target effective components and the contents of the target effective components to obtain target product design information; and obtaining target traditional Chinese medicine products by digital deployment based on the target product design information. The application proposes a "five-in-one" traditional Chinese medicine product design path, fundamentally solves the transparency problem in the prior art, makes traditional Chinese medicine products quantifiable and controllable through quantitative component information, thereby overcoming the international market access barriers of traditional Chinese medicine caused by the complexity and volatility of components, and represents a paradigm shift from experience-driven to data-driven, thereby providing necessary tools and infrastructure for realizing a new paradigm of scientific, efficient and reliable traditional Chinese medicine industry.

Description

Technical Field

[0001] This invention belongs to the field of modernization technology of traditional Chinese medicine, specifically involving a method, system and medium for developing standardized products of traditional Chinese medicine based on component analysis. Background Technology

[0002] Currently, the traditional Chinese medicine (TCM) industry is receiving strong support at the national strategic level. Its inheritance and innovation have been incorporated into the Healthy China strategy, and TCM standardization is considered key to its modernization, aiming to help TCM reach the world stage. However, the standardization process of TCM still faces many severe challenges.

[0003] First, the complexity and volatility of the components of traditional Chinese medicine (TCM) are the core challenges. TCM components are numerous and highly variable, their content and composition influenced by factors such as origin, harvesting time, and processing methods, leading to batch-to-batch quality instability. Traditional analytical methods often struggle to comprehensively detect all components, increasing the difficulty of standardization and making precise control of the overall quality of TCM products difficult. These complexities and dynamic changes that traditional methods fail to capture are the root cause of TCM quality instability. Without a comprehensive identification and quantification of the full chemical composition of TCM, any standardization based on limited indicators will be incomplete and unable to effectively control potential fluctuations in product quality.

[0004] Secondly, the limitations of the current pharmacopoeia significantly restrict the modernization of traditional Chinese medicine (TCM). Current pharmacopoeias typically only test a limited number of components in TCM, failing to comprehensively reflect its complex chemical composition and overall quality. Furthermore, some TCM standards are too broad, making it difficult to effectively control product quality, and the pharmacopoeia's update speed lags behind, failing to meet the demands of the modern TCM industry for precise and dynamic quality control. This lag and limitation make the pharmacopoeia unable to adapt to the inherent complexity of TCM and its dynamic needs in the modern market. When the regulatory framework cannot keep pace with the development of scientific analytical capabilities, a key bottleneck forms in the modernization process of TCM, hindering industry progress and the establishment of international trust.

[0005] Furthermore, the high cost and low efficiency of component analysis are major obstacles to the standardization and promotion of traditional Chinese medicine (TCM). Traditional component analysis methods are time-consuming, costly, and highly dependent on specialized equipment and experienced experts. This high economic and technical threshold makes large-scale commercial application difficult, severely limiting the popularization and promotion of TCM standardization technology. This means that comprehensive and meticulous quality control often becomes a "luxury" for a few high-value products or research projects, failing to benefit the entire TCM industry, thus making it difficult to fundamentally solve the problem of inconsistent TCM quality.

[0006] Furthermore, the internationalization challenges facing the traditional Chinese medicine (TCM) industry are becoming increasingly prominent. The limited market share of TCM in the international market is largely due to its low level of standardization. Regions like Europe and the United States have stringent requirements for drug quality standards, and clearly defined ingredient information is a necessary condition for market access. The lack of internationally recognized quantitative standards is a fundamental obstacle to TCM's global expansion. Western pharmaceutical regulatory systems are based on precise chemical definitions, dosages, and clearly defined mechanisms of action, which directly conflict with the holistic, experiential, and complex, variable chemical composition of traditional Chinese medicine. The inability to provide clear, quantifiable, and traceable ingredient data makes it difficult for TCM products to gain international trust and widespread recognition.

[0007] Finally, batch-to-batch variability is an inherent problem in traditional Chinese medicine (TCM) production. Due to a lack of precise ingredient control methods, the quality of different batches of TCM products varies significantly during production, severely impacting product consistency and stability. This uncontrollability in the production process directly weakens the market competitiveness of TCM products and damages consumer trust. For any medicine, batch-to-batch stability and reproducibility are the cornerstones of ensuring efficacy and safety. This instability poses a significant challenge to TCM in conducting rigorous clinical trials or obtaining international regulatory approvals, thus limiting its industrialization and large-scale development. Summary of the Invention

[0008] The main objective of this invention is to provide a method, system, and medium for developing standardized traditional Chinese medicine products based on component analysis, in order to overcome the shortcomings of existing technologies.

[0009] To achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0010] In a first aspect, the present invention provides a method for developing standardized traditional Chinese medicine products based on component analysis, comprising:

[0011] A full component analysis was performed on multiple Chinese herbal raw materials to obtain chemical composition data;

[0012] A dynamic component database is established based on the chemical component data, and the dynamic component database is dynamically updated based on the batches of the Chinese herbal raw materials.

[0013] Based on the chemical composition data in the dynamic component database, quality standards are formulated for Chinese medicinal materials and / or Chinese medicinal products, and the quality standards include multi-component fingerprint profiles and groups of effective components;

[0014] For various product efficacies, based on the quality standards and ingredient information in the dynamic ingredient database, as well as the synergistic relationships between ingredients, the target effective ingredients and their content are determined, resulting in multiple target product design information.

[0015] Based on the design information of multiple target products, and combined with the chemical composition data in the dynamic component database of multiple batches of the Chinese herbal raw materials, a digital blending method is used to combine multiple Chinese herbal raw materials to obtain multiple target Chinese herbal products. This ensures that the effective components and contents in the target Chinese herbal products are consistent with the design information of the target products, and maximizes the utilization rate of the current batches of the Chinese herbal raw materials.

[0016] Secondly, the present invention provides a standardized product development system for traditional Chinese medicine based on component analysis, comprising:

[0017] The rapid full-component analysis module is used to perform full-component analysis on multiple Chinese herbal raw materials to obtain chemical composition data;

[0018] A dynamic component database module is used to establish a dynamic component database based on the chemical component data, and the dynamic component database is dynamically updated based on the batches of the Chinese herbal raw materials;

[0019] The quality standard setting module is used to set quality standards for Chinese medicinal materials and / or Chinese medicinal products based on the chemical composition data in the dynamic component database. The quality standards include multi-component fingerprints and groups of active ingredients.

[0020] The product design module is used to determine the target effective ingredient and its content based on the quality standards and ingredient information in the dynamic ingredient database, as well as the synergistic relationship between ingredients, for various product efficacies, thereby obtaining multiple target product design information.

[0021] The digital blending and production module is used to combine multiple Chinese herbal medicine raw materials in a digital blending manner based on multiple target product design information and chemical component data in a dynamic component database of multiple batches of the Chinese herbal medicine raw materials to obtain multiple target Chinese herbal medicine products. This ensures that the effective components and contents in the target Chinese herbal medicine products are consistent with the target product design information, and maximizes the utilization rate of the current multiple batches of the Chinese herbal medicine raw materials.

[0022] Thirdly, the present invention provides a readable storage medium storing a computer program, which, when run, executes the steps of the above-described method for developing standardized traditional Chinese medicine products.

[0023] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0024] Based on the above technical solutions, this invention proposes a "five-in-one" design path for traditional Chinese medicine (TCM) products, fundamentally solving the transparency problem in existing technologies. By quantifying component information, TCM products become quantifiable and controllable, thereby overcoming the international market access barriers caused by the complexity and volatility of TCM components. This represents a paradigm shift from experience-driven to data-driven approaches, providing the necessary tools and infrastructure for realizing a scientific, efficient, and reliable new paradigm for the TCM industry. Furthermore, through coordinated development across the five aspects, different batches of TCM raw materials can be adaptively allocated to meet the needs of products with different efficacies. While meeting standardization and quantification requirements, this significantly improves the utilization rate of TCM raw materials and reduces the development and manufacturing costs of TCM-related products.

[0025] The above description is merely an overview of the technical solution of the present invention. In order to enable those skilled in the art to better understand the technical means of this application and to implement it in accordance with the contents of the specification, the preferred embodiments of the present invention are described below in conjunction with detailed drawings. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the overall process of the traditional Chinese medicine product design method provided in one embodiment of this application. Detailed Implementation

[0028] In view of the shortcomings of the prior art, the inventors of this invention, through long-term research and extensive practice, have proposed the technical solution of this invention. The following will further explain and illustrate this technical solution, its implementation process, and its principles.

[0029] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and therefore the scope of protection of the invention is not limited to the specific embodiments disclosed below.

[0030] See Figure 1 As shown, embodiments of the present invention first provide a method for developing standardized traditional Chinese medicine products based on component analysis, which includes the following steps:

[0031] M1. Perform full component analysis on multiple Chinese herbal raw materials to obtain chemical composition data;

[0032] M2. A dynamic component database is established based on the chemical component data, and the dynamic component database is dynamically updated based on the batches of the Chinese herbal raw materials;

[0033] M3. Based on the chemical composition data in the dynamic component database, formulate quality standards for Chinese medicinal materials and / or Chinese medicinal products, wherein the quality standards include multi-component fingerprint profiles and groups of effective components;

[0034] M4. For various product efficacies, based on the quality standards and ingredient information in the dynamic ingredient database, as well as the synergistic relationships between ingredients, determine the target effective ingredient and its content, and obtain multiple target product design information.

[0035] M5. Based on the design information of multiple target products, and combined with the chemical composition data in the dynamic composition database of multiple batches of the Chinese herbal raw materials, multiple Chinese herbal raw materials are combined using a digital blending method to obtain multiple target Chinese herbal products. This ensures that the effective components and contents in the target Chinese herbal products are consistent with the design information of the target products, and maximizes the utilization rate of the current multiple batches of the Chinese herbal raw materials.

[0036] This invention provides a "five-in-one" standardization pathway for traditional Chinese medicine (TCM). By constructing a comprehensive and integrated solution from testing to production, it aims to achieve a new paradigm of scientific, efficient, and reliable development for the TCM industry. This pathway overcomes the limitations of existing technologies, providing a solid technological foundation for the modernization and internationalization of TCM. This data closed-loop and intelligent processing enables predictive quality control and automated optimization, transforming TCM from a practice primarily reliant on experience into a data-driven pharmaceutical science. This systematically addresses all the core challenges facing TCM, including key bottlenecks such as unclear components, uncontrollable quality, and poor reproducibility of efficacy. It significantly improves the safety and efficacy verification levels of TCM products, meets international drug regulatory requirements, and provides a standardized implementation framework compliant with international standards such as GMP and ICH for TCM to enter the global mainstream pharmaceutical market, promoting a leap from experience-based inheritance to technological innovation in TCM.

[0037] Meanwhile, the above-mentioned technical solutions can actively adjust the proportion of relevant functional ingredient groups to meet specific efficacy needs (such as general-purpose, antibacterial, and calming types), thus achieving "one ingredient for multiple types".

[0038] Regarding rapid full-component analysis, existing technologies include a method for analyzing the components of a mixture disclosed in WO2015143963A1, and a method for rapidly screening target substances disclosed in CN108663437B. These patents provide the foundation for the rapid full-component analysis technology in this invention. Regarding the construction of a dynamic component database, CN108375639A discloses a method for rapidly establishing a mass spectrometry database of components in a sample, which is related to the concept of constructing a dynamic component database in this invention. Regarding digital blending and production, CN116959604A discloses a product homogenization method based on component analysis, while CN115862763A discloses a method for generating sub-products based on component composition recombination. These patents provide technical references for the digital blending and production in this invention.

[0039] Of course, the specific technical means used in each step or module are not limited to the above examples. Those skilled in the art can replace them with other technical means or develop their own, as long as they can achieve the corresponding functions.

[0040] In some implementations, the digital allocation step further includes the following process:

[0041] When the concentration of the active ingredient in any of the target traditional Chinese medicine products fails to meet the design information of the target product, the concentration of the active ingredient is reduced, and the concentration of the remaining ingredients is reduced proportionally to perform low-concentration digital formulation, thereby obtaining a low-concentration target traditional Chinese medicine product. A dose compensation suggestion for the low-concentration target traditional Chinese medicine product is also output. When the low-concentration target traditional Chinese medicine product is taken in combination with the dose compensation suggestion, the actual intake of the active ingredient is consistent with the design information of the target product.

[0042] In practical applications, the mixing ratio can be calculated and physical recombination can be performed with the objective function of satisfying the design information and maximizing the comprehensive utilization rate of raw materials. If the concentration of effective ingredients in the mixed product is lower than the preset threshold, an elastic compensation mechanism is activated to ensure that the efficacy intake is constant by locking the ratio, scaling the concentration, and outputting dosage compensation suggestions.

[0043] In the above implementation, when the overall abundance of the active components of the natural raw materials declines significantly, resulting in a "concentration reduction," the system no longer discards the raw materials due to their substandard quality. Instead, it activates a flexible compensation logic. By locking the molecular ratio and scaling the target concentration value proportionally, the system automatically calculates and outputs dosage compensation recommendations to ensure that the absolute amount of the effective components ingested by the patient remains constant.

[0044] Through the "five-in-one" data closed loop, not only is the consistency control of all components achieved, but also the unique "elastic dosage compensation mechanism" solves the problem of reduced efficacy caused by fluctuations in the abundance of natural raw materials, meeting the stringent requirements of international regulations for high consistency between batches.

[0045] In some implementations, the full component analysis specifically includes:

[0046] Several batches of the Chinese herbal raw materials that have been clinically approved were selected as the target material, and other batches of the Chinese herbal raw materials were selected as the reference material.

[0047] High-throughput full-component chemical analysis was performed on the target and reference compounds;

[0048] The chemical composition data is obtained by fusing the molecular composition information of the target and the reference.

[0049] In some implementations, the process of establishing the dynamic component database specifically includes:

[0050] The chemical composition data of the target and reference substances, along with the corresponding batch information and selective efficacy information, are entered to form a basic database;

[0051] The commercial / academic testing information of the Chinese herbal raw materials is updated in real time, and the basic database is updated synchronously to obtain the dynamic component database.

[0052] In some implementation schemes, the traditional Chinese medicine raw materials in the dynamic ingredient database are stored as a multi-level product catalog structure, which is classified based on the species, source, batch, and processing stage of the traditional Chinese medicine raw materials.

[0053] In some implementation schemes, the process of establishing the quality standards specifically includes:

[0054] The molecular composition information is divided into core functional components, synergistic regulatory components, and trace fingerprint components;

[0055] The molecular fingerprint spectrum and component content of the target substance are used as baselines;

[0056] The quality standard of the core functional component is set to ±(5-15) of the corresponding content of the target substance, the quality standard of the synergistic regulatory component is set to ±(20-40) of the corresponding content of the target substance, and the quality standard of the trace fingerprint component is set to 0-130% of the corresponding content of the target substance. The quality standard is established.

[0057] In some implementation schemes, the process of obtaining the target product design information specifically includes:

[0058] Identify the efficacy requirements for multiple target products;

[0059] Based on the efficacy requirements, and combined with the quality index, target effective ingredient groups are selected.

[0060] Within the range of the quality standards, the design content corresponding to the target effective ingredient group is set to a relatively high value, forming multiple target product design information.

[0061] In some implementation schemes, the digital allocation process specifically includes:

[0062] Based on the chemical composition data of multiple batches of the Chinese herbal raw materials, multiple basic combinations are formulated and combined according to the efficacy requirements of multiple target products, and the component concentrations of multiple virtual products in the basic combinations meet the quality standards.

[0063] The combination with the highest utilization rate among multiple batches of the Chinese herbal raw materials in the basic combination is selected as the output result of the digital dispensing.

[0064] This invention also provides a system for developing standardized traditional Chinese medicine products based on component analysis, comprising:

[0065] The rapid full-component analysis module is used to perform full-component analysis on multiple Chinese herbal raw materials to obtain chemical composition data;

[0066] A dynamic component database module is used to establish a dynamic component database based on the chemical component data, and the dynamic component database is dynamically updated based on the batches of the Chinese herbal raw materials;

[0067] The quality standard setting module is used to set quality standards for Chinese medicinal materials and / or Chinese medicinal products based on the chemical composition data in the dynamic component database. The quality standards include multi-component fingerprints and groups of active ingredients.

[0068] The product design module is used to determine the target effective ingredient and its content based on the quality standards and ingredient information in the dynamic ingredient database, as well as the synergistic relationship between ingredients, for various product efficacies, thereby obtaining multiple target product design information.

[0069] The digital blending and production module is used to combine multiple Chinese herbal medicine raw materials in a digital blending manner based on multiple target product design information and chemical component data in a dynamic component database of multiple batches of the Chinese herbal medicine raw materials to obtain multiple target Chinese herbal medicine products. This ensures that the effective components and contents in the target Chinese herbal medicine products are consistent with the target product design information, and maximizes the utilization rate of the current multiple batches of the Chinese herbal medicine raw materials.

[0070] In some implementations, the rapid full-component analysis module includes a mass spectrometry device and corresponding analysis software, which operates based on the entropy minimization algorithm.

[0071] In some implementations, the dynamic component database module includes a data storage unit and data management software, wherein the data management software is used to realize real-time updates of the data storage unit, hierarchical directory management, support for analysis method libraries, and connectivity verification with existing databases.

[0072] In some implementations, the quality standard setting module includes a data processing unit and an algorithm for constructing multi-component fingerprints, evaluating effective component groups, and calculating quality indices.

[0073] In some implementations, the product design module includes design algorithms and a user interface for functionalizing and differentiating designs based on component synergies and design requirements.

[0074] In some implementations, the digital blending production module includes a precision blending device and a control system, the control system being based on full-component recombination / cloning technology and using algorithms to control the mixing ratio between the same products.

[0075] As a representative implementation of the above technical solution, the embodiments of the present invention provide a "five-in-one" method and system, which consists of the following five interrelated and synergistic core links, jointly constructing a complete closed loop from data acquisition to industrial implementation, and achieving systemic synergistic efficiency:

[0076] Rapid full-component analysis (M1): As the end-to-end data input, it overcomes the high cost and low efficiency of traditional analysis, providing a high-throughput, comprehensive and accurate component data stream, which is the foundation for all subsequent data steps.

[0077] Dynamic Component Database (M2): Based on the massive data stream provided by M1, it constructs a real-time updated, multi-dimensionally correlated component data infrastructure, which can comprehensively reflect the real dynamic component composition of traditional Chinese medicine and is the core of achieving scientific standardization and data-driven approach.

[0078] The quality standard system based on component information (M3) utilizes the comprehensive and dynamic data of M2 to construct a scientifically quantified, multi-component fingerprint-based quality evaluation system. M3 not only ensures the controllability and traceability of product quality, but more importantly, it provides scientific and quantified quality targets for M4, driving enterprises to pursue high quality.

[0079] Functionalization and differentiation of traditional Chinese medicine products and the integration of Western medicine with traditional Chinese medicine (M4): Based on the component information of M2, data-driven product innovation and market segmentation are realized to meet diverse needs; the M3 system provides quality traceability assurance and scientific objectives for the innovative design of M4, ensuring that the quality of innovative products is based on evidence.

[0080] Digitalized Production (M5): As the final industrialization stage of the scientific achievements from M1 to M4, M5 solves the core pain points of batch instability and difficulty in reproducibility in traditional production. Through digitalized production technology, M5 ensures and achieves high precision, high stability, and high repeatability in the production process. It is the only stable path to realize the theories and standards of M1-M4, transforming scientific achievements into efficient, low-cost, large-scale products.

[0081] This "five-in-one" system is closely integrated with the following five interconnected and synergistic core links (M1-M5) to form a data closed loop, jointly promoting the transformation of traditional Chinese medicine from the traditional experience-based model to the modern science and data-driven model, significantly improving the overall quality control level, market competitiveness and international influence of traditional Chinese medicine.

[0082] The synergistic effect of this "five-in-one" approach far exceeds the sum of its parts, and its core technological characteristics are reflected in the integration and efficiency enhancement of the following key aspects:

[0083] High-throughput data empowerment (M1→M2): Rapid full-component analysis technology (M1), with its ultra-high speed, low cost, and comprehensive detection capabilities, overcomes the obstacles of traditional data acquisition and provides a massive, real-time, and commercially viable stream of component data. This is the fundamental premise for the dynamic component database (M2) to build a data infrastructure that is updated in real time and comprehensively reflects the real components, completely breaking the limitations of the static and lagging nature of traditional databases.

[0084] Data-driven standard upgrade (M2→M3): The real-time, comprehensive, and traceable information on real components provided by the dynamic database (M2) enables the quality standard system (M3) to break through the limitations of the traditional "single indicator". By constructing a high-dimensional "multi-component fingerprint spectrum" and introducing a "quality index", M3 has achieved a quantitative assessment of the "effective component group" of traditional Chinese medicine and its synergistic effects, completing a creative leap from "qualitative identification" to "quantitative quality assessment".

[0085] Precision Design and Industrialization Integration (M3→M4→M5): The quantitative and efficacy-related quality standards established by M3 directly provide data-driven formulation basis for product functional design (M4), realizing a scientific quantitative interpretation of traditional compatibility principles. Subsequently, the precise and differentiated product formulation goals determined by M4 can be directly transformed into algorithmic instructions for digital blending and production (M5). Based on full-component recombination / cloning technology, M5 implements the innovative designs of M4 on a large scale in a highly consistent, repeatable, and low-cost manner, completely solving the core problem of large batch variations and difficulty in large-scale control in the production of traditional Chinese medicine.

[0086] Finally, the integrated system has constructed a "digital twin" management system for the entire life cycle of traditional Chinese medicine. This data closed-loop and intelligent processing have achieved predictive quality control and automated optimization, transforming traditional Chinese medicine from a practice mainly relying on experience into a data-driven pharmaceutical science, thus systematically addressing all the core challenges faced by traditional Chinese medicine, including the key bottlenecks such as unclear ingredients, uncontrollable quality, and poor repeatability of efficacy, significantly enhancing the safety and effectiveness verification level of traditional Chinese medicine products, meeting international drug regulatory requirements, providing a standardized implementation framework compliant with international norms such as GMP and ICH for traditional Chinese medicine to enter the global mainstream pharmaceutical market, and promoting the leap of traditional Chinese medicine from experience inheritance to technological innovation.

[0087] The implementation of this "five-in-one" standardization path for traditional Chinese medicine will bring many significant beneficial effects to the traditional Chinese medicine industry:

[0088] Improve the controllability of traditional Chinese medicine quality: Through comprehensive ingredient analysis and multi-component fingerprint maps, the quality assessment of traditional Chinese medicine has been quantified, no longer relying on subjective judgment or single ingredients, thus ensuring the consistency and stability of each batch of products. This multi-component quality evaluation system effectively improves the discrimination ability of traditional Chinese medicine, making it difficult for counterfeit and shoddy products to mix in the market, thereby enhancing consumers' trust in traditional Chinese medicine products.

[0089] Efficient and low-cost standardization of traditional Chinese medicine: Disruptive analysis technologies can quickly obtain the comprehensive ingredient information of traditional Chinese medicine, complete the detection of large-scale samples within a few days, significantly reducing time and financial costs. The simplification of the operation process and the generalization of equipment reduce the dependence on high-end talents for the technology, making the technology widely applicable to large-scale production and popularization, thus achieving the efficiency and low cost of traditional Chinese medicine standardization.

[0090] Support for differentiated and personalized traditional Chinese medicine products: By analyzing the ingredient relationships of "so-called monarch, minister, assistant, and envoy", this path can accurately adjust the ingredient ratios according to different needs to produce traditional Chinese medicine products with differentiated functions, supporting personalized customization. This customized product R & D ability can better meet the personalized needs of different consumers, promoting the development of traditional Chinese medicine products towards functionality, refinement, and differentiation.

[0091] Achieve the stability and repeatability of the traditional Chinese medicine production process: Digital dispensing technology ensures the stable quality of traditional Chinese medicine products between different production batches through precise ingredient dispensing and concentration control, completely solving the problem of large batch differences in traditional Chinese medicine production. This efficient production management makes the production process more precise and efficient, reducing manual intervention and errors, and enabling the low-cost replication and large-scale production of high-grade traditional Chinese medicine.

[0092] Promoting the internationalization and global trade of traditional Chinese medicine (TCM): Standardization technologies based on ingredient information can align the quality standards of TCM products with international standards, providing crucial support for TCM to enter the international market. By establishing a digital and standardized trading platform and traceability system, this approach will strongly promote the international trade of TCM materials, forming a global market for TCM trading and futures trading.

[0093] Accelerating the industrialization and large-scale production of traditional Chinese medicine (TCM): The introduction of standardized and digitalized TCM preparation technologies will drive the transformation of the TCM industry from manual, traditional methods to a modern, large-scale industrial chain, significantly improving production efficiency and market competitiveness. The high added value of standardized products can increase the market price of TCM raw materials, creating greater market space, such as for high-end health products, pharmaceuticals, and functional products.

[0094] Enhancing the innovation and R&D capabilities of traditional Chinese medicine (TCM): Systematic component data, quality standards, and differentiated product design capabilities provide solid technical support for TCM R&D, stimulating innovation and driving the transformation of TCM from traditional "empirical formulas" to scientific and modern preparations. Flexible product formulation and rapid component testing response enable TCM companies to respond more quickly to market changes and consumer trends, achieving rapid iteration and innovation.

[0095] In summary, this "five-in-one" system achieves a fundamental shift from "empirical science" to "data science" by constructing a "data closed loop" across the entire TCM industry chain. The system ensures seamless data flow throughout the entire value chain—from initial analysis (rapid analysis) to knowledge creation (dynamic databases, quality standards), product design (functionalization), and ultimately, manufacturing (digitalized formulation). This continuous data flow and intelligent processing fundamentally transforms TCM from a practice primarily reliant on experience and manual operation into a data-driven, scientifically rigorous industry. This transformation brings predictive quality control, proactively identifying and mitigating quality issues; automated optimization, continuously improving processes and formulations based on real-time data; global scalability, reliably producing and distributing high-quality, consistent products; and accelerated innovation, enabling rapid prototyping and testing of new formulations based on precise ingredient control. This is not merely an industrial improvement, but a paradigm shift that positions traditional Chinese medicine as a modern and scientifically robust contributor to global health, transforming it from a often-skeptical "traditional medicine" into a "data-driven pharmaceutical science." This empowers the traditional Chinese medicine industry to achieve leapfrog development and contributes Chinese wisdom to the global health industry.

[0096] The true value of the "five-in-one" system provided by the above technical solution lies in its integration, namely the powerful synergy formed between data, standards, design, and manufacturing, achieving exponential benefits that go beyond the simple summation of the individual parts. This is mainly reflected in the following aspects.

[0097] 1. Integration of speed and range (M1-M2-M3):

[0098] To achieve predictive quality control, M1's ultra-high-speed analysis capabilities provide M2 ​​with massive amounts of real-time commercial testing data. This continuous data flow is a prerequisite for M2 to build a truly "dynamic" database, enabling the quality standards set by M3 to be based on the latest and most comprehensive real component information.

[0099] This M1-M2-M3 causal chain transforms quality control from passive to proactive. The system no longer needs to wait for batch completion before testing; instead, it uses dynamic data from M2 to predict potential raw material fluctuations and feeds this information back to the M5 algorithm to proactively adjust the blending ratio before production. This achieves predictive quality control, fundamentally solving the core challenges of unclear Chinese medicine components and uncontrollable quality.

[0100] 2. Design-to-production integration (M3-M4-M5):

[0101] To achieve high-fidelity scalability, the quantitative quality standards established by M3 and the precise functional designs implemented by M4 are combined and transformed into algorithmic instructions for digitally orchestrated production in M5. M5's full-component recombination / cloning technology is crucial to ensuring the precise execution of these scientific design intentions at an industrial scale.

[0102] If M5 lacks this high-precision formulation capability, the scientific achievements of M3 and M4 cannot be translated into stable products, leading to standardization failure. The synergistic effect of M3-M4-M5 ensures that innovative formulation designs can be mass-produced with extremely high batch consistency and repeatability. This guaranteed consistency is the fundamental guarantee for obtaining international GMP certification and promoting the entry of traditional Chinese medicine products into the global mainstream pharmaceutical market.

[0103] 3. Risk mitigation and global trust: addressing batch differences and regulatory compliance issues.

[0104] By integrating the quantitative standards of M3 with the stable production of M5, the system provides a rigorous scientific framework to meet the safety, effectiveness and reliable manufacturing requirements of international regulatory agencies.

[0105] Furthermore, the M3 multi-component fingerprint spectrum, supported by the comprehensive testing capabilities of M1, greatly enhances the identification capabilities of traditional Chinese medicine. It requires any counterfeit or imitation product to simultaneously match more than 100 components, thus effectively combating counterfeit and substandard products and strengthening consumer and international market trust. Improved standardization and traceability have also strongly promoted the formation of spot and futures trading markets in the international trade of traditional Chinese medicinal materials.

[0106] The table below lists the improvements achieved by this invention compared to the traditional mechanisms of action of traditional Chinese medicine:

[0107] This invention also provides a readable storage medium storing a computer program, which, when run, executes the steps of the method for developing standardized traditional Chinese medicine products provided in any of the above embodiments.

[0108] The technical solution of the present invention will be further described in detail below through several embodiments and in conjunction with the accompanying drawings. However, the selected embodiments are only for illustrating the present invention and do not limit the scope of the present invention.

[0109] Example 1

[0110] This embodiment proposes a "five-in-one" development path for standardized traditional Chinese medicine products. Through close collaboration among various modules, it constructs a complete, intelligent, and efficient traditional Chinese medicine industry ecosystem, from testing to production. Its overall workflow is as follows:

[0111] I. Rapid Full Component Analysis Technology

[0112] The primary step in this embodiment is rapid full-component analysis technology, the core of which lies in employing advanced analytical methods to achieve rapid and comprehensive component detection. This technology can efficiently identify, quantify, and characterize multiple chemical components of traditional Chinese medicine from complex samples, significantly surpassing the limitations of traditional analytical methods in terms of comprehensiveness and efficiency.

[0113] Existing technologies for rapid full-component analysis mainly include:

[0114] Chromatography-mass spectrometry techniques, such as high performance liquid chromatography-mass spectrometry (HPLC-MS / MS), gas chromatography-mass spectrometry (GC-MS), and ultra-high performance liquid chromatography (UPLC), are characterized by high sensitivity, high selectivity, and high throughput, and are suitable for qualitative and quantitative analysis of complex components in traditional Chinese medicine.

[0115] Nuclear magnetic resonance (NMR): can be used for structural identification and quantitative analysis of components in traditional Chinese medicine.

[0116] Mass spectrometry (MSI): can be used to locate chemical components in Chinese medicinal materials and monitor metabolites in vivo.

[0117] Traditional analytical methods, such as thin-layer chromatography, ultraviolet-visible spectroscopy (UV-Vis), and infrared spectroscopy (IR), are relatively simple to operate, but may have limitations in terms of comprehensiveness, sensitivity, or efficiency.

[0118] The rapid full-component analysis technology in this embodiment has disruptive features and advantages compared to existing technologies. This embodiment emphasizes a holistic workflow that enables rapid, comprehensive, and low-cost analysis, rather than being limited to a specific instrument or software. This embodiment employs SmartDalton mass spectrometry full-component analysis software based on the "entropy minimization algorithm," combined with an ultra-high-speed chromatographic mass spectrometry / liquid chromatography-mass spectrometry (LC-MS) system. Compared to existing technologies, the analysis speed and sensitivity of this embodiment are improved by 100 times. This means that traditional methods may require several years and millions of dollars to obtain information on a small number of components, while this technology can complete a comprehensive analysis of 100-300 components within a few days, significantly shortening the R&D and quality control cycle. Simultaneously, this technology significantly reduces analysis costs, with labor costs reduced by 90% and overall costs reduced by up to 95%. This order-of-magnitude performance improvement and cost reduction transforms full-component analysis from expensive laboratory research into an economically feasible solution for large-scale commercial applications. The SmartDalton software supports automated operation, reducing reliance on specialized equipment and highly specialized personnel, making it more suitable for promotion and widespread adoption in large-scale industrial production environments. Furthermore, this technology is universally applicable and can handle various complex analytical targets for traditional Chinese medicine. This rapid, low-cost, and comprehensive data generation capability forms the foundation of the entire "five-in-one" system, solving the core problems of traditional component analysis, such as long processing time, high cost, and low efficiency, and providing solid data support for subsequent data-driven standardization steps.

[0119] II. Dynamic Component Database

[0120] As a fundamental infrastructure for the standardization of traditional Chinese medicine (TCM), the dynamic component database is the second key component in this embodiment. Its core technology lies in its real-time updates based on commercial testing data, thereby comprehensively reflecting the true composition of TCM products. This database can be built upon existing mass spectrometry database frameworks and distributed using specialized software.

[0121] Existing technologies for building dynamic component databases mainly include:

[0122] Traditional Chinese medicine (TCM) component databases include those from the Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences (TCM and Chemical Components Database), the TCM module database of the Yaorong Cloud platform, and the TCM image database of Hong Kong Baptist University. These databases provide rich information on TCM materials, prescriptions, chemical components, and pharmacological effects; however, most are based on literature data, information updates are lagging, and there is a lack of mechanisms for linking with real-time commercial testing data.

[0123] Big data platforms and cloud computing technologies have been applied to data storage, processing, and analysis in the pharmaceutical field, but most have not been specifically optimized and integrated for the dynamic characteristics of Chinese medicine components and commercial testing data.

[0124] Blockchain technology: Some studies explore the use of blockchain technology to ensure the credibility and tamper-proof nature of traditional Chinese medicine ingredient data, but a large-scale, real-time updated dynamic database has not yet been formed.

[0125] The dynamic component database used in this embodiment has significant technical features and advantages compared to existing technologies. This embodiment emphasizes integrating existing technologies to construct a dynamically updated component database based on real-time commercial testing data and closely linked to products, overcoming the limitations of existing databases. Unlike traditional static databases, which are mainly derived from literature and suffer from delayed information updates, the dynamic database in this embodiment can capture and update data in real time, comprehensively reflecting the true component information of traditional Chinese medicine products, overcoming the limitations of traditional databases in terms of data timeliness and completeness. This real-time update mechanism based on commercial testing data enables the database to meet the needs of modern commercial applications, greatly facilitating the commercial development, quality control, and market circulation of traditional Chinese medicine products. The database has a three-level product catalog structure (e.g., "Rose - Chinese Rose - Dark Red Rose"), allowing each component information to be accurately associated with a specific product and its source and processing stage, thereby achieving full-chain traceability. Furthermore, the database also supports the establishment of an analytical method library, allowing multiple spectra of the same component to be stored, and can be connected and cross-validated with the existing NIST database, further improving the scientific rigor and reliability of the data. This dynamic ingredient database transforms static academic knowledge into a continuously updated, commercially valuable information infrastructure, providing real-time, comprehensive, and verifiable ingredient data support for industrial-scale quality control, agile product development, and efficient supply chain management. It is not merely a data repository, but an active and evolving knowledge base that underpins the reliability and adaptability of the entire standardized process, making it crucial for modern pharmaceutical manufacturing and global trade.

[0126] III. Quality Standard System Based on Ingredient Information

[0127] The third core component of this embodiment is a quality standard system based on ingredient information, which aims to comprehensively reflect the quality of traditional Chinese medicine and enhance its credibility through scientific and quantitative methods.

[0128] Existing technologies in the formulation of quality standards mainly include:

[0129] The Chinese Pharmacopoeia standard evaluates the quality of traditional Chinese medicine by the content of one or more indicator components, but this may not fully reflect the overall quality and efficacy of the complex system of traditional Chinese medicine.

[0130] Fingerprinting technology: This involves establishing fingerprint profiles for traditional Chinese medicine materials or preparations using chromatographic or spectroscopic methods. These profiles are systematic, holistic, and characteristic, and are used for identification and quality control. However, existing fingerprint profiles may suffer from a lack of clarity and relevance to efficacy.

[0131] The Quality Assurance and Evaluation Method (QAMS) involves simultaneously measuring multiple components using a single reference standard. This method is considered a multi-indicator quality control and evaluation model suitable for the characteristics of traditional Chinese medicine.

[0132] Multi-index comprehensive evaluation method: Combining multiple physicochemical indicators, bioactivity indicators and fingerprint spectrum, etc., to comprehensively evaluate traditional Chinese medicine.

[0133] Research on standardized cultivation and processing of Chinese medicinal materials: controlling the quality of Chinese medicinal materials from the source and establishing limits for harmful substances.

[0134] Compared with existing technologies, the quality standard system in this embodiment is comprehensive, scientific, and correlated with efficacy. This embodiment emphasizes building upon existing technologies such as fingerprinting, through full-component analysis and precise evaluation of effective component groups, and by introducing quality indices, to achieve a more scientific and quantitative quality standard system, thereby compensating for the shortcomings of traditional methods in terms of comprehensiveness and correlation with efficacy. This embodiment breaks through the traditional model of focusing only on single components or a few indicator components in the quality control of traditional Chinese medicine, instead comprehensively and scientifically reflecting the overall quality of traditional Chinese medicine by constructing a high-dimensional "multi-component fingerprint spectrum" and accurately evaluating "effective component groups" related to efficacy. This system utilizes rapid full-component analysis technology and the big data provided by dynamic component databases to formulate scientific and quantitative quality standards for Chinese medicinal materials and products, and introduces innovative quality indices for intuitive evaluation. The core of the quality standard is no longer a simple judgment of authenticity, but focuses on the evaluation of "effective component groups" closely related to the efficacy of traditional Chinese medicine. By deeply analyzing the synergistic effects between components, it ensures that the quality standards are closely integrated with the actual therapeutic effects of traditional Chinese medicine, providing a more solid scientific basis for the efficacy of traditional Chinese medicine. This embodiment introduces the innovative concept of a "quality index," enabling a direct and quantitative assessment of the overall quality of a product and the concentration of specific efficacy-related components. This quantitative approach provides consumers with a more transparent and reliable basis for purchasing decisions, and also provides regulatory authorities with clearer regulatory indicators. Furthermore, the multi-component quality evaluation system effectively enhances the identification capabilities of traditional Chinese medicine (TCM), making it difficult for counterfeit and substandard products to slip through using a single indicator, thereby strengthening consumer trust in TCM products and improving market order. This shift from simple "identification" to "overall quality and efficacy assessment" represents a significant breakthrough in the field of quality control in this embodiment. It transcends the traditional scope of merely confirming "what" a product is, moving towards a scientific assessment of "what efficacy" and "how effective" the product is.

[0135] To visually demonstrate the assessment capability of the quality index, the following table compares the quality indices of different samples, using moxa sticks and Panax notoginseng as examples:

[0136] Note: The specific quality index values ​​in the table need to be filled in based on actual test data; this is for illustrative purposes only. For example, the antibacterial index of large Panax notoginseng may be higher, while the anti-inflammatory index of medium Panax notoginseng may be higher.

[0137] IV. Functionalization and Differentiation of Traditional Chinese Medicine Products and the Incorporation of Western Medicine into Traditional Chinese Medicine

[0138] The fourth step in this embodiment is the functionalization and differentiation of traditional Chinese medicine products and the integration of Western medicine with traditional Chinese medicine. This aims to achieve innovative design and market expansion of traditional Chinese medicine products through a deep understanding of ingredient information.

[0139] Existing technologies in the functionalization and differentiation of traditional Chinese medicine products, as well as the "traditionalization of Western medicine," mainly include:

[0140] Traditional experience-based formulation: Formulas are formulated based on traditional Chinese medicine theory and clinical experience, but lack quantitative basis and are difficult to achieve precise functional design.

[0141] Development of functional foods derived from both food and medicine: Based on the physical database of medicinal and edible ingredients and big data analysis of online pharmacology, develop functional foods that prevent or alleviate specific diseases.

[0142] Preparation of active ingredients (components) of traditional Chinese medicine: obtaining the effective ingredients or components of traditional Chinese medicine through extraction, separation, purification and other techniques, and conducting functional research and product development.

[0143] Development of Chinese herbal cosmetics: Developing cosmetics with whitening, anti-aging, and other effects using ingredients from Chinese herbal medicines, but must comply with relevant regulations.

[0144] Development of Traditional Chinese Medicine-Based Health Products: Discovering health-preserving and nourishing foods from classic ancient prescriptions, as well as beauty and daily chemical products made from traditional animal and plant ingredients.

[0145] The advantage of this embodiment lies in its ability to meet diverse market demands and develop customized traditional Chinese medicine (TCM) products with different efficacy and functions. This module delves into the synergistic effects of different components in TCM and combines this with the traditional Chinese medicine principle of "principal, assistant, adjuvant, and guide" in formulation, interpreting and verifying these effects with modern scientific data. This allows for precise functionalization and differentiated design of TCM products. Compared to existing technologies, this method overcomes the limitations of traditional experience and achieves a more precise understanding of the functions and efficacy of TCM products.

[0146] Precise design and quantitative control. By precisely quantifying and regulating specific functional components, traditional Chinese medicine (TCM) products can be developed into daily chemical, health product, or functional food products with specific effects, similar to Western medicine, achieving an innovative path of "Western medicine becoming TCM." For example, by quantifying the content of thujone in mugwort, mugwort products with calming effects can be developed; by increasing and quantifying the content of antifungal components, mugwort products can be developed into broad-spectrum antifungal agents and other daily chemical products. This strategic expansion enables TCM products to transcend the scope of traditional medicine and enter new market areas, thereby significantly enhancing product added value and market competitiveness, and promoting the high-end and international development of the TCM industry. In addition, systematic component data, precise quality standards, and differentiated product design capabilities provide solid technical support for the research and development of new TCM products, stimulating the innovative vitality of TCM's transformation from traditional "empirical prescriptions" to scientific and modern formulations. Combined with artificial intelligence and big data analysis, this embodiment can also optimize the formulation and compatibility of TCM, further improving research and development efficiency.

[0147] V. Digitalized Production Coordination

[0148] The fifth and final core step in this embodiment is digital production allocation, which transforms the analysis and standard results of the first four steps into actual productivity.

[0149] Existing technologies in digital production scheduling mainly include:

[0150] Traditional Chinese medicine granule dispensing: Through the extraction, concentration, drying, and granulation of single medicinal materials, standardized dispensing of traditional Chinese medicine is achieved, which has the advantages of accurate dosage and convenient use.

[0151] Automated production line for traditional Chinese medicine: Through automated equipment and robots, the entire process of traditional Chinese medicine production, from feeding, preparation, packaging to warehousing, is automated, improving production efficiency and quality traceability.

[0152] Digital pharmaceutical factories: Through technologies such as industrial IoT, big data, and artificial intelligence, the production process is digitized and intelligently managed, improving intelligent operation and maintenance capabilities and business decision-making efficiency.

[0153] Knowledge system for Chinese medicine production process: Through data collection, capability evaluation, monitoring feedback and design space search, it realizes intelligent regulation and feedback of the Chinese medicine production process.

[0154] Traditional Chinese Medicine Quality Traceability System: Utilizing computer information technology and Internet of Things technology, this system records information about the entire process of traditional Chinese medicine from planting to use, enabling traceability of origin, destination, and process control.

[0155] Compared with existing technologies, the digital blending and production method of this embodiment has significant advantages in terms of precise blending and batch stability, construction of a "digital TCM factory" model, improved production efficiency and quality control, and realization of low-cost replication and large-scale production. Specifically, it is based on whole-component recombination / cloning technology, the basic principle of which is to control product quality and efficacy by adjusting the molecular composition of the product. The specific implementation method uses algorithms and a dynamic component database to precisely control the mixing ratio between similar products (such as TCM raw materials), thereby achieving a product composition similar to the target product and accurately controlling its components and concentrations, thus achieving precise regulation of product properties. It is worth emphasizing that this technology, through a "wine-to-wine" mixing method, requires no additives or chemical treatments, maintaining the natural properties of the product. Utilizing real-time component data, the system can achieve precise blending of the concentration of each component, thereby ensuring a high degree of consistency and stability in product quality between different production batches. This completely solves the problem of large batch variations and unstable quality commonly found in traditional TCM production. This module closely links digital blending technology with upstream quality standards and component databases to achieve digitalization and intelligentization of the production process. This has established a fully digital management system covering the entire chain, from raw material warehousing, component testing, intelligent formulation, automated blending, online quality monitoring to finished product delivery, thus forming a highly efficient and controllable "digital TCM factory." Through digitalization, the production process has been optimized, production efficiency has been significantly improved, and full-process quality monitoring has been achieved, reducing human intervention and operational errors. This technology has been successfully industrialized in multiple fields, including baijiu (Chinese liquor), the localization of Japanese Kampo products, high-end whiskey, and flavorings, fully demonstrating its universality and maturity in the precise blending of complex mixtures. This provides a reliable path for the low-cost replication and large-scale production of high-quality TCM products, and reduces reliance on highly skilled experts such as traditional bartenders and perfumers. This transformation from traditional craftsmanship to industrialized, highly repeatable production is a crucial step in the modernization of the TCM industry and is essential for meeting modern market demands and international regulatory standards.

[0156] To more clearly compare the differences between digital dispensing technology and traditional Chinese medicine dispensing, the following table provides a detailed explanation:

[0157] Example 2

[0158] This embodiment provides a detailed operational flow of the system and method provided in Embodiment 1, as shown below:

[0159] Overall workflow:

[0160] Input of Chinese herbal raw materials / samples: The process begins with the Chinese herbal raw materials or samples to be standardized. These samples can be raw medicinal materials, processed slices, extracts, or intermediate products.

[0161] Rapid full component analysis (see attached) Figure 1 (The "Full Component Analysis" module in the text)

[0162] Input: Chinese herbal raw materials / samples.

[0163] Process: Standardized pretreatment of traditional Chinese medicine samples is performed, followed by detection using advanced analytical equipment such as ultra-high-speed chromatography-mass spectrometry (UHS-MS / LC-MS). The core lies in utilizing efficient algorithms (such as the "entropy minimization algorithm") to rapidly and comprehensively analyze the massive amounts of mass spectrometry data generated, identifying and quantifying up to 100-300 chemical components in the samples.

[0164] Output: Raw full component data, including detailed information such as the type and content of each component.

[0165] Advantages: Compared to traditional analytical methods, this step significantly improves analytical speed and sensitivity, while greatly reducing manpower and overall costs, making large-scale, high-throughput component detection possible and providing a timely and accurate data foundation for subsequent steps.

[0166] Construction of dynamic component database (corresponding appendix) Figure 1 (Dynamic Component Database module)

[0167] Input: Raw full-component data from rapid full-component analysis.

[0168] Process: Real-time raw full-component data are entered and integrated into a dynamic component database. This database is based on an advanced mass spectrometry database framework (such as NIST2023) and managed and distributed using specialized software. The database is updated in real time and employs hierarchical directory management (e.g., "Rose - Chinese Rose - Dark Red Rose") to ensure that each component is accurately associated with a specific product, its source, and processing stage. Simultaneously, the database supports the establishment of an analytical method library and can be validated and interconnected with existing authoritative databases.

[0169] Output: A real-time, comprehensive, and traceable dynamic component database.

[0170] Advantages: It overcomes the limitations of traditional static databases, such as lagging information updates and inability to reflect the true ingredients of products, and provides a solid data infrastructure for the quality traceability, batch management and market circulation of traditional Chinese medicine.

[0171] Quality standards based on component information (see attached document) Figure 1 (The "General Quality Standards" and "Differentiated Product Quality Standards" modules in the text)

[0172] Input: Real-time component data from the dynamic component database.

[0173] process:

[0174] Construction of multi-component fingerprint spectrum: Extract the full component information of traditional Chinese medicine from dynamic component database to construct a unique "multi-component fingerprint spectrum" that comprehensively reflects the overall chemical composition of traditional Chinese medicine.

[0175] Evaluation of effective ingredient groups: Based on this, identify and accurately evaluate the "effective ingredient groups" that are closely related to the efficacy of traditional Chinese medicine, analyze their synergistic effects in depth, and ensure that quality standards are closely integrated with the actual efficacy of traditional Chinese medicine.

[0176] Quality Standards and Quality Indices Development: Based on the evaluation results of fingerprint profiles and active ingredient groups, scientific and quantitative quality standards are developed for Chinese medicinal materials and / or Chinese medicinal products. This embodiment introduces the concept of a "quality index," quantifying the overall quality of the product or the concentration of ingredients related to specific efficacy into intuitive numerical values ​​(e.g., the quality index of moxa sticks and Panax notoginseng), thereby forming general quality standards and / or differentiated product quality standards for specific functions.

[0177] Output: Scientific, quantitative, and efficacy-related general quality standards and / or differentiated product quality standards.

[0178] Advantages: It significantly improves the controllability and identification ability of Chinese medicine quality, shifting from the traditional "qualified or not" to a multi-dimensional assessment of "quality and quality classification", enhancing consumer trust and providing a solid foundation for the internationalization of Chinese medicine.

[0179] Functionalization and Differentiation Design of Traditional Chinese Medicine Products (with corresponding appendix) Figure 1 (The "Differentiated Product Design" module in the text)

[0180] Input: Ingredient information from a dynamic ingredient database, and established quality standards (especially quality standards for differentiated products).

[0181] Process: In-depth research into the synergistic effects of different components in traditional Chinese medicine (TCM), combined with the traditional TCM formula principle of "principal, assistant, adjuvant, and guide," is used to interpret and verify these effects using modern scientific data. Based on market segmentation needs and personalized health requirements of consumers, the proportions of ingredients are precisely adjusted to design TCM products with clear functional positioning and differentiated efficacy. This includes developing TCM products into daily chemical products, health supplements, or functional foods with specific effects, achieving an innovative path of "Western medicine becoming TCM" (for example, developing calming products by quantifying the content of thujone in Artemisia argyi, or developing broad-spectrum antifungal agents by increasing the content of antifungal components).

[0182] Output: Design schemes and corresponding formulas for traditional Chinese medicine products with specific functions and / or differentiated characteristics.

[0183] Advantages: It breaks through the limitations of traditional experience, realizes the precise design and quantitative control of the functions and effects of Chinese medicine products, greatly expands the application boundaries and market potential of Chinese medicine products, and enhances the added value of products.

[0184] Digitalized production allocation (corresponding appendix) Figure 1 (Digital allocation module in the text)

[0185] Input: Chinese herbal raw materials or intermediate products, differentiated product design schemes / new product formulas, dynamic ingredient database data, and general / differentiated quality standards.

[0186] Process: The core of this module is "whole-component recombination / cloning technology." Through algorithms and a dynamic component database, the system can accurately calculate and control the mixing ratio between the same Chinese herbal raw materials or intermediate products, thereby achieving a final product composition highly similar to the target standard and precisely controlling its components and concentrations. This process requires no additives or additional chemical treatments, preserving the natural properties of Chinese herbal medicines to the maximum extent. The entire production process is automated and intelligent, constructing a "digital Chinese medicine factory" model.

[0187] Output: Standardized Chinese medicine products (finished products).

[0188] Advantages: It completely solves the problems of large batch-to-batch variations and unstable quality in traditional Chinese medicine production, ensuring high consistency and repeatability between product batches. It significantly improves production efficiency and quality control, and enables low-cost replication and large-scale production of high-quality Chinese medicine products.

[0189] Finished product full component testing and quality assessment (corresponding appendix) Figure 1 (The "Full Component Testing" and "Quality Assessment and Feedback" modules are included.)

[0190] Input: Standardized Chinese medicine products (finished products) produced through digital formulation.

[0191] Process: The finished product undergoes another full component test, which is then compared with the preset quality standards to conduct a quality assessment.

[0192] Output: Quality assessment report.

[0193] Feedback and Optimization: The quality assessment results will generate feedback to continuously optimize the parameters and strategies of the dynamic component database, quality standard setting, and digital blending production, forming a closed-loop system for continuous improvement to ensure the continuous stability and improvement of the quality of traditional Chinese medicine products.

[0194] Market circulation and trade (corresponding appendix) Figure 1 (The modules on "Spot and Futures Trading of Traditional Chinese Medicine" and "Standardized Traditional Chinese Medicine Products")

[0195] Output: Traditional Chinese medicine products that meet standardization requirements enter the market circulation, including those used for spot and futures trading, as well as various functional and differentiated traditional Chinese medicine products.

[0196] Advantages: Through standardization across the entire supply chain, the credibility and competitiveness of Chinese medicine products in the international market are greatly enhanced, which helps to promote the internationalization of Chinese medicine and global trade, and accelerates the large-scale development of the Chinese medicine industry.

[0197] Example 3

[0198] This embodiment uses mulberry twig extract as an example to illustrate the specific process of the above technical solution, as shown below:

[0199] This example illustrates how to utilize whole-component analysis, dynamic databases, and digital formulation technology to achieve batch-to-batch consistency, quality control, and functional differentiation of Mulberry Twig Extract (MTE) for its adjunctive treatment of diabetes. This fully embodies the core technological processes from testing to production within the "five-in-one" standardization pathway for traditional Chinese medicine.

[0200] Step 1: Full Component Analysis and Data Acquisition (corresponding to the molecular information module in the "Five-in-One" approach).

[0201] Sample collection: A batch of mulberry twig extract with clinically proven efficacy was selected as the target reference, and mulberry twig extracts from 9 different origins, seasons, or production batches were collected as raw material batches.

[0202] Rapid analysis: All 10 samples (1 target + 9 reference samples from raw material batches) underwent the same comprehensive chemical analysis using high-throughput analytical techniques such as GC-MS (gas chromatography-mass spectrometry) and LC-MS (liquid chromatography-mass spectrometry).

[0203] Data processing: Applying AI-driven analytics software (such as SmartDalton) ® The mass spectrometry data is analyzed.

[0204] Target analysis: Identifying and quantifying all detectable compounds from a target analyte. For example, GC-MS yields 212 components, LC-MS yields 185 components, and after deducting overlaps, approximately 350 molecular profiles are obtained.

[0205] Raw material batch analysis: The same rapid chemical analysis was performed on the other 9 raw material batches to obtain the total composition information of all batches. For example, the final comprehensive analysis yielded information on 618 different molecular components (including known active ingredients such as D-cortisol, total alkaloids, and a large number of unknown trace components).

[0206] Step 2: Establish a dynamic component database (corresponding to the dynamic component database module in the "five-in-one" system).

[0207] Data entry: Enter all 618 component information parsed in step one into the database, including:

[0208] Structural information of the components (for known components) or pure mass spectrometry information (for unknown components, with custom naming), relative concentration or relative content of each component in 10 samples, therapeutic data for each sample (if available), and batch information.

[0209] Dynamic updates: The database is designed with a dynamically updatable structure. As more batches and more research data related to mulberry twigs (such as the correlation data between components and mechanisms of blood sugar and blood pressure reduction) are generated, the database can continuously incorporate new components and new correlation data, and continuously improve the molecular fingerprint spectrum of mulberry twig extracts.

[0210] Step 3: Develop a quality standard formulation based on all components (corresponding to the standardization module in the "five-in-one" approach).

[0211] Establish a quality standard baseline: use the molecular fingerprint and component content of the target substance (batch with excellent efficacy) as the baseline.

[0212] Target Group of Compounds (TCG) range: Based on database information, 618 components are divided into three categories, and their respective allowable concentration ranges are set to form a full component quality standard.

[0213] Core functional ingredients (68): The ingredients known to contribute the most to lowering blood sugar or other therapeutic effects, and their content is set at ±10% of the target substance content.

[0214] Synergistic moderating components (80): known components with synergistic or auxiliary effects, the content of which is set at ±30% of the target substance content.

[0215] Trace fingerprint components (470): Their specific function is unknown, but they exist in the raw materials as trace fingerprints, and their content is set to 0-130% of the highest detectable content of this component in the database.

[0216] Establish reference standards: Based on this full-component quality standard, the analytical system is calibrated using available single-component reference standards (such as D-dericoside), and high-purity, full-component calibrated internal reference standards are used as the reference for local instrument analysis. The content of all components in the standard is uniformly converted into the relative concentration after local instrument calibration.

[0217] Step 4: Determine the target product design information and functionalization (corresponding to the differentiated product design module in the "five-in-one" approach).

[0218] Determine the target spectrum: Based on the full-component quality standards established in step three, determine an ideal target molecule spectrum as the design information for the final product.

[0219] Functional differentiation design (optional): Adjust the standard according to market demand to achieve specific functions. For example, if you want to develop a product that focuses on stabilizing blood sugar, you can raise the upper limit of the concentration of D-cortisol and other components related to glucosidase inhibition in the database to +15% of the target substance content and use it as one of the main constraints.

[0220] For example, if you want to develop a product that focuses on protecting the pancreas, you can set the concentration of specific antioxidant and anti-inflammatory ingredients to a high level.

[0221] Step 5: Digital Blending and Standardized Product Production (corresponding to the Digital Blending / Large-Scale Production module in the "Five-in-One" approach).

[0222] Calculate the blending formula: Input the composition profiles (input data) of 9 raw material batches and the target product design map (target data) into the digital blending system (existing optimization algorithms can be used).

[0223] Formula output: The system calculates and outputs the optimal mixing ratio. For example, mixing batches #1, #3, #7, and #9 in a ratio of $10:30:40:20$ will make the full component spectrum of the mixed product meet the standards set in step three or four. This is a product design that can simultaneously design multiple products to meet various efficacy needs and achieve combinations.

[0224] Actual production and verification:

[0225] In industrial production, standardized products can be obtained simply by mixing these nine batches of products according to the calculated proportions (without complicated chemical separation or addition steps).

[0226] Verification analysis was performed on the mixed product to confirm the consistency between its molecular fingerprint spectrum and the target or design spectrum (e.g., the component difference is within 2%).

[0227] Maximizing resource utilization: During the digital allocation process, the system can intelligently allocate raw materials. For example, a batch that cannot be used for the formulation of blood sugar stabilization products due to its low D-cortisol content may still be used for the formulation of general blood sugar lowering products or pancreatic islet protection products. This ensures that all raw material batches are used efficiently. Therefore, among the multiple combinations designed and arranged, the utilization rate of raw materials in each batch can be calculated by combining business information (such as the supply or inventory of raw materials in different batches), and the one with the highest or relatively high utilization rate can be selected as the final product design combination.

[0228] Example 4

[0229] This embodiment details how to develop mulberry twig extract into standardized products for different clinical needs through the M1-M5 pathway, and how to utilize digital recombination to address the challenges posed by fluctuations in raw material concentration. The process for developing standardized traditional Chinese medicine products is shown below.

[0230] M1: Full Component Analysis and Digital Modeling

[0231] Target and reference selection: First, one batch of mulberry twig extract with excellent clinical efficacy was selected as the target; at the same time, nine batches of mulberry twig extract raw materials from different producing areas, harvesting seasons and extraction processes were collected as references to be formulated.

[0232] High-throughput detection: High-throughput chromatography-mass spectrometry / liquid chromatography-mass spectrometry was used to simultaneously analyze the above 10 samples, extract molecular component information and convert it into digital chemical composition data.

[0233] Digital profiling: Through analysis software based on the minimum entropy algorithm, 350 molecular information was identified in the target, and combined with 9 reference materials, a digital global fingerprint spectrum covering 618 molecular components was finally integrated.

[0234] M2: Construction of Dynamic Component Database

[0235] Data association and entry: The structural information of the above 618 components, their relative concentrations in 10 samples, batch information, and efficacy data are associated and entered into the system.

[0236] Dynamic update management: The database adopts a three-level directory structure based on species, source, batch, and processing stage, and is dynamically updated in sync with the real-time detection data stream.

[0237] M3: Quantitative Quality Standards Development

[0238] Using the molecular fingerprint spectrum of the target substance as a baseline, and based on the degree of influence of the ingredients on efficacy, 618 ingredients were divided into three control layers to establish quality standards:

[0239] Core functional ingredients (68): These are the active ingredients that contribute most to lowering blood sugar or regulating metabolism, such as 1-deoxynojirimycin. Their quality standard fluctuation range is set to ±(5-15%) of the target substance content.

[0240] Synergistic regulatory components (80): Components identified as having auxiliary or synergistic effects, such as morin A, etc., are set to have a quality standard fluctuation range of ±(20-40%) of the target substance content.

[0241] Trace fingerprint components (470): These were identified as components whose function is not yet clear but which constitute the molecular background. Their quality standard fluctuation range was set to 0-130% of the highest detection value in the database.

[0242] M4: Differentiated Design and Flexible Compensation Mechanism for Multifunctional Products

[0243] Based on the synergistic relationships of ingredients in the database, the system generates product design information for three different efficacy positions:

[0244] General-purpose products: Based on the full composition spectrum of the target product, ensure that the proportions of all core components are highly consistent with those of the target product.

[0245] Stable blood sugar products: Focus on strengthening the components with α-glucosidase inhibitory effects, and set the designed content of 1-deoxynojirimycin at 115% of the target substance content.

[0246] Pancreatic islet protection products: These products focus on enhancing the anti-inflammatory, antioxidant, and pancreatic islet cell protective functions, and set the designed content of effective ingredients such as linalool G and morin C at a relatively high value within the quality standard range.

[0247] Elastic compensation logic: If the absolute concentration of the active ingredient (such as morin C) in the above 9 batches of raw materials generally fails to meet the target standard after calculation by the algorithm, the system will automatically adjust the overall concentration target value proportionally to maintain the consistency of molecular ratio, and output a dose compensation suggestion at the same time (for example, because the actual measured concentration is only 80% of the standard, the system will automatically prompt that the single dose be increased from 1.0g to 1.25g).

[0248] M5: Digitally allocate production and maximize resource utilization

[0249] Algorithm-based mixing simulation: The digital blending system calculates the optimal mixing ratio based on real-time chemical composition data of nine batches of raw materials to be blended, combined with the target product design information.

[0250] Multi-task raw material balancing: The system automatically balances raw materials among multiple production tasks. For example, batches with lower content of key components are allocated to general solutions, while batches with higher content are prioritized for specific functional tasks.

[0251] Maximizing output utilization: Among multiple optional allocation combinations, the system prioritizes the combination with the highest raw material utilization as the final digital allocation instruction, ensuring that the finished product meets the standards and minimizes raw material waste.

[0252] Example 5

[0253] This embodiment illustrates a standardized and differentiated product development based on the full component analysis of Artemisia argyi. By utilizing the fingerprint spectral characteristics of the full components of Artemisia argyi, it is possible to achieve precise recombination of specific functional components and the development of multiple standardized products. The specific steps are as follows.

[0254] M1: Full Component Analysis and Digital Modeling

[0255] Target and reference selection: First, one batch of clinically recognized high-quality Artemisia argyi was selected as the target; at the same time, 15 batches of Artemisia argyi raw materials from different producing areas (such as Qizhou Artemisia and wild Artemisia), different harvesting seasons and drying processes were collected as references to be formulated.

[0256] High-throughput detection: High-throughput full-component chemical analysis of the above 16 Artemisia argyi samples was performed using gas chromatography-mass spectrometry (GC-MS).

[0257] Digital profiling: By analyzing the detection data using software based on the minimum entropy algorithm, at least 36 key beneficial chemical components in Artemisia argyi were identified and quantified, along with a total of 356 other components, to construct a complete digital molecular fingerprint profile.

[0258] M2: Construction of Dynamic Component Database

[0259] Data integration and entry: The molecular information, relative concentration in each batch, batch information, and associated therapeutic data of the 356 core beneficial components and hundreds of trace fingerprint components identified will be entered into the system.

[0260] Three-level catalog management: The database is managed using a three-level product catalog structure based on Artemisia species, source, batch, and processing stage, and is dynamically updated in real time along with commercial testing data streams.

[0261] M3: Quantitative Quality Standards Development

[0262] Using the molecular fingerprint spectrum of the target substance as a baseline, the entire composition of Artemisia argyi was divided into three control zones using a quality index evaluation system to formulate standards:

[0263] Core functional components: 36 key beneficial components directly related to the efficacy of the drug are set as core indicators, and their content fluctuation range is set to ±(5-15%) of the corresponding content of the target substance.

[0264] Synergistic regulatory components: Volatile oil components and flavonoid components with synergistic effects are set as synergistic indicators, and their content fluctuation range is set to ±(20-40%) of the corresponding content of the target substance.

[0265] Trace fingerprint components: Other trace components that serve as molecular background are set as auxiliary indicators, and their content range is set to 0-130% of the target substance content.

[0266] M4: Differentiated Design and Flexible Adjustment of Multifunctional Products

[0267] Based on the synergistic relationships between ingredients, the system generates three product design information sets targeting different efficacy positions by adjusting the design proportions of specific ingredient groups:

[0268] Category 1 functional products (digestive and circulatory regulation type): These products focus on enhancing the components that stimulate gastric juice production, regulate the heart, and improve circulation, and their designed content is set at a relatively high value.

[0269] The second category of functional products (broad-spectrum bactericidal type) focuses on strengthening components with antifungal, bactericidal, antiparasitic, and anti-inflammatory effects, and increases their quality proportion in the design information.

[0270] The third category of functional products (deep analgesic and anti-inflammatory type): focuses on increasing the concentration of ingredients with pain-relieving, analgesic, and anti-inflammatory effects.

[0271] Flexible compensation mechanism: If, after calculation by the algorithm, the absolute concentration of some core components of the above 15 batches of raw materials is lower than the preset threshold and cannot be adjusted to the preset target value, the system will automatically adjust the overall concentration target value proportionally to maintain a consistent molecular ratio, and simultaneously output a dosage compensation suggestion (for example, if the actual measured concentration is only 75% of the standard, the system will automatically suggest increasing the single-use dosage by 33.3%).

[0272] M5: Digitally allocate production and maximize resource utilization

[0273] Algorithm-simulated mixing: The digital blending production module calculates the optimal physical recombination ratio based on the real-time chemical composition data of 16 batches of raw materials to be blended, combined with the target product design information.

[0274] Recombinant consistency verification: By combining multiple raw materials through a precise blending device, the difference between the full component fingerprint spectrum of the finished product and the target design spectrum is controlled within 2%, and no chemical additives are added throughout the process, preserving the natural properties.

[0275] Maximizing utilization: When processing multiple product orders, the system automatically balances raw material inventory and allocates raw materials with specific component contents that deviate from the target to the most matching functional model scheme, thereby significantly improving the overall utilization rate of raw materials in the entire batch.

[0276] It should be understood that the above embodiments are merely illustrative of the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A method for developing standardized traditional Chinese medicine products based on component analysis, characterized in that, include: A full component analysis was performed on multiple Chinese herbal raw materials to obtain chemical composition data; A dynamic component database is established based on the chemical component data, and the dynamic component database is dynamically updated based on the batches of the Chinese herbal raw materials. Based on the chemical composition data in the dynamic component database, quality standards are formulated for Chinese medicinal materials and / or Chinese medicinal products, and the quality standards include multi-component fingerprint profiles and groups of effective components; For various product efficacies, based on the quality standards and ingredient information in the dynamic ingredient database, as well as the synergistic relationships between ingredients, the target effective ingredients and their content are determined, resulting in multiple target product design information. Based on the design information of multiple target products, and combined with the chemical composition data in the dynamic component database of multiple batches of the Chinese herbal raw materials, a digital blending method is used to combine multiple Chinese herbal raw materials to obtain multiple target Chinese herbal products. This ensures that the effective components and contents in the target Chinese herbal products are consistent with the design information of the target products, and maximizes the utilization rate of the current batches of the Chinese herbal raw materials.

2. The method for developing standardized traditional Chinese medicine products according to claim 1, characterized in that, Also includes: When the concentration of the active ingredient in any of the target traditional Chinese medicine products fails to meet the design information of the target product, the concentration of the active ingredient is reduced, and the concentration of the remaining ingredients is reduced proportionally to perform low-concentration digital formulation, thereby obtaining a low-concentration target traditional Chinese medicine product. A dose compensation suggestion for the low-concentration target traditional Chinese medicine product is also output. When the low-concentration target traditional Chinese medicine product is taken in combination with the dose compensation suggestion, the actual intake of the active ingredient is consistent with the design information of the target product.

3. The method for developing standardized traditional Chinese medicine products according to claim 1, characterized in that, The full component analysis specifically includes: Several batches of the Chinese herbal raw materials that have been clinically approved were selected as the target material, and other batches of the Chinese herbal raw materials were selected as the reference material. High-throughput full-component chemical analysis was performed on the target and reference compounds; The chemical composition data is obtained by fusing the molecular composition information of the target and the reference.

4. The method for developing standardized traditional Chinese medicine products according to claim 3, characterized in that, The process of establishing the dynamic component database specifically includes: The chemical composition data of the target and reference substances, along with the corresponding batch information and selective efficacy information, are entered to form a basic database; The commercial / academic testing information of the Chinese herbal raw materials is updated in real time, and the basic database is updated synchronously to obtain the dynamic component database.

5. The method for developing standardized traditional Chinese medicine products according to claim 4, characterized in that, The traditional Chinese medicine raw materials in the dynamic ingredient database are stored in a multi-level product catalog structure, which is classified according to the species, source, batch, and processing stage of the traditional Chinese medicine raw materials.

6. The method for developing standardized traditional Chinese medicine products according to claim 4, characterized in that, The process of establishing the quality standards specifically includes: The molecular composition information is divided into core functional components, synergistic regulatory components, and trace fingerprint components; The molecular fingerprint spectrum and component content of the target substance are used as baselines; The quality standard of the core functional component is set to ±(5-15) of the corresponding content of the target substance, the quality standard of the synergistic regulatory component is set to ±(20-40) of the corresponding content of the target substance, and the quality standard of the trace fingerprint component is set to 0-130% of the corresponding content of the target substance. The quality standard is established.

7. The method for developing standardized traditional Chinese medicine products according to claim 6, characterized in that, The process of obtaining the target product design information specifically includes: Identify the efficacy requirements for multiple target products; Based on the efficacy requirements, and combined with the quality index, target effective ingredient groups are selected. Within the range of the quality standards, the design content corresponding to the target effective ingredient group is set to a relatively high value, forming multiple target product design information.

8. The method for developing standardized traditional Chinese medicine products according to claim 7, characterized in that, The digital allocation process specifically includes: Based on the chemical composition data of multiple batches of the Chinese herbal raw materials, and based on the efficacy requirements of multiple target products, multiple basic combinations are formulated and blended. The combination with the highest utilization rate among multiple batches of the Chinese herbal raw materials in the basic combination is selected as the output result of the digital dispensing.

9. A standardized product development system for traditional Chinese medicine based on component analysis, characterized in that, include: The rapid full-component analysis module is used to perform full-component analysis on multiple Chinese herbal raw materials to obtain chemical composition data; A dynamic component database module is used to establish a dynamic component database based on the chemical component data, and the dynamic component database is dynamically updated based on the batches of the Chinese herbal raw materials; The quality standard setting module is used to set quality standards for Chinese medicinal materials and / or Chinese medicinal products based on the chemical composition data in the dynamic component database. The quality standards include multi-component fingerprints and groups of active ingredients. The product design module is used to determine the target effective ingredient and its content based on the quality standards and ingredient information in the dynamic ingredient database, as well as the synergistic relationship between ingredients, for various product efficacies, thereby obtaining multiple target product design information. The digital blending and production module is used to combine multiple Chinese herbal medicine raw materials in a digital blending manner based on multiple target product design information and chemical component data in a dynamic component database of multiple batches of the Chinese herbal medicine raw materials to obtain multiple target Chinese herbal medicine products. This ensures that the effective components and contents in the target Chinese herbal medicine products are consistent with the target product design information, and maximizes the utilization rate of the current multiple batches of the Chinese herbal medicine raw materials.

10. A readable storage medium, characterized in that, The readable storage medium stores a computer program, which, when run, executes the steps of the method for developing standardized traditional Chinese medicine products according to any one of claims 1-8.

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