Low-temperature wet-process clean moxa preparation method based on multi-physics field synergy

Abstract

The invention discloses a low-temperature wet-process clean moxa preparation method based on multi-physics field synergy, and relates to the field of traditional Chinese medicinal material processing and traditional Chinese medicine medical instruments. The method comprises the following steps: under the conditions that the whole process is closed and the process temperature is less than or equal to 60 DEG C, sequentially performing closed airflow cleaning and leaf-stem separation, low-temperature airflow tearing crushing and online screening, controllable aging or directional fermentation, dynamic gas-liquid two-phase microfluidic rinsing and dehydration, vacuum-microwave-heat pump coupling drying sterilization and sterile subpackaging. The key point lies in the cooperation of non-soaking type microfluidic rinsing and vacuum-microwave-heat pump coupling drying; the non-soaking type microfluidic rinsing and vacuum-microwave-heat pump coupling drying realize deep surface cleaning through tiny liquid drops, so that the loss of active ingredients is reduced to a great extent; the latter realizes rapid and uniform low-temperature drying and sterilization under vacuum and heat pump latent heat recovery. According to the method, high cleanliness (the total number of bacterial colonies is smaller than 200 CFU / g), high activity retention and high batch consistency are synchronously achieved, and moxa products meet the high-end medical consumable standard.

Description

Technical Field

[0001] This invention relates to the fields of traditional Chinese medicine processing and medical materials, and particularly to a method for preparing clean moxa floss using a low-temperature wet process based on multi-physical field synergy, the resulting moxa floss product, and a dedicated preparation system thereof. Background Technology

[0002] Moxa wool is the core material of moxibustion therapy, and its quality directly affects efficacy and safety. Traditional moxa wool preparation mainly relies on the "dry method," which involves obtaining moxa leaf fibers through physical processes such as sun-drying, aging, pounding, and sieving. This traditional process has three inherent drawbacks: 1. Poor cleanliness ("dirty"): Open processing easily introduces microorganisms and dust contamination, resulting in low product hygiene levels; 2. Loss of activity ("heat"): Heat generated by friction during processing or heat generated by improper stacking and fermentation can easily destroy the heat-sensitive active ingredients (such as volatile oils) in Artemisia argyi. 3. High quality fluctuation ("low"): The process relies on experience, and the product uniformity and standardization are low.

[0003] To improve cleanliness, the industry once tried to introduce the "wet method" (i.e., soaking and washing with water), but this immediately led to a serious loss of water-soluble and fat-soluble effective ingredients. Water is yin in nature, which also goes against the fundamental principle of "pure yang medicinal properties" of moxa wool. Therefore, it has long been regarded as a technical taboo in the industry.

[0004] Therefore, the processing of mugwort floss has long faced an irreconcilable technical contradiction: if the "dry method" is insisted upon to ensure the active ingredients, the fundamental problem of poor cleanliness cannot be solved; if the "wet method" is introduced to improve cleanliness, it will lead to a catastrophic loss of active ingredients and even changes in medicinal properties. Finding a method for preparing mugwort floss that can simultaneously achieve "deep cleanliness" and "high activity retention" at low temperatures has become a technical bottleneck that the industry urgently needs to overcome. Summary of the Invention

[0005] The technical problem to be solved by this invention is to overcome the technical bottleneck that "cleanliness" and "activity retention" cannot be achieved simultaneously in the traditional processing of moxa floss. By introducing a controlled liquid cleaning medium into the processing of moxa floss, a standardized method for preparing moxa floss that can simultaneously achieve deep cleaning and high activity retention at low temperature (≤60℃) is provided.

[0006] To achieve the above objectives, the core of the technical solution of this invention lies in: under the constraint of a low-temperature, sealed environment of ≤60℃ throughout the entire process, through the coupled synergy of two innovative processes—"dynamic gas-liquid two-phase microfluidic rinsing" and "vacuum-microwave-heat pump coupled drying"—a "seemingly wet but actually dry" cleaning effect is achieved at the molecular level; while adhering to the golden rule of "low-temperature property preservation" in the processing of moxa wool, the invention systematically overcomes the fundamental contradictions between cleaning and preservation, and between efficiency and safety.

[0007] The "systematic synergy" is manifested in the following ways: microfluidic rinsing uses extremely small atomized droplets carried by high-speed airflow to perform non-immersion surface rinsing of the moxa floss. While efficiently removing impurities, the liquid does not penetrate the fiber interior, thus maximizing the preservation of the moxa floss's porous and loose structure. This lays a favorable material foundation for the rapid and uniform removal of moisture in the subsequent drying stage. The coupled drying, through the synergy of vacuum and heat pump latent heat recovery, achieves rapid and uniform dehydration and sterilization at low temperatures, avoiding microbial growth or component hydrolysis caused by prolonged storage of wet materials. The two processes are closely linked and mutually reinforcing in terms of process logic, forming a mutually promoting closed loop. This simultaneously achieves deep cleaning and high activity retention of the moxa floss, and relies on digital closed-loop control to ensure uniform and stable product quality.

[0008] I. Overall Process Architecture: This invention adopts an Industry 5.0 architecture design to construct a fully enclosed intelligent production line. The core process route is as follows: enclosed airflow cleaning and blade separation → low-temperature airflow tearing and crushing and online sieving → controllable oxygen-enriched aging or directional accelerated fermentation → dynamic gas-liquid two-phase microfluidic rinsing and dehydration → far-infrared vacuum-microwave-heat pump coupled sterilization and drying → aseptic intelligent dispensing.

[0009] The entire process strictly controls key environmental and equipment parameters: overall temperature <60℃, pressure difference 10-50Pa, airflow velocity 1-3m / s, no chemical additives, integrated high-speed wireless communication network sensor online monitoring system and online process analysis technology (PAT), and transmits monitoring data to the cloud platform in real time through industrial communication protocols to achieve full-process digital closed-loop control.

[0010] II. Technical Details of Core Processes S1: Closed-loop cleaning and blade separation This process aims to clean and separate raw materials from the source, achieve precise grading of raw materials, control impurity contamination, and lay the foundation for subsequent cleaning processes.

[0011] Processing medium: A closed negative pressure chamber (pressure difference 10-50Pa) is used. Fresh / aged mugwort leaves are transported through pharmaceutical-grade stainless steel pipes (clean airflow at a velocity of 1-3m / s) to avoid heavy dust and microbial contamination caused by open environments.

[0012] Dynamic gradient pressure control is adopted, i.e., the pressure in the clean zone > the semi-clean zone > the contaminated zone, to construct an airflow barrier to prevent external pollution from intruding or internal dust from escaping.

[0013] Separation mechanism: The mechanical vibration field is coupled with the negative pressure airflow field, and a low-frequency vibrating screen (vibration frequency <100Hz) is configured to separate the mugwort leaves and stems and remove surface dust through the synergistic effect of airflow and vibration.

[0014] Intelligent grading: Integrating a high-speed wireless communication network intelligent vision system based on deep learning image recognition algorithms or convolutional neural network deep learning models, it acquires images in real time through high-definition industrial cameras, accurately identifies stems, fresh mugwort leaves and aged mugwort leaves, and guides raw materials of different grades to corresponding closed transmission pipelines through airflow guide plates to achieve initial screening and separation of raw materials.

[0015] S2: Low-temperature airflow tearing and online sieving The core of this process is to solve the problem of high-temperature damage caused by traditional mechanical crushing, ensuring that the moxa fibers are uniform and that the active ingredients are not lost.

[0016] Crushing equipment: adopts low-temperature nitrogen jet mill, using low-temperature nitrogen gas (<40℃) as the crushing medium, and achieves crushing through mutual collision and tearing between materials, eliminating mechanical friction heat at the source.

[0017] Parameter control: Control the airflow velocity to <10m / s to avoid fiber damage caused by excessive material impact.

[0018] Online monitoring and diversion: The integrated online terahertz (THz) spectrometer monitors the particle size (D90=100-180 mesh) and fingerprint spectrum / fingerprint spectrum of the crushed moxa wool in real time. When the detected value exceeds the preset threshold, the diversion mechanism is automatically triggered to ensure product quality consistency.

[0019] Fresh mugwort floss retains 15% of its original fresh mugwort powder to maintain the original environmental conditions for fermentation and aging. After thorough mixing, it is transported to the corresponding oxygen-enriched aging chamber or directional accelerated fermentation tank. The pre-processing of fresh mugwort floss separation can significantly reduce the burden of mugwort floss aging, while improving the utilization rate of active ingredients during the systematic extraction and utilization of fresh mugwort residue, highlighting its outstanding value in cost reduction and efficiency improvement.

[0020] After the mugwort floss is completely sieved and separated into mugwort powder, it directly enters the subsequent rinsing and cleaning process.

[0021] The stems are collected through independent pipes and temporarily stored in dedicated sealed containers. Artemisia powder by-products are collected separately for aged and fresh Artemisia, and similarly temporarily stored in dedicated sealed containers for later use. The process also includes the centralized collection and unified treatment of Artemisia residue generated during the washing and centrifugation of Artemisia floss.

[0022] By concentrating these Artemisia argyi powder by-products, they can be directly fed into subsequent molecular / ionic high-pressure water jet cell disruption production lines to directly extract different Artemisia argyi materials such as micro-nano essences, cellulose, and organic culture media, truly achieving high-quality and full-value utilization of Artemisia argyi raw materials.

[0023] Dust control: The screening process uses a low-frequency vibrating screen, equipped with a negative pressure dust collection device to prevent dust pollution and ensure that the production environment meets GMP standards.

[0024] S3: Controlled oxygen-enriched aging or directed fermentation This process enhances the active ingredients of mugwort floss through a gentle fermentation and aging process, while avoiding the high-temperature risks of traditional aging, providing two implementation paths to suit different needs.

[0025] Pathway 1: Oxygen-enriched natural aging: The separated fresh mugwort floss is loosely placed on an open, room-temperature aging warehouse with high shelves, layered and airy, with the pile thickness controlled (cotton bags for airy natural fermentation) <12kg / m³. 3 Keep the oxygen-rich air treated by the filtration system in full contact with the mugwort floss, with an O2 concentration of 21-23%, maintain an ambient temperature of 20-30℃ and a humidity of 60-70%, turn it over and air it out 1-2 times a month, and the aging period is 12-36 months. Pathway 2: Directed Fermentation: The mugwort floss obtained in S2 enters the fermentation tank via pipes and is inoculated with an artificially synthesized microbial community composed of lactic acid bacteria, yeast, and specific filamentous fungi (e.g., lactic acid bacteria + yeast + Aspergillus oryzae, in a ratio of 3:1:0.5), with an inoculation amount of 10. 6 CFU / g. Metabolites (lactic acid, ethanol, and specific enzyme activities) in the fermentation system are monitored in real time using a 5G IoT sensor network. The temperature is dynamically adjusted to 30±0.5℃, humidity to 65±3%, and pH to 4.5-5.0. The fermentation cycle is 7-21 days, and the monitoring data is uploaded to the GAIA-X cloud platform in real time.

[0026] After the fermentation process is completed, the fresh mugwort floss needs to be sieved to remove the mugwort powder. The fresh mugwort floss then proceeds to the next process, while the mugwort powder is collected separately for later use.

[0027] Key advantages: By precisely controlling the oxidation / fermentation process, avoiding the heating effect of pile accumulation, the antioxidant activity of DPPH is increased by 38%, and specific thermal active ingredients that can be generated in a targeted manner that would take several years of traditional aging can be formed, which greatly shortens the production cycle and reduces the huge costs of natural aging storage (≥93%).

[0028] In traditional artemisia floss extraction processes, "aging / fermentation" is an indispensable key step. Natural fermentation and aging processes achieve a transformation in medicinal properties, from raw to cooked, which is crucial for maintaining the pure yang nature, gentle medicinal properties, and stable fiber combustion. This invention standardizes the "aging / fermentation" process, making it more resistant to subsequent microfluidic rinsing without structural collapse or abnormal component loss. This fully demonstrates its synergistic effect with the core process technology and its strong correlation, thus confirming its necessity.

[0029] S4: Dynamic Gas-Liquid Two-Phase Microfluidic Washing and Dehydration This process uses physical cleaning to deeply remove impurities, solving the core problem of traditional moxa wool being "dirty," while protecting the integrity of the moxa wool fiber structure as much as possible.

[0030] Rinsing Process: S3-treated moxa fibers (fresh or aged) are fed into a dynamic water flow rinsing bed through a closed pipeline. A high-speed airflow combined with an ultrasonic atomizer creates a gas-liquid two-phase flow. The airflow velocity is controlled at 15 m / s, and the atomized droplet size is approximately Dv50 ≤ 50 μm ≤ 30 μm. The gas-liquid volume ratio is controlled between 1000:1 and 5000:1. Ultrasonic frequency: 30-50 kHz, power density controlled at 0.3-0.5 W / cm³. 2 The non-immersion dynamic cleaning process takes 3-6 minutes at a temperature of 30-40℃, using deionized water as the cleaning medium. This process rinses and cleans the surface of the mugwort fibers; it achieves deep cleaning while ensuring the cleaning solution does not penetrate the internal structure of the mugwort fibers. Preferably, the crushed mugwort fibers enter a dynamic multi-directional water flow rinsing bed through a closed pipe, using pure water at a flow rate of 0.6L / min (0.5-0.8L / min range). The first stage uses low-temperature (e.g., 4-10℃) water for rapid rinsing 4 times (3-5 times range) to remove heavy impurities such as mud and sand, as well as impurities attached to the surface of the mugwort fibers.

[0031] Wet cleanliness monitoring: Integrated online turbidity sensor to monitor the turbidity of rinse water in real time. When the turbidity is ≥5 NTU, the water exchange program is automatically started until the turbidity is <5 NTU, ensuring that the impurity removal rate is ≥98%.

[0032] Dehydration treatment: After rinsing, a low-speed centrifuge is used for dehydration, with the speed controlled at <300r / min, and the solid-liquid separation efficiency ≥99%, to avoid damage to the moxa fibers caused by high speed.

[0033] In the wastewater recycling process, an oil-water separator is installed to recover the lost volatile oils and other flavor substances from the mugwort and spray them back onto the mugwort floss, thus achieving a closed-loop "preservation of properties" in the process logic.

[0034] As the core innovative breakthrough of this invention, the non-immersion gas-liquid two-phase microfluidic dry cleaning (a historical breakthrough): This step scientifically introduces a liquid cleaning medium into the processing of Artemisia argyi for the first time, completely overturning the traditional immersion mode. We creatively use a high-speed airflow (carrier) to carry extremely small amounts of ultra-fine atomized droplets (cleaning medium) to form a gas-liquid two-phase flow, performing a "surface storm-style dry cleaning" on the Artemisia argyi. By precisely controlling the gas-liquid ratio within the "quasi-dry" range of 1000:1 to 5000:1, and the droplet size ≤50μm, we ensure that the cleaning medium acts only on the dust and impurities on the surface of the Artemisia argyi fibers with extremely high kinetic energy, and instantly peels them off and carries them away under the shear force of the airflow. At the same time, it physically avoids the channels for liquid to wet and penetrate into the fiber interior, leading to the loss of active ingredients. This step is carried out at ≤60℃, inheriting the principle of low-temperature processing. This minimizes the disturbance and loss rate of active ingredients inside the Artemisia argyi fibers.

[0035] S5: Vacuum-microwave-heat pump coupled drying and sterilization This process integrates drying and sterilization, simultaneously achieving moisture control and sterilization requirements under low-temperature conditions coupled with vacuum, microwave, and heat pump. In the initial stage of this coupled drying process, the microwave power density is progressively increased from 0.5 W / g to over 2 W / g within 2-5 minutes, while maintaining a vacuum level below -60 kPa.

[0036] Equipment parameters: Far-infrared drying with a wavelength of 8-14μm is used, with the drying temperature controlled at 50-60℃, vacuum degree at -60kPa to -80kPa, and time at 30-45 minutes. Microwave power: 10-30kW, to avoid localized overheating. The moisture content of the dried moxa wool is <10%.

[0037] Temperature effect: Equipped with a 5G thermal imaging camera, it uses multi-point temperature monitoring and zoned power control in real time to ensure that the temperature difference between any two points in the drying chamber does not exceed 3°C, preventing the destruction of active ingredients due to local overheating; Dual effect: Simultaneous drying and sterilization. After sterilization, the total bacterial count of the moxa wool is <200 CFU / g, meeting the hygienic quality requirements for medical device consumables. In addition, the infrared emissivity of the moxa wool meets the standard of ≥0.92, ensuring the clinical effectiveness.

[0038] As a further optimization of this invention, vacuum-microwave-heat pump coupled drying combines modern thermophysics technology with traditional wisdom. Under vacuum conditions (-60kPa to -80kPa), the boiling point of water is significantly reduced, making it easier for the moisture inside the moxa wool to vaporize at low temperatures. Microwaves provide unique volumetric heating, allowing moisture to migrate rapidly from the inside out, avoiding the temperature gradient and overheating of the outer layer caused by traditional heat conduction from the outside in. The heat pump efficiently recovers the latent heat in the drying exhaust gas and continuously dehumidifies, maintaining a low dew point environment within the drying chamber. The synergy of these three elements enables efficiency far exceeding that of traditional hot air drying at temperatures ≤60℃, and due to uniform temperature and the absence of overheating spots, it perfectly inherits the processing tradition of "low-temperature property preservation." The microwave and vacuum environments themselves also have significant inhibitory or killing effects on microorganisms, comprehensively solving the problems of low-temperature, rapid, and uniform drying and sterilization.

[0039] S6: Aseptic Intelligent Dispensing This process focuses on product storage stability, enhancing product added value and compliance.

[0040] Environmental requirements: The process must be carried out in a Class 10,000 GMP environment, using vacuum or nitrogen-filled packaging to control residual oxygen in the packaging to <0.5%, delaying the oxidation of active ingredients. Hygiene testing must ensure that the final product meets the sterile quality standards for medical device consumables.

[0041] Traceability Management: Each package is equipped with a 5G RFID tag to achieve full lifecycle traceability from raw materials to finished products; product information is recorded through blockchain, which complies with EUGMP Annex 11 requirements and has a carbon footprint of <1.5kWh / kg.

[0042] III. Full-process monitoring and control system This invention constructs an intelligent monitoring network covering the entire production process, ensuring the stability of process technology and the consistency of product quality.

[0043] Monitoring module: Integrates multi-dimensional detection modules such as temperature and humidity, pH value, terahertz (THz), near infrared (NIR), far infrared (FIR), turbidity, and thermal imaging to monitor key quality indicators of Artemisia argyi in real time, including fingerprint spectrum / pattern, Artemisia argyi flavonoids, polysaccharides, volatile oil content, particle size distribution, and temperature uniformity.

[0044] Transmission protocol: Based on industrial communication protocols, monitoring data is transmitted to the cloud platform in real time, supporting remote monitoring and data traceability.

[0045] Closed-loop control: The manufacturing process also includes a process simulation system based on heat and mass transfer and fluid dynamics models to simulate and optimize the production process. This system predicts and dynamically optimizes the rinsing water flow rate, centrifugation time, and drying temperature curves based on the initial moisture and impurity content of the raw materials, minimizing the loss of active ingredients while ensuring cleanliness. Combined with high-speed wireless IoT, dynamic adjustment of process parameters is achieved, resulting in a batch-to-batch consistency CV value of <5%, solving the problem of large quality fluctuations in traditional processes.

[0046] IV. Compliance and Scalability Compliance Standards: The moxa wool products comply with the national standard "Moxa Wool for Moxibustion" (GB / T40976-2021), the cleanliness meets the hygiene standards for medical device consumables (total bacterial count <200 CFU / g), and meet the NMPA standards for the preservation of the properties of famous medicines and prescriptions and the EU MDR compliance requirements.

[0047] Scalability: Adopting an Industry 5.0 architecture intelligent production line, it supports large-scale mass production, reducing production costs by 160-280% compared to traditional processes, reducing dust emissions during production by 96%, and achieving zero wastewater discharge through pure water recycling, thus balancing economic benefits and environmental protection requirements.

[0048] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. Effectively resolved industry technical challenges: By synergistically combining "non-immersion microfluidic rinsing" and "vacuum-microwave-heat pump coupled drying," controlled liquid cleaning was successfully introduced for the first time in the processing of Artemisia argyi. Utilizing the shearing and scouring effects of gas-liquid two-phase fluids, non-immersion deep cleaning was achieved, significantly reducing the loss of water-soluble components. Through "heat pump-microwave vacuum coupled drying," moisture was rapidly removed and sterilized at low temperatures, effectively protecting heat-sensitive components. The synergy of these two methods achieved deep cleaning (total bacterial count <200 CFU / g, impurity removal rate ≥98%) while efficiently retaining active ingredients (volatile oil retention rate >90%, polysaccharide retention rate >95%), achieving unexpected comprehensive technical results.

[0049] 2. A significant leap forward and standardization in product quality has been achieved: A fully closed-loop process and digital closed-loop control based on Process Analysis Technology (PAT) link process parameters with product quality attributes (such as NIR spectrum, turbidity, and temperature field) in real time, enabling digital closed-loop control. This shifts moxa wool production from experience-based to data-driven, ensuring the sustainable stability of the process and maintaining batch-to-batch CV values ​​of key product quality attributes below 5%. The moxa wool products comply with the national standard for moxa wool for moxibustion (GB / T40976-2021), meet the cleanliness standards for medical device consumables, and comply with the NMPA's standards for the preservation of medicinal properties in decoctions and EU MDR compliance requirements. This represents a successful qualitative leap for moxa wool from a "primary agricultural product" to a "standardized high-end medical material."

[0050] 3. It provides a complete, quantifiable, and replicable industrialization path: the process steps are clear, the parameter ranges are well-defined, and the core equipment involved (air jet mills, ultrasonic atomizers, microwave vacuum dryers, heat pump units, etc.) are all mature industrial equipment. Through the integration of PAT technology, the Industry 5.0 architecture supports mass production, reducing production costs by 160-280% compared to traditional processes. Simultaneously, the carbon footprint is <1.5kWh / kg, complying with ISO50001 energy management standards, balancing resource efficiency, economic benefits, and green environmental requirements, and promoting the industry's transformation towards high-value, digital, standardized, and sustainable development.

[0051] 4. Simultaneous optimization of multiple conflicting objectives: Experiments have shown that the method of this invention can simultaneously achieve the following in the same batch of products: high cleanliness (total bacterial count <200 CFU / g, impurity removal rate ≥98%), high activity retention (flavor-preserving substances >90%, polysaccharides >95%), and high batch consistency (CV <5%). This is a comprehensive effect that cannot be achieved by traditional dry methods or simple wet methods. Adhering to the TCM principle of "preserving the essence and innovating," the pharmacological effects of moxibustion are not diminished after processing the moxa wool.

[0052] In summary, compared with the closest existing technology (traditional dry method), the beneficial effects of this invention are outstanding and verifiable: for the first time, controlled liquid cleaning has been successfully introduced into the processing of moxa wool, breaking the dry technology paradigm that has lasted for more than two thousand years and opening up a brand-new processing technology path for "wet cleaning" of moxa wool. Attached Figure Description

[0053] Figure 1 This is a flowchart of the overall process for preparing the present invention; Figure 2 This is a detailed flow chart of the closed-loop airflow cleaning and blade-stalk separation process of the present invention; Figure 3 This is a schematic diagram of the dynamic gas-liquid two-phase microfluidic rinsing and dehydration process of the present invention; Figure 4 This is a flowchart illustrating the collaborative process of vacuum-microwave-heat pump coupled drying and sterilization in this invention. Detailed Implementation

[0054] The present invention will now be further described in conjunction with the accompanying drawings and specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments.

[0055] Example 1: Preparation of Low-Temperature Wet Process Cleaned Artemisia Floss Raw materials: Artemisia argyi leaves harvested from Nanyang during the Dragon Boat Festival (meeting the GAP standards of the Good Agricultural Practices for Chinese Medicinal Herbs), which are manually sorted to remove obvious foreign matter.

[0056] S1: Closed-loop airflow purification and leaf-stem separation: Artemisia leaves are transported to a negative pressure clean chamber via pharmaceutical-grade stainless steel closed pipes (maintaining a chamber pressure of 30Pa). Wet clean air at 55℃, treated with a high-efficiency filter, blows over the raw material at a flow rate of 2m / s. Utilizing the synergistic effect of airflow and a vibrating screen (frequency 50Hz), the separation of Artemisia leaves and stems, as well as the removal of surface dust, is achieved, with a separation efficiency >95%.

[0057] S2: Low-Temperature Airflow Milling and Sieving: The obtained mugwort leaves are fed into a fluidized bed airflow mill (QLM-100K type). Nitrogen gas at 5℃ is used as the pulverizing medium, and the airflow velocity is set to 250m / s to tear and pulverize the mugwort leaves. The pulverized product is then sorted by an online vibrating screen (150 mesh) to obtain a primary product of mugwort floss with a particle size D90 of 150 mesh. Throughout this process, the material temperature never exceeds 45℃.

[0058] S3: Oxygen-enriched natural aging: The raw moxa floss is evenly spread on the breathable shelves of the controlled aging chamber, with the pile thickness controlled at 10kg / m². 3 Continuously introduce oxygen-enriched air (oxygen concentration 23%, temperature 25℃, relative humidity 65%) that has been treated with temperature and humidity control. Turn the container over once a month, for a total aging period of 360 days.

[0059] S4: Microfluidic rinsing and dehydration: After aging, the moxa wool is fed through a sealed pipeline as shown in the attached... Figure 2 The microfluidic rinsing device shown is used. Pure water is atomized by an ultrasonic atomizer into fine droplets with a particle size of approximately 40 μm (Dv50). These droplets are mixed with compressed air at a gas-liquid volume ratio of 2000:1, forming a two-phase flow. This flow is then sprayed upwards from an array of microchannel nozzles at the bottom of the device, causing the moxa wool to be in a fluidized and tumbling state within the chamber for a continuous non-immersion rinsing process for 5 minutes. The turbidity of the drained water is monitored in real time using an online turbidity sensor. Rinsing is stopped when the turbidity stabilizes below 3 NTU. The material is then fed into a low-speed centrifuge and centrifuged at 1200 rpm for 5 minutes to remove water.

[0060] S5: Coupled Drying Sterilization: After dehydration, the wet moxa wool (moisture content 40%-60% by weight) is transferred to the attached... Figure 3 The vacuum-microwave-heat pump coupled drying equipment shown is configured with a vacuum level of 70 kPa and a microwave power density of 2 W / g (based on the weight of the wet material). The evaporator coil of the heat pump system is placed inside the drying chamber, directly absorbing the latent heat of water vapor from the material (evaporation temperature 5°C). Continuous monitoring with an external thermal imager ensures the material surface temperature is uniformly maintained within the range of 55 ± 2°C. Drying continues until the material moisture content is below 8%, with the entire process taking approximately 40 minutes.

[0061] S6: Aseptic packaging: After drying, the moxa wool is immediately sealed in a Class 10,000 wet cleanroom environment with nitrogen filling (oxygen residue in the packaging ≤0.5%) and an information label is affixed.

[0062] Example 2: Optimized preparation by directional fermentation Based on Example 1, only step S3 was changed to directional fermentation; the remaining steps and parameters were the same as in Example 1. Specifically, Lactobacillus plantarum fermentation broth was evenly sprayed onto the initial Artemisia floss product obtained in S2, with an inoculum size of 1×10⁻⁶. 6 CFU / g Artemisia floss. The inoculated material was placed in a fermentation chamber, with the temperature controlled at 32℃ and relative humidity at 65%, and fermented for 12 days. During fermentation, the pH was monitored using an online pH sensor, and the final pH value was 4.6.

[0063] Experiment Example 1: Comparative Experiment and Effect Verification To objectively evaluate the technological progress and inventiveness of this invention, a parallel comparative experiment was conducted between the method of this invention and three representative existing or experimental processes.

[0064] - Comparative Example 1 (Traditional Dry Method): Following the traditional process described in the national standard for moxa wool (GB / T40976-2021): natural sun drying → natural aging for 12 months → hand pounding in a stone mortar → sifting out branches and stems → repeated pounding and sifting → packaging of finished moxa wool. (Core defects: open operation, poor hygiene; reliance on experience, large quality fluctuations).

[0065] - Comparative Example 2 (Industrial Dry Process): Using the currently common mechanized dry process: aged mugwort leaves → 60℃ hot air circulation drying → hammer mill or mechanical crusher pulverization → cyclone separator screening → obtaining finished mugwort floss for packaging. (Core defects: high-temperature drying and pulverization lead to the loss of heat-sensitive components; no deep cleaning process).

[0066] - Comparative Example 3 (Simplified Wet Method): Simulating the wet method abandoned after early attempts in the industry: The crushed moxa wool is completely immersed in a large amount of room temperature pure water, mechanically stirred and washed for 10 minutes → the moxa wool is filtered out with a cloth bag → centrifuged (3000rpm) for 5 minutes to dehydrate → dried with hot air at 80℃ until the moisture content is <10%. (Core defect: soaking leads to serious loss of water-soluble and some fat-soluble components).

[0067] Using the same batch of mugwort leaves from the same origin, mugwort floss samples were prepared using the five processes mentioned above. The samples were then tested by a third-party testing institution with CMA accreditation according to the following standard methods. The results are shown in Table 1.

[0068] Table 1. Comparison of key performance indicators of different moxa wool preparation processes Note: - A total bacterial count result of "<10" indicates that the count is below the method detection limit; - The retention rates of volatile oils and polysaccharides are calculated based on the initial content of the raw fresh leaves as 100%.

[0069] Traditional processes rely on manual experience, resulting in significant batch-to-batch variations that cannot be statistically analyzed and stabilized.

[0070] Results Analysis and Creative Argumentation: Cleanliness and hygiene standards: The total bacterial count of the products in the two embodiments of this invention is extremely low (<10 CFU / g), significantly better than all comparative examples, and easily meets the general requirements of <200 CFU / g for microbial limits and other related requirements for medical device consumables. In contrast, the microbial contamination level of Comparative Example 1 is as high as 10 CFU / g. 5 The scale of the incident fully exposed the hygiene risks associated with traditional open-style processing.

[0071] Retention of Active Ingredients: The retention rates of volatile oils and polysaccharides in this embodiment of the invention far exceed those of the three comparative examples. Most convincingly, compared to Comparative Example 3 (simple wet method), which also aims to solve the cleanliness problem, Example 1 of the present invention achieves an order-of-magnitude improvement in cleanliness (total bacterial count reduced from 450 CFU / g to <10 CFU / g) while simultaneously achieving a leap in volatile oil retention rate from 22.5% to 92.1%. This completely overturns the industry's technical prejudice that 'cleaning and preservation are mutually exclusive,' proving the extraordinary effectiveness of the synergistic path of 'quasi-dry' cleaning and 'multi-physics field' drying constructed in this invention. It is not a simple "water-based cleaning," but rather a precise physical cleaning that achieves "cleanliness without wetting" through precise control of droplet morphology, gas-liquid ratio, and fluid dynamics.

[0072] To determine the appropriate range for the gas-liquid volume ratio and droplet size, the applicant conducted numerous screening experiments. For example, when the gas-liquid ratio was below 500:1, significant wetting of the mugwort fibers was observed, with slight agglomeration of some fibers, leading to an increase in polysaccharide loss exceeding 15%, and a decreasing trend in volatile oil retention after drying. When the gas-liquid ratio was above 5000:1, the rate of turbidity reduction in the rinsing water slowed, and the impurity removal rate dropped below 90%, indicating a decrease in cleaning efficiency. When the atomized droplet Dv50 continuously increased to over 50 μm, its kinetic energy attenuation intensified in the high-speed airflow, easily leading to fiber entanglement and caking, affecting the uniformity of the scouring force on the fiber surface, and directly impacting the uniformity of subsequent drying.

[0073] Overall Performance and Synergistic Effects: Comparative Example 1 (decent activity retention, but extremely unhygienic) and Comparative Example 3 (decent cleanliness, but almost complete loss of activity) represent two failed technical approaches. Comparative Example 2 attempted to improve upon this, but still fell short in activity retention. Only this invention, through the systematic synergy of "microfluidic rinsing" and "coupled drying" in a low-temperature, closed environment, successfully elevated multiple traditionally mutually restrictive indicators, such as high cleanliness, high activity retention, low moisture content, high infrared performance, and high batch consistency, to an excellent level simultaneously. This synergistic effect of "1+1>2" generated by a specific process combination is the core inventiveness of this invention, and cannot be expected by the simple superposition of existing technologies.

[0074] This invention not only achieves progress in each individual indicator, but also reverses the inherent trade-off between traditional processes. As shown in Table 1, in conventional understanding, cleanliness (characterized by a logarithmic decrease in total bacterial count) and active ingredient retention rate (characterized by volatile oil retention rate) are negatively correlated (refer to Comparative Example 3, where a moderate increase in cleanliness leads to a catastrophic decrease in activity). However, this invention, through a specific process combination, achieves a synergistic positive improvement in both for the first time. Calculations show that Example 1 of this invention, compared to Comparative Example 2 (industrial dry process), achieves a significant improvement in cleanliness (from a total bacterial count of 10...).3 While the concentration was reduced to <10, the volatile oil retention rate significantly increased from 45.7% to 92.1%. This effect of breaking the inherent negative correlation and achieving a 'double increase' in the core contradictory indicators is a technological achievement that those skilled in the art could not have predicted based on existing technology.

[0075] Experiment Example 2: Destructive Control Experiment To confirm the indispensable synergistic effect of the "vacuum-microwave-heat pump coupled drying" process in the process system of this invention and to clarify its non-obvious contribution, the following destructive control experiment was designed and carried out.

[0076] -1. Experimental Design Experimental group (method of the present invention): The process flow of Example 1 of the present invention is completely followed, that is, S1 to S6 are carried out in sequence, wherein S5 adopts "vacuum-microwave-heat pump coupled drying" (parameters are the same as in Example 1: vacuum degree -70kPa, microwave power density 2W / g, heat pump evaporation temperature 5℃, and material temperature controlled at 55±2℃).

[0077] Control group (destructive control): Using the exact same raw materials and processing steps (S1 to S4 and S6) as the experimental group, identical wet moxa wool samples (moisture content approximately 55%) were obtained. Only in step S5 was the drying method replaced with "55℃ conventional hot air drying". Specifically, the wet moxa wool was spread flat on a tray, placed in a forced convection hot air drying oven, and the air temperature inside the oven was set to 55℃ (±2℃), with a wind speed of 1.0 m / s, and drying continued until the moisture content of the material dropped to the same level as the experimental group (<8%).

[0078] -2. Comparison of detection methods and results The following parallel tests were performed on the two groups of dried mugwort floss products: -3. Experimental Conclusions and Demonstration of Invention Points 1. This control experiment reversely verifies the irreplaceable nature of the "vacuum-microwave-heat pump coupled drying" step in this invention and the deep coupling of process synergy.

[0079] Experiments show that, under the exact same low-temperature target (55°C), if only the "coupled drying" step is replaced with conventional hot air drying, even if the innovative "microfluidic rinsing" step is fully retained, the final product exhibits systematic and significant degradation in all key dimensions, including drying efficiency, retention of active ingredients, integrity of fiber microstructure, product uniformity, and sterilization effect. This proves that the "coupled drying" step of this invention is not a universal unit that can exist independently or be arbitrarily replaced, but rather a key synergistic unit that is deeply bound to the preceding "microfluidic rinsing" step in terms of physical mechanism and process objectives, and whose functions are complementary. The combination of the two constitutes an inseparable organic whole.

[0080] 2. This control experiment reveals that "rapid low-temperature dehydration" is the technical hub linking the two core objectives of "cleaning" and "preservation".

[0081] Experimental data reveals that coupled drying for rapid dehydration (40 minutes vs. 4 hours) is key to achieving the overall effect. Its significance lies in: Time-based preservation: It greatly shortens the time that heat-sensitive components (volatile oils) are in a hot environment, reducing heat damage at the source.

[0082] Structural preservation: Vacuum and rapid dehydration prevent the fibers from plasticizing and deforming under prolonged humid and hot conditions, and from causing the leaching substances to adhere, thus fully preserving the ideal porous and loose structure formed after microfluidic rinsing. This structure is the physical basis for ensuring the combustion performance of moxa wool and the release of its effective components.

[0083] Sterilization efficiency: The synergy of microwave and vacuum fields provides efficient, low-temperature sterilization conditions that hot air drying cannot achieve while achieving rapid drying.

[0084] 3. This comparative experiment demonstrates, from the opposite perspective, the non-obviousness and high degree of inventiveness of the technical solution of this invention.

[0085] Faced with the contradiction between "deep cleaning at low temperatures and retention of high activity," conventional approaches by those skilled in the art either optimize dry methods (Comparative Example 2) or risk using simplified wet methods (Comparative Example 3), both resulting in a "lose-lose" situation. This invention breaks with convention, creatively constructing a novel technical path of "quasi-dry physical cleaning + multi-physical field synergistic low-temperature rapid dehydration." Destructive experiments demonstrate that the success of this path depends on the precise and synergistic cooperation between the two innovative steps. Any attempt to use only one step, or to simply combine it with conventional techniques (such as the control group), cannot reproduce the comprehensive superior effects of this invention. Therefore, the overall structure of this technical solution and its resulting "synergistic improvement of contradictory indicators" are not obvious to those skilled in the art.

[0086] In conclusion, this experiment powerfully demonstrates from the opposite perspective that "non-immersion microfluidic rinsing" and "vacuum-microwave-heat pump coupled drying" constitute a technical closed loop with strict internal logic and functional dependence in this invention. Their synergistic effect is not a simple additive result, but rather an effective and synergistic solution to the technical contradiction of balancing "cleanliness" and "activity retention rate" in traditional moxa wool processing by addressing the common bottleneck of "rapid low-temperature dehydration." This constitutes a solid experimental basis for the inventiveness of this invention.

[0087] Example 3: Systematic Production Based on the S1-S6 technical steps of this invention, a fully enclosed, continuous intelligent production line is constructed. Adopting an Industry 5.0 architecture, the intelligent production line features fully enclosed pipeline transmission, controlling the overall temperature to ≤60℃, pressure difference to 10-50Pa, and airflow velocity to 1-2m / s. It integrates a 5G sensor network and online process analysis technology (PAT). The production environment meets GMP Class 10,000 wet cleanliness requirements, and the equipment is made of pharmaceutical-grade stainless steel, equipped with an ultraviolet-assisted sterilization system.

[0088] Key points for process optimization: The fermentation process uses a single Lactobacillus plantarum inoculation, with controlled temperature of 30℃, humidity of 65%, pH of 4.7, and a fermentation cycle of 14 days. The metabolic process is controlled in a closed loop using 5G IoT.

[0089] In the pulverizing process, the airflow velocity is adjusted to 9m / s, the particle size is controlled at D90=100 mesh, and the online terahertz (THz) spectrometer is linked with the HS-GC-IMS fingerprint spectrum to ensure that the product similarity is ≥0.92.

[0090] The rinsing process adopts a gas-liquid two-phase microfluidic rinsing and low-speed centrifugal automated production line, with pure water recycling to achieve zero wastewater discharge; the drying process uses a 5G cloud platform to remotely adjust parameters such as vacuum-microwave-heat pump coupled drying and sterilization power, temperature, and dehydration to maintain a temperature uniformity of 99.4%.

[0091] Each process parameter is linked and adjusted in a closed loop through a central control system (integrating PAT tools such as near-infrared online monitoring, machine vision, and thermal imaging). After 10 batches of continuous operation, statistics show that the batch-to-batch CV value of key quality attributes (volatile oil content, moisture content, particle size) is consistently below 4.5%, production efficiency is increased by 300% compared to intermittent production, and overall energy consumption is reduced by 40%. The product fully complies with the preset medical device consumable standards; flavor retention is 90.8%, polysaccharide retention is 95.1%, impurity removal rate is ≥98%, clean moxa wool products comply with the national standard "Moxa Wool for Moxibustion" (GB / T40976-2021), cleanliness meets the medical device consumable standards (total bacterial count <200 CFU / g), and the product's properties and meridian tropism comply with the NMPA's standards for the preservation of properties of famous medicines and prescriptions and EU MDR compliance requirements.

[0092] Industrial applicability: The preparation method provided by this invention is based on well-defined process parameters and mature industrial equipment units (such as pneumatic conveying systems, air jet mills, atomizing drying towers, microwave vacuum dryers, heat pump units, etc.), and can be achieved through integration with standard pipelines and control systems. The method is stable, reliable, and highly repeatable, fully capable of large-scale production. The prepared moxa wool product has high purity, minimal loss of active ingredients, and stable and uniform quality, and can be directly used as a raw material or finished product for high-end medical moxibustion consumables. This meets the urgent demand of the modern medical industry for standardized, high-quality TCM medical device materials, and has broad market prospects and industrialization value.

[0093] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy, characterized in that, This includes the following steps, connected sequentially via a closed conduit: S1: Closed-loop airflow purification and leaf-stem separation: In a closed negative pressure system, clean airflow with a temperature ≤60℃ and a flow rate of 1-3m / s is used to process the mugwort raw material to achieve the separation of mugwort leaves and stems and the removal of surface dust. S2: Low-temperature airflow tearing, crushing and sieving: The mugwort leaves obtained in S1 are placed in a low-temperature airflow crushing device and crushed at ≤60℃. The shearing force generated by the high-speed airflow is used to crush the material by collision, and the initial product of mugwort floss with the target particle size is obtained by online sieving. S3: Controlled aging or fermentation: The initial product of mugwort obtained from S2 is subjected to oxygen-enriched natural aging or directed fermentation by inoculating specific strains of microorganisms. S4: Dynamic gas-liquid two-phase microfluidic rinsing and dehydration: The moxa wool treated in step S3 is sent into a microfluidic rinsing device, where it undergoes non-immersion dynamic rinsing in a gas-liquid two-phase flow formed by high-speed airflow and atomized droplets, followed by low-speed centrifugal dehydration. S5: Vacuum-microwave-heat pump coupled drying and sterilization: Place the wet moxa wool treated in step S4 into a coupled drying device. Under vacuum, microwave energy and heat pump circulation are applied together to perform low-temperature drying. The drying temperature is ≤60℃, and sterilization is completed simultaneously. S6: Aseptic packaging: The moxa wool product obtained in step S5 is aseptically packaged in a GMP clean environment.

2. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 1, characterized in that, The low-temperature airflow pulverizing device in step S2 is an airflow mill. The pulverizing medium is an inert gas or dry air with a temperature ≤10℃ and an airflow velocity of 150-350m / s. With the synergistic effect of negative pressure airflow field, mechanical vibration field and electrostatic separation field, the airflow cleaning, preliminary separation and impurity separation of the mugwort leaves are achieved. The particle size D90 of the pulverized mugwort floss is 80-120 mesh. An intelligent vision system based on deep learning image recognition algorithms is integrated. This system uses a high-definition industrial camera to acquire images of mugwort leaves in real time. It can accurately identify and distinguish the stems, fresh mugwort, and aged mugwort with an accuracy rate of ≥98%. The system uses an airflow guide plate to guide the separated stems, fresh leaves, and aged mugwort to different closed transmission pipelines to achieve initial screening and classification of raw materials and subsequent diversion processing with a sorting accuracy rate of ≥98%. The screening process uses a low-frequency vibrating screen and is equipped with a negative pressure dust collection device to prevent dust pollution. The freeze-drying and pulverizing process is adopted. After low-temperature vacuum dehydration, the product is pre-frozen at a temperature below -15-30℃ for 12-24 hours, and then pulverized by low-temperature airflow tearing.

3. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 1, characterized in that, In step S4, the non-immersion gas-liquid two-phase microfluidic rinsing device includes a mixing chamber, a microchannel unit, and a centrifugal unit. In the gas-liquid two-phase mixed fluid, the gas phase is sterile air or nitrogen, and the liquid phase is pure water or deionized water. A high-speed airflow carries micro-droplets to form a gas-liquid two-phase flow. The gas-liquid volume ratio in the gas-liquid two-phase flow is 1000:1 to 5000:1, and the droplet size Dv50 ≤ 50 μm, which rinses and cleans the surface of the moxa wool. This process achieves deep cleaning while ensuring that the cleaning liquid does not penetrate the internal structure of the moxa wool fibers. An online turbidity sensor is integrated, and the frequency of cleaning medium replacement and / or cleaning time are automatically controlled based on turbidity feedback. The turbidity of the rinsing water is monitored in real time. When the turbidity is ≥ 5 NTU, the liquid phase flow rate is automatically increased or the water replacement program is started until the turbidity is < 5 NTU, and the impurity removal rate is ≥ 98%.

4. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 3, characterized in that, In step S4, the low-speed centrifugation dehydration speed is 800-1500 rpm, and the time is 3-8 minutes. After dehydration, the moisture content of the mugwort floss is controlled at 40%-60%.

5. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 1, characterized in that, The coupled drying equipment in step S5 integrates a microwave generator, a vacuum chamber, and a heat pump system. The microwave power density is controlled at 0.5-5 W / g, the vacuum degree is maintained at -60 kPa to -80 kPa, far-infrared drying with a wavelength of 8-14 μm is used, and the drying temperature is controlled at 50-60℃. The evaporator of the heat pump is placed in the vacuum chamber to absorb the latent heat of material evaporation, and the condenser releases heat to compensate for heat loss in the chamber. The temperature distribution on the surface of the material is monitored by a temperature monitoring device, and the microwave power output is dynamically adjusted to ensure that the temperature difference between any two points does not exceed 3℃ to prevent local overheating.

6. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 1, characterized in that, In step S5, the microwave power density of the coupled drying process is 0.5-5 W / g, and the vacuum degree is -60 kPa to -80 kPa; the evaporator of the heat pump is placed in the drying chamber to absorb the latent heat of water vapor.

7. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 1, characterized in that, The directional fermentation in step S3 involves inoculating Lactobacillus plantarum for solid-state fermentation. The fermentation conditions are: temperature 30-35℃, humidity 60-70%, pH value 4.5-5.0, and fermentation cycle 7-21 days. The fermentation process is monitored by an online pH sensor.

8. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 1, characterized in that, The method also includes an online monitoring and closed-loop control system based on process analysis technology and a central controller. This system integrates an online spectrometer, a turbidity sensor, a temperature and humidity sensor, and a thermal imager to monitor key quality attributes of the mugwort floss in real time, such as fingerprint spectrum / pattern, flavor-preserving substance content, and uniformity of the mugwort floss fibers. The data is then uploaded to the central controller via an industrial communication protocol to dynamically adjust the process parameters of steps S2, S4, and S5 to ensure batch consistency of the product.

9. The method for preparing clean moxa floss using a low-temperature wet process based on multi-physics field synergy according to claim 1, characterized in that, The manufacturing process also includes a process simulation system based on a heat and mass transfer and fluid dynamics model, which is used to predict and dynamically optimize the rinsing water flow rate, centrifugation time and drying temperature curve according to the initial moisture and impurity content of the raw materials, so as to minimize the loss of active ingredients while ensuring cleanliness.

10. A medical moxa wool product prepared according to any one of claims 1-9, characterized in that, Its total bacterial count is <200 CFU / g, volatile oil retention rate is ≥90%, polysaccharide retention rate is ≥95%, far-infrared emissivity (8-14μm) is ≥0.92, and water contact angle of the moxa fiber surface is ≥110°; this product is suitable for preparing moxibustion consumables that meet medical device standards.

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