Channel tropism medicine acupoint application device with body surface positioning marks and personalized loading method

Abstract

According to the personalized acupoint application device, the traditional Chinese medicine channel tropism dialectical logic is solidified into structural characteristics through the forced space corresponding relation between a medicine slow release layer and a body surface positioning mark layer. The geometric center of the marking layer coincides with the coordinates of the acupuncture points corresponding to the channel tropism medicine, and the positioning precision of + / -1.5 mm is achieved. The medicines are loaded according to 14 meridians and collaterals, and the released CV value lt is clinically verified; the permeation flux of the channel tropism medicine in the corresponding acupuncture point is 3.2 times that of a non-channel tropism acupuncture point. The technical problems that an existing application device is dialectically separated from a product, positioning repeatability is poor, and release is unstable are solved, and standard external treatment application is achieved for classical pathogenesis such as stomach disharmony and lying restlessness.

Description

Technical Field

[0001] This invention belongs to the interdisciplinary field of TCM external treatment medical devices and TCM preparation technology, and relates to an acupoint application device that realizes the solidification of TCM syndrome differentiation logic through structural features, as well as a personalized preparation method based on pulse-media synergy. Background Technology

[0002] Existing acupoint application techniques have three fundamental technical flaws:

[0003] First, there is a disconnect between dialectical thinking and product form. Commercially available Sanfu and Sanjiu plasters adopt a "one-size-fits-all" model, failing to translate the core TCM diagnostic and treatment philosophy of "syndrome differentiation and treatment" into the structural characteristics of the product. For example, the cervical spondylosis plaster disclosed in CN101618200B only targets a single symptom and cannot achieve personalized formulation based on the principle of "treating different diseases with the same method and treating the same disease with different methods." This disconnect between thinking and product leads to the loss of the dialectical advantage of TCM external treatment devices.

[0004] Second, acupoint location relies on experience and lacks structural constraints. Existing products do not have a positioning structure on the device itself that forcibly corresponds to the drug's target point. Clinical research shows (Journal of Traditional Chinese Medicine External Treatment, Vol. 31, 2022) that different operators have a 15-30mm deviation in applying the drug to the same acupoint, causing the drug center to deviate from the meridian pathway and reducing transdermal penetration efficiency by more than 60%.

[0005] Third, the release stability and meridian specificity are not synergistic. Traditional plasters have a drug release coefficient of variation (CV) >40%, and do not consider the matching between the drug's meridian tropism and the skin microenvironment at acupoints. It is well known to those skilled in the art that the porosity of the stratum corneum at acupoints of the Stomach Meridian of Foot-Yangming (12.3±1.8%) is significantly higher than that at acupoints of the Kidney Meridian of Foot-Shaoyin (7.2±1.5%), but the existing technology has not adjusted the drug loading scheme accordingly.

[0006] This invention aims to provide a technical solution that solidifies the diagnostic logic of traditional Chinese medicine into structural features and achieves a forced correspondence between location, drug, and symptom. Summary of the Invention

[0007] (I) Purpose of the Invention The primary purpose of this invention is to provide an acupoint patch device that, through the spatial forced correspondence between the drug sustained-release layer and the body surface positioning marker layer, transforms the syndrome differentiation and selection of "meridian-specific drugs-specific acupoints" into an indispensable structural feature, enabling non-professionals to achieve accurate syndrome differentiation and positioning.

[0008] The secondary objective of this invention is to provide a personalized preparation method that synergizes pulse pattern and medium, breaking through the technical prejudice that "medium is only a solvent", and making the medium an active component that regulates the meridian targeting of drugs.

[0009] (2) Technical Solution The breakthrough point of the technical concept of this invention lies in: transforming the TCM syndrome differentiation thinking into the structural constraint conditions of the device.

[0010] 1. Structurally forced correspondence feature The core of the device described in claim 1 is that "the geometric center of the mark coincides with the coordinate of the anatomical projection of the acupoint corresponding to the drug carried by the sustained-release layer on the body surface". This "coincidence" is not a temporary alignment during use, but a preset and unchangeable structural parameter during manufacturing. For example, when the sustained-release layer carries drugs of the Stomach Meridian of Foot-Yangming, the center of the mark layer pattern has been physically locked at the coordinate of Zusanli acupoint during the three-dimensional assembly process, and the user cannot change this corresponding relationship through routine operations. This structural constraint ensures the inescapability of the syndrome differentiation logic.

[0011] 2. Construction of the drug system classified by meridians This invention establishes a drug classification library for the fourteen meridians. Standardized extracts are obtained from each type of medicinal material by supercritical CO2 extraction. The classification is based on the meridian-entry theory in "Leigong's Compendium of Pharmacological Properties" and is verified by the percutaneous-meridian-viscera conduction experiment. The key verification experiments are as follows:

[0012] Experimental design: Take the skin on the back of a pig's ear. Drill holes in the area of the Stomach Meridian of Foot-Yangming (simulating Zusanli) and the non-meridian area respectively, and install Franz diffusion cells. The supply chambers are respectively the extract of Pinellia ternata (a drug of the Stomach Meridian) and the extract of Schisandra chinensis (a non-meridian drug), and the receiving chamber is pH7.4 PBS buffer solution. The temperature is 32±0.5°C, and the sampling time points are 0.5, 1, 2, 4, 8, and 12 hours.

[0013] Experimental results: The steady-state permeation flux of Pinellia ternata in the Stomach Meridian area is 15.8±2.3 μg / cm² / h, and in the non-meridian area is 4.9±1.1 μg / cm² / h, with a ratio of 3.2±0.5 times (p<0.01, n = 6). There is no significant difference in the permeation flux of Schisandra chinensis in the two areas (p>m0.05). This result confirms that meridian-entry drugs have meridian-specific permeation characteristics, which constitutes the experimental basis of this invention.

[0014] 3. Pulse condition - medium synergy mechanism This invention discovers for the first time that the selection of the medium can regulate the targeting of drugs in specific meridians. The experimental data shows that:

[0015] For the drugs of the Stomach Meridian of Foot-Yangming prepared with ginger juice, the penetration rate at Zusanli acupoint is 47% higher than that with white wine as the medium (p<0.05);

[0016] For the drugs of the Liver Meridian of Foot-Jueyin prepared with vinegar, the residence time at Taichong acupoint is extended by 2.8 hours (p<0.01).

[0017] This mechanism transforms the medium from an "inert solvent" to an "active guiding component", which constitutes a substantial breakthrough in the technical prejudice that "the medium is only an auxiliary material".

[0018] (III) Beneficial Effects Compared with the prior art, the present invention achieves the following non-obvious technical effects:

[0019] 1. The solidified diagnostic logic structure transforms the physician-experience-dependent diagnostic process into a deterministic action that can be performed autonomously by the patient through a pre-defined "drug-acupoint" correspondence. Clinical trials (n=40, covering ages 20-65, including 20 patients without a TCM background) showed that the diagnostic accuracy rate of non-professionals using the device reached 82%, with an average deviation of 1.4±0.6mm between the drug center and the acupoint center, significantly better than the 31% accuracy rate and 12.8±3.2mm deviation of traditional experience-based application (p<0.001).

[0020] 2. Breakthrough in positioning accuracy and repeatability: A blinded test was conducted on 20 operators (including 10 untrained patients). The positioning deviation CV value in the invention group was 14.3%, while the CV value in the control group was 45.7% (p<0.001). The operation time was reduced from 52 seconds in the control group to 18 seconds in the invention group.

[0021] 3. Improved release stability: HPLC analysis of residual drug levels in the patch showed that the CV value of drug release in this invention was <15%, while the CV value of commercially available products was >42%. The bioavailability (AUC) of the meridian-targeting drugs at corresponding acupoints was 2.1-3.2 times that at non-corresponding acupoints.

[0022] 4. Solving the Problem of Applying Classical Theories: Addressing the pathogenesis of "restless sleep due to stomach disharmony," this invention utilizes the Foot Yangming Stomach Meridian device (containing Pinellia ternata and Citrus aurantium loaded at Zusanli and Zhongwan acupoints) to shorten the sleep latency from a baseline of 45.3±12.1 minutes to 18.7±8.4 minutes (n=30, p<0.01), and reduce the Pittsburgh Sleep Quality Index (PSQI) from 13.2±2.8 to 7.5±2.1. Simultaneously, an 83% relief rate for morning bitter taste and a 76% relief rate for abdominal distension were observed, confirming the efficacy of treating different diseases with the same method.

[0023] 5. Unexpected Systemic Regulation: After 3 months of treatment with a Foot Jueyin Liver Meridian device (Bupleurum + Vinegar-processed Turtle Shell loaded on Taichong and Qimen acupoints) in 30 patients with fatty liver, ALT decreased from 78.3±15.2 U / L to 42.1±8.7 U / L (p<0.01), liver ultrasound echogenicity improved by 63%, SDS depression score decreased from 56.3±8.4 to 41.2±6.8 (p<0.01), and LDL cholesterol decreased by 22%. These results are consistent with the classic theory that "the liver governs the free flow of Qi, and when Qi is regulated, phlegm and turbidity will naturally dissipate," but current technology has not yet realized the material application of this effect.

[0024] Inventiveness argument (referring to Section 3.2.1.1 of Chapter 4 in Part II of the Examination Guidelines)

[0025] This invention is a simple superposition of a positioning marker and a sustained-release layer, or it may fall under the category of "methods for the diagnosis and treatment of diseases".

[0026] The non-obviousness of this invention is demonstrated as follows:

[0027] 1. Overcoming the Technological Bias of "Unstructured Dialectical Thinking": Existing technologies generally consider TCM diagnosis to be a "physician's thought process," which cannot be achieved through physical structures. This invention is the first to discover that the forced spatial correspondence between the meridian tropism of drugs and the anatomical coordinates of acupoints can be solidified into irreversible structural parameters in a layered assembly process. This transformation requires overcoming three major technical obstacles:

[0028] Material compatibility issues: The interfacial reaction between the marking layer ink and the slow-release layer gel causes accuracy drift. This invention solves this problem by using a PET film isolation layer.

[0029] Precision maintenance obstacle: The flexible patch may become misaligned with the drug layer during storage and transportation. This invention uses ultrasonic welding to lock the relative position.

[0030] Dialectical logic coding barrier: Mapping multiple parameters of "pulse-medium-drug" into manufacturable structural parameters requires the establishment of a process database of more than 200 sets.

[0031] 2. Unexpected Technical Effects: This invention achieves a systemic effect of "treating different diseases with the same method": the Foot Yangming Stomach Meridian device not only improves insomnia (effective rate 76.7%), but also simultaneously lowers blood triglycerides (average decrease of 0.8 mmol / L), and relieves bitter taste in the mouth (83%) and bloating (76%). This is consistent with the classic theory that "the Foot Yangming Stomach Meridian governs descending, and when it descends, the Qi of the whole body descends," but existing technologies have not realized the material application of this theory, representing an unexpected overall regulatory effect.

[0032] 3. The Non-Obviousness of the Mediator Synergistic Mechanism Although ginger, vinegar, and wine have been disclosed as solvents, this invention reveals for the first time the novel function of mediator flavor in regulating the meridian tropism and targeting of drugs. For example, vinegar (acid astringency) prolongs the residence time of Bupleurum in the liver meridian by 2.8 hours. This three-dimensional synergistic effect of "mediator-meridian-time" requires screening through more than 200 sets of experiments to discover, and cannot be predicted by those skilled in the art through conventional experiments.

[0033] 4. Circumvention of the closest prior art: Although CN101618200B discloses a cervical spondylosis plaster, its drugs are not classified according to meridian tropism, nor are mandatory corresponding positioning markers set. When faced with the technical problem of "improving the repeatability of application," those skilled in the art have no motivation to transform the TCM syndrome differentiation logic into structural constraints, because this requires interdisciplinary knowledge (TCM basic theory + precise coating process + transdermal drug delivery kinetics), and it is impossible to predict the synergistic effect (2.1-3.2 times) of "meridian-tropist drugs - specific acupoints" through limited experiments.

[0034] 5. Argument that this invention is not a treatment method: Claims 1-7 of this invention protect the physical structure of the product, and claim 9 protects the method of drug preparation; neither involves a "diagnosis" or "treatment" step. The determination of pulse type and the diagnosis are completed by the physician through independent medical action before use. The product of this invention is merely a material carrier of the diagnostic results, which falls under the exceptions stipulated in Article 25 of the Patent Law. Detailed Implementation

[0035] Example 1: Foot Yangming Stomach Meridian Insomnia Treatment Device (Model: ST36-WA) Clinical Background: Insomnia due to spleen deficiency and stomach rebellion, characterized by difficulty falling asleep, excessive dreaming, bitter taste in the mouth upon waking, weak and deep pulse at the right Guan position, pale tongue with a white and greasy coating. Diagnostic Logic Chain: Spleen and stomach deficiency → Stomach Meridian failure to descend → Disharmony between spirit and essence → Restless sleep. Technical Implementation:

[0036] Sustained-release layer: Supercritical CO2 extract of Pinellia ternata (50mg) + extract of Citrus aurantium (30mg), loading 12mg / cm², Carbomer 940 gel matrix (concentration 1.5%).

[0037] Transdermal medium: Blended with fresh ginger juice (content ≥50%), pH 5.8-6.2, to enhance the effects of warming, purging, and relieving adverse reactions;

[0038] Positioning marker: Red ring, 5mm in diameter, screen-printed on 0.03mm PET film, with the center of the ring coinciding with the anatomical coordinates of Zusanli (ST36) on the body surface, and a preset deviation of ≤1.2mm;

[0039] Adhesive layer: Acrylic pressure-sensitive adhesive, peel strength 0.7 N / cm. Clinical validation: 30 patients (aged 35-62 years) were included. The patch was applied once daily for 8 hours each time, for 4 consecutive weeks. Polysomnography showed that the sleep latency decreased from 45.3±12.1 minutes to 18.7±8.4 minutes (p<0.01), the arousal index decreased by 41%, and the gastric electrical rhythm disorder index improved by 38%. The tongue coating thickness score decreased from 3.2±0.8 to 1.5±0.6.

[0040] Comparative Example 1-1: In the same batch of patients, ordinary Pinellia ternata powder (without meridian classification) was manually applied to Zusanli acupoint. The average positioning deviation was 12.3 mm, and the effective rate was only 33%, which was significantly different from the 76.7% of the group of the present invention (p<0.01), proving the synergistic necessity of meridian classification + forced structural correspondence.

[0041] Example 2: Foot Jueyin Liver Meridian Stagnation Treatment Device (Model: LR3-QG) Clinical Background: Non-alcoholic fatty liver disease complicated with emotional depression, symptoms include hypochondriac distending pain, frequent sighing, wiry pulse, and dark red tongue. Diagnostic Logic Chain: Liver dysfunction → Stagnation of Spleen Qi → Internal generation of Phlegm → Dyslipidemia + Depression. Technical Implementation:

[0042] Sustained-release layer: Saussurea saponin extract (40mg) + vinegar-processed turtle shell ultrafine powder (20mg), loading capacity 10mg / cm², liposome structure (lecithin to cholesterol mass ratio 4:1).

[0043] Transdermal medium: diluted with aged vinegar (total acid ≥4.5g / 100ml), pH 4.2-4.5, to guide the drug to the liver;

[0044] Location marker: a cyan triangle with a side length of 5mm, corresponding to the Taichong acupoint (LR3).

[0045] Treatment course: Once daily, 6 hours each time, for 3 consecutive months. Clinical verification: In 30 patients, liver function ALT decreased from 78.3±15.2 U / L to 42.1±8.7 U / L (p<0.01), liver ultrasound echogenicity improved by 63%, SDS depression score decreased from 56.3±8.4 to 41.2±6.8 (p<0.01), and low-density lipoprotein decreased by 22%.

[0046] Comparative Examples 1-2: Intramuscular injection of Bupleurum chinense (a routine clinical treatment) resulted in a liver function improvement rate of only 29% and no significant change in mood scores, demonstrating the advantages of transdermal drug delivery through acupoint-drug synergy.

[0047] Example 3: Hand Taiyin Lung Meridian Wind-Cold Regulating Device (Model: LI4-FH) Clinical Background: Wind-Cold type common cold, symptoms include aversion to cold without sweating, nasal congestion with clear runny nose, and a floating and tight pulse. Technical Implementation:

[0048] Sustained-release layer: Perilla leaf volatile oil (25mg) + Platycodon saponins (15mg), loading 8mg / cm², porous chitosan carrier (pore size 50-200μm).

[0049] Transdermal medium: ginger juice (50% fresh ginger juice content), which promotes the penetration of volatile oils;

[0050] Location marker: Yellow dot, 4mm in diameter, corresponding to Hegu acupoint (LI4). Onset time: The drug release reaches its peak in 1.5 hours, and nasal resistance decreases from baseline 0.85Pa / (cm³·s) to 0.31Pa / (cm³·s), which is 2.3 hours earlier than oral granules.

[0051] Application areas that can be expanded based on the inventive concept by those skilled in the art

[0052] The core concept of this invention lies in the three-in-one structural forced correspondence of "meridian-tropized drug classification - specific acupoint location - synergistic effect of properties and flavor mediators". Based on this concept, those skilled in the art can extend this invention to the following positioning systems and drug combinations without creative effort:

[0053] (I) Extension of the Acupoint Location System The "meridian-associated acupoints" described in claim 1 of this invention are not limited to the seven acupoints listed in the embodiments. Those skilled in the art should understand that the acupoints include:

[0054] The twelve primary acupoints system includes: Taiyuan (LU9), Shenmen (HT7), Daling (PC7), Taibai (SP3), Taichong (LR3), Taixi (KI3), Qiuxu (GB40), Chongyang (ST42), Hegu (LI4), Yangchi (SJ4), Wangu (SI4), and Jinggu (BL64). These primary acupoints are the "entry and exit points of the spirit and qi of the twelve meridians," which highly aligns with the "spirit communicating with essence" theory of this invention. Employing the sustained-release layer structure (loading capacity 5-20 mg / cm²) described in claim 5 of this invention, the steady-state osmotic flux can reach over 90% of that in Example 1.

[0055] The Eight Meeting Points system includes: Zhongwan (CV12, Fu Meeting), Zhangmen (LR13, Zang Meeting), Tanzhong (CV17, Qi Meeting), Geshu (BL17, Blood Meeting), Yanglingquan (GB34, Tendon Meeting), Dazhu (BL11, Bone Meeting), Taiyuan (LU9, Pulse Meeting), and Juegu (GB39, Marrow Meeting). The liposome sustained-release structure of this invention (loading capacity 10-18 mg / cm²) achieves a long-lasting effect.

[0056] The Eight Extraordinary Meridians (Eight Confluent Points) system includes: Gongsun (SP4, Chong Meridian), Neiguan (PC6, Yin Wei Meridian), Zulinqi (GB41, Dai Meridian), Waiguan (SJ5, Yang Wei Meridian), Houxi (SI3, Du Meridian), Shenmai (BL62, Yang Qiao Meridian), Lieque (LU7, Ren Meridian), and Zhaohai (KI6, Yin Qiao Meridian). The porous chitosan carrier (pore size 100-300μm) of this invention can improve cross-skin barrier efficiency.

[0057] Clinically used acupoints include: Sanyinjiao (SP6, meeting point of the three Yin meridians of the foot), Tianshu (ST25, the Mu point of the large intestine), Guanyuan (CV4, the root of vital energy), Mingmen (DU4, the gate of life), Dazhui (DU14, the meeting point of all Yang meridians), and Yongquan (KI1, the Jing point of the kidney meridian). Using the positioning marker layer (3-8mm in diameter) described in claim 4 of this invention ensures accurate self-operation at home for patients.

[0058] The common characteristics of the aforementioned acupoints are: they are all located in the corresponding meridian dermal distribution areas, and the skin's microenvironment parameters such as stratum corneum porosity and transcutaneous potential exhibit specific interactions with the corresponding meridian drugs, as verified in this invention (permeability difference of more than 2.5 times). Therefore, loading the meridian-associated drugs of this invention onto the aforementioned acupoints can achieve equivalent technical effects without altering the sustained-release layer structural parameters.

[0059] (II) Extension of the combination of drugs based on properties and meridians The fourteen meridian drug categories described in claim 2 of this invention each contain 3-8 core medicinal materials, which can be combined according to the synergistic principle of "property-medium-pulse-symptom".

[0060] The following table shows preferred extension schemes that can be deduced by those skilled in the art: Pulse type Meridian Category Preferred medicinal properties (nature and flavor) Transdermal mediators (synergistic flavors) Target disease Corresponding acupoint group Floating and tight pulse Hand Taiyin Lung Meridian Perilla leaf (pungent and warm), Platycodon root (pungent and neutral) Ginger juice (50%) Common cold, nasal congestion and cough Hegu, Taiyuan, Lieque The pulse is deep and weak. Stomach Meridian of Foot Yangming Pinellia ternata (pungent and warm), Codonopsis pilosula (sweet and neutral) Baijiu (38-60%) Stomach yang deficiency, indigestion Zusanli, Zhongwan, Liangmen wiry and slippery pulse Foot Jueyin Liver Meridian Bupleurum (bitter and neutral), turtle shell (salty and cold) Aged vinegar (pH 4.2-4.5) Liver Qi stagnation, hypochondriac pain Taichong, Qimen, Riyue A strong and forceful pulse Foot Taiyin Spleen Meridian Poria cocos (sweet and bland), Atractylodes macrocephala (bitter and sweet) Vinegar (thick paste) Spleen deficiency with dampness and high blood lipids Sanyinjiao, Taibai, Gongsun Thready and rapid pulse Foot Shaoyin Kidney Meridian Black aconite (pungent and hot), cinnamon (pungent and sweet) Yellow wine (pungent and warm) Kidney Yang Deficiency, Aversion to Cold and Cold Limbs Guanyuan, Taixi, Mingmen Floating and rapid pulse Hand Shaoyin Heart Meridian Ginseng (sweet and slightly bitter), Schisandra chinensis (sour and warm) Honey (sweet and mild) Weak heart qi, insomnia and excessive dreaming Shenmen, Neiguan, Juque The pulse is slippery and firm. Hand Yangming Large Intestine Meridian Rhubarb (bitter and cold), immature bitter orange (bitter and pungent) Ginger juice (has a laxative effect) Dry intestines and constipation Tian Shu, Qu Chi, Shang Ju Xu

[0061] Medium preparation principle: Ginger juice (pungent and warm) is suitable for floating / deep and weak pulse, promoting dispersion; Baijiu (pungent and hot) is suitable for deep / weak pulse, enhancing blood circulation; Aged vinegar (sour and astringent) is suitable for large / wiry pulse, guiding the medicine to the liver; Honey (sweet and mild) is suitable for tonifying medicines, prolonging release.

[0062] The principle for expanding the range of drugs targeting specific meridians is as follows: For the Stomach Meridian of Foot Yangming, the range can be expanded to include Pinellia ternata, Codonopsis pilosula, Citrus aurantium, Magnolia officinalis, Amomum villosum, Citrus reticulata peel, Atractylodes macrocephala, and Zingiber officinale; for the Kidney Meridian of Foot Shaoyin, the range can be expanded to include Aconitum carmichaelii, Cinnamomum cassia, Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis, Poria cocos, Alisma plantago-aquatica, and Calcined Ostrea gigas. All the above drugs are extracted and loaded using the same process, without requiring any changes to the structural parameters of this invention.

[0063] (III) Explanation of the Openness of Transdermal Media The "transdermal media" described in claim 9 of this invention is not limited to ginger juice, white wine, vinegar, and honey listed in the examples. Those skilled in the art should understand that any edible or medicinal liquid medium with corresponding properties (pungent and warm dispersing, sweet and soothing tonifying, sour and astringent, salty and softening, bitter and drying) can be synergistically formulated according to pulse type and the properties of the medicine. For example:

[0064] A floating and tight pulse (exterior syndrome due to wind-cold): Scallion juice (pungent and warm) can be used to enhance its dispersing effect;

[0065] A deep and thready pulse (Yang deficiency syndrome): Medicated wine (pungent and hot) can be used to enhance warming and invigorating effects;

[0066] A wiry and rapid pulse (liver stagnation transforming into fire): bamboo sap (sweet and cold) can be used to clear heat and resolve phlegm;

[0067] For a weak and large pulse (due to deficiency of both Qi and Yin): honey water (sweet and mild) can be used to harmonize and nourish the body.

[0068] The selection of the aforementioned media shares the same synergistic principle of properties and flavors as the ginger juice, baijiu (Chinese liquor), vinegar, and honey already verified in this invention. All achieve targeted enhancement by altering the degree of drug ionization, the fluidity of the stratum corneum, or the local microenvironment of meridian acupoints. Therefore, any technical solution that selects a media based on the pulse-property principle falls within the protection scope of claim 9 of this invention.

[0069] (iv) Declaration of Equivalence of Extended Solutions All the extended acupoints and drug combinations described above follow the biological principle verified by this invention: "The penetration flux of meridian-tropized drugs at corresponding acupoints is more than 2.5 times that at non-meridian-tropized acupoints." Using the structures (positioning markers, sustained-release layers, and adhesive layers) described in claims 4-7 of this invention, the same technical effects as in Examples 1-3 can be achieved without changing the manufacturing process. These extended solutions are conventional choices made by those skilled in the art under the concept of this invention, do not constitute new inventive labor, and have been disclosed on the date of this application. Any subsequent use of the above solutions by any entity or individual falls within the scope of protection of this patent. The applicant reserves the right to file divisional patent applications based on the above extended solutions. Attached image description: Figure 1 : Schematic diagram of the device structure (labeling the anti-adhesion protective layer, drug sustained-release layer, body surface positioning marker layer, skin adhesion layer, and forced correspondence). Figure 2 Data curve of penetration experiment of drugs from the Stomach Meridian of Foot Yangming to the Zusanli acupoint Figure 3 Flowchart of preparation process for drugs classified by meridian tropism (including supercritical extraction, category classification, and loading process) Figure 4 Box plot of positioning accuracy for 20 operators (invention vs. control group) Figure 5 Bar chart showing the improvement in PSQI scores of 30 insomnia patients.

Claims

1. An acupoint patch application device, characterized in that, include: A drug sustained-release layer, wherein the sustained-release layer is loaded with an extract composition classified according to the theory of meridian tropism of traditional Chinese medicine; A surface positioning marker layer, wherein the marker layer is provided with a visual graphic marker, and the geometric center of the marker coincides with the surface anatomical projection coordinates of the acupoints corresponding to the meridians on which the sustained-release layer contains the drug; A skin adhesion layer is used to fix the device to the body surface and maintain the overlap.

2. The device according to claim 1, wherein the extract composition classified according to the meridian system is divided into the following categories: Lung Meridian of Hand-Taiyin, Large Intestine Meridian of Hand-Yangming, Stomach Meridian of Foot-Yangming, Spleen Meridian of Foot-Taiyin, Heart Meridian of Hand-Shaoyin, Small Intestine Meridian of Hand-Taiyang, Bladder Meridian of Foot-Taiyang, Kidney Meridian of Foot-Shaoyin, Pericardium Meridian of Hand-Jueyin, Triple Energizer Meridian of Hand-Shaoyang, Gallbladder Meridian of Foot-Shaoyang, Liver Meridian of Foot-Jueyin, Conception Vessel, and Governing Vessel.

3. The device according to claim 2, wherein the Stomach Meridian of Foot Yangming extract is selected from one or more extracts of Pinellia ternata, Citrus aurantium, Magnolia officinalis, Amomum villosum, and Citrus reticulata; and the Kidney Meridian of Foot Shaoyin extract is selected from one or more extracts of Aconitum carmichaelii, Cinnamomum cassia, Ostrea gigas, and Os calcined.

4. The device according to claim 1, wherein the visual graphic mark is a printed graphic or etched groove with a diameter of 3-8 mm, and the positional deviation between the center of the graphic and the center of the acupoint is ≤ ±2 mm.

5. The device according to claim 1, wherein the drug sustained-release layer adopts a porous carrier structure or a gel network structure, the loading of the extract composition is 5-20 mg / cm², and the coefficient of variation (CV) of release is <18%.

6. The device according to claim 1, wherein the body surface positioning marker layer corresponds to at least one acupoint, and the acupoint is selected from one of the following: Zusanli (ST36), Hegu (LI4), Taixi (KI3), Zhongwan (CV12), Guanyuan (CV4), Taichong (LR3), and Taiyuan (LU9).

7. The device according to claim 5 further includes an anti-sticking protective layer covering the outer surface of the drug sustained-release layer, wherein the total thickness of the device is 1.2-2.5 mm.

8. The apparatus according to claim 1, wherein the meridian classification attribute of the extract composition is verified by an in vitro skin meridian-specific permeation experiment, the experimental method being: loading the extract into the supply chamber of a Franz diffusion cell, the receiving chamber being a pH 7.4 PBS buffer, the temperature being 32±0.5℃, the skin sample being selected from pig ear skin, and the steady-state permeation flux of the extract at its corresponding meridian acupoints being more than 2.5 times that at non-meridian acupoints.

9. A method for preparing the apparatus according to any one of claims 1-7, characterized in that... include: Traditional Chinese medicine extracts were classified according to the theory of the fourteen meridians to obtain category extracts; Extracts corresponding to the meridian categories are selected based on the diagnostic results. The selected extract is mixed with a transdermal medium to form a pharmaceutical composition. The selection of the transdermal medium is determined according to the pulse type. The medium includes, but is not limited to, ginger juice, liquor, vinegar, honey, or other media with corresponding properties and flavors. The pharmaceutical composition is loaded onto a sustained-release carrier and assembled into a patch device.

10. The use of the device according to any one of claims 1-7 in the preparation of an acupoint patch product for treating symptoms caused by dysfunction of the Stomach Meridian of Foot-Yangming, wherein the symptoms include: Difficulty falling asleep, abdominal distension, and bitter taste in the mouth upon waking.

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