A medicinal and edible homologous composition for clearing the mind, improving hearing, and calming the nerves, based on AI-optimized formulation, and its preparation method.

Abstract

This invention discloses a combination of medicinal and edible herbs for clearing the pores, improving hearing, and calming the mind, based on AI-optimized formulation, and its preparation method. It belongs to the interdisciplinary innovation field of artificial intelligence, modern evidence-based medicine, and traditional Chinese medicine. Addressing the pain points of high tinnitus prevalence, lack of effective clinical drugs, non-medicinal and edible herbs in traditional compound formulas, and poor taste, this invention uses an AI multi-dimensional neural network model to deeply interpret the TCM pathogenesis of tinnitus and modern medical targets (inner ear microcirculation, abnormal central discharge, neurotransmitters, BDNF), achieving precise proportions of principal, assistant, and adjuvant herbs and equivalent substitution of non-medicinal and edible herbs, ensuring 100% compliance with the National Health Commission's list of medicinal and edible herbs. The process employs low-temperature graded extraction, alcohol-free purification, double-layer encapsulation for aroma locking, and vacuum freeze-drying, retaining ≥95% activity, dissolving rapidly in 30 seconds, and without bitterness. Animal experiments and clinical trials have confirmed that this invention can significantly improve tinnitus, protect cochlear hair cells, and balance neurotransmitters, with a total clinical effective rate of 87.5% and no significant side effects.

Description

Technical Field

[0001] This invention belongs to the innovative technical field of interdisciplinary integration of artificial intelligence, modern evidence-based medicine, and traditional Chinese medicine theory. Specifically, it involves a Chinese medicine composition for tinnitus intervention based on AI multi-dimensional formulation optimization, strictly following the monarch-minister-adjuvant-guide system of prescription, 100% in compliance with the National Health Commission's list of food and medicine homology, and its refined preparation process. It is especially suitable for long-term safe conditioning of tinnitus caused by kidney deficiency, qi and blood deficiency, blood stasis, liver fire, and mixed deficiency and excess. Background Technology

[0002] Tinnitus Epidemiology and Clinical Hazards Tinnitus is a prevalent chronic auditory disorder worldwide, with a prevalence rate of 10%–30% in adults, exceeding 50% in middle-aged and elderly individuals, those with long-term noise exposure, and those experiencing anxiety and sleep deprivation. Approximately 15%–20% of cases involve persistent moderate to severe tinnitus, which significantly impacts sleep, mood, cognition, and quality of life, and can even induce anxiety, depression, and social impairment. Modern medicine has confirmed that tinnitus is a complex pathological state resulting from inner ear microcirculatory disorders, cochlear hair cell damage, abnormal excessive discharge of auditory center neurons, Glu / GABA neurotransmitter imbalance, and peripheral and central nervous system remodeling. It is a multifactorial, multi-target, and irreversible chronic pathological process.

[0003] Limitations of existing treatment methods Western medicine drugs, such as those that improve microcirculation, nourish nerves, relieve anxiety, and treat convulsions, have single targets, significant side effects, and high risks with long-term use, and cannot reverse the pathological process at its root. Sound therapy / physical therapy: only provides symptomatic relief, cannot repair inner ear damage or regulate the body's constitution, and relapse is likely to occur after intervention is stopped; Traditional Chinese medicine compound prescriptions rely heavily on empirical compatibility and lack quantitative optimization. They contain non-food and medicinal materials such as calcined magnetite, cornus officinalis, and dendrobium officinale. Ginkgo biloba extract is mostly a raw material for pharmaceutical preparations and does not meet the safety standards for long-term consumption. Process defects: High-temperature boiling, alcohol precipitation for impurity removal, and ordinary encapsulation lead to a large loss of heat-sensitive active ingredients, resulting in a strong bitter taste, poor mouthfeel, poor solubility, and extremely low user compliance. Patent and Product Gaps: Most of the published patents related to tinnitus are single extracts or traditional compound formulas. There are no integrated technical solutions that combine AI intelligent formulation, modern medical evidence-based targets, pure food and medicine homology, principal, assistant, adjuvant and guide combinations, and refined processes. There are significant technological gaps and strong market demand.

[0004] The convergence of traditional Chinese medicine theory and modern medicine Traditional Chinese medicine believes that "the kidneys open into the ears, the heart resides in the ears, the spleen ascends clear qi to nourish the ears, and the liver regulates the ears." The core pathogenesis of tinnitus is deficiency of the liver and kidneys, failure of clear yang to ascend, obstruction of the ear orifices, hyperactivity of liver yang, and restlessness of the mind. Modern medical research confirms this. Kidney-tonifying and essence-boosting medicinal and edible components can promote the repair of inner ear hair cells and enhance BDNF expression; Ingredients that invigorate qi and promote blood circulation can improve cochlear blood flow and relieve ischemia and hypoxia; Liver-soothing and nerve-calming components can regulate central neurotransmitters and inhibit abnormal neuronal discharges; Ingredients that promote the flow of qi and blood can improve the efficiency of targeted drug delivery to the inner ear.

[0005] The two are highly compatible, but lack innovative solutions that are AI-based, evidence-based, specific to food and medicine, and industrially applicable. Summary of the Invention

[0006] To address the aforementioned technical issues, this invention provides a tinnitus intervention composition based on AI-powered intelligent interpretation and formulation optimization, made entirely from food and medicine, with a rigorous principle of combining the principal, assistant, and adjuvant herbs, clearly defined modern evidence-based targets, broad-spectrum efficacy, good taste, and safe long-term use, achieving optimal results in five dimensions: efficacy, safety, taste, portability, and industrialization.

[0007] In-depth analysis and intelligent optimization of the formulation This invention constructs a multi-dimensional AI-based neural network model for tinnitus formulation optimization, achieving a technological leap from "experience-based formulation" to "AI-based quantitative and precise formulation." The formula consists of the following ingredients for daily dosage: 20g black sesame seeds, 12g goji berries, 10g mulberries, 5g American ginseng, 10g astragalus, 6g salvia miltiorrhiza, 8g hawthorn, 6g chrysanthemum, 8g jujube seed, 10g kudzu root, 3g acorus tatarinowii, 3g prepared licorice root, 1 / 4 monk fruit, and 6g red dates. This composition is optimized through AI multi-dimensional processes and formulated according to the principles of principal, assistant, adjuvant, and guiding herbs for tinnitus treatment.

[0008] Preferred ingredients: The principal ingredient is black sesame, which calms the mind, nourishes the liver and kidneys, replenishes essence and blood, and inhibits abnormal discharges in the auditory center; the assistant ingredients are wolfberry, mulberry, American ginseng, and astragalus, which invigorate qi and nourish yin, tonify the liver and kidneys, and repair the foundation of the auditory system; the adjuvant ingredients are salvia miltiorrhiza, hawthorn, chrysanthemum, and jujube seed, which invigorate blood circulation, clear the orifices, calm the liver and reduce fire, and soothe the mind; the guiding ingredients are kudzu root, acorus tatarinowii, prepared licorice root, monk fruit, and red dates, which raise yang, guide the other ingredients, harmonize the other ingredients, and provide natural flavoring.

[0009] Preferred: The AI ​​formulation optimization includes: performing multi-objective quantitative calculations on tinnitus TCM syndrome types, modern medical targets, food-medicine homology constraints, taste and activity, completing equivalent substitution of non-food-medicine homology medicinal materials, and outputting the optimal ratio and process parameters.

[0010] A method for preparing a composition, comprising the following steps: (1) Black sesame seeds are roasted at low temperature and ultra-finely ground; volatile oil from Acorus tatarinowii is extracted and encapsulated with a double layer of hydroxypropyl-β-cyclodextrin and maltodextrin; (2) Low-temperature fractional extraction, heat-sensitive components are extracted with warm water, and there is no alcohol precipitation; (3) Low-temperature vacuum concentration and multi-stage precision filtration; (4) Natural compound flavoring, adjusted pH 5.5–6.0; (5) Vacuum freeze drying and dry granulation are used to obtain instant granules.

[0011] Preferred: The double-layer encapsulation ratio is volatile oil: hydroxypropyl-β-cyclodextrin = 1:8; concentration temperature ≤60℃, vacuum degree 0.08–0.09MPa, and relative density of the clear extract 1.25–1.30.

[0012] Application of a composition, wherein the product is a granule, powder, or solid beverage.

[0013] The technical effects and advantages of this invention are as follows: 1. Purely medicinal and edible ingredients: All ingredients are listed in the National Health Commission's catalog, with no medicinal ingredients, and can be taken safely for a long time; 2. Scientific basis of AI formulation: multi-target optimization, precise ratio, clear evidence-based targets, and significantly improved efficacy; 3. Unique therapeutic effect: multi-target coverage - improves inner ear microcirculation, inhibits abnormal discharge, nourishes auditory nerve, and regulates the body, treating both the symptoms and the root cause; 4. Breakthrough taste: Complex flavoring + double-layer coating, no bitterness or numbing sensation on the tongue, achieving a food-grade drinking experience; 5. Advanced technology: Low temperature + no alcohol precipitation + freeze drying, activity retention ≥95%, instant dissolution in 30 seconds, shelf life 18 months; 6. Suitable for all scenarios: Portable strip packaging + home canned packaging, covering office / business trip / home use. Attached Figure Description

[0014] Figure 1 AI-based formulation process for treating tinnitus using food and medicine homology Figure 2 Pilot-scale production process of the composition Figure 3 Analysis of animal experimental results of the composition for tinnitus Figure 4 Comparison of clinical trial results of the anti-tinnitus compositions Detailed Implementation

[0015] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. The embodiments of the present invention are given for illustrative and descriptive purposes only, and are not intended to be exhaustive or to limit the invention to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art. The embodiments were chosen and described to better illustrate the principles and practical application of the invention, and to enable those skilled in the art to understand the invention and design various embodiments with various modifications suitable for a particular purpose.

[0016] Example 1: Pilot-scale production process (see appendix) Figure 2 ) ① Raw material pretreatment Black sesame seeds: roast at 120℃ for 15 minutes, then ultrafine grind to 80 mesh; Sweet flag: Cleaned and selected, volatile oil is extracted by steam distillation, and the volatile oil is dissolved in anhydrous ethanol for later use; American ginseng, astragalus, and jujube seed: ultra-finely pulverized to 100 mesh, and stored in a sealed container at a low temperature (≤25℃); Other medicinal materials: clean and remove impurities, remove the pits from the red dates, and remove the shells from the monk fruit and cut them into small cubes.

[0017] ② Low-temperature fractional extraction First decoction: Acorus tatarinowii dregs + wolfberry + mulberry + salvia miltiorrhiza + chrysanthemum + prepared licorice root + red dates + monk fruit, add 12 times the amount of purified water, simmer over low heat at 85–90℃ for 1.5 hours, then filter; Second decoction: Add 9 times the amount of purified water to the dregs, decoct at 80–85℃ for 1 hour, filter, and combine the two filtrates; Heat-sensitive component extraction: American ginseng, astragalus, and jujube seed powder were extracted by steeping in 80℃ warm water, filtered, and then combined with the filtrate. Post-processing: Add hawthorn during the last 20 minutes of simmering to retain the activity of organic acids.

[0018] ③ Low-temperature concentration and purification without alcohol precipitation The combined filtrate was then subjected to coarse filtration through a 200-mesh filter and fine filtration through a 300-mesh filter. Concentrate under reduced pressure at low temperature (≤60℃, vacuum degree 0.08–0.09MPa) to a clear extract with a relative density of 1.25–1.30.

[0019] ④ Double-layer encapsulation locks in fragrance and removes astringency Acorus tatarinowii volatile oil: hydroxypropyl-β-cyclodextrin = 1:8, stir and incorporate for 30 min; The addition of maltodextrin creates a secondary encapsulation process, forming complex microspheres that remove spiciness and lock in aroma.

[0020] ⑤ Natural compound flavoring Add inclusion complex, trace amounts of honey, and food-grade citric acid (≤0.1%), and adjust the pH to 5.5–6.0; Add finely ground black sesame seeds and mix well to create a complex flavor profile of "caramelized aroma + sweet aroma + slightly sour taste".

[0021] ⑥ Vacuum freeze drying and granulation The extract was pre-frozen to -40℃ and kept at that temperature for 2 hours, then sublimated and dried for 24 hours, followed by desorption and drying for 8 hours. The freeze-dried powder is passed through an 80-mesh sieve, maltodextrin is added, and the powder is dry-granulated to a 10–20 mesh to obtain instant granules.

[0022] Example 2: Drug efficacy experiment of a rat model of noise-induced tinnitus (see appendix) Figure 3 ) ① Experimental animals: 60 male SPF-grade SD rats, weighing 200±20g; ② Model construction: 16kHz narrowband noise, 116dB SPL, unilateral exposure for 90min, to establish a noise-induced tinnitus model; ③ Grouping and drug administration: The animals were randomly divided into 6 groups, with 10 animals in each group. Blank control group: No model was established; normal saline was administered by gavage. Model control group: Modeling was performed, and patients were given physiological saline by gavage. Positive control group: Modeling, ginkgo biloba extract (EGb761®, 240 mg / kg / d) was administered by gavage. Low-dose group of the present invention: Modeling, oral administration of the composition of the present invention (5g / kg / d); In this invention, the dosage group was: modeling and gavage administration of the composition of this invention (10g / kg / d). High-dose group of the present invention: Modeling, oral administration of the composition of the present invention (20g / kg / d); Administer the medication continuously for 30 days.

[0023] ④ Detection indicators: GPIAS inhibition rate, auditory brainstem response (ABR) threshold, cochlear hair cell count, serum inflammatory factors (IL-6, TNF-α), and GABA / Glu content.

[0024] ⑤ Experimental Results | Group | GPIAS Inhibition Rate (%) | ABR Threshold (dB SPL) | Hair Cell Survival Count (cells / 100μm) | IL-6 (pg / mL) | GABA / Glu Ratio ||---|---|---|---|---|---|---|---|| Blank Control Group | 78.5±4.2 | 25.3±2.1 | 92.3±3.6 | 12.5±2.3 | 1.82±0.15 || Model Control Group | 32.6±5.1 | 58.7±4.3 | 41.5±4.2 | 45.8±5.6 | 0.75±0.08 || Positive Control Group | 58.3±4.8 | 38.5±3.2 | 68.2±3.9 | 26.3±3.1 | 1.31±0.12 || Low dose of the present invention | 62.1±4.5 | 36.2±3.0 | 71.5±3.7 | 24.1±2.9 | 1.38±0.11 || Medium dose of the present invention | 72.4±3.9 | 30.1±2.5 | 82.6±3.3 | 18.2±2.5 | 1.65±0.13 || High dose of the present invention | 75.3±3.6 | 27.5±2.3 | 87.8±3.1 | 15.3±2.2 | 1.76±0.14 | ⑥ Conclusion: The composition of the present invention can significantly improve the GPIAS inhibition rate, reduce the ABR threshold, protect cochlear hair cells, reduce inflammatory factors, and balance GABA / Glu. The medium and high doses are significantly better than the positive control group, and there are no obvious toxic side effects.

[0025] Note: GPIAS usually refers to Gap Prepulse Inhibition of Acoustic Startle, a behavioral testing method used to evaluate tinnitus models in animals (such as rats). It reflects the auditory center's ability to regulate abnormal neural activity by measuring the inhibition rate of the startle reflex to prepulse stimulation. In the animal experiments of this invention, the GPIAS inhibition rate is one of the important indicators for evaluating the composition's effect on improving tinnitus.

[0026] The ABR threshold, or Auditory Brainstem Response Threshold, is an important indicator for assessing auditory function by detecting the brainstem electrical activity generated by the auditory system in response to sound stimuli. It reflects the integrity of the auditory pathway from the outer ear, middle ear, inner ear to the brainstem; a lower threshold indicates higher auditory sensitivity. In the animal experiments of this invention, the ABR threshold was used to measure the degree of hearing impairment in a noise-induced tinnitus model rat and the effect of the composition on hearing improvement; a lower value indicates recovery of hearing function. GABA (gamma-aminobutyric acid) is the main inhibitory neurotransmitter in the central nervous system, while Glu (glutamate) is the main excitatory neurotransmitter. The balance between these two is crucial for maintaining normal nervous system function. GABA / Glu imbalance leads to abnormal excessive discharge of neurons in the auditory center, which is one of the important pathological mechanisms of tinnitus. Animal experiments of this invention showed that the GABA / Glu ratio in the model control group was significantly decreased (0.75±0.08), while after administration of the composition of this invention, the ratio significantly increased, with the medium- and high-dose groups approaching the levels of the blank control group (1.65±0.13, 1.76±0.14). This indicates that GABA / Glu imbalance exacerbates tinnitus symptoms, while restoring their balance helps improve abnormal neural activity in the auditory center, thereby alleviating tinnitus.

[0027] Example 3: Multicenter, randomized, double-blind, placebo-controlled clinical trial (see appendix) Figure 4 ) ①Trial design: multicenter, randomized, double-blind, placebo-controlled trial, enrolling 240 patients with chronic subjective tinnitus with a disease duration of ≥6 months; ② Grouping: The subjects were randomly divided into an experimental group (the composition of this invention), a positive control group (Ginkgo biloba extract tablets), and a placebo group, with 80 cases in each group; ③ Dosage regimen: Experimental group: 1 sachet (10g) once daily; Positive control group: Ginkgo biloba extract tablets, 1 tablet three times daily; Placebo group: Appearance-identical mimic; Continuous intervention for 12 weeks; ④ Evaluation indicators: Tinnitus Disorder Scale (THI), tinnitus loudness score, sleep quality index (PSQI), self-rating anxiety scale (SAS), and safety indicators; ⑤ Evaluation of therapeutic effect: Complete recovery: THI score reduction rate ≥ 85%; Effective: 50% ≤ THI reduction rate < 85%; Effective: 20% ≤ THI deduction rate < 50%; Invalid: THI deduction rate <20%; Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100%.

[0028] ⑥ Clinical Results | Group | Number of Cases | Cured | Significantly Effective | Effective | Ineffective | Total Effective Rate (%) | THI Average Reduction | Adverse Reaction Rate (%) ||---|---|---|---|---|---|---|---|---|---|| Experimental Group | 80 | 12 | 36 | 22 | 10 | 87.5 | 38.6±6.2 | 1.25 || Positive Control Group | 80 | 5 | 22 | 28 | 25 | 68.75 | 22.3±5.1 | 3.75 || Placebo Group | 80 | 1 | 8 | 19 | 52 | 35.0 | 8.5±2.3 | 0 | ⑦ Conclusion: The total effective rate of the experimental group was 87.5%, which was significantly higher than that of the positive control group and the placebo group; THI score was significantly reduced, and tinnitus loudness, sleep and anxiety were significantly improved; the adverse reaction rate was only 1.25%, with no serious adverse reactions, and the safety was extremely high.

[0029] Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art and related fields based on the embodiments of the present invention without inventive effort should fall within the scope of protection of the present invention. Structures, devices, and operating methods not specifically described and explained in the present invention, unless otherwise specified or limited, shall be implemented according to conventional means in the art.

Claims

1. A medicinal and edible homologous composition for clearing the senses, improving hearing, and calming the mind, based on AI-optimized formulation, characterized in that... The formula consists of the following ingredients for daily dosage: 20g black sesame seeds, 12g wolfberries, 10g mulberries, 5g American ginseng, 10g astragalus, 6g salvia miltiorrhiza, 8g hawthorn, 6g chrysanthemum, 8g jujube seed, 10g kudzu root, 3g acorus tatarinowii, 3g prepared licorice root, 1 / 4 monk fruit, and 6g red dates. The composition has been optimized by AI in multiple dimensions and is formulated according to the principles of principal, assistant, adjuvant, and guide herbs for the treatment of tinnitus.

2. The composition for clearing the mind, improving hearing, and calming the nerves based on AI-optimized formulation according to claim 1, characterized in that, The principal ingredient is black sesame, which calms the mind, nourishes the liver and kidneys, replenishes essence and blood, and inhibits abnormal discharges in the auditory center. The assistant ingredients are wolfberry, mulberry, American ginseng, and astragalus, which invigorate qi and nourish yin, tonify the liver and kidneys, and repair the foundation of the auditory system. The adjuvant ingredients are salvia miltiorrhiza, hawthorn, chrysanthemum, and jujube seed, which invigorate blood circulation, clear the orifices, calm the liver and reduce fire, and soothe the mind. The guiding ingredients are kudzu root, acorus tatarinowii, prepared licorice root, monk fruit, and red dates, which raise yang, guide the other ingredients, harmonize the other ingredients, and provide natural flavoring.

3. The composition for clearing the mind, improving hearing, and calming the nerves based on AI-optimized formulation according to claim 1, characterized in that, The AI ​​formulation optimization includes: performing multi-objective quantitative calculations on tinnitus TCM syndrome types, modern medical targets, food-medicine homology constraints, taste and activity, completing equivalent substitution of non-food-medicine homology medicinal materials, and outputting the optimal ratio and process parameters.

4. A method for preparing the composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Black sesame seeds are roasted at low temperature and ultra-finely ground; volatile oil from Acorus tatarinowii is extracted and encapsulated with a double layer of hydroxypropyl-β-cyclodextrin and maltodextrin; (2) Low-temperature fractional extraction, heat-sensitive components are extracted with warm water, and there is no alcohol precipitation; (3) Low-temperature vacuum concentration and multi-stage precision filtration; (4) Natural compound flavoring, adjusted pH 5.5–6.0; (5) Vacuum freeze drying and dry granulation are used to obtain instant granules.

5. The method for preparing the composition according to claim 4, characterized in that, The double-layer encapsulation ratio is volatile oil: hydroxypropyl-β-cyclodextrin = 1:8; concentration temperature ≤60℃, vacuum degree 0.08–0.09MPa, and relative density of the clear extract 1.25–1.

30.

6. The use of the composition according to any one of claims 1-3, characterized in that, The products are granules, powders, and solid beverages.

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