Compound preparation suitable for traditional Chinese medicine constitution conditioning and preparation method thereof

Abstract

The invention discloses a compound preparation suitable for traditional Chinese medicine constitution conditioning and a preparation method thereof. The compound preparation comprises a stepped ternary-quaternary-quinary compound preparation. The ternary complex is based on hydroxypropyl methyl cellulose, fumed silica and silicified microcrystalline cellulose, and digestive tract mucosa protection and body safety tolerance establishment are achieved; in the quaternary compound, resistant dextrin is added on the basis of the ternary compound, so that the digestion function and the defecation rhythm are stable; l-glutamine is further added to the quinary compound on the basis of a quaternary compound, so that the whole body state is harmonized, and nine constitutions in traditional Chinese medicine are balanced. The three components strictly follow a ternary-quaternary-quinary sequence for use, and a complete conditioning path from safe tolerance establishment to intestinal environment regulation to whole body consolidation is formed. The invention provides a preparation process which is high in forming rate, good in stability, resistant to moisture absorption, excellent in reconstituability and suitable for industrial large-scale production.

Description

Technical Field

[0001] This invention belongs to the field of food technology, specifically relating to a composite formulation with a ladder-like structure of hydroxypropyl methylcellulose, fumed silica, and silicified microcrystalline cellulose as the base carrier, and resistant dextrin and L-glutamine stacked in stages to form a ternary complex-quaternary complex-pentamericary complex. Background Technology

[0002] During seasonal transitions, significant changes in temperature, humidity, and air pressure can easily lead to problems such as gastrointestinal sensitivity, digestive disorders, bloating, abnormal bowel movements, sleep disturbances, fatigue, irritability, imbalances in constitution, and decreased adaptability of the body. Currently available conditioning products generally suffer from drawbacks such as single-ingredient formulas, poor stability, susceptibility to moisture absorption and clumping, limited effects, strong irritant properties, risk of dependence, burden on liver and kidney metabolism, and intestinal flora imbalance. There is a lack of a product that uses cellulose and silicon-based carriers as a physical foundation, combines resistant dextrin to regulate digestion, and supplements L-glutamine to strengthen the whole body. Furthermore, it should be purely physically safe, progressively enhanced, layered, without side effects, suitable for long-term consumption, and systematically cover nine body types and seasonal conditioning needs.

[0003] Existing technologies cannot achieve a complete conditioning pathway from mucosal protection and tolerance establishment → digestion and bowel stability → systemic harmony and constitution balance. They also lack a strictly hierarchical, non-skipping, and synergistic system design, resulting in unstable efficacy, insufficient safety, and limited applicability. Therefore, this invention proposes a step-by-step compound formulation and its preparation method to overcome all the shortcomings of existing technologies. Summary of the Invention

[0004] The technical problem to be solved by this invention is to provide a safe, mild, stable, side-effect-free, progressively enhanced, and layered compound preparation suitable for seasonal changes and the conditioning of the nine constitutions in traditional Chinese medicine. This preparation achieves a complete pathway from protection of the digestive tract mucosa and establishment of the body's safety tolerance to stabilization of digestive function and defecation rhythm to overall body condition harmony and balance with the nine constitutions in traditional Chinese medicine. At the same time, it provides a preparation method that is industrially producible, has a high molding rate, good stability, moisture resistance, and excellent reconstitution properties.

[0005] The principle of this invention: This invention employs a scientific design of progressive enhancement, layer-by-layer superposition, and synergistic effect: The ternary complex system, based on hydroxypropyl methylcellulose, fumed silica, and silicified microcrystalline cellulose, achieves protection of the digestive tract mucosa and establishes the body's safe tolerance; the quaternary complex system, based on the ternary complex, adds resistant dextrin to achieve stable digestive function and defecation rhythm; the quinary complex system, based on the quaternary complex, further adds L-glutamine to achieve overall body harmony and balance with the nine constitutions of traditional Chinese medicine. The effects of the three components are sequential, inseparable, and cannot be skipped or reversed.

[0006] As a first aspect of the present invention, the technical solution adopted by the present invention to solve the above-mentioned technical problems is as follows: a compound preparation suitable for conditioning constitution in traditional Chinese medicine, comprising a ternary compound, a quaternary compound and a quinary compound;

[0007] The ternary complex includes hydroxypropyl methylcellulose, fumed silica, and silicified microcrystalline cellulose;

[0008] The quaternary complex comprises hydroxypropyl methylcellulose, fumed silica, silicified microcrystalline cellulose, and resistant dextrin;

[0009] The pentagonal complex comprises hydroxypropyl methylcellulose, fumed silica, silicified microcrystalline cellulose, resistant dextrin, and L-glutamine.

[0010] The ternary complex is based on hydroxypropyl methylcellulose, fumed silica, and silicified microcrystalline cellulose, which achieves gastrointestinal mucosal protection and establishes the body's safe tolerance.

[0011] The quaternary complex system adds resistant dextrin to the ternary complex to achieve stable digestive function and defecation rhythm;

[0012] The five-component complex system further adds L-glutamine to the four-component complex to achieve overall body condition harmony and balance with the nine constitutions of traditional Chinese medicine.

[0013] Furthermore, the components of the ternary complex, by weight, are: 30-60 parts hydroxypropyl methylcellulose, 1-5 parts fumed silica, and 35-65 parts silicified microcrystalline cellulose. Specifically, the ternary complex is based on hydroxypropyl methylcellulose, fumed silica, and silicified microcrystalline cellulose; the mass ratio of each component is: 30%-60%, 1%-5%, and 35%-65%. Preferably, the mass ratio of each component is: 45%-50%, 2%-3%, and 47%-52%. The ternary complex can achieve gastrointestinal mucosal protection and establish the body's safe tolerance through a basic physical layer.

[0014] Furthermore, the components, by weight, are as follows: in the quaternary complex, the ternary complex comprises 70-90 parts, and resistant dextrin comprises 10-30 parts. The quaternary complex is based on a ternary complex system with the addition of resistant dextrin; the ternary complex system comprises 70%-90%, and the resistant dextrin comprises 10%-30%. A further preferred ratio is: the ternary complex system comprises 75%-82%, and the resistant dextrin comprises 18%-25%. The quaternary complex stabilizes digestive function and defecation rhythm through the intestinal regulatory layer.

[0015] Furthermore, the components, by weight, are as follows: in the pentagonal complex, the quaternary complex comprises 85-95 parts, and L-glutamine comprises 5-15 parts. The pentagonal complex further increases L-glutamine on the basis of the quaternary complex system; the quaternary complex system accounts for 85%-95%, and L-glutamine accounts for 5%-15%; a further preferred ratio is: the quaternary complex system accounts for 88%-92%, and L-glutamine accounts for 8%-12%; the pentagonal complex achieves overall body balance and harmony with the nine constitutions of Traditional Chinese Medicine through a whole-body balance layer.

[0016] Furthermore, the dosage forms of the ternary complex, the quaternary complex, and the pentagonal complex are independently selected from any one of granules, powders, capsules, tablets, aqueous beverages, agar crystals, pastes, gels, soft candies, pills, drop pills, solid beverages, compressed candies, jelly candies, oral liquids, and extracts.

[0017] In another aspect, the present invention provides a method for preparing the compound preparation suitable for TCM constitution conditioning, comprising the following steps: 1) pulverizing the raw materials through an 80-200 mesh sieve; 2) accurately dispensing the ingredients according to the formulas of ternary, quaternary, and pentagonal compound preparations; 3) mixing in a three-dimensional motion mixer for 20-30 minutes; 4) wet granulation / dry granulation / direct mixing / dissolving and blending / concentration / gelling; 5) boiling drying at 50-65℃ / hot air drying / vacuum drying / low-temperature concentration to a moisture content of 3.0%-5.0%; 6) granulating, mixing, testing, and packaging to produce granules, powders, capsules, tablets, aqueous beverages, agar crystals, pastes, gels, soft candies, pills, or solid beverage products.

[0018] Furthermore, in the preparation method of the compound preparation suitable for TCM constitution conditioning, in step 4), granulation is performed using a 1.0-1.5 mm sieve, sizing is performed using a 14-16 mesh sieve, and the granule / powder forming rate is ≥96%.

[0019] Furthermore, the preparation process of this invention utilizes the following main production equipment:

[0020] Crushing and screening equipment: universal crusher, vibrating screen (80-200 mesh);

[0021] Mixing equipment: Three-dimensional motion mixer;

[0022] Granulation equipment: wet mixing granulator, rotary extrusion granulator;

[0023] Drying equipment: fluidized bed dryer, hot air circulating oven;

[0024] Granulation equipment: rotary granulator;

[0025] Mixing equipment: Two-dimensional mixer;

[0026] Packaging equipment: automatic granule packaging machine, sealing machine.

[0027] Furthermore, the detailed process of the preparation of this invention can be as follows:

[0028] 1) Raw material pretreatment: Raw and auxiliary materials are crushed by a universal pulverizer and passed through an 80-200 mesh sieve to remove impurities and coarse powder.

[0029] 2) Precise ingredient proportions: The electronic scale accurately weighs ingredients according to the corresponding formula ratios of ternary, quaternary, and pentaneous compounds.

[0030] 3) Overall mixing: Put the mixture into a three-dimensional motion mixer and mix for 20 to 30 minutes. The mixing uniformity RSD should be ≤5%.

[0031] 4) Wet granulation: Add purified water or an appropriate amount of ethanol slurry and granulate in a wet granulation mixer; the stirring speed is 100-200 r / min and the granulation time is 8-15 minutes.

[0032] 5) Extrusion molding: Using a rotary extrusion granulator with a screen aperture of 1.0 to 1.5 mm, uniform wet granules are produced.

[0033] 6) Boiling drying: air inlet temperature 50-65℃, material temperature 40-55℃, drying to moisture content 3.0%-5.0%.

[0034] 7) Granulation: A rotary granulator with a 14-16 mesh sieve is used to obtain uniform dry granules.

[0035] 8) General mixing: After granulation, the granules are put into a two-dimensional mixer and mixed for 10 to 15 minutes to ensure uniformity.

[0036] 9) Intermediate product testing: Test for appearance, moisture, particle size, and microbial limits. If the product passes the test, it will be packaged.

[0037] 10) Repackaging: Automatic granule packaging machine repackages 5.0g / bag, and puts the granules into storage after passing the sealing test.

[0038] In step 4), the ethanol concentration of the ethanol slurry is 50%-95%; the amount of ethanol slurry used is 8%-18% of the total mass of the raw materials.

[0039] The key process parameter ranges for the composite of this invention are:

[0040] Particle size: 80-200 mesh;

[0041] Mixing time: 20–30 min;

[0042] Granulation moisture content: 25%–35%;

[0043] Drying temperature: 50~65℃;

[0044] Finished product moisture content: 3.0%–5.0%;

[0045] Particle size: 14-16 mesh accounts for ≥90%.

[0046] In another aspect, the present invention provides a method for applying the above-mentioned compound preparation suitable for TCM constitution conditioning, wherein the mandatory order of administration is: ternary compound → quaternary compound → pentagonal compound, administered step by step, and skipping, jumping, regressing, or omitting any stage is strictly prohibited.

[0047] The principle of progressive administration: The ternary complex is responsible for protecting the digestive tract mucosa and establishing the body's safety tolerance; the quaternary complex is responsible for stabilizing digestive function and defecation rhythm; and the pentagonal complex is responsible for harmonizing the overall condition and balancing the nine constitutions in traditional Chinese medicine. The three effects are layered, synergistic, and indispensable.

[0048] Reasons for strictly prohibiting skipping levels of medication: Taking a quaternary / pentalytic compound directly without a ternary compound as a foundation will lead to intolerance, discomfort, and unstable effects due to the lack of physical carrier buffers and mucosal protection from hydroxypropyl methylcellulose, fumed silica, and silicified microcrystalline cellulose. Taking a pentalytic compound directly without a quaternary compound as a foundation will not allow for the full exertion of the systemic regulating effect of L-glutamine because the digestion and bowel rhythm have not been stabilized by resistant dextrin, resulting in a significant reduction in the conditioning effect.

[0049] The reason why it is strictly forbidden to take the medication backwards is that if you have already entered the quaternary or pentagonal complex stage, going back to taking the ternary complex system will disrupt the established stable state of the body, leading to a decrease in effectiveness, repeated physical sensations, and violating the design logic of progressive enhancement.

[0050] Furthermore, the present invention provides the application of the compound preparation suitable for TCM constitution conditioning, the standard dosing regimen of which is: the ternary compound is taken continuously for 15 days, the quaternary compound is taken continuously for 15 days, the pentagonal compound is taken continuously for 15 days, and the complete cycle is 45 days.

[0051] Furthermore, depending on the sensitivity of the population and the type of symptoms, a ternary complex / quadrivalent complex / pentalytic complex can be used alone for emergency improvement first. After the symptoms stabilize, the complete cycle of ternary complex → quadrivalent complex → pentalytic complex can be completed.

[0052] Furthermore, the compound preparation applicable to TCM constitution conditioning is used for: intestinal sensitivity conditioning, digestive rhythm improvement, seasonal discomfort relief, TCM nine major constitution imbalance conditioning, overall body condition harmonization, digestive tract mucosal protection, intestinal barrier repair, and seasonal health conditioning.

[0053] Furthermore, the unified usage rules of this invention are as follows:

[0054] Order of administration: Three yuan → Four yuan → Five yuan;

[0055] Daily dosage: 1 sachet / day;

[0056] Time of administration: Morning;

[0057] Dosage: Dissolve in warm water after meals;

[0058] Single bag weight: 5.0g;

[0059] Complete cycle: 45 days (15 days each).

[0060] Furthermore, the treatment cycle and improvement criteria for each stage are as follows: 1) Tri-component complex system (15 days): The digestive tract mucosa is protected, the body's safety tolerance is established, there is no discomfort or irritation in the gastrointestinal tract, and the body feels stable; 2) Quadri-component complex system (15 days): Digestive function is improved, bowel movement rhythm is stable, abdominal distension disappears, and digestion is smooth; 3) Penta-component complex system (15 days): The overall condition is harmonized, the nine major constitutions in traditional Chinese medicine tend to be balanced, mental and physical strength is improved, sleep is improved, and adaptability is enhanced.

[0061] Furthermore, solutions for special circumstances:

[0062] 1. The ternary complex can be used directly first: for people with extremely sensitive stomachs, weak constitution, prone to diarrhea, easily irritated, first-time users, the elderly and children, and those who are weak after surgery, the ternary system can be used first to achieve protection of the digestive tract mucosa and establish the body's safe tolerance.

[0063] 2. You can directly use the quaternary complex first: for intestinal disorders, irregular bowel movements, bloating, indigestion, seasonal gastrointestinal discomfort, etc., the quaternary system can quickly stabilize digestive function and bowel rhythm.

[0064] 3. You can directly use the Five Elements Complex first: for seasonal fatigue, poor sleep, fatigue, irritability, heaviness in the body, weak constitution, etc., the Five Elements system can achieve overall body condition harmony and balance with the nine constitutions of traditional Chinese medicine.

[0065] Furthermore, a unified rule applies to special cases: after symptoms have improved and stabilized for 3 days, the patient must return to the complete stepwise treatment course: 15 days of ternary complex → 15 days of quaternary complex → 15 days of pentagonal complex.

[0066] This invention protects all compound formulations based on a ternary-quaternary-pentalytic compound stepwise superposition system, not limited to any single dosage form, single population, or single field. The scope of protection includes, but is not limited to: product system structure, core formulation ratios, stepwise administration methods, stepwise conditioning logic, preparation process, applicable population, application fields, and all oral dosage forms. Any formulation employing a stepwise administration method based on hydroxypropyl methylcellulose, fumed silica, or silanized microcrystalline cellulose (ternary compound with added resistant dextrin) to pentalytic compound, without skipping or reversing steps, falls within the scope of this invention.

[0067] The protective formulation of this invention includes preparing the complex into the following formulations:

[0068] Granules, fine granules, drop pills, pills, micro-pills;

[0069] Powders, granules, fine powders, and ultrafine powders;

[0070] Tablets, chewable tablets, lozenges, effervescent tablets, dispersible tablets, and sustained-release tablets;

[0071] Capsules, hard capsules, soft capsules, sustained-release capsules, enteric-coated capsules;

[0072] Aqueous beverages, oral liquids, nutrient solutions, plant-based beverages, functional drinks, concentrated slurries;

[0073] Syrups, extracts, fluid extracts;

[0074] Agar-agar, pastes, gelling agents, soft candies, jellies, puddings, and ready-to-eat gels;

[0075] Solid beverages, meal replacement powders, meal replacement bars, convenience foods, compressed candies, and gel candies;

[0076] Food, health food, food and medicine homology products, special dietary food, and dietary supplements.

[0077] The detailed definition of agar crystal preparations in this invention includes, but is not limited to: paste agar crystals, concentrated agar crystals, gel agar crystals, soft agar crystals, ready-to-eat agar crystals, powdered agar crystals, solid agar crystals, semi-solid agar crystals, nourishing agar crystals, herbal agar crystals, functional agar crystals, dietary agar crystals, throat-soothing agar crystals, health-preserving agar crystals, intestinal conditioning agar crystals, constitution-regulating agar crystals, and seasonal health-preserving agar crystals. All paste-like, thick, gel-like, soft, ready-to-eat / powder-preserving semi-solid preparations are included within the scope of protection of agar crystal preparations in this invention.

[0078] This invention protects the following application areas:

[0079] Food technology, food, health food, special dietary food;

[0080] Products that are both food and medicine, gut health products, and products for conditioning the body;

[0081] Seasonal conditioning, seasonal health preservation, and conditioning for nine body constitutions;

[0082] Protecting the digestive tract mucosa, maintaining the intestinal barrier, and regulating the intestinal environment;

[0083] Health conditioning for adults, middle-aged and elderly people, children, people with weak constitutions, people recovering from illness, and people with sensitivities.

[0084] The table below illustrates the overall effects of the ternary, quaternary, and pentagonal complexes of this invention on the nine constitutions and four seasons in Traditional Chinese Medicine.

[0085]

[0086] Compared with the prior art, the beneficial effects of the present invention are:

[0087] (1) Performance of the formulation prepared by the present invention: moisture content 3.0%~5.0% (solid formulation), molding rate ≥96%, uniform and stable, moisture resistant, and excellent solubility / gelling properties.

[0088] (2) This invention is the first to create a ternary complex-quaternary complex-pentalytic complex stepwise superposition system. It uses hydroxypropyl methylcellulose, fumed silica and silicified microcrystalline cellulose as the basis to achieve mucosal protection and tolerance establishment. The addition of resistant dextrin achieves digestion and defecation stability. L-glutamine is added to achieve whole-body conditioning and body balance. The product is safe, mild, stable and without side effects. It systematically solves the discomfort of seasonal transition and the nine major body conditioning problems. The process is mature, fully domestic, and can be produced on a large scale. The appearance, taste, solubility, stability and granulation rate of the granules are all at or above the level of the top domestic and foreign similar products. It has extremely high application value and market prospects.

[0089] (3) Advantages of this invention: Step-by-step superposition, with layer-by-layer enhancement of effects: Pure physical safety starting point, zero stimulation and zero side effects: Suitable for nine types of body constitution and seasonal changes: Strict logic for use, no skipping steps, stable effects: Particles are moisture-resistant, do not clump, and have a long shelf life: Applicable to a wide range of people: Stable data from small-scale / intermediate-scale / large-scale trials: Fully qualified by third parties: All raw materials and equipment are domestically produced: Fills the domestic technology gap and can replace imports: Explanation of the domestic production of raw materials and equipment.

[0090] (4) All raw materials, excipients, production equipment, testing instruments and packaging materials used in the compound preparation products of this invention are 100% domestically sourced and supplied domestically, without relying on imports. The production supply chain is safe, stable and controllable, and large-scale industrial continuous production can be achieved. Detailed Implementation

[0091] To better understand the content of this invention, further description is provided below with reference to specific embodiments. It should be understood that these embodiments are only for further illustration of the invention and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art may make some non-essential modifications or adjustments to the invention, which still fall within the protection scope of this invention.

[0092] 1.1 Proportions of ternary, quaternary, and pentagonal complexes

[0093] The components of the ternary complex are as follows by weight: 30 parts of hydroxypropyl methylcellulose, 4 parts of fumed silica, and 35 parts of silicified microcrystalline cellulose.

[0094] In the quaternary complex, there are 70 parts of the ternary complex and 30 parts of resistant dextrin;

[0095] The pentagonal complex contains 85 parts of the quaternary complex and 15 parts of L-glutamine.

[0096] 1.2 Preparation Examples

[0097] The preparation process of this invention uses the following main production equipment:

[0098] Crushing and screening equipment: universal crusher, vibrating screen (80-200 mesh);

[0099] Mixing equipment: Three-dimensional motion mixer;

[0100] Granulation equipment: wet mixing granulator, rotary extrusion granulator;

[0101] Drying equipment: fluidized bed dryer, hot air circulating oven;

[0102] Granulation equipment: rotary granulator;

[0103] Mixing equipment: Two-dimensional mixer;

[0104] Packaging equipment: automatic granule packaging machine, sealing machine.

[0105] The detailed process of the preparation of this invention can be as follows:

[0106] 1) Raw material pretreatment: Raw and auxiliary materials are crushed by a universal pulverizer and passed through an 80-200 mesh sieve to remove impurities and coarse powder.

[0107] 2) Precise ingredient proportioning: The electronic scale accurately weighs the ingredients according to the 1.1 formula ratio corresponding to the ternary compound, quaternary compound, and pentagonal compound.

[0108] 3) Overall mixing: Put the mixture into a three-dimensional motion mixer and mix for 20 to 30 minutes. The mixing uniformity RSD should be ≤5%.

[0109] 4) Wet granulation: Add purified water or an appropriate amount of ethanol slurry (ethanol concentration 50%-95%, the standard in this example is 75%; the amount is 8%-18% of the total mass of raw materials, the standard in this example is 13%), and granulate in a wet mixing granulator; the stirring speed is 100-200 r / min, and the granulation time is 8-15 minutes.

[0110] 5) Extrusion molding: Using a rotary extrusion granulator with a screen aperture of 1.0 to 1.5 mm, uniform wet granules are produced.

[0111] 6) Boiling drying: air inlet temperature 50-65℃, material temperature 40-55℃, drying to moisture content 3.0%-5.0%.

[0112] 7) Granulation: A rotary granulator with a 14-16 mesh sieve is used to obtain uniform dry granules.

[0113] 8) General mixing: After granulation, the granules are put into a two-dimensional mixer and mixed for 10 to 15 minutes to ensure uniformity.

[0114] 9) Intermediate product testing: Test for appearance, moisture, particle size, and microbial limits. If the product passes the test, it will be packaged.

[0115] 10) Repackaging: Automatic granule packaging machine repackages 5.0g / bag, and puts the granules into storage after passing the sealing test.

[0116] The key process parameter ranges for the composite in this invention embodiment are:

[0117] Particle size: 80-200 mesh;

[0118] Mixing time: 20–30 min;

[0119] Granulation moisture content: 25%–35%;

[0120] Drying temperature: 50~65℃;

[0121] Finished product moisture content: 3.0%–5.0%;

[0122] Particle size: 14-16 mesh accounts for ≥90%.

[0123] 1.3 Case Study

[0124] Case 1 (Single symptom - Triad treatment initially)

[0125] Gender: Female, Age: 28, Time: March (Spring) Symptoms: Extreme gastrointestinal sensitivity and irritation due to seasonal changes, mild bloating, and aversion to raw or cold foods; no other discomfort. Emergency Use: Administer the three-element system alone. After 3 days, gastrointestinal irritation disappeared, bloating subsided, and mucosal comfort returned. Follow-up Standard Use: Supplement with the three-element system for 15 days → the four-element system for 15 days → the five-element system for 15 days. Final Results: Significantly improved gastrointestinal tolerance; no longer sensitive during the spring season; stable constitution.

[0126] Case 2 (Single symptom - use quaternary drugs first)

[0127] Gender: Male, Age: 33, Time: July (Summer), Symptoms: Summer heat and humidity, irregular bowel movements, significant abdominal distension, indigestion after meals, occasional bad breath, single intestinal problem. Emergency Use: Take the four-element system alone. After 5 days, bowel movements became regular, abdominal distension disappeared, and digestion returned to normal. Subsequent Standard Use: Supplement with three-element system for 15 days → four-element system for 15 days → five-element system for 15 days to consolidate the treatment. Final Result: Stable intestinal function, improved heat and humidity, no recurrence.

[0128] Case 3 (Single symptom - start with five yuan)

[0129] Gender: Female, Age: 31, Time: October (Autumn) Symptoms: Autumn dryness, fatigue, poor mental state, light sleep, easy awakening, no gastrointestinal discomfort. Emergency Use: Taking the Five Elements System alone resulted in improved energy, better sleep, and significantly reduced fatigue after 7 days. Follow-up Standard Use: Supplement with the Three Elements System for 15 days → Four Elements System for 15 days → Five Elements System for 15 days to complete the full cycle. Final Results: Stable overall condition, significantly improved seasonal adaptability.

[0130] Case 4 (Single symptom - start with quaternary drugs)

[0131] Gender: Male, Age: 36, Time: February (Winter), Symptoms: Oily winter diet, irritable bowel, mild abdominal pain, occasional diarrhea, isolated intestinal discomfort. Emergency Use: Administer the four-element system alone; abdominal pain disappeared, bowel stabilized, and diarrhea stopped after 4 days. Follow-up Standard Use: Supplement with the three-element system for 15 days → the four-element system for 15 days → the five-element system for 15 days for overall conditioning. Final Result: Enhanced intestinal barrier, reduced irritability, and improved tolerance.

[0132] Case 5 (Single symptom - Triad treatment first)

[0133] Gender: Female, Age: 42, Time: September (Autumn) Symptoms: Autumn dryness, dry intestines, constipation, slight abdominal bloating, no other problems. Emergency Use: Administer the three-element system alone. After 3 days, the intestines felt warm and comfortable, and the dryness disappeared. Subsequent Standard Use: 15 days with the three-element system → 15 days with the four-element system → 15 days with the five-element system, gradually consolidating the effect. Final Result: Healthy mucous membranes, no more dryness and discomfort during seasonal changes.

[0134] Case 6 (Single symptom - start with five yuan)

[0135] Gender: Male, Age: 45, Time: June (early summer) Symptoms: Heavy humidity during the rainy season, feeling heavy and lethargic, mild lower limb edema, slow metabolism (single symptom). Emergency Use: Take the Five-Element System alone. After 6 days, the heaviness and lethargy lessened, edema subsided, and the body felt lighter. Follow-up Standard Use: Supplement with Three-Element System for 15 days → Four-Element System for 15 days → Five-Element System for 15 days for complete conditioning. Final Results: Normal fluid metabolism, lighter physique, and less prone to recurrence.

[0136] Case 7 (Comprehensive symptoms, progressing step-by-step from level three to level five throughout the entire process)

[0137] Gender: Female, Age: 49, Time: April (Spring) Symptoms: Qi deficiency and weakness, sensitive stomach, poor sleep, irritability, and discomfort during seasonal changes. Treatment Plan: Strictly follow a 15-day regimen of three-element supplements → 15-day regimen of four-element supplements → 15-day regimen of five-element supplements. Improvement Process: Days 1-15: Tolerance established, stomach comfort; Days 16-30: Regular bowel movements, stable mood; Days 31-45: Overall stable condition. Final Outcome: Comprehensive improvement in constitution, harmonious organ function, and adaptability to seasonal changes.

[0138] Case 8 (Comprehensive symptoms, progressing step-by-step from level three to level five throughout the entire process)

[0139] Gender: Male, Age: 52, Time: January (Winter) Symptoms: Weak spleen and stomach, slow digestion, fatigue, lower back and knee pain, aversion to cold. Treatment Plan: 15 days of the three-element formula → 15 days of the four-element formula → 15 days of the five-element formula, without skipping levels or regressing. Improvement Process: Gradually relieved gastrointestinal discomfort, increased physical strength, and reduced aversion to cold. Final Results: Stronger spleen and stomach, abundant energy, and significantly improved physical condition.

[0140] Case 9 (Middle-aged and elderly with frailty - progressing step-by-step through stages three, four, and five)

[0141] Gender: Female, Age: 63, Time: December (Winter) Symptoms: Decreased bodily functions in middle-aged and elderly individuals, weak digestion, irregular bowel movements, lack of energy, susceptibility to colds. Treatment Plan: Strictly follow a 15-day course of three-element formula → 15-day course of four-element formula → 15-day course of five-element formula, gradually adjusting the regimen. Improvement Process: Gradually build tolerance → strengthen the gut → consolidate overall health. Final Outcome: Regular digestion, abundant energy and spirit, enhanced immunity, and stable health.

[0142] Case 10 (Long-term recurring discomfort, progressing step by step from level three to level five throughout)

[0143] Gender: Male, Age: 58, Time: Seasonal transition, Symptoms: Recurring discomfort across seasons, fluctuating digestive health, unbalanced constitution, coexisting sleep and fatigue. Treatment Plan: A standard 45-day cycle of three-element → four-element → five-element formulas. Improvement Process: From superficial to deep, from localized to systemic repair. Final Outcome: Achieving a stable and healthy constitution, no discomfort during seasonal transitions, and long-term well-being.

[0144] 1.2 Case Study Effect Comparison Explanation

[0145] Results from use across different age groups, genders, and physical constitutions indicate that this product's conditioning effects on the internal organs progress from rapid to stable, and from superficial to profound.

[0146] 1-3 days: Gastrointestinal discomfort is quickly relieved, mucosal protection takes effect, and tolerance is established;

[0147] 3-7 days: Symptoms such as intestinal sensitivity, abdominal pain, and diarrhea improve, and digestion and bowel movements tend to stabilize;

[0148] 7–14 days: Fatigue, sleep, and mood problems gradually improve, and the body's overall condition begins to harmonize;

[0149] 15–30 days: The synergy of the internal organs is enhanced, and the body gradually achieves balance;

[0150] 30-60 days: Physical fitness is fully consolidated and seasonal adaptability is greatly improved.

[0151] The product has a gentle, gradual effect, is non-irritating, has no side effects, and is non-addictive. Long-term consumption can maintain the stable balance of the five internal organs.

[0152] 1.4 Experimental data of small-scale, pilot-scale, and large-scale preparation processes

[0153] The particle formation rate of the ternary composite system was 96.0%–96.5% in small-scale trials, 96.2%–96.8% in pilot-scale trials, and 96.5%–97.0% in large-scale trials. The particle uniformity, flowability, solubility, and stability all met the excellent standards.

[0154] The particle forming rate of the quaternary composite system is 97.0%~97.3% in small-scale trials, 97.2%~97.5% in pilot-scale trials, and 97.5%~97.8% in large-scale trials. The particle roundness, moisture resistance, mixing properties, and batch consistency are all superior to those of products made with conventional processes.

[0155] The particle molding rate of the pentagonal composite system is 98.0%~98.2% in small-scale trials, 98.1%~98.4% in pilot-scale trials, and 98.3%~98.6% in large-scale trials. The particle strength, appearance quality, taste, and long-term stability have reached the top level at home and abroad.

[0156] Overall conclusion: The ternary, quaternary, and pentaneous compound particles were verified on a small-scale, pilot-scale, and large-scale basis. The molding rate, uniformity, stability, and flowability all met the corresponding indicators in the comparative table of this invention. The production process is stable and reliable and suitable for continuous industrial production.

[0157] 1.5 Third-party testing data

[0158]

[0159]

[0160] Test results: All indicators of this product meet national food safety standards, and it is safe, stable, and of controllable quality.

[0161] 1.6 Summary Table of Differentiated Advantages of This Product Compared with Similar Domestic and International Products

[0162]

[0163]

[0164] 1.7 Comparison Table of Granular Properties, Color, and Taste with Top Domestic and International Products

[0165]

[0166]

[0167] 1.8 Comparison Table of Particle Output / Molding State from Domestic and Foreign Factories with Particles Produced Using This Process

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[0170] 1.9 Comparison of the product in this embodiment with probiotics, pharmaceuticals, and cellulose products

[0171]

[0172] The foregoing description is not intended to limit the invention, nor is the invention limited to the examples given. Any changes, modifications, additions, or substitutions made by those skilled in the art within the scope of the invention should also be considered within the protection scope of the invention.

Claims

1. A compound preparation suitable for conditioning constitution according to traditional Chinese medicine, characterized in that, Including ternary complexes, quaternary complexes, and quinary complexes; The ternary complex includes hydroxypropyl methylcellulose, fumed silica, and silicified microcrystalline cellulose; The quaternary complex comprises hydroxypropyl methylcellulose, fumed silica, silicified microcrystalline cellulose, and resistant dextrin; The pentagonal complex comprises hydroxypropyl methylcellulose, fumed silica, silicified microcrystalline cellulose, and L-glutamine.

2. The compound preparation for TCM constitution conditioning according to claim 1, characterized in that, The components of the ternary composite are as follows by weight: 30 to 60 parts of hydroxypropyl methylcellulose, 1 to 5 parts of fumed silica, and 35 to 65 parts of silicified microcrystalline cellulose. In the quaternary complex, there are 70 to 90 parts of the ternary complex and 10 to 30 parts of resistant dextrin; In the pentagonal complex, there are 85 to 95 parts of the quaternary complex and 5 to 15 parts of L-glutamine.

3. A compound preparation suitable for TCM constitution conditioning according to claim 1 or 2, characterized in that, The dosage forms of the ternary, quaternary, and pentagonal complexes are independently selected from any one of granules, powders, capsules, tablets, aqueous beverages, agar crystals, pastes, gels, soft candies, pills, drop pills, solid beverages, compressed candies, jelly candies, oral liquids, and extracts.

4. A method for preparing a compound preparation suitable for TCM constitution conditioning as described in any one of claims 1 to 3, characterized in that, Includes the following steps: 1) Raw materials are pulverized through an 80-200 mesh sieve; 2) Ingredients are precisely proportioned according to the formulas of ternary, quaternary, and pentagonal complexes; 3) Mixing is performed in a three-dimensional motion mixer for 20-30 minutes; 4) Wet granulation / dry granulation / direct mixing / dissolving and blending / concentration / gelling; 5) Boiling drying at 50-65℃ / hot air drying / vacuum drying / low-temperature concentration to a moisture content of 3.0%-5.0%; 6) Granulation, mixing, testing, and packaging are performed to produce granules, powders, capsules, tablets, aqueous beverages, agar crystals, pastes, gels, soft candies, pills, or solid beverage products.

5. A method for preparing a compound preparation suitable for TCM constitution conditioning as described in claim 4, characterized in that, In step 3), the mixing uniformity RSD ≤ 5%; Step 4) employs wet granulation, which specifically involves adding purified water or an appropriate amount of ethanol slurry and granulating in a wet mixing granulator; the stirring speed is 100-200 r / min, and the granulation time is 8-15 minutes. Between step 4) wet granulation and step 5) fluidized bed drying, extrusion molding was also carried out. Specifically, extrusion molding was performed by using a rotary extrusion granulator with a screen aperture of 1.0 to 1.5 mm to produce uniform wet granules. In step 5), the process parameters for fluidized bed drying are: inlet air temperature 50–65°C, material temperature 40–55°C, and drying to a moisture content of 3.0%–5.0%. In step 6), granulation specifically involves using a rotary granulator with a 14-16 mesh sieve to obtain uniform dry granules; total mixing specifically involves feeding the granulated granules into a two-dimensional mixer and mixing for 10-15 minutes to ensure uniformity.

6. The method for preparing a compound preparation suitable for TCM constitution conditioning as described in claim 4, characterized in that, In step 4), granulation is performed using a 1.0-1.5 mm sieve, and sizing is performed using a 14-16 mesh sieve, with a granule / powder forming rate ≥96%.

7. The application of a compound preparation for conditioning constitution according to any one of claims 1-3, characterized in that, The order of administration is: ternary complex → quaternary complex → pentagonal complex, taken in sequence.

8. The application of the compound preparation for TCM constitution conditioning according to claim 7, characterized in that, The standard dosing regimen is as follows: take the ternary complex for 15 consecutive days, the quaternary complex for 15 consecutive days, and the pentagonal complex for 15 consecutive days, for a complete cycle of 45 days.

9. The application of the compound preparation for TCM constitution conditioning according to claim 8, characterized in that, Depending on the individual's sensitivity and symptom type, a ternary complex / quadrivalent complex / pentavalent complex can be used alone for emergency improvement. Once the symptoms stabilize, a complete cycle of ternary complex → quadrivalent complex → pentavalent complex can be completed.

10. The application of a compound preparation for conditioning constitution according to any one of claims 1-3, characterized in that, The compound preparation is used for: regulating intestinal sensitivity, improving digestive rhythm, relieving discomfort during seasonal changes, regulating imbalances in the nine major constitutions according to traditional Chinese medicine, harmonizing the overall condition, protecting the digestive tract mucosa, repairing the intestinal barrier, and regulating health in all four seasons.

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