Traditional Chinese medicine composition based on ternary carrier and quaternary monarch, minister, assistant and guide reconstruction and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition based on ternary carrier and quaternary monarch, minister, assistant and guide reconstruction and a preparation method thereof. The traditional Chinese medicine composition comprises a ternary carrier and a quaternary prescription, according to the weight ratio, the ternary carrier accounts for 30%, and the quaternary prescription accounts for 70%; the ternary carrier comprises 15% of silicified microcrystalline cellulose, 5% of fumed silica and 10% of hydroxypropyl methyl cellulose; the quaternary prescription comprises 35% of monarch drugs, 20% of ministerial drugs, 10% of adjuvant drugs and 5% of conductant drugs. The traditional Chinese medicine composition can be prepared into various dosage forms, realizes dual adaptation of oral administration and external use, has the advantages of standardization, industrialization, definite curative effect and the like, solves the industrial pain points of traditional Chinese medicines and western medicines, and has important clinical and industrial values.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition based on the reconstruction of a ternary carrier and a quaternary principal, assistant, adjuvant, and guide agent, and its preparation method. Background Technology

[0002] Traditional Chinese medicine (TCM) has a long history of clinical application, demonstrating unique advantages in treating various diseases through its multi-component and multi-target mechanisms of action. However, traditional TCM preparations generally suffer from problems such as poor stability of active ingredients, low bioavailability, and insufficient targeting. Due to the lack of suitable carrier systems, the active ingredients of TCM are easily metabolized or degraded rapidly in the body, making it difficult to achieve effective therapeutic concentrations at the lesion site. This not only limits the full realization of the efficacy of TCM, but also makes its formulation and production difficult to standardize due to the lack of carrier systems. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a molded, standardized, effective and industrially producible traditional Chinese medicine composition, which improves its targeting and bioavailability by means of a carrier system.

[0004] The present invention solves the above-mentioned technical problems by adopting the following technical solution: a traditional Chinese medicine composition based on the reconstruction of a ternary carrier and a quaternary formula, characterized in that it comprises a ternary carrier and a quaternary formula; the ternary carrier accounts for 30% by weight and the quaternary formula accounts for 70% by weight.

[0005] The ternary carrier comprises 15% silicified microcrystalline cellulose, 5% fumed silica, and 10% hydroxypropyl methylcellulose; the quaternary formula comprises 35% principal drug, 20% assistant drug, 10% adjuvant drug, and 5% guiding drug.

[0006] Furthermore, the quaternary formula is selected from any one of the following combinations:

[0007] Combination 1: Principal herb: Saposhnikovia divaricata; Assistant herb: Schizonepeta tenuifolia; Adjuvant herb: Platycodon grandiflorus; Guide herb: Glycyrrhiza uralensis.

[0008] Combination 2: Principal herb: apricot kernel; Assistant herb: mulberry leaf; Adjuvant herb: fritillaria bulb; Guide herb: stemona root.

[0009] Combination 3: Ephedra as the principal herb, gypsum as the assistant herb, pinellia as the adjuvant herb, and licorice as the guiding herb;

[0010] Combination 4: Scutellaria baicalensis as the principal herb, Lonicera japonica as the assistant herb, Forsythia suspensa as the adjuvant herb, and Houttuynia cordata as the guiding herb;

[0011] Combination 5: Principal herb: Perilla seed; Assistant herb: Radish seed; Adjuvant herb: White mustard seed; Guide herb: Coltsfoot flower.

[0012] Combination 6: Astragalus membranaceus as the principal herb, Codonopsis pilosula as the assistant herb, Atractylodes macrocephala as the adjuvant herb, and Schisandra chinensis as the guiding herb;

[0013] Combination 7: Scrophularia ningpoensis as the principal herb, Ophiopogon japonicus as the assistant herb, Platycodon grandiflorus as the adjuvant herb, and Mentha haplocalyx as the guiding herb;

[0014] Combination 8: Principal herb: Isatis root; Assistant herb: Isatis leaf; Adjuvant herb: Arctium fruit; Guide herb: Licorice root;

[0015] Combination Nine: Primitive herb Magnolia biondii, assistant herb Xanthium sibiricum, adjuvant herb Angelica dahurica, and guiding herb Mentha haplocalyx;

[0016] Combination 10: Principal herb: Pueraria lobata; Assistant herb: Bupleurum chinense; Adjuvant herb: Magnolia biondii; Guide herb: Xanthium sibiricum.

[0017] Combination 11: Principal herb Gastrodia elata, assistant herb Uncaria rhynchophylla, adjuvant herb Haliotis diversicolor, and guiding herb Achyranthes bidentata;

[0018] Combination 12: Hawthorn as the principal herb, Cassia seed as the assistant herb, lotus leaf as the adjuvant herb, and Alisma plantago-aquatica as the guiding herb;

[0019] Combination 13: Chief herb: Salvia miltiorrhiza; Assistant herb: Ligusticum chuanxiong; Adjuvant herb: Carthamus tinctorius; Guide herb: Santalum album.

[0020] Combination 14: Principal herb Panax notoginseng, assistant herb Borneol, adjuvant herb Salvia miltiorrhiza, guiding herb Ligusticum chuanxiong;

[0021] Combination 15: Astragalus membranaceus as the principal herb, Angelica sinensis as the assistant herb, Codonopsis pilosula as the adjuvant herb, and Ophiopogon japonicus as the guiding herb;

[0022] Combination 16: Principal herb: Pueraria lobata; Assistant herb: Ligusticum chuanxiong; Adjuvant herb: Salvia miltiorrhiza; Guide herb: Ginkgo biloba.

[0023] Combination 17: Principal herb: earthworm; Assistant herb: scorpion; Adjuvant herb: centipede; Guide herb: astragalus.

[0024] Combination 18: Leech as the principal ingredient, horsefly as the assistant ingredient, peach kernel as the adjuvant ingredient, and safflower as the guiding ingredient;

[0025] Combination 19: Principal herb: Codonopsis pilosula; Assistant herb: Atractylodes macrocephala; Adjuvant herb: Poria cocos; Guide herb: Glycyrrhiza uralensis.

[0026] Combination 20: Cuttlebone (chief herb), Fritillaria thunbergii (assistant herb), Bletilla striata (adjuvant herb), and Glycyrrhiza uralensis (guide herb);

[0027] Combination 21: Astragalus membranaceus as the principal herb, Cinnamomum cassia as the assistant herb, Paeonia lactiflora as the adjuvant herb, and maltose as the guiding herb;

[0028] Combination 22: Chief herb Coptis chinensis, assistant herb Phellodendron chinense, adjuvant herb Fraxinus chinensis, and guiding herb Pulsatilla chinensis;

[0029] Combination 23: Rhubarb as the principal herb, Glauber's salt as the assistant herb, Citrus aurantium as the adjuvant herb, and Magnolia officinalis as the guiding herb;

[0030] Combination 24: Principal herb: Psoralea corylifolia; Assistant herb: Myristica fragrans; Adjuvant herb: Schisandra chinensis; Guide herb: Evodia rutaecarpa.

[0031] Combination 25: Principal herb: Bupleurum; Assistant herb: Curcuma longa; Adjuvant herb: Artemisia capillaris; Guide herb: Crataegus pinnatifida.

[0032] Combination 26: Principal ingredient: turtle shell; Assistant ingredient: tortoise plastron; Adjuvant ingredient: oyster shell; Guiding ingredient: salvia miltiorrhiza.

[0033] Combination 27: Principal herb Artemisia capillaris, assistant herb Gardenia jasminoides, adjuvant herb Rheum palmatum, guiding herb Lysimachia christinae;

[0034] Combination 28: Principal herb Lysimachia christinae, assistant herb Lygodium japonicum, adjuvant herb chicken gizzard membrane, and guiding herb Curcuma longa;

[0035] Combination 29: Principal herb: Bupleurum chinense; Assistant herb: Scutellaria baicalensis; Adjuvant herb: Paeonia lactiflora; Guide herb: Corydalis yanhusuo.

[0036] Combination 30: Chief herb: Patchouli; Assistant herb: Eupatorium fortunei; Adjuvant herb: Amomum villosum; Guide herb: Glycyrrhiza uralensis.

[0037] Combination 31: Astragalus membranaceus as the principal herb, Codonopsis pilosula as the assistant herb, Atractylodes macrocephala as the adjuvant herb, and Poria cocos as the guiding herb;

[0038] Combination 32: Principal herb Lysimachia christinae, assistant herb Lygodium japonicum, adjuvant herb Pyrrosia lingua, and guiding herb Dianthus superbus;

[0039] Combination 33: Chief herb: Plantago seed; Assistant herb: Akebia stem; Adjuvant herb: Talc; Guide herb: Licorice root.

[0040] Combination 34: Principal herb: Phellodendron bark; Assistant herb: Anemarrhena rhizome; Adjuvant herb: Cinnamon bark; Guiding herb: Alpinia oxyphylla.

[0041] Combination 35: Astragalus membranaceus as the principal herb, Angelica sinensis as the assistant herb, Prunus persica as the adjuvant herb, and Carthamus tinctorius as the guiding herb;

[0042] Combination 36: Principal herb: Dianthus superbus; Assistant herb: Polygonum aviculare; Adjuvant herb: Talc; Guide herb: Licorice.

[0043] Combination 37: Principal herb: Mantis egg case; Assistant herb: Alpinia oxyphylla; Adjuvant herb: Lindera strychnifolia; Guide herb: Dioscorea opposita.

[0044] Combination 38: Principal herb: Aconitum carmichaelii; Assistant herb: Cinnamomum cassia; Adjuvant herb: Rehmannia glutinosa; Guide herb: Dioscorea opposita.

[0045] Combination 39: Astragalus membranaceus as the principal herb, Dioscorea opposita as the assistant herb, Pueraria lobata as the adjuvant herb, and Trichosanthes kirilowii as the guiding herb;

[0046] Combination 40: Principal herb: Prunella vulgaris; Assistant herb: Fritillaria thunbergii; Adjuvant herb: Scrophularia ningpoensis; Guide herb: Oyster shell.

[0047] Combination 41: Principal herb: Rehmannia glutinosa; Assistant herb: Scrophularia ningpoensis; Adjuvant herb: Ophiopogon japonicus; Guiding herb: Oyster shell.

[0048] Combination 42: Principal herb: Aconitum carmichaelii; Assistant herb: Cinnamomum cassia; Adjuvant herb: Zingiber officinale; Guiding herb: Glycyrrhiza uralensis.

[0049] Combination 43: Principal herb: Angelica sinensis; Assistant herb: Ligusticum chuanxiong; Adjuvant herb: Paeonia lactiflora; Guide herb: Rehmannia glutinosa.

[0050] Combination 44: Principal herb Rehmannia glutinosa, assistant herb Angelica sinensis, adjuvant herb Paeonia lactiflora, guiding herb Bupleurum chinense;

[0051] Combination 45: The principal herb is lotus leaf, the assistant herb is cassia seed, the adjuvant herb is hawthorn, and the guiding herb is alisma.

[0052] Combination 46: Principal herb: Phellodendron bark; Assistant herb: Atractylodes rhizome; Adjuvant herb: Achyranthes root; Guide herb: Coix seed;

[0053] Combination 47: Principal herb: Smilax glabra; Assistant herb: Dioscorea hypoglauca; Adjuvant herb: Plantago asiatica; Guide herb: Alisma plantago-aquatica.

[0054] Combination 48: The principal herb is hawthorn, the assistant herb is cassia seed, the adjuvant herb is lotus leaf, and the guiding herb is alisma.

[0055] Combination 49: Principal herb: Pueraria lobata; Assistant herb: Cinnamomum cassia; Adjuvant herb: Paeonia lactiflora; Guide herb: Glycyrrhiza uralensis.

[0056] Combination 50: Eucommia ulmoides as the principal herb, Dipsacus as the assistant herb, Achyranthes bidentata as the adjuvant herb, and Angelica pubescens as the guiding herb;

[0057] Combination 51: Chief herb: Notopterygium root; Assistant herb: Saposhnikovia root; Adjuvant herb: Curcuma root; Guide herb: Licorice root;

[0058] Combination 52: Principal herb Angelica pubescens, assistant herb Notopterygium incisum, adjuvant herb Saposhnikovia divaricata, and guiding herb Asarum heterotropoides;

[0059] Combination 53: Tripterygium wilfordii (chief herb), Sinomenium acutum (assistant herb), Piper kadsura (adjuvant herb), and Glycyrrhiza uralensis (guide herb);

[0060] Combination 54: Principal herb Rehmannia glutinosa, assistant herb Dioscorea opposita, adjuvant herb Cornus officinalis, and guiding herb Eucommia ulmoides;

[0061] Combination 55: Principal herb: Phellodendron bark; Assistant herb: Atractylodes lancea; Adjuvant herb: Achyranthes bidentata; Guide herb: Coix seed.

[0062] Combination 56: Sophora flavescens (chief herb), Phellodendron chinense (assistant herb), Kochia scoparia (adjuvant herb), and Dictamnus dasycarpus (guide herb);

[0063] Combination 57: Chief herb: Schizonepeta tenuifolia; Assistant herb: Saposhnikovia divaricata; Adjuvant herb: Cicadae Periostracum; Guide herb: Glycyrrhiza uralensis.

[0064] Combination 58: Scutellaria baicalensis as the principal herb, Coptis chinensis as the assistant herb, Phellodendron chinense as the adjuvant herb, and Taraxacum mongolicum as the guiding herb;

[0065] Combination 59: Principal herb Angelica sinensis, assistant herb Ligusticum chuanxiong, adjuvant herb Paeonia lactiflora, and guiding herb Rehmannia glutinosa;

[0066] Combination 60: Principal herb: Saposhnikovia divaricata, Assistant herb: Schizonepeta tenuifolia, Adjuvant herb: Cicadae periostracum, Guide herb: Dictamnus dasycarpus;

[0067] Combination 61: Principal herb: Rehmannia glutinosa; Assistant herb: Paeonia suffruticosa; Adjuvant herb: Paeonia lactiflora; Guiding herb: Lithospermum erythrorhizon.

[0068] Combination 62: The principal herb is Angelica sinensis, the assistant herb is Ligusticum chuanxiong, the adjuvant herb is Saposhnikovia divaricata, and the guiding herb is Schizonepeta tenuifolia.

[0069] Combination 63: Principal herb: Scutellaria barbata; Assistant herb: Hedyotis diffusa; Adjuvant herb: Paris polyphylla; Guide herb: Astragalus membranaceus.

[0070] Combination 64: Principal herb: Sparganium rhizome; Assistant herb: Curcuma rhizome; Adjuvant herb: Hirudo medicinalis; Guiding herb: Astragalus membranaceus.

[0071] Combination 65: Principal herb Artemisia capillaris, assistant herb Gardenia jasminoides, adjuvant herb Rheum palmatum, guiding herb Scutellaria barbata;

[0072] Combination 66: Principal herb: Pulsatilla chinensis; Assistant herb: Coptis chinensis; Adjuvant herb: Phellodendron chinense; Guide herb: Fraxinus chinensis.

[0073] Combination 67: Principal herb: dandelion; Assistant herb: honeysuckle; Adjuvant herb: forsythia; Guide herb: astragalus.

[0074] Combination 68: Astragalus membranaceus as the principal herb, Atractylodes macrocephala as the assistant herb, Saposhnikovia divaricata as the adjuvant herb, and Glycyrrhiza uralensis as the guiding herb;

[0075] Combination 69: Principal herb: Codonopsis pilosula; Assistant herb: Atractylodes macrocephala; Adjuvant herb: Poria cocos; Guide herb: Glycyrrhiza uralensis.

[0076] Combination 70: Principal herb Rehmannia glutinosa, assistant herb Dioscorea opposita, adjuvant herb Cornus officinalis, and guiding herb Aconitum carmichaelii;

[0077] Combination 71: Principal herb: Ginseng; Assistant herb: Astragalus; Adjuvant herb: Angelica sinensis; Guide herb: Rehmannia glutinosa.

[0078] Combination 72: Principal herb: Ziziphus jujuba seed; Assistant herb: Platycladus orientalis seed; Adjuvant herb: Polygala tenuifolia root; Guide herb: Albizia julibrissin bark.

[0079] Combination 73: Principal herb: Bupleurum; Assistant herb: Curcuma longa; Adjuvant herb: Cyperus rotundus; Guide herb: Albizia julibrissin bark.

[0080] Combination 74: Chief herb: Bupleurum; Assistant herb: White peony root; Adjuvant herb: Angelica sinensis; Guide herb: Atractylodes macrocephala.

[0081] Combination 75: Chief herb: Ligusticum chuanxiong; Assistant herb: Angelica dahurica; Adjuvant herb: Asarum heterotropoides; Guide herb: Glycyrrhiza uralensis.

[0082] Combination 76: Astragalus membranaceus as the principal herb, Codonopsis pilosula as the assistant herb, Atractylodes macrocephala as the adjuvant herb, and Glycyrrhiza uralensis as the guiding herb;

[0083] Combination 77: Astragalus membranaceus as the principal herb, Atractylodes macrocephala as the assistant herb, Saposhnikovia divaricata as the adjuvant herb, and Glycyrrhiza uralensis as the guiding herb;

[0084] Combination 78: Principal herb Rehmannia glutinosa, assistant herb Angelica sinensis, adjuvant herb Paeonia lactiflora, guiding herb Ligusticum chuanxiong;

[0085] Combination 79: The principal herb is Angelica sinensis, the assistant herb is Astragalus membranaceus, the adjuvant herb is Codonopsis pilosula, and the guiding herb is Atractylodes macrocephala.

[0086] In the above technical solutions, combinations one through ten are used to treat respiratory diseases; combination one is used to treat colds, combination two is used to treat coughs, combination three is used to treat bronchitis, combination four is used to treat pneumonia, combination five is used to treat asthma, combination six is ​​used to treat COPD, combination seven is used to treat pharyngitis, combination eight is used to treat tonsillitis, combination nine is used to treat rhinitis, and combination ten is used to treat sinusitis.

[0087] In the above technical solutions, combinations eleven to eighteen are used to treat circulatory system diseases. Combination eleven is used to treat hypertension, combination twelve is used to treat hyperlipidemia, combination thirteen is used to treat coronary heart disease, combination fourteen is used to treat angina pectoris, combination fifteen is used to treat myocardial ischemia, combination sixteen is used to treat cerebral ischemia, combination seventeen is used to treat sequelae of cerebral infarction, and combination eighteen is used to treat varicose veins.

[0088] In the above technical solutions, combinations nineteen to thirty are used to treat digestive system diseases. Combination nineteen is used to treat gastritis, combination twenty is used to treat gastric ulcers, combination twenty-one is used to treat duodenal ulcers, combination twenty-two is used to treat enteritis, combination twenty-three is used to treat constipation, combination twenty-four is used to treat diarrhea, combination twenty-five is used to treat fatty liver, combination twenty-six is ​​used to treat cirrhosis, combination twenty-seven is used to treat cholecystitis, combination twenty-eight is used to treat gallstones, combination twenty-nine is used to treat pancreatitis, and combination thirty is used to treat halitosis.

[0089] In the above technical solutions, combinations 31 to 38 are used to treat urinary system diseases. Combination 31 is used to treat nephritis, combination 32 is used to treat kidney stones, combination 33 is used to treat urinary tract infections, combination 34 is used to treat prostatitis, combination 35 is used to treat benign prostatic hyperplasia, combination 36 is used to treat cystitis, combination 37 is used to treat urinary incontinence, and combination 38 is used to treat renal insufficiency.

[0090] In the above technical solutions, combinations 39 to 48 are used to treat endocrine system-related diseases. Combination 39 is used to treat diabetes, combination 40 is used to treat thyroid nodules, combination 41 is used to treat hyperthyroidism, combination 42 is used to treat hypothyroidism, combination 43 is used to treat polycystic ovary syndrome, combination 44 is used to treat menopausal syndrome, combination 45 is used to treat obesity, combination 46 is used to treat gout, combination 47 is used to treat hyperuricemia, and combination 48 is used to treat dyslipidemia.

[0091] In the above technical solutions, combinations 49 to 55 are used to treat musculoskeletal related diseases. Combination 49 is used to treat cervical spondylosis, combination 50 is used to treat lumbar disc herniation, combination 51 is used to treat frozen shoulder, combination 52 is used to treat rheumatism, combination 53 is used to treat rheumatoid arthritis, combination 54 is used to treat osteoporosis, and combination 55 is used to treat synovitis.

[0092] In the above technical solutions, combinations 56 to 62 are used to treat skin-related diseases. Combination 56 is used to treat eczema, combination 57 is used to treat dermatitis, combination 58 is used to treat acne, combination 59 is used to treat melasma, combination 60 is used to treat urticaria, combination 61 is used to treat psoriasis, and combination 62 is used to treat pruritus.

[0093] Of the above technical solutions, combinations 63 to 67 are used to treat oncology-related diseases. Combination 63 is used to treat lung cancer, combination 64 is used to treat gastric cancer, combination 65 is used to treat liver cancer, combination 66 is used to treat colorectal cancer, and combination 67 is used as adjuvant therapy after breast cancer surgery.

[0094] In the above technical solutions, combinations 68 to 71 are used to treat congenital or hereditary diseases. Combination 68 is used to treat allergic constitution, combination 69 is used to treat spleen and stomach weakness, combination 70 is used to treat kidney deficiency, and combination 71 is used to treat developmental delay.

[0095] In the above technical solutions, combinations 72 to 75 are used to treat neurological or mental illnesses. Combination 72 is used to treat insomnia, combination 73 is used to treat anxiety, combination 74 is used to treat depression, and combination 75 is used to treat migraines.

[0096] Of the above technical solutions, combinations 76 to 79 are used for sub-health or health maintenance. Combination 76 is used as an adjunct treatment for chronic fatigue syndrome, combination 77 is used as an adjunct treatment for low immunity, combination 78 is used as an adjunct treatment for premature aging, and combination 79 is used as an adjunct treatment for qi and blood deficiency.

[0097] Furthermore, the dosage form of the traditional Chinese medicine composition is any one of gel, ointment, poultice, granules, capsules, or tablets.

[0098] In another aspect, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition based on the reconstruction of a ternary carrier and a quaternary principal-assistant-guide component, comprising the following steps:

[0099] (1) Raw material pretreatment:

[0100] (11) Incoming material inspection: Inspect the Chinese medicinal materials to ensure that they meet the standards of the Chinese Pharmacopoeia, and inspect the ternary carrier materials and excipients to ensure that they meet the pharmaceutical grade standards;

[0101] (12) Pre-treatment of Chinese medicinal materials: cleaning, cutting, drying to a moisture content of ≤8%, and pulverizing the dried Chinese medicinal materials to 80-100 mesh;

[0102] (2) Extraction process:

[0103] (21) Extraction of the four-element formula: accurately weigh the principal, assistant, adjuvant and guide medicinal materials, extract with water or alcohol, filter, and then concentrate to a relative density of 1.10-1.20 (60℃).

[0104] (22) Drying and powdering: The product concentrated in step (21) is spray-dried to obtain quaternary dry powder; the moisture content of the quaternary dry powder is ≤5% and the particle size is 80-100 mesh;

[0105] (3) Total mixture:

[0106] (31) The quaternary dry powder obtained in step (22) and the ternary carrier material are added into a mixer in proportion to obtain ternary + quaternary composite powder;

[0107] (32) The mixing order is as follows: first mix the quaternary dry powder and siliconized microcrystalline cellulose, then add hydroxypropyl methylcellulose, and finally add fumed silica;

[0108] (33) Total mixing time ≥ 45 min, mixing uniformity RSD ≤ 5%;

[0109] (4) Molding:

[0110] (41) Matrix preparation: Dissolve purified water, glycerol, and carbomer by heating, and cool to 40°C to obtain the matrix;

[0111] (42) Adding powder: Slowly add the ternary + quaternary composite powder obtained in step (3) to the matrix and stir at 300-500 r / min for 30 min.

[0112] (43) Adjust the pH to 5.5-7.0 to form a uniform, translucent gel;

[0113] (5) Curing, filling and inspection:

[0114] (51) Let the molded product stand at room temperature for 24 hours to mature;

[0115] (52) Filling and sealing, wherein the filling amount of gel is 5-50 g / tube and the filling amount of ointment is 10-30 g / tube;

[0116] (53) Conduct finished product inspection on the sealed canned products, and put them into storage if they pass the inspection.

[0117] In step (21), the extraction method is water extraction or alcohol extraction.

[0118] Preferably, in step (21), the extraction method is a combination of water extraction and alcohol extraction, including a first water extraction and a second alcohol extraction.

[0119] Preferably, in step (21), the concentration is reduced to a relative density of 1.15; the relative density is measured at 60°C.

[0120] Compared with the prior art, the beneficial effects of the present invention are:

[0121] (1) In the ternary carrier of this invention, the functions of silicified microcrystalline cellulose are: shaping, disintegration, and dissolution promotion. The functions of fumed silica are: flow aid, anti-caking, stabilization, and thickening. The functions of hydroxypropyl methylcellulose are: sustained release, adhesion, penetration promotion, and core formation. The core structure and function of the ternary carrier have irreplaceable technical value and are the core innovation of this invention.

[0122] (2) Quaternary matching logic of the present invention:

[0123] Jun: Main disease and main symptoms, core target.

[0124] Minister: To assist and enhance effectiveness.

[0125] Assistant: to restrain toxicity and harmonize the properties of medicines.

[0126] To guide or harmonize various medicines.

[0127] (3) The ternary carrier material of the present invention has strong versatility and compatibility, and its protection scope can cover a variety of combined use scenarios. Any combination of the ternary composite material carrier structure described in the present invention with any disclosed material, component, formulation or technical solution falls within the protection scope of this patent right. Regardless of the source, properties, or form of disclosure (including literature disclosure, product disclosure, technical disclosure, etc.) of the disclosed material, as long as it together with the ternary composite material carrier structure constitutes a technical solution for a traditional Chinese medicine composition, it falls within the protection scope of this patent.

[0128] Combined use of classified publicly disclosed ingredients: Any publicly disclosed ingredients, components, or formulations in nationally classified drugs or materials, when used in combination with the ternary carrier material structure described in this invention, fall within the scope of protection of this patent. The aforementioned publicly disclosed ingredients in nationally classified drugs / materials include, but are not limited to, their disclosed core components, proportioning parameters, and disclosed steps in the preparation process. This protection scope covers all application forms, including direct combination, indirect combination, and modified combination, and is not limited by the confidentiality level of the drug / material itself.

[0129] (4) Product application and performance advantages: The traditional Chinese medicine composition of the present invention can achieve the following performance improvements:

[0130] Good formability: Relying on the ternary carrier structure and the characteristics of the specific preparation method, the composition has stable formability and can be adapted to the preparation needs of various dosage forms;

[0131] Wide range of applications: It can cover a variety of diseases and provide support for the treatment of different conditions;

[0132] Standardized and controllable quality: The preparation process and product quality can be standardized and controlled to ensure consistency and stability between batches;

[0133] Dual adaptability for usage scenarios: It takes into account both internal and external use, expanding the application scenarios of the product and meeting different drug administration needs;

[0134] Balance between efficacy and safety: Practice has proven that the composition is effective and safe and non-toxic, improving medication safety while ensuring therapeutic effect;

[0135] High feasibility for industrialization: The preparation process is adapted to the requirements of industrial production, enabling large-scale mass production, reducing production costs and improving production efficiency. Detailed Implementation

[0136] 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.

[0137] The embodiments of this invention describe 11 major categories, 79 types of diseases, and 79 exhaustive prescriptions, all of which are within the scope of core rights protection. Any equivalent substitutions, deletions, or modifications fall within the scope of protection.

[0138] The composition of this invention consists of 30% ternary carrier + 70% quaternary agent;

[0139] Ternary carrier: 15% silicified microcrystalline cellulose, 5% fumed silica, and 10% hydroxypropyl methylcellulose.

[0140] Four-element formula: 35% principal ingredient, 20% assistant ingredient, 10% adjuvant ingredient, and 5% guiding ingredient.

[0141] Dosage forms: gels, ointments, poultices, granules, capsules, tablets.

[0142] This invention also provides a method for preparing a traditional Chinese medicine composition based on a ternary carrier and a quaternary principal-assistant-guide reconstructed composition, comprising the following steps:

[0143] (1) Raw material pretreatment:

[0144] (11) Incoming material inspection: Inspect the Chinese medicinal materials to ensure that they meet the standards of the Chinese Pharmacopoeia, and inspect the ternary carrier materials and excipients to ensure that they meet the pharmaceutical grade standards;

[0145] (12) Pre-treatment of Chinese medicinal materials: cleaning, cutting, drying to a moisture content of ≤8%, and pulverizing the dried Chinese medicinal materials to 80-100 mesh;

[0146] (2) Extraction process:

[0147] (21) Extraction of the four-element formula: accurately weigh the principal, assistant, adjuvant and guide medicinal materials, extract them together, filter them, and then concentrate them to a relative density of 1.10-1.20 (60℃).

[0148] (22) Drying and powdering: The product concentrated in step (21) is spray-dried to obtain quaternary dry powder; the moisture content of the quaternary dry powder is ≤5% and the particle size is 80-100 mesh;

[0149] (3) Total mixture:

[0150] (31) The quaternary dry powder obtained in step (22) and the ternary carrier material are added into a mixer in proportion to obtain ternary + quaternary composite powder;

[0151] (32) The mixing order is as follows: first mix the quaternary dry powder and siliconized microcrystalline cellulose, then add hydroxypropyl methylcellulose, and finally add fumed silica;

[0152] (33) Total mixing time ≥ 45 min, mixing uniformity RSD ≤ 5%;

[0153] (4) Molding:

[0154] (41) Matrix preparation: Dissolve purified water, glycerol, and carbomer by heating, and cool to 40°C to obtain the matrix;

[0155] (42) Adding powder: Slowly add the ternary + quaternary composite powder obtained in step (3) to the matrix and stir at 300-500 r / min for 30 min.

[0156] (43) Adjust the pH to 5.5-7.0 to form a uniform, translucent gel;

[0157] (5) Curing, filling and inspection:

[0158] (51) Let the molded product stand at room temperature for 24 hours to mature;

[0159] (52) Filling and sealing, wherein the filling amount of gel is 5-50 g / tube and the filling amount of ointment is 10-30 g / tube;

[0160] (53) Conduct finished product inspection on the sealed canned products, and put them into storage if they pass the inspection.

[0161] In step (21), the extraction method is a combination of water extraction and alcohol extraction, that is, a first water extraction and a second alcohol extraction are performed sequentially. Specifically, the water-alcohol extraction process is used to extract the medicinal material, and the extraction method is a combination of water extraction and alcohol extraction, that is, a first water extraction and a second alcohol extraction are performed sequentially. The first extraction is a water extraction using purified water as the extraction solvent; the second extraction is an alcohol extraction using ethanol (95% pharmaceutical grade) as the extraction solvent. The specific parameters are as follows: For the first water extraction, the material-to-liquid ratio is 1:8 (g:mL), that is, 1000g of medicinal material is added to 8000mL of purified water, soaked at room temperature for 30min, and then heated at 95~100℃ under a slight boiling state for 120min. The extract is filtered while hot through a 200-mesh filter cloth, and filtrate A is collected, while the residue is reserved for later use. For the second alcohol extraction, the residue after water extraction is used as raw material, and 6000mL of 60% ethanol is added at a material-to-liquid ratio of 1:6 (g:mL). The extract is heated at 75~80℃ under reflux for 90min. The extract is filtered through a 200-mesh filter cloth, and filtrate B is collected. After extraction, filtrate A and filtrate B are combined to obtain the total extract. The total extract is concentrated under reduced pressure at a vacuum degree of -0.06~-0.08Mpa, a water bath temperature of 60℃, and a stirring speed of 60r / min. Concentration is complete when the relative density of the concentrated product at 60℃ reaches 1.10~1.20. Each of the four medicinal materials needs to be extracted separately.

[0162] Preparation Example 1

[0163] The composition consists of 30% ternary carrier and 70% quaternary formula.

[0164] Ternary carrier: 15% silicified microcrystalline cellulose, 5% fumed silica, and 10% hydroxypropyl methylcellulose.

[0165] The four-element formula consists of: 35% Saposhnikovia divaricata (chief herb), 20% Schizonepeta tenuifolia (assistant herb), 10% Platycodon grandiflorus (adjuvant herb), and 5% Glycyrrhiza uralensis (guide herb).

[0166] The preparation method of the traditional Chinese medicine composition reconstructed from the ternary carrier and the quaternary principal, assistant, adjuvant, and guide elements includes the following steps:

[0167] (1) Raw material pretreatment:

[0168] (11) Incoming material inspection: Inspect the principal, assistant, adjuvant and guide Chinese medicinal materials to ensure that they meet the standards of the Chinese Pharmacopoeia, and inspect the ternary carrier materials and excipients to ensure that they meet the pharmaceutical grade standards;

[0169] (12) Pre-treatment of Chinese medicinal materials: cleaning, cutting, drying to a moisture content of ≤8%, and pulverizing the dried Chinese medicinal materials to 80-100 mesh;

[0170] (2) Extraction process:

[0171] (21) Extraction of the four-element formula: The principal, assistant, adjuvant, and guiding medicinal materials are accurately weighed and extracted by a combination of water extraction and alcohol extraction to obtain a concentrated product of the total extract; wherein, the medicinal materials are extracted by a combination of water extraction and alcohol extraction, that is, water extraction and alcohol extraction are performed sequentially. The first extraction is water extraction, using purified water as the extraction solvent; the second extraction is alcohol extraction, using ethanol (pharmaceutical grade 95%) as the extraction solvent. The specific parameters are as follows: For the first water extraction, the material-to-liquid ratio is 1:8 (g:mL), that is, 1000g of medicinal material is added to 8000mL of purified water, soaked at room temperature for 30min, and then heated and extracted at 95~100℃ under a slight boiling state for 120min. The extract is filtered hot through a 200-mesh filter cloth, and filtrate A is collected, while the residue is reserved for later use. For the second alcohol extraction, the residue after water extraction is used as raw material, and 6000mL of 60% ethanol is added at a material-to-liquid ratio of 1:6 (g:mL). The extract is heated and refluxed at 75~80℃ for 90min. The extract is filtered through a 200-mesh filter cloth, and filtrate B is collected. After extraction, filtrate A and filtrate B are combined to obtain the total extract. The total extract is concentrated under reduced pressure at a vacuum degree of -0.06~-0.08Mpa, a water bath temperature of 60℃, and a stirring speed of 60r / min. Concentration is complete when the relative density of the concentrated product at 60℃ reaches 1.15. Each of the four medicinal materials needs to be extracted separately.

[0172] (22) Drying and powdering: The product concentrated in step (21) is spray-dried to obtain quaternary dry powder; the moisture content of the quaternary dry powder is ≤5% and the particle size is 80-100 mesh;

[0173] (3) Total mixture:

[0174] (31) The quaternary dry powder obtained in step (22) and the ternary carrier material are added into a mixer in proportion to obtain ternary + quaternary composite powder;

[0175] (32) The mixing order is as follows: first mix the quaternary dry powder and siliconized microcrystalline cellulose, then add hydroxypropyl methylcellulose, and finally add fumed silica;

[0176] (33) Total mixing time ≥ 45 min, mixing uniformity RSD ≤ 5%;

[0177] (4) Molding:

[0178] (41)Matrix preparation: Heat and dissolve purified water, glycerol, and carbomer, and cool to 40°C to obtain the matrix. Specifically, the matrix is composed of the following components by weight percentage: purified water 95.0%, glycerol 1.5%, carbomer 1.0%, triethanolamine 2.0%, and preservative 0.5%. Mix purified water and glycerol, stir at 300 r / min for 10 min, slowly add carbomer, and continue stirring for 30 min until completely swollen. Heat to 60°C and keep warm for 10 min, then cool to 40°C. Add triethanolamine to adjust the pH to 5.5 - 7.0. Slowly add the ternary + quaternary composite powder at a ratio of 10% of the matrix weight to the matrix, control the stirring speed at 400 r / min, continuously stir for 30 min until uniform and delicate, let it stand and ripen at room temperature for 24 h, and then fill into containers to obtain the product.

[0179] (42)Addition of medicinal powder: Slowly add the ternary + quaternary composite powder obtained in step (3) to the matrix at a ratio of 10% of the matrix weight, control the stirring speed at 400 r / min, continuously stir for 30 min until uniform and delicate, adjust the pH to 5.5 - 7.0, let it stand and ripen at room temperature for 24 h, and then fill into containers to obtain the product.

[0180] Detailed examples of formula compositions: Exhaustive examples for 79 types of diseases + 79 detailed formula compositions of monarch, minister, assistant, and courier herbs

[0181] I. Respiratory system (10 types - detailed formula compositions)

[0182] 1. Cold: Monarch (Saposhnikovia divaricata), Minister (Schizonepeta tenuifolia), Assistant (Platycodon grandiflorum), Courier (Glycyrrhiza glabra);

[0183] 2. Cough: Monarch (Prunus armeniaca), Minister (Morus alba), Assistant (Fritillaria thunbergii), Courier (Stemona japonica);

[0184] 3. Bronchitis: Monarch (Ephedra sinica), Minister (Gypsum fibrosum), Assistant (Pinellia ternata), Courier (Glycyrrhiza glabra);

[0185] 4. Pneumonia: Monarch (Scutellaria baicalensis), Minister (Lonicera japonica), Assistant (Forsythia suspensa), Courier (Houttuynia cordata);

[0186] 5. Asthma: Monarch (Perilla frutescens), Minister (Raphanus sativus), Assistant (Sinapis alba), Courier (Tussilago farfara);

[0187] 6. COPD: Monarch (Astragalus membranaceus), Minister (Codonopsis pilosula), Assistant (Atractylodes macrocephala), Courier (Schisandra chinensis);

[0188] 7. Pharyngitis: Monarch (Scrophularia ningpoensis), Minister (Ophiopogon japonicus), Assistant (Platycodon grandiflorum), Courier (Mentha haplocalyx);

[0189] 8. Tonsillitis: Monarch (Isatis indigotica), Minister (Isatis tinctoria), Assistant (Arctium lappa), Courier (Glycyrrhiza glabra);

[0190] 9. Rhinitis: Principal ingredient (Magnolia biondii), assistant ingredient (Xanthium sibiricum), adjuvant ingredient (Angelica dahurica), and guide ingredient (Mentha haplocalyx);

[0191] 10. Sinusitis: Chief ingredient (Pueraria lobata), assistant ingredient (Bupleurum chinense), adjuvant ingredient (Magnolia biondii), and guide ingredient (Xanthium sibiricum).

[0192] II. Circulatory System (8 categories, formulation details)

[0193] 1. Hypertension: Principal ingredient (Gastrodia elata), assistant ingredient (Uncaria rhynchophylla), adjuvant ingredient (Abalone shell), guide ingredient (Achyranthes bidentata);

[0194] 2. Hyperlipidemia: Principal ingredient (hawthorn), assistant ingredient (cassia seed), adjuvant ingredient (lotus leaf), guide ingredient (alism);

[0195] 3. Coronary heart disease: Chief ingredient (Salvia miltiorrhiza), Assistant ingredient (Ligusticum chuanxiong), adjuvant ingredient (Carthamus tinctorius), guide ingredient (Santalum album);

[0196] 4. Angina pectoris: Chief ingredient (Sanqi), Assistant ingredient (Bingpian), Adjuvant ingredient (Danshen), Guide ingredient (Chuanxiong);

[0197] 5. Myocardial ischemia: Chief ingredient (Astragalus membranaceus), Assistant ingredient (Angelica sinensis), adjuvant ingredient (Codonopsis pilosula), guiding ingredient (Ophiopogon japonicus);

[0198] 6. Insufficient blood supply to the brain: Principal ingredient (Pueraria lobata), Assistant ingredient (Ligusticum chuanxiong), adjuvant ingredient (Salvia miltiorrhiza), guiding ingredient (Ginkgo biloba);

[0199] 7. Sequelae of cerebral infarction: Principal ingredient (earthworm), assistant ingredient (scorpion), adjuvant ingredient (centipede), guide ingredient (astragalus);

[0200] 8. Varicose veins: Leech (chief), horsefly (assistant), peach kernel (adjuvant), safflower (guide).

[0201] III. Digestive System (12 categories, detailed formulation)

[0202] 1. Gastritis: Chief ingredient (Codonopsis pilosula), Assistant ingredient (Atractylodes macrocephala), adjuvant ingredient (Poria cocos), guide ingredient (Glycyrrhiza uralensis);

[0203] 2. Gastric ulcer: Chief ingredient (cuttlebone), assistant ingredient (Fritillaria thunbergii), adjuvant ingredient (Bletilla striata), guide ingredient (Glycyrrhiza uralensis);

[0204] 3. Duodenal ulcer: Chief ingredient (Astragalus membranaceus), assistant ingredient (Cinnamomum cassia), adjuvant ingredient (Paeonia lactiflora), guide ingredient (maltose);

[0205] 4. Enteritis: Chief ingredient (Coptis chinensis), assistant ingredient (Phellodendron chinense), adjuvant ingredient (Fraxinus chinensis), and guide ingredient (Pulsatilla chinensis).

[0206] 5. Constipation: Chief ingredient (rhubarb), assistant ingredient (sodium sulfate), adjuvant ingredient (citrus aurantium), guide ingredient (magnolia officinalis);

[0207] 6. Diarrhea: Principal ingredient (Psoralea corylifolia), assistant ingredient (Myristica fragrans), adjuvant ingredient (Schisandra chinensis), guide ingredient (Evodia rutaecarpa);

[0208] 7. Fatty liver: Chief ingredient (Bupleurum), Assistant ingredient (Turmeric), Assisting ingredient (Artemisia capillaris), Guide ingredient (Hawthorn);

[0209] 8. Liver cirrhosis: Principal ingredient (turtle shell), assistant ingredient (tortoise plastron), adjuvant ingredient (oyster shell), guiding ingredient (salvia miltiorrhiza);

[0210] 9. Cholecystitis: Chief ingredient (Artemisia capillaris), Assistant ingredient (Gardenia jasminoides), adjuvant ingredient (Rheum palmatum), guide ingredient (Lysimachia christinae);

[0211] 10. Gallstones: Chief ingredient (Lysimachia christinae), assistant ingredient (Lygodium japonicum), adjuvant ingredient (chicken gizzard lining), guide ingredient (Curcuma longa);

[0212] 11. Pancreatitis: Chief ingredient (Bupleurum chinense), Assistant ingredient (Scutellaria baicalensis), adjuvant ingredient (Paeonia lactiflora), guiding ingredient (Corydalis yanhusuo);

[0213] 12. Halitosis: Chief ingredient (Agastache rugosa), assistant ingredient (Eupatorium fortunei), adjuvant ingredient (Amomum villosum), guide ingredient (Glycyrrhiza uralensis);

[0214] IV. Urinary System (8 categories, formulation details);

[0215] 1. Nephritis: Chief ingredient (Astragalus membranaceus), Assistant ingredient (Codonopsis pilosula), adjuvant ingredient (Atractylodes macrocephala), guide ingredient (Poria cocos);

[0216] 2. Kidney stones: Chief ingredient (Lysimachia christinae), Assistant ingredient (Lygodium japonicum), Assistant ingredient (Pyrrosia lingua), Guide ingredient (Dianthus superbus);

[0217] 3. Urinary tract infection: Chief ingredient (Plantago asiatica), Assistant ingredient (Akebia quinata), adjuvant ingredient (talc), guide ingredient (licorice);

[0218] 4. Prostatitis: Principal ingredient (Phellodendron bark), assistant ingredient (Anemarrhena rhizome), adjuvant ingredient (Cinnamon bark), guide ingredient (Alpinia oxyphylla).

[0219] 5. Benign prostatic hyperplasia: Chief ingredient (Astragalus membranaceus), Assistant ingredient (Angelica sinensis), adjuvant ingredient (Prunus persica), guiding ingredient (Carthamus tinctorius);

[0220] 6. Cystitis: Chief ingredient (Dianthus superbus), assistant ingredient (Polygonum aviculare), adjuvant ingredient (talc), guide ingredient (Glycyrrhiza uralensis);

[0221] 7. Urinary incontinence: Chief ingredient (mantis egg case), assistant ingredient (alpinia oxyphylla), adjuvant ingredient (lindera root), guide ingredient (yam);

[0222] 8. Renal insufficiency: Chief ingredient (Aconite), Assistant ingredient (Cinnamon), Assistant ingredient (Rehmannia glutinosa), Guide ingredient (Dioscorea opposita).

[0223] V. Endocrine / Metabolism (10 categories, formulation details)

[0224] 1. Diabetes: Chief ingredient (Astragalus membranaceus), Assistant ingredient (Dioscorea opposita), Assistant ingredient (Pueraria lobata), Guide ingredient (Trichosanthes kirilowii).

[0225] 2. Thyroid nodules: Chief ingredient (Prunella vulgaris), Assistant ingredient (Fritillaria thunbergii), adjuvant ingredient (Scrophularia ningpoensis), guide ingredient (Ostrea gigas);

[0226] 3. Hyperthyroidism: Chief ingredient (Rehmannia glutinosa), Assistant ingredient (Scrophularia ningpoensis), adjuvant ingredient (Ophiopogon japonicus), guide ingredient (Ostrea gigas);

[0227] 4. Hypothyroidism: Chief ingredient (Aconite), Assistant ingredient (Cinnamon), Supporting ingredient (Dried Ginger), Guiding ingredient (Licorice);

[0228] 5. Polycystic ovary syndrome: Chief ingredient (Angelica sinensis), Assistant ingredient (Ligusticum chuanxiong), adjuvant ingredient (Paeonia lactiflora), guide ingredient (Rehmannia glutinosa);

[0229] 6. Menopausal syndrome: Chief ingredient (Rehmannia glutinosa), Assistant ingredient (Angelica sinensis), adjuvant ingredient (Paeonia lactiflora), guide ingredient (Bupleurum chinense);

[0230] 7. Obesity: The main ingredient is lotus leaf, the assistant ingredient is cassia seed, the adjuvant ingredient is hawthorn, and the guiding ingredient is alisma.

[0231] 8. Gout: Chief ingredient (Phellodendron bark), assistant ingredient (Atractylodes lancea), adjuvant ingredient (Achyranthes bidentata), and guide ingredient (Coix lacryma-jobi).

[0232] 9. High uric acid: Chief ingredient (Smilax glabra), Assistant ingredient (Dioscorea hypoglauca), adjuvant ingredient (Plantago asiatica), guide ingredient (Alisma plantago-aquatica);

[0233] 10. Dyslipidemia: The main ingredient is hawthorn, the assistant ingredient is cassia seed, the adjuvant ingredient is lotus leaf, and the guiding ingredient is alisma.

[0234] VI. Skeletal Muscles (7 categories, formulation details)

[0235] 1. Cervical spondylosis: Chief ingredient (Pueraria lobata), Assistant ingredient (Cinnamomum cassia), adjuvant ingredient (Paeonia lactiflora), guide ingredient (Glycyrrhiza uralensis);

[0236] 2. Lumbar disc herniation: Chief ingredient (Eucommia ulmoides), Assistant ingredient (Dipsacus asper), Adjuvant ingredient (Achyranthes bidentata), Guide ingredient (Angelica pubescens);

[0237] 3. Frozen shoulder: Chief ingredient (Notopterygium root), Assistant ingredient (Saposhnikovia root), adjuvant ingredient (Curcuma longa), guide ingredient (Glycyrrhiza root);

[0238] 4. Rheumatism: Chief ingredient (Angelica pubescens), Assistant ingredient (Notopterygium incisum), adjuvant ingredient (Saposhnikovia divaricata), guide ingredient (Asarum heterotropoides);

[0239] 5. Rheumatoid arthritis: Chief ingredient (Tripterygium wilfordii), Assistant ingredient (Sinomenium acutum), Assistant ingredient (Piper kadsura), Guide ingredient (Glycyrrhiza uralensis);

[0240] 6. Osteoporosis: Chief ingredient (Rehmannia glutinosa), Assistant ingredient (Dioscorea opposita), adjuvant ingredient (Cornus officinalis), guiding ingredient (Eucommia ulmoides);

[0241] 7. Synovitis: Chief ingredient (Phellodendron bark), assistant ingredient (Atractylodes lancea), adjuvant ingredient (Achyranthes bidentata), and guide ingredient (Coix lacryma-jobi).

[0242] VII. Dermatology (7 categories, formulation details)

[0243] 1. Eczema: Chief ingredient (Sophora flavescens), Assistant ingredient (Phellodendron chinense), adjuvant ingredient (Kochia scoparia), and guide ingredient (Dictamnus dasycarpus).

[0244] 2. Dermatitis: Chief ingredient (Schizonepeta tenuifolia), Assistant ingredient (Saposhnikovia divaricata), adjuvant ingredient (Cicada slough), guide ingredient (Glycyrrhiza uralensis);

[0245] 3. Acne: Chief ingredient (Scutellaria baicalensis), assistant ingredient (Coptis chinensis), adjuvant ingredient (Phellodendron chinense), guide ingredient (Taraxacum mongolicum);

[0246] 4. Melasma: Chief ingredient (Angelica sinensis), Assistant ingredient (Ligusticum chuanxiong), adjuvant ingredient (Paeonia lactiflora), guide ingredient (Rehmannia glutinosa);

[0247] 5. Urticaria: Chief ingredient (Saposhnikovia divaricata), Assistant ingredient (Schizonepeta tenuifolia), adjuvant ingredient (Cicada slough), guide ingredient (Dictamnus dasycarpus);

[0248] 6. Psoriasis: Chief ingredient (Rehmannia glutinosa), Assistant ingredient (Paeonia suffruticosa), adjuvant ingredient (Paeonia lactiflora), and guiding ingredient (Lithospermum erythrorhizon);

[0249] 7. Skin itching: Chief ingredient (Angelica sinensis), assistant ingredient (Ligusticum chuanxiong), adjuvant ingredient (Saposhnikovia divaricata), and guide ingredient (Schizonepeta tenuifolia).

[0250] VIII. Oncology (5 categories, detailed prescriptions)

[0251] 1. Lung cancer: Chief ingredient (Scutellaria barbata), Assistant ingredient (Hedyotis diffusa), Assistant ingredient (Paris polyphylla), Guide ingredient (Astragalus membranaceus);

[0252] 2. Stomach cancer: Chief ingredient (Sparganium rhizome), Assistant ingredient (Curcuma zedoaria rhizome), adjuvant ingredient (Hirudo medicinalis rhizome), guiding ingredient (Astragalus membranaceus rhizome);

[0253] 3. Liver cancer: Chief ingredient (Artemisia capillaris), Assistant ingredient (Gardenia jasminoides), Assistant ingredient (Rheum palmatum), Guide ingredient (Scutellaria barbata);

[0254] 4. Colorectal cancer: Principal ingredient (Pulsatilla chinensis), assistant ingredient (Coptis chinensis), adjuvant ingredient (Phellodendron chinense), and guide ingredient (Fraxinus chinensis).

[0255] 5. Breast Cancer (Postoperative Adjuvant Therapy): Chief ingredient (Dandelion), Assistant ingredient (Honeysuckle), Assistant ingredient (Forsythia), Guide ingredient (Astragalus).

[0256] IX. Congenital / Hereditary (4 categories, formulation details)

[0257] 1. Allergic constitution: Chief ingredient (Astragalus membranaceus), Assistant ingredient (Atractylodes macrocephala), adjuvant ingredient (Saposhnikovia divaricata), guide ingredient (Glycyrrhiza uralensis);

[0258] 2. For spleen and stomach deficiency: Chief ingredient (Codonopsis pilosula), Assistant ingredient (Atractylodes macrocephala), adjuvant ingredient (Poria cocos), and guiding ingredient (Glycyrrhiza uralensis);

[0259] 3. Kidney Qi Deficiency: Chief (Rehmannia glutinosa), Assistant (Dioscorea opposita), Adjuvant (Cornus officinalis), Guide (Aconitum carmichaelii);

[0260] 4. Developmental delay: Principal (ginseng), Assistant (astragalus), adjuvant (angelica), guide (rehmannia).

[0261] 10. Neurological / Psychiatric (4 categories, prescription details)

[0262] 1. Insomnia: Chief ingredient (Ziziphus jujuba seed), assistant ingredient (Platycladus orientalis seed), adjuvant ingredient (Polygala tenuifolia root), and guide ingredient (Albizia julibrissin bark);

[0263] 2. Anxiety: Chief ingredient (Bupleurum), Assistant ingredient (Turmeric), Assistant ingredient (Cyperus), Guide ingredient (Albizia bark);

[0264] 3. Depression: Chief ingredient (Bupleurum chinense), Assistant ingredient (Paeonia lactiflora), adjuvant ingredient (Angelica sinensis), guide ingredient (Atractylodes macrocephala);

[0265] 4. Migraine: Chief ingredient (Ligusticum chuanxiong), assistant ingredient (Angelica dahurica), adjuvant ingredient (Asarum heterotropoides), and guide ingredient (Glycyrrhiza uralensis).

[0266] XI. Sub-health / Wellness (4 categories, detailed formula)

[0267] 1. Fatigue Syndrome: Chief ingredient (Astragalus membranaceus), Assistant ingredient (Codonopsis pilosula), adjuvant ingredient (Atractylodes macrocephala), guiding ingredient (Glycyrrhiza uralensis);

[0268] 2. Low immunity: Chief ingredient (Astragalus membranaceus), Assistant ingredient (Atractylodes macrocephala), adjuvant ingredient (Saposhnikovia divaricata), guide ingredient (Glycyrrhiza uralensis);

[0269] 3. Premature aging: Chief ingredient (Rehmannia glutinosa), Assistant ingredient (Angelica sinensis), adjuvant ingredient (Paeonia lactiflora), guide ingredient (Ligusticum chuanxiong);

[0270] 4. Qi and Blood Deficiency: Chief ingredient (Angelica sinensis), Assistant ingredient (Astragalus membranaceus), adjuvant ingredient (Codonopsis pilosula), and guide ingredient (Atractylodes macrocephala).

[0271] Effect Example

[0272] I. Inclusion Criteria

[0273] 1. Age 25-65, gender not limited;

[0274] 2. Meets the Western medicine diagnostic criteria and the traditional Chinese medicine syndrome differentiation criteria for the corresponding disease;

[0275] 3. No similar drugs, hormone drugs, or other targeted interventions have been used in the past 4 weeks;

[0276] 4. Did not receive non-drug targeted treatments such as acupuncture, physical therapy, or dietary therapy;

[0277] 5. Voluntarily participate in this study, sign informed consent form, and demonstrate good compliance.

[0278] II. Exclusion Criteria

[0279] 1. Individuals with severe heart, liver, or kidney dysfunction, or those with coagulation disorders;

[0280] 2. Individuals with serious underlying conditions such as malignant tumors, autoimmune diseases, or mental illnesses;

[0281] 3. Pregnant or breastfeeding women;

[0282] 4. Individuals allergic to any of the drug components used in this study;

[0283] 5. Individuals who have participated in other clinical trials within the past 4 weeks;

[0284] 6. Patients with poor compliance who are unable to complete the treatment course and follow-up.

[0285] III. General Information

[0286] A total of 158 patients who met the inclusion and exclusion criteria and were admitted to relevant departments of a tertiary hospital between May 10, 2025 and December 10, 2025 were selected. They were randomly divided into a control group and a treatment group, with 79 patients in each group. There were no statistically significant differences between the two groups in terms of age, disease duration, disease severity, and TCM syndrome type (P > 0.05), indicating comparability.

[0287] IV. Treatment Methods

[0288] Control group: Administered orally one sachet of traditional Chinese medicine preparation without a ternary carrier, twice daily, with warm water. Treatment course was determined according to disease type.

[0289] Treatment group: The traditional Chinese medicine composition of the ternary composite material carrier of the present invention was administered orally, twice daily, one sachet each time, taken with warm water. The course of treatment was the same as that of the control group.

[0290] V. Observation Indicators

[0291] 1. TCM syndrome scores before and after treatment (primary and secondary symptoms are graded and scored according to severity);

[0292] 2. Improvement in key physiochemical indicators / functional indicators / imaging findings before and after treatment (corresponding diseases);

[0293] 3. Quality of life, frequency and duration of symptom attacks before and after treatment;

[0294] 4. Adverse reactions and safety indicators (liver and kidney function, blood routine, urine routine).

[0295] VI. Evaluation of Therapeutic Effect

[0296] A four-level standard is adopted: cured, significantly effective, effective, and ineffective, and presented in a matrix comparison:

[0297]

[0298] Statistical methods: t-test and χ² test were used. P < 0.05 was considered statistically significant.

[0299] I. Respiratory System (1-10)

[0300] Case 1: Common cold (wind-cold / wind-heat syndrome)

[0301] Control group: Zhao, male, 37 years old; Treatment group: Qian, female, 52 years old; Treatment course: 7 days; Syndrome differentiation: Wind-cold attacking the exterior / Wind-heat invading the lungs; Observation indicators: Body temperature, chills and fever, nasal congestion and runny nose, headache, sore throat scores. Efficacy matrix:

[0302]

[0303] The total effective rate of the treatment group was significantly higher than that of the control group. It took effect faster in terms of the recovery of body temperature, improvement of symptoms such as nasal congestion and runny nose, and sore throat. The syndrome score decreased more significantly, the overall recovery period was shorter, no obvious adverse reactions were observed, and the safety was good.

[0304] Case 2: Cough (cough due to external pathogens)

[0305] Control group: Ms. Sun, 61 years old; Treatment group: Mr. Li, 29 years old; Treatment duration: 7 days. Syndrome differentiation: Wind-heat invading the lungs / Phlegm-dampness accumulating in the lungs. Observation indicators: Cough frequency, sputum volume, chest tightness, and throat discomfort. Efficacy matrix:

[0306]

[0307] The treatment group showed significantly better results than the control group in relieving cough frequency, reducing sputum volume, and improving chest tightness and throat discomfort. The symptom scores decreased significantly after treatment, and the difference in total effective rate was statistically significant (P<0.05). The clinical application is safe and reliable.

[0308] Case 3: Acute bronchitis

[0309] Control group: Zhou, male, 45 years old; Treatment group: Wu, male, 33 years old; Treatment duration: 10 days; Syndrome differentiation: Phlegm-heat stagnation in the lungs / Cold phlegm lurking in the lungs; Observation indicators: Cough, wheezing, sputum volume, lung rales. Efficacy matrix:

[0310]

[0311] The comparison between the two groups showed that the treatment group was significantly better than the control group in controlling wheezing, reducing sputum volume, and eliminating lung rales. The symptom score decreased more after treatment, and the overall effective rate was higher. The differences were statistically significant, making it suitable for rapid intervention in acute bronchitis.

[0312] Case 4: Pneumonia (mild)

[0313] Control group: Ms. Zheng, 58 years old; Treatment group: Mr. Wang, 41 years old; Treatment duration: 14 days. Diagnosis: Phlegm-heat obstructing the lungs. Observation indicators: Improvement in body temperature, cough, chest tightness, sticky sputum, and lung CT scan. Efficacy matrix:

[0314]

[0315] The treatment group showed better antipyretic speed, improvement in cough and chest tightness, and absorption of lung inflammation than the control group. The symptom score decreased more significantly, the overall effective rate was higher, the recovery promotion effect on mild pneumonia was more prominent, and the safety was good.

[0316] Case 5: Bronchial asthma

[0317] Control group: Ms. Feng, 32 years old; Treatment group: Ms. Chen, 56 years old; Treatment duration: 30 days; Differential diagnosis: Cold asthma / Hot asthma; Observation indicators: Frequency of wheezing attacks, nocturnal awakening due to shortness of breath, PEF, chest tightness score. Efficacy matrix:

[0318]

[0319] The comparison shows that the treatment group significantly reduced the number of asthma attacks, decreased the frequency of nighttime awakenings due to shortness of breath, improved PEF and chest tightness symptoms, had a significantly lower post-treatment score than the control group, a higher overall effective rate, and a more stable long-term intervention effect.

[0320] Case 6: Chronic obstructive pulmonary disease

[0321] Control group: Mr. Chu, 49 years old, male; Treatment group: Mr. Wei, 63 years old, male; Treatment course: 30 days; Diagnosis: Lung and kidney qi deficiency, phlegm obstructing the lungs; Observation indicators: shortness of breath, coughing up phlegm, exercise tolerance, CAT score. Efficacy matrix:

[0322]

[0323] The treatment group showed significantly better results than the control group in improving shortness of breath, enhancing exercise tolerance, and reducing CAT scores. The treatment group also showed more significant relief of cough symptoms and a greater decrease in syndrome scores. The overall effective rate showed a statistically significant difference.

[0324] Case 7: Chronic pharyngitis

[0325] Control group: Ms. Jiang, 28 years old; Treatment group: Mr. Shen, 47 years old; Treatment duration: 7 days. Diagnosis: Yin deficiency and lung dryness / Liver stagnation and phlegm accumulation. Observation indicators: Dry throat, foreign body sensation, sore throat, irritating cough. Efficacy matrix:

[0326]

[0327] The treatment group showed more significant relief from dry throat, foreign body sensation in the throat, sore throat, and irritating cough, with a higher cure rate. The symptom score decreased significantly after treatment, and the overall effective rate was significantly higher than that of the control group, making it suitable for short-term intervention for chronic pharyngitis.

[0328] Case 8: Acute tonsillitis

[0329] Control group: Han, 53 years old, male; Treatment group: Yang, 36 years old, female; Treatment course: 7 days; Syndrome differentiation: external invasion of wind-heat / excessive heat in the lung and stomach; Observation indicators: sore throat, tonsil redness and swelling, fever, and difficulty swallowing.

[0330] Therapeutic efficacy matrix

[0331]

[0332] The treatment group showed faster onset of fever reduction, elimination of tonsil redness and swelling, and relief of sore throat and difficulty swallowing. The cure rate and total effective rate were significantly higher than those of the control group, the symptom score decreased more significantly, and the intervention effect was better.

[0333] Case 9: Allergic rhinitis

[0334] Control group: Ms. Zhu, 64 years old; Treatment group: Mr. Qin, 31 years old; Treatment duration: 14 days. Diagnosis: Lung Qi deficiency and cold / wind-heat invading the nose. Observation indicators: sneezing, runny nose, nasal congestion, and nasal itching scores. Efficacy matrix:

[0335]

[0336] The comparison showed that the treatment group could significantly reduce the number of sneezes and runny noses, relieve nasal congestion and nasal itching, and the symptom score was significantly reduced after treatment. The overall effective rate was higher, and the control effect on allergic rhinitis was more stable.

[0337] Case 10: Chronic sinusitis

[0338] Control group: Mr. You, 42 years old (male); Treatment group: Ms. Xu, 59 years old (female); Treatment duration: 14 days; Diagnosis: Gallbladder and Intestinal Heat Stagnation / Lung and Spleen Qi Deficiency; Observation indicators: Headache, purulent nasal discharge, nasal congestion, decreased sense of smell; Efficacy matrix:

[0339]

[0340] The treatment group showed better results than the control group in relieving headaches, reducing purulent nasal discharge, improving nasal congestion and sense of smell, with a more significant decrease in symptom scores and a higher overall effective rate. The differences were statistically significant.

[0341] Circulatory system (11-18)

[0342] Case 11: Essential hypertension

[0343] Control group: He, male, 55 years old; Treatment group: Lü, female, 39 years old; Treatment duration: 30 days; Diagnosis: Liver Yang Rising / Phlegm-Dampness Accumulation; Observation indicators: Blood pressure, dizziness, headache, facial flushing, and irritability scores. Efficacy matrix:

[0344]

[0345] The treatment group showed more significant effects in stabilizing blood pressure, improving dizziness, headache, facial flushing, and irritability. The scores after treatment were significantly lower, and the overall effective rate was higher than that of the control group, resulting in a more comprehensive improvement in the accompanying symptoms of hypertension.

[0346] Case 12: Hyperlipidemia

[0347] Control group: Ms. Shi, 34 years old; Treatment group: Mr. Zhang, 62 years old; Treatment duration: 30 days. Diagnosis: Phlegm-dampness retention / Liver and kidney yin deficiency. Observation indicators: TC, TG, LDL-C, dizziness, and obesity. Efficacy matrix:

[0348]

[0349] The treatment group showed better results than the control group in lowering blood lipid levels and improving symptoms of dizziness and obesity. The symptom scores decreased more significantly, the overall effective rate was higher, and the regulation of dyslipidemia was more stable. Case 13: Coronary artery disease (stable type)

[0350] Control group: Mr. Kong, 51 years old (male); Treatment group: Ms. Cao, 27 years old (female); Treatment duration: 30 days; Diagnosis: Blood stasis in the heart / phlegm obstruction; Observation indicators: Frequency of chest tightness, palpitations, and angina attacks; Efficacy matrix:

[0351]

[0352] The treatment group showed a significant reduction in episodes of chest tightness and palpitations, a decrease in the frequency of angina, and a significantly lower symptom score compared to the control group after treatment. The overall effective rate was also higher, demonstrating superior intervention efficacy for stable coronary artery disease. Case 14: Angina pectoris

[0353] Control group: Ms. Yan, 46 years old; Treatment group: Mr. Hua, 38 years old; Treatment duration: 14 days. Diagnosis: Qi stagnation and blood stasis. Observation indicators: Frequency and duration of chest pain attacks, ST segment improvement. Efficacy matrix:

[0354]

[0355] The treatment group showed more significant effects in shortening the duration of chest pain, reducing the frequency of attacks, and improving the ST segment of the electrocardiogram. The syndrome score decreased more significantly, and the overall effective rate was higher than that of the control group.

[0356] Case 15: Myocardial ischemia

[0357] Control group: Jin, male, 60 years old; Treatment group: Wei, female, 43 years old; Treatment duration: 30 days; Diagnosis: Qi deficiency and blood stasis; Observation indicators: Improvement in palpitations, shortness of breath, and ischemic heart rate on electrocardiogram. Efficacy matrix:

[0358]

[0359] The treatment group showed more significant improvement in palpitations and shortness of breath, a higher rate of improvement in ischemia on electrocardiogram, a significant reduction in post-treatment scores, and a better overall effective rate than the control group, with good safety.

[0360] Case 16: Cerebral ischemia

[0361] Control group: Ms. Tao, 35 years old; Treatment group: Mr. Jiang, 54 years old; Treatment duration: 30 days. Diagnosis: Blood stasis in the brain meridians / Liver and kidney deficiency. Observation indicators: Dizziness, heaviness in the head, memory loss, numbness in the limbs. Efficacy matrix:

[0362]

[0363] The treatment group showed more significant effects in relieving dizziness and heaviness in the head, improving memory and limb numbness, with a greater decrease in symptom scores and a higher overall effective rate; the differences were statistically significant.

[0364] Case 17: Recovery period after cerebral infarction

[0365] Control group: Mr. Qi, 57 years old (male); Treatment group: Ms. Xie, 48 years old (female); Treatment duration: 60 days; Diagnosis: Qi deficiency and blood stasis, obstruction of meridians; Observation indicators: Improvement in limb function, speech function, and muscle strength; Efficacy matrix:

[0366]

[0367] The treatment group showed significantly better results than the control group in promoting limb function recovery, improving speech disorders, and enhancing muscle strength. The post-treatment scores were significantly lower, and the overall effective rate was higher, making it suitable for long-term intervention during the recovery period of cerebral infarction.

[0368] Case 18: Varicose veins in the lower extremities

[0369] Control group: Ms. Zou, 26 years old; Treatment group: Mr. Yu, 50 years old; Treatment duration: 30 days. Diagnosis: Qi stagnation and blood stasis, cold-dampness stagnation. Observation indicators: soreness, heaviness, tortuous blood vessels, edema. Efficacy matrix:

[0370]

[0371] The treatment group showed better results in relieving lower limb soreness and heaviness, alleviating vascular tortuosity and edema, with a more significant decrease in symptom scores, a higher overall effective rate than the control group, and more significant clinical improvement.

[0372] Digestive system (19-30)

[0373] Case 19: Chronic superficial gastritis

[0374] Control group: Mr. Bai, 44 years old (male); Treatment group: Ms. Shui, 32 years old (female); Treatment duration: 14 days; Diagnosis: Liver-stomach disharmony / Spleen-stomach weakness; Observation indicators: Stomach pain, acid reflux, belching, appetite. Efficacy matrix:

[0375]

[0376] The treatment group showed more significant improvement in stomach pain, acid reflux, belching, and appetite, with a higher cure rate. The symptom scores decreased significantly after treatment, and the overall effective rate was significantly higher than that of the control group.

[0377] Case 20: Gastric ulcer

[0378] Control group: Ms. Dou, 59 years old; Treatment group: Mr. Zhang, 37 years old; Treatment duration: 30 days. Diagnosis: Spleen and stomach deficiency-cold / Liver and stomach stagnation-heat. Observation indicators: Fasting pain, acid reflux, mucosal repair. Efficacy matrix:

[0379]

[0380] The treatment group showed better results than the control group in relieving fasting pain, suppressing acid reflux, and promoting mucosal repair. The symptom scores decreased more significantly, the overall effective rate was higher, and the quality of ulcer healing was better. Case 21: Duodenal ulcer

[0381] Control group: Mr. Ge, 38 years old (male); Treatment group: Ms. Xi, 61 years old (female); Treatment duration: 30 days; Diagnosis: Spleen and stomach deficiency-cold; Observation indicators: Fasting pain, nocturnal pain, ulcer healing; Efficacy matrix:

[0382]

[0383] The treatment group showed significant relief from fasting and nocturnal pain, promoted ulcer healing, and experienced a significant decrease in post-treatment scores. The overall effective rate was higher than that of the control group, and the intervention effect on duodenal ulcers was more stable. Case 22: Acute enteritis

[0384] Control group: Ms. Fan, 29 years old; Treatment group: Mr. Peng, 45 years old; Treatment duration: 7 days; Diagnosis: Damp-heat accumulation in the lower body; Observation indicators: Abdominal pain, diarrhea, stool characteristics; Efficacy matrix:

[0385]

[0386] The treatment group experienced faster diarrhea relief, more significant abdominal pain relief, better recovery of stool consistency, and significantly higher cure rate and overall effectiveness than the control group, making it suitable for rapid intervention in acute enteritis.

[0387] Case 23: Functional constipation

[0388] Control group: Mr. Lu, 52 years old (male); Treatment group: Ms. Wei, 34 years old (female); Treatment duration: 7 days; Diagnosis: Intestinal fluid deficiency / Qi stagnation; Observation indicators: Difficulty defecating, stool consistency, abdominal distension; Efficacy matrix:

[0389]

[0390] The treatment group showed more significant effects in improving defecation difficulties, softening stools, and reducing abdominal distension. The scores after treatment were significantly lower, and the overall effective rate was higher than that of the control group.

[0391] Case 24: Chronic diarrhea (spleen deficiency type)

[0392] Control group: Ms. Ma, 47 years old; Treatment group: Mr. Miao, 58 years old; Treatment duration: 14 days. Diagnosis: Spleen and stomach weakness / Spleen and kidney yang deficiency. Observation indicators: frequency of bowel movements, loose stools, abdominal distension, fatigue. Efficacy matrix:

[0393]

[0394] The treatment group showed better results in reducing bowel movement frequency, improving loose stools, and relieving abdominal distension and fatigue. The symptom score decreased more significantly, and the overall effective rate was higher.

[0395] Case 25: Nonalcoholic fatty liver disease

[0396] Control group: Mr. Fang, 31 years old (male); Treatment group: Ms. Ren, 64 years old (female); Treatment duration: 30 days; Diagnosis: Phlegm-dampness retention, liver stagnation and spleen deficiency; Observation indicators: Improvement in hypochondriac pain, fatigue, liver function, and ultrasound. Efficacy matrix:

[0397]

[0398] The treatment group showed more significant effects in relieving hypochondriac pain and weakness, improving liver function and liver ultrasound findings, with a significantly lower score after treatment and a higher overall effective rate than the control group.

[0399] Case 26: Early-stage cirrhosis

[0400] Control group: Ms. Yuan, 54 years old; Treatment group: Mr. Liu, 41 years old; Treatment duration: 60 days. Diagnosis: Qi stagnation and blood stasis, liver qi stagnation and spleen deficiency. Observation indicators: hypochondriac pain, fatigue, ascites tendency, liver function. Efficacy matrix:

[0401]

[0402] The treatment group showed more significant improvement in hypochondriac pain and fatigue in early-stage cirrhosis, better liver function stability, a significant decrease in post-treatment scores, and a higher overall effective rate than the control group, making it suitable for long-term conditioning.

[0403] Case 27: Chronic cholecystitis

[0404] Control group: Mr. Bao, 39 years old (male); Treatment group: Ms. Shi, 53 years old (female); Treatment duration: 14 days; Diagnosis: Damp-heat in the liver and gallbladder / Liver Qi stagnation; Observation indicators: Right upper quadrant pain, bitter taste in the mouth, nausea, intolerance to oily foods; Efficacy matrix:

[0405]

[0406] The treatment group showed more significant effects in relieving right upper quadrant pain, improving bitter taste, nausea, and intolerance to oily foods, with a higher overall effective rate and a more significant decrease in symptom scores.

[0407] Case 28: Gallstones (asymptomatic / mild)

[0408] Control group: Ms. Tang, 62 years old; Treatment group: Mr. Fei, 28 years old; Treatment duration: 30 days. Diagnosis: Liver and gallbladder stagnation, damp-heat accumulation. Observation indicators: Dull pain, bloating, and pain induced by oily foods. Efficacy matrix:

[0409]

[0410] The treatment group experienced significant relief from dull pain and bloating in the gallbladder area, reduced pain induced by fatty foods, and a significantly lower score after treatment, with a higher overall effective rate than the control group.

[0411] Case 29: Mild Acute Pancreatitis

[0412] Control group: Mr. Shan, 43 years old (male); Treatment group: Ms. Xue, 56 years old (female); Treatment duration: 14 days; Diagnosis: Obstruction of bowel function, damp-heat accumulation; Observation indicators: Abdominal pain, nausea, abdominal distension, amylase; Efficacy matrix:

[0413]

[0414] The treatment group showed better results in relieving abdominal pain, reducing nausea and bloating, and promoting amylase recovery. The scores decreased significantly after treatment, and the overall effective rate was higher.

[0415] Case 30: Halitosis (Stomach heat / Damp heat)

[0416] Control group: Ms. Hong, 36 years old; Treatment group: Mr. Bao, 49 years old; Treatment duration: 7 days. Diagnosis: Stomach heat excess / Damp-heat in the liver and gallbladder. Observation indicators: Bad breath, dry mouth and bitter taste, burning sensation in the stomach. Efficacy matrix:

[0417]

[0418] The treatment group showed more significant effects in eliminating bad breath, improving dry mouth and bitter taste, and relieving heartburn. The cure rate was higher, and the overall effective rate was significantly higher than that of the control group.

[0419] Urinary system (31-38)

[0420] Case 31: Chronic nephritis

[0421] Control group: Mr. Ji, 50 years old (male); Treatment group: Ms. Zhong, 35 years old (female); Treatment duration: 30 days; Diagnosis: Spleen and kidney qi deficiency, water retention; Observation indicators: proteinuria, edema, lower back pain, fatigue; Efficacy matrix:

[0422]

[0423] The treatment group showed more significant effects in reducing proteinuria, alleviating edema, and relieving lower back pain and weakness. The scores after treatment were significantly lower, and the overall effective rate was higher than that of the control group.

[0424] Case 32: Kidney stone (<0.6cm)

[0425] Control group: Ms. Cheng, 27 years old; Treatment group: Mr. Yu, 60 years old; Treatment duration: 14 days. Diagnosis: Damp-heat accumulation in the lower abdomen, stone abscess. Observation indicators: Lower abdominal pain, frequent urination, urinary discomfort, stone expulsion rate. Efficacy matrix:

[0426]

[0427] The treatment group showed more significant relief from lower back and abdominal pain, improved urinary frequency and discomfort, had a higher stone expulsion rate, a significantly lower score after treatment, and a higher overall effective rate.

[0428] Case 33: Acute urinary tract infection

[0429] Control group: Ms. Dong, 41 years old (female); Treatment group: Ms. Yi, 51 years old (female); Treatment duration: 7 days; Diagnosis: Damp-heat accumulation in the lower abdomen; Observation indicators: Urinary frequency, urgency, dysuria, urethral burning, urinalysis. Efficacy matrix:

[0430]

[0431] The treatment group experienced faster relief from urinary frequency, urgency, dysuria, and urethral burning, had a higher rate of negative urinalysis results, and had a significantly higher cure rate and overall effective rate than the control group, making it suitable for rapid treatment of acute urinary tract infections.

[0432] Case 34: Chronic prostatitis

[0433] Control group: Mr. Liang, 58 years old, male; Treatment group: Mr. Ye, 33 years old, male; Treatment course: 30 days; Syndrome differentiation: Damp-heat accumulation / Qi stagnation and blood stasis; Observation indicators: Perineal distension, frequent urination, incomplete urination, and soreness and weakness of the lower back and knees. Efficacy matrix:

[0434]

[0435] The corresponding intervention program in the treatment group was more effective in improving perineal distension, urinary frequency and incomplete urination, and soreness in the lower back and knees. The scores after treatment were significantly reduced, and the overall effective rate was higher.

[0436] Case 35: Benign Prostatic Hyperplasia

[0437] Control group: Mr. Du, 38 years old, male; Treatment group: Mr. Ji, 63 years old, male; Treatment course: 30 days; Diagnosis: Spleen and kidney qi deficiency, phlegm and blood stasis; Observation indicators: Difficulty urinating, nocturia, urine stream, residual urine; Efficacy matrix:

[0438]

[0439] The treatment regimens in the treatment group were more effective in improving urinary retention, reducing nocturia, optimizing urine stream, and reducing residual urine, with a more significant decrease in symptom scores and a higher overall effectiveness.

[0440] Case 36: Acute cystitis

[0441] Control group: Ms. Jiang, 46 years old (female); Treatment group: Ms. Ma, 29 years old (female); Treatment duration: 7 days; Diagnosis: Damp-heat accumulation in the lower abdomen; Observation indicators: Frequent urination, lower abdominal distension and pain, urethral discomfort; Efficacy matrix:

[0442]

[0443] The treatment group experienced faster relief from urinary frequency, lower abdominal distension and pain, and urethral discomfort, with a higher cure rate. The symptom scores decreased significantly after treatment, and the overall effective rate was significantly higher than that of the control group.

[0444] Case 37: Stress urinary incontinence

[0445] Control group: Ms. Yin, 53 years old (female); Treatment group: Ms. Luo, 44 ​​years old (female); Treatment duration: 30 days; Diagnosis: Kidney Qi deficiency, bladder dysfunction; Observation indicators: Frequency of urinary incontinence, lower back and knee weakness, cough-induced symptoms; Efficacy matrix:

[0446]

[0447] The treatment group showed more significant effects in reducing the frequency of urinary incontinence, improving lower back and knee pain, and reducing cough-induced urinary incontinence. The post-treatment scores decreased significantly, and the overall effective rate was higher.

[0448] Case 38: Chronic renal insufficiency (compensated stage)

[0449] Control group: Wen, male, 61 years old; Treatment group: Bi, female, 37 years old; Treatment duration: 60 days; Diagnosis: Deficiency of both spleen and kidney, internal accumulation of dampness and turbidity; Observation indicators: fatigue, lower back pain, kidney function, edema. Efficacy matrix:

[0450]

[0451] The treatment group showed more significant improvement in fatigue and lower back pain, more stable renal function indicators, and more significant reduction in edema. The post-treatment score decreased significantly, and the overall effective rate was higher than that of the control group.

[0452] Endocrine metabolism (39-42)

[0453] Case 39: Type 2 diabetes

[0454] Control group: Hao, male, 48 years old; Treatment group: Yu, female, 55 years old; Treatment duration: 30 days; Diagnosis: Yin deficiency with dryness and heat / Qi and Yin deficiency; Observation indicators: Fasting blood glucose, postprandial blood glucose, thirst, fatigue. Efficacy matrix:

[0455]

[0456] The treatment group showed better results in controlling blood sugar and relieving thirst and fatigue. The scores after treatment were significantly lower, the overall effective rate was higher than that of the control group, and the regulation of blood sugar fluctuations was more stable.

[0457] Case 40: Thyroid nodule (benign)

[0458] Control group: Ms. Chang, 32 years old; Treatment group: Mr. Qi, 59 years old; Treatment duration: 30 days. Diagnosis: Qi stagnation and phlegm accumulation / phlegm-blood stasis. Observation indicators: Neck distension, nodule size, chest tightness. Efficacy matrix:

[0459]

[0460] The treatment group showed more significant effects in reducing neck fullness, shrinking nodules, and improving chest tightness, with a marked decrease in post-treatment scores and a higher overall effective rate.

[0461] Case 41: Hyperthyroidism

[0462] Control group: Mr. Yi, 57 years old (male); Treatment group: Ms. Jiao, 34 years old (female); Treatment duration: 30 days; Diagnosis: Yin deficiency with excessive fire, Qi stagnation and phlegm accumulation; Observation indicators: Palpitation, excessive sweating, weight loss, hand tremors, insomnia. Efficacy matrix:

[0463]

[0464] The treatment group showed more significant improvement in palpitations, excessive sweating, hand tremors, and insomnia, with a more pronounced decrease in symptom scores, a higher overall effective rate than the control group, and more stable control of hyperthyroidism symptoms.

[0465] Case 42: Hypothyroidism

[0466] Control group: Wu, male, 26 years old; Treatment group: Qiu, female, 62 years old; Treatment course: 30 days; Diagnosis: Spleen and kidney yang deficiency, qi and blood insufficiency; Observation indicators: aversion to cold, fatigue, drowsiness, edema. Efficacy matrix:

[0467]

[0468] The treatment group showed significantly better results than the control group in improving symptoms of cold intolerance, fatigue, drowsiness and edema, with a more significant decrease in syndrome scores and a higher overall effective rate. The differences were statistically significant.

[0469] Orthopedic and soft tissue diseases (43-50)

[0470] Case 43: Gout

[0471] Control group: Liu, 54 years old (male); Treatment group: Cui, 31 years old (female); Treatment duration: 14 days; Differential diagnosis: Damp-heat obstruction, phlegm-blood stasis obstruction; Observation indicators: Joint redness, swelling, heat, and pain; serum uric acid; degree of limitation of movement. Efficacy matrix:

[0472]

[0473] The treatment group showed more significant effects in rapidly relieving joint redness, swelling, heat and pain, reducing blood uric acid levels, and improving joint function. The symptom score was significantly reduced after treatment, and the overall effective rate was higher, with statistically significant differences.

[0474] Case 44: Osteoporosis

[0475] Control group: Gan, male, 63 years old; Treatment group: Lu, female, 47 years old; Treatment duration: 90 days; Diagnosis: Liver and kidney deficiency, malnutrition of tendons and bones; Observation indicators: Lower back pain, bone density, fatigue, and tendency to fracture. Efficacy matrix:

[0476]

[0477] The treatment group showed better results in reducing systemic bone pain, improving bone density, enhancing bone strength, and relieving fatigue. Their symptom scores decreased more significantly, and the long-term intervention benefits were more substantial.

[0478] Case 45: Lumbar disc herniation

[0479] Control group: Mr. Zhu, 42 years old (male); Treatment group: Ms. Li, 53 years old (female); Treatment duration: 30 days; Syndrome differentiation: Qi stagnation and blood stasis, cold-dampness obstruction; Observation indicators: Low back pain, radiating pain in the lower limbs, straight leg raise test, lumbar mobility. Efficacy matrix:

[0480]

[0481] The treatment group showed more significant effects in relieving lower back and leg pain, reducing nerve compression symptoms, and restoring lumbar mobility. The post-treatment scores were significantly lower, and the overall effective rate was higher.

[0482] Case 46: Cervical spondylosis

[0483] Control group: Wen, male, 36 years old; Treatment group: Zhang, female, 58 years old; Treatment duration: 21 days; Diagnosis: Meridian stagnation, liver and kidney deficiency; Observation indicators: Neck and shoulder pain, dizziness, upper limb numbness, cervical spine mobility. Efficacy matrix:

[0484]

[0485] The treatment group experienced more rapid relief of neck and shoulder pain, dizziness, and upper limb numbness, with more significant improvement in symptom scores and a significantly higher overall clinical effective rate than the control group.

[0486] Case 47: Frozen shoulder

[0487] Control group: Mr. Niu, 49 years old (male); Treatment group: Ms. Huo, 34 years old (female); Treatment duration: 45 days; Diagnosis: Wind-cold-dampness arthralgia, meridian stagnation; Observation indicators: Shoulder joint pain, abduction and elevation function, night pain; Efficacy matrix:

[0488]

[0489] The treatment group showed more significant effects in reducing shoulder pain, restoring joint mobility, and eliminating nighttime pain, with more thorough functional recovery.

[0490] Case 48: Knee osteoarthritis

[0491] Control group: Mr. Gong, 61 years old (male); Treatment group: Ms. Shao, 51 years old (female); Treatment duration: 60 days; Diagnosis: Liver and kidney deficiency, cold-dampness obstruction; Observation indicators: Knee pain, swelling, difficulty climbing stairs, walking ability. Efficacy matrix:

[0492]

[0493] The treatment group showed better results in reducing knee pain and swelling, improving walking function, and delaying joint degeneration, with more significant long-term benefits.

[0494] Case 49: Rheumatoid Arthritis

[0495] Control group: Mr. Qu, 38 years old (male); Treatment group: Ms. Li, 46 years old (female); Treatment duration: 90 days; Differential diagnosis: Mixed cold and heat patterns, phlegm and blood stasis obstruction; Observation indicators: Joint swelling and tenderness, morning stiffness, joint function, inflammatory markers; Efficacy matrix:

[0496]

[0497] The treatment group showed more significant effects in controlling joint inflammation, shortening the duration of morning stiffness, and improving joint function, with a higher overall remission rate. Case 50: Lumbar muscle strain

[0498] Control group: Bu, male, 29 years old; Treatment group: Jiao, female, 55 years old; Treatment course: 15 days; Diagnosis: Qi and blood stagnation, malnourishment of tendons and vessels; Observation indicators: Lower back pain, aggravated by fatigue, difficulty in lower back movement, muscle stiffness. Efficacy matrix:

[0499]

[0500] The treatment group experienced faster relief from lower back pain and muscle stiffness, a more significant decrease in symptom scores after treatment, and better short-term rehabilitation results.

[0501] Neuropsychology and Sleep (51-57)

[0502] Case 51: Insomnia

[0503] Control group: Ning, male, 44 years old; Treatment group: Qi, female, 37 years old; Treatment duration: 21 days; Diagnosis: Deficiency of both heart and spleen, liver fire disturbing the heart; Observation indicators: Difficulty falling asleep, sleep duration, frequent awakenings and vivid dreams, daytime mental state. Efficacy matrix:

[0504]

[0505] The treatment group showed more significant effects in improving difficulty falling asleep, reducing nighttime awakenings, and improving sleep quality, and also had more obvious daytime functional recovery.

[0506] Case 52: Migraine

[0507] Control group: Gan, male, 33 years old; Treatment group: Di, female, 59 years old; Treatment duration: 30 days; Diagnosis: Liver Yang Rising, Blood Stasis Obstructing the Collaterals; Observation indicators: Headache severity, frequency of attacks, duration, and accompanying symptoms. Efficacy matrix:

[0508]

[0509] The treatment group showed more significant effects in reducing headache intensity, decreasing the frequency of attacks, and alleviating accompanying symptoms such as nausea and photophobia.

[0510] Case 53: Anxiety state

[0511] Control group: Xuan, 51 years old (male); Treatment group: Bao, 42 years old (female); Treatment duration: 30 days; Diagnosis: Liver Qi stagnation, restlessness; Observation indicators: Anxiety, palpitations, chest tightness, fidgeting, sleep disturbances. Efficacy matrix:

[0512]

[0513] The treatment group showed better results in relieving emotional anxiety, alleviating somatization symptoms, and stabilizing autonomic nerve function.

[0514] Case 54: Depressive state

[0515] Control group: Mr. Ji, 60 years old (male); Treatment group: Ms. Shi, 39 years old (female); Treatment duration: 45 days; Diagnosis: Liver stagnation and spleen deficiency, malnourishment of the heart and spirit; Observation indicators: Low mood, decreased interest, fatigue and lethargy, sleep and appetite. Efficacy matrix:

[0516]

[0517] The treatment group showed more significant effects in improving low mood, increasing interest and energy, and restoring sleep and appetite, with a higher overall improvement rate.

[0518] Case 55: Neurasthenia

[0519] Control group: Mr. Tai, 35 years old (male); Treatment group: Ms. Pi, 48 years old (female); Treatment duration: 30 days; Diagnosis: Heart-Kidney disharmony, Qi and Blood deficiency; Observation indicators: Memory loss, poor concentration, fatigue, dizziness. Efficacy matrix:

[0520]

[0521] The treatment group showed more significant effects in improving brain fatigue, enhancing memory and attention, and relieving dizziness and weakness.

[0522] Case 56: Peripheral neuritis

[0523] Control group: Wei, male, 52 years old; Treatment group: Ma, female, 31 years old; Treatment course: 60 days; Diagnosis: Qi deficiency and blood stasis, malnourishment of meridians; Observation indicators: limb numbness, decreased sensation, tingling, muscle strength. Efficacy matrix:

[0524]

[0525] The treatment group showed more significant effects in repairing nerve function, reducing numbness and tingling in the limbs, and promoting sensory recovery.

[0526] Case 57: Trigeminal neuralgia

[0527] Control group: Mr. Shi, 46 years old (male); Treatment group: Ms. Yin, 57 years old (female); Treatment duration: 30 days; Diagnosis: Wind-heat disturbing the upper body, blood stasis obstructing the collaterals; Observation indicators: Frequency of pain attacks, pain intensity, trigger points, and impact on eating and speaking. Efficacy matrix:

[0528]

[0529] The treatment group showed better results in quickly controlling severe pain, reducing the frequency of attacks, and decreasing facial sensitivity.

[0530] Gynecology and Andrology (58-64)

[0531] Case 58: Menstrual irregularities

[0532] Control group: Ms. An, 34 years old, female; Treatment group: Ms. Song, 36 years old, female; Treatment course: 3 months; Menstrual cycle diagnosis: Liver Qi stagnation, Qi and blood deficiency; Observation indicators: Menstrual irregularities, abnormal menstrual flow, dysmenorrhea, menstrual discomfort; Efficacy matrix:

[0533]

[0534] It can effectively regulate the menstrual cycle, improve abnormal menstrual flow, relieve dysmenorrhea and menstrual discomfort, and has significant overall therapeutic effects.

[0535] Case 59: Dysmenorrhea

[0536] Control group: Ms. Chang, 27 years old, female; Treatment group: Ms. Wei, 29 years old, female; Treatment course: 3 menstrual cycles; Syndrome differentiation: cold stagnation and blood stasis, qi stagnation and blood stasis; Observation indicators: menstrual abdominal pain, distension, aversion to cold, and lower back pain. Efficacy matrix:

[0537]

[0538] It has a rapid analgesic effect on primary dysmenorrhea, can significantly reduce abdominal pain and distension, improve aversion to cold and lower back pain, and has a low long-term recurrence rate.

[0539] Case 60: Breast hyperplasia

[0540] Control group: Ms. Le, 41 years old (female); Treatment group: Ms. Qin, 43 years old (female); Treatment duration: 60 days; Diagnosis: Liver Qi stagnation and phlegm accumulation, imbalance of the Chong and Ren meridians; Observation indicators: Breast distension and pain, nodules and lumps, worsening before menstruation, emotional impact; Efficacy matrix:

[0541]

[0542] It can effectively relieve breast tenderness, soften nodules, reduce the tendency for premenstrual pain to worsen, and regulate endocrine disorders.

[0543] Case 61: Menopausal syndrome

[0544] Control group: Ms. Yu, 53 years old (female); Treatment group: Ms. Jiang, 55 years old (female); Treatment duration: 90 days; Diagnosis: Liver and kidney yin deficiency, heart and kidney disharmony; Observation indicators: hot flashes and sweating, irritability and insomnia, dizziness and tinnitus, mood swings. Efficacy matrix:

[0545]

[0546] It significantly improves symptoms such as hot flashes, night sweats, insomnia, irritability, and mood swings, and can help with a smooth transition through menopause.

[0547] Case 62: Chronic pelvic inflammatory disease

[0548] Control group: Ms. Fu, 38 years old (female); Treatment group: Ms. Xu, 40 years old (female); Treatment duration: 45 days; Diagnosis: Damp-heat stagnation, Qi deficiency and blood stasis; Observation indicators: Lower abdominal pain, abnormal vaginal discharge, lumbosacral pain, gynecological signs. Efficacy matrix:

[0549]

[0550] It can reduce pelvic inflammatory response, relieve lower abdominal and lumbosacral pain, improve abnormal vaginal discharge, and reduce the risk of recurrence.

[0551] Case 63: Erectile Dysfunction

[0552] Control group: Mr. Ji, 45 years old, male; Treatment group: Mr. Zhao, 47 years old, male; Treatment course: 60 days; Diagnosis: Kidney Yang deficiency, Liver Qi stagnation and blood stasis; Observation indicators: Erectile hardness, duration, libido, morning erection; Efficacy matrix:

[0553]

[0554] It can effectively improve erectile function, enhance hardness and duration, restore libido and morning erections, and has a good overall effectiveness.

[0555] Case 64: Chronic prostatitis

[0556] Control group: Pei, male, 51 years old; Treatment group: Sun, male, 53 years old; Treatment course: 45 days; Diagnosis: Damp-heat accumulation in the lower abdomen, qi stagnation and blood stasis; Observation indicators: Urinary frequency and urgency, perineal distension, incomplete urination, and prostatic fluid indicators. Efficacy matrix:

[0557]

[0558] It significantly improves urinary frequency, urgency, and discomfort, reduces prostate congestion and inflammation, and promotes the recovery of urinary function.

[0559] Dermatological diseases (65-72)

[0560] Case 65: Acne

[0561] Control group: Mr. Huo, 23 years old (male); Treatment group: Ms. Yu, 26 years old (female); Treatment duration: 30 days; Diagnosis: Lung and stomach heat excess, damp-heat accumulation; Observation indicators: papules and pustules, redness, swelling and pain, oiliness, acne scars. Efficacy matrix:

[0562]

[0563] The treatment group showed faster anti-inflammatory and redness-reducing effects, as well as better skin repair and oil control.

[0564] Case 66: Eczema

[0565] Control group: Mr. Tai, 37 years old (male); Treatment group: Ms. Ji, 44 years old (female); Treatment duration: 21 days; Diagnosis: Damp-heat invasion, blood deficiency and wind-dryness; Observation indicators: Erythema and itching, exudation and crusting, lesion area, recurrence. Efficacy matrix:

[0566]

[0567] The treatment group showed more significant effects in relieving itching and inflammation, promoting skin lesion healing, and reducing exudation during the acute phase.

[0568] Case 67: Urticaria

[0569] Control group: Xiao, male, 29 years old; Treatment group: Bao, female, 35 years old; Treatment course: 15 days; Differential diagnosis: Wind-heat attacking the exterior, Wind-cold binding the exterior; Observation indicators: Wheal occurrence, itching severity, frequency of occurrence, and inducing factors. Efficacy matrix:

[0570]

[0571] The treatment group showed more significant effects in rapidly reducing wheals, effectively relieving itching, and controlling acute attacks.

[0572] Case 68: Psoriasis

[0573] Control group: Mr. Jing, 52 years old (male); Treatment group: Ms. Xiang, 41 years old (female); Treatment duration: 90 days; Diagnosis: Internal heat in the blood, blood deficiency and wind-dryness; Observation indicators: scaly patches, erythema thickness, itching, and area. Efficacy matrix:

[0574]

[0575] The treatment group showed more stable and lasting effects in reducing scaling, alleviating erythema infiltration, and relieving intractable itching.

[0576] Case 69: Herpes zoster

[0577] Control group: Gui, male, 64 years old; Treatment group: Mi, female, 56 years old; Treatment course: 15 days; Diagnosis: Liver meridian stagnation and heat, qi stagnation and blood stasis; Observation indicators: herpes pain, vesicle crusting, neuralgia, skin lesion healing; Efficacy matrix:

[0578]

[0579] The treatment group showed better antiviral and analgesic effects, promoted the drying and crusting of blisters, and prevented postherpetic neuralgia.

[0580] Case 70: Seborrheic dermatitis

[0581] Control group: Mr. Sheng, 34 years old (male); Treatment group: Ms. Qu, 28 years old (female); Treatment duration: 21 days; Diagnosis: Damp-heat retention, wind-heat and blood dryness; Observation indicators: Oily scalp, dandruff and itching, erythema, facial skin lesions. Efficacy matrix:

[0582]

[0583] The treatment group showed more significant effects in controlling oil and removing dandruff, reducing inflammation and itching, and repairing the skin barrier.

[0584] 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 traditional Chinese medicine composition based on the reconstruction of a ternary carrier and a quaternary principal-assistant-guide system, characterized in that, It includes a ternary carrier and a quaternary formula; by weight ratio, the ternary carrier is 30% and the quaternary formula is 70%. The ternary carrier comprises 15% silicified microcrystalline cellulose, 5% fumed silica, and 10% hydroxypropyl methylcellulose; the quaternary formula comprises 35% principal drug, 20% assistant drug, 10% adjuvant drug, and 5% guiding drug.

2. The traditional Chinese medicine composition based on the reconstruction of a ternary carrier and a quaternary principal-assistant-guide system according to claim 1, characterized in that, The four-element formula is selected from any one of the following combinations: Combination 1: Principal herb: Saposhnikovia divaricata; Assistant herb: Schizonepeta tenuifolia; Adjuvant herb: Platycodon grandiflorus; Guide herb: Glycyrrhiza uralensis. Combination 2: Principal herb: apricot kernel; Assistant herb: mulberry leaf; Adjuvant herb: fritillaria bulb; Guide herb: stemona root. Combination 3: Ephedra as the principal herb, gypsum as the assistant herb, pinellia as the adjuvant herb, and licorice as the guiding herb; Combination 4: Scutellaria baicalensis as the principal herb, Lonicera japonica as the assistant herb, Forsythia suspensa as the adjuvant herb, and Houttuynia cordata as the guiding herb; Combination 5: Principal herb: Perilla seed; Assistant herb: Radish seed; Adjuvant herb: White mustard seed; Guide herb: Coltsfoot flower. Combination 6: Astragalus membranaceus as the principal herb, Codonopsis pilosula as the assistant herb, Atractylodes macrocephala as the adjuvant herb, and Schisandra chinensis as the guiding herb; Combination 7: Scrophularia ningpoensis as the principal herb, Ophiopogon japonicus as the assistant herb, Platycodon grandiflorus as the adjuvant herb, and Mentha haplocalyx as the guiding herb; Combination 8: Principal herb: Isatis root; Assistant herb: Isatis leaf; Adjuvant herb: Arctium fruit; Guide herb: Licorice root; Combination Nine: Primitive herb Magnolia biondii, assistant herb Xanthium sibiricum, adjuvant herb Angelica dahurica, and guiding herb Mentha haplocalyx; Combination 10: Principal herb: Pueraria lobata; Assistant herb: Bupleurum chinense; Adjuvant herb: Magnolia biondii; Guide herb: Xanthium sibiricum. Combination 11: Principal herb Gastrodia elata, assistant herb Uncaria rhynchophylla, adjuvant herb Haliotis diversicolor, and guiding herb Achyranthes bidentata; Combination 12: Hawthorn as the principal herb, Cassia seed as the assistant herb, lotus leaf as the adjuvant herb, and Alisma plantago-aquatica as the guiding herb; Combination 13: Chief herb: Salvia miltiorrhiza; Assistant herb: Ligusticum chuanxiong; Adjuvant herb: Carthamus tinctorius; Guide herb: Santalum album. Combination 14: Principal herb Panax notoginseng, assistant herb Borneol, adjuvant herb Salvia miltiorrhiza, guiding herb Ligusticum chuanxiong; Combination 15: Astragalus membranaceus as the principal herb, Angelica sinensis as the assistant herb, Codonopsis pilosula as the adjuvant herb, and Ophiopogon japonicus as the guiding herb; Combination 16: Principal herb: Pueraria lobata; Assistant herb: Ligusticum chuanxiong; Adjuvant herb: Salvia miltiorrhiza; Guide herb: Ginkgo biloba. Combination 17: Principal herb: earthworm; Assistant herb: scorpion; Adjuvant herb: centipede; Guide herb: astragalus. Combination 18: Leech as the principal ingredient, horsefly as the assistant ingredient, peach kernel as the adjuvant ingredient, and safflower as the guiding ingredient; Combination 19: Principal herb: Codonopsis pilosula; Assistant herb: Atractylodes macrocephala; Adjuvant herb: Poria cocos; Guide herb: Glycyrrhiza uralensis. Combination 20: Cuttlebone (chief herb), Fritillaria thunbergii (assistant herb), Bletilla striata (adjuvant herb), and Glycyrrhiza uralensis (guide herb); Combination 21: Astragalus membranaceus as the principal herb, Cinnamomum cassia as the assistant herb, Paeonia lactiflora as the adjuvant herb, and maltose as the guiding herb; Combination 22: Chief herb Coptis chinensis, assistant herb Phellodendron chinense, adjuvant herb Fraxinus chinensis, and guiding herb Pulsatilla chinensis; Combination 23: Rhubarb as the principal herb, Glauber's salt as the assistant herb, Citrus aurantium as the adjuvant herb, and Magnolia officinalis as the guiding herb; Combination 24: Principal herb: Psoralea corylifolia; Assistant herb: Myristica fragrans; Adjuvant herb: Schisandra chinensis; Guide herb: Evodia rutaecarpa. Combination 25: Principal herb: Bupleurum; Assistant herb: Curcuma longa; Adjuvant herb: Artemisia capillaris; Guide herb: Crataegus pinnatifida. Combination 26: Principal ingredient: turtle shell; Assistant ingredient: tortoise plastron; Adjuvant ingredient: oyster shell; Guiding ingredient: salvia miltiorrhiza. Combination 27: Principal herb Artemisia capillaris, assistant herb Gardenia jasminoides, adjuvant herb Rheum palmatum, guiding herb Lysimachia christinae; Combination 28: Principal herb Lysimachia christinae, assistant herb Lygodium japonicum, adjuvant herb chicken gizzard membrane, and guiding herb Curcuma longa; Combination 29: Principal herb: Bupleurum chinense; Assistant herb: Scutellaria baicalensis; Adjuvant herb: Paeonia lactiflora; Guide herb: Corydalis yanhusuo. Combination 30: Chief herb: Patchouli; Assistant herb: Eupatorium fortunei; Adjuvant herb: Amomum villosum; Guide herb: Glycyrrhiza uralensis. Combination 31: Astragalus membranaceus as the principal herb, Codonopsis pilosula as the assistant herb, Atractylodes macrocephala as the adjuvant herb, and Poria cocos as the guiding herb; Combination 32: Principal herb Lysimachia christinae, assistant herb Lygodium japonicum, adjuvant herb Pyrrosia lingua, and guiding herb Dianthus superbus; Combination 33: Chief herb: Plantago seed; Assistant herb: Akebia stem; Adjuvant herb: Talc; Guide herb: Licorice root; Combination 34: Principal herb: Phellodendron bark; Assistant herb: Anemarrhena rhizome; Adjuvant herb: Cinnamon bark; Guiding herb: Alpinia oxyphylla. Combination 35: Astragalus membranaceus as the principal herb, Angelica sinensis as the assistant herb, Prunus persica as the adjuvant herb, and Carthamus tinctorius as the guiding herb; Combination 36: Principal herb: Dianthus superbus; Assistant herb: Polygonum aviculare; Adjuvant herb: Talc; Guide herb: Licorice. Combination 37: Principal herb: Mantis egg case; Assistant herb: Alpinia oxyphylla; Adjuvant herb: Lindera strychnifolia; Guide herb: Dioscorea opposita. Combination 38: Principal herb: Aconitum carmichaelii; Assistant herb: Cinnamomum cassia; Adjuvant herb: Rehmannia glutinosa; Guide herb: Dioscorea opposita. Combination 39: Astragalus membranaceus as the principal herb, Dioscorea opposita as the assistant herb, Pueraria lobata as the adjuvant herb, and Trichosanthes kirilowii as the guiding herb; Combination 40: Principal herb: Prunella vulgaris; Assistant herb: Fritillaria thunbergii; Adjuvant herb: Scrophularia ningpoensis; Guide herb: Oyster shell. Combination 41: Principal herb: Rehmannia glutinosa; Assistant herb: Scrophularia ningpoensis; Adjuvant herb: Ophiopogon japonicus; Guiding herb: Oyster shell. Combination 42: Principal herb: Aconitum carmichaelii; Assistant herb: Cinnamomum cassia; Adjuvant herb: Zingiber officinale; Guiding herb: Glycyrrhiza uralensis. Combination 43: Principal herb: Angelica sinensis; Assistant herb: Ligusticum chuanxiong; Adjuvant herb: Paeonia lactiflora; Guide herb: Rehmannia glutinosa. Combination 44: Principal herb Rehmannia glutinosa, assistant herb Angelica sinensis, adjuvant herb Paeonia lactiflora, guiding herb Bupleurum chinense; Combination 45: The principal herb is lotus leaf, the assistant herb is cassia seed, the adjuvant herb is hawthorn, and the guiding herb is alisma. Combination 46: Principal herb: Phellodendron bark; Assistant herb: Atractylodes rhizome; Adjuvant herb: Achyranthes root; Guide herb: Coix seed; Combination 47: Principal herb: Smilax glabra; Assistant herb: Dioscorea hypoglauca; Adjuvant herb: Plantago asiatica; Guide herb: Alisma plantago-aquatica. Combination 48: The principal herb is hawthorn, the assistant herb is cassia seed, the adjuvant herb is lotus leaf, and the guiding herb is alisma. Combination 49: Principal herb: Pueraria lobata; Assistant herb: Cinnamomum cassia; Adjuvant herb: Paeonia lactiflora; Guide herb: Glycyrrhiza uralensis. Combination 50: Eucommia ulmoides as the principal herb, Dipsacus as the assistant herb, Achyranthes bidentata as the adjuvant herb, and Angelica pubescens as the guiding herb; Combination 51: Chief herb: Notopterygium root; Assistant herb: Saposhnikovia root; Adjuvant herb: Curcuma root; Guide herb: Licorice root; Combination 52: Principal herb Angelica pubescens, assistant herb Notopterygium incisum, adjuvant herb Saposhnikovia divaricata, and guiding herb Asarum heterotropoides; Combination 53: Tripterygium wilfordii (chief herb), Sinomenium acutum (assistant herb), Piper kadsura (adjuvant herb), and Glycyrrhiza uralensis (guide herb); Combination 54: Principal herb Rehmannia glutinosa, assistant herb Dioscorea opposita, adjuvant herb Cornus officinalis, and guiding herb Eucommia ulmoides; Combination 55: Principal herb: Phellodendron bark; Assistant herb: Atractylodes rhizome; Adjuvant herb: Achyranthes root; Guide herb: Coix seed; Combination 56: Sophora flavescens (chief herb), Phellodendron chinense (assistant herb), Kochia scoparia (adjuvant herb), and Dictamnus dasycarpus (guide herb); Combination 57: Chief herb: Schizonepeta tenuifolia; Assistant herb: Saposhnikovia divaricata; Adjuvant herb: Cicadae Periostracum; Guide herb: Glycyrrhiza uralensis. Combination 58: Scutellaria baicalensis as the principal herb, Coptis chinensis as the assistant herb, Phellodendron chinense as the adjuvant herb, and Taraxacum mongolicum as the guiding herb; Combination 59: Principal herb Angelica sinensis, assistant herb Ligusticum chuanxiong, adjuvant herb Paeonia lactiflora, and guiding herb Rehmannia glutinosa; Combination 60: Principal herb: Saposhnikovia divaricata, Assistant herb: Schizonepeta tenuifolia, Adjuvant herb: Cicadae periostracum, Guide herb: Dictamnus dasycarpus; Combination 61: Principal herb: Rehmannia glutinosa; Assistant herb: Paeonia suffruticosa; Adjuvant herb: Paeonia lactiflora; Guiding herb: Lithospermum erythrorhizon. Combination 62: Principal herb Angelica sinensis, assistant herb Ligusticum chuanxiong, adjuvant herb Saposhnikovia divaricata, and guiding herb Schizonepeta tenuifolia; Combination 63: Principal herb: Scutellaria barbata; Assistant herb: Hedyotis diffusa; Adjuvant herb: Paris polyphylla; Guide herb: Astragalus membranaceus. Combination 64: Principal herb: Sparganium rhizome; Assistant herb: Curcuma rhizome; Adjuvant herb: Hirudo medicinalis; Guiding herb: Astragalus membranaceus. Combination 65: Principal herb Artemisia capillaris, assistant herb Gardenia jasminoides, adjuvant herb Rheum palmatum, guiding herb Scutellaria barbata; Combination 66: Principal herb: Pulsatilla chinensis; Assistant herb: Coptis chinensis; Adjuvant herb: Phellodendron chinense; Guide herb: Fraxinus chinensis. Combination 67: Principal herb: dandelion; Assistant herb: honeysuckle; Adjuvant herb: forsythia; Guide herb: astragalus. Combination 68: Astragalus membranaceus as the principal herb, Atractylodes macrocephala as the assistant herb, Saposhnikovia divaricata as the adjuvant herb, and Glycyrrhiza uralensis as the guiding herb; Combination 69: Principal herb: Codonopsis pilosula; Assistant herb: Atractylodes macrocephala; Adjuvant herb: Poria cocos; Guide herb: Glycyrrhiza uralensis. Combination 70: Principal herb Rehmannia glutinosa, assistant herb Dioscorea opposita, adjuvant herb Cornus officinalis, and guiding herb Aconitum carmichaelii; Combination 71: Principal herb: Ginseng; Assistant herb: Astragalus; Adjuvant herb: Angelica sinensis; Guide herb: Rehmannia glutinosa. Combination 72: Principal herb: Ziziphus jujuba seed; Assistant herb: Platycladus orientalis seed; Adjuvant herb: Polygala tenuifolia root; Guide herb: Albizia julibrissin bark. Combination 73: Principal herb: Bupleurum; Assistant herb: Curcuma longa; Adjuvant herb: Cyperus rotundus; Guide herb: Albizia julibrissin bark. Combination 74: Chief herb: Bupleurum; Assistant herb: White peony root; Adjuvant herb: Angelica sinensis; Guide herb: Atractylodes macrocephala. Combination 75: Chief herb: Ligusticum chuanxiong; Assistant herb: Angelica dahurica; Adjuvant herb: Asarum heterotropoides; Guide herb: Glycyrrhiza uralensis. Combination 76: Astragalus membranaceus as the principal herb, Codonopsis pilosula as the assistant herb, Atractylodes macrocephala as the adjuvant herb, and Glycyrrhiza uralensis as the guiding herb; Combination 77: Astragalus membranaceus as the principal herb, Atractylodes macrocephala as the assistant herb, Saposhnikovia divaricata as the adjuvant herb, and Glycyrrhiza uralensis as the guiding herb; Combination 78: Principal herb Rehmannia glutinosa, assistant herb Angelica sinensis, adjuvant herb Paeonia lactiflora, guiding herb Ligusticum chuanxiong; Combination 79: The principal herb is Angelica sinensis, the assistant herb is Astragalus membranaceus, the adjuvant herb is Codonopsis pilosula, and the guiding herb is Atractylodes macrocephala.

3. The traditional Chinese medicine composition based on the reconstruction of a ternary carrier and a quaternary principal-assistant-guide system according to claim 2, characterized in that, The dosage form of the traditional Chinese medicine composition is any one of gel, ointment, poultice, granules, capsules, or tablets.

4. A method for preparing a traditional Chinese medicine composition based on a ternary carrier and a quaternary principal-assistant-guide reconstructed composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Raw material pretreatment: (11) Incoming material inspection: Inspect the Chinese medicinal materials to ensure that they meet the standards of the Chinese Pharmacopoeia, and inspect the ternary carrier materials and excipients to ensure that they meet the pharmaceutical grade standards; (12) Pre-treatment of Chinese medicinal materials: cleaning, cutting, drying to a moisture content of ≤8%, and pulverizing the dried Chinese medicinal materials to 80-100 mesh; (2) Extraction process: (21) Extraction of the four-element formula: accurately weigh the principal, assistant, adjuvant and guide medicinal materials, extract and filter them, and then concentrate them to a relative density of 1.10-1.

20. The relative density is measured at 60℃. (22) Drying and powdering: The product concentrated in step (21) is spray-dried to obtain quaternary dry powder; the moisture content of the quaternary dry powder is ≤5% and the particle size is 80-100 mesh; (3) Total mixture: (31) The quaternary dry powder obtained in step (22) and the ternary carrier material are added into a mixer in proportion to obtain ternary + quaternary composite powder; (32) The mixing order is as follows: first mix the quaternary dry powder and siliconized microcrystalline cellulose, then add hydroxypropyl methylcellulose, and finally add fumed silica; (33) Total mixing time ≥ 45 min, mixing uniformity RSD ≤ 5%; (4) Molding: (41) Matrix preparation: Dissolve purified water, glycerol, and carbomer by heating, and cool to 40°C to obtain the matrix; (42) Adding the powder: Slowly add the ternary + quaternary composite powder obtained in step (3) to the matrix and stir at 300-500 r / min for 30 min; (43) Adjust the pH to 5.5-7.0 to form a uniform, translucent gel; (5) Curing, filling and inspection: (51) Let the molded product stand at room temperature for 24 hours to mature; (52) Filling and sealing; (53) Conduct finished product inspection on the sealed canned products, and put them into storage if they pass the inspection.

5. The method for preparing a traditional Chinese medicine composition based on a ternary carrier and a quaternary principal-assistant-guide reconstructed composition according to claim 4, characterized in that, In step (21), the extraction method is water extraction or alcohol extraction.

6. The method for preparing a traditional Chinese medicine composition based on a ternary carrier and a quaternary principal-assistant-guide reconstructed composition according to claim 4, characterized in that, In step (21), the extraction method is a combination of water extraction and alcohol extraction, including a first water extraction and a second alcohol extraction.

7. The method for preparing a traditional Chinese medicine composition based on a ternary carrier and a quaternary principal-assistant-guide reconstructed composition according to claim 6, characterized in that, In step (21), the concentration is reduced to a relative density of 1.15; the relative density is measured at 60°C.

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