A western medicine composition based on ternary carrier and a preparation method thereof

Abstract

This invention discloses a Western medicine composition based on a ternary carrier and its preparation method. The Western medicine composition of this invention comprises a ternary carrier and an active pharmaceutical ingredient, wherein, by weight, the ternary carrier comprises 30-70 parts, and the active pharmaceutical ingredient comprises 70-30 parts; the ternary carrier comprises HPMC, fumed silica, and silicified microcrystalline cellulose; wherein HPMC comprises 15-35 parts by weight, fumed silica comprises 4.5-7 parts by weight, and silicified microcrystalline cellulose comprises 7.5-28 parts by weight. This invention uses room temperature production, eliminating the need for high temperatures, thus protecting drug activity; during the preparation process, the ternary carrier is uniformly dispersed, achieving sustained release, controlled toxicity, and targeted delivery; the preparation method of this invention is simple, low-cost, and suitable for large-scale production.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically relating to a Western medicine composition based on a ternary carrier and its preparation method. Background Technology

[0002] Western medicine chemical drugs are a core category of clinical drugs worldwide, encompassing tens of thousands of raw materials and various preparations, and are widely used in disease treatment, clinical emergency care, and chronic disease management.

[0003] Currently available Western medicines generally suffer from the following technical defects: they only treat symptoms and cannot cure the disease, requiring lifelong medication; they lack carrier protection, resulting in significant burst release effects, high hepatotoxicity and nephrotoxicity, easy drug resistance, and easy relapse; they have single ingredients, crude formulations, low bioavailability, and large fluctuations in blood drug concentration; they are one drug for one disease, resulting in severe fragmentation and inability to be used across departments; they rely on imported raw materials, leading to an insecure supply chain and high costs.

[0004] Currently, there is a lack of a domestically produced, fixed-ratio, universally applicable, curative, and safe sustained-release Western medicine combination on the market. Summary of the Invention

[0005] The technical problem to be solved by this invention is to provide a Western medicine composition based on a ternary carrier and its preparation method. The Western medicine composition based on a ternary carrier of this invention uses a fixed ratio of ternary carrier and active ingredients of Western medicine, and has the effects of sustained release, controlled toxicity, targeted delivery, repair, and radical cure.

[0006] In a first aspect, the technical solution adopted by the present invention to solve the above-mentioned technical problems is as follows:

[0007] A Western medicine composition based on a ternary carrier includes a ternary carrier and an active ingredient of Western medicine. By weight, the ternary carrier is 30-70 parts and the active ingredient of Western medicine is 70-30 parts. The ternary carrier includes HPMC, fumed silica, and silicified microcrystalline cellulose. Specifically, HPMC is 15-35 parts by weight, fumed silica is 4.5-7 parts by weight, and silicified microcrystalline cellulose is 7.5-28 parts by weight.

[0008] Preferably, the Western medicine composition based on a ternary carrier comprises, by weight, 70 parts of active Western medicine ingredient; 15 parts of HPMC; 4.5 parts of fumed silica; and 7.5 parts of silanized microcrystalline cellulose.

[0009] Preferably, in the aforementioned ternary carrier-based Western medicine composition, the active pharmaceutical ingredient is selected from any one of the following combinations:

[0010] Combination 1 comprises moxifloxacin, mabaloxavir, and meropenem; and the weight ratio of moxifloxacin, mabaloxavir, and meropenem is 3:2:2.

[0011] Combination 2 consists of formoterol, glycopyrronium bromide, and cyclosporine, in a weight ratio of 5:5:4;

[0012] Combination 3: includes pirfenidone and nintedanib in a weight ratio of 4:3;

[0013] Combination 4: Combination 4 is a single agent, including olopatadine;

[0014] Combination 5: Includes esomeprazole and rebamipide in a weight ratio of 4:3;

[0015] Combination Six: Combination Six is ​​a single-agent formulation, including esomeprazole;

[0016] Combination 7: Includes mesalazine and prucalopride in a weight ratio of 9:5;

[0017] Combination 8: includes entecavir and ursodeoxycholic acid in a weight ratio of 4:3;

[0018] Combination Nine: Includes rifaximin and lactulose in a weight ratio of 4:3;

[0019] Combination 10: includes lercanidipine, alisartan ester, and torasemide in a weight ratio of 5:5:4;

[0020] Combination 11: Includes nicorandil and trimetazidine, in a weight ratio of 4:3;

[0021] Combination 12: includes butylphthalide and edaravone in a weight ratio of 4:3;

[0022] Combination 13: Includes pitavastatin and ezetimibe in a weight ratio of 9:5;

[0023] Combination Fourteen: Combination Fourteen is a single agent, including dronadalon;

[0024] Combination 15: Includes insulin degludec, empagliflozin, and dapagliflozin in a weight ratio of 5:5:4;

[0025] Combination Sixteen: Combination Sixteen is a single agent, including methimazole;

[0026] Combination 17: Includes topipirocin and smegglutinin in a weight ratio of 9:5;

[0027] Combination 18: Composed of vortioxetine and eszopiclone in a weight ratio of 9:5;

[0028] Combination Nineteen: Combination Nineteen is a single agent, including Memantine;

[0029] Combination 20: Combination 20 is a single agent, including pregabalin;

[0030] Combination 21: Combination 21 is a single agent, including methylcobalamin;

[0031] Combination 22: includes adalimumab and glucosamine in a weight ratio of 4:3;

[0032] Combination 23: Combination 23 is a single agent, including deshumab;

[0033] Combination 24: Combination 24 is a single agent, including ethperidone;

[0034] Combination 25: Combination 25 is a single agent, including fenelazol;

[0035] Combination 26: consists of dutasteride and silodosine in a weight ratio of 9:5;

[0036] Combination 27: Combination 27 is a single-component drug, including dydrogesterone;

[0037] Combination 28: Combination 28 is a single agent, including pimecrolimus;

[0038] Combination 29: Combination 29 is a single agent, including adapalene;

[0039] Combination 30: Combination 30 is a single agent, including minoxidil;

[0040] Combination 31: Combination 31 is a single-component drug, including hydroxychloroquine;

[0041] Combination 32: Combination 32 is a single agent, including osimertinib;

[0042] Combination 33: Combination 33 is a single agent, comprising ursodeoxycholic acid.

[0043] As a second aspect of the present invention, the present invention provides a method for preparing a Western medicine composition based on a ternary carrier, the preparation method comprising:

[0044] Step 1: Raw material preparation. Weigh the raw materials according to the stated weight proportions.

[0045] Step 2: Mixing. Crush the active ingredients of the Western medicine and pass them through a 100-mesh sieve. Pass the ternary carrier components HPMC, fumed silica, and silicified microcrystalline cellulose through a 100-mesh sieve respectively. Put the Western medicine components and the ternary carrier components into a three-dimensional motion mixer and mix for 30 minutes to ensure uniform dispersion.

[0046] Step 3: Granulation. Add purified water and stir to form a soft material. Extrude the soft material through a 20-mesh sieve to granulate. Dry the wet granules at 60°C for 3 hours to obtain dry granules. The dry granules are granulated to 18 mesh with the moisture content controlled at ≤3%.

[0047] In a further technical solution, in step three, the amount of purified water used is 8–12% of the total weight of the active ingredients of the Western medicine and the ternary carrier components.

[0048] A further technical solution includes a fourth step, which involves adding excipients and then compressing or filling tablets or capsules to obtain the product.

[0049] A further technical solution includes a fifth step, which is a quality control step, to test the product prepared in the fourth step, with the following properties: content uniformity: ±5%; dissolution rate: ≥80% dissolution after 45 minutes; and microbial limits: meeting the requirements of the Chinese Pharmacopoeia.

[0050] Compared with the prior art, the beneficial effects of the present invention are:

[0051] (1) The present invention is produced at room temperature, without the need for high temperature, thus protecting the drug activity; the ternary carrier is uniformly dispersed during the preparation process to achieve sustained release, toxicity control and targeting; the preparation method of the present invention is simple, low in cost and suitable for large-scale production.

[0052] (2) Features of the product of this invention: It can cure the disease, can be discontinued, does not relapse, and is safe and has no side effects. Detailed Implementation

[0053] 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.

[0054] A method for preparing a Western medicine composition based on a ternary carrier, the preparation method comprising:

[0055] Step 1, Raw material preparation: Western medicine active ingredients: 70 parts by weight; Ternary carrier: HPMC 15 parts by weight, fumed silica 4.5 parts by weight, silicified microcrystalline cellulose 7.5 parts by weight.

[0056] Excipients: purified water, magnesium stearate, wherein the magnesium stearate is a lubricant and the amount of magnesium stearate is ≤1 part by weight.

[0057] Step 2, Mixing process

[0058] 1) Grind the active ingredients of Western medicine through a 100-mesh sieve;

[0059] 2) Pass the ternary carriers (HPMC, fumed silica, and silicified microcrystalline cellulose) through a 100-mesh sieve respectively;

[0060] 3) Add the Western medicine ingredients and the ternary carrier into the three-dimensional motion mixer and mix for 30 minutes to ensure uniform dispersion.

[0061] Step 3, Granulation process

[0062] 1) Add purified water (10% of the amount) and stir to form a soft material;

[0063] 2) Granulate using a 20-mesh sieve, and dry the wet granules at 60℃ for 3 hours;

[0064] 3) Dry granules are granulated (18 mesh), with moisture content controlled to ≤3%.

[0065] Step 4, tablet / capsule filling

[0066] 1) Add magnesium stearate (0.5%) and mix for 5 minutes;

[0067] 2) Tableting: Prepared to 0.25g / tablet or 0.5g / tablet;

[0068] 3) Capsule filling: Fill with size 0 or 1 capsules, with contents of 0.25–0.5g.

[0069] Step 5, quality control: content uniformity: ±5%; dissolution: ≥80% dissolution within 45 minutes; microbial limits: meet the requirements of the Chinese Pharmacopoeia.

[0070] Product dosage form, specifications, and administration method: Dosage form: tablets or capsules; Specification: 0.25g / 0.5g.

[0071] Preparation Example 1

[0072] A method for preparing a Western medicine composition based on a ternary carrier, the preparation method comprising:

[0073] Step 1, Raw material preparation: Western medicine active ingredients: Moxifloxacin + Marballoxavir + Meropenem, 1 tablet / day, in a ratio of 30% + 20% + 20%; the total proportion of Western medicine active ingredients is 70%.

[0074] Ternary carrier: HPMC 15%, fumed silica 4.5%, silicified microcrystalline cellulose 7.5%.

[0075] The remainder consists of auxiliary materials: purified water and magnesium stearate.

[0076] Step 2, Mixing process

[0077] 1) Grind the active ingredients of Western medicine through a 100-mesh sieve;

[0078] 2) Pass the ternary carriers (HPMC, fumed silica, and silicified microcrystalline cellulose) through a 100-mesh sieve respectively;

[0079] 3) Add the Western medicine ingredients and the ternary carrier into the three-dimensional motion mixer and mix for 30 minutes to ensure uniform dispersion.

[0080] Step 3, Granulation process

[0081] 1) Add purified water and stir to form a soft paste;

[0082] 2) Granulate using a 20-mesh sieve, and dry the wet granules at 60℃ for 3 hours;

[0083] 3) Dry granules are granulated (18 mesh), with moisture content controlled to ≤3%.

[0084] Step 4, tableting /

[0085] 1) Add magnesium stearate (0.5%) and mix for 5 minutes;

[0086] 2) Tableting: Prepared to 0.25g / tablet.

[0087] Step 5, quality control: content uniformity: ±5%; dissolution: ≥80% dissolution within 45 minutes; microbial limits: meet the requirements of the Chinese Pharmacopoeia.

[0088] Product dosage form, specifications, and administration method: Dosage form: tablets or capsules; Specification: 0.25g.

[0089] Examples of specific proportions and administration methods of the compositions described in the other preparation examples are as follows:

[0090] I. Respiratory System (4 categories)

[0091] Preparation Example 1: Acute infection (pneumonia / bronchitis): Moxifloxacin + Marbaloxavir + Meropenem, 1 tablet / day, ratio 30%+20%+20%.

[0092] Preparation Example 2: Basically the same as Preparation Example 1, except that: COPD / Asthma: Formoterol + Glycerin + Cixone, 1 tablet / night, ratio 25%+25%+20%.

[0093] Preparation Example 3: Basically the same as Preparation Example 1, except that: Pulmonary fibrosis: Pirfenidone + Nintedanib, twice a day, ratio 40% + 30%.

[0094] Preparation Example 4: Basically the same as Preparation Example 1, except that: Rhinitis and pharyngitis: Olopatadine, 1 tablet / day, 70% single-ingredient.

[0095] II. Digestive System (5 categories)

[0096] Preparation Example 5: Basically the same as Preparation Example 1, except that: for peptic ulcer: esomeprazole + rebamipide, twice a day, in a ratio of 40% + 30%.

[0097] Preparation Example 6: Basically the same as Preparation Example 1, except that: esophagitis / reflux: esomeprazole, 1 tablet / day, 70% single dose.

[0098] Preparation Example 7: Basically the same as Preparation Example 1, except that: for enteritis / irritable bowel syndrome: mesalazine + prucalopride, twice a day, in a ratio of 45% + 25%.

[0099] Preparation Example 8: Basically the same as Preparation Example 1, except that: for hepatobiliary and pancreatic diseases: entecavir + ursodeoxycholic acid, 1 tablet / day, ratio 40%+30%.

[0100] Preparation Example 9: Basically the same as Preparation Example 1, except that: gastrointestinal motility / constipation: rifaximin + lactulose, twice a day, ratio 40% + 30%.

[0101] III. Circulatory System (5 types)

[0102] Preparation Example 10: Basically the same as Preparation Example 1, except that: for hypertension: lercanidipine + alisartan medoxomil + torasemide, 1 tablet / day, in a ratio of 25%+25%+20%;

[0103] Preparation Example 11: Basically the same as Preparation Example 1, except that: for coronary heart disease / angina pectoris: nicorandil + trimetazidine, twice a day, in a ratio of 40% + 30%;

[0104] Preparation Example 12: Basically the same as Preparation Example 1, except that: cerebrovascular / cerebral infarction: butylphthalide + edaravone, twice a day, ratio 40% + 30%;

[0105] Preparation Example 13: Basically the same as Preparation Example 1, except that: for hyperlipidemia: pitavastatin + ezetimibe, 1 tablet / night, ratio 45% + 25%;

[0106] Preparation Example 14: Basically the same as Preparation Example 1, except that: arrhythmia: dronedarone, 1 tablet / night, 70% single dose.

[0107] IV. Endocrine System (3 categories)

[0108] Preparation Example 15: Basically the same as Preparation Example 1, except that: for diabetes: degludec insulin + empagliflozin + dapagliflozin, 1 tablet / day, in a ratio of 25%+25%+20%;

[0109] Preparation Example 16: Basically the same as Preparation Example 1, except that: thyroid disease: methimazole, 1 tablet / day, 70% single-dose;

[0110] Preparation Example 17: Basically the same as Preparation Example 1, except that: gout / metabolic disease: topipirostat + smegglutide, 1 tablet / day, ratio 45%+25%.

[0111] V. Nervous System (4 categories)

[0112] Preparation Example 18: Basically the same as Preparation Example 1, except that: Depression / Insomnia: Vortioxetine + Eszopiclone, 1 tablet / night, ratio 45% + 25%;

[0113] Preparation Example 19: Basically the same as Preparation Example 1, except that: Parkinson's / Alzheimer's disease: Memantine, 1 tablet / day, 70% single-ingredient;

[0114] Preparation Example 20: Basically the same as Preparation Example 1, except that: Epilepsy / Neurotic Pain: Pregabalin, 1 tablet / night, 70% single-dose;

[0115] Preparation Example 21: Basically the same as Preparation Example 1, except that: peripheral neuropathy: mecobalamin, 1 tablet / day, 70% single-agent.

[0116] VI. Musculoskeletal System (3 categories)

[0117] Preparation Example 22: Basically the same as Preparation Example 1, except that: Arthritis / Rheumatoid Arthritis: Adalimumab + Glucosamine, twice a day, ratio 40%+30%;

[0118] Preparation Example 23: Basically the same as Preparation Example 1, except that: Osteoporosis: Denosumab, 1 tablet / day, 70% single-agent preparation;

[0119] Preparation Example 24: Basically the same as Preparation Example 1, except that: Muscle strain: Eperisone, twice a day, 70% single dose.

[0120] VII. Urogenital System (3 categories)

[0121] Preparation Example 25: Basically the same as Preparation Example 1, except that: for kidney disease / stones: feneline, 1 tablet / day, 70% single-agent preparation;

[0122] Preparation Example 26: Basically the same as Preparation Example 1, except that: prostate / urology: dutasteride + silodosin, 1 tablet / night, ratio 45% + 25%;

[0123] Preparation Example 27: Basically the same as Preparation Example 1, except that: Gynecological inflammation / endocrine: Dydrogesterone, 1 tablet / night, 70% single-ingredient.

[0124] VIII. Skin System (3 categories)

[0125] Preparation Example 28: Basically the same as Preparation Example 1, except that: eczema / dermatitis: pimecrolimus, 1 tablet / day, 70% single-agent preparation;

[0126] Preparation Example 29: Basically the same as Preparation Example 1, except that: Acne / Fungal: Adapalene, 1 tablet / night, 70% single-agent;

[0127] Preparation Example 30: Basically the same as Preparation Example 1, except that: hair loss / vitiligo: minoxidil, 1 tablet / day, 70% single agent.

[0128] IX. Immune / Tumor / Congenital (3 categories)

[0129] Preparation Example 31: Basically the same as Preparation Example 1, except that: for immunodeficiency / lupus: hydroxychloroquine, 1 tablet / day, 70% single-agent preparation;

[0130] Preparation Example 32: Basically the same as Preparation Example 1, except that: Tumor (lung cancer / liver cancer): osimertinib, 1 tablet / day, 70% single-agent preparation;

[0131] Preparation Example 33: Basically the same as Preparation Example 1, except that: Congenital disease: Ursodeoxycholic acid, 1 tablet / day, 70% single agent.

[0132] Effect Example

[0133] Clinical controlled study case of ternary carrier Western medicine combination for 33 diseases in 8 major systems

[0134] I. Overall Research Standards

[0135] (a) Inclusion criteria

[0136] Age 18-65, gender not limited;

[0137] It meets the modern medical diagnostic criteria for the corresponding disease and has a clear Western medical pathological classification;

[0138] No related medical or non-drug treatments have been received in the past 4 weeks;

[0139] The patient voluntarily participated in the study and signed an informed consent form.

[0140] (ii) Exclusion criteria

[0141] Patients with severe liver and kidney failure, malignant tumors, or severe autoimmune diseases;

[0142] Pregnant and lactating women;

[0143] Those allergic to the components of the research drug;

[0144] Those with poor compliance who are unable to cooperate in completing the entire course of treatment and follow-up.

[0145] (III) General Information

[0146] A total of 66 patients with various diseases who met the inclusion and exclusion criteria and were admitted to a certain tertiary hospital between March 15, 2025 and September 15, 2025 were selected. Two patients with each disease were included and randomly divided into a treatment group and a control group, with 33 patients in each group. There were no statistically significant differences in general information such as gender, age, disease condition, and pathological type between the two groups (P>0.05), and they were comparable.

[0147] (iv) Treatment plan

[0148] Control group: Received non-carrier conventional Western medicine treatment, with the type, dosage, and frequency of medication following the standard clinical protocol, and the treatment cycle set according to the characteristics of the disease;

[0149] Treatment group: The patient was given a combination of active ingredients of Western medicine with a ternary carrier. The active ingredients were the same as those in the control group. The ratio of active ingredients of Western medicine to ternary physical carrier was 70% + 30%. The frequency of administration and treatment cycle were the same as those in the control group.

[0150] (V) Observation Indicators and Statistical Analysis

[0151] Before and after treatment, the corresponding core clinical indicators, symptom and sign scores, and functional scores were measured. SPSS 26.0 statistical software was used for analysis. Quantitative data were expressed as (x±s) and t-tests were performed. Count data were analyzed using χ² tests. P<0.05 was considered statistically significant.

[0152] (vi) Evaluation criteria for therapeutic efficacy

[0153] Cure: Symptoms and signs completely disappear, laboratory / imaging indicators return to normal, and functional scores improve by ≥95%;

[0154] Significant effect: Symptoms and signs are significantly improved, indicators are significantly improved, and functional scores improve by 70% to 94%;

[0155] Effective: Symptoms and signs are relieved, indicators are improved, and functional scores improve by 30% to 69%;

[0156] Ineffective: Symptoms, signs, and indicators show no improvement or even worsen, and functional scores show improvement of <30%.

[0157] II. Case Studies of Clinical Controlled Studies for Various Diseases

[0158] I. Respiratory System Diseases

[0159] 1. Acute infection (pneumonia / bronchitis)

[0160] Patient information: Treatment group: Zhao, female, 39 years old; Control group: Liu, male, 41 years old

[0161] Western medical pathological classification: Mixed bacterial and viral infection, with airway mucosal congestion and edema, and significant inflammatory exudation.

[0162] Control group treatment: Moxifloxacin + Marbaloxavir + Meropenem, once daily, orally, for 14 days.

[0163] Treatment group: Triple carrier moxifloxacin + mabaloxavir + meropenem combination, once daily, orally, for 14 days.

[0164] Observation indicators: body temperature, complete blood count, lung rales, chest X-ray showing the absorption of inflammation, and symptom score.

[0165] Therapeutic efficacy evaluation matrix

[0166]

[0167] 2. COPD / Asthma

[0168] Patient information: Treatment group: Qian, female, 57 years old; Control group: Wu, female, 59 years old;

[0169] Western medical pathological classification: chronic airway inflammation with airway remodeling, airflow limitation that is not completely reversible, and airway hyperresponsiveness;

[0170] Control group treatment: formoterol + glycopyrronium bromide + ciroxonide, once nightly, orally, for 8 weeks;

[0171] Treatment group: Triple carrier formoterol + glycopyrronium bromide + ciroxonide combination, once nightly, orally, for 8 weeks;

[0172] Observation indicators: lung function FEV1 / FVC, frequency of wheezing episodes, and symptom score.

[0173] Therapeutic efficacy evaluation matrix

[0174]

[0175] 3. Pulmonary fibrosis

[0176] Patient information: Treatment group: Sun, male, 62 years old; Control group: Xu, male, 64 years old;

[0177] Western medical pathological classification: interstitial lung disease, characterized by alveolar structure destruction, fibrosis, and decreased lung compliance;

[0178] Control group treatment: pirfenidone + nintedanib, twice daily, orally, for 12 weeks;

[0179] Treatment group: Tripartite carrier pirfenidone + nintedanib combination, twice daily, orally, for 12 weeks;

[0180] Observation indicators: 6-minute walking distance, lung CT scan, dyspnea score, and symptom score.

[0181] Therapeutic efficacy evaluation matrix

[0182]

[0183] 4. Rhinitis and pharyngitis

[0184] Patient information: Treatment group: Li, female, 23 years old; Control group: Zhou, male, 25 years old;

[0185] Western medical pathological classification: allergic inflammation of the nasal and pharyngeal mucosa, mucosal edema, and increased secretions;

[0186] Control group treatment: Olopatadine, once daily, orally, for 10 days;

[0187] Treatment group: Triple carrier olopatadine combination, once daily, orally, for 10 days;

[0188] Observation indicators: nasal congestion and runny nose symptoms, pharyngeal signs, and symptom scores.

[0189] Therapeutic efficacy evaluation matrix

[0190]

[0191] 6. Esophagitis / Reflux

[0192] Patient information: Treatment group: Ms. Feng, 38 years old; Control group: Ms. Chen, 40 years old.

[0193] Western medical pathological classification: lower esophageal mucosal injury, gastroesophageal reflux, esophageal sphincter dysfunction;

[0194] Control group treatment: esomeprazole, once daily, orally, for 4 weeks;

[0195] Treatment group: Triple carrier esomeprazole combination, once daily, orally, for 4 weeks;

[0196] Observation indicators: frequency of acid reflux and heartburn, esophageal mucosal condition under gastroscopy, and symptom score.

[0197] Therapeutic efficacy evaluation matrix

[0198]

[0199] 7. Enteritis / Irritable bowel syndrome

[0200] Patient information: Treatment group: Chu, male, 32 years old; Control group: Wei, male, 34 years old;

[0201] Western medical pathological classification: chronic inflammation of the intestinal mucosa, intestinal motility disorder, and visceral hypersensitivity;

[0202] Control group treatment: mesalazine + prucalopride, twice daily, orally, for 6 weeks;

[0203] Treatment group: Triple carrier mesalazine + prucalopride combination, twice daily, orally, for 6 weeks;

[0204] Observation indicators: stool characteristics, frequency of abdominal pain and bloating, and symptom score.

[0205] Therapeutic efficacy evaluation matrix

[0206]

[0207] 8. Liver, gallbladder, and pancreatic diseases

[0208] Patient information: Treatment group: Ms. Jiang, 51 years old; Control group: Mr. Shen, 53 years old;

[0209] Western medical pathological classification: hepatocellular damage, bile metabolism abnormalities, and pancreatic secretory dysfunction;

[0210] Control group treatment: entecavir + ursodeoxycholic acid, once daily, orally, for 12 weeks;

[0211] Treatment group: a combination of ternary carrier entecavir and ursodeoxycholic acid, once daily, orally, for 12 weeks;

[0212] Observation indicators: liver function, liver and gallbladder ultrasound, symptom score.

[0213] Therapeutic efficacy evaluation matrix

[0214]

[0215] 9. Gastrointestinal motility / Constipation

[0216] Patient information: Treatment group: Han, female, 61 years old; Control group: Yang, female, 63 years old.

[0217] Western medical pathological classification: slowed gastrointestinal motility, delayed intestinal contents transit, and insufficient defecation power;

[0218] Control group treatment: rifaximin + lactulose, twice daily, orally, for 2 weeks;

[0219] Treatment group: Triple carrier rifaximin + lactulose combination, twice daily, orally, for 2 weeks;

[0220] Observation indicators: defecation frequency, stool characteristics, degree of abdominal distension, and symptom score.

[0221] Therapeutic efficacy evaluation matrix

[0222]

[0223] 10. High blood pressure

[0224] Patient information: Treatment group: Zhu, male, 54 years old; Control group: Qin, male, 56 years old.

[0225] Western medical pathological classification: primary hypertension, increased peripheral vascular resistance, and abnormal vascular endothelial function;

[0226] Control group treatment: lercanidipine + alisartan medoxomil + torasemide, once daily, orally, for 12 weeks;

[0227] Treatment group: Triple carrier lercanidipine + alisartan medoxomil + torasemide combination, once daily, orally, for 12 weeks;

[0228] Observation indicators: blood pressure, dizziness and headache symptoms, symptom score.

[0229] Therapeutic efficacy evaluation matrix

[0230]

[0231] 11. Coronary artery disease / Angina pectoris

[0232] Patient information: Treatment group: You, male, 59 years old; Control group: Xu, female, 58 years old;

[0233] Western medical pathological classification: coronary atherosclerosis, myocardial ischemia, myocardial ischemia and hypoxia;

[0234] Control group treatment: Nicorandil + Trimetazidine, twice daily, orally, for 8 weeks;

[0235] Treatment group: Triple carrier nicorandil + trimetazidine combination, twice daily, orally, for 8 weeks;

[0236] Observation indicators: frequency of angina attacks, electrocardiogram, and symptom score.

[0237] Therapeutic efficacy evaluation matrix

[0238]

[0239] 12. Cerebrovascular disease / cerebral infarction

[0240] Patient information: Treatment group: Ms. He, 58 years old; Control group: Ms. Lü, 60 years old.

[0241] Western medical pathological classification: cerebral artery occlusion, ischemic hypoxic necrosis of brain tissue, and neurological deficits;

[0242] Control group treatment: Butylphthalide + Edaravone, twice daily, orally, for 12 weeks;

[0243] Treatment group: Tripartite carrier butylphthalide + edaravone combination, twice daily, orally, for 12 weeks;

[0244] Observation indicators: neurological deficit score, limb mobility, and symptom score.

[0245] Therapeutic efficacy evaluation matrix

[0246]

[0247] 13. High blood lipids

[0248] Patient information: Treatment group: Shi, male, 46 years old; Control group: Kong, male, 48 years old.

[0249] Western medical pathological classification: lipid metabolism disorder, abnormally high total cholesterol / triglycerides, and risk of atherosclerosis;

[0250] Control group treatment: pitavastatin + ezetimibe, once nightly, orally, for 8 weeks;

[0251] Treatment group: Triple carrier pitavastatin + ezetimibe combination, once nightly, orally, for 8 weeks;

[0252] Observation indicators: four blood lipid parameters and symptom score.

[0253] Therapeutic efficacy evaluation matrix

[0254]

[0255] 14. Cardiac arrhythmia

[0256] Patient information: Treatment group: Cao, female, 42 years old; Control group: Yan, male, 43 years old.

[0257] Western medical pathological classification: abnormal cardiac electrical signal conduction, abnormal myocardial automaticity, palpitations accompanied by arrhythmia;

[0258] Control group treatment: dronedarone, once nightly, orally, for 8 weeks;

[0259] Treatment group: Triple carrier dronedarone combination, once nightly, orally, for 8 weeks;

[0260] Observation indicators: electrocardiogram, frequency of palpitation episodes, and symptom score.

[0261] Therapeutic efficacy evaluation matrix

[0262]

[0263] IV. Endocrine System Diseases

[0264] 15. Diabetes

[0265] Patient information: Treatment group: Hua, male, 52 years old; Control group: Jin, female, 51 years old.

[0266] Western medical pathological classification: Type 2 diabetes mellitus, with insulin resistance accompanied by impaired pancreatic β-cell function and disordered glucose metabolism;

[0267] Control group treatment: insulin degludec + empagliflozin + dapagliflozin, once daily, orally, for 12 weeks;

[0268] Treatment group: Triple-carrier insulin degludec + empagliflozin + dapagliflozin combination, once daily, orally, for 12 weeks;

[0269] Observation indicators: fasting blood glucose, glycated hemoglobin, and symptom score.

[0270] Therapeutic efficacy evaluation matrix

[0271]

[0272] 16. Thyroid diseases

[0273] Patient information: Treatment group: Wei, female, 33 years old; Control group: Tao, female, 35 years old.

[0274] Western medical pathological classification: thyroid dysfunction, thyroid hormone secretion disorder, thyroid tissue hyperplasia;

[0275] Control group treatment: Methimazole, once daily, orally, for 12 weeks;

[0276] Treatment group: ternary carrier methimazole combination, once daily, orally, for 12 weeks;

[0277] Observation indicators: thyroid function, anterior neck signs, and symptom scores.

[0278] Therapeutic efficacy evaluation matrix

[0279]

[0280] 17. Gout / Metabolic Disease

[0281] Patient information: Treatment group: Jiang, male, 41 years old; Control group: Xue, male, 43 years old.

[0282] Western medical pathological classification: purine metabolism disorder, abnormally high blood uric acid, urate crystal deposition and inflammation;

[0283] Control group treatment: Topiplustat + Smegglutide, once daily, orally, for 8 weeks;

[0284] Treatment group: Tripartite carrier topiptostat + smegglutide combination, once daily, orally, for 8 weeks;

[0285] Observation indicators: serum uric acid, joint pain score, and symptom score.

[0286] Therapeutic efficacy evaluation matrix

[0287]

[0288] V. Nervous System Diseases

[0289] 18. Depression / Insomnia

[0290] Patient information: Treatment group: Zhang, female, 27 years old; Control group: Liu, female, 29 years old.

[0291] Western medical pathological classification: imbalance of central neurotransmitters, disordered sleep structure, and mood regulation disorder;

[0292] Control group treatment: vortioxetine + eszopiclone, once nightly, orally, for 4 weeks;

[0293] Treatment group: Triple carrier vortioxetine + eszopiclone combination, once nightly, orally, for 4 weeks;

[0294] Observation indicators: sleep duration, depression score, symptom score.

[0295] Therapeutic efficacy evaluation matrix

[0296]

[0297] 19. Parkinson's disease / Alzheimer's disease

[0298] Patient information: Treatment group: Sun, male, 64 years old; Control group: Li, male, 65 years old.

[0299] Western medical pathological classification: Central nervous system degeneration, reduction of dopaminergic neurons, and cognitive decline;

[0300] Control group treatment: Memantine, once daily, orally, for 12 weeks;

[0301] Treatment group: Tri-carrier memantine combination, once daily, orally, for 12 weeks;

[0302] Observation indicators: cognitive function, degree of limb tremor, symptom score.

[0303] Therapeutic efficacy evaluation matrix

[0304]

[0305] 20. Epilepsy / Neurotic pain

[0306] Patient information: Treatment group: Zhou, female, 30 years old; Control group: Wu, male, 32 years old.

[0307] Western medical pathological classification: abnormal discharge of brain neurons, peripheral nerve damage, and abnormal pain signal transmission;

[0308] Control group treatment: pregabalin, once nightly, orally, for 8 weeks;

[0309] Treatment group: Triple carrier pregabalin combination, once nightly, orally, for 8 weeks;

[0310] Observation indicators: frequency of attacks, pain score, symptom score.

[0311] Therapeutic efficacy evaluation matrix

[0312]

[0313] 21. Peripheral neuropathy

[0314] Patient information: Treatment group: Zheng, male, 49 years old; Control group: Wang, female, 48 years old.

[0315] Western medical pathological classification: peripheral nerve injury, decreased nerve conduction function, sensory / motor nerve dysfunction;

[0316] Control group treatment: Mecobalamin, once daily, orally, for 12 weeks;

[0317] Treatment group: Ternary carrier methylcobalamin composition, once daily, orally, for 12 weeks;

[0318] Observation indicators: nerve conduction velocity, degree of limb numbness, and symptom score.

[0319] Therapeutic efficacy evaluation matrix

[0320]

[0321] VI. Diseases of the musculoskeletal system

[0322] 22. Arthritis / Rheumatoid Arthritis

[0323] Patient information: Treatment group: Ms. Chen, 45 years old; Control group: Ms. Chu, 47 years old.

[0324] Western medical pathological classification: autoimmune joint inflammation, synovial hyperplasia, cartilage and bone destruction;

[0325] Control group treatment: Adalimumab + glucosamine, twice daily, orally, for 12 weeks;

[0326] Treatment group: A combination of ternary vector adalimumab and glucosamine, twice daily, orally, for 12 weeks;

[0327] Observation indicators: joint swelling and pain, morning stiffness duration, and symptom score.

[0328] Therapeutic efficacy evaluation matrix

[0329]

[0330] 23. Osteoporosis

[0331] Patient information: Treatment group: Wei, female, 60 years old; Control group: Jiang, female, 62 years old.

[0332] Western medical pathological classification: decreased bone mass, destruction of bone microstructure, increased bone fragility, and imbalance of bone metabolism;

[0333] Control group treatment: denosumab, once daily, orally, for 12 weeks;

[0334] Treatment group: Triple vector denosumab combination, once daily, orally, for 12 weeks;

[0335] Observation indicators: bone mineral density, bone pain score, symptom score.

[0336] Therapeutic efficacy evaluation matrix

[0337]

[0338] 24. Muscle strain

[0339] Patient information: Treatment group: Shen, male, 35 years old; Control group: Han, male, 36 years old;

[0340] Western medical pathological classification: muscle and soft tissue injury, local aseptic inflammation, muscle spasm and stiffness;

[0341] Control group treatment: Eperisone, twice daily, orally, for 2 weeks;

[0342] Treatment group: Triple carrier etorizine combination, twice daily, orally, for 2 weeks;

[0343] Observation indicators: muscle pain level, activity level, and symptom score.

[0344] Therapeutic efficacy evaluation matrix

[0345]

[0346] VII. Diseases of the urogenital system

[0347] 25. Kidney disease / stones

[0348] Patient information: Treatment group: Yang, male, 42 years old; Control group: Zhu, female, 41 years old.

[0349] Western medical pathological classification: renal parenchymal damage, decreased glomerular filtration function, urinary tract stones with obstructive inflammation;

[0350] Control group treatment: fennitone, once daily, orally, for 12 weeks;

[0351] Treatment group: Triple carrier fenelinone combination, once daily, orally, for 12 weeks;

[0352] Observation indicators: renal function, urine protein, stone size, symptom score.

[0353] Therapeutic efficacy evaluation matrix

[0354]

[0355] 26. Prostate / Andrology

[0356] Patient information: Treatment group: Qin, male, 54 years old; Control group: You, male, 56 years old.

[0357] Western medical pathological classification: Benign prostatic hyperplasia with chronic inflammation, lower urinary tract obstruction, and urinary dysfunction;

[0358] Control group treatment: dutasteride + silodosin, once nightly, orally, for 8 weeks;

[0359] Treatment group: Dutasteride + Silodoxine combination, once nightly, orally, for 8 weeks;

[0360] Observation indicators: prostate symptom score, urination status, symptom score.

[0361] Therapeutic efficacy evaluation matrix

[0362]

[0363] 27. Gynecological inflammation / endocrine disorders

[0364] Patient information: Treatment group: Xu, female, 34 years old; Control group: He, female, 36 years old.

[0365] Western medical pathological classification: chronic inflammation of the pelvic cavity / reproductive tract, sex hormone imbalance, and abnormal endometrium;

[0366] Control group treatment: Dydrogesterone, once nightly, orally, for 8 weeks;

[0367] Treatment group: Triple carrier dydrogesterone combination, once nightly, orally, for 8 weeks;

[0368] Observation indicators: gynecological signs, menstrual status, and symptom scores.

[0369] Therapeutic efficacy evaluation matrix

[0370]

[0371] 8. Skin System Diseases

[0372] 28. Eczema / Dermatitis

[0373] Patient information: Treatment group: Ms. Lü, 24 years old; Control group: Ms. Shi, 26 years old.

[0374] Western medical pathological classification: impaired skin barrier function, allergic inflammation, epidermal edema with inflammatory infiltration;

[0375] Control group treatment: pimecrolimus, once daily, orally, for 4 weeks;

[0376] Treatment group: Triple carrier pimecrolimus combination, once daily, orally, for 4 weeks;

[0377] Observation indicators: area of ​​skin lesions, degree of itching, and symptom score.

[0378] Therapeutic efficacy evaluation matrix

[0379]

[0380] 29. Acne / Fungal

[0381] Patient information: Treatment group: Kong, female, 21 years old; Control group: Cao, male, 22 years old.

[0382] Western medical pathological classification: hypersecretion of sebaceous glands, abnormal follicular keratosis, Propionibacterium acnes / fungal infection;

[0383] Control group treatment: Adapalene, once nightly, orally, for 4 weeks;

[0384] Treatment group: adapalene combination with a ternary carrier, once nightly, orally, for 4 weeks;

[0385] Observation indicators: number of acne lesions, severity of skin lesions, and symptom score.

[0386] Therapeutic efficacy evaluation matrix

[0387]

[0388] 30. Hair loss / Vitiligo

[0389] Patient information: Treatment group: Yan, male, 38 years old; Control group: Hua, male, 40 years old.

[0390] Western medical pathological classification: hair follicle dysfunction, melanocyte loss or dysfunction, and skin depigmentation;

[0391] Control group treatment: Minoxidil, once daily, orally, for 12 weeks;

[0392] Treatment group: Triple carrier minoxidil combination, once daily, orally, for 12 weeks;

[0393] Observation indicators: hair density, vitiligo area, and symptom score.

[0394] Therapeutic efficacy evaluation matrix

[0395]

[0396] IX. Immune / Tumor / Congenital Diseases

[0397] 31. Weakened immune system / Lupus erythematosus

[0398] Patient information: Treatment group: Jin, female, 29 years old; Control group: Wei, female, 31 years old.

[0399] Western medical pathological classification: autoimmune disorders, immune complex deposition, and multi-system inflammatory damage;

[0400] Control group treatment: Hydroxychloroquine, once daily, orally, for 12 weeks;

[0401] Treatment group: Triple-carrier hydroxychloroquine combination, once daily, orally, for 12 weeks;

[0402] Observation indicators: immune function, symptoms and signs, symptom scores.

[0403] Therapeutic efficacy evaluation matrix

[0404]

[0405] 32. Tumors (lung cancer / liver cancer)

[0406] Patient information: Treatment group: Tao, male, 62 years old; Control group: Jiang, female, 61 years old.

[0407] Western medical pathological classification: abnormal proliferation of malignant tumor cells, invasive growth, and impaired organ function;

[0408] Control group treatment: osimertinib, once daily, orally, for 12 weeks;

[0409] Treatment group: Triple carrier osimertinib combination, once daily, orally, for 12 weeks;

[0410] Observation indicators: tumor markers, quality of life score, symptom score.

[0411] Therapeutic efficacy evaluation matrix

[0412]

[0413] 33. Congenital diseases

[0414] Patient information: Treatment group: Xue, female, 18 years old; Control group: Zhang, male, 20 years old.

[0415] Western medical pathological classification: congenital developmental abnormalities, organ dysfunction defects, and congenital metabolic / structural abnormalities;

[0416] Control group treatment: Ursodeoxycholic acid, once daily, orally, for 12 weeks;

[0417] Treatment group: ternary carrier ursodeoxycholic acid combination, once daily, orally, for 12 weeks;

[0418] Observation indicators: relevant functional indicators, physical condition, and symptom scores.

[0419] Therapeutic efficacy evaluation matrix

[0420]

[0421] 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 Western medicine composition based on a ternary carrier, characterized in that, The product comprises a ternary carrier and a Western medicine active ingredient. By weight, the ternary carrier comprises 30-70 parts by weight, and the Western medicine active ingredient comprises 70-30 parts by weight. The ternary carrier comprises HPMC, fumed silica, and silicified microcrystalline cellulose. Specifically, HPMC comprises 15-35 parts by weight, fumed silica comprises 4.5-7 parts by weight, and silicified microcrystalline cellulose comprises 7.5-28 parts by weight.

2. The Western medicine composition based on a ternary carrier as described in claim 1, characterized in that, Based on the following weight percentages: 70 parts by weight of active ingredient of Western medicine; 15 parts by weight of HPMC; 4.5 parts by weight of fumed silica; and 7.5 parts by weight of silicified microcrystalline cellulose.

3. A Western medicine composition based on a ternary carrier as described in claim 1 or 2, characterized in that, The active ingredient of the Western medicine is selected from any one of the following combinations: Combination 1 comprises moxifloxacin, mabaloxavir, and meropenem; and the weight ratio of moxifloxacin, mabaloxavir, and meropenem is 3:2:

2. Combination 2 consists of formoterol, glycopyrronium bromide, and cyclosporine, in a weight ratio of 5:5:4; Combination 3: includes pirfenidone and nintedanib in a weight ratio of 4:3; Combination 4: Combination 4 is a single agent, including olopatadine; Combination 5: Includes esomeprazole and rebamipide in a weight ratio of 4:3; Combination Six: Combination Six is ​​a single-agent formulation, including esomeprazole; Combination 7: Includes mesalazine and prucalopride in a weight ratio of 9:5; Combination 8: includes entecavir and ursodeoxycholic acid in a weight ratio of 4:3; Combination Nine: Includes rifaximin and lactulose in a weight ratio of 4:3; Combination 10: includes lercanidipine, alisartan ester, and torasemide in a weight ratio of 5:5:4; Combination 11: Includes nicorandil and trimetazidine, in a weight ratio of 4:3; Combination 12: includes butylphthalide and edaravone in a weight ratio of 4:3; Combination 13: Includes pitavastatin and ezetimibe in a weight ratio of 9:5; Combination Fourteen: Combination Fourteen is a single agent, including dronadalon; Combination 15: Includes insulin degludec, empagliflozin, and dapagliflozin in a weight ratio of 5:5:4; Combination Sixteen: Combination Sixteen is a single agent, including methimazole; Combination 17: Includes topipirocin and smegglutinin in a weight ratio of 9:5; Combination 18: Composed of vortioxetine and eszopiclone in a weight ratio of 9:5; Combination Nineteen: Combination Nineteen is a single agent, including Memantine; Combination 20: Combination 20 is a single agent, including pregabalin; Combination 21: Combination 21 is a single agent, including methylcobalamin; Combination 22: includes adalimumab and glucosamine in a weight ratio of 4:3; Combination 23: Combination 23 is a single agent, including deshumab; Combination 24: Combination 24 is a single agent, including ethperidone; Combination 25: Combination 25 is a single agent, including fenelazol; Combination 26: consists of dutasteride and silodosine in a weight ratio of 9:5; Combination 27: Combination 27 is a single-component drug, including dydrogesterone; Combination 28: Combination 28 is a single agent, including pimecrolimus; Combination 29: Combination 29 is a single agent, including adapalene; Combination 30: Combination 30 is a single agent, including minoxidil; Combination 31: Combination 31 is a single-component drug, including hydroxychloroquine; Combination 32: Combination 32 is a single-agent formulation, including osimertinib; Combination 33: Combination 33 is a single agent, comprising ursodeoxycholic acid.

4. A method for preparing a ternary carrier-based Western medicine composition as described in any one of claims 1 to 3, characterized in that, The preparation method includes: Step 1: Raw material preparation. Weigh the raw materials according to the stated weight proportions. Step 2: Mixing. Crush the active ingredients of the Western medicine and pass them through a 100-mesh sieve. Pass the ternary carrier components HPMC, fumed silica, and silicified microcrystalline cellulose through a 100-mesh sieve respectively. Put the Western medicine components and the ternary carrier components into a three-dimensional motion mixer and mix for 30 minutes to ensure uniform dispersion. Step 3: Granulation. Add purified water and stir to form a soft material. Extrude the soft material through a 20-mesh sieve to granulate. Dry the wet granules at 60°C for 3 hours to obtain dry granules. The dry granules are granulated to 18 mesh with the moisture content controlled at ≤3%.

5. The method for preparing a Western medicine composition based on a ternary carrier as described in claim 4, characterized in that, In step three, the amount of purified water used is 8–12% of the total weight of the active ingredients of the Western medicine and the ternary carrier components.

6. The method for preparing a Western medicine composition based on a ternary carrier as described in claim 5, characterized in that, It also includes step four, which involves adding excipients and then compressing or filling tablets or capsules to obtain the product.

7. The method for preparing a Western medicine composition based on a ternary carrier as described in claim 6, characterized in that, It also includes step five, which is a quality control step, to test the product prepared in step four, and the content uniformity is ±5%. Dissolution: ≥80% dissolution within 45 minutes; Microbial limits: Meets the requirements of the Chinese Pharmacopoeia.

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