Pharmaceutical composition for bone joints as well as preparation method and application of pharmaceutical composition

Abstract

The invention provides a pharmaceutical composition for bone joints as well as a preparation method and application of the pharmaceutical composition. The pharmaceutical composition is prepared from the following components in parts by weight: 20 to 2000 parts of N-acetylglucosamine and 10 to 1000 parts of non-denatured type II collagen. In the compound composition of the N-acetylglucosamine and the non-denatured type II collagen, the two core components play a complementary role: the N-acetylglucosamine is focused on promoting synthesis of a cartilage matrix and provides a material basis for cartilage repair; the non-denatured type II collagen reduces damage of autoimmune response to cartilage through immunoregulation, the non-denatured type II collagen and the non-denatured type II collagen have a synergistic effect, the symptoms such as arthralgia and swelling can be relieved, the joint structure can be improved from the double angles of repairing and protecting, and particularly the treatment effect on patients with severe osteoarthritis is remarkably superior to that of a single-component preparation; and an innovative and efficient choice is provided for the treatment of osteoarticular diseases.

Description

Technical Field

[0001] The present invention belongs to the field of biomedicine technology, and particularly relates to a pharmaceutical composition for bone and joints, a preparation method thereof, and an application thereof. Background Art

[0002] Bone and joint diseases, especially arthritis and osteoarthritis, are common chronic degenerative diseases that have become a significant health issue affecting the quality of life of middle-aged and elderly people, athletes, and manual laborers worldwide. Patients often suffer from joint pain, stiffness, swelling, and limited mobility. Severe disease progression can even lead to disability, placing a heavy burden on individuals, families, and society.

[0003] Currently, N-acetylglucosamine (GlcNAc) and non-denatured type II collagen (UC-II) are two ingredients that have attracted much attention in the treatment of bone and joint diseases. As a key component of the articular cartilage matrix, N-acetylglucosamine can directly participate in chondrocyte metabolism and promote the synthesis of glycosaminoglycans, collagen and other components in the cartilage matrix, thereby helping to maintain the integrity of the cartilage structure, slowing the rate of cartilage degradation, and relieving joint pain and inflammation to a certain extent. However, clinical practice has shown that the efficacy of N-acetylglucosamine when used alone is limited, and the treatment effect on patients with severe osteoarthritis is often not ideal.

[0004] Undenatured type II collagen, a natural protein extracted from cartilage, is unique in its ability to modulate the immune system through an oral tolerance mechanism. When taken orally, it can induce specific immune tolerance, reducing autoimmune attacks against articular cartilage and diminishing inflammatory damage to cartilage, thereby improving joint function. However, when used alone, undenatured type II collagen is relatively ineffective in promoting cartilage matrix repair, making it difficult to fully address the pathological damage of osteoarticular diseases.

[0005] While products containing either N-acetylglucosamine or undenatured type II collagen alone are available on the market, research and development of a combination formula that scientifically combines the two ingredients to achieve synergistic therapeutic effects is relatively scarce. Therefore, developing a compound formulation that combines the strengths of both ingredients to achieve enhanced and complementary benefits has significant clinical significance and application value in breaking through existing treatment bottlenecks and improving the efficacy of osteoarthritis treatment. Summary of the Invention

[0006] In response to the problems existing in the prior art, the purpose of the present invention is to provide a pharmaceutical composition for bone and joint treatment, as well as its preparation method and application. The two core ingredients in the pharmaceutical composition - N-acetylglucosamine and non-denatured type II collagen - play a complementary role, synergistically enhance the effect, significantly relieve bone and joint pain, swelling and other symptoms, and can greatly improve the quality of life of osteoarthritis patients.

[0007] The purpose of the present invention is achieved through the following technical solutions:

[0008] The first aspect of the present invention provides a pharmaceutical composition for bone and joint treatment, comprising, by weight:

[0009] N-acetylglucosamine 20-2000 parts

[0010] 10-1000 copies of non-denatured type II collagen.

[0011] Preferably, the pharmaceutical composition comprises, by weight:

[0012] N-acetylglucosamine 500-1700 parts

[0013] 50-500 parts of non-denatured type II collagen.

[0014] More preferably, the pharmaceutical composition comprises, by weight:

[0015] 300-400 parts of N-acetylglucosamine

[0016] 50-150 parts of non-denatured type II collagen.

[0017] Furthermore, the pharmaceutical composition also includes pharmaceutically acceptable excipients.

[0018] Furthermore, the pharmaceutically acceptable excipients include microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, magnesium stearate, sodium carboxymethyl starch and micronized silica gel.

[0019] Furthermore, the dosage forms of the pharmaceutical composition include tablets, granules, capsules, oral solutions, soft capsules, soft candies, and injections.

[0020] A second aspect of the present invention provides a method for preparing a compound tablet for bone and joint treatment, wherein the compound tablet comprises, in parts by weight:

[0021] N-acetylglucosamine 20-2000 parts

[0022] 10-1000 copies of non-denatured type II collagen;

[0023] The preparation method comprises the following steps:

[0024] 1) Raw material pretreatment: N-acetylglucosamine and non-denatured type II collagen were crushed and sieved;

[0025] 2) Excipient screening: sieve the pharmaceutically acceptable excipients separately;

[0026] 3) Mixing: Mix N-acetylglucosamine, non-denatured type II collagen and excipients in a high-speed mixer;

[0027] 4) Tablet compression: Press the mixed powder into tablets, controlling tablet weight and hardness;

[0028] 5) Coating: coating the compressed tablets with a coating material to obtain the composite tablets for bone and joints.

[0029] Furthermore, in step 4), the hardness of the tablet is 30N to 100N; in step 5), the coating material is Opadry premixed coating powder, and the coating weight gain is 0.75% to 3%.

[0030] The third aspect of the present invention provides the use of the pharmaceutical composition for bone and joints described in the first aspect in the preparation of drugs for preventing and treating bone and joint related diseases and for cartilage repair. The cartilage repair mentioned is for sports medicine and trauma repair, such as cartilage repair after joint surgery.

[0031] Furthermore, the bone and joint related diseases include osteoarthritis, rheumatoid arthritis, and metabolic joint disease.

[0032] The beneficial effects of the present invention compared to the prior art are:

[0033] The N-acetylglucosamine and non-denatured type II collagen compound composition of the present invention, through scientific design and innovative preparation, exhibits significant advantages in many aspects, as follows:

[0034] 1. Synergistic effect to improve treatment effect

[0035] The two core ingredients complement each other: N-acetylglucosamine promotes cartilage matrix synthesis, providing a material foundation for cartilage repair; non-denatured type II collagen reduces pro-inflammatory factors (such as TNF-α and IL-6), reducing cartilage damage caused by autoimmune responses through immune regulation. The synergistic effect of the two ingredients not only relieves symptoms such as joint pain and swelling, but also reduces joint inflammation at the root by reducing pro-inflammatory factors. Through a dual action of treatment, repair, and protection, it improves joint structure, especially for patients with severe osteoarthritis, with significantly better therapeutic effects than single-ingredient preparations. N-acetylglucosamine, as a hyaluronic acid precursor, promotes skin repair, and non-denatured type II collagen has potential anti-inflammatory effects, and the two ingredients work together to promote wound healing.

[0036] Pharmacodynamic experiments have confirmed that the compound composition can significantly reduce the levels of inflammatory factors such as IL-1β and TNF-α in the serum of arthritis model animals, alleviate the inflammatory response, while improving the structural integrity of articular cartilage tissue and reducing inflammatory cell infiltration. Its therapeutic effect is better than the use of any component alone and traditional control drugs (such as methotrexate).

[0037] 2. Various dosage forms to meet different needs

[0038] The combination of N-acetylglucosamine and non-denatured type II collagen is not only suitable for tablets, but also covers a variety of dosage forms such as injections, granules, capsules, oral solutions, soft capsules, and gummies. It can meet the medication preferences and clinical needs of different patients (such as those with dysphagia, children, the elderly, etc.) and improve patients' medication compliance.

[0039] In summary, the compound composition of the present invention shows significant advantages in terms of efficacy, formulation performance, production feasibility and patient adaptability, providing an innovative and efficient option for the treatment of bone and joint related diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The present invention will be further described below with reference to the accompanying drawings and examples:

[0041] Figure 1 Shows the therapeutic effects of different compound tablets on the degree of joint swelling in rats;

[0042] Figure 2 To show the effects of different compound tablets on the activity of rats;

[0043] Figure 3 To show the effects of different compound tablets on inflammatory factors in rat serum;

[0044] Figure 4 To show the effects of different compound tablets on the structure of rat articular cartilage tissue. DETAILED DESCRIPTION

[0045] The endpoints of the ranges and any values ​​disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoints of each range, the endpoints of each range and individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered to be specifically disclosed herein.

[0046] The present invention will be described in detail below through examples. It should be understood that the following examples are only used to further explain and illustrate the content of the present invention in detail, and are not intended to limit the present invention.

[0047] Example 1

[0048] This embodiment provides a compound tablet for bone and joint treatment, the prescription of which is shown in the following table:

[0049] Raw material name Dosage (mg) N-acetylglucosamine 250 Non-denatured type II collagen 80 microcrystalline cellulose 80 Croscarmellose sodium 10 Sodium carboxymethyl starch 5 magnesium stearate 5 Micronized silica gel 5 Tablet weight 435

[0050] The compound tablet is prepared by a powder direct compression process, which specifically includes the following steps:

[0051] 1) Raw material pretreatment: Grind N-acetylglucosamine and non-denatured type II collagen to a suitable particle size and sieve;

[0052] 2) Excipient sieving: sieve the excipients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, sodium carboxymethyl starch, and silica gel separately;

[0053] 3) Mixing: Mix the sieved N-acetylglucosamine, non-denatured type II collagen, microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, and silica gel in a high-speed mixer; add magnesium stearate and mix again to ensure even distribution of the lubricant;

[0054] 4) Tabletting: The mixed powder is compressed into tablets with a tablet weight of 420-450 mg and a hardness of 45-60 N. 5) Coating: The compressed tablets are coated with Opadry premixed coating powder with a coating weight gain of 1.3-1.5%, thereby obtaining the composite tablets for bone and joint treatment.

[0055] Example 2

[0056] This embodiment provides a compound tablet for bone and joint treatment, the prescription of which is shown in the following table:

[0057] Raw material name Dosage (mg) N-acetylglucosamine 320 Non-denatured type II collagen 100 microcrystalline cellulose 80 Sodium carboxymethyl cellulose 15 Sodium carboxymethyl starch 5 magnesium stearate 5 Micronized silica gel 5 Tablet weight 530

[0058] The compound tablet is prepared by a powder direct compression process, which specifically includes the following steps:

[0059] 1) Raw material pretreatment: Grind N-acetylglucosamine and non-denatured type II collagen to a suitable particle size and sieve;

[0060] 2) Excipient sieving: sieve the excipients microcrystalline cellulose, sodium carboxymethyl cellulose, magnesium stearate, sodium carboxymethyl starch, and silica gel separately;

[0061] 3) Mixing: N-acetylglucosamine, non-denatured type II collagen, microcrystalline cellulose, sodium carboxymethyl cellulose, sodium carboxymethyl starch, and silica gel are mixed in a high-speed mixer; magnesium stearate is added and mixed again to ensure that the lubricant is evenly distributed;

[0062] 4) Tabletting: Press the mixed powder into tablets with a tablet weight of 515-545 mg and a hardness of 45-60 N.

[0063] 5) Coating: Coat the compressed tablets with Opadry premixed coating powder to a coating weight gain of 1.1-1.3%, thereby obtaining the composite tablets for bone and joints.

[0064] Example 3

[0065] This embodiment provides a compound tablet for bone and joint treatment, the prescription of which is shown in the following table:

[0066] Raw material name Dosage (mg) N-acetylglucosamine 375 Non-denatured type II collagen 120 microcrystalline cellulose 60 Low-substituted hydroxypropyl cellulose 20 Sodium carboxymethyl starch 10 magnesium stearate 5 Micronized silica gel 10 Tablet weight 600

[0067] The compound tablet is prepared by a powder direct compression process, which specifically includes the following steps:

[0068] 1) Raw material pretreatment: Grind N-acetylglucosamine and non-denatured type II collagen to a suitable particle size and sieve;

[0069] 2) Excipient sieving: sieve the excipients microcrystalline cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, sodium carboxymethyl starch, and silica gel separately;

[0070] 3) Mixing: N-acetylglucosamine, non-denatured type II collagen, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, and silica gel are mixed in a high-speed mixer; magnesium stearate is added and mixed again to ensure that the lubricant is evenly distributed;

[0071] 4) Tabletting: Press the mixed powder into tablets with a tablet weight of 590-610 mg and a hardness of 45-60 N;

[0072] 5) Coating: Coat the compressed tablets with Opadry premixed coating powder to a coating weight gain of 1.1-1.3%, thereby obtaining the composite tablets for bone and joints.

[0073] Example 4

[0074] This embodiment provides a compound tablet for bone and joint treatment, the prescription of which is shown in the following table:

[0075]

[0076]

[0077] The compound tablet is prepared by a powder direct compression process, which specifically includes the following steps:

[0078] 1) Raw material pretreatment: Grind N-acetylglucosamine and non-denatured type II collagen to a suitable particle size and sieve;

[0079] 2) Excipient sieving: sieve the excipients microcrystalline cellulose, pregelatinized starch, magnesium stearate, crospovidone, and silica gel separately;

[0080] 3) Mixing: N-acetylglucosamine, non-denatured type II collagen, microcrystalline cellulose, pregelatinized starch, crospovidone, and silica gel are mixed in a high-speed mixer; magnesium stearate is added and mixed again to ensure that the lubricant is evenly distributed;

[0081] 4) Tabletting: Press the mixed powder into tablets with a tablet weight of 590-610 mg and a hardness of 45-60 N;

[0082] 5) Coating: Coat the compressed tablets with Opadry premixed coating powder to a coating weight gain of 1.1-1.3%, thereby obtaining the composite tablets for bone and joints.

[0083] Example 5

[0084] This embodiment provides a compound tablet for bone and joint treatment, the prescription of which is shown in the following table:

[0085] Raw material name Dosage (mg) N-acetylglucosamine 500 Non-denatured type II collagen 100 microcrystalline cellulose 75 Sodium carboxymethyl cellulose 15 Sodium carboxymethyl starch 5 magnesium stearate 5 Micronized silica gel 5 Tablet weight 705

[0086] The compound tablet is prepared by a powder direct compression process, which specifically includes the following steps:

[0087] 1) Raw material pretreatment: Grind N-acetylglucosamine and non-denatured type II collagen to a suitable particle size and sieve;

[0088] 2) Excipient sieving: sieve the excipients microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, low-substituted hydroxypropyl cellulose, and silica gel separately;

[0089] 3) Mixing: N-acetylglucosamine, non-denatured type II collagen, microcrystalline cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and silica gel are mixed in a high-speed mixer; magnesium stearate is added and mixed again to ensure that the lubricant is evenly distributed;

[0090] 4) Tabletting: The mixed powder is compressed into tablets with a tablet weight of 690-715 mg and a hardness of 50-70 N.

[0091] 5) Coating: Coat the compressed tablets with Opadry premixed coating powder to a coating weight gain of 0.9-1.2% to obtain the composite tablets for bone and joints.

[0092] Example 6

[0093] This embodiment provides a compound injection for bone and joint treatment, the prescription of which is shown in the following table:

[0094] Raw material name Dosage (mg) N-acetylglucosamine 100 Non-denatured type II collagen 40 glycerin 20 Vitamin C 10 Sodium chloride 9 Polysorbate 80 5 Phosphate buffer appropriate amount Water for injection 1ml

[0095] The preparation process of the compound injection comprises the following steps:

[0096] 1) Preparation: Dissolve N-acetylglucosamine, glycerol, vitamin C, sodium chloride, and polysorbate 80 in a portion of water for injection, add phosphate buffer, and stir until uniform. Add non-denatured type II collagen to the above solution and use a high shear mixer or ultrasonic treatment to form a uniform suspension. Make up to the required volume with water for injection and continue stirring until uniform.

[0097] 2) Sterilization: The solution was sterilized by filtration through a 0.22 μm filter membrane;

[0098] 3) Aliquot: Dispense the sterilized solution into brown ampoules, 1 ml each;

[0099] 4) Sealing and storage: After sealing, store in a refrigerated environment and avoid light.

[0100] Example 7

[0101] This embodiment provides a compound granule for bone and joint treatment, the prescription of which is shown in the following table:

[0102] Raw material name Dosage (mg) N-acetylglucosamine 500 Non-denatured type II collagen 150 dextrin 200 lactose 100 Micronized silica gel 5 Sodium carboxymethyl cellulose 10

[0103] The preparation process of the compound granules comprises the following steps:

[0104] 1) Raw material pretreatment: N-acetylglucosamine and non-denatured type II collagen were pulverized to appropriate particle sizes and passed through a 60-mesh sieve; dextrin, lactose, micronized silica gel, and sodium carboxymethyl cellulose were sieved separately;

[0105] 2) Mixing: Mix all ingredients in a high-speed mixer to ensure uniform distribution of ingredients;

[0106] 3) Granulation: The mixed materials are wet granulated using an appropriate amount of water or ethanol as a wetting agent to form uniform granules;

[0107] 4) Drying: Place the granules in a dryer to dry them, ensuring that the moisture content of the granules is between 3% and 5%;

[0108] 5) Sieving: After drying, the granules are sieved through a 40-mesh sieve to ensure uniform granules.

[0109] Example 8

[0110] This embodiment provides a compound capsule for bone and joint treatment, the prescription of which is shown in the following table:

[0111] Raw material name Dosage (mg) N-acetylglucosamine 300 Non-denatured type II collagen 100 microcrystalline cellulose 185 magnesium stearate 10 Sodium carboxymethyl cellulose 5

[0112] The preparation process of the compound capsule comprises the following steps:

[0113] 1) Raw material pretreatment: N-acetylglucosamine and non-denatured type II collagen were pulverized to appropriate particle sizes and passed through a 60-mesh sieve; microcrystalline cellulose and sodium carboxymethyl cellulose were sieved through a 60-mesh sieve;

[0114] 2) Mixing: Mix all ingredients in a high-speed mixer until evenly combined, add magnesium stearate, and continue mixing for 1 minute to ensure even distribution of the lubricant.

[0115] 3) Filling: Fill the mixed powder into gelatin capsule shells, 600 mg per capsule.

[0116] Example 9

[0117] This embodiment provides a compound oral solution for bone and joint treatment, the prescription of which is shown in the following table:

[0118] Raw material name Dosage (mg) N-acetylglucosamine 200 Non-denatured type II collagen 80 sweeteners 200 Sodium benzoate 2 essence 10 Vitamin C 20 Xanthan gum 5 Deionized water 100ml

[0119] The preparation process of the compound oral solution comprises the following steps:

[0120] 1) Dissolve: Dissolve N-acetylglucosamine and vitamin C in a portion of deionized water and stir well. Add sweetener, preservative, flavor, and thickener in sequence and stir well to ensure complete dissolution and even distribution. Add undenatured type II collagen: Add undenatured type II collagen to the solution and stir at low speed to ensure it is evenly dispersed. Make up to 100ml with deionized water and continue stirring to ensure that all ingredients are evenly distributed.

[0121] 2) Aliquoting: Divide the filtered solution into brown bottles, 100 ml per bottle;

[0122] 3) Sealing and storage: After sealing, store in a refrigerated environment and avoid light.

[0123] Example 10

[0124] This embodiment provides a compound soft capsule for bone and joint treatment, the prescription of which is shown in the following table:

[0125]

[0126]

[0127] The preparation process of the compound soft capsule comprises the following steps:

[0128] 1) Dissolve N-acetylglucosamine in partially purified water and stir well;

[0129] 2) Emulsification: Add non-denatured type II collagen to fish oil, use soy lecithin as an emulsifier, mix well to form a uniform oil phase emulsion;

[0130] 3) Mixing: Mix the dissolved N-acetylglucosamine solution with the oil phase emulsion and continue stirring until evenly mixed;

[0131] 4) Capsule preparation: Mix gelatin, glycerin, and purified water and heat until completely dissolved to form the capsule shell;

[0132] 5) Filling: Fill the mixed drug solution into the capsule shell, 500 mg per capsule;

[0133] 6) Sealing: After sealing, store in a dry environment.

[0134] Example 11

[0135] This embodiment provides a compound soft candy for bone and joint treatment, the prescription of which is shown in the following table:

[0136] Raw material name Dosage (mg) N-acetylglucosamine 300 Non-denatured type II collagen 100 syrup 300 gelatin 100 juice appropriate amount Vitamin C 5 Citric acid appropriate amount guar gum 10 glycerin 5

[0137] The preparation process of the compound soft candy comprises the following steps:

[0138] 1) Dissolve: Dissolve N-acetylglucosamine and vitamin C in part of the juice and stir well;

[0139] 2) Mixing: Combine the syrup, gelatin, and guar gum. Heat until the gelatin and guar gum are completely dissolved, forming a uniform mixture. Add the N-acetylglucosamine solution, non-denatured type II collagen, and glycerin to the mixture and stir until evenly combined. Add an appropriate amount of citric acid to adjust the taste and acidity, and stir until evenly combined.

[0140] 3) Mold: Pour the mixture into the soft candy mold and cool it to solidify;

[0141] 4) Demolding: Remove the cooled candy from the mold and sprinkle with a small amount of powdered sugar to prevent sticking;

[0142] 5) Packaging: Pack the soft candies into aluminum foil bags and seal them for storage.

[0143] Test example: Pharmacodynamic investigation

[0144] To verify the therapeutic effect of the compound tablet of the present invention on patients with arthritis and osteoarthritis, the following animal experiments were conducted in this test example:

[0145] Experimental materials: the compound tablets described in Example 1; control drug (methotrexate, MTX).

[0146] Experimental animals: Arthritis model rats.

[0147] Experimental methods:

[0148] 1. Establishment of arthritis model: An arthritis model was established in rats by appropriate surgical or chemical methods.

[0149] 2. Drug grouping: The arthritis model rats were randomly divided into 7 groups, with 12 rats in each group, namely, blank group, N-acetylglucosamine group (NAG), non-denatured type II collagen group (UC-II), compound tablet treatment group 1 (low dose), compound tablet treatment group 2 (medium dose), compound tablet treatment group 3 (high dose), and control drug group (methotrexate as control).

[0150] 3. Administration: Oral gavage once a day. The blank group was not given any drug. The N-acetylglucosamine group (NAG) was given a dose of 40.77 mg / kg / d, the non-denatured type II collagen group (UC-II) was given a dose of 13.05 mg / kg / d, and the compound tablet treatment group was given the compound tablet of the present invention every day, wherein the low-dose group was given a dose of N-acetylglucosamine: 27.18 mg / kg / d, and non-denatured type II collagen: 7.56 mg / kg / d. The medium-dose group was given a dose of N-acetylglucosamine: 40.77 mg / kg / d, and non-denatured type II collagen: 13.05 mg / kg / d. The high-dose group was given a dose of N-acetylglucosamine: 54.36 mg / kg / d, and non-denatured type II collagen: 18.47 mg / kg / d. The control drug group was given methotrexate 1 mg / kg, and the administration was continuous for 28 days.

[0151] 4. Observation indicators: Record the degree of joint swelling and mobility of the rats, and collect serum for pathological examination after the experiment.

[0152] Experimental results:

[0153] 1. Degree of joint swelling: Figure 1 As shown, the degree of joint swelling in the rats in the compound tablet treatment group was significantly lower than that in the control group, showing a better therapeutic effect compared with the control drug group.

[0154] 2. Activity ability: such as Figure 2 As shown, the activity of rats in the compound tablet treatment group (expressed as the pain hypersensitivity index) was significantly improved, with a significant difference compared with the control group.

[0155] 3. Biochemical indicators: such as Figure 3 As shown in the figure, the levels of serum inflammatory factors (such as IL-1β, TNF-α) decreased significantly in the compound tablet treatment group and were close to normal levels.

[0156] 4. Histopathological examination: Figure 4As shown, the articular cartilage tissue structure of the compound tablet treatment group was more complete and the inflammatory cell infiltration was reduced, showing a better tissue protection effect compared with the control group.

[0157] in conclusion:

[0158] The compound tablets of the present invention have shown significant therapeutic effects in animal models of arthritis and have obvious advantages over single-ingredient drug combinations. Specifically,

[0159] Synergistic Effect: The scientifically formulated combination of N-acetylglucosamine and non-denatured type II collagen significantly enhances the therapeutic efficacy of arthritis through a synergistic effect. The combined tablet effectively promotes cartilage matrix synthesis and repair while reducing inflammation, achieving a comprehensive therapeutic effect not achievable by a single ingredient.

[0160] Comprehensive Improvement: The combination tablet not only effectively reduces joint swelling and improves mobility, but also significantly reduces serum levels of inflammatory factors (such as IL-1β and TNF-α), comprehensively improving joint health. In contrast, the efficacy of single-ingredient drugs in these areas is relatively limited.

[0161] Superiority: The combination tablet demonstrated superior efficacy compared to the single-ingredient drugs at multiple doses, with the highest efficacy observed at high doses, demonstrating its potential clinical value in the treatment of osteoarthritis. This advantage reflects the flexibility and effectiveness of the combination tablet across varying disease severity.

[0162] Experimental results demonstrate that the compound tablets of the present invention have significant therapeutic effects. Compared with single-ingredient medications, they are more effective in alleviating joint inflammation, improving joint function, and promoting cartilage repair, thereby significantly improving patients' quality of life. This research indicates that compound tablets have broad application prospects in the treatment of arthritis and osteoarthritis, providing patients with a more effective treatment option.

[0163] Finally, it should be noted that the above is only used to illustrate the technical solution of the present invention and is not limiting. Although the present invention is described in detail with reference to the preferred arrangement scheme, ordinary technicians in this field should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the spirit and scope of the technical solution of the present invention.

Claims

1. A pharmaceutical composition for bone and joint, characterized in that: The pharmaceutical composition comprises, in parts by weight: N-acetylglucosamine 20-2000 parts 10-1000 copies of non-denatured type II collagen.

2. The pharmaceutical composition for bone and joint according to claim 1, characterized in that The pharmaceutical composition comprises, in parts by weight: N-acetylglucosamine 500-1700 parts 50-500 parts of non-denatured type II collagen.

3. The pharmaceutical composition for bone and joint according to claim 2, characterized in that The pharmaceutical composition comprises, in parts by weight: 300-400 parts of N-acetylglucosamine 50-150 parts of non-denatured type II collagen.

4. The pharmaceutical composition for bone and joint according to any one of claims 1 to 3, characterized in that The pharmaceutical composition further includes pharmaceutically acceptable excipients.

5. The pharmaceutical composition for bone and joint according to claim 4, characterized in that The pharmaceutically acceptable excipients include microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, magnesium stearate, sodium carboxymethyl starch and micronized silica gel.

6. The pharmaceutical composition for bone and joint according to any one of claims 1 to 3, characterized in that The dosage forms of the pharmaceutical composition include tablets, granules, capsules, oral solutions, soft capsules, soft candies, and injections.

7. A method for preparing a compound tablet for bone and joint, characterized in that: The compound tablet comprises, by weight: N-acetylglucosamine 20-2000 parts 10-1000 copies of non-denatured type II collagen; The preparation method comprises the following steps: 1) Raw material pretreatment: N-acetylglucosamine and non-denatured type II collagen were crushed and sieved; 2) Excipient screening: sieve the pharmaceutically acceptable excipients separately; 3) Mixing: Mix N-acetylglucosamine, non-denatured type II collagen and excipients in a high-speed mixer; 4) Tablet compression: Press the mixed powder into tablets, controlling tablet weight and hardness; 5) Coating: coating the compressed tablets with a coating material to obtain the composite tablets for bone and joints.

8. The preparation method according to claim 7, characterized in that In step 4), the hardness of the tablet is 30N to 100N; in step 5), the coating material is Opadry premixed coating powder, and the coating weight gain is 0.75% to 3%.

9. Use of the pharmaceutical composition for bone and joint according to any one of claims 1 to 6 in the preparation of drugs for preventing and treating bone and joint related diseases and for cartilage repair.

10. The use according to claim 9, characterized in that The bone and joint related diseases include osteoarthritis, rheumatoid arthritis, and metabolic joint disease.

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