A composition for improving osteoarthritis and a preparation method, use and product thereof

Abstract

This invention belongs to the technical field of bone and joint health products, and provides a composition for improving osteoarthritis, its preparation method, application, and product. The composition comprises, by weight, 1-300 parts mangosteen fruit powder, 1-150 parts eggshell membrane, and 1-250 parts turmeric. The composition of this invention is simple in composition, and through the compounding of mangosteen fruit powder, eggshell membrane, and turmeric in a specific ratio, it shows significant effects in repairing osteoarthritis.

Description

Technical Field

[0001] This invention belongs to the technical field of bone and joint health products, and provides a composition for improving osteoarthritis, its preparation method, application and product. Background Technology

[0002] Osteoarthritis (OA), also known as degenerative joint disease, bone hyperplasia, or osteoarthropathy, is a heterogeneous group of diseases caused by the destruction of the integrity of articular cartilage and lesions of the subchondral bone plate at the joint margins, leading to joint symptoms and signs. Articular cartilage damage is the main pathological change in osteoarthritis. Currently, commonly used medications for OA, such as nonsteroidal anti-inflammatory drugs (NSAIDs) like celecoxib capsules and diclofenac sodium sustained-release tablets, and analgesics like acetaminophen, are mainly used for rapid pain and inflammation relief, but their effects on cartilage repair are generally limited or poor. Current main treatments for articular cartilage damage repair include topical medications, chondrocyte transplantation, and surgery (joint replacement). While these can alleviate symptoms to some extent, the repair is often incomplete because the articular cartilage's own repair mechanisms are not fully activated, and may even lead to degradation of surrounding tissues, resulting in secondary osteoarthritis. Therefore, articular cartilage repair has become an important issue in the field of orthopedics.

[0003] Chinese invention patent CN119318691B discloses a composition for improving osteoarthritis health, its preparation method, and its application. This composition for improving osteoarthritis health comprises the following components: collagen peptides, mangosteen extract, non-denatured type II collagen peptides, milk mineral salts, bone collagen peptides, cartilage extract, N-acetylglucosamine, sodium hyaluronate, and turmeric extract. Through multiple combinations of mangosteen extract and turmeric extract, and cartilage extract and sodium hyaluronate, the resulting composition is low-cost, highly safe, and has a good effect on the prevention or improvement of osteoarthritis.

[0004] Chinese invention patent application CN120021779A discloses a composition for improving osteoarthritis, its preparation method, application, and product. It comprises the following components: type II collagen chondroitin powder, eggshell membrane, and N-acetylglucosamine. It has been found that the type II collagen chondroitin powder, eggshell membrane, and N-acetylglucosamine, in a specific ratio, have a synergistic effect in preventing or alleviating osteoarthritis.

[0005] However, verification revealed that while the aforementioned compositions exhibited varying degrees of positive regulatory effects on inflammatory factors such as IL-1β, IL-6, and TNF-α, their efficacy in cartilage repair was unsatisfactory. Therefore, further in-depth research is needed on the composition, formulation, and preparation process of these existing compositions to improve their overall performance in OA treatment. Summary of the Invention

[0006] To address the problems existing in the prior art, this invention provides a composition for improving osteoarthritis, its preparation method, application, and product. It not only effectively regulates inflammation levels in OA rats but also exhibits excellent effects in cartilage repair.

[0007] The technical solution of the present invention is as follows:

[0008] In a first aspect, the present invention provides a composition for improving osteoarthritis, the composition comprising the following raw materials in parts by weight: 1-300 parts of mangosteen fruit powder, 1-150 parts of eggshell membrane and 1-250 parts of turmeric.

[0009] Preferably, the composition comprises the following raw materials in parts by weight: 1-150 parts mangosteen fruit powder, 1-75 parts eggshell membrane, and 1-125 parts turmeric.

[0010] As some preferred embodiments of the present invention, the composition is composed of the following raw materials in parts by weight: 100-150 parts of mangosteen fruit powder, 1-10 parts of eggshell membrane and 1-25 parts of turmeric; The preferred composition is 125-150 parts mangosteen fruit powder, 1-5 parts eggshell membrane, and 1-12.5 parts turmeric; Further preferred ingredients include 150 parts mangosteen fruit powder, 1 part eggshell membrane, and 1 part turmeric.

[0011] As some preferred embodiments of the present invention, the composition consists of the following raw materials in parts by weight: 1-10 parts of mangosteen fruit powder, 50-75 parts of eggshell membrane, and 1-7.5 parts of turmeric; The preferred ingredients are 1-5 parts mangosteen fruit powder, 60-75 parts eggshell membrane, and 1-3 parts turmeric; Further preferred ingredients include 1 part mangosteen fruit powder, 75 parts eggshell membrane, and 1 part turmeric.

[0012] As some preferred embodiments of the present invention, the composition is composed of the following raw materials in parts by weight: 1-30 parts of mangosteen fruit powder, 1-15 parts of eggshell membrane and 100-125 parts of turmeric; The preferred ingredients are 1-10 parts mangosteen fruit powder, 1-7.5 parts eggshell membrane, and 120-125 parts turmeric; Further preferred ingredients include 1 part mangosteen fruit powder, 1 part eggshell membrane, and 125 parts turmeric.

[0013] As some preferred embodiments of the present invention, the composition consists of the following raw materials in parts by weight: 100-200 parts of mangosteen fruit powder, 50-100 parts of eggshell membrane and 100-200 parts of turmeric. The preferred ingredients are 120-180 parts mangosteen fruit powder, 60-80 parts eggshell membrane, and 100-150 parts turmeric; Further preferred ingredients include 150 parts mangosteen fruit powder, 75 parts eggshell membrane, and 125 parts turmeric.

[0014] Secondly, the present invention also provides a method for preparing the above-mentioned composition for improving osteoarthritis, specifically: Thoroughly crush turmeric, mangosteen fruit powder, and eggshell membrane, then stir and mix them evenly to obtain the final product.

[0015] Thirdly, the present invention provides the use of the composition described in any one of the above claims, the composition prepared by the above preparation method, or the product described in any one of the above claims in products for relieving osteoarthritis.

[0016] Furthermore, the product may be food or medicine.

[0017] Furthermore, the dosage form of the food is any formulation suitable for oral administration, including but not limited to any one of liquid dosage forms, jelly dosage forms, gel dosage forms, tablets, powders, and capsules. The food also contains excipients and / or additives acceptable in the food industry.

[0018] As some preferred embodiments of the present invention, the excipients include, but are not limited to, one or more of maltodextrin, starch, modified starch, yeast products, natural sugar, processed sugar, dietary fiber, fruit and vegetable powder, and plant and animal extracts.

[0019] As some preferred embodiments of the present invention, the additives include, but are not limited to, one or more of flavor enhancers, sweeteners, emulsifiers, flavorings, stabilizers, thickeners, antioxidants, acidity regulators, preservatives, and colorants.

[0020] Furthermore, the drug is in any form of formulation suitable for oral administration, including but not limited to granules, tablets, capsules, oral liquids, ointments, and patches. The drug also includes pharmaceutically acceptable excipients.

[0021] As some preferred embodiments of the present invention, the excipients include, but are not limited to, one or more of fillers, binders, disintegrants, lubricants, flavor maskers, stabilizers, skeleton materials, coating materials, cosolvents, and solubilizers.

[0022] Fourthly, the present invention also provides a product comprising the composition described in any one of the above claims or the composition prepared by the above preparation method, the product further comprising: excipients and / or additives.

[0023] Furthermore, the dosage form of the product is any formulation suitable for oral administration.

[0024] Compared with the prior art, the present invention has the following beneficial effects: (1) The composition of the present invention is simple. Based on the existing composition, many components are omitted. However, under the same dosage, through the optimization of the ratio, its effect on OA treatment, such as the regulation of inflammation level, can still reach the level of multiple components in the existing technology. At the same time, the repair effect on cartilage damage in OA rats is significantly improved.

[0025] (2) In addition, by further compounding other components, the present invention has further improved the effects of reducing inflammation levels in OA rats, promoting cartilage regeneration and repair, and provides a research basis for the development of cartilage repair foods and drugs. Attached Figure Description

[0026] Figure 1 The effect of the composition of the present invention on the degree of joint swelling in a rat model of osteoarthritis; compared with the normal control group, ## p < 0.01; compared with the model control group, & p < 0.05 && p < 0.01; compared with Example 7, ^ p < 0.05; Figure 2 The effect of the composition of the present invention on the levels of inflammatory factors in the joint tissue of a rat model of osteoarthritis; wherein, compared with the normal control group, # p < 0.05 ## p < 0.01; compared with the model control group, & p < 0.05 && p < 0.01; compared with Example 7, ^ p < 0.05; Figure 3 The composition of the present invention affects the levels of Hsp70 and Hsp90 proteins in the articular cartilage of rats with sports injuries, wherein, compared with the quiet control group, # p < 0.05 ## p < 0.01; compared with the model control group, & p < 0.05 && p < 0.01; after administration, compared with Example 7, ^ p < 0.05 ^^ p < 0.01. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] The mangosteen fruit powder used in the following examples was purchased from Fytexia (model: mangoselect); the eggshell membrane was purchased from Eggnovo (model: MM); and the turmeric was purchased from Arjuna Natural (model: BCM-95).

[0029] Example 1 A composition for improving osteoarthritis comprises, by weight: 300 parts mangosteen fruit powder, 1 part eggshell membrane, and 1 part turmeric; weigh each ingredient, pulverize them separately through an 80-mesh sieve, and then mix them evenly to obtain the final product.

[0030] Example 2 A composition for improving osteoarthritis comprises, by weight, 150 parts mangosteen fruit powder, 1 part eggshell membrane, and 1 part turmeric; weigh each ingredient, pulverize them separately through an 80-mesh sieve, and then mix them evenly to obtain the final product.

[0031] Example 3 A composition for improving osteoarthritis comprises, by weight, 1 part mangosteen fruit powder, 150 parts eggshell membrane and 1 part turmeric; weigh each raw material, pulverize them separately through an 80-mesh sieve, and then stir and mix them evenly to obtain the final product.

[0032] Example 4 A composition for improving osteoarthritis comprises, by weight, 1 part mangosteen fruit powder, 75 parts eggshell membrane and 1 part turmeric; weigh each raw material, pulverize them separately through an 80-mesh sieve, and then stir and mix them evenly to obtain the final product.

[0033] Example 5 A composition for improving osteoarthritis comprises, by weight, 1 part mangosteen fruit powder, 1 part eggshell membrane, and 250 parts turmeric; weigh each ingredient, pulverize them separately through an 80-mesh sieve, and then mix them evenly to obtain the final product.

[0034] Example 6 A composition for improving osteoarthritis comprises, by weight, the following components: 1 part mangosteen fruit powder, 1 part eggshell membrane, and 125 parts turmeric; each raw material is weighed, pulverized separately through an 80-mesh sieve, and then stirred and mixed evenly to obtain the final product.

[0035] Example 7 A composition for improving osteoarthritis comprises, by weight: 5 parts mangosteen fruit powder, 2 parts eggshell membrane and 5 parts turmeric; weigh each raw material, pulverize them separately through an 80-mesh sieve, and then stir and mix them evenly to obtain the final product.

[0036] Comparative Example 1 A composition for improving osteoarthritis comprises, by weight, 350 parts mangosteen fruit powder, 1 part eggshell membrane, and 1 part turmeric; weigh each ingredient, pulverize them separately through an 80-mesh sieve, and then mix them evenly to obtain the final product.

[0037] Comparative Example 2 A composition for improving osteoarthritis comprises, by weight, 1 part mangosteen fruit powder, 175 parts eggshell membrane and 1 part turmeric; weigh each raw material, pulverize them separately through an 80-mesh sieve, and then stir and mix them evenly to obtain the final product.

[0038] Comparative Example 3 A composition for improving osteoarthritis comprises, by weight, 1 part mangosteen fruit powder, 1 part eggshell membrane, and 300 parts turmeric; weigh each ingredient, pulverize them separately through an 80-mesh sieve, and then mix them evenly to obtain the final product.

[0039] Comparative Example 4 A component for improving osteoarthritis is obtained by directly crushing egg yolk membranes and passing them through an 80-mesh sieve.

[0040] Comparative Example 5 A composition for improving osteoarthritis, by weight, consists of 5 parts mangosteen fruit powder and 2 parts turmeric; weigh each raw material, pulverize them separately through an 80-mesh sieve, and then mix them evenly to obtain the final product.

[0041] Comparative Example 6 A composition for improving osteoarthritis comprises, by weight: 5 parts mangosteen fruit powder and 2 parts eggshell membrane; weigh each raw material, pulverize them separately through an 80-mesh sieve, and then stir and mix them evenly to obtain the final product.

[0042] Comparative Example 7 The composition was prepared according to the component amounts specified in Example 1 of CN202411432265.9, as follows: A composition for improving bone health, by weight parts, comprises: 2 parts collagen peptides, 15 parts mangosteen extract, 2 parts non-denatured type II collagen peptides, 0.8 parts milk mineral salts, 0.8 parts bone collagen peptides, 0.2 parts cartilage extract, 0.2 parts N-acetylglucosamine, 0.2 parts sodium hyaluronate, and 0.8 parts turmeric extract; each raw material is weighed, pulverized and sieved separately, and then stirred and mixed evenly to obtain the final product.

[0043] Comparative Example 8 The composition was prepared according to the component amounts specified in Example 1 of CN202510126550.6, as follows: A composition for improving osteoarthritis, by weight, comprises: 5 parts of type II collagen chondroitin powder, 100 parts of eggshell membrane, and 10 parts of N-acetylglucosamine; weigh each raw material, pulverize and sieve them separately, and then mix them evenly to obtain the final product.

[0044] Test Example 1: Pharmacological effects of the composition of the present invention on a rat model of osteoarthritis. 1. Experimental grouping: Male Wistar rats were randomly divided into normal control group, model control group, positive control group, Examples 1-7 and Comparative Examples 1-6 groups, with 10 rats in each group after 7 days of acclimatization.

[0045] 2. Modeling: 10% papain and 0.03 mol / L L-cysteine ​​were mixed at a 1:1 ratio, and the resulting solution was allowed to stand for 30 minutes before use. On days 1, 4, and 7 of the experiment, 0.2 mL of the above mixed solution was injected into the knee joint cavity of rats in the model control group, positive control group, Examples 1-7, and Comparative Examples 1-8 to induce a rat osteoarthritis model. The normal control group was injected with an equal volume of physiological saline.

[0046] 3. Drug Administration: After modeling, drug administration began on day 8 of the experiment. The positive control group was administered amino acid glucose hydrochloride (Aoteling, manufactured by Ausnutria Pharmaceuticals) by gavage at a dose of 90 mg / kg. Examples 1-7 and Comparative Examples 1-6 were administered the samples of Examples 1-7 and Comparative Examples 1-6 by gavage (the compositions of Examples 1-7 and Comparative Examples 1-6 were dissolved in deionized water before administration). The dosage was 0.075 g of the composition / kg·d. The normal control group and the model control group were administered the same dose of deionized water by gavage. Each rat was administered the drug once daily for 4 weeks. The entire experiment, including modeling and drug administration, lasted for 5 weeks.

[0047] 4. Characterization: (1) Observation of general condition of rats: Observe the mental state, hair and food intake of rats.

[0048] (2) Changes in knee joint width in rats: The ankle joint width was measured before drug administration, at week 2 of drug administration, and at week 4 of drug administration. The average value of the three measurements was taken. The results are shown in the table below. Figure 1 .

[0049] (3) Two hours after the last oral administration, the rats were anesthetized, and physiological saline was injected into both knee joint cavities for irrigation. The joint lavage fluid was centrifuged at 1500 r / min for 15 min at 4℃, and the supernatant was separated, aliquoted, and stored at -80℃ for later use. The contents of IL-1β, IL-6, and TNF-α in the lavage fluid were determined according to the ELISA kit instructions. The results are shown in the table below. Figure 2 .

[0050] 5. Results: (1) Observation results of the general condition of rats: No rat deaths occurred during the modeling process. After the modeling was completed, except for the normal control group which exhibited normal movement, the rats in the other groups showed lethargy and slight lameness in the knee joints. After 4 weeks of treatment, the normal control group rats showed normal knee joint movement, normal diet and water intake, glossy fur, and quick reflexes; the model control group rats all showed local swelling of the knee joint, reduced movement, decreased diet and water intake, and slowed reflexes. The other treatment groups showed varying degrees of improvement in knee joint swelling, activity level, diet and water intake, and reflexes.

[0051] (2) Ankle width results: according to Figure 1 The results showed that before drug administration, compared with the normal control group, the joint swelling of rats in the model control group and each group was significantly increased (ankle joint width was significantly increased), indicating successful modeling. Compared with the model control group, the examples and comparative examples all showed varying degrees of inhibitory effect on joint swelling. Among them, the positive control group, examples 1, 2, 5, and 7 showed significant differences compared with the model control group (p < 0.01), and comparative examples 1-6 (except comparative example 4) showed statistically significant differences compared with the model control group at week 4 of drug administration (p < 0.05). In addition, compared with example 7, there were no significant differences in the positive control group, examples 1, 3, and 5 (p > 0.05), while comparative examples 1-3, 5, and 6 showed statistically significant differences compared with example 5 (p < 0.05), and comparative example 4 showed a significant difference (p < 0.01). This indicates that the composition and ratio of the raw materials in this composition affect the inhibitory effect on joint swelling, and all three raw materials in the composition of this invention are indispensable.

[0052] (3) Levels of joint inflammation factors: according to Figure 2The results showed that, compared with the normal control group, the levels of inflammatory factors IL-1β, IL-6, and TNF-α in the model control group rats were significantly different (p < 0.01), indicating successful model establishment. Compared with the model control group, the compositions of the positive control group, Examples 2, 4, 6, 7, and Comparative Examples 1-6 (except Comparative Example 4) all had varying degrees of positive regulatory effects on the levels of IL-1β, IL-6, and TNF-α. Among them, compared with Example 7, there were no statistically significant differences in the positive control group, Examples 2, 4, and 6, while the differences in Comparative Examples 1-3 and 5 and 6 were statistically significant (p < 0.05 or p < 0.01). The levels of inflammatory factors IL-1β, IL-6, and TNF-α in Comparative Example 4 rats were all significantly different (p < 0.01). These results are consistent with the above conclusions, indicating that the composition and ratio of the raw materials in this composition have an impact on the inhibitory effect on joint swelling.

[0053] Test Example 2: Pharmacological Effect of the Composition of the Present Invention on Joints with Sports Injuries 1. Experimental grouping: Male Wistar rats were randomly divided into a quiet control group, a model control group, a positive control group, and groups 2, 4, 6, 7 and 1-8 of the Examples, with 10 rats in each group.

[0054] 2. Modeling: Except for the quiet control group, rats in the other groups underwent running exercise for 4 weeks, with the following exercise protocol: 60 min / session, 5 times / week (non-weekends). The first 10 minutes were for warm-up running at a speed of 20 cm / s (0.72 km / h), followed by 50 minutes of running at a speed of 33.3 cm / s (1.20 km / h), for 4 weeks (equivalent to completing a 30 km vigorous run).

[0055] 3. Drug Administration: After modeling, drug administration began on day 1 of week 5 of the experiment. The positive control group was administered amino acid glucose hydrochloride (Aoteling, manufactured by Ausnutria Pharmaceuticals) by gavage at a dose of 90 mg / kg. Examples 2, 4, 6, 7 and Comparative Examples 1-6 were administered the samples of Examples 2, 4, 6, 7 and Comparative Examples 1-8 by gavage (the compositions of Examples 2, 4, 6, 7 and Comparative Examples 1-6 were dissolved in deionized water before administration). The dosage was 0.075 g of the composition / kg·d. The normal control group and the model control group were administered the same dose of deionized water by gavage. Each rat received the drug 3 times a week, every other day (except weekends), for 4 weeks. The entire experiment, including modeling and drug administration, lasted for 8 weeks.

[0056] 4. Characterization: Hsp90 primarily plays a pro-inflammatory and cartilage-destructive role in osteoarthritis, while Hsp70 tends to protect chondrocytes, inhibit inflammation, and promote repair. The imbalance between these two proteins in the pathological process of osteoarthritis may be closely related to disease progression. Western blotting was used to determine the protein levels of Hsp70 and Hsp90 in articular cartilage (β-tubulin was used as a control). The results are shown in [Figure number missing]. Figure 3 .

[0057] according to Figure 3 The results showed that, compared with the quiet control group, the relative expression level of Hsp70 in the model control group rats was significantly decreased, and the relative expression level of Hsp90 was significantly increased (both p < 0.01), indicating successful model establishment. Compared with the model control group rats, the relative expression levels of Hsp70 and Hsp90 in the positive control group and groups 2, 4, 6, and 7 showed varying degrees of recovery (p < 0.05 or p < 0.01); while the relative expression levels of Hsp70 and Hsp90 in comparative groups 1-8 were not statistically significant. This indicates that the composition of the present invention has significant effects in regulating the levels of inflammatory factors in arthritis in exercise-induced rats and in protecting or repairing cartilage damage.

[0058] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for improving osteoarthritis, characterized in that, The composition consists of the following raw materials in parts by weight: 1-300 parts mangosteen fruit powder, 1-150 parts eggshell membrane, and 1-250 parts turmeric.

2. The composition according to claim 1, characterized in that, The composition consists of the following raw materials in parts by weight: 1-150 parts mangosteen fruit powder, 1-75 parts eggshell membrane, and 1-125 parts turmeric.

3. The composition according to claim 2, characterized in that, The composition comprises the following raw materials in parts by weight: 100-150 parts mangosteen fruit powder, 1-10 parts eggshell membrane, and 1-25 parts turmeric; preferably 125-150 parts mangosteen fruit powder, 1-5 parts eggshell membrane, and 1-12.5 parts turmeric; more preferably 150 parts mangosteen fruit powder, 1 part eggshell membrane, and 1 part turmeric.

4. The composition according to claim 2, characterized in that, The composition comprises the following raw materials in parts by weight: 1-10 parts mangosteen fruit powder, 50-75 parts eggshell membrane, and 1-7.5 parts turmeric; preferably 1-5 parts mangosteen fruit powder, 60-75 parts eggshell membrane, and 1-3 parts turmeric; more preferably 1 part mangosteen fruit powder, 75 parts eggshell membrane, and 1 part turmeric.

5. The composition according to claim 2, characterized in that, The composition comprises the following raw materials in parts by weight: 1-30 parts mangosteen fruit powder, 1-15 parts eggshell membrane, and 100-125 parts turmeric; preferably 1-10 parts mangosteen fruit powder, 1-7.5 parts eggshell membrane, and 120-125 parts turmeric; more preferably 1 part mangosteen fruit powder, 1 part eggshell membrane, and 125 parts turmeric.

6. The composition according to claim 2, characterized in that, The composition comprises the following raw materials in parts by weight: 100-200 parts mangosteen fruit powder, 50-100 parts eggshell membrane, and 100-200 parts turmeric; preferably 120-180 parts mangosteen fruit powder, 60-80 parts eggshell membrane, and 100-150 parts turmeric; more preferably 150 parts mangosteen fruit powder, 75 parts eggshell membrane, and 125 parts turmeric.

7. The method for preparing the composition according to any one of claims 1-6, characterized in that, Thoroughly crush turmeric, mangosteen fruit powder, and eggshell membrane, then stir and mix them evenly to obtain the final product.

8. The use of the composition according to any one of claims 1-6, or the composition prepared by the preparation method according to claim 7, in products for relieving osteoarthritis.

9. A product comprising the composition according to any one of claims 1-6 or the composition prepared by the preparation method according to claim 7, characterized in that, It also includes excipients and / or additives.

10. The product according to claim 9, characterized in that, The product is available in any formulation suitable for oral administration.

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