A composition for promoting joint health, and methods of making and using the same

Abstract

The application discloses a composition for promoting joint health, a preparation method and application, and relates to the field of food.The composition comprises the following components in parts by weight: animal protein: 20-80; non-denatured type II collagen: 0.2-1; sodium hyaluronate: 0.5-2; proteoglycan: 0.5-2; sour cherry extract: 3-10; and calcium beta-hydroxy-beta-methylbutyrate: 5-20.The application takes non-denatured type II collagen as a main efficacy component, and additionally adds animal protein, sodium hyaluronate, proteoglycan, sour cherry extract and calcium beta-hydroxy-beta-methylbutyrate, synergistically acts through the multiple efficacy components, relieves joint discomfort through multiple pathways, maintains muscle health, and enables the product to have the optimal effect of repairing joint damage, improving joint and skeletal muscle health.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of food, in particular to a composition for promoting joint health and a preparation method and application. BACKGROUND

[0002] Osteoarthritis (OA) is a degenerative joint disease, which is an acute or chronic inflammation of the joint, often accompanied by pain and structural changes. There are many causes of this disease, which is caused by aging, obesity, overwork, trauma, congenital joint abnormalities, joint deformity, infection and other factors. When the joint is inflamed, symptoms such as joint stiffness, fever, swelling, redness and pain may occur. According to the data in the "China Osteoarthritis Diagnosis and Treatment Guide (2021 Edition)", the prevalence rates of primary OA in different age groups of people aged 40 and above in China are: 30.1% (40-49 years old), 48.7% (50-59 years old), 62.2% (60-69 years old) and 62.1% (70 years old and above). As can be seen from the data, not only the elderly, but also the middle-aged have a very high prevalence rate. In addition, a certain proportion of sports groups may also cause joint damage due to improper or excessive exercise.

[0003] Research on knee arthritis shows that weakness of the knee joint skeletal muscle (skeletal muscle atrophy, muscle strength decline) is an important pathological link of knee arthritis, which is usually caused by muscle inhibition and secondary atrophy caused by arthritis pain. Moreover, studies have shown that age-related quadriceps muscle atrophy plays an important role in the pathogenesis of knee osteoarthritis. In addition, other studies have shown that bone and muscle, as two adjacent tissues, have a clear cross-linking effect. Osteoarthritis and muscle atrophy, muscle strength decline not only coexist, but also influence each other.

[0004] However, the joint health-related products on the market are mostly single-effect interventions, without considering the impact of skeletal muscle on joint health. Secondly, the functional food for joints has a single efficacy component, such as calcium and / or vitamin D alone to improve osteoporosis, and ingredients such as glucosamine and / or chondroitin sulfate alone to relieve cartilage degeneration. Therefore, there is a serious problem of ingredient homogenization in commercially available products. Therefore, developing a product that can improve joint health and enhance muscle strength has application prospects. SUMMARY

[0005] The present application provides a composition for promoting joint health and a preparation method and application. By selecting and content matching of specific components, a composition for effectively increasing muscle mass, anti-inflammatory and improving joint pain can be obtained.

[0006] To solve the above technical problems, one of the purposes of the present application is to provide a composition for promoting joint health, comprising the following components by weight:

[0007] Animal protein: 20-80 parts;

[0008] Non-denatured type II collagen: 0.2-1 parts;

[0009] Sodium hyaluronate: 0.5-2 parts;

[0010] Proteoglycans: 0.5-2 parts;

[0011] Sour cherry extract: 3-10 parts;

[0012] Calcium beta-hydroxy-beta-methylbutyrate: 5-20 parts.

[0013] By adopting the above scheme, the synergistic effect of the contents of animal protein, non-denatured type II collagen, sodium hyaluronate, proteoglycans, sour cherry extract, and calcium beta-hydroxy-beta-methylbutyrate can achieve good results in improving joint health. In addition, the content of each component of animal protein, non-denatured type II collagen, sodium hyaluronate, proteoglycans, sour cherry extract, and calcium beta-hydroxy-beta-methylbutyrate will directly affect the effect of improving joint health. The effect of the content of a single component on the composition is not linear. The above composition has better effect on relieving joint discomfort and improving skeletal muscle strength.

[0014] As a preferred scheme, it comprises the following components by weight:

[0015] Animal protein: 30-70 parts;

[0016] Non-denatured type II collagen: 0.4-0.8 parts;

[0017] Sodium hyaluronate: 1-1.8 parts;

[0018] Proteoglycans: 1-1.6 parts;

[0019] Sour cherry extract: 5-8 parts;

[0020] Calcium beta-hydroxy-beta-methylbutyrate: 10-18 parts.

[0021] As a preferred scheme, the composition further comprises an auxiliary material.

[0022] As a preferred scheme, it comprises the following components by mass fraction:

[0023] Animal protein: 20-80 wt%;

[0024] Non-denatured collagen type II: 0.2wt%-1wt%;

[0025] Sodium hyaluronate: 0.5wt%-2wt%;

[0026] Proteoglycans: 0.5wt%-2wt%;

[0027] Sour cherry extract: 3wt%-10wt%;

[0028] Calcium beta-hydroxy-beta-methylbutyrate: 5wt%-20wt%;

[0029] Excipients: the balance.

[0030] As a preferred solution, the excipients are maltodextrin and / or resistant dextrin.

[0031] As a preferred solution, the animal protein is at least one of whey protein, milk protein, casein protein, and egg protein.

[0032] As a preferred solution, the composition is a granular preparation, a powder preparation, a tablet, a pill, a capsule, or an enema preparation.

[0033] As a preferred solution, the composition is a granular preparation, the particle size of the composition is 30-80 mesh, and the proportion of 60-80 mesh particles is less than 10%.

[0034] To solve the above technical problems, the second object of the present application provides a preparation method of a composition for promoting joint health, comprising the following steps: weighing and uniformly mixing components, granulating after preliminary sieving, then drying at a temperature of 30-50°C, and obtaining the composition after secondary sieving.

[0035] As a preferred solution, the mesh size of the screen is 60 mesh during preliminary sieving.

[0036] As a preferred solution, the granulation process is wet granulation, dry granulation, or swing granulation.

[0037] As a preferred solution, the drying method is fluidized drying or oven drying.

[0038] As a preferred solution, the secondary sieving controls the particle size of the composition to be 30-80 mesh, and the proportion of 60-80 mesh particles is less than 10%.

[0039] To solve the above technical problems, the third object of the present application provides an application of a composition for promoting joint health in the field of preparing processed food, health food, or medicine.

[0040] Compared with the prior art, the present application has the following beneficial effects:

[0041] The animal protein provided by the present application is high-quality complete protein, the animal protein has complete amino acid types and appropriate proportions, can reduce muscle damage and soreness, and promote muscle recovery and muscle protein synthesis; the non-denatured type II collagen can delay the occurrence of osteoarthritis, and improve joint comfort, flexibility and flexibility, and the effect is significantly better than that of glucosamine and chondroitin; sodium hyaluronate is the main component of synovial fluid, has high viscoelasticity, plays a shock-absorbing and lubricating protective role on articular cartilage, and forms a protective barrier on the surface of articular cartilage, in addition, sodium hyaluronate can also stabilize and repair cartilage and has anti-inflammatory effect; proteoglycan is the best partner of sodium hyaluronate, has a repairing effect on joint cartilage damage, can reduce joint inflammation, and promote cartilage tissue growth; sour cherry extract can reduce oxidative stress, quickly repair muscle, reduce the level of inflammatory factors caused by exercise, reduce muscle pain, and can reduce blood uric acid content, improve arthralgia, stiffness and the like; calcium beta-hydroxy-beta-methylbutyrate can reduce skeletal muscle damage caused by exercise by inhibiting protein hydrolysis and increasing protein synthesis, thereby promoting skeletal muscle recovery, and calcium beta-hydroxy-beta-methylbutyrate can also reduce muscle protein consumption.

[0042] The present application takes non-denatured type II collagen as the main efficacy component, and additionally adds animal protein, sodium hyaluronate, proteoglycan, sour cherry extract and calcium beta-hydroxy-beta-methylbutyrate, synergistically through multiple efficacy components, relieves joint discomfort through multiple pathways, maintains muscle health, effectively improves joint health, and the combination of specific component selection and content ratio makes the product have the best effect of repairing joint damage and improving joint and skeletal muscle health. BRIEF DESCRIPTION OF DRAWINGS

[0043] Figure 1 : ELISA statistical chart of IL-1β in joint lavage fluid of mice in the example or the comparative example of the present application;

[0044] Figure 2 : ELISA statistical chart of IL-10 in joint lavage fluid of mice in the example or the comparative example of the present application;

[0045] Figure 3 : ELISA statistical chart of TNF-ɑ in joint lavage fluid of mice in the example or the comparative example of the present application. DETAILED DESCRIPTION

[0046] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0047] It can be understood that the composition described in the embodiments of the present application can also be prepared into various suitable processed foods or drugs by adding different food or pharmaceutical acceptable adjuvants, including but not limited to diluents, wetting agents, binding agents, disintegrants, lubricants, color, flavor and taste adjusting agents, solvents, solubilizers, co-solvents, emulsifiers, antioxidants, metal complexing agents, preservatives, pH adjusting agents, etc. Further, the diluents include, for example, starch, sucrose, cellulose, inorganic salts, etc.; the wetting agents include, for example, water, ethanol, etc.; the binding agents include, for example, starch paste, dextrin, sugar, cellulose derivatives, gelatin, povidone, polyethylene glycol, etc.; the disintegrants include, for example, starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, surfactants, etc.; the lubricants include, for example, talc, calcium stearate, magnesium stearate, magnesium lauryl sulfate, polyethylene glycol, etc.; the color, flavor and taste adjusting agents include, for example, pigments, sweeteners, spices, gum agents, etc.; the solvents include, for example, water, glycerol, ethanol, etc.; the solubilizers include, for example, Tween, Brij, sulfates, sulfonates, etc.; the co-solvents include, for example, organic acids (such as citric acid) and their salts, inorganic salts, polyethylene glycol, etc.; the emulsifiers include, for example, Spans, glycerol fatty acid esters, gum arabic, gelatin, agar, sodium alginate, etc.; the antioxidants include, for example, sulfites, ascorbic acid, gallic acid and its salts, etc.; the metal complexing agents include, for example, disodium ethylenediaminetetraacetate, polycarboxylic acid compounds, etc.; the preservatives include, for example, nipagin, quaternary ammonium compounds, chlorhexidine acetate, etc.; the pH adjusting agents include, for example, hydrochloric acid, tartaric acid, acetic acid, sodium hydroxide, sodium bicarbonate, ethylenediamine, meglumine, phosphate, citrate, etc.

[0048] In the following examples, the experimental methods used are conventional methods unless otherwise specified, and the materials, reagents, etc. used are commercially available unless otherwise specified. The specific sources of the raw materials used in the embodiments of the present application are as follows: animal proteins, whey protein from Jenke Food Science and Technology (Shanghai) Co., Ltd., meat protein from Xi'an Aopt Biological Technology Co., Ltd., non-denatured type II collagen from Anhui Shengmei Nu Biological Technology Co., Ltd., collagen peptide from Anhui Shengmei Nu Biological Technology Co., Ltd., sodium hyaluronate from Huaxi Biological Technology Co., Ltd., proteoglycan from Shanghai Huiwen Biological Technology Co., Ltd., sour cherry extract from Shanghai Chengyi Health Technology Group Co., Ltd., and calcium beta-hydroxy-beta-methylbutyrate (CaHMB) from Jinyuan Technology (China) Co., Ltd.

[0049] Examples 1-6

[0050] A composition for promoting joint health, as shown in Table 1 below, comprises animal protein, non-denatured type II collagen, sodium hyaluronate, proteoglycan, sour cherry extract, calcium beta-hydroxy-beta-methylbutyrate, and a bulking agent, which is maltodextrin or resistant dextrin. The composition is a solid preparation, and the specific preparation method is as follows: after weighing and mixing the components uniformly, the mixture is granulated with a 60-mesh screen, and then dried in an oven at a temperature of 40°C. After secondary sieving, the particle size of the product should be uniformly dispersed in 30-80 mesh, and the proportion of 60-80 mesh particles should be less than 10%, to obtain the composition.

[0051] Table 1 - Components and contents of the composition in the examples and comparative examples of the present application

[0052]

[0053]

[0054] Comparative Example 4

[0055] A composition for promoting joint health, each step and the reagents and process parameters used in each step are the same as in Example 3, except that the animal protein is replaced by maltodextrin.

[0056] Comparative Example 5

[0057] A composition for promoting joint health, each step and the reagents and process parameters used in each step are the same as in Example 3, except that the non-denatured type II collagen is replaced by maltodextrin.

[0058] Comparative Example 6

[0059] A composition for promoting joint health, each step and the reagents and process parameters used in each step are the same as in Example 3, except that the sodium hyaluronate is replaced by maltodextrin.

[0060] Comparative Example 7

[0061] A composition for promoting joint health, each step and the reagents and process parameters used in each step are the same as in Example 3, except that the proteoglycan is replaced by maltodextrin.

[0062] Comparative Example 8

[0063] A composition for promoting joint health, each step and the reagents and process parameters used in each step are the same as in Example 3, except that the sour cherry extract is replaced by maltodextrin.

[0064] Comparative Example 9

[0065] A composition for promoting joint health, each step and reagents, process parameters used in each step are the same as example 3, the difference is that the β-hydroxy-β-methyl butyric acid calcium is replaced by maltodextrin.

[0066] Comparative example 10

[0067] A composition for promoting joint health, each step and reagents, process parameters used in each step are the same as example 3, the difference is that the acid cherry extract is replaced by β-hydroxy-β-methyl butyric acid calcium.

[0068] Comparative example 11

[0069] A composition for promoting joint health, each step and reagents, process parameters used in each step are the same as example 3, the difference is that the content of non-denatured type II collagen is 0.05wt%, the content of hyaluronic acid is 2.3wt%, and the content of proteoglycan is 0.1wt%.

[0070] Comparative example 12

[0071] A composition for promoting joint health, each step and reagents, process parameters used in each step are the same as example 3, the difference is that the content of animal protein is 64wt%, the content of acid cherry extract is 1wt%, and the content of β-hydroxy-β-methyl butyric acid calcium is 3wt%.

[0072] Performance detection test

[0073] Example 1 for verifying the effect

[0074] Example 1 for verifying the effect of improving knee arthritis:

[0075] 1) The mice were randomly divided into 20 groups, 10 in each group, half male and half female, examples 1-6 groups, comparative examples 1-12 groups, normal group, model group;

[0076] 2) 10% papain and 0.03mol / L L-cysteine were mixed at a ratio of 1:1 and stood for 30min, then 0.2mL of the mixed solution was injected into the knee joint cavity of the mice in the model control group, example group and comparative example group on the 0th, 3rd and 6th day to induce the mouse osteoarthritis model, and the normal control group was injected with the same amount of normal saline;

[0077] 3) During the experiment, 2g of example or comparative example solid preparation sample was weighed and diluted with pure water to 20mL for standby, and the example group and the comparative example group were diluted according to their respective formulations and administered, with a dose of 0.2mL per mouse, and the normal control group was injected with the same amount of pure water, each mouse was given medicine once a day, and a total of 4 weeks of administration;

[0078] 4) Detection index: ①General state of mice: observe the mental state, hair, food intake and the degree of activity of mice in each group; ②Change of width of mouse double knee joints: measure the width of knee joints (mm) of mice before modeling, before administration, and at the 1st, 2nd, 3rd and 4th week of administration, measure 3 times for each mouse and take the average value, calculate the joint swelling degree according to the following formula: joint swelling degree (mm) = ankle joint width after inflammation (after administration) - ankle joint width before inflammation (mm); ③Use ELISA method to detect the content of IL-1β, IL-10 and TNF-ɑ in the knee joint cavity lavage fluid of mice: after anesthesia, inject normal saline into the knee joint cavity of mice for lavage, centrifuge the joint lavage fluid at 12000 r / min at 4℃ for 15 min, separate the supernatant, and store it at -80℃ for standby, take the supernatant to determine the content of inflammatory factors IL-1β and TNF-ɑ and anti-inflammatory factor IL-10 according to the requirements of the ELISA kit instruction.

[0079] 5) Test results: the mice were in normal state before the start of the test, the joint activity of mice in each group was normal, there was no swelling in each joint, the mouse fur was clean, the diet was normal, and the reaction was agile; no mice died during the modeling process, after the modeling was completed, the mice in each modeling group appeared listless, and the knee joints were slightly lame; the statistical results of the change of the width of the double knee joints of mice after the administration test are shown in Table 2, and the content results of IL-1β, IL-10 and TNF-ɑ in the lavage fluid are shown in Table 3.

[0080] Table 2-Change of width of double knee joints of mice in arthritis test of examples and comparative examples before and after the test

[0081]

[0082]

[0083] Note: compared with the normal control group, ** indicates P<0.01; compared with the model control group, ## indicates P<0.01.

[0084] From the results of the change of the width of the knee joints of mice in Table 2 above, the change of the width of the knee joints of mice in the normal control group given normal saline was not significant (P>0.05) before and after the test. Compared with the normal control group, the width of the knee joints of mice in each modeling group was significantly increased (P<0.01), and there was no significant difference between each modeling group (P>0.05). Compared with the model control group, the width of the knee joints of mice in each example group was significantly reduced (P<0.01). Compared with the comparative example group, the width of the knee joints of mice in each example group was reduced more, and the difference was significant (P<0.01).

[0085] In Examples 1-6, the mouse knee joint width of Example 3 is reduced most, indicating that this example is the optimal combination, and the effect of improving arthritis is best. The mouse knee joint width of Comparative Examples 1-12 is also reduced to a certain extent, indicating that the components of the composition, animal protein, non-denatured type II collagen, sodium hyaluronate, proteoglycan, sour cherry extract and β-hydroxy-β-methyl butyric acid calcium, respectively, have different degrees of effect on relieving arthritis.

[0086] In addition, from Comparative Example 3 and Comparative Example 10, it can be seen that the sour cherry extract has anti-inflammatory and muscle building effects, can repair muscle by reducing oxidative stress, and β-hydroxy-β-methyl butyric acid calcium has muscle building and protein generation promoting effects, and turmeric belongs to a material with anti-inflammatory effect. The use of turmeric or β-hydroxy-β-methyl butyric acid calcium instead of sour cherry extract reduces the treatment effect of Comparative Examples 1 and 10 on arthritis, and the mouse knee joint width is wider than that of Example 3, indicating that the functions of the components cannot be simply replaced.

[0087] Compared with the model group, the mouse knee joint width of Comparative Example 11 is also reduced to a certain extent, but the reduction amount is significantly lower than that of Examples 1-6, and the difference is significant (P<0.01). Therefore, it is shown that when the weight parts of the composition provided by the present application are not within a specific range, even if the components are the same, the effect of relieving arthritis will be greatly reduced.

[0088] Compared with Example 3, the mouse knee joint width of Comparative Example 3 is reduced to a lesser extent, and the difference is significant (P<0.01), indicating that the composition provided by the present application is selected by the inventors through a large number of experiments, and the components produce a synergistic effect. Even if the same type of collagen peptide is used to replace non-denatured type II collagen, the final effect is still significantly worse than that of the examples of the present application.

[0089] Table 3-ELISA detection results of joint lavage fluid of arthritis test mice in examples and comparative examples of the present application

[0090]

[0091]

[0092] Note: Compared with the normal control group, ** indicates P<0.01; compared with the model control group, ## indicates P<0.01.

[0093] The results of Table 2 show that, compared with the control group, the IL-1β and TNF-α in the knee joint cavity lavage fluid of the model group mice are significantly increased (P<0.01), and the IL-10 is significantly decreased (P<0.01). Compared with the model group, the IL-1β and TNF-α in the knee joint cavity lavage fluid of each example group mice are significantly decreased (P<0.01), and the IL-10 is significantly increased (P<0.01). Compared with the control example group, the IL-1β and TNF-α in the knee joint cavity lavage fluid of each example group mice are more significantly decreased, and the IL-10 is more significantly increased, and the difference is significant (P<0.01).

[0094] In Examples 1-6, the IL-1β and TNF-α in the knee joint cavity lavage fluid of Example 3 are most significantly decreased, and the IL-10 is most significantly increased, indicating that this example is the optimal combination, and the effect of improving knee arthritis is best. The IL-1β and TNF-α in the knee joint cavity lavage fluid of Comparative Examples 1-12 are to a certain extent decreased, and the IL-10 is to a certain extent increased, indicating that the components of animal protein, non-denatured type II collagen, sodium hyaluronate, proteoglycan, sour cherry extract and β-hydroxy-β-methyl butyric acid calcium in the composition have different degrees of effect on relieving arthritis.

[0095] In addition, it can be known from Comparative Example 3 and Comparative Example 10 that the sour cherry extract has anti-inflammatory and muscle increasing effects, can repair muscle by reducing oxidative stress, and the β-hydroxy-β-methyl butyric acid calcium has muscle increasing and protein generation promoting effects, and turmeric belongs to a material with anti-inflammatory effect. By using turmeric or β-hydroxy-β-methyl butyric acid calcium to replace the sour cherry extract, the arthritis treatment effects of Comparative Examples 1 and 10 are lower than that of Example 3, the IL-1β and TNF-α are higher than those of Example 3, and the IL-10 is lower than that of Example 3, indicating that the functions of the components cannot be simply replaced.

[0096] Compared with the model group, the IL-1β and TNF-α in the knee joint cavity lavage fluid of Comparative Example 11 are to a certain extent decreased, and the IL-10 is to a certain extent increased, but the decreasing or increasing degree is obviously lower than that of Examples 1-6, and the difference is significant (P<0.01). It is thus indicated that when the weight parts of the composition provided by the application are not in the specific range, even if the components are the same, the effect of relieving arthritis will be greatly reduced.

[0097] Compared with Example 3, the IL-1β and TNF-α in the knee joint cavity lavage fluid of Comparative Example 3 are to a lesser extent decreased, and the IL-10 is to a lesser extent increased, and the difference is significant (P<0.01), indicating that the composition provided by the application is selected by the inventors through a large number of experiments, and the components produce a synergistic effect. Even if the same type of collagen peptide is used to replace the non-denatured type II collagen, the final effect is obviously poorer than that of the examples of the application.

[0098] Example 2

[0099] Test of improving muscle attenuation effect of the musculoskeletal system:

[0100] Test procedure: 6-7 month old C57BL / 6 mice were randomly divided into 20 groups, 10 in each group, half male and half female. Except for the normal group, the model group, examples 1-6 and comparative examples 1-12 were given 0.1 mL / 10g of dexamethasone subcutaneously for 42 days to establish a muscle attenuation model, and the normal control group was injected with an equal amount of normal saline; the example groups and the comparative example groups were given the respective formulations after dilution, and the dosage was 0.2 mL per mouse, and the normal control group was injected with an equal amount of pure water; each mouse was given medicine once a day, for a total of 4 weeks; before modeling and after drug treatment, the body composition of each group of mice was detected, and the muscle content was determined, and the test results are shown in Table 4.

[0101] Table 4 - Muscle content of mice before and after muscle attenuation modeling of examples and comparative examples of the present application

[0102] Group Before modeling / g After modeling before treatment / g After treatment (4 weeks by gavage) / g Normal control group 23.22±0.33 23.45±0.36 23.51±0.35 Model control group 23.26±0.32 17.52 ± 0.28 ** ]] 18.12 ± 0.36 ** ]] Example 1 23.19±0.31 18.01±0.20 21.13 ± 0.19 ## ]] Example 2 23.25±0.24 17.77±0.25 21.67 ± 0.23 ## ]] Example 3 23.27±0.28 17.89±0.31 22.27 ± 0.15 ## ]] Example 4 23.39±0.26 18.03±0.26 21.56 ± 0.18 ## ]] Example 5 23.21±0.33 18.05±0.19 21.08 ± 0.21 ## ]] Example 6 23.29±0.25 17.95±0.24 22.30±0.18 Comparative Example 1 23.31±0.19 18.03±0.15 19.28±0.13 Comparative Example 2 23.24±0.23 17.90±0.11 19.91±0.12 Comparative Example 3 23.24±0.25 17.58±0.17 19.23±0.24 Comparative Example 4 23.23±0.28 17.82±0.24 19.88±0.23 Comparative Example 5 23.32±0.32 17.75±0.22 19.05±0.11 Comparative Example 6 23.27±0.34 17.69±0.30 19.54±0.25 Comparative Example 7 23.28±0.27 18.02±0.21 19.62±0.18 Comparative Example 8 23.35±0.29 17.92±0.27 19.04±0.23 Comparative Example 9 23.33±0.21 18.00±0.21 19.13±0.20 Comparative Example 10 23.27±0.18 17.84±0.19 19.69±0.17 Comparative Example 11 23.26±0.32 17.88±0.23 19.25±0.16 Comparative Example 12 23.30±0.28 18.05±0.26 19.08±0.21

[0103] Note: Compared with the normal control group, ** indicates P<0.01; compared with the model control group, ## indicates P<0.01.

[0104] From the results of the change in muscle content of mice in Table 4 above, the change in muscle content of mice in the normal control group before and after the test was not significant (P>0.05). Compared with the normal control group, the muscle content of mice in each modeling group was significantly reduced (P<0.01), and there was no significant difference between each modeling group (P>0.05). Compared with the model control group, the muscle content of mice in each example group was significantly increased (P<0.01). Compared with the comparative example group, the increase in muscle content of mice in each example group was more, and the difference was significant (P<0.01).

[0105] In examples 1-6, the muscle content of mice in example 3 increased the most, indicating that this example was the optimal combination, and the effect of improving muscle attenuation was the best. The muscle content of mice in comparative examples 1-12 also increased to a certain extent, indicating that the components of animal protein, non-denatured type II collagen, sodium hyaluronate, proteoglycan, sour cherry extract, and β-hydroxy-β-methyl butyric acid calcium in the composition had different degrees of effect on relieving muscle attenuation.

[0106] In addition, as can be seen from Comparative Example 3 and Comparative Example 10, the sour cherry extract has anti-inflammatory and muscle-building effects, can reduce oxidative stress to repair muscle, while the calcium beta-hydroxy-beta-methylbutyrate has muscle-building and protein-promoting effects, and the curcuma is an anti-inflammatory substance. When the sour cherry extract is replaced by the curcuma or the calcium beta-hydroxy-beta-methylbutyrate, the muscle attenuation alleviating effects of Comparative Examples 1 and 10 are reduced, and the muscle content of the mice is lower than that of Example 3, indicating that the functions of the components cannot be simply replaced.

[0107] Compared with the model group, the muscle content of the mice in Comparative Example 12 also increased to a certain extent, but the increase was significantly lower than that of Examples 1-6, and the difference was significant (P<0.01). This indicates that when the weight parts of the composition provided by the present application are not within a specific range, even if the components are the same, the muscle attenuation alleviating effect will be greatly reduced.

[0108] Effect verification example 3

[0109] Acute toxicity test (MTD method):

[0110] Test process: Mice weighing 18-22 g were selected, half male and half female, and divided into 7 groups (blank control group, Examples 1-6), 10 in each group. The experimental animals were used in accordance with the Experimental Animal Use Regulations, the animals were bred to ensure a 12h / 12h light-dark cycle, the temperature was 23±1℃, the humidity was 50±10%, and the animals were free to eat and drink. All test mice were fasted for 16h overnight before the experiment, and water was not restricted. During the formal experiment, 10g of the solid preparation sample of the example was weighed, diluted with purified water to 100mL for testing, according to the maximum gavage concentration, gavage volume and safety factor of the sample, the test substance dose was 20.0g / kg BW, i.e. the gavage amount was 0.4mL / each time, the test sample (the blank control group was given purified water) was given once every 6h within one day, a total of twice, and the test substance was given orally by gavage for 3d. After the administration was completed, the mice were observed continuously for 14d, and the poisoning performance and death of the mice were recorded.

[0111] Test results: No death and abnormal phenomenon occurred in the mice during the 14d after administration, which proves that the preparations of Examples 1-6 have no toxic side effects and can be used safely.

[0112] Effect verification example 4

[0113] Human trial evaluation of joint function improvement verification:

[0114] At present, there is no corresponding standard test and evaluation method for joint injury repair and improvement of joint function. In this experiment, a corresponding questionnaire was designed according to the related symptoms and adverse reactions of joint and muscle diseases, in order to carry out feedback analysis of the efficacy results.

[0115] Test procedure: 100 volunteers aged 40-60 years old, half male and half female, with different degrees of joint swelling, pain, and other joint problems or muscle atrophy problems were selected. They were randomly divided into two groups, the competitor group and the Example 3 group. The competitor group included the following ingredients: hydrolyzed collagen 71wt%, glucosamine sulfate 11wt%, chondroitin sulfate 6wt%, turmeric 0.28wt%, hyaluronic acid 0.07wt%, and the balance of malt dextrin. The volunteers consumed the competitor or the solid beverage prepared according to Example 3 (10g / bag) once a day, which was dissolved in warm water and then consumed. The consumption lasted for 8 weeks, and during this period, the volunteers' diet and lifestyle were not adjusted in any way. Before the test began and after the experiment ended, a questionnaire survey on joint improvement effects was conducted, and the evaluation results are shown in Table 5 below.

[0116] Evaluation of joint function improvement:

[0117] A. Degree of joint pain:

[0118] 1) Degree of pain when standing on the knee joint: 0 points for no pain; 1 point for mild pain; 2 points for moderate pain; 3 points for severe pain;

[0119] 2) Degree of pain when sitting or lying on the knee joint: 0 points for no pain; 1 point for mild pain; 2 points for moderate pain; 3 points for severe pain;

[0120] 3) Degree of pain when walking on the knee joint: 0 points for no pain; 1 point for mild pain; 2 points for moderate pain; 3 points for severe pain;

[0121] B. Degree of joint stiffness: Degree of joint stiffness in the morning: 0 points for no stiffness; 1 point for mild stiffness; 2 points for moderate stiffness; 3 points for severe stiffness;

[0122] C. Swelling: Degree of swelling of the knee joint: 0 points for no swelling; 1 point for mild swelling, clear knee; 2 points for moderate swelling, unclear knee; 3 points for severe swelling, unclear knee, and positive float test;

[0123] D. Flexibility: Degree of knee joint flexibility: 0 points for normal; 1 point for knee joint flexibility 90-119°; 2 points for knee joint flexibility 20-89°; 3 points for knee joint flexibility less than 20°.

[0124] Table 5 - Evaluation results of joint function of Example 3 of the present application

[0125]

[0126] As can be seen from the questionnaire results in Table 5, after the 8-week test, the joint symptom scores of the competitor group and the Example 3 group are both decreased, and the score reduction degree of the Example 3 group is greater than that of the competitor group. The difference between the scores before and after the test is significant, and the effect of the application Example 3 on improving joint discomfort is more obvious.

[0127] The above-described specific embodiments further illustrate the purpose, technical solutions and beneficial effects of the present application. It should be understood that the above-described specific embodiments are merely examples of the present application and are not intended to limit the protection scope of the present application. It is particularly pointed out that any modification, equivalent replacement, improvement, etc. made by those skilled in the art within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A composition for promoting joint health, characterized in that, consists of the following components by mass fraction: animal protein: 20wt%-80wt%; non-denatured type II collagen: 0.2wt%-1wt%; sodium hyaluronate: 0.5wt%-2wt%; proteoglycan: 0.5wt%-2wt%; sour cherry extract: 3wt%-10wt%; calcium beta-hydroxy-beta-methylbutyrate: 5wt%-20wt%; excipient: balance; the excipient is maltodextrin and / or resistant dextrin, and the animal protein is whey protein.

2. A composition for promoting joint health according to claim 1, wherein the composition is a granular preparation, the particle size of the composition is 30-80 mesh, and the proportion of 60-80 mesh particles is less than 10%.

3. A method of preparing a composition for promoting joint health according to any one of claims 1-2, characterized in that, comprises the following steps: after weighing the components, mix them uniformly, granulate after primary sieving, then dry at a temperature of 30-50°C, and obtain the composition after secondary sieving.

4. A method of preparing a composition for promoting joint health according to claim 3, wherein satisfies at least one of the following a)-d): a) the mesh size of the screen is 60 mesh when primary sieving; b) the granulation process is wet granulation or dry granulation; c) the drying method is fluidized drying or oven drying; d) the secondary sieving controls the particle size of the composition to be 30-80 mesh, and the proportion of 60-80 mesh particles is less than 10%.

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