Composition for improving osteoporosis and related products and application thereof

Abstract

The invention discloses a composition for improving osteoporosis as well as a related product and application thereof, and relates to the field of biology. By accurately optimizing the ratio of the rhizoma polygonati to the colostrum basic protein to the folium cortex eucommiae to the bifidobacterium lactis, a composition system with stable coexistence and synergistic interaction among the components is constructed. The system not only effectively overcomes the problem that the efficacy is reduced due to mutual restriction and proportion imbalance of common components in a traditional compound, but also obviously improves the stability and bioavailability of the composition. In the aspect of efficacy, the composition comprehensively regulates and controls bone metabolism balance through a multi-target and multi-channel synergistic effect, the technical bottleneck that a single component or a simple mixture is limited in effect and incomplete in curative effect is fundamentally overcome, and a safer, more efficient and more stable solution is provided for prevention and adjuvant therapy of osteoporosis.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of biology, in particular to a composition for improving osteoporosis and related products and applications thereof. BACKGROUND

[0002] Osteoporosis is a systemic bone disease characterized by low bone mass, damage to bone microstructure, increased bone fragility, and susceptibility to fractures. The pathological mechanism is mainly attributed to the destruction of bone metabolism balance, that is, bone resorption exceeds bone formation, leading to progressive decline in bone density and bone mass. Currently, clinical treatment drugs mainly include two categories: one is bone resorption inhibitor (such as bisphosphonate, RANKL inhibitor, estrogen, etc.), aiming to slow down bone loss; the other is bone formation promoter (such as teriparatide, etc. parathyroid hormone analogues), aiming to stimulate new bone formation. However, the existing therapies still have many limitations: long-term use of bone resorption inhibitors may inhibit normal bone turnover, have potential risks such as osteonecrosis of the jaw and atypical fractures, and are difficult to repair the damaged bone microstructure; while bone formation promoters are expensive, inconvenient to administer (usually daily injection), and have limited treatment duration. In addition, many current synthetic drugs often target a single target or pathway, making it difficult to comprehensively regulate the complex bone metabolism network, resulting in limited efficacy or side effects.

[0003] In recent years, finding active substances with multiple regulatory effects and higher safety from natural products has become a research hotspot. However, the action intensity and efficacy spectrum of a single natural extract are often limited, making it difficult to achieve the desired therapeutic balance. Therefore, how to optimize the combination of active ingredients with different mechanisms of action through scientific compounding to synergistically promote bone formation, inhibit bone resorption, and consider safety and convenience of use has become a key technical problem for developing a new generation of osteoporosis improvement scheme. There is still a lack of an efficient composition with clear efficacy suitable for daily health care or adjuvant therapy in the prior art.

[0004] In view of this, the present application is proposed. SUMMARY

[0005] The purpose of the present application is to provide a composition for improving osteoporosis and related products and applications thereof.

[0006] The present application is implemented as follows: In a first aspect, embodiments of the present application provide a composition, wherein the main materials of the composition include, in terms of weight fraction: 0.3-10 parts of Rhizoma Polygonati, 0.2-22.5 parts of colostrum basic protein, 1-10 parts of Eucommia ulmoides leaf, and 1-3 parts of Bifidobacterium lactis.

[0007] In a second aspect, embodiments of the present application provide a preparation method of the composition as described in the preceding embodiments, which includes mixing the components in the composition as described in the preceding embodiments.

[0008] In a third aspect, embodiments of the present application provide use of the composition as described in the foregoing embodiments in the preparation of a composition for improving osteoporosis or helping to improve bone density.

[0009] In a fourth aspect, embodiments of the present application provide a food product comprising the composition as described in the foregoing embodiments.

[0010] The present application has the following beneficial effects: The present application has the following beneficial effects: BRIEF DESCRIPTION OF DRAWINGS

[0011] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some of the embodiments of the present application, and therefore should not be regarded as a limitation on the scope. For those of ordinary skill in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0012] Figure 1 Typical graph of fluorescence intensity of zebrafish head bone after sample treatment; Figure 2 Typical graph of fluorescence intensity of zebrafish osteogenesis after sample treatment. DETAILED DESCRIPTION

[0013] In order to make the purpose, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be described clearly and completely below. If the specific conditions are not specified in the embodiments, the conventional conditions or the conditions suggested by the manufacturer are used. If the manufacturers of the reagents or instruments are not specified, they are all conventional products that can be purchased on the market.

[0014] The "colostrum basic protein" (CBP) in this paper is a natural active substance extracted from colostrum (milk in the first few days after birth).

[0015] In one aspect, the present application provides a composition, which comprises, by weight, 0.3-10 parts of rhizoma polygonati, 0.2-22.5 parts of colostrum basic protein, 1-10 parts of eucommia ulmoides leaf, and 1-3 parts of lactobacillus bifidus.

[0016] In some embodiments, the rhizoma polygonati can be in a range of any one or between any two of 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 parts by weight.

[0017] In some embodiments, the colostrum basic protein can be in a range of any one or between any two of 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 22.5 parts by weight.

[0018] In some embodiments, the eucommia ulmoides leaf can be in a range of any one or between any two of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 parts by weight.

[0019] In some embodiments, the lactobacillus bifidus can be in a range of any one or between any two of 1, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8, and 3 parts by weight.

[0020] In some embodiments, the main material comprises any one of (1)-(2) by weight: (1) 4-8 parts of rhizoma polygonati, 20-22.5 parts of colostrum basic protein, 4-8 parts of eucommia ulmoides leaf, and 1-3 parts of lactobacillus bifidus; (2) 0.3-1 parts of rhizoma polygonati, 0.2-1 parts of colostrum basic protein, 1-3 parts of eucommia ulmoides leaf, and 1-3 parts of lactobacillus bifidus.

[0021] In some embodiments, the rhizoma polygonati is rhizoma polygonati powder.

[0022] In some embodiments, the eucommia ulmoides leaf is eucommia ulmoides leaf powder.

[0023] In some embodiments, the colostrum basic protein is selected from one or more of bovine colostrum basic protein and sheep colostrum basic protein.

[0024] In some embodiments, the lactobacillus bifidus is live bacteria, attenuated bacteria, killed bacteria, freeze-dried bacteria, or irradiated bacteria.

[0025] In some embodiments, the lactobacillus bifidus bacteria powder has a bacterial activity of 1×10 7 , 1×108 1×10 9 1×10 10 and 1×10 11 The range between any one or any two of CFU / g.

[0026] In some embodiments, the Bifidobacterium lactis is Bifidobacterium lactis HN019, which is deposited at the Australian Government Analytical Laboratory (AGAL) with accession number NM97 / 09513. This strain has been disclosed in patent number CN112515170A, entitled "A Combination of Bifidobacterium lactis and Prebiotics for Enhancing Gastrointestinal Immunity and Its Application".

[0027] In some embodiments, the composition further includes a pharmaceutically acceptable carrier.

[0028] In some embodiments, the pharmaceutically acceptable carrier includes any one or more of the following: pharmaceutically acceptable solvents, diluents, surfactants, suspending agents, preservatives, antioxidants, and desiccants.

[0029] In some embodiments, the solvent includes aqueous solvents (e.g., water for injection or purified water) and non-aqueous solvents (e.g., ethanol, glycerol, propylene glycol, polyethylene glycol (PEG), or ethyl oleate).

[0030] In some embodiments, the diluent includes lactose, microcrystalline cellulose, starch, pregelatinized starch, mannitol, or dicalcium phosphate.

[0031] In some embodiments, the surfactant includes polysorbates (Tween), poloxamer, or sodium dodecyl sulfate (SDS).

[0032] In some embodiments, the antioxidant includes ascorbic acid (vitamin C), sodium bisulfite, propyl gallate, or tocopherol (vitamin E).

[0033] In some embodiments, the composition may be formulated in any possible dosage form, including but not limited to powders, tablets, capsules, gel capsules, liquid syrups, soft gels, suppositories, and enemas.

[0034] In some embodiments, the composition is suitable for use as a functional food or health food for children, adolescents, middle-aged and elderly people and postmenopausal women.

[0035] On the other hand, embodiments of the present invention provide a method for preparing the composition as described in any of the foregoing embodiments, which includes mixing the components in the composition described in any of the foregoing embodiments.

[0036] On the other hand, embodiments of the present invention provide the use of the compositions as described in any of the foregoing embodiments in the preparation of compositions for improving osteoporosis.

[0037] On the other hand, embodiments of the present invention provide a food product comprising the composition described in any of the foregoing embodiments.

[0038] In some embodiments, the food is a nutritional supplement, health food, or food for medical purposes.

[0039] In some embodiments, the food is adult formulated milk powder.

[0040] In some embodiments, improving osteoporosis includes: preventing or reducing the occurrence of osteoporosis; slowing the rate of osteoporosis onset or progression; reducing the risk of developing osteoporosis; preventing or delaying the development of osteoporosis-related clinical symptoms or complications (such as bone pain, height loss, spinal deformities, or fractures); alleviating or terminating osteoporosis-related clinical symptoms; partially reversing the pathological state of osteoporosis (such as increasing bone density, optimizing bone microstructure, and enhancing bone strength); curing osteoporosis; or any combination of the above.

[0041] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0042] Example 1 A composition for improving osteoporosis comprises the following components: 44.3 μg / mL of Polygonatum sibiricum powder, 154.5 μg / mL of colostrum basic protein, 44.3 μg / mL of Eucommia ulmoides leaf powder, 6.87 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, Eucommia ulmoides leaf powder, and Bifidobacterium lactis is 6.45:22.5:6.45:1.

[0043] Example 2 A composition for improving osteoporosis comprises the following components: 30.0 μg / mL of Polygonatum sibiricum powder, 20.0 μg / mL of colostrum basic protein, 100 μg / mL of Eucommia ulmoides leaf powder, 100 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, Eucommia ulmoides leaf powder, and Bifidobacterium lactis is 0.3:0.2:1:1.

[0044] Example 3 A composition for improving osteoporosis comprises the following components: 100 μg / mL of Polygonatum sibiricum powder, 40.0 μg / mL of colostrum basic protein, 100 μg / mL of Eucommia ulmoides leaf powder, 10.0 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, Eucommia ulmoides leaf powder, and Bifidobacterium lactis is 10:4:10:1.

[0045] Example 4: A composition for improving osteoporosis comprises the following components: 44.3 μg / mL of Polygonatum sibiricum powder, 154.5 μg / mL of colostrum basic protein, 30.6 μg / mL of Eucommia ulmoides leaf powder, 20.6 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, Eucommia ulmoides leaf powder, and Bifidobacterium lactis is 6.45:22.5:4.45:3.

[0046] Example 5 A composition for improving osteoporosis comprises the following components: 44.3 μg / mL of Polygonatum sibiricum powder, 140.8 μg / mL of colostrum basic protein, 58.0 μg / mL of Eucommia ulmoides leaf powder, 6.87 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, Eucommia ulmoides leaf powder, and Bifidobacterium lactis is 6.45:20.5:8.44:1.

[0047] Example 6 A composition for improving osteoporosis comprises the following components: 44.3 μg / mL of Polygonatum sibiricum powder, 140.8 μg / mL of colostrum basic protein, 44.3 μg / mL of Eucommia ulmoides leaf powder, 20.6 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, Eucommia ulmoides leaf powder, and Bifidobacterium lactis is 6.45:20.5:6.45:3.

[0048] Comparative Example 1 A composition for improving osteoporosis comprises the following components: 55.6 μg / mL of Polygonatum sibiricum powder, 194.4 μg / mL of colostrum basic protein, and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder to colostrum basic protein is 1:3.5.

[0049] Comparative Example 2 A composition for improving osteoporosis comprises the following components: 125 μg / mL of Polygonatum sibiricum powder, 125 μg / mL of Eucommia ulmoides leaf powder, and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder to Eucommia ulmoides leaf powder is 1:1.

[0050] Comparative Example 3 A composition for improving osteoporosis comprises the following components: 216.4 μg / mL of Polygonatum sibiricum powder, 33.6 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder to Bifidobacterium lactis is 6.45:1.

[0051] Comparative Example 4 A composition for improving osteoporosis comprises the following components: 55.6 μg / mL of Eucommia ulmoides leaf powder, 194.4 μg / mL of colostrum basic protein, and a solvent (water); wherein the weight ratio of Eucommia ulmoides leaf powder to colostrum basic protein is 1:3.5.

[0052] Comparative Example 5 A composition for improving osteoporosis comprises the following components: 10.6 μg / mL of Bifidobacterium lactis (HN019), 239.4 μg / mL of colostrum basic protein, and a solvent (water); wherein the weight ratio of Bifidobacterium lactis to colostrum basic protein is 1:22.6.

[0053] Comparative Example 6 A composition for improving osteoporosis comprises the following components: 216.4 μg / mL of Eucommia ulmoides leaf powder, 33.6 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Eucommia ulmoides leaf powder to Bifidobacterium lactis is 6.44:1.

[0054] Comparative Example 7 A composition for improving osteoporosis comprises the following components: 45.5 μg / mL of Polygonatum sibiricum powder, 159 μg / mL of colostrum basic protein, 45.5 μg / mL of Eucommia ulmoides leaf powder, and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, and Eucommia ulmoides leaf powder is 1:3.5:1.

[0055] Comparative Example 8 A composition for improving osteoporosis comprises the following components: 53.8 μg / mL of Polygonatum sibiricum powder, 187.8 μg / mL of colostrum basic protein, 8.35 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, colostrum basic protein, and Bifidobacterium lactis is 6.44:22.5:1.

[0056] Comparative Example 9 A composition for improving osteoporosis comprises the following components: 53.8 μg / mL of Eucommia ulmoides leaf powder, 187.8 μg / mL of colostrum basic protein, 8.35 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Eucommia ulmoides leaf powder, colostrum basic protein, and Bifidobacterium lactis is 6.44:22.5:1.

[0057] Comparative Example 10 A composition for improving osteoporosis comprises the following components: 116 μg / mL of Polygonatum sibiricum powder, 116 μg / mL of Eucommia ulmoides leaf powder, 18.0 μg / mL of Bifidobacterium lactis (HN019), and a solvent (water); wherein the weight ratio of Polygonatum sibiricum powder, Eucommia ulmoides leaf powder, and Bifidobacterium lactis is 6.44:6.44:1.

[0058] Comparative Example 11 A composition for improving osteoporosis comprises the following components: 250 μg / mL of Polygonatum sibiricum powder and a solvent (water).

[0059] Comparative Example 12 A composition for improving osteoporosis comprises the following components: 250 μg / mL colostrum basic protein and a solvent (water).

[0060] Comparative Example 13 A composition for improving osteoporosis comprises the following components: 250 μg / mL of Eucommia ulmoides leaf powder and a solvent (water).

[0061] Comparative Example 14 A composition for improving osteoporosis comprises the following components: Bifidobacterium lactis (HN019) 250 μg / mL and solvent (water).

[0062] The concentrations of each component in Examples 1-6 and Comparative Examples 1-14 are final concentrations.

[0063] Experimental Example 1 Experimental methods: 1. Experimental materials: Bovine colostrum-derived basic protein, Eucommia ulmoides leaf powder, Polygonatum sibiricum powder, and Bifidobacterium lactis (HN019) live bacterial powder with a colony activity of 3 × 10⁻⁶. 10 CFU / g, all solvents were standard dilution water. Positive control: Alendronate sodium tablets (hereinafter referred to as alendronate sodium), white tablets, batch number Y009451, Savio Industrial SrL, solvent was ultrapure water.

[0064] 2. Laboratory animals: Zebrafish were raised in aquarium water at 28℃ (water quality: 200mg of instant sea salt added per 1L of reverse osmosis water, conductivity 450~550 μS / cm; pH 6.5~8.5; hardness 50~100 mg / L CaCO3), laboratory animal use license number: SYXK (Zhejiang) 2022-0004, husbandry and management met the requirements of international AAALAC certification (certification number: 001458), IACUC ethics review number: IACUC-2025-12646-01.

[0065] 3. Evaluation of efficacy in improving osteoporosis (skull fluorescence intensity) Wild-type AB strain zebrafish with a 3-day pod fly fold (dpf) were randomly selected and placed in beakers, with 30 zebrafish treated in each well (experimental group). Samples were administered (see Table 1), and a normal control group, a positive control group, and a model control group were also set up. Each beaker had a volume of 20 mL. Except for the normal control group, all experimental groups were given dexamethasone in water to establish a zebrafish osteoporosis model. After treatment at 28℃ for 4 days, the zebrafish were fixed and stained with alizarin red. Ten zebrafish from each experimental group were randomly selected and photographed under a fluorescence microscope. Images were saved, and data were analyzed and collected using NIS-Elements D 3.10 advanced image processing software. The fluorescence intensity of the zebrafish skull was analyzed, and the statistical analysis results of this index were used to evaluate the osteoporosis-improving efficacy of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 indicated statistical significance.

[0066] 4. Evaluation of efficacy in improving osteoporosis (osteogenic fluorescence intensity) 3 dpf transgenic bony green fluorescent zebrafish were randomly selected and placed in beakers, with 30 zebrafish treated in each well (experimental group). Samples were administered (see Table 2), and a normal control group and a model control group were also set up. Each beaker had a volume of 20 mL. Except for the normal control group, all other experimental groups were given dexamethasone in water to establish a zebrafish osteoporosis model. After treatment at 28℃ for 4 days, 10 zebrafish from each experimental group were randomly selected and photographed under a fluorescence microscope. Images were saved, and data were analyzed and collected using NIS-Elements D3.10 advanced image processing software. The osteogenic fluorescence intensity of the zebrafish was analyzed, and the statistical analysis results of this index were used to evaluate the osteoporosis-improving efficacy of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software. p A value <0.05 indicates that the difference is statistically significant.

[0067] 5. Test Results 5.1 Results of skull fluorescence intensity experiment Under the experimental conditions, both comparative examples and specific examples showed efficacy in improving osteoporosis. Comparative examples 5-10, examples 1, 2, 3, 4, 5, and comparative example 6 showed better efficacy in improving osteoporosis than comparative example 11, while comparative examples 1-4 showed no statistically significant difference compared to comparative example 11. Comparative examples 2, 3, 5, 6, 7, 8, 9, 10, 1, 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than comparative example 12, while comparative examples 1 and 4 showed no statistically significant difference compared to comparative example 12. Examples 1, 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than comparative example 13, while comparative examples 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 showed no statistically significant difference compared to comparative example 13.Comparative Example 9, Examples 1, 2, 3, 4, 5, and 6 showed better osteoporosis-improving effects than Comparative Example 14. Comparative Examples 1, 2, 3, 4, 5, 6, 7, 8, and 10 showed no statistically significant difference in osteoporosis-improving effects compared to Comparative Example 14. Comparative Examples 6, 7, 8, 9, 10, Examples 1, 2, 3, 4, 5, and 6 also showed significant osteoporosis-improving effects. The efficacy of Examples 1, 2, 3, 4, and 5 in improving osteoporosis was superior to Comparative Example 1. Comparative Examples 2, 3, 4, and 5 showed no statistically significant difference compared to Comparative Example 1. Examples 1, 2, 3, 4, 5, and 6 showed superior efficacy in improving osteoporosis compared to Comparative Example 2. Comparative Examples 1, 3, 4, 5, 6, 7, 8, 9, and 10 showed no statistically significant difference compared to Comparative Example 2. Examples 1, 2, 3, 4, 5, and 6 showed superior efficacy in improving osteoporosis compared to Comparative Example 2. Comparison 3, Comparison 1, Comparison 2, Comparison 4, Comparison 5, Comparison 6, Comparison 7, Comparison 8, Comparison 9, and Comparison 10 showed no statistical difference compared to Comparison 3; Comparison 7, Comparison 9, Comparison 10, Examples 1, 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than Comparison 4, while Comparison 1, 2, 3, 5, 6, and 8 showed no statistical difference compared to Comparison 4; Examples 1, 2, and 3... Examples 4, 5, and 6 showed better efficacy in improving osteoporosis than Comparative Example 5. Comparative Examples 1, 2, 3, 4, 6, 7, 8, 9, and 10 showed no statistical difference compared to Comparative Example 5. Examples 1, 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than Comparative Example 6. Comparative Examples 2, 3, 4, 5, 7, 8, 9, and 10 showed no statistical difference compared to Comparative Example 6.

[0068] See Table 1 and Figure 1 .

[0069] Table 1. Experimental results evaluating the efficacy of the samples in improving osteoporosis (n = 10)

[0070] Compared with the model control group, * p <0.05,** p <0.01, *** p <0.001; Compared with Comparative Example 1, $ p <0.05, $$ p<0.01, $$$ p <0.001; Compared with Comparative Example 2, ## p <0.01; Compared with Comparative Example 3, %% p <0.01; Compared with Comparative Example 4, & p <0.05, && p <0.01, &&& p <0.001; Compared with Comparative Example 5, a p <0.05, aa p <0.01; Compared with Comparative Example 6, b p <0.05, bb p <0.01; Compared with Comparative Example 11, c p <0.05, cc p <0.01, ccc p <0.001; Compared with Comparative Example 12, d p <0.05, dd p <0.01, ddd p <0.001; Compared with Comparative Example 13, e p <0.05, ee p <0.01; Compared with Comparative Example 14, f p <0.05, ff p <0.01.

[0071] 5.2 Results of osteogenic fluorescence intensity experiment Under the experimental conditions, both comparative examples and specific examples showed efficacy in improving osteoporosis. Comparative examples 8, 9, 10, 1, 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than comparative example 11. Comparative examples 1, 2, 3, 4, 5, 6, and 7 showed no statistically significant difference compared to comparative example 11. Specific examples 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than comparative example 12. Comparative examples 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 1, and 12 also showed efficacy. Specific example 2... Examples 3, 4, 5, and 6 showed better osteoporosis-improving efficacy than Comparative Example 13. Comparative Examples 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, and Example 1 showed no statistically significant difference compared to Comparative Example 13. Examples 3, 4, and 6 showed better osteoporosis-improving efficacy than Comparative Example 14. Comparative Examples 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, and Example 1, 2, and 5, showed no statistically significant difference compared to Comparative Example 14. Comparative Examples 9, 1, 2, 3, and 6, and Example 1, 2, and 6, showed better osteoporosis-improving efficacy than Comparative Example 14. Examples 4, 5, and 6 showed better efficacy in improving osteoporosis than Comparative Example 1; Comparative Examples 2, 3, 4, 5, 6, 7, 8, and 10 showed no statistically significant difference compared to Comparative Example 1. Comparative Examples 9, 1, 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than Comparative Example 2; Comparative Examples 1, 3, 4, 5, 6, 7, 8, and 10 showed no statistically significant difference compared to Comparative Example 2. Examples 2, 3, 4, 5, and 6 showed better efficacy in improving osteoporosis than Comparative Example 3; Comparative Examples 1, 2, 4, 5, and 6 showed no statistically significant difference compared to Comparative Example 2. Examples 6, 7, 8, 9, and 10 show no statistical difference between Example 1 and Comparative Example 3; Examples 2, 3, 4, 5, and 6 show better efficacy in improving osteoporosis than Comparative Example 4; Examples 1, 2, 3, 5, 6, 7, 8, 9, and 10 show no statistical difference between Example 1 and Comparative Example 4; Examples 4 and 6 show better efficacy in improving osteoporosis than Comparative Example 5; Examples 1, 2, 3, 4, 6, 7, 8, 9, and 10 show no statistical difference between Example 1, 2, 3, and 5.Examples 4 and 6 showed better efficacy in improving osteoporosis than Comparative Example 6. Comparative Examples 1, 2, 3, 4, 5, 7, 8, 9, 10, 1, 2, 3, and 5 showed no statistically significant difference compared to Comparative Example 6. See Table 2 for details. Figure 2 .

[0072] Table 2. Experimental results evaluating the efficacy of the samples in improving osteoporosis (n = 10)

[0073] Compared with the model control group, * p <0.05,** p <0.01, *** p <0.001; Compared with Comparative Example 1, $ p <0.05, $$ p <0.01; Compared with Comparative Example 2, # p <0.05, ## p <0.01; Compared with Comparative Example 3, % p <0.05, %% p <0.01; Compared with Comparative Example 4, & p <0.05, && p <0.01; Compared with Comparative Example 5, a p <0.05; Compared with Comparative Example 6, b p <0.05; Compared with Comparative Example 11, c p <0.05, cc p <0.01, ccc p <0.001; Compared with Comparative Example 12, d p <0.05, dd p <0.01; Compared with Comparative Example 13, e p <0.05, ee p <0.01; Compared with Comparative Example 14, f p <0.05.

[0074] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A composition characterized in that, The main ingredients of the composition include, by weight, 0.3-10 parts of polygonatum sibiricum, 0.2-22.5 parts of colostrum basic protein, 1-10 parts of eucommia ulmoides leaf, and 1-3 parts of Bifidobacterium lactis.

2. The composition of claim 1, wherein, The main ingredients include any one of (1)-(2) as follows, by weight: (1) 4-8 parts of polygonatum sibiricum, 20-22.5 parts of colostrum basic protein, 4-8 parts of eucommia ulmoides leaf, and 1-3 parts of Bifidobacterium lactis; (2) 0.3-1 part of polygonatum sibiricum, 0.2-1 part of colostrum basic protein, 1-3 parts of eucommia ulmoides leaf, and 1-3 parts of Bifidobacterium lactis.

3. The composition of claim 1, wherein, The polygonatum sibiricum is polygonatum sibiricum powder; The eucommia ulmoides leaf is eucommia ulmoides leaf powder; The Bifidobacterium lactis is Bifidobacterium lactis HN019.

4. The composition according to any one of claims 1 to 3, characterized in that, The composition further includes a pharmaceutically acceptable carrier.

5. The composition of claim 4, wherein, The pharmaceutically acceptable carrier includes any one or more of a pharmaceutically acceptable solvent, diluent, surfactant, suspending agent, preservative, antioxidant, and drying agent.

6. A process for the preparation of a composition according to any one of claims 1 to 5, characterised in that, It includes mixing the components in the composition of any one of claims 1-5.

7. Use of the composition of any one of claims 1-5 in the preparation of a composition for improving osteoporosis or helping to improve bone density.

8. A food product, characterized by, It includes the composition of any one of claims 1-5.

9. The food product of claim 8, wherein, The food is a nutritional product, a health food, or a medical use formula food.

10. The food product of claim 8, wherein, The food is an adult formula milk powder. The food is an adult formula milk powder.

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