Polygonatum sibiricum and saussurea involucrate bone marrow peptide tablet as well

Abstract

The invention relates to the technical field of functional product preparation, and provides a rhizoma polygonati and saussurea involucrata bone marrow peptide tablet as well as a preparation method and application thereof. The rhizoma polygonati and saussurea involucrata bone marrow peptide tablet is prepared from the following components: collagen peptide powder, L-isoleucine, a compound nutrient supplement, rhizoma polygonati, sorbitol, yak bone marrow peptide powder, fructus phyllanthi, fructus alpiniae oxyphyllae, mulberry powder, a saussurea involucrata culture and magnesium stearate. All the components of the rhizoma polygonati and saussurea involucrata bone marrow peptide tablet disclosed by the invention have a synergistic effect, so that the effects of conditioning sub-health, maintaining joints and assisting in treating diseases can be achieved.

Description

Technical Field

[0001] This application relates to the field of functional product preparation technology, and in particular to a Polygonatum odoratum and snow lotus bone marrow peptide tablet, its preparation method and uses. Background Technology

[0002] With the fast pace of modern life, the proportion of people in a sub-healthy state is increasing year by year, manifesting as symptoms such as fatigue, low immunity, and sleep disorders. At the same time, joint diseases are also showing a trend of affecting younger people. Factors such as long-term desk work, lack of exercise, and the aging population are causing joint problems such as arthritis and bone hyperplasia to plague people of different ages.

[0003] Currently, most products on the market targeting sub-health conditions and joint care are single-function preparations, such as simple vitamin supplements, calcium supplements, or joint cartilage protectants, which are difficult to achieve multi-target synergistic conditioning. Furthermore, while traditional Chinese medicine compound formulas have advantages in overall conditioning, they suffer from slow onset of action and inconvenient administration. In the field of adjunctive disease treatment, existing products often focus on single preparation technologies, emphasizing the pharmacological effects of single components, lacking comprehensive regulation of overall bodily functions, and lacking research on their application in different populations and health scenarios, thus failing to fully explore the product's value.

[0004] Therefore, there is an urgent need to develop a functional product that integrates multiple benefits, simultaneously addressing sub-health conditioning, joint care, and disease adjuvant treatment. Summary of the Invention

[0005] In view of this, this application aims to propose a Polygonatum and Snow Lotus Bone Marrow Peptide Tablet, which can provide a product that can simultaneously address sub-health conditioning, joint care, and adjunctive treatment of diseases.

[0006] To achieve the above objectives, the technical solution of this application is implemented as follows:

[0007] A Polygonatum and Snow Lotus Bone Marrow Peptide Tablet, wherein the components of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablet include collagen peptide powder, L-isoleucine, compound nutritional fortifier, Polygonatum, sorbitol, yak bone marrow peptide powder, Phyllanthus emblica, Alpinia oxyphylla, mulberry powder, snow lotus culture and magnesium stearate.

[0008] Furthermore, the compound nutritional fortifier includes calcium carbonate, maltodextrin, and cholecalciferol.

[0009] Compared with the prior art, this application has the following advantages:

[0010] The Huangjing Xuelian bone marrow peptide tablets of this application have a synergistic effect among their components, which can promote B cell activation, promote immunoglobulin G (IgG) synthesis, inhibit tumor necrosis factor-α (TNF-α) secretion, enhance the mechanical strength of bone matrix and increase bone density detection value. They can be used for sub-health conditioning, joint maintenance and adjuvant treatment of diseases.

[0011] Specifically, the polysaccharides in Polygonatum sibiricum can stimulate macrophages to release cytokines and promote B cell activation; the vitamin C and polyphenols in Phyllanthus emblica can protect immune cells from oxidative damage, prolong their lifespan, and indirectly improve antibody secretion efficiency. These two compounds, together with L-isoleucine, form a chain of "raw material supply + cell activation + protection," which can synergistically promote IgG synthesis. Mulberry powder contains mulberry polysaccharides that can enhance T lymphocyte activity and assist B cell maturation through cytokines secreted by T cells; the flavonoids in Saussurea involucrata culture can regulate immune balance, avoid excessive immunosuppression, and provide a suitable immune microenvironment for IgG secretion. Therefore, the Polygonatum sibiricum and Saussurea involucrata bone marrow peptide tablets of this application can be used for the conditioning of sub-health conditions.

[0012] Meanwhile, the flavonoids in snow lotus culture can inhibit the NF-κB pathway, directly blocking the transcription of the TNF-α gene; Polygonatum saponins can downregulate TLR4 receptors on the surface of macrophages, reducing the release signal of TNF-α, forming a synergistic effect of "pathway blocking + signal reduction". The vitamin C in Phyllanthus emblica, the anthocyanins in mulberry powder, and Polygonatum polysaccharides are all potent antioxidants capable of scavenging free radicals. ROS is a key signal stimulating TNF-α synthesis; the synergistic effect of these three can reduce ROS activation of macrophages, inhibiting TNF-α secretion from its source, making the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets of this application suitable for adjuvant treatment of diseases.

[0013] Furthermore, collagen peptides provide type I collagen, and yak bone marrow peptides provide calcium-binding peptides, phosphorus, and other minerals. Together, they construct the bone matrix framework, providing a structural basis for mineral deposition and directly increasing bone mineral content. Meanwhile, Polygonatum polysaccharides can inhibit osteoclast activity; L-isoleucine, by maintaining the energy metabolism and protein synthesis of osteoblasts, can promote osteoblast proliferation, forming a balance of "inhibiting osteoclasts and promoting osteoblasts." Snow lotus culture and mulberry powder can reduce bone loss by lowering pro-inflammatory factors such as TNF-α; the vitamin C in Phyllanthus emblica promotes collagen cross-linking and maturation, enhancing the mechanical strength of the bone matrix and indirectly increasing bone mineral density. Therefore, the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets of this application can be used for joint care.

[0014] Another objective of this application is to propose a method for preparing Polygonatum and Snow Lotus Bone Marrow Peptide Tablets to improve the retention of the raw material's activity and enhance product quality.

[0015] To achieve the above objectives, the technical solution of this application is implemented as follows:

[0016] A method for preparing Polygonatum and Saussurea involucrata bone marrow peptide tablets, the preparation method comprising:

[0017] The cultures of Polygonatum sibiricum, Saussurea involucrata and yak bone marrow peptide powder were refined separately.

[0018] The refined Polygonatum, the snow lotus culture and the yak bone marrow peptide powder are mixed to obtain a mixture.

[0019] The mixture is prepared into uniform particles;

[0020] The uniform particles are mixed with collagen peptide powder, L-isoleucine, compound nutritional fortifier, sorbitol, amla, alpinia oxyphylla, mulberry powder and magnesium stearate to prepare a total mixture.

[0021] The total mixture is compressed into tablets to obtain the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets.

[0022] Furthermore, the purification of Polygonatum sibiricum, Saussurea involucrata culture, and yak bone marrow peptide powder includes:

[0023] The Polygonatum slices were pretreated, vacuum freeze-dried for a preset time, pulverized and sieved;

[0024] The snow lotus culture was extracted using a polyethylene glycol / potassium phosphate aqueous double-water system, and then purified by supercritical carbon dioxide.

[0025] The yak bone marrow peptide powder was filtered and purified to remove macromolecular impurities, and then sieved.

[0026] Furthermore, the pretreatment includes microwave pretreatment under vacuum conditions for 5-8 minutes;

[0027] The vacuum level is between -0.06MPa and 0.10MPa, and the microwave power is between 250W and 350W.

[0028] Furthermore, the mixture of the refined Polygonatum sibiricum, the snow lotus culture, and the yak bone marrow peptide powder to obtain a mixture comprises:

[0029] The refined Polygonatum, the snow lotus culture, and the yak bone marrow peptide powder were three-dimensionally mixed until the coefficient of variation (CV) was ≤3% to obtain the mixture.

[0030] Furthermore, the step of preparing uniform particles from the mixture includes:

[0031] The mixture is subjected to a spray granulation process to obtain uniform particles of a preset particle size;

[0032] The spray granulation process includes an inlet air temperature between 160℃ and 180℃ and an atomization pressure between 0.2MPa and 0.4MPa.

[0033] Furthermore, the step of compressing the total mixture into tablets to obtain the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets includes:

[0034] The total mixture is compressed into tablets of a preset size using a pressure pulsation control process to obtain the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets.

[0035] The main pressure of the pressure pulsation control process is between 8-12 kN, and the pulsation pressure superimposed on the main pressure is between ±0.5 kN.

[0036] Compared with the prior art, this application has the following advantages:

[0037] The preparation method of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets in this application utilizes microwave-assisted vacuum freeze-drying of Polygonatum and aqueous two-phase extraction-supercritical CO2 purification of Snow Lotus, which can improve the retention rate of Polygonatum polysaccharides and the extraction rate of Snow Lotus flavonoids, and maximize the preservation of the biological activity of the raw materials.

[0038] Meanwhile, by controlling the mixing process, using spray granulation to precisely control the particle size, and combining pressure pulsation technology to optimize tableting parameters, the tablet disintegration time can be kept within 30 minutes, thus improving product quality uniformity and batch stability.

[0039] This application also proposes the use of a Polygonatum and Snow Lotus Bone Marrow Peptide Tablet, characterized in that:

[0040] The application of Polygonatum and Snow Lotus Bone Marrow Peptide Tablets in sub-health conditioning, joint care, or adjunctive treatment of diseases.

[0041] Furthermore, the adjuvant treatment for the disease includes adjuvant radiotherapy and chemotherapy for cancer patients. Attached Figure Description

[0042] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments and descriptions of this application are used to explain this application and do not constitute an undue limitation of this application. In the drawings:

[0043] Figure 1 This is a flowchart illustrating the preparation method of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets described in this application. Detailed Implementation

[0044] To make the technical solution and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0045] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other.

[0046] For items where specific conditions are not specified in this application, conventional conditions or conditions recommended by the manufacturer of the equipment used shall apply. For items where the manufacturer of the reagents or instruments used is not specified, conventional products that can be purchased commercially shall be used. As for the technical means or processes involved, if specific conditions are not specified, they shall be carried out in accordance with the existing methods in the relevant field.

[0047] The present application will now be described in detail with reference to the accompanying drawings and embodiments.

[0048] An embodiment of the first aspect of this application provides a Polygonatum and Snow Lotus Bone Marrow Peptide Tablet, which can provide a product that can be used for sub-health conditioning, joint care, or adjunctive treatment of diseases.

[0049] Existing technologies mostly involve single products based on one of the following: Polygonatum sibiricum, Saussurea involucrata, or bone marrow peptides. Furthermore, research on their application in different populations and health scenarios is lacking, making it impossible to fully explore the product's value.

[0050] In view of this, in order to overcome the shortcomings of the prior art, the Huanglian bone marrow peptide tablets of this embodiment are designed to include collagen peptide powder, L-isoleucine, compound nutritional fortifier, Polygonatum sibiricum, sorbitol, yak bone marrow peptide powder, Phyllanthus emblica, Alpinia oxyphylla, mulberry powder, snow lotus culture and magnesium stearate.

[0051] Specifically, the main component of the collagen peptide powder mentioned above is collagen, a crucial element of the organic matter in bones, comprising 70%-80% of the bone's organic structure. Supplementing with collagen peptide powder helps maintain bone strength and resilience, preventing osteoporosis and other bone diseases. Simultaneously, collagen also helps maintain the health of articular cartilage, reducing joint pain and inflammation, improving joint flexibility, and offering some preventative and alleviating effects against arthritis and other joint diseases.

[0052] L-Isoleucine is an important component of proteins, participating in the synthesis and repair of muscles, organs, enzymes, etc. It helps maintain normal physiological metabolism and regulate physiological functions. It is a precursor to neurotransmitters and helps improve attention and mood.

[0053] Polygonatum rhizome is sweet in taste, neutral in nature, and moist in texture. It enters the lung, spleen, and kidney meridians, nourishing yin and moistening dryness, replenishing kidney essence, and also replenishing lung qi and spleen qi. It is used to treat dry cough, chronic cough, and hemoptysis caused by deficiency of both lung qi and yin, as well as fatigue and weakness caused by spleen qi deficiency. Polygonatum rhizome contains a variety of active ingredients that can promote the activity of immune cells, enhance disease resistance, help improve myocardial ischemia, insufficient cerebral blood supply, and other diseases. It can also persistently lower blood pressure, blood lipids, and blood sugar, and has a certain effect on preventing arteriosclerosis and fatty liver formation. In this embodiment, Polygonatum rhizome polysaccharides are used to stimulate macrophages to release cytokines and promote B cell activation.

[0054] Sorbitol has a refreshing sweetness and can be used as a raw material for tablets. In this example, it is used as a flavoring agent to improve the taste of the tablets.

[0055] Yak bone marrow peptide powder contains a variety of collagen proteins that can provide the body with a variety of nutrients, help enhance the function of the immune system, and also have the effects of calcium supplementation, bone nourishment and joint care. In this embodiment, it is used together with collagen peptides to construct the bone matrix framework.

[0056] The fruit of the Phyllanthus emblica has a sweet and astringent taste, and is cool in nature. It can clear heat and cool the blood, aid digestion and strengthen the stomach, and promote the production of body fluids and quench thirst. The polyphenols it contains have a strong ability to scavenge various free radicals, and possess antioxidant, antibacterial, anti-inflammatory, cardiovascular protective, cataract prevention, and immune-regulating effects. Furthermore, the gallic acid in the Phyllanthus emblica pulp can promote insulin secretion and has a therapeutic effect on diabetes; tannins can fight tumors, mutations, and lipid peroxidation.

[0057] Alpinia oxyphylla has a pungent taste and warm nature. It enters the spleen and kidney meridians and is good at warming the spleen and stomach and controlling saliva. It can be used for excessive salivation, abdominal cold pain, diarrhea or drooling in children caused by spleen yang deficiency, inability to retain fluids, and water overflow.

[0058] Mulberry powder is rich in various vitamins, minerals, antioxidants, dietary fiber, protein, and amino acids. It can be used to nourish yin and blood, enhance immunity, regulate blood pressure and blood lipids, and aid sleep. In this embodiment, it is used as an antioxidant.

[0059] Snow lotus culture is obtained by subculturing isolated tissue of *Saussurea involucrata* (a plant in the Asteraceae family) through dedifferentiation to form callus tissue, followed by subculture under specific conditions. The resulting granules are either agglomerated or powdered. It possesses analgesic, anti-inflammatory, and antirheumatic properties, and can be used to relieve symptoms such as joint pain, swelling, and limited mobility caused by rheumatoid arthritis and osteoarthritis. It can also inhibit platelet aggregation, lower blood lipids, improve blood circulation, and help prevent and treat cardiovascular diseases. Furthermore, it has a regulatory effect on the immune system, enhancing immunity, and possesses antioxidant, anti-radiation, and anti-fatigue properties, making it useful for relieving fatigue and improving the body's stress response.

[0060] Magnesium stearate is a pharmaceutical excipient, which in this embodiment is used as a lubricant to smooth the tablet surface and improve the flowability of the granules.

[0061] Compound nutritional fortifiers are food additives made by compounding multiple nutritional fortifiers in a certain proportion. They can supplement the nutrients lacking in food or make up for the loss of nutrients caused by processing and other factors. The preferred components may include, for example, calcium carbonate, maltodextrin and cholecalciferol.

[0062] Based on the above description of each component, the Polygonatum component in the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets of this embodiment contains Polygonatum polysaccharides, which can stimulate macrophages to release cytokines and promote B cell activation; the vitamin C and polyphenols of Phyllanthus emblica can protect immune cells from oxidative damage, prolong their survival period, and indirectly improve antibody secretion efficiency. These two components, together with L-isoleucine, form a chain of "raw material supply + cell activation + protection," which can synergistically promote IgG synthesis. Meanwhile, the mulberry polysaccharides in mulberry powder can enhance T lymphocyte activity and assist B cell maturation through cytokines secreted by T cells; the flavonoids in snow lotus culture can regulate immune balance, avoid excessive immunosuppression, and provide a suitable immune microenvironment for IgG secretion.

[0063] Meanwhile, the flavonoids in snow lotus culture can inhibit the NF-κB pathway, directly blocking the transcription of the TNF-α gene; Polygonatum saponins can downregulate TLR4 receptors on the surface of macrophages, reducing the release signal of TNF-α, forming a synergistic effect of "pathway blocking + signal reduction". The vitamin C in Phyllanthus emblica, the anthocyanins in mulberry powder, and the polysaccharides in Polygonatum sibiricum are all potent antioxidants capable of scavenging free radicals. ROS is a key signal stimulating TNF-α synthesis; the synergistic effect of these three can reduce ROS activation of macrophages, inhibiting TNF-α secretion at its source.

[0064] In addition, collagen peptides provide type I collagen, and yak bone marrow peptides provide calcium-binding peptides, phosphorus, and other minerals. Together, they construct the bone matrix framework, providing a structural basis for mineral deposition and directly increasing bone mineral content. Meanwhile, Polygonatum polysaccharides can inhibit osteoclast activity; L-isoleucine, by maintaining the energy metabolism and protein synthesis of osteoblasts, can promote osteoblast proliferation, forming a balance of "inhibiting osteoclasts and promoting osteoblasts." Snow lotus culture and mulberry powder can reduce bone loss by lowering pro-inflammatory factors such as TNF-α; and the vitamin C in Phyllanthus emblica promotes collagen cross-linking and maturation, enhancing the mechanical strength of the bone matrix and indirectly increasing bone mineral density.

[0065] Therefore, as can be seen from the above description, the synergistic effect of the components of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets in this embodiment can play a role in regulating sub-health, joint care, and adjuvant treatment of diseases.

[0066] The second aspect of this application provides a method for preparing Polygonatum odoratum and Saussurea involucrata bone marrow peptide tablets to improve the retention of raw material activity and enhance product quality.

[0067] In existing technologies, high-temperature drying (such as 65°C hot air drying) is often used to process Polygonatum sibiricum, which leads to the breakage of its core component polysaccharide chains and an activity loss rate of over 40%. Snow lotus extraction relies on traditional water decoction or ethanol reflux methods, and the extraction rate of heat-sensitive components such as flavonoids is less than 25%. Furthermore, prolonged high temperatures damage the structure of its secondary metabolites, significantly weakening the medicinal value of the raw material.

[0068] The preparation process parameters are crude, resulting in unstable product quality and a lack of precise control in the formulation stage: the mixing process relies on a two-dimensional mixer and empirical time settings (15-30 minutes), leading to poor material homogeneity (mixing coefficient of variation (CV) as high as 12%); the granulation process uses wet granulation, resulting in a wide particle size distribution (50-500 μm), which causes large fluctuations in tablet disintegration time (15-40 minutes); the tableting process uses only constant pressure, resulting in a hardness coefficient of variation of 8%, which affects product stability and bioavailability.

[0069] In view of this, in order to overcome the shortcomings of the prior art, the preparation method of Polygonatum sibiricum and Saussurea involucrata bone marrow peptide tablets in this embodiment is, as an exemplary implementation, combined with Figure 1 As shown, the preparation method may include, for example, the following steps.

[0070] Step S1: Refine the Polygonatum sibiricum, snow lotus culture and yak bone marrow peptide powder separately.

[0071] In step S1 above, the Polygonatum sibiricum, Saussurea involucrata culture, and yak bone marrow peptide powder are purified separately. As a preferred embodiment, this may include, for example, the following:

[0072] The slices of Polygonatum were pretreated, vacuum freeze-dried for a preset time, pulverized and sieved;

[0073] The snow lotus culture was extracted using a polyethylene glycol / potassium phosphate aqueous double-water system and then purified by supercritical carbon dioxide.

[0074] The yak bone marrow peptide powder is filtered and purified to remove macromolecular impurities, and then sieved.

[0075] It is worth noting that pre-treating the Polygonatum slices is a preferred implementation method, for example, pre-treating the Polygonatum slices under vacuum conditions with microwave for 5-8 minutes.

[0076] The vacuum conditions described above are preferably, for example, a vacuum degree between -0.06MPa and 0.10MPa, and microwave power between 250W and 350W.

[0077] The above-mentioned freeze-drying, as a preferred embodiment, can be, for example, vacuum freeze-drying at -45°C for 16 hours.

[0078] Step S2: Mix the refined Polygonatum sibiricum, snow lotus culture and yak bone marrow peptide powder to obtain a mixture.

[0079] In step S2 above, the refined Polygonatum, snow lotus culture and yak bone marrow peptide powder are mixed to obtain a mixture. As a preferred embodiment, for example, the refined Polygonatum, snow lotus culture and yak bone marrow peptide powder can be three-dimensionally mixed until the coefficient of variation of the mixture is ≤3% to obtain the mixture.

[0080] Step S3: Prepare uniform particles from the mixture.

[0081] Step S3 above prepares uniform particles from the mixture. As a preferred embodiment, for example, the mixture can be prepared by spray granulation to obtain uniform particles of a preset particle size.

[0082] It is worth noting that the above-mentioned spray granulation process, as a preferred implementation, can, for example, use an inlet air temperature between 160℃ and 180℃ and an atomization pressure between 0.2MPa and 0.4MPa.

[0083] The preset particle size is preferably between 100-300 μm.

[0084] Step S4: Mix the uniform particles with collagen peptide powder, L-isoleucine, compound nutritional fortifier, sorbitol, amla, alpinia oxyphylla, mulberry powder and magnesium stearate to obtain the total mixture.

[0085] The mixing in step S4 above can preferably be performed by mechanical mixing, for example.

[0086] Step S5: Compress the total mixture into tablets to obtain Polygonatum odoratum and snow lotus bone marrow peptide tablets.

[0087] In step S5 above, the total mixture is compressed into tablets to obtain Polygonatum and Snow Lotus Bone Marrow Peptide Tablets. As a preferred embodiment, for example, the total mixture can be compressed into tablets of a preset specification using a pressure pulsation control process to obtain the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets.

[0088] Of particular note is the pressure pulsation control process, which is a preferred implementation. For example, the main pressure of the control process can be between 8 and 12 kN, and the pulsation pressure superimposed on the main pressure can be between ±0.5 kN.

[0089] Based on the above description, the preparation method of Polygonatum and Snow Lotus Bone Marrow Peptide Tablets in this embodiment utilizes microwave-assisted vacuum freeze-drying of Polygonatum and aqueous two-phase extraction-supercritical CO2 refining of Snow Lotus, which can improve the retention rate of Polygonatum polysaccharides and the extraction rate of Snow Lotus flavonoids, thus maximizing the preservation of the bioactivity of the raw materials.

[0090] Meanwhile, by controlling the mixing process, using spray granulation to precisely control the particle size, and combining pressure pulsation technology to optimize tableting parameters, the tablet disintegration time can be kept within 30 minutes, thus improving product quality uniformity and batch stability.

[0091] Furthermore, the embodiments of the third aspect of this application provide the uses of the above-mentioned Polygonatum and Snow Lotus Bone Marrow Peptide Tablets. Specifically, the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets of this embodiment are used for sub-health conditioning, joint care, or as an adjunct treatment for diseases.

[0092] Among these, adjuvant therapy for diseases, preferably, can be an adjuvant therapy for cancer patients undergoing radiotherapy and chemotherapy.

[0093] This application clarifies the effectiveness of Polygonatum and Snow Lotus Bone Marrow Peptide Tablets in multiple scenarios such as sub-health conditioning, joint care, and adjunctive treatment of diseases, filling the gap in application research of similar products and providing a scientific basis for precise market positioning and product function development.

[0094] It is worth noting that, regarding the Polygonatum and Saussurea bone marrow peptide tablets, their preparation method, and uses in this embodiment, based on the above preferred embodiments, the following preparation examples can be referred to in specific implementations.

[0095] Example 1

[0096] Example 1 describes the preparation of the above-mentioned Polygonatum and Saussurea bone marrow peptide tablets. The specific preparation steps are as follows:

[0097] Step S1: Dynamically freeze-dry the Polygonatum slices using microwave-assisted vacuum drying (microwave 300W, -0.08MPa, 5min), then pulverize and pass through a 120-mesh sieve for later use;

[0098] After extraction using a polyethylene glycol / potassium phosphate system, the snow lotus culture was purified into powder using supercritical CO2 (25 MPa, 40 °C, 120 min) for later use.

[0099] Yak bone marrow peptide powder is filtered through a nano-membrane (500 Da cutoff) and passed through a 100-mesh sieve for later use.

[0100] Step S2: Mix 14 kg of refined Polygonatum sibiricum, 0.02 kg of snow lotus culture and 2 kg of yak bone marrow peptide powder to obtain a mixture.

[0101] Step S3: After mixing the materials by near-infrared monitoring, spray granulation (air inlet 160℃, atomization 0.3MPa) is performed to prepare uniform particles.

[0102] Step S4: Mix the uniform granules with 35kg of collagen peptide powder, 28kg of L-isoleucine, 16kg of compound nutritional fortifier, 3.68kg of sorbitol, 0.1kg of amla, 0.1kg of alpinia oxyphylla, 0.1kg of mulberry powder and 1kg of magnesium stearate to obtain the total mixture.

[0103] Step S5: Compress the total mixture into tablets under a main pressure of 10kN and a pulsating pressure of ±0.5kN to obtain Polygonatum and Snow Lotus Bone Marrow Peptide Tablets with a tablet weight of 0.5g / tablet, a hardness of 4.5±0.3kg, and a friability of ≤0.5%.

[0104] Example 2

[0105] Example 2 describes the preparation of the above-mentioned Polygonatum and Saussurea involucrata bone marrow peptide tablets. The specific preparation steps are as follows:

[0106] Step S1: Dynamically freeze-dry the Polygonatum slices using microwave-assisted vacuum drying (microwave 300W, -0.08MPa, 5min), then pulverize and pass through a 120-mesh sieve for later use;

[0107] After extraction using a polyethylene glycol / potassium phosphate system, the snow lotus culture was purified into powder using supercritical CO2 (25 MPa, 40 °C, 120 min) for later use.

[0108] Yak bone marrow peptide powder is filtered through a nano-membrane (500 Da cutoff) and passed through a 100-mesh sieve for later use.

[0109] Step S2: Mix 15kg of refined Polygonatum sibiricum, 0.03kg of snow lotus culture and 3kg of yak bone marrow peptide powder to obtain a mixture.

[0110] Step S3: After mixing the materials by near-infrared monitoring, spray granulation (air inlet 160℃, atomization 0.3MPa) is performed to prepare uniform particles.

[0111] Step S4: Mix the uniform granules with 30kg of collagen peptide powder, 28kg of L-isoleucine, 19kg of compound nutritional fortifier, 3.67kg of sorbitol, 0.1kg of amla, 0.1kg of alpinia oxyphylla, 0.1kg of mulberry powder and 1kg of magnesium stearate to obtain the total mixture.

[0112] Step S5: Compress the total mixture into tablets under a main pressure of 10kN and a pulsating pressure of ±0.5kN to obtain Polygonatum and Snow Lotus Bone Marrow Peptide Tablets with a tablet weight of 0.5g / tablet, a hardness of 4.5±0.3kg, and a friability of ≤0.5%.

[0113] Verification Example 1

[0114] The uses of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets prepared in the above examples, specifically for regulating sub-health and joint care, were verified using the following methods:

[0115] 1. The Polygonatum and Snow Lotus Bone Marrow Peptide Tablets prepared in Example 1 were used on sub-healthy individuals. The tablets were taken twice daily, 3 tablets each time, for 8 consecutive weeks. The results are shown in Table 1 below.

[0116] Table 1. Fatigue scores and IgG levels in sub-healthy individuals

[0117]

[0118] As shown in Table 1, after taking 3 tablets twice a day for 8 consecutive weeks, the average decrease in the subjects' Fatigue Scale (FS-14) score was 28%, and the average increase in serum immunoglobulin IgG level was 15%.

[0119] 2. The Polygonatum and Saussurea bone marrow peptide tablets prepared in Example 1 were administered to rats with osteoarthritis by gavage for animal experiments. After 8 weeks of continuous gavage, the results are shown in Table 2 below.

[0120] Table 2. Type II collagen expression and TNF-α level in rats

[0121] Osteoarthritis model rats Increase in type II collagen expression (%) TNF-α level decrease rate (%) Gavage group 1 42％ 35％ Gavage group 2 38％ 29％ Gavage group 3 48％ 28％ Gavage group 4 30％ 34％ Gavage group 5 42％ 34％

[0122] As shown in Table 2, in the osteoarthritis model rats after continuous gavage administration of this tablet, the expression level of type II collagen in the cartilage tissue increased by an average of 40%, and the level of the inflammatory factor TNF-α decreased by an average of 32%.

[0123] Verification Example 2

[0124] The following are the verification methods for the use of the Polygonatum and Saussurea bone marrow peptide tablets prepared in the above examples as an adjunct therapy for diseases:

[0125] 1. The Polygonatum and Saussurea involucrata bone marrow peptide tablets prepared in Example 2 were administered to cancer patients during radiotherapy and chemotherapy. Blood indicators and the improvement of adverse reactions were monitored to aid in the recovery of cancer patients after radiotherapy and chemotherapy. This validation included 120 patients with solid tumors (stage II-III), who were randomly divided into a control group and an experimental group. The experimental group began taking Polygonatum and Saussurea involucrata bone marrow peptide tablets orally 3 days before radiotherapy and chemotherapy (3 tablets twice daily) and continued until 4 weeks after the end of chemotherapy. The monitoring results are detailed in Table 3 below.

[0126] Table 3. Clinical improvement data of Huangjing Xuelian bone marrow peptide tablets in cancer patients undergoing radiotherapy and chemotherapy.

[0127]

[0128]

[0129] The results showed that in the combined treatment group, patients who took the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets prepared in this example 2 in combination with radiotherapy and chemotherapy experienced a 21.7% decrease in the incidence of grade IV leukopenia, and 65% of patients experienced a weight loss of ≤5%.

[0130] 2. The Polygonatum and Saussurea involucrata bone marrow peptide tablets prepared in Example 2 were used for postmenopausal osteoporosis intervention. A randomized, double-blind, controlled trial was conducted, enrolling 160 postmenopausal women with osteoporosis (T-score ≤ 2.5), aged 55-75 years. Control group: Calcium carbonate D3 tablets (600mg calcium + 125IU VD / time, twice daily). Experimental group: basal body plus Polygonatum and Saussurea involucrata bone marrow peptide tablets (3 tablets twice daily). The results of the index detection are shown in Table 4 below.

[0131] Table 4. Huangjing Xuelian Bone Marrow Peptide Tablets for Postmenopausal Osteoporosis Intervention

[0132]

[0133]

[0134] The results showed that in a study of postmenopausal women with osteoporosis, after 12 months of continuous use, the T-score of lumbar spine bone mineral density increased by 0.8 and the osteocalcin level increased by 25%.

[0135] As can be seen from the above verification example 1, the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets prepared in Example 1 can increase the level of immunoglobulins, improve the immunity of sub-healthy people, and at the same time increase the expression of type II collagen and reduce the level of inflammatory factor TNF-α, thus achieving the effect of joint care.

[0136] Meanwhile, as can be seen from the above verification example 2, the Huangjing Xuelian bone marrow peptide tablets prepared in Example 2, when used in combination with tumor radiotherapy and chemotherapy, can reduce the incidence of neutropenia and weight loss, and can also increase the bone mineral density and osteocalcin levels in postmenopausal osteoporosis patients.

[0137] In summary, the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets prepared in this example can be used to improve fatigue in sub-healthy individuals, as an adjunct to radiotherapy and chemotherapy in cancer patients, as an intervention for postmenopausal osteoporosis, and as a treatment for osteoarthritis. This fills a gap in the application research of similar products and provides a scientific basis for precise market positioning and product function development.

[0138] The above descriptions are merely some embodiments of this application and are not intended to limit this application. The technical features or structures in the foregoing different embodiments can be arbitrarily combined to form other specific technical solutions as needed. For those skilled in the art, this application can have various modifications and variations. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of the claims of this application.

Claims

1. A Polygonatum and Snow Lotus Bone Marrow Peptide Tablet, characterized in that: The components of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets include collagen peptide powder, L-isoleucine, compound nutritional fortifier, Polygonatum, sorbitol, yak bone marrow peptide powder, Phyllanthus emblica, Alpinia oxyphylla, mulberry powder, snow lotus culture, and magnesium stearate.

2. The Polygonatum and Snow Lotus Bone Marrow Peptide Tablets according to claim 1, characterized in that: The compound nutritional fortifier includes calcium carbonate, maltodextrin, and cholecalciferol.

3. The preparation method of Polygonatum and Saussurea involucrata bone marrow peptide tablets as described in claim 1 or 2, characterized in that, The preparation method includes: The cultures of Polygonatum sibiricum, Saussurea involucrata and yak bone marrow peptide powder were refined separately. The refined Polygonatum, the snow lotus culture and the yak bone marrow peptide powder are mixed to obtain a mixture. The mixture is prepared into uniform particles; The uniform particles are mixed with collagen peptide powder, L-isoleucine, compound nutritional fortifier, sorbitol, amla, alpinia oxyphylla, mulberry powder and magnesium stearate to prepare a total mixture. The total mixture is compressed into tablets to obtain the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets.

4. The preparation method of Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 3, characterized in that, The process of refining Polygonatum sibiricum, Saussurea involucrata culture, and yak bone marrow peptide powder separately includes: The Polygonatum slices were pretreated, vacuum freeze-dried for a preset time, pulverized and sieved; The snow lotus culture was extracted using a polyethylene glycol / potassium phosphate aqueous double-water system, and then purified by supercritical carbon dioxide. The yak bone marrow peptide powder was filtered and purified to remove macromolecular impurities, and then sieved.

5. The preparation method of Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 4, characterized in that: The pretreatment includes microwave pretreatment under vacuum conditions for 5-8 minutes; The vacuum level is between -0.06MPa and 0.10MPa, and the microwave power is between 250W and 350W.

6. The method for preparing Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 3, characterized in that, The process involves mixing the refined Polygonatum sibiricum, the snow lotus culture, and the yak bone marrow peptide powder to obtain a mixture comprising: The refined Polygonatum, the snow lotus culture, and the yak bone marrow peptide powder were three-dimensionally mixed until the coefficient of variation (CV) was ≤3% to obtain the mixture.

7. The preparation method of Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 3, characterized in that, The step of preparing uniform particles from the mixture includes: The mixture is subjected to a spray granulation process to obtain uniform particles of a preset particle size; The spray granulation process includes an inlet air temperature between 160℃ and 180℃ and an atomization pressure between 0.2MPa and 0.4MPa.

8. The preparation method of Polygonatum and Saussurea involucrata bone marrow peptide tablets according to claim 3, characterized in that, The step of compressing the total mixture into tablets to obtain the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets includes: The total mixture is compressed into tablets of a preset size using a pressure pulsation control process to obtain the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets. The main pressure of the pressure pulsation control process is between 8-12 kN, and the pulsation pressure superimposed on the main pressure is between ±0.5 kN.

9. The use of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets as described in claim 1 or 2, characterized in that: The application of Polygonatum and Snow Lotus Bone Marrow Peptide Tablets in sub-health conditioning, joint care, or adjunctive treatment of diseases.

10. The use of the Polygonatum and Snow Lotus Bone Marrow Peptide Tablets according to claim 9, characterized in that: The adjuvant therapy for the disease includes adjuvant radiotherapy and chemotherapy for cancer patients.

Images