Immune homeostasis regulation type cartilage repair compound nutrient and preparation process thereof

Abstract

The invention belongs to the technical field of nutrients, and discloses an immune steady-state regulation type cartilage repair compound nutrient and a preparation process thereof. The nutrient comprises 150 parts of calcium L-aspartate, 100 parts of purified konjac powder, 80 parts of marine fish oligopeptide, 70 parts of roxburgh rose powder, 10 parts of taurine, 30 parts of angelica sinensis extract, 20 parts of turmeric extract, 20 parts of rhizoma polygonati extract, 15 parts of selenium-enriched barley malt powder, 10 parts of yeast B-glucan, 50 parts of bovine bone collagen peptide powder, 5 parts of sodium hyaluronate, 25 parts of 2-oxoglutaric acid and 30 parts of earthworm protein. The formula comprises the following components in parts by weight: 20 parts of colostrum basic protein powder, 40 parts of non-denatured II-type bone collagen, 0.01 part of vitamin D3, 50 parts of soluble soybean polysaccharide, 5 parts of citric acid, 0.5 part of nisin, 0.5 part of B-carotene and 1 part of sucralose. The product can scavenge free radicals, clean intestinal tracts, regulate immunity, regulate clogging and qi and blood, supplement calcium ions and high-quality multi-layer nutrient substances, and repair damaged cartilage tissues and skeletal systems.

Description

Technical Field

[0001] The present invention belongs to the technical field of nutrients, and in particular relates to an immune homeostasis-regulating cartilage repair composite nutrient and a preparation process thereof. Background Art

[0002] In today's society, more than 80% of the elderly have knee joint diseases, of which 60% suffer from cartilage diseases. Among these 48% of elderly people, more than 90% cannot find suitable treatment options in the early stages of cartilage damage and can only "raise a tiger to harm themselves."

[0003] Cartilage damage has no direct correlation with height, weight, or size. Research has found that the direct cause of cartilage damage is organic cartilage failure, primarily due to a decrease in the amount of undenatured type II collagen within the cartilage. This decrease in undenatured type II collagen leads to a sharp decrease in sodium hyaluronate secretion, reducing the amount of filling and lubrication between collagen fibers on the surface of the cartilage. This increases friction during joint movement and prevents the absorption of the stress and impact of movement. Based on this, experiments have shown that even if cartilage is adequately supplied with undenatured type II collagen and sodium hyaluronate, over time, the undenatured type II collagen will rapidly decrease, and the sodium hyaluronate will be completely depleted. Extensive experiments have revealed that the rapid decrease in undenatured type II collagen is caused by an attack by the body's immune cells. Research into the mechanism by which immune cells drive out undenatured type II collagen has shown that immune cells only misdirect undenatured type II collagen when the immune system is dysfunctional. Only then did researchers truly discover the cause of cartilage damage: a disrupted immune system! In other words, to heal cartilage damage, we must first strengthen our immune system, then rapidly restore health by adding nutrients like non-denatured type II collagen and sodium hyaluronate.

[0004] Existing cartilage repair nutritional supplements generally have three major defects: Single ingredient: Most products focus solely on the mechanical superposition of calcium and collagen (e.g., calcium alone + type II collagen), lacking coordinated regulation of the immune microenvironment (e.g., imbalance in macrophage M1 / M2 polarization), resulting in low repair efficiency (clinical data show that only 28% of patients experience significant improvement in joint function). Severe activity loss: In traditional wet granulation processes, the inactivation rate of heat-sensitive ingredients such as curcumin and VC reaches over 40% due to high temperatures (>60°C), and peptides are prone to Maillard reaction cross-linking; Bioavailability bottleneck: Free pro-inflammatory factor antagonists (such as earthworm protein) denature and become ineffective in the gastric acid environment, with an oral bioavailability of less than 15%, and cannot be delivered to the joint cavity in a targeted manner. Summary of the Invention

[0005] In order to overcome the above technical problems, the present invention provides an immune homeostasis regulating cartilage repair compound nutrient and a preparation process thereof.

[0006] The present invention adopts the following technical solutions: Immune homeostasis regulating cartilage repair complex nutrients, by mass, include: 150 parts of L-aspartic acid calcium, 100 parts of purified konjac flour, 80 parts of marine fish oligopeptides, 70 parts of roxburghii powder, 10 parts of taurine, 30 parts of angelica extract, 20 parts of turmeric extract, 20 parts of polygonatum extract, 15 parts of selenium-enriched barley malt powder, 10 parts of yeast B-glucan, 50 parts of bovine collagen peptide powder, 5 parts of sodium hyaluronate, 25 parts of 2-oxoglutaric acid (AKG), 30 parts of earthworm protein, 20 parts of colostrum alkaline protein powder, 40 parts of non-denatured type ‖ collagen, 0.01 parts of vitamin D3, 50 parts of soluble soybean polysaccharides, 5 parts of citric acid, 0.5 parts of nisin, 0.5 parts of B-carotene, and 1 part of sucralose.

[0007] The present invention also discloses a preparation process of an immune homeostasis-regulating cartilage repair composite nutrient, comprising the following steps: S1. Raw material pretreatment Heat-sensitive components: taurine, AKG, VB-glucan, frozen and crushed at -30℃, passed through 80-mesh sieve, temperature ≤15℃, RH ≤45%; Chinese herbal medicine extracts: Angelica sinensis, Curcuma longa, Polygonatum sibiricum, supercritical CO2 extraction, pressure 25MPa, 45℃, nanoliposome encapsulation; Protein: premix of non-denatured type II collagen, colostrum basic protein and soluble soybean polysaccharide; Hydrophobic ingredients: Vitamin D3 and β-carotene, dissolved in MCT oil (40°C) to make a microemulsion (HLB value = 12); S2. Module mixing Mineral-fiber base: calcium L-aspartate, selenium-enriched malt powder, and pregelatinized konjac flour were dry-mixed in a gravity mixer for 15 minutes at 20 rpm; then passed through a 60-mesh sieve with a strong magnetic iron remover. Protein peptide active group: marine fish oligopeptides, bovine collagen peptides, earthworm protein, colostrum alkaline protein powder, step-by-step addition of targeted protective agent (0.5% anti-bitter peptide + PEG4000), fluidized bed bottom spray embedding (inlet air temperature 40°C, atomization pressure 0.8MPa); Functional excipient group: sodium hyaluronate, AKG, roxburghii powder, citric acid, dissolved in 5% xylitol solution, ultrasonic-assisted dissolution, 40kHz, 15min; S3. Dynamic fluidization integrated granulation The mineral-fiber base material is put into the fluidized bed, the inlet air temperature is 35℃, and nitrogen protection is turned on; Three-way spraying: spray gun 1: functional excipient group solution, atomized particle size 40-60μm; spray gun 2: protein peptide active group embedded particles, simultaneously sprayed with anti-caking agent silicon dioxide 0.2%; spray gun 3: traditional Chinese medicine liposome suspension, VD3 microemulsion; Granulation and drying integration: Spray speed: 120ml / min; Fluidizing air speed: 1.2m³ / s; End point determination: Material temperature rises to 42℃±1℃, moisture ≤4.5%; S4. Intelligent final mixing and coating Three-dimensional mixing activation: add β-glucan, taurine, sucralose, and nisin, rotate / revolve the mixer at 15 / 35 rpm for 20 min, and monitor the homogeneity using near-infrared online monitoring (RSD) ≤ 3%; Dual functional coating: the inner layer uses chitosan-sodium alginate (1:1) hydrogel to protect the tail; the outer layer uses pullulan + 0.5% propolis to resist oxidation and prevent moisture.

[0008] Compared with the prior art, the present invention has the following beneficial effects: This immune homeostasis-regulating cartilage repair complex nutrient can scavenge free radicals, cleanse the intestines, regulate immunity, regulate congestion and blood circulation, replenish calcium ions and high-quality multi-level nutrients, and repair damaged cartilage tissue and skeletal system. Multi-target synergistic mechanism: Dual-axis formula—— Immune regulation axis: Yeast β-glucan (Toll receptor activation) coupled with angelica-roxburghii (downregulation of TNF-α / IL-1β) reduces the pro-inflammatory factor IL-6; Matrix repair axis: non-denatured type II collagen (antigen-specific tolerance) combined with AKG (activation of the HIF pathway) to enhance the activity of collagen synthase (LOXL2); Active preservation process: Dynamic fluidized bed low-temperature granulation combined with liposome encapsulation; The gastric-enteric double coating increases the intestinal release rate of earthworm protein to 80%; Metabolic Boosting Design: L-aspartic acid calcium forms a chelated calcium carrier with VD3, and its absorption rate is higher than that of calcium carbonate; Selenomethionine in selenium-enriched malt powder eliminates free radicals in the joint cavity through the GPx4 pathway. DETAILED DESCRIPTION

[0009] The following embodiments of the present invention are described in detail. Unless otherwise specified, the raw materials and equipment used are commercially available or commonly used in the art. The methods in the embodiments, unless otherwise specified, are conventional methods in the art. The following embodiments are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0010] Preparation of immune homeostasis-regulating cartilage repair complex nutrients 1. Raw material pretreatment 1. Treatment of heat-sensitive components (taurine / AKG / β-glucan) -30℃ Frozen Crushing: Liquid nitrogen pre-cools the crushing chamber to -50°C, and maintains -30°C ± 2°C after feeding; The material is crushed under nitrogen protection (oxygen content ≤ 0.5%) and the material temperature is monitored in real time (thermocouple alarm threshold > -25°C).

[0011] After passing through an 80-mesh sieve, it is transported to a transfer tank via a vacuum feeder (the tank is filled with nitrogen, with a positive pressure of 0.05 MPa).

[0012] 2. Treatment with Chinese herbal extracts (Angelica / Turmeric / Polygonatum) Supercritical CO2 extraction, pressure 25MPa, 45°C, nanoliposome encapsulation: Entrainer: 5% anhydrous ethanol (to increase the yield of Polygonatum sibiricum polysaccharide); The pressure of separation kettle I is 6 MPa (collecting fat-soluble components), and the pressure of separation kettle II is 2 MPa (collecting polar components).

[0013] Nanoliposome encapsulation: Rehydration solution formula: PBS buffer (pH 7.0) containing 0.1% trehalose (lyophilization protective agent); Freeze-drying after encapsulation: pre-freeze at -40℃ for 4h → vacuum sublimation (25℃ / 10Pa) → moisture ≤3%.

[0014] 3. Protein premix (premix of non-denatured type II collagen + colostrum alkaline protein and soluble soybean polysaccharides) Electrostatic coating process: Mixing equipment: conical mixer (inclination angle 45°); Add the materials in steps: first add non-denatured type II collagen (mix at low speed 15 rpm for 3 minutes), then spray in 5% soybean polysaccharide solution (atomization pressure 0.4 MPa), and finally add colostrum basic protein (mix for 10 minutes).

[0015] 4. Preparation of hydrophobic microemulsion (VD3 and β-carotene dissolved in MCT oil (40°C) to form a microemulsion (HLB value = 12)) Vitamin D3 and β-carotene were dissolved in MCT oil (40°C) to prepare a microemulsion (HLB value = 12).

[0016] High shear emulsification parameters: Primary emulsification: 10,000 rpm / 3 min (coarse emulsion); secondary homogenization: 40 MPa pressure / 3 cycles (particle size detection: Malvern laser diffractometer).

[0017] 2. Module Mixing 1. Mineral-fiber base: Calcium L-aspartate, selenium-enriched malt powder, and pregelatinized konjac flour were dry-mixed in a gravity mixer for 15 min at 20 rpm; the mixture was passed through a 60-mesh sieve and subjected to strong magnetic iron removal.

[0018] Pregelatinized konjac flour operation: First add purified water (material-water ratio 1:5) into the colloidation tank, stir at 70℃ until a transparent colloid is obtained, and spray dry (inlet air 180℃ / outlet air 85℃).

[0019] Iron removal standard: The distance between strong magnetic bars is ≤10cm, the processing capacity of each batch is ≤20kg, and automatic alarm will be given when magnetic force attenuates.

[0020] 2. Protein peptide active group: marine fish oligopeptides, bovine collagen peptides, earthworm protein, colostrum alkaline protein powder, step-by-step addition of targeted protective agents (0.5% anti-bitter peptide + PEG4000), fluidized bed bottom spray embedding (inlet air temperature 40°C, atomization pressure 0.8MPa).

[0021] Targeted protective agent preparation: Anti-bitter peptide (cyclodextrin derivative) and PEG4000 were pre-dissolved in 40°C pure water at a ratio of 1:2.

[0022] Fluidized bed bottom spraying operation: Start the machine and preheat to 40℃, add 50% protein peptide base material, spray the protective agent solution, fluidize and dry for 10 minutes, add the remaining protein peptide, and spray embed for the second time.

[0023] 3. Functional excipient group: sodium hyaluronate, AKG, roxburghii powder, citric acid, dissolved in 5% xylitol solution, ultrasonic-assisted dissolution, 40 kHz, 15 min.

[0024] Ultrasonic dissolution enhancement: The diameter of the horn is Φ25mm, the power density is 80W / cm², and the distance between the probe and the liquid surface is fixed at 5cm.

[0025] Sterile filtration system: Titanium alloy filter housing (0.22μm PVDF membrane), pipeline online sterilization (SIP 121℃ / 30min).

[0026] 3. Dynamic fluidized bed granulation The mineral-fiber base material is put into the fluidized bed, the inlet air temperature is 35℃, and nitrogen protection is turned on; 1. Fluidized bed parameter calibration 2. Three-gun coordinated spray strategy Three-way spraying: spray gun 1: functional excipient group solution, atomized particle size 40-60μm; spray gun 2: protein peptide active group embedded particles, simultaneously sprayed with anti-caking agent silicon dioxide 0.2%; spray gun 3: traditional Chinese medicine liposome suspension, VD3 microemulsion; 0-5min: Only spray gun 1 works (functional excipient solution, wetting base material); 5-15min: Spray gun 1 and spray gun 2 work (add protein particles simultaneously); 15-25min: Three shots in full (introduction of traditional Chinese medicine / Vd3 active ingredients).

[0027] 3. Dual system for endpoint determination: Temperature determination: The temperature difference of the thermocouples at 6 points in the bed is ≤1°C; Moisture determination: Near-infrared probe (wavelength 1940nm) scans every 30s, and the error compared with the oven method is ≤0.2%.

[0028] 4. Final Mixing and Coating Three-dimensional mixing activation: add β-glucan, taurine, sucralose, and nisin, rotate / revolve the mixer at 15 / 35 rpm for 20 min, and monitor the homogeneity using near-infrared online monitoring (RSD) ≤ 3%; Pre-dispersion before mixing: β-glucan and sucralose were mixed three times in equal increments; Mixing parameters: The orbital axis is tilted at 30° to produce a vortex convection effect; Uniformity verification: sampling every 5 minutes, HPLC detection of taurine RSD ≤ 3.0%.

[0029] Anti-static measures: Mixing tank grounding resistance ≤ 4Ω; Add 0.1% food grade antistatic agent (glyceryl monostearate).

[0030] Mixing uniformity verification: Sampling points: 3 points each in the upper / middle / lower layers; HPLC was used to measure the sucralose content; RSD ≤ 2.5%.

[0031] Double-layer coating precise control: Inner layer: chitosan-sodium alginate solution (1:1, 2% concentration), spray rate 15ml / min, inlet air temperature 40℃, weight gain 2.0%±0.3%; Outer layer: pullulan solution (8%) + 0.5% propolis; gradient drying: 45℃→35℃ (to prevent cracking), weight gain 3.0%±0.5%.

[0032] Although the embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations may be made to the above embodiments without departing from the principles and purpose of the present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. Immune homeostasis regulating cartilage repair complex nutrient, characterized by: By quality, including: 150 parts of L-aspartic acid calcium, 100 parts of purified konjac flour, 80 parts of marine fish oligopeptides, 70 parts of roxburghii powder, 10 parts of taurine, 30 parts of angelica extract, 20 parts of turmeric extract, 20 parts of polygonatum extract, 15 parts of selenium-enriched barley malt powder, 10 parts of yeast B-glucan, 50 parts of bovine collagen peptide powder, 5 parts of sodium hyaluronate, 25 parts of 2-oxoglutaric acid (AKG), 30 parts of earthworm protein, 20 parts of colostrum alkaline protein powder, 40 parts of non-denatured type ‖ collagen, 0.01 parts of vitamin D3, 50 parts of soluble soybean polysaccharides, 5 parts of citric acid, 0.5 parts of nisin, 0.5 parts of B-carotene, and 1 part of sucralose.

2. The preparation process of immune homeostasis regulating cartilage repair compound nutrient, characterized in that: The following steps are involved: S1. Raw material pretreatment Heat-sensitive components: taurine, AKG, VB-glucan, frozen and crushed at -30℃, passed through 80-mesh sieve, temperature ≤15℃, RH ≤45%; Chinese herbal medicine extracts: Angelica sinensis, Curcuma longa, Polygonatum sibiricum, supercritical CO2 extraction, pressure 25MPa, 45℃, nanoliposome encapsulation; Protein: premix of non-denatured type II collagen, colostrum basic protein and soluble soybean polysaccharide; Hydrophobic ingredients: Vitamin D3 and β-carotene, dissolved in MCT oil (40°C) to make a microemulsion (HLB value = 12); S2. Module mixing Mineral-fiber base: calcium L-aspartate, selenium-enriched malt powder, and pregelatinized konjac flour were dry-mixed in a gravity mixer for 15 minutes at 20 rpm; then passed through a 60-mesh sieve with a strong magnetic iron remover. Protein peptide active group: marine fish oligopeptides, bovine collagen peptides, earthworm protein, colostrum alkaline protein powder, step-by-step addition of targeted protective agent (0.5% anti-bitter peptide + PEG4000), fluidized bed bottom spray embedding (inlet air temperature 40°C, atomization pressure 0.8MPa); Functional excipient group: sodium hyaluronate, AKG, roxburghii powder, citric acid, dissolved in 5% xylitol solution, ultrasonic-assisted dissolution, 40kHz, 15min; S3. Dynamic fluidization integrated granulation The mineral-fiber base material is put into the fluidized bed, the inlet air temperature is 35℃, and nitrogen protection is turned on; Three-way spraying: spray gun 1: functional excipient group solution, atomized particle size 40-60μm; spray gun 2: protein peptide active group embedded particles, simultaneously sprayed with anti-caking agent silicon dioxide 0.2%; spray gun 3: traditional Chinese medicine liposome suspension, VD3 microemulsion; Granulation and drying integration: Spray speed: 120ml / min; Fluidizing air speed: 1.2m³ / s; End point determination: Material temperature rises to 42℃±1℃, moisture ≤4.5%; S4. Intelligent final mixing and coating Three-dimensional mixing activation: add β-glucan, taurine, sucralose, and nisin, rotate / revolve the mixer at 15 / 35 rpm for 20 min, and monitor the homogeneity using near-infrared online monitoring (RSD) ≤ 3%; Dual functional coating: the inner layer uses chitosan-sodium alginate (1:1) hydrogel to protect the tail; the outer layer uses pullulan + 0.5% propolis to resist oxidation and prevent moisture.

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