Production process of oral remodeling stem cell product
By using nanoification technology and process optimization in the extraction and preparation of dihydroquercetin, the problems of water solubility and bioavailability of dihydroquercetin are solved, and more efficient drug absorption and more stable drug efficacy are achieved.
Patent Information
- Application Number
- CN202411417253.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-11
- Publication Date
- 2025-03-14
AI Technical Summary
The prior art is difficult to effectively improve the water solubility and bioavailability of dihydroquercetin, and its stability and release rate are poorly controlled.
The oral remodeling stem cell product production process is adopted, and dihydroquercetin is extracted through ultrasonic assisted extraction and water vapor distillation, and its water solubility is improved through nano-treating treatment. The process includes mixing, granulation, drying and capsule filling steps to ensure the stability and quality of the finished product.
The water solubility and bioavailability of dihydroquercetin are significantly improved, controlled release characteristics in the body are achieved, effective duration is enhanced, and preparation costs are reduced.
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Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of fish farming, and in particular to a production process of an oral remodeled stem cell product. Background Art
[0002] Dihydroquercetin is a known flavonoid compound with anti-inflammatory, antioxidant and anti-tumor biological activities; however, its clinical application is limited by its low water solubility and bioavailability. Currently, common methods to improve the water solubility and bioavailability of drugs include preparing microparticles, liposomes and polymer carriers, but these methods are often complex and costly. In addition, traditional methods have failed to effectively solve the problems of poor stability and uncontrollable release rate.
[0003] In this context, developing a new type of dihydroquercetin nanoparticles that can improve its water solubility and bioavailability is a technical problem that technicians in this field urgently need to solve; the application of nanotechnology has shown great potential in drug delivery systems, especially in improving drug stability and controlling drug release. Summary of the invention
[0004] 1. Technical issues to be resolved
[0005] Currently, stem cell therapy has attracted widespread attention as a potential strategy for treating a variety of diseases; however, the application of stem cells usually requires complex in vitro processing and expensive medical facility support; therefore, the development of a convenient oral stem cell therapy preparation can significantly reduce treatment costs and improve patient convenience.
[0006] (II) Technical solution
[0007] To achieve the above-mentioned purpose, the present invention provides the following technical solution: a production process of an oral remodeled stem cell product, comprising the following steps:
[0008] S1. Extraction
[0009] a. Pretreatment: Source of quercetin extract: Dihydroquercetin is extracted from the leaves and roots of quercetin. The plant material of quercetin needs to be cleaned and dried to ensure that there are no impurities and pesticide residues.
[0010] b. Extraction method: Use ultrasonic assisted extraction or steam distillation. The specific operation includes crushing the dried leaves and roots of Psoralea corylifolia into 60-80 mesh, then adding ethanol solvent at a ratio of 1:10 (material to solvent weight ratio), ultrasonic treatment for 30-60 minutes, maintaining the extraction temperature at 40-60℃, and extraction times 3-5 times.
[0011] c. Refining: The extract was concentrated by rotary evaporator under reduced pressure to remove ethanol to obtain a crude extract. The crude extract was then separated and purified by column chromatography using a silica gel column and an eluent of ethyl acetate-ethanol (4:1). The two main peaks of dihydroquercetin were collected by elution, and then concentrated and dried to obtain dihydroquercetin with a purity of at least 98%.
[0012] S2, Mixed:
[0013] a. Raw material preparation: Obtain dihydroquercetin, NMN (β-nicotinamide mononucleotide) and licorice zinc raw materials. NMN and licorice zinc must meet pharmaceutical standards to ensure purity and activity.
[0014] b. Ratio: Dihydroquercetin, NMN and glycyrrhizic zinc are mixed in a specific ratio. The preferred ratio is that dihydroquercetin accounts for 20% of the total mass of the mixture, NMN accounts for 50%, and glycyrrhizic zinc accounts for 30%. According to different needs, the content of dihydroquercetin can be adjusted within the range of 10-30%, NMN within the range of 10-60%, and glycyrrhizic zinc within the range of 10-60%.
[0015] c. Even mixing: Each component must be screened through a 100-mesh screen before mixing. Then pour the screened components into a V-type mixer or high-speed homogenizer for at least 30 minutes to ensure even distribution.
[0016] S3, granulation:
[0017] a. Wet granulation: Add an appropriate amount of binder solution (such as 1-3% hydroxypropyl methylcellulose solution) to the uniformly mixed powder to wet it. The degree of wetting must reach the optimal state required for granule formation.
[0018] b. Granulation: The wet mixture is processed into granules with a diameter of 0.2-0.5 mm by an extruder or a rotary granulator. The particle size should be evenly distributed and the granules should be round and smooth in appearance.
[0019] c. Drying: Place the wet granules in a hot air circulation drying oven at a temperature not exceeding 60°C for 2-4 hours to ensure that the granules are dried to a moisture content of less than 5%.
[0020] S4, filling:
[0021] a. Capsule filling: The dried granules are loaded into an automatic capsule filling machine for standardized filling. The total weight of the granules filled in each capsule is 0.5 grams.
[0022] b. Quality Control: Each batch of capsules is subject to appearance inspection, weight difference detection and dissolution test to ensure that the ingredients in each capsule are uniform and consistent and meet the pharmacopoeia standards.
[0023] Preferably, the purification step comprises testing the purity of dihydroquercetin by high performance liquid chromatography (HPLC) to ensure that the purity is at least 98%.
[0024] Preferably, the method further comprises performing a stability test on dihydroquercetin, wherein the stability test comprises an accelerated aging test and a long-term stability test to ensure that dihydroquercetin maintains chemical and physical stability for at least 24 months under predetermined storage conditions.
[0025] Preferably, the extracted dihydroquercetin is subjected to a nano-processing step to improve its water solubility. The nano-processing includes two main processes: using ultrasonic technology to set the ultrasonic treatment time of the dihydroquercetin suspension to 30 minutes and the frequency to 40kHz; then treating it with a high-pressure homogenizer, wherein the pressure is set to 1500 bar, and a total of 5 cycles.
[0026] Preferably, the method further comprises sealing the treated dihydroquercetin in a specially prepared multi-layer composite material package, wherein the packaging material has excellent moisture-proof, light-proof and antioxidant properties to ensure the long-term stability of the product.
[0027] Preferably, the method further comprises injecting nitrogen into the packaging container before encapsulating the dihydroquercetin to exhaust the air inside the container, and the nitrogen filling amount is controlled to be more than 99% of the container space to ensure that the oxidation reaction caused by oxygen is minimized.
[0028] Preferably, the method further comprises the step of heat-sealing the dihydroquercetin, wherein the heat-sealing temperature is set to 150° C., the pressure is 5 bar, and the heat-sealing time is 2 seconds to ensure the sealing and moisture-proof properties of the package.
[0029] Preferably, the encapsulated dihydroquercetin is stored in an environment with a temperature controlled at 20° C. to 25° C. and a relative humidity controlled at 40% to 50% to further ensure the stability of the product and extend its shelf life.
[0030] (III) Beneficial effects
[0031] Compared with the prior art, the present invention provides a production process for oral remodeled stem cell products, which has the following beneficial effects:
[0032] Improved water solubility: Through nano-sizing, the water solubility of dihydroquercetin is significantly improved, thereby enhancing its absorption and utilization in the body.
[0033] Controlled release properties: Nanoparticles can achieve controlled release in the body, increase the duration of drug efficacy, and reduce side effects.
[0034] Enhanced stability: The preparation process used optimizes the thermal stability and antioxidant stability of dihydroquercetin, extending its shelf life.
[0035] Reduce preparation costs: Compared with traditional drug solubilization technology, the nanotechnology used simplifies the production process and reduces production costs.
[0036] Potential for wide application: The unique properties of nanoparticles give them the potential for application in a variety of products, including pharmaceuticals, health supplements and cosmetics.
[0037] Through these beneficial effects, the present invention not only improves the efficacy and safety of dihydroquercetin, but also provides feasibility for its commercialization and clinical application; these advantages indicate broad market prospects and expansion of application fields, and meet the market demand for efficient and safe drugs. DETAILED DESCRIPTION
[0038] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0039] Embodiment 1:
[0040] A production process for an oral remodeling stem cell product, comprising the following steps: S1, extraction: a. Pretreatment: Source of galactopyran extract: dihydroquercetin is extracted from the leaves and roots of galactopyran; the plant material of galactopyran is washed and dried to ensure that there are no impurities and pesticide residues; b. Extraction method: ultrasonic-assisted extraction or steam distillation is used; the specific operation includes crushing the dried galactopyran leaves and roots into 60 meshes, then adding ethanol solvent at a ratio of 1:10 (material to solvent weight ratio), and ultrasonic treatment for 3 0 minutes, the extraction temperature was maintained at 40°C, and the extraction times were 3 times; c. Refining: the extract was concentrated under reduced pressure by a rotary evaporator to remove ethanol to obtain a crude extract; the crude extract was then separated and purified by column chromatography, wherein the purification step included a purity test of dihydroquercetin by high performance liquid chromatography (HPLC) to ensure that the purity was at least 98%, using a silica gel column and an eluent of ethyl acetate-ethanol (4:1); two main peaks of dihydroquercetin were collected by elution, and then concentrated and dried to obtain dihydroquercetin with a purity of at least 98%.
[0041] S2. Mixing: a. Raw material preparation: obtain dihydroquercetin, NMN (β-nicotinamide mononucleotide) and licorice zinc raw materials; NMN and licorice zinc must meet pharmaceutical standards to ensure purity and activity; b. Proportioning: Mix dihydroquercetin, NMN and licorice zinc in a specific proportion; the preferred ratio is 20% of the total mass of the mixture for dihydroquercetin, 50% for NMN, and 30% for licorice zinc; according to different needs, the content of dihydroquercetin can be adjusted within the range of 10-30%, NMN within the range of 10-60%, and licorice zinc within the range of 10-60%; c. Uniform mixing: Each component must be sieved through 100 mesh before mixing; then pour the sieved components into a V-type mixer or a high-speed homogenizer for a mixing time of not less than 30 minutes to ensure uniform distribution.
[0042] S3. Granulation: a. Wet granulation: Add an appropriate amount of binder solution (such as 1-3% hydroxypropyl methylcellulose solution) to the uniformly mixed powder to make it moist; the degree of moistening must reach the optimal state required for particle forming; b. Granulation: The moist mixture is processed into particles with a diameter of 0.2-0.5 mm through an extruder or a rotary granulator; the particle size should be evenly distributed and the particles should have a round and smooth appearance; c. Drying: Place the wet particles in a hot air circulation drying oven at a drying temperature not exceeding 60°C for 2-4 hours to ensure that the particles are dried to a moisture content of less than 5%.
[0043] S4. Filling: a. Capsule filling: Load the dried granules into the automatic capsule filling machine for standardized filling. The total weight of each capsule filled with granules is 0.5 grams; b. Quality control: Each batch of capsules is subject to appearance inspection, weight difference detection and dissolution test to ensure that the ingredients in each capsule are uniform and consistent and meet the pharmacopoeia standards. Dihydroquercetin is subjected to stability testing, where the stability test includes accelerated aging test and long-term stability test to ensure that dihydroquercetin maintains chemical and physical stability under predetermined storage conditions for at least 24 months. The extracted dihydroquercetin is subjected to nano-processing to improve its water solubility; the nano-processing includes two main processes: using ultrasonic technology to set the ultrasonic treatment time of the dihydroquercetin suspension to 30 minutes and the frequency to 40kHz; followed by processing through a high-pressure homogenizer, where the pressure is set to 1500bar, for a total of 24 cycles. The method further comprises the steps of sealing the treated dihydroquercetin in a special multi-layer composite material package, wherein the packaging material has excellent moisture-proof, light-proof and antioxidant properties to ensure the long-term stability of the product, and further comprises injecting nitrogen into the packaging container before encapsulating the dihydroquercetin to exhaust the air inside the container, wherein the nitrogen filling amount is controlled to be more than 99% of the container space to ensure that the oxidation reaction caused by oxygen is minimized, and further comprises the step of heat-sealing the dihydroquercetin, wherein the heat-sealing temperature is set to 150°C, the pressure is 5 bar, and the heat-sealing time is 2 seconds to ensure the sealing and moisture-proof properties of the package, and storing the packaged dihydroquercetin in an environment controlled at a temperature of 20°C and a relative humidity of 40% to further ensure the stability of the product and extend its shelf life.
[0044] Embodiment 2:
[0045] A production process for an oral remodeling stem cell product, comprising the following steps: S1, extraction: a. Pretreatment: Source of galactopyran extract: dihydroquercetin is extracted from the leaves and roots of galactopyran; the plant material of galactopyran is washed and dried to ensure that there are no impurities and pesticide residues; b. Extraction method: ultrasonic-assisted extraction or steam distillation is used; the specific operation includes crushing the dried galactopyran leaves and roots into 70 meshes, then adding ethanol solvent at a ratio of 1:10 (material to solvent weight ratio), and ultrasonically treating for 4 5 minutes, the extraction temperature is maintained at 50°C, and the extraction times are 4 times; c. Refining: the extract is concentrated under reduced pressure by a rotary evaporator to remove ethanol to obtain a crude extract; the crude extract is then separated and purified by column chromatography, wherein the purification step includes performing a purity test on dihydroquercetin by high performance liquid chromatography (HPLC) to ensure that the purity is at least 98%, using a silica gel column and an eluent of ethyl acetate-ethanol (4:1); two main peaks of dihydroquercetin are collected by elution, and then concentrated and dried to obtain dihydroquercetin with a purity of at least 98%.
[0046] S2. Mixing: a. Raw material preparation: obtain dihydroquercetin, NMN (β-nicotinamide mononucleotide) and licorice zinc raw materials; NMN and licorice zinc must meet pharmaceutical standards to ensure purity and activity; b. Proportioning: Mix dihydroquercetin, NMN and licorice zinc in a specific proportion; the preferred ratio is that dihydroquercetin accounts for 20% of the total mass of the mixture, NMN accounts for 50%, and licorice zinc accounts for 30%; according to different needs, the content of dihydroquercetin can be adjusted within the range of 20%, NMN can be adjusted within the range of 10-60%, and licorice zinc can be adjusted within the range of 35%; c. Uniform mixing: Each component must be sieved through 100 mesh before mixing; then the sieved components are poured into a V-type mixer or a high-speed homogenizer, and the mixing time is not less than 30 minutes to ensure uniform distribution.
[0047] S3. Granulation: a. Wet granulation: Add an appropriate amount of binder solution (such as 1-3% hydroxypropyl methylcellulose solution) to the uniformly mixed powder to make it moist; the degree of moistening must reach the optimal state required for particle forming; b. Granulation: The moist mixture is processed into particles with a diameter of 0.35 mm through an extruder or a rotary granulator; the particle size should be evenly distributed and the particles should have a round and smooth appearance; c. Drying: Place the wet particles in a hot air circulation drying oven at a drying temperature not exceeding 60°C for 3 hours to ensure that the particles are dried to a moisture content of less than 5%.
[0048] S4. Filling: a. Capsule filling: The dried granules are loaded into an automatic capsule filling machine for standardized filling; the total weight of the granules filled in each capsule is 0.5 grams; b. Quality control: Each batch of capsules is subject to appearance inspection, weight difference detection and dissolution test to ensure that the ingredients in each capsule are uniform and consistent and meet the pharmacopoeia standards. The dihydroquercetin is subjected to stability testing, wherein the stability test includes accelerated aging test and long-term stability test to ensure that the dihydroquercetin maintains chemical and physical stability under predetermined storage conditions for at least 24 months. The extracted dihydroquercetin is subjected to nano-processing to improve its water solubility; the nano-processing includes two main processes: using ultrasonic technology to set the ultrasonic treatment time of the dihydroquercetin suspension to 30 minutes and the frequency to 40kHz; and then treating it with a high-pressure homogenizer , wherein the pressure is set to 1500 bar, and the cycle is performed 5 times in total, further comprising a step of sealing the treated dihydroquercetin in a specially prepared multi-layer composite material package, wherein the packaging material has excellent moisture-proof, light-proof and antioxidant properties to ensure the long-term stability of the product, further comprising injecting nitrogen into the packaging container before encapsulating the dihydroquercetin to exhaust the air inside the container, and the nitrogen filling amount is controlled to be more than 99% of the container space to ensure that the oxidation reaction caused by oxygen is minimized, and further comprising the step of heat-sealing the dihydroquercetin, wherein the heat-sealing temperature is set to 150°C, the pressure is 5 bar, and the heat-sealing time is 2 seconds to ensure the sealing and moisture-proof properties of the package, and the encapsulated dihydroquercetin is stored in an environment controlled at a temperature of 23°C and a relative humidity of 45% to further ensure the stability of the product and extend its shelf life.
[0049] Embodiment three:
[0050] A production process for an oral remodeling stem cell product, comprising the following steps: S1, extraction: a. Pretreatment: Source of euphorbia pulverata extract: dihydroquercetin is extracted from the leaves and roots of euphorbia pulverata; the plant material of euphorbia pulverata needs to be cleaned and dried to ensure that there are no impurities and pesticide residues; b. Extraction method: ultrasonic-assisted extraction or steam distillation is used; the specific operation includes crushing the dried euphorbia pulverata leaves and roots into 80 meshes, then adding ethanol solvent at a ratio of 1:10 (material to solvent weight ratio), and ultrasonically treating for 6 0 minutes, the extraction temperature was maintained at 60°C, and the extraction times were 5 times; c. Refining: the extract was concentrated under reduced pressure by a rotary evaporator to remove ethanol to obtain a crude extract; the crude extract was then separated and purified by column chromatography, wherein the purification step included a purity test of dihydroquercetin by high performance liquid chromatography (HPLC) to ensure that the purity was at least 98%, using a silica gel column and an eluent of ethyl acetate-ethanol (4:1); two main peaks of dihydroquercetin were collected by elution, and then concentrated and dried to obtain dihydroquercetin with a purity of at least 98%.
[0051] S2. Mixing: a. Raw material preparation: obtain dihydroquercetin, NMN (β-nicotinamide mononucleotide) and licorice zinc raw materials; NMN and licorice zinc must meet pharmaceutical standards to ensure purity and activity; b. Proportioning: Mix dihydroquercetin, NMN and licorice zinc in a specific proportion; the preferred ratio is that dihydroquercetin accounts for 20% of the total mass of the mixture, NMN accounts for 50%, and licorice zinc accounts for 30%; according to different needs, the content of dihydroquercetin can be adjusted within the range of 30%, NMN can be adjusted within the range of 60%, and licorice zinc can be adjusted within the range of 60%; c. Uniform mixing: Each component must be sieved through 100 mesh before mixing; then the sieved components are poured into a V-type mixer or a high-speed homogenizer, and the mixing time is not less than 30 minutes to ensure uniform distribution.
[0052] S3. Granulation: a. Wet granulation: Add an appropriate amount of binder solution (such as 1-3% hydroxypropyl methylcellulose solution) to the uniformly mixed powder to make it moist; the degree of moistening must reach the optimal state required for particle forming; b. Granulation: The moist mixture is processed into particles with a diameter of 0.5 mm through an extruder or a rotary granulator; the particle size should be evenly distributed and the particles should have a round and smooth appearance; c. Drying: Place the wet particles in a hot air circulation drying oven at a drying temperature not exceeding 60°C for 4 hours to ensure that the particles are dried to a moisture content of less than 5%.
[0053] S4. Filling: a. Capsule filling: The dried granules are loaded into an automatic capsule filling machine for standardized filling; the total weight of the granules filled in each capsule is 0.5 grams; b. Quality control: Each batch of capsules is subject to appearance inspection, weight difference detection and dissolution test to ensure that the ingredients in each capsule are uniform and consistent and meet the pharmacopoeia standards. The dihydroquercetin is subjected to stability testing, wherein the stability test includes accelerated aging test and long-term stability test to ensure that the dihydroquercetin maintains chemical and physical stability under predetermined storage conditions for at least 24 months. The extracted dihydroquercetin is subjected to nano-processing to improve its water solubility; the nano-processing includes two main processes: using ultrasonic technology to set the ultrasonic treatment time of the dihydroquercetin suspension to 30 minutes and the frequency to 40kHz; and then treating it with a high-pressure homogenizer , wherein the pressure is set to 1500 bar, and the cycle is performed 5 times in total, further comprising a step of sealing the treated dihydroquercetin in a specially prepared multi-layer composite material package, wherein the packaging material has excellent moisture-proof, light-proof and antioxidant properties to ensure the long-term stability of the product, further comprising injecting nitrogen into the packaging container before encapsulating the dihydroquercetin to exhaust the air inside the container, and the nitrogen filling amount is controlled to be more than 99% of the container space to ensure that the oxidation reaction caused by oxygen is minimized, and further comprising the step of heat-sealing the dihydroquercetin, wherein the heat-sealing temperature is set to 150°C, the pressure is 5 bar, and the heat-sealing time is 2 seconds to ensure the sealing and moisture-proof properties of the package, and the encapsulated dihydroquercetin is stored in an environment controlled at a temperature of 25°C and a relative humidity of 50% to further ensure the stability of the product and extend its shelf life.
[0054] Process comparison experiment:
[0055] Experimental Project 1: Preparation Efficiency and Quality Evaluation of Dihydroquercetin Nanoparticles
[0056] Objective: To determine the effects of ultrasound, high pressure homogenization, microfluidics, and laser sintering on the particle size and distribution of dihydroquercetin.
[0057] method:
[0058] Dynamic light scattering (DLS) was used to determine the average particle size and distribution of the nanoparticles.
[0059] The particle morphology was observed using a scanning electron microscope (SEM).
[0060] Data table:
[0061]
[0062] Experimental Project 2: Solubility Test
[0063] Objective: To test the improvement of water solubility of nanosized dihydroquercetin.
[0064] method:
[0065] The solubility at different time points was measured by spectrophotometry.
[0066] Data table:
[0067]
[0068] Through this detailed comparison, we can more clearly see the specific effects of different processes on the physical properties and solubility of nanoparticles, thus providing a scientific basis for selecting the most suitable production process. This presentation of data helps researchers evaluate the practical application potential of various technologies.
[0069] It can be seen that the present invention not only improves the efficacy and safety of dihydroquercetin, but also provides feasibility for its commercialization and clinical application. These advantages indicate a broad market prospect and expansion of application fields, and meet the market demand for efficient and safe drugs.
Claims
1. A production process for an oral remodeled stem cell product, characterized in that: The following steps are involved: S1. Extraction: a. Pretreatment: Source of quercetin extract: Dihydroquercetin is extracted from the leaves and roots of quercetin. The plant material of quercetin needs to be cleaned and dried to ensure that there are no impurities and pesticide residues. b. Extraction method: Use ultrasonic assisted extraction or steam distillation. The specific operation includes crushing the dried leaves and roots of Psoralea corylifolia into 60-80 mesh, then adding ethanol solvent at a ratio of 1:10 (material to solvent weight ratio), ultrasonic treatment for 30-60 minutes, maintaining the extraction temperature at 40-60℃, and extraction times 3-5 times. c. Refining: The extract was concentrated by rotary evaporator under reduced pressure to remove ethanol to obtain a crude extract. The crude extract was then separated and purified by column chromatography using a silica gel column and an eluent of ethyl acetate-ethanol (4:1). The two main peaks of dihydroquercetin were collected by elution, and then concentrated and dried to obtain dihydroquercetin with a purity of at least 98%. S2, Mixed: a. Raw material preparation: Obtain dihydroquercetin, NMN (β-nicotinamide mononucleotide) and licorice zinc raw materials. NMN and licorice zinc must meet pharmaceutical standards to ensure purity and activity. b. Ratio: Dihydroquercetin, NMN and glycyrrhizic zinc are mixed in a specific ratio. The preferred ratio is that dihydroquercetin accounts for 20% of the total mass of the mixture, NMN accounts for 50%, and glycyrrhizic zinc accounts for 30%. According to different needs, the content of dihydroquercetin can be adjusted within the range of 10-30%, NMN within the range of 10-60%, and glycyrrhizic zinc within the range of 10-60%. c. Even mixing: Each component must be screened through a 100-mesh screen before mixing. Then pour the screened components into a V-type mixer or high-speed homogenizer for at least 30 minutes to ensure even distribution. S3, granulation: a. Wet granulation: Add an appropriate amount of binder solution (such as 1-3% hydroxypropyl methylcellulose solution) to the uniformly mixed powder to wet it. The degree of wetting must reach the optimal state required for granule formation. b. Granulation: The wet mixture is processed into granules with a diameter of 0.2-0.5 mm by an extruder or a rotary granulator. The particle size should be evenly distributed and the granules should be round and smooth in appearance. c. Drying: Place the wet granules in a hot air circulation drying oven at a temperature not exceeding 60°C for 2-4 hours to ensure that the granules are dried to a moisture content of less than 5%. S4, filling: a. Capsule filling: The dried granules are loaded into an automatic capsule filling machine for standardized filling. The total weight of the granules filled in each capsule is 0.5 grams. b. Quality Control: Each batch of capsules is subject to appearance inspection, weight difference detection and dissolution test to ensure that the ingredients in each capsule are uniform and consistent and meet the pharmacopoeia standards.
2. The production process of an oral remodeled stem cell product according to claim 1, characterized in that: The purification step includes testing the purity of dihydroquercetin by high performance liquid chromatography (HPLC) to ensure that the purity is at least 98%.
3. The production process of an oral remodeled stem cell product according to claim 1, characterized in that: The method further includes performing a stability test on dihydroquercetin, wherein the stability test includes an accelerated aging test and a long-term stability test to ensure that the dihydroquercetin maintains chemical and physical stability for at least 24 months under predetermined storage conditions.
4. The production process of an oral remodeled stem cell product according to claim 1, characterized in that: The extracted dihydroquercetin is subjected to nano-processing to improve its water solubility. The nano-processing includes two main processes: using ultrasonic technology to set the ultrasonic treatment time of the dihydroquercetin suspension to 30 minutes and the frequency to 40kHz; then processing by a high-pressure homogenizer, wherein the pressure is set to 1500bar, and a total of 5 cycles.
5. The production process of an oral remodeled stem cell product according to claim 1, characterized in that: The method further includes sealing the processed dihydroquercetin in a specially prepared multi-layer composite material package, wherein the packaging material has excellent moisture-proof, light-proof and antioxidant properties to ensure the long-term stability of the product.
6. The production process of an oral remodeled stem cell product according to claim 1, characterized in that: The method further includes injecting nitrogen into the packaging container before encapsulating the dihydroquercetin to exhaust the air inside the container, and the nitrogen filling amount is controlled to be more than 99% of the container space to ensure that the oxidation reaction caused by oxygen is minimized.
7. The production process of an oral remodeled stem cell product according to claim 1, characterized in that: The method further includes heat-sealing the dihydroquercetin, wherein the heat-sealing temperature is set to 150° C., the pressure is 5 bar, and the heat-sealing time is 2 seconds to ensure the sealing and moisture-proof properties of the package.
8. The production process of an oral remodeled stem cell product according to claim 1, characterized in that: The encapsulated dihydroquercetin is stored in an environment with a temperature controlled at 20° C. to 25° C. and a relative humidity controlled at 40% to 50% to further ensure the stability of the product and extend its shelf life.