Anti-aging seabuckthorn proanthocyanidin compound preparation and preparation method thereof

Abstract

This invention relates to the field of anti-aging functional food technology, specifically to a sea buckthorn proanthocyanidin anti-aging compound preparation and its preparation method; comprising sea buckthorn proanthocyanidin powder and food-acceptable excipients; the method includes: selecting defatted sea buckthorn seed meal; extracting the defatted sea buckthorn seed meal to obtain an extract mixture; separating and filtering the extract mixture to remove solid residues to obtain an extract; concentrating the extract under low temperature and reduced pressure to obtain a high-concentration concentrate; transferring the sterilized concentrate to a clean operating area for drying to obtain sea buckthorn proanthocyanidin powder; thoroughly mixing the sea buckthorn proanthocyanidin powder and food-acceptable excipients; molding the compound powder material; conducting physicochemical index testing on the semi-finished preparation, then performing metal detection and foreign object control; and finally sealing and storing the finished product after packaging, thereby enhancing the anti-aging intervention effect of sea buckthorn proanthocyanidin-based anti-aging functional foods.

Description

Technical Field

[0001] This invention relates to the field of anti-aging functional food technology, and in particular to a sea buckthorn proanthocyanidin anti-aging compound preparation and its preparation method. Background Technology

[0002] Aging is a biological process in which the functions of tissues and cells gradually decline over time. Mitochondrial dysfunction and telomere loss are the two core driving factors mediating cellular senescence. As the center of cellular energy metabolism, impaired mitochondria lead to decreased ATP synthesis, release of large amounts of reactive oxygen species, and exacerbation of oxidative damage to cells. Telomeres shorten continuously with cell division, and insufficient telomerase activity directly triggers replicative cellular senescence. The mitochondrial-telomere axis has a close regulatory relationship with each other.

[0003] Seabuckthorn seed meal is an agricultural and forestry byproduct produced after seabuckthorn fruit is pressed for oil. It contains abundant proanthocyanidins, which have antioxidant activity and are an excellent raw material for preparing anti-aging functional foods.

[0004] However, existing anti-aging functional foods, when developing products related to sea buckthorn proanthocyanidins, only utilize the single antioxidant pathway of scavenging free radicals, failing to integrate and develop the dual anti-aging intervention mechanism of sea buckthorn proanthocyanidins, namely mitochondrial enhancement and telomerase activation. As a result, the anti-aging potential of sea buckthorn proanthocyanidins is not fully released, and the anti-aging intervention effect of the products is limited. Summary of the Invention

[0005] The purpose of this invention is to provide a compound anti-aging preparation of sea buckthorn proanthocyanidins and its preparation method. This invention solves the problem that existing anti-aging functional foods, when developing sea buckthorn proanthocyanidins-related products, only utilize the single antioxidant pathway of sea buckthorn proanthocyanidins to scavenge free radicals, failing to integrate and develop the dual anti-aging intervention mechanisms of mitochondrial enhancement and telomerase activation possessed by sea buckthorn proanthocyanidins. As a result, the anti-aging potential of sea buckthorn proanthocyanidins is not fully released, and the anti-aging intervention effect of the products is limited.

[0006] To achieve the above objectives, the present invention employs a sea buckthorn proanthocyanidin anti-aging compound preparation comprising the following raw materials in parts by weight: 20-90 parts sea buckthorn proanthocyanidin powder and 10-80 parts food-acceptable excipients; wherein the food-acceptable excipients are selected from one or more of maltodextrin, fructooligosaccharides, erythritol, microcrystalline cellulose, and magnesium stearate.

[0007] This invention also provides a method for preparing a sea buckthorn proanthocyanidin anti-aging compound preparation, comprising the following steps: The raw materials for sea buckthorn seed meal are inspected upon arrival at the factory. Unqualified raw materials are removed, and the qualified sea buckthorn seed meal is degreased to obtain degreased sea buckthorn seed meal material. Edible alcohol was selected as the extraction solvent to extract defatted sea buckthorn seed meal, fully dissolving the proanthocyanidin active substances in the sea buckthorn seed meal and releasing the extraction mixture. The solid residue of the extraction mixture is removed by solid-liquid separation and filtration to obtain the extract. The extract is then concentrated under low temperature and reduced pressure to obtain a high-concentration concentrate, and the concentrate is then subjected to heat sterilization. After sterilization, the concentrated liquid is transferred to a clean operating area for drying. Then, it is sieved and graded by a vibrating screen to remove large clumps and obtain sea buckthorn proanthocyanidin powder with uniform particle size. Weigh out the sea buckthorn proanthocyanidin powder and food-acceptable excipients separately, put them into a mixing device and mix thoroughly to obtain a homogeneous mixture. The composite powder material is shaped and processed, the powder is packaged in inner bags, the granules are granulated and sized, the tablets are dry-compressed, and the hard capsules are filled to obtain the finished pharmaceutical preparation material with inner packaging. The semi-finished formulation is tested for physicochemical properties, then metal detection and foreign object control are carried out, and finally it is sealed and stored in the warehouse after the outer packaging is completed.

[0008] Furthermore, in the process of inspecting the seabuckthorn seed meal raw materials upon arrival at the factory, removing unqualified raw materials, and then defatting the qualified seabuckthorn seed meal to obtain defatted seabuckthorn seed meal material, Collect batches of sea buckthorn seed meal raw material samples and test the raw material sensory properties, impurities, moisture ≤10%, and acid value ≤5mg / g according to CCP key control points; Remove substandard sea buckthorn seed meal that is moldy or contains excessive impurities; Qualified sea buckthorn seed meal is degreased using solvent at a temperature of 45-55℃ for 2-3 hours.

[0009] Furthermore, in the step of selecting edible alcohol as the extraction solvent to extract defatted sea buckthorn seed meal, fully dissolving the proanthocyanidin active substances in the sea buckthorn seed meal and releasing the extraction mixture, Prepare an extraction solvent with a volume fraction of 60-70% edible alcohol; Defatted sea buckthorn seed meal and edible alcohol are added to the extraction tank at a solid-liquid ratio of 1:8 to 1:12. The extraction temperature is 50 to 60°C, and the extraction is carried out 2 to 3 times, with each extraction lasting 1.5 to 2 hours. After the extraction is complete, all the extracted mixture is drained from the tank.

[0010] Furthermore, in the steps of separating the solid and liquid components of the extraction mixture by filtration to remove solid residues and obtain an extract, concentrating the extract under low temperature and reduced pressure to obtain a high-concentration concentrate, and then subjecting the concentrate to heat sterilization, Plate and frame filtration is used to separate the solid and liquid components of the extracted mixture, with a filtration precision of 80-100 mesh, to remove solid residues from the seed meal. The obtained extract was sent to a vacuum concentration tank and concentrated at a temperature of 55~65℃ and a vacuum degree of -0.06~-0.08MPa until the relative density of the liquid was 1.10~1.20. Pasteurization is used at a temperature of 80-85℃ and a holding time of 15-20 minutes.

[0011] Furthermore, in the step of transferring the sterilized concentrated liquid to a clean operating area for drying, and then sieving and classifying it through a vibrating screen to remove large agglomerates, uniformly sized sea buckthorn proanthocyanidin powder, The sterilized concentrated liquid is transported to the Class 10,000 clean area; The spray drying process is adopted, with an inlet air temperature of 160~170℃ and an outlet air temperature of 75~85℃ for drying. The dried powder is screened and classified using an 80-100 mesh vibrating screen to remove large agglomerated particles and collect the undersized powder material.

[0012] Furthermore, in the step of separately weighing sea buckthorn proanthocyanidin powder and food-acceptable excipients, and then thoroughly mixing them in a mixing device to obtain a homogeneous mixture, Weigh out the sea buckthorn proanthocyanidin powder and food-acceptable excipients according to the formula mass proportions, wherein the sea buckthorn proanthocyanidin powder is 20-90 parts and the food-acceptable excipients are 10-80 parts. The food-acceptable excipients are selected from one or more of maltodextrin, fructooligosaccharides, erythritol, microcrystalline cellulose, and magnesium stearate. Put all materials into the three-dimensional motion mixer, set the mixing speed to 20~30 r / min, and mix continuously for 15~25 min.

[0013] Furthermore, in the steps of molding and processing the composite powder material, dispensing the powder into inner bags, granulating and sizing the granules, dry compressing the tablets, and filling the hard capsules to obtain the finished pharmaceutical preparation material with inner packaging, The powder is packaged into inner bags using an automatic dispensing machine, with each bag containing 1-5g. When preparing granules, add an appropriate amount of purified water for granulation and use a 14-20 mesh sieve for granulation. The tablets are prepared by dry compression, with a single tablet weighing 0.5~1.0g; To prepare hard capsules, the powder is filled into empty capsules, with a single capsule weighing 0.3~0.6g.

[0014] Furthermore, in the process of conducting physicochemical tests on the semi-finished formulation, controlling for metal foreign matter through detection, and sealing and storing the product after completing the outer packaging, Sampling and testing were conducted on the proanthocyanidin content, moisture, microorganisms, and sensory physicochemical indicators of the finished product. After the indicators are qualified, CCP control is implemented through a metal detector to detect ferrous, non-ferrous and stainless steel foreign objects. After the metal detection is normal, the cardboard box outer packaging operation is carried out. Store the finished product in a sealed warehouse that is protected from light, dry, at a temperature of 10~25℃ and is well-ventilated.

[0015] This invention discloses a sea buckthorn proanthocyanidin anti-aging compound preparation and its preparation method, comprising the following raw materials in parts by weight: 20-90 parts sea buckthorn proanthocyanidin powder and 10-80 parts food-acceptable excipients; wherein the food-acceptable excipients are selected from one or more of maltodextrin, fructooligosaccharides, erythritol, microcrystalline cellulose, and magnesium stearate, and the following steps are adopted: raw material inspection upon arrival at the factory is carried out on sea buckthorn seed meal, unqualified raw materials are removed, and the qualified sea buckthorn seed meal is defatted to obtain defatted sea buckthorn seed meal material; edible alcohol is selected as the extraction solvent to extract the defatted sea buckthorn seed meal, fully dissolving the proanthocyanidin active substances in the sea buckthorn seed meal and releasing the extraction mixture; the extraction mixture is subjected to solid-liquid separation and filtration to remove solid residues to obtain an extract; the extract is concentrated under low temperature and reduced pressure to obtain a high-concentration concentrated liquid, and the concentrated liquid is subjected to heat sterilization treatment; the sterilized... The concentrated liquid is then transferred to a clean operating area for drying, and then sieved through a vibrating screen to remove large clumps, resulting in uniformly sized sea buckthorn proanthocyanidin powder. Sea buckthorn proanthocyanidin powder and food-acceptable excipients are weighed separately and added to a mixing device for thorough mixing to obtain a homogeneous mixture. The composite powder material is then shaped and processed: powder is packaged in inner bags, granules are granulated and sized, tablets are dry-compressed, and hard capsules are filled, resulting in a fully packaged formulation. The semi-finished formulation undergoes physicochemical testing, and metal detection and foreign matter control are implemented. After outer packaging, it is sealed and stored in a warehouse. This method fully taps the potential of sea buckthorn proanthocyanidins in mitochondrial enhancement and telomerase activation for dual aging intervention, breaking the limitations of existing products that rely solely on a single antioxidant pathway and enhancing the anti-aging intervention effect of sea buckthorn proanthocyanidin-based anti-aging functional foods. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 This is a flowchart of the preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation of the present invention.

[0018] Figure 2 This is a flowchart of steps S100 of the present invention.

[0019] Figure 3 This is a flowchart of steps S200 of the present invention.

[0020] Figure 4 This is a flowchart of steps S300 of the present invention.

[0021] Figure 5 This is a flowchart of steps S400 of the present invention.

[0022] Figure 6 This is a flowchart of steps S500 of the present invention.

[0023] Figure 7 This is a flowchart of steps S600 of the present invention.

[0024] Figure 8 This is a flowchart of steps S700 of the present invention. Detailed Implementation

[0025] Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0026] This invention provides a sea buckthorn proanthocyanidin anti-aging compound preparation comprising the following raw materials in parts by weight: 20-90 parts sea buckthorn proanthocyanidin powder and 10-80 parts food-acceptable excipients; wherein the food-acceptable excipients are selected from one or more of maltodextrin, fructooligosaccharides, erythritol, microcrystalline cellulose, and magnesium stearate.

[0027] Please see Figures 1 to 8 The present invention also provides a method for preparing a sea buckthorn proanthocyanidin anti-aging compound preparation, comprising the following steps: S100: Conduct incoming raw material inspection of sea buckthorn seed meal, remove unqualified raw materials, and perform degreasing treatment on qualified sea buckthorn seed meal to obtain degreased sea buckthorn seed meal material.

[0028] In this embodiment, the sea buckthorn seed meal raw material undergoes an incoming raw material inspection, rejecting unqualified raw materials, and the qualified sea buckthorn seed meal is subjected to defatting treatment to obtain defatted sea buckthorn seed meal material. The specific process is as follows: S101: Collect batches of sea buckthorn seed meal raw material samples and test the raw material sensory properties, impurities, moisture ≤10%, and acid value ≤5mg / g according to CCP key control points; S102: Remove substandard sea buckthorn seed meal that is moldy or contains excessive impurities; S103: Qualified sea buckthorn seed meal is degreased using solvent at a temperature of 45-55℃ for 2-3 hours.

[0029] In the above process, representative samples were collected from multiple locations at different positions (top, middle, and bottom) of the same batch of sea buckthorn seed meal raw material pile according to the batch sampling rules; the appearance and odor of the samples were checked by manual visual inspection and smelling; the proportion of impurities was determined by sieving and weighing; the moisture content was detected by drying; and the acid value was detected by oil acid value titration. The test results were compared with the CCP critical control point limit indicators for judgment.

[0030] If the sample shows signs of mold, or if any of the indicators of impurities, moisture, or acid value exceeds the CCP critical control point limit, the batch of sea buckthorn seed meal is determined to be unqualified raw material. The entire batch of unqualified raw material is isolated, labeled, and stored separately, and is rejected and returned to the warehouse.

[0031] The qualified seabuckthorn seed meal is put into a defatting kettle, and food-grade defatting solvent is added to immerse the material. The internal temperature of the defatting kettle is controlled to be maintained within the range of 45~55℃, and the defatting process is carried out for 2~3 hours. After defatting, the solvent is separated to remove the residual oil in the seabuckthorn seed meal, and defatted seabuckthorn seed meal material is obtained.

[0032] S200: Edible alcohol is selected as the extraction solvent to extract defatted sea buckthorn seed meal, fully dissolving the proanthocyanidin active substances in the sea buckthorn seed meal and releasing the extraction mixture.

[0033] In this embodiment, edible alcohol is selected as the extraction solvent to extract defatted sea buckthorn seed meal, fully dissolving the proanthocyanidin active substances in the sea buckthorn seed meal and releasing the extraction mixture. The specific process is as follows: S201: Prepare an extraction solvent with a volume fraction of 60-70% edible alcohol; S202: Defatted sea buckthorn seed meal and edible alcohol are added to the extraction tank at a solid-liquid ratio of 1:8~1:12, the extraction temperature is 50~60℃, and the extraction is carried out 2~3 times, with a single extraction time of 1.5~2 hours; S203: After the extraction is completed, all the extracted mixture is discharged from the tank.

[0034] In the above process, food-grade edible alcohol and purified water are selected and mixed according to the volume ratio. The mixture is stirred evenly to prepare an edible alcohol aqueous solution with a volume fraction of 60-70%. After preparation, the volume fraction of alcohol is measured to confirm that the solvent concentration meets the process requirements before use.

[0035] Add defatted seabuckthorn seed meal into a sealed extraction tank, and add prepared edible alcohol extraction solvent at a solid-liquid mass-volume ratio of 1:8 to 1:12; turn on the heating and stirring device of the extraction tank, and stabilize the system temperature at 50 to 60°C for extraction; maintain stirring for 1.5 to 2 hours for each extraction, separate the liquid after extraction, and repeat the above feeding-heating extraction operation a total of 2 to 3 times, and combine the liquids obtained from each extraction.

[0036] After all extraction cycles are completed, open the discharge valve at the bottom of the extraction tank to discharge the entire mixture containing sea buckthorn seed meal solid residue and proanthocyanidin extract, and then transport it to the next process equipment.

[0037] S300: The solid mixture is separated and filtered to remove solid residues to obtain an extract. The extract is then concentrated under low temperature and reduced pressure to obtain a high-concentration concentrate, which is then subjected to thermal sterilization.

[0038] In this embodiment, the extraction mixture is subjected to solid-liquid separation and filtration to remove solid residues, resulting in an extract. The extract is then concentrated under low temperature and reduced pressure to obtain a high-concentration concentrate, which is then subjected to thermal sterilization. The specific process is as follows: S301: Plate and frame filtration is used to separate the solid and liquid components of the extracted mixture, with a filtration accuracy of 80~100 mesh, to remove solid residues from the seed meal; S302: The obtained extract is sent to a vacuum concentration tank and concentrated at a temperature of 55~65℃ and a vacuum degree of -0.06~-0.08MPa until the relative density of the liquid is 1.10~1.20. S303: Pasteurization is performed at a temperature of 80-85℃ for 15-20 minutes.

[0039] In the above process, a plate and frame filter press equipped with 80-100 mesh filter cloth is selected. The extracted mixture is pumped into the feed inlet of the plate and frame filter press. The solid-liquid separation is achieved by relying on pressure to drive the liquid through the filter cloth. The solid residue of sea buckthorn seed meal is trapped on one side of the filter cloth, and the filtrate is collected in the filtrate storage tank through the filter cloth. After the filtration operation is completed, the solid residue of seed meal trapped inside the plate and frame filter press is cleaned to ensure smooth flow of subsequent liquid.

[0040] The extract collected by plate and frame filtration is transferred to a vacuum concentration tank. The vacuum system is turned on to maintain the vacuum level in the tank at -0.06 to -0.08 MPa. At the same time, the heating system is turned on to control the temperature of the liquid to be stable at 55 to 65°C for vacuum evaporation to remove the solvent. During the concentration process, the relative density of the liquid is sampled and tested at regular intervals. When the relative density of the liquid reaches the range of 1.10 to 1.20, the concentration operation is stopped to obtain a high-concentration proanthocyanidin concentrate.

[0041] The concentrated liquid is transported to the pasteurization equipment for heat exchange and heating, so that the overall temperature of the liquid reaches 80~85℃, and is maintained at this temperature range for 15~20 minutes. After the heat preservation and sterilization is completed, the liquid is cooled appropriately to kill the microorganisms in the liquid, and the sterilized concentrated liquid is obtained and transported to the next process.

[0042] S400: The sterilized concentrated liquid is transferred to a clean operating area for drying, and then sieved and graded by a vibrating screen to remove large clumps and particles, thus obtaining sea buckthorn proanthocyanidin powder with uniform particle size.

[0043] In this embodiment, the sterilized concentrated liquid is transferred to a clean operating area for drying, and then sieved and graded by a vibrating screen to remove large agglomerates, thus obtaining sea buckthorn proanthocyanidin powder with uniform particle size. The specific process is as follows: S401: Transport the sterilized concentrated liquid to a Class 10,000 clean area; S402: Spray drying process is used, with an inlet air temperature of 160~170℃ and an outlet air temperature of 75~85℃ for drying. S403: The dried powder is screened and classified using an 80-100 mesh vibrating screen to remove large agglomerated particles and collect the undersize powder.

[0044] During the above process, the pasteurized concentrated liquid is transported into the Class 10,000 cleanroom through a closed pipeline. The cleanroom has undergone air purification and environmental disinfection in advance to ensure that the dust particles and microbial indicators in the area meet the Class 10,000 cleanliness requirements. The liquid is transported in a closed system throughout the process to avoid secondary pollution of the liquid by the external environment.

[0045] The sterilized concentrated liquid is fed into the feeding system of the spray dryer. The hot air inlet temperature is controlled to be stable at 160~170℃, and the feeding rate is adjusted to maintain the drying tower outlet temperature at 75~85℃. The liquid is atomized by the atomizer to form fine droplets, which come into full contact with the high-temperature hot air and are quickly dehydrated. The droplets are converted into solid powder, and the powder settles and is collected in the bottom collection device of the spray dryer.

[0046] The powder collected by spray drying is fed into a vibrating screen equipped with an 80-100 mesh screen. The vibrating motor is started to make the screen body vibrate continuously. The powder with lumps and larger particles is trapped above the screen, while qualified fine particles fall through the screen. The powder material that passes through the screen is collected, which is the sea buckthorn proanthocyanidin powder with uniform particle size. The lumpy material on the screen is disposed of as waste.

[0047] S500: Weigh the sea buckthorn proanthocyanidin powder and food-acceptable excipients separately, put them into the mixing equipment and mix them thoroughly to obtain a uniform mixture.

[0048] In this embodiment, sea buckthorn proanthocyanidin powder and food-acceptable excipients are weighed separately, put into a mixing device and thoroughly stirred to obtain a homogeneous mixture. The specific process is as follows: S501: Weigh out sea buckthorn proanthocyanidin powder and food-acceptable excipients according to the formula mass parts, wherein the sea buckthorn proanthocyanidin powder is 20-90 parts and the food-acceptable excipients are 10-80 parts. The food-acceptable excipients are selected from one or more of maltodextrin, fructooligosaccharides, erythritol, microcrystalline cellulose, and magnesium stearate. S502: Put all materials into the three-dimensional motion mixer, set the mixing speed to 20~30 r / min, and mix continuously for 15~25 min.

[0049] In the above process, according to the preset formula ratio, in a clean environment, use an electronic scale to weigh sea buckthorn proanthocyanidin powder and one or more food-acceptable excipients. The weighing range of sea buckthorn proanthocyanidin powder is controlled at 20~90 parts by weight, and the weighing range of food-acceptable excipients is controlled at 10~80 parts by weight. After weighing, check the material name and weighing mass to confirm that the material type and the amount of material added meet the formula requirements, and avoid incorrect or missing materials.

[0050] Add the weighed and verified sea buckthorn proanthocyanidin powder and all food-acceptable excipients into the drum of the three-dimensional motion mixer, and close the mixer cover; start the equipment, adjust the mixing speed to 20~30 r / min, and the equipment performs three-dimensional reciprocating oscillation mixing for 15~25 minutes; after mixing is completed, stop the machine and release the mixed powder material from the discharge port to ensure that the active ingredients of sea buckthorn proanthocyanidins and excipients are evenly distributed.

[0051] S600: The process involves molding and processing composite powder materials, dispensing powders into inner bags, granulating and sizing granules, dry compressing tablets, and filling hard capsules to obtain the finished pharmaceutical preparation materials with inner packaging.

[0052] In this embodiment, the composite powder material is shaped and processed, the powder is packaged in inner bags, the granules are granulated and sized, the tablets are dry-compressed, and the hard capsules are filled to obtain the finished pharmaceutical preparation material with inner packaging. The specific process is as follows: S601: The powder is packaged into inner bags using an automatic dispensing machine, with a single bag containing 1~5g; S602: When preparing granules, add an appropriate amount of purified water for granulation and use a 14-20 mesh sieve for granulation. S603: Tablets are prepared by dry compression, with a single tablet weighing 0.5~1.0g; S604: Preparation of hard capsules: Fill empty capsules with powder, with a single capsule weight of 0.3~0.6g.

[0053] In the above process, within a Class 10,000 clean area, the mixed composite powder material is fed into the hopper of an automatic dispensing machine, and the equipment filling parameters are set to 1~5g / bag. The equipment automatically completes bag feeding, metering filling, and heat sealing operations. During the dispensing process, the filling amount inside the bag is checked at regular intervals to ensure that the weight of each bag of powder is controlled within the range of 1~5g, thus obtaining the powder inner packaging material.

[0054] Take a uniformly mixed composite powder and place it in a wet granulator. While stirring, slowly add an appropriate amount of purified water as a wetting agent and stir to prepare a soft material. Extrude the soft material through a 14-20 mesh sieve to obtain wet granules. After drying the wet granules to remove moisture, use a 14-20 mesh sieve again for granulation to remove long strips and agglomerated particles and collect dry granules with uniform particle size.

[0055] The mixed compound powder is directly fed into the hopper of the dry tableting machine. The tableting machine mold and pressure parameters are adjusted, and the weight of a single tablet is set to be controlled between 0.5 and 1.0 g. The powder is filled into the mold hole by the feeding mechanism and pressed into tablets by the upper and lower punches. During the production process, the tablet weight is sampled and tested at intervals, and unqualified tablets with excessive weight are rejected.

[0056] Under Class 10,000 cleanroom conditions, the composite powder material is conveyed to the hopper of the hard capsule filling machine. Food-grade hollow hard capsules are selected, and the filling metering parameters of the filling machine are adjusted to control the powder content of a single capsule to 0.3~0.6g. The equipment sequentially completes capsule cap separation, powder filling, and capsule locking. During the production process, the capsule content is checked at regular intervals, and the filling material of the hard capsule formulation is collected.

[0057] S700: Conduct physicochemical tests on the semi-finished formulation, then perform metal detection and foreign object control, and finally seal and store it in the warehouse after completing the outer packaging.

[0058] In this embodiment, the semi-finished formulation undergoes physicochemical index testing, followed by metal detection and foreign object control. After outer packaging, it is sealed and stored in a warehouse. The specific process is as follows: S701: Sampling and testing of proanthocyanidin content, moisture, microorganisms, and sensory physicochemical indicators in the finished product; After passing the test, S702 performs CCP control through a metal detector to detect ferrous, non-ferrous, and stainless steel foreign objects. After the metal detector detects no abnormalities, cardboard box packaging operations are carried out. S703: Store the finished product in a sealed warehouse in a dark, dry, well-ventilated place at a temperature of 10~25℃.

[0059] In the above process, representative samples were randomly selected from the finished inner packaging materials according to the batch sampling specifications; the color, odor, and appearance of the samples were evaluated by visual inspection and smell; the moisture content was tested by drying method; the proanthocyanidin content in the samples was determined by ultraviolet-visible spectrophotometry; microbiological items were tested according to the food microbiology inspection standards; and all test results were compared with the product quality standards to determine whether the samples were qualified.

[0060] Pharmaceutical materials that pass physicochemical and microbiological testing continuously pass through a metal detector. The CCP (Critical Control Point) settings are as follows: ferromagnetic metals ≥1.5mm, non-ferrous metals ≥2.0mm, and stainless steel ≥2.5mm trigger an alarm and are rejected. The performance of the metal detector is verified every 30-60 minutes during production using a standard test block. After the material is rejected due to the absence of metal foreign objects, the inner packaging finished product is placed into the corresponding cardboard box to complete the outer packaging process. When an alarm occurs, the alarmed product is rejected, and products produced since the last verification are isolated and re-inspected.

[0061] After the finished products have been packaged, they are transferred to the finished product warehouse. The warehouse should be protected from direct sunlight and kept dry and well-ventilated. The warehouse temperature should be maintained at 10~25℃ by manual means or temperature control equipment. The finished products should be stacked away from the ground and walls and stored in a sealed manner. Batch labels should be properly marked to prevent the product's active ingredients from decaying or deteriorating due to changes in light, temperature and humidity.

[0062] The above description discloses only one preferred embodiment of the present invention, and should not be construed as limiting the scope of the present invention. Those skilled in the art will understand that all or part of the processes of the above embodiments can be implemented, and equivalent changes made in accordance with the claims of the present invention are still within the scope of the invention.

Claims

1. A sea buckthorn proanthocyanidin anti-aging compound preparation, characterized in that, The ingredients include the following parts by weight: 20-90 parts of sea buckthorn proanthocyanidin powder and 10-80 parts of food-acceptable excipients; wherein the food-acceptable excipients are selected from one or more of maltodextrin, fructooligosaccharides, erythritol, microcrystalline cellulose, and magnesium stearate.

2. A method for preparing a sea buckthorn proanthocyanidin anti-aging compound preparation, applied to the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, Includes the following steps: The raw materials for sea buckthorn seed meal are inspected upon arrival at the factory. Unqualified raw materials are removed, and the qualified sea buckthorn seed meal is degreased to obtain degreased sea buckthorn seed meal material. Edible alcohol was selected as the extraction solvent to extract defatted sea buckthorn seed meal, fully dissolving the proanthocyanidin active substances in the sea buckthorn seed meal and releasing the extraction mixture. The solid residue of the extraction mixture is removed by solid-liquid separation and filtration to obtain the extract. The extract is then concentrated under low temperature and reduced pressure to obtain a high-concentration concentrate, and the concentrate is then subjected to heat sterilization. After sterilization, the concentrated liquid is transferred to a clean operating area for drying. Then, it is sieved and graded by a vibrating screen to remove large clumps and obtain sea buckthorn proanthocyanidin powder with uniform particle size. Weigh out the sea buckthorn proanthocyanidin powder and food-acceptable excipients separately, put them into a mixing device and mix thoroughly to obtain a homogeneous mixture. The composite powder material is shaped and processed, the powder is packaged in inner bags, the granules are granulated and sized, the tablets are dry-compressed, and the hard capsules are filled to obtain the finished pharmaceutical preparation material with inner packaging. The semi-finished formulation is tested for physicochemical properties, then metal detection and foreign object control are carried out, and finally it is sealed and stored in the warehouse after the outer packaging is completed.

3. The preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, In the process of inspecting incoming sea buckthorn seed meal, removing substandard raw materials, and then defatting the qualified sea buckthorn seed meal to obtain defatted sea buckthorn seed meal material, the following steps are involved. Collect batches of sea buckthorn seed meal raw material samples and test the raw material sensory properties, impurities, moisture ≤10%, and acid value ≤5mg / g according to CCP key control points; Remove substandard sea buckthorn seed meal that is moldy or contains excessive impurities; Qualified sea buckthorn seed meal is degreased using solvent at a temperature of 45-55℃ for 2-3 hours.

4. The preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, In the step of selecting edible alcohol as the extraction solvent to extract defatted sea buckthorn seed meal, fully dissolving the proanthocyanidin active substances in the sea buckthorn seed meal and releasing the extraction mixture,... Prepare an extraction solvent with a volume fraction of 60-70% edible alcohol; Defatted sea buckthorn seed meal and edible alcohol are added to the extraction tank at a solid-liquid ratio of 1:8 to 1:

12. The extraction temperature is 50 to 60°C, and the extraction is carried out 2 to 3 times, with each extraction lasting 1.5 to 2 hours. After the extraction is complete, all the extracted mixture is drained from the tank.

5. The preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, In the steps of separating and filtering the mixture to remove solid residues to obtain the extract, concentrating the extract under low temperature and reduced pressure to obtain a high-concentration concentrate, and then subjecting the concentrate to heat sterilization, Plate and frame filtration is used to separate the solid and liquid components of the extracted mixture, with a filtration precision of 80-100 mesh, to remove solid residues from the seed meal. The obtained extract was sent to a vacuum concentration tank and concentrated at a temperature of 55~65℃ and a vacuum degree of -0.06~-0.08MPa until the relative density of the liquid was 1.10~1.

20. Pasteurization is used at a temperature of 80-85℃ for 15-20 minutes.

6. The preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, In the process of transferring the sterilized concentrated liquid to a clean operating area for drying, and then sieving and classifying it through a vibrating screen to remove large agglomerates, uniformly sized sea buckthorn proanthocyanidin powder, the following steps are followed: The sterilized concentrated liquid is transported to the Class 10,000 clean area; The spray drying process is adopted, with an inlet air temperature of 160~170℃ and an outlet air temperature of 75~85℃ for drying. The dried powder is screened and classified using an 80-100 mesh vibrating screen to remove large agglomerated particles and collect the undersize powder.

7. The preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, In the step of separately weighing sea buckthorn proanthocyanidin powder and food-acceptable excipients, adding them into a mixing device and thoroughly mixing them to obtain a homogeneous mixture,... Weigh out the sea buckthorn proanthocyanidin powder and food-acceptable excipients according to the formula mass proportions, wherein the sea buckthorn proanthocyanidin powder is 20-90 parts and the food-acceptable excipients are 10-80 parts. The food-acceptable excipients are selected from one or more of maltodextrin, fructooligosaccharides, erythritol, microcrystalline cellulose, and magnesium stearate. Put all materials into the three-dimensional motion mixer, set the mixing speed to 20~30 r / min, and mix continuously for 15~25 min.

8. The preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, In the steps of molding and processing composite powder materials, dispensing powders into inner bags, granulating and sizing granules, dry compressing tablets, and filling hard capsules to obtain the finished pharmaceutical preparation material with inner packaging,... The powder is packaged into inner bags using an automatic dispensing machine, with each bag containing 1-5g. When preparing granules, add an appropriate amount of purified water for granulation and use a 14-20 mesh sieve for granulation. The tablets are prepared by dry compression, with a single tablet weighing 0.5~1.0g; To prepare hard capsules, the powder is filled into empty capsules, with a single capsule weighing 0.3~0.6g.

9. The preparation method of the sea buckthorn proanthocyanidin anti-aging compound preparation as described in claim 1, characterized in that, The process involves conducting physicochemical tests on the semi-finished pharmaceutical preparation, controlling for metal contamination, completing outer packaging, and then sealing and storing the product in a warehouse. Sampling and testing were conducted on the proanthocyanidin content, moisture, microorganisms, and sensory physicochemical indicators of the finished product. After the indicators are qualified, CCP control is implemented through a metal detector to detect ferrous, non-ferrous and stainless steel foreign objects. After the metal detection is normal, the cardboard box outer packaging operation is carried out. Store the finished product in a sealed warehouse that is protected from light, dry, at a temperature of 10~25℃ and is well-ventilated.

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