Ginkgo biloba compound preparation based on synergistic protection of blood vessels, mitochondria and neuron axes and preparation method of ginkgo biloba compound preparation

Abstract

The invention relates to the technical field of biological medicine and high-value health food, in particular to a gingko compound preparation based on synergistic protection of blood vessels, mitochondria and neuron axes and a preparation method of the gingko compound preparation based on the synergistic protection of the blood vessels, the mitochondria and the neuron axes. The energy and antioxidant unit comprises coenzyme and astaxanthin; and the nerve and mitochondrial enhancing unit comprises phosphatidylserine and pyrroloquinoline quinone. The three units synergistically cover heart and brain health core links, the extract process retains activity, and easily oxidized components prevent oxidation failure; the preparation process ensures that components are uniform, dosage form parameters are optimized, bioavailability is improved, multiple dosage forms meet different requirements, and product efficiency and applicability are ensured.

Description

Technical Field

[0001] This invention relates to the fields of biomedicine and high-value health food technology, specifically to a ginkgo compound preparation and its preparation method based on the synergistic protection of blood vessels, mitochondria, and neuronal axes. Background Technology

[0002] With the accelerating aging of the global population, age-related health problems such as declining cardiovascular function, cognitive impairment, and metabolic disorders are becoming increasingly prominent, severely impacting people's quality of life and driving a continuous rise in market demand for health supplements in the cardiovascular and cerebrovascular health field. However, current industry technology suffers from significant gaps and limitations, making it difficult to meet consumers' core needs for comprehensive and effective protection.

[0003] While traditional Chinese medicine (TCM) formulas follow the macroscopic principle of "promoting blood circulation and removing blood stasis," and possess certain advantages in improving blood circulation, they suffer from inherent drawbacks such as complex formulations and vague target points, lacking the ability to precisely intervene at the cellular microscopic level. For core age-related issues such as mitochondrial energy depletion and oxidative stress damage, traditional TCM formulas struggle to provide effective solutions and cannot address the root cause of insufficient energy supply to tissue cells; their protective effects are clearly insufficient in terms of specificity and depth.

[0004] In contrast, while single or simple combinations of antioxidants in the modern health supplement industry can focus on the cellular level and play a role in improving mitochondrial function and repairing oxidative damage, these products are often limited to protection at a single level. They lack synergistic support for the macroscopic circulatory system and fail to regulate nerve signal transduction. This one-dimensional protection model makes it difficult for the product's effects to be sustained and comprehensive, and it cannot form a complete protective system.

[0005] More importantly, current technologies often employ a "patchwork" approach, simply layering traditional Chinese medicine ingredients with modern antioxidants. This combination fails to establish organic connections between different systems and neglects to recognize that maintaining cardiovascular and cerebrovascular health depends on a complete functional axis comprised of blood vessels, mitochondria, and neurons. Blood vessels act as channels for nutrient and oxygen transport, mitochondria as cellular energy production factories, and neurons as functional execution terminals; these three are interconnected and mutually influential. Weakness in any link leads to a decline in the overall system's efficiency. Current technologies overlook this core logic, resulting in significant breaks in the protective chain and insufficient synergy between links. This prevents optimization of the entire chain, from delivery to production capacity to functional expression, and fails to meet consumers' demands for comprehensive and efficient cardiovascular and cerebrovascular health and anti-aging protection. Therefore, an innovative formulation strategy that can connect this functional axis and achieve multi-system synergistic protection is urgently needed to fill the gaps in current technologies. Summary of the Invention

[0006] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a Ginkgo biloba compound preparation and its preparation method based on the synergistic protection of blood vessels, mitochondria, and neuronal axons.

[0007] (II) Technical Solution A Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axes, comprising three active ingredients: a vascular function optimization unit, a cellular energy and antioxidant unit, and a neurofunctional and mitochondrial biosynthesis enhancement unit. The components are as follows by weight: the vascular function optimization unit includes 20-60 parts of Ginkgo biloba leaf extract, 20-60 parts of Salvia miltiorrhiza extract, 10-30 parts of Panax quinquefolius extract, 10-30 parts of Astragalus membranaceus extract, and 5-15 parts of Hippophae rhamnoides flavonoids; the cellular energy and antioxidant unit includes 5-10 parts of Coenzyme Q10 and 5-10 parts of Astaxanthin; the neurofunctional and mitochondrial biosynthesis enhancement unit includes 3-5 parts of phosphatidylserine and 0.2-0.3 parts of pyrrolidinequinoline quinone. Among them, the flavonoid content of Ginkgo biloba leaf extract is 24%–30%, with flavonol glycosides accounting for ≥80%, and the lactone content is 5%–7%, with ginkgolide B accounting for ≥40%; the tanshinone IIA in tanshinone extract is ≥0.8%, and salvianolic acid B is ≥5%; the ginsenoside Rg1 in American ginseng extract is ≥2.5%, and Rb1 is ≥2.5%; the phosphatidylserine purity is ≥95%, which can maintain the expression level of PSD95 protein on the postsynaptic membrane of neurons at ≥80%; the pyrroloquinoline quinone purity is ≥99%, which can activate the PGC-1α pathway and promote an increase in mitochondrial DNA copy number at ≥40%.

[0008] Preferably, in the vascular function optimization unit, the weight parts of Ginkgo biloba extract are 35-45 parts, the weight parts of Salvia miltiorrhiza extract are 32-40 parts, the weight parts of American ginseng extract are 18-25 parts, the weight parts of Astragalus membranaceus extract are 15-25 parts, and the weight parts of Hippophae rhamnoides flavonoids are 8-12 parts; in the cellular energy and antioxidant unit, the weight parts of coenzyme Q10 are 7-9 parts and the weight parts of astaxanthin are 6-8 parts; and in the nerve function and mitochondrial biosynthesis enhancement unit, the weight parts of phosphatidylserine are 3.8-4.5 parts and the weight parts of pyrroloquinoline quinone are 0.24-0.28 parts.

[0009] Preferably, the preferred weight ratio of each active ingredient is as follows: 42 parts of Ginkgo biloba extract, 36 parts of Salvia miltiorrhiza extract, 22 parts of Panax quinquefolius extract, 20 parts of Astragalus membranaceus extract, 10 parts of Hippophae rhamnoides flavonoids, 8.5 parts of Coenzyme Q10, 7 parts of Astaxanthin, 4.2 parts of Phosphatidylserine, and 0.26 parts of Pyrroloquinoline quinone.

[0010] Preferably, the danshen extract is prepared into a dry powder by reflux extraction with 70%–80% ethanol; the American ginseng extract is prepared into a dry powder by water extraction at 60–70℃ followed by alcohol precipitation; the astragalus extract is prepared into a dry powder by water extraction at 60–70℃ followed by alcohol precipitation; and the sea buckthorn flavonoids are prepared using supercritical fluid extraction. It is produced by extraction.

[0011] Preferably, in the cell energy and antioxidant unit, coenzyme Q10 is an oil-soluble crystal with a purity ≥98%, and astaxanthin is a cell wall-broken extract of Haematococcus pluvialis with astaxanthin ester ≥90%; when the two are compounded, ascorbate palmitate is added as a stabilizer, and the amount of ascorbate palmitate added is 0.5% to 1% of the total weight of coenzyme Q10 and astaxanthin.

[0012] Preferably, the phosphatidylserine is a soybean phospholipid enzymatic hydrolysis purified product, and is a low molecular weight phospholipid purified by molecular distillation with an average molecular weight of 750-800 Da; the pyrroloquinoline quinone is a colorless crystal prepared by bio-fermentation and purified by HPLC.

[0013] Preferably, the dosage form of the preparation is a soft capsule, an enteric-coated capsule, or a tablet; the contents of the soft capsule contain 10% to 15% medium-chain triglycerides as a dispersion medium; the coating material of the enteric-coated capsule is a mixture of acrylic resin IV and diethyl phthalate in a weight ratio of 9:1, with a coating weight gain of 6% to 7%; the tablet contains 2% to 3% crospovidone as a disintegrant.

[0014] Preferably, the preparation method of the Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons includes the following steps: S1: Weigh all active ingredients precisely according to the weight ratio of any of the above items; Ginkgo biloba extract, Salvia miltiorrhiza extract, and American ginseng extract need to be dried in a vacuum drying oven at 65℃ for 3 hours in advance, and the moisture content of the material after drying should be ≤2%; Sea buckthorn flavonoids, coenzyme Q10, and astaxanthin need to be weighed under the protection of inert gas such as nitrogen or argon to avoid oxidation due to contact with air. S2: Place the weighed active ingredients in a V-type mixer, set the speed to 20 r / min and the mixing time to 25 minutes, and stop the machine every 5 minutes to take a sample to check the mixing uniformity until the relative standard deviation (RSD) of the content of all active ingredients is ≤2.5%, and obtain the active ingredient mixture; S3: Add appropriate excipients according to the target dosage form requirements. If preparing soft capsules, first put the active ingredient mixture and medium-chain triglycerides into a high-speed homogenizer at a weight ratio of 1:1.8, set the speed to 8000-10000 r / min, homogenize for 5-8 minutes, and then compress the capsules. If preparing tablets, first premix the active ingredient mixture and microcrystalline cellulose at a weight ratio of 2:1 for 10 minutes, then add starch, crospovidone, and magnesium stearate, granulate, dry at 70℃ for 3 hours, granulate, and then compress the tablets. After tableting, test the dissolution rate of the tablets after 45 minutes to ensure that the dissolution rate is ≥88%.

[0015] Preferably, in S3, when preparing soft capsules, the capsule material is prepared according to the following weight ratio: gelatin: glycerin: purified water: vitamin E = 1:0.4:1.3:0.002; the capsule material preparation requires first dissolving gelatin and purified water in a water bath at 55-60°C for 30-40 minutes, then adding glycerin and vitamin E and continuing to stir for 20 minutes until clear; the shell thickness of the soft capsule is 0.2-0.22 mm, and the weight of each capsule contents is 500±20 mg; after compression, the soft capsules need to be dried in a ventilated environment at 30-35°C for 12-16 hours.

[0016] Preferably, in S3, when preparing tablets, the specific amounts of excipients are 20-22 parts microcrystalline cellulose, 9-10 parts starch, 2.5 parts crospovidone, and 1 part magnesium stearate. During granulation, starch paste is used as a binder. The premixed materials and binder are fed into a vibrating granulator at a weight ratio of 10:3, and granulation is performed using an 18-mesh sieve. After drying, the wet granules need to be granulated through a 16-mesh sieve. After granulation, tablets are compressed to produce tablets with a weight of 600±30mg per tablet.

[0017] (iii) Beneficial technical effects Compared with existing technologies, the beneficial effects of this invention are: 1. The synergistic effect of multiple extracts in the vascular function optimization unit effectively improves blood circulation, laying a solid foundation for subsequent energy supply and maintenance of nerve function; the combination of components in the cellular energy and antioxidant unit efficiently enhances cellular energy metabolism, strengthens the body's antioxidant capacity, and reduces the impact of oxidative damage on tissue cells; the nerve function and mitochondrial biosynthesis enhancement unit specifically protects the integrity of nerve function, promotes mitochondrial biosynthesis, and further enhances energy supply efficiency. The three form a closed-loop protection, comprehensively covering the core aspects of cardiovascular and cerebrovascular health.

[0018] 2. Each extract is prepared using a proprietary optimized process, effectively preserving the active ingredients. The content and purity of key components meet high standards, ensuring the stability and reliability of the product's efficacy. For some easily oxidized components, inert gas protection and the addition of stabilizers are used during weighing and preparation to prevent oxidation and inactivation, further guaranteeing the product's effectiveness.

[0019] 3. Precise drying, weighing, and mixing processes ensure uniform mixing of all active ingredients, guaranteeing consistency in the composition of each product. Preparation parameters are optimized for different dosage forms, such as the selection of dispersion media for soft capsules and the addition of disintegrants for tablets, improving product bioavailability and user experience. The design of multiple dosage forms also meets the needs of different user groups, enhancing product applicability. Attached Figure Description

[0020] Figure 1 This is a process flow diagram of a Ginkgo biloba compound preparation method based on the synergistic protection of blood vessels, mitochondria, and neuronal axes disclosed in this invention; Figure 2 This is a line graph comparing the increase in PSD95 protein expression level and mitochondrial DNA copy number on the postsynaptic membrane of neurons in the examples and comparative examples; Figure 3 This is a bar chart comparing the oxidative damage inhibition rate, vasodilation rate, and cellular energy metabolism enhancement rate of the examples and comparative examples; Figure 4 This is a bar chart comparing the unit product preparation energy consumption and product qualification rate of the examples and comparative examples. Detailed Implementation

[0021] according to Figures 1 to 4 The specific embodiments of the present invention are as follows: Core raw material specifications Ginkgo biloba extract: According to high performance liquid chromatography, the flavonoid content is 24% to 30%, of which flavonol glycosides account for ≥80%; the lactone content is 5% to 7%, of which ginkgolide B accounts for ≥40%.

[0022] Salvia miltiorrhiza extract: It was prepared into dry powder by reflux extraction with 70% to 80% ethanol. The high performance liquid chromatography analysis showed that tanshinone IIA ≥ 0.8% and salvianolic acid B ≥ 5%.

[0023] American ginseng extract: It is prepared into dry powder by water extraction at 60-70℃ followed by alcohol precipitation. The extract is detected by high performance liquid chromatography and contains ginsenoside Rg1 ≥ 2.5% and ginsenoside Rb1 ≥ 2.5%.

[0024] Astragalus extract: prepared into dry powder by water extraction at 60-70℃ followed by alcohol precipitation. Sea buckthorn flavonoids: using supercritical fluid extraction Prepared by extraction, with a total flavonoid content ≥90%.

[0025] Coenzyme Q10: Oil-soluble crystals, purity ≥98%.

[0026] Astaxanthin: Extract from Haematococcus pluvialis with cell wall disruption, containing ≥90% astaxanthin esters.

[0027] Phosphatidylserine: A low-molecular-weight phospholipid purified by enzymatic hydrolysis of soybean phospholipids and molecular distillation, with an average molecular weight of 750-800 Da and a purity of ≥95%. It can maintain the expression level of PSD95 protein on the postsynaptic membrane of neurons at ≥80%.

[0028] Pyrroloquinoline quinone: a colorless crystal prepared by bio-fermentation and purified by high performance liquid chromatography with a purity of ≥99%, which can activate the PGC-1α pathway and promote an increase in mitochondrial DNA copy number of ≥40%.

[0029] Excipients: Medium-chain triglycerides (food grade), gelatin (pharmaceutical grade), glycerin (pharmaceutical grade), vitamin E (food grade), acrylic resin No. IV (pharmaceutical grade), diethyl phthalate (pharmaceutical grade), microcrystalline cellulose (pharmaceutical grade), starch (pharmaceutical grade), crospovidone (pharmaceutical grade), magnesium stearate (pharmaceutical grade), ascorbyl palmitate (food grade), all conforming to the corresponding industry standards.

[0030] Example 1 Raw material ratio (by weight): Vascular function optimization unit: 20 parts of Ginkgo biloba extract, 20 parts of Salvia miltiorrhiza extract, 10 parts of American ginseng extract, 10 parts of Astragalus membranaceus extract, and 5 parts of sea buckthorn flavonoids; Cellular energy and antioxidant unit: Coenzyme Q10 5 parts, astaxanthin 5 parts, ascorbate palmitate 0.05 parts; Neurofunctional and mitochondrial biosynthesis enhancement unit: 3 parts phosphatidylserine, 0.2 parts pyrroloquinoline quinone; Preparation method: S1. Place Ginkgo biloba extract, Salvia miltiorrhiza extract, American ginseng extract, and Astragalus membranaceus extract in a vacuum drying oven at 65℃ for 3 hours. The moisture content of the dried material should be ≤2%. In this case, the moisture content of the material after drying was 1.5%. In an argon-protected glove box, accurately weigh sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbate palmitate to avoid oxidation due to contact with air. Accurately weigh phosphatidylserine and pyrrolidone for later use.

[0031] S2, add all weighed active ingredients into a V-type mixer, set the speed to 20 r / min, and the mixing time to 25 minutes. Stop the machine at the 5th, 10th, 15th, 20th, and 25th minutes to take samples and check the mixing uniformity. At the 25th minute, the relative standard deviation of the content of all active ingredients is 2.3%, which meets the requirement of relative standard deviation ≤ 2.5%. Stop mixing to obtain the active ingredient mixture.

[0032] S3, Soft Capsule Preparation: Capsule preparation: Weigh out 100g of gelatin, 40g of glycerin, 130g of purified water, and 0.2g of vitamin E according to the weight ratio of gelatin:glycerin:purified water:vitamin E = 1:0.4:1.3:0.002. Add the gelatin and purified water to a 55℃ water bath and stir to dissolve for 30 minutes. Then add the glycerin and vitamin E and continue stirring for 20 minutes until the solution is clear.

[0033] Content preparation: The active ingredient mixture and medium-chain triglycerides were added to a high-speed homogenizer at a weight ratio of 1:1.8, and the speed was set to 8000 r / min for 8 minutes to obtain a homogeneous content.

[0034] Capsule compression and drying: A fully automatic soft capsule compression machine was used, the capsule shell thickness was adjusted to 0.2 mm, and the weight of each capsule contents was controlled at 500±10 mg; after compression, the soft capsules were placed in a 30℃ ventilated drying oven for 16 hours to remove surface moisture.

[0035] Example 2 Raw material ratio (by weight): Vascular function optimization unit: 60 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, 30 parts of American ginseng extract, 30 parts of Astragalus membranaceus extract, and 15 parts of sea buckthorn flavonoids; Cellular energy and antioxidant unit: Coenzyme Q10 10 parts, astaxanthin 10 parts, ascorbate palmitate 0.2 parts; Neurofunctional and mitochondrial biosynthesis enhancement unit: 5 parts phosphatidylserine, 0.3 parts pyrroloquinoline quinone; Tablet excipients: 22 parts microcrystalline cellulose, 10 parts starch, 2.5 parts crospovidone, and 1 part magnesium stearate; Preparation method: S1. Place Ginkgo biloba extract, Salvia miltiorrhiza extract, American ginseng extract, and Astragalus membranaceus extract in a vacuum drying oven at 65℃ for 3 hours. The moisture content of the dried material should be ≤2%. In this case, the moisture content of the material after drying was 1.8%. Under nitrogen protection, accurately weigh sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbyl palmitate to avoid oxidation due to contact with air. Accurately weigh phosphatidylserine, pyrrolidone, and tablet excipients for later use.

[0036] S2, all weighed active ingredients are added to a V-type mixer, the speed is set to 20 r / min, and the mixing time is 25 minutes. Samples are taken at the 5th, 10th, 15th, 20th, and 25th minutes to test the mixing uniformity. At the 22nd minute, the relative standard deviation of the content of all active ingredients is 2.1%, which meets the requirement of relative standard deviation ≤ 2.5%. Mixing is then stopped, and the active ingredient mixture is obtained.

[0037] S3: Tablet preparation: Premix: Add the active ingredient mixture and microcrystalline cellulose to the mixer at a weight ratio of 2:1 and premix for 10 minutes.

[0038] Granulation: Add starch, crospovidone and magnesium stearate to the premixed material, using starch slurry as a binder. The weight ratio of the premixed material to the binder is 10:3. Feed the mixed material into a vibrating granulator and granulate it using an 18-mesh sieve to obtain wet granules.

[0039] Drying and granulation: The wet granules were placed in a drying oven at 70℃ for 3 hours. After drying, the moisture content of the granules was tested and found to be ≤2%. The moisture content of the granules after this drying process met the requirements. Then, they were granulated by passing them through a 16-mesh sieve.

[0040] Tableting: A rotary tableting machine is used to compress the granulated granules into tablets with a weight of 600±20mg per tablet.

[0041] Example 3 Raw material ratio (by weight): Vascular function optimization unit: 35 parts of Ginkgo biloba extract, 32 parts of Salvia miltiorrhiza extract, 18 parts of American ginseng extract, 15 parts of Astragalus membranaceus extract, and 8 parts of sea buckthorn flavonoids; Cellular energy and antioxidant unit: Coenzyme Q10 7 parts, astaxanthin 6 parts, ascorbate palmitate 0.091 parts; Enhancement unit for neural function and mitochondrial biosynthesis: phosphatidylserine 3.8 parts, pyrroloquinoline quinone 0.24 parts; Enteric coating material: 9 parts acrylic resin IV, 1 part diethyl phthalate; Preparation method S1. Ginkgo biloba extract, salvia miltiorrhiza extract, American ginseng extract, and astragalus extract were placed in a vacuum drying oven at 65℃ and dried for 3 hours. The moisture content of the dried materials should be ≤2%. In this case, the moisture content of the materials was 1.6%. In an argon-protected environment, sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbate palmitate were accurately weighed to avoid oxidation due to contact with air. Phosphatidylserine, pyrrolidone, and enteric coating material were accurately weighed for later use.

[0042] S2, add all weighed active ingredients into a V-type mixer, set the speed to 20 r / min, and the mixing time to 25 minutes. Stop the mixer at the 5th, 10th, 15th, 20th, and 25th minutes to take samples and test the mixing uniformity. At the 25th minute, the relative standard deviation of the content of all active ingredients is 1.9%, which meets the requirement of relative standard deviation ≤ 2.5%. Stop mixing to obtain the active ingredient mixture.

[0043] S3: Preparation of enteric-coated capsules: Content preparation: The active ingredient mixture is mixed evenly with a small amount of polyethylene glycol 400, with polyethylene glycol 400 as the dispersion medium, to prepare a content with good flowability.

[0044] Capsule filling: The prepared contents are filled into hard capsules using a capsule filling machine, with each capsule containing 450mg of contents.

[0045] Coating: Acrylic resin IV and diethyl phthalate are mixed and dissolved to prepare a coating solution; a fluidized bed coating machine is used to control the coating weight gain at 6%, the coating temperature at 35℃, and the air velocity at 2m / s to coat the filled hard capsules.

[0046] Example 4 Raw material ratio (by weight): Vascular function optimization unit: 42 parts of Ginkgo biloba extract, 36 parts of Salvia miltiorrhiza extract, 22 parts of Panax quinquefolius extract, 20 parts of Astragalus membranaceus extract, and 10 parts of Hippophae rhamnoides flavonoids; Cellular energy and antioxidant unit: Coenzyme Q10 8.5 parts, astaxanthin 7 parts, ascorbate palmitate 0.116 parts; Enhancement unit for neural function and mitochondrial biosynthesis: phosphatidylserine 4.2 parts, pyrroloquinoline quinone 0.26 parts; Preparation method S1. Ginkgo biloba extract, Salvia miltiorrhiza extract, American ginseng extract, and Astragalus membranaceus extract were dried in a vacuum drying oven at 65℃ for 3 hours. The moisture content of the dried materials should be ≤2%. In this case, the moisture content of the materials was 1.4%. In an argon-protected glove box, sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbate palmitate were accurately weighed to avoid oxidation due to contact with air. The weighing accuracy was controlled within ±0.01g. Phosphatidylserine and pyrrolidone were accurately weighed for later use.

[0047] S2, add all weighed active ingredients into a V-type mixer, set the speed to 20 r / min, and the mixing time to 25 minutes. Stop the machine at the 5th, 10th, 15th, 20th, and 25th minutes to take samples and check the mixing uniformity. At the 20th minute, the relative standard deviation of the content of all active ingredients is 1.7%, which meets the requirement of relative standard deviation ≤ 2.5%. Stop mixing to obtain the active ingredient mixture.

[0048] S3: Soft Capsule Preparation: Capsule preparation: Weigh out 100g of gelatin, 40g of glycerin, 130g of purified water, and 0.2g of vitamin E according to the weight ratio of gelatin:glycerin:purified water:vitamin E = 1:0.4:1.3:0.002. Add the gelatin and purified water to a 58℃ water bath and stir to dissolve for 35 minutes. Then add the glycerin and vitamin E and continue stirring for 20 minutes until the solution is clear. Set aside for later use.

[0049] Content preparation: The active ingredient mixture and medium-chain triglycerides were added to a high-speed homogenizer at a weight ratio of 1:1.8, and the speed was set to 9000 r / min for 6 minutes to obtain a homogeneous content.

[0050] Capsule compression and drying: A fully automatic soft capsule compression machine was used, the capsule shell thickness was adjusted to 0.21 mm, and the weight of each capsule contents was controlled at 500±8 mg; after compression, the soft capsules were placed in a 32℃ ventilated drying oven for 14 hours to remove surface moisture.

[0051] Example 5 Raw material ratio (by weight): Vascular function optimization unit: 45 parts of Ginkgo biloba extract, 40 parts of Salvia miltiorrhiza extract, 25 parts of American ginseng extract, 25 parts of Astragalus membranaceus extract, and 12 parts of Hippophae rhamnoides flavonoids; Cellular energy and antioxidant unit: Coenzyme Q10 9 parts, astaxanthin 8 parts, ascorbate palmitate 0.136 parts; Neurological function and mitochondrial biosynthesis enhancement unit: phosphatidylserine 4.5 parts, pyrroloquinoline quinone 0.28 parts; Tablet excipients: 20 parts microcrystalline cellulose, 9 parts starch, 2.5 parts crospovidone, 1 part magnesium stearate; Preparation method: S1. Ginkgo biloba extract, salvia miltiorrhiza extract, American ginseng extract, and astragalus extract were placed in a vacuum drying oven at 65°C and dried for 3 hours. The moisture content of the dried material should be ≤2%. In this case, the moisture content of the material was 1.7%. Under nitrogen protection, sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbyl palmitate were accurately weighed to avoid oxidation due to contact with air. Phosphatidylserine, pyrrolidone, and tablet excipients were accurately weighed for later use.

[0052] S2, add all weighed active ingredients into a V-type mixer, set the speed to 20 r / min, and the mixing time to 25 minutes. Stop the machine at the 5th, 10th, 15th, 20th, and 25th minutes to take samples and test the mixing uniformity. At the 25th minute, the relative standard deviation of the content of all active ingredients is 1.8%, which meets the requirement of relative standard deviation ≤ 2.5%. Stop mixing to obtain the active ingredient mixture.

[0053] S3: Tablet preparation: Premix: Add the active ingredient mixture and microcrystalline cellulose to the mixer at a weight ratio of 2:1 and premix for 10 minutes.

[0054] Granulation: Add starch, crospovidone and magnesium stearate to the premixed material, using starch slurry as a binder. The weight ratio of the premixed material to the binder is 10:3. Feed the mixed material into a vibrating granulator and granulate it using an 18-mesh sieve to obtain wet granules.

[0055] Drying and granulation: The wet granules were placed in a drying oven at 70℃ for 3 hours. After drying, the moisture content of the granules was tested and found to be ≤2%. The moisture content of the granules after this drying process met the requirements. Then, they were granulated by passing them through a 16-mesh sieve.

[0056] Tableting: A rotary tableting machine is used to compress the granulated granules into tablets with a weight of 600±15mg per tablet.

[0057] Example 6 Raw material ratio (by weight): Vascular function optimization unit: 30 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 15 parts of American ginseng extract, 18 parts of Astragalus membranaceus extract, and 10 parts of sea buckthorn flavonoids; Cellular energy and antioxidant unit: Coenzyme Q10 6 parts, astaxanthin 6 parts, ascorbate palmitate 0.072 parts; Enhancement unit for neural function and mitochondrial biosynthesis: 4 parts phosphatidylserine, 0.25 parts pyrroloquinoline quinone; Enteric coating material: 9 parts acrylic resin IV, 1 part diethyl phthalate; 2. Preparation method S1. Ginkgo biloba extract, Salvia miltiorrhiza extract, American ginseng extract, and Astragalus membranaceus extract were placed in a vacuum drying oven at 65℃ and dried for 3 hours. The moisture content of the dried materials should be ≤2%. In this case, the moisture content of the materials was 1.5%. In an argon-protected glove box, sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbate palmitate were accurately weighed, and the entire process was kept away from air to avoid oxidation. Phosphatidylserine, pyrrolidone, and enteric coating material were accurately weighed and set aside.

[0058] S2, add all weighed active ingredients into a V-type mixer, set the speed to 20 r / min, and the mixing time to 25 minutes. Stop the machine at the 5th, 10th, 15th, 20th, and 25th minutes to take samples and check the mixing uniformity. At the 25th minute, the relative standard deviation of the content of all active ingredients is 2.0%, which meets the requirement of relative standard deviation ≤ 2.5%. Stop mixing to obtain the active ingredient mixture.

[0059] S3: Preparation of enteric-coated capsules: Content preparation: The active ingredient mixture is mixed evenly with polyethylene glycol 400, with polyethylene glycol 400 as the dispersion medium, to prepare a content with good flowability.

[0060] Capsule filling: The prepared contents are filled into hard capsules using a capsule filling machine, with each capsule containing 480mg of contents.

[0061] Coating: Acrylic resin IV and diethyl phthalate are mixed and dissolved to prepare a coating solution with a concentration of 15%; a fluidized bed coating machine is used to control the coating weight gain at 7% and the coating temperature at 38℃ to coat the filled hard capsules.

[0062] Comparative Example 1: Vascular Function Unit Only Raw material ratio (by weight): Vascular function optimization unit: 42 parts of Ginkgo biloba extract, 36 parts of Salvia miltiorrhiza extract, 22 parts of American ginseng extract, 20 parts of Astragalus membranaceus extract, and 10 parts of Hippophae rhamnoides flavonoids; Dosage form: soft capsules Preparation method: S1. Place Ginkgo biloba extract, Salvia miltiorrhiza extract, American ginseng extract, and Astragalus membranaceus extract in a vacuum drying oven at 65℃ and dry for 3 hours. The moisture content of the dried material should be ≤2%. In this case, the moisture content of the material was 1.4% after drying. Accurately weigh the sea buckthorn flavonoids for later use.

[0063] S2, all weighed vascular function optimization unit components are added to a V-type mixer. The speed is set to 20 r / min and the mixing time to 25 minutes. Samples are taken at the 5th, 10th, 15th, 20th, and 25th minutes to test the mixing uniformity. At the 20th minute, the relative standard deviation of all component contents is 1.8%, which meets the requirement of relative standard deviation ≤ 2.5%. Mixing is then stopped, and the component mixture is obtained.

[0064] S3: Soft Capsule Preparation: Capsule preparation: Weigh out 100g of gelatin, 40g of glycerin, 130g of purified water, and 0.2g of vitamin E according to the weight ratio of gelatin:glycerin:purified water:vitamin E = 1:0.4:1.3:0.002. Add the gelatin and purified water to a 58℃ water bath and stir to dissolve for 35 minutes. Then add the glycerin and vitamin E and continue stirring for 20 minutes until the solution is clear. Set aside for later use.

[0065] Content preparation: The mixture of ingredients and medium-chain triglycerides were added to a high-speed homogenizer at a weight ratio of 1:1.8. The speed was set to 9000 r / min and homogenized for 6 minutes to obtain a homogeneous content.

[0066] Capsule compression and drying: A fully automatic soft capsule compression machine was used, the capsule shell thickness was adjusted to 0.21 mm, and the weight of each capsule contents was controlled at 500±8 mg; after compression, the soft capsules were placed in a 32℃ ventilated drying oven for 14 hours to remove surface moisture.

[0067] Comparative Example 2 Raw material ratio (by weight): 100 parts Ginkgo biloba extract, 20 parts Coenzyme Q10, 10 parts Phosphatidylserine Dosage form: tablets Preparation method: S1. Place the ginkgo leaf extract in a vacuum drying oven at 65℃ and dry for 3 hours. The moisture content of the material after drying should be ≤2%. The moisture content of the material after drying was 1.8% in this case. Under nitrogen protection, accurately weigh coenzyme Q10. Accurately weigh phosphatidylserine and tablet excipients (22 parts microcrystalline cellulose, 10 parts starch, 2.5 parts crospovidone, and 1 part magnesium stearate) for later use.

[0068] S2, all weighed ingredients are added to a V-type mixer, the speed is set to 20 r / min, and the mixing time is 25 minutes. Samples are taken at the 5th, 10th, 15th, 20th, and 25th minutes to test the mixing uniformity. At the 25th minute, the relative standard deviation of the content of all ingredients is 3.8%, which does not meet the requirement of relative standard deviation ≤2.5%, but mixing is still stopped to obtain the component mixture.

[0069] S3: Tablet preparation: Premix: Add the component mixture and microcrystalline cellulose to the mixer at a weight ratio of 2:1 and premix for 10 minutes.

[0070] Granulation: Add starch, crospovidone and magnesium stearate to the premixed material, using starch slurry as a binder. The weight ratio of the premixed material to the binder is 10:3. Feed the mixed material into a vibrating granulator and granulate it using an 18-mesh sieve to obtain wet granules.

[0071] Drying and granulation: The wet granules were placed in a drying oven at 70℃ for 3 hours. After drying, the moisture content of the granules was tested and found to be ≤2%. The moisture content of the granules after this drying process met the requirements. Then, they were granulated by passing them through a 16-mesh sieve.

[0072] Tableting: A rotary tableting machine is used to compress the granulated granules into tablets with a weight of 600±20mg per tablet.

[0073] Comparative Example 3 Raw material ratio (by weight): Same as Example 4, but the raw material specifications are adjusted as follows: Ginkgo biloba extract: flavonoid content 22%, flavonol glycosides account for 75%. Tanshinone IIA content 0.6%, Danshen acid B content 4% Pyrroloquinoline quinone: 95% purity Preparation method: S1. Place the adjusted Ginkgo biloba extract, Salvia miltiorrhiza extract, and Panax quinquefolius extract in a vacuum drying oven at 65℃ for 3 hours. The moisture content of the dried material should be ≤2%. In this case, the moisture content of the material after drying was 1.4%. In an argon-protected glove box, accurately weigh sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbate palmitate, with the weighing accuracy controlled within ±0.01g. Accurately weigh the adjusted phosphatidylserine and pyrrolidone for later use.

[0074] S2, add all weighed active ingredients into a V-type mixer, set the speed to 20 r / min, and the mixing time to 25 minutes. Stop the machine at the 5th, 10th, 15th, 20th, and 25th minutes to take samples and check the mixing uniformity. At the 20th minute, the relative standard deviation of the content of all active ingredients is 1.7%, which meets the requirement of relative standard deviation ≤ 2.5%. Stop mixing to obtain the active ingredient mixture.

[0075] S3: Soft Capsule Preparation: Capsule preparation: Weigh out 100g of gelatin, 40g of glycerin, 130g of purified water, and 0.2g of vitamin E according to the weight ratio of gelatin:glycerin:purified water:vitamin E = 1:0.4:1.3:0.002. Add the gelatin and purified water to a 58℃ water bath and stir to dissolve for 35 minutes. Then add the glycerin and vitamin E and continue stirring for 20 minutes until the solution is clear. Set aside for later use.

[0076] Content preparation: The active ingredient mixture and medium-chain triglycerides were added to a high-speed homogenizer at a weight ratio of 1:1.8, and the speed was set to 9000 r / min for 6 minutes to obtain a homogeneous content.

[0077] Capsule compression and drying: A fully automatic soft capsule compression machine was used, the capsule shell thickness was adjusted to 0.21 mm, and the weight of each capsule contents was controlled at 500±8 mg; after compression, the soft capsules were placed in a 32℃ ventilated drying oven for 14 hours to remove surface moisture.

[0078] Comparative Example 4 Raw material ratio (by weight): Vascular function optimization unit: 42 parts of Ginkgo biloba extract, 36 parts of Salvia miltiorrhiza extract, 22 parts of American ginseng extract, 20 parts of Astragalus membranaceus extract, and 10 parts of Hippophae rhamnoides flavonoids; Cellular energy and antioxidant unit: Coenzyme Q10 8.5 parts, astaxanthin 7 parts, ascorbate palmitate 0.116 parts; Lack of phosphatidylserine and pyrroloquinoline quinone Preparation method: S1. Place Ginkgo biloba extract, Salvia miltiorrhiza extract, American ginseng extract, and Astragalus membranaceus extract in a vacuum drying oven at 65℃ and dry for 3 hours. The moisture content of the dried material should be ≤2%. In this case, the moisture content of the dried material was 1.4%. In an argon-protected glove box, accurately weigh sea buckthorn flavonoids, coenzyme Q10, astaxanthin, and ascorbate palmitate, with the weighing accuracy controlled within ±0.01g. Set aside for later use.

[0079] S2, add all weighed active ingredients into a V-type mixer, set the speed to 20 r / min, and the mixing time to 25 minutes. Stop the machine at the 5th, 10th, 15th, 20th, and 25th minutes to take samples and check the mixing uniformity. At the 20th minute, the relative standard deviation of the content of all active ingredients is 1.7%, which meets the requirement of relative standard deviation ≤ 2.5%. Stop mixing to obtain the active ingredient mixture.

[0080] S3: Soft Capsule Preparation: Capsule preparation: Weigh out 100g of gelatin, 40g of glycerin, 130g of purified water, and 0.2g of vitamin E according to the weight ratio of gelatin:glycerin:purified water:vitamin E = 1:0.4:1.3:0.002. Add the gelatin and purified water to a 58℃ water bath and stir to dissolve for 35 minutes. Then add the glycerin and vitamin E and continue stirring for 20 minutes until the solution is clear. Set aside for later use.

[0081] Content preparation: The active ingredient mixture and medium-chain triglycerides were added to a high-speed homogenizer at a weight ratio of 1:1.8, and the speed was set to 9000 r / min for 6 minutes to obtain a homogeneous content.

[0082] Capsule compression and drying: A fully automatic soft capsule compression machine was used, the capsule shell thickness was adjusted to 0.21 mm, and the weight of each capsule contents was controlled at 500±8 mg; after compression, the soft capsules were placed in a 32℃ ventilated drying oven for 14 hours to remove surface moisture.

[0083] The core functional performance of the embodiments and comparative examples is compared in the table below: The following table compares the process and product quality of the examples and comparative examples: Compared with comparative formulations that only contain vascular functional units, simple ingredient superposition, or substandard raw materials and crude processes, this invention solves the core pain points of traditional preparations—"single target, poor synergy, uneven composition, and unstable effects"—through a comprehensive innovation of "vascular-mitochondrial-neuron three-unit synergistic formulation + high-standard raw material control + precise preparation process," achieving a comprehensive breakthrough in the whole-chain protection of cardiovascular and cerebrovascular health.

[0084] The embodiment, through the three-unit closed-loop synergy, achieved a neuronal postsynaptic membrane PSD95 protein expression level of 81%–85% and a mitochondrial DNA copy number increase of 41%–45%, far exceeding Comparative Examples 1 and 2, confirming the protective effect of the neural and mitochondrial enhancement units on functional terminals; the oxidative damage inhibition rate of 72%–78% and the cellular energy metabolism enhancement rate of 25%–30% were significantly higher than the comparative examples, demonstrating the synergistic value of the energy and antioxidant units; the vasodilation rate of 28%–32% was comparable to the effect of the high-quality vascular unit in the comparative examples, ensuring smooth nutrient delivery channels and forming a whole-chain optimization of "delivery-energy production-function".

[0085] The mixing uniformity RSD of the examples was only 1.7% to 2.3%, the oxidation rate of easily oxidized components was 1.2% to 1.6%, the energy consumption per unit product was 0.75 to 0.95 kW·h / 100 granules, and the product qualification rate was 100%. In contrast, Comparative Example 2, due to simple mixing that did not meet the uniformity standard, had an oxidation rate of 3.5% for easily oxidized components and a qualification rate of only 85%. Comparative Example 3, due to substandard raw material specifications, had reduced functional effects but a qualification rate of 90%. This fully demonstrates the process advantages of the present invention, namely "high-standard raw materials + inert gas protection + precise mixing," which ensures the uniformity of product components and the stability of efficacy.

[0086] Specifically, Comparative Example 1 contained only the vascular function unit, with extremely poor neural and mitochondrial related indicators, highlighting that a single unit cannot cover the needs of the entire chain; Comparative Example 4 lacked neural and mitochondrial enhancement units, and its related functional indicators lagged far behind, verifying the irreplaceable nature of the synergy of the three units; Comparative Example 2 simply stacked the ingredients and mixed them unevenly, with all functions at a low level, demonstrating the importance of formulation logic and precise process.

[0087] In summary, the performance data of the embodiments fully demonstrate the beneficial effects of the present invention: the three units work together to achieve full-chain protection of "unobstructed blood vessels - sufficient energy - stable nerves", high-standard raw materials and exclusive extraction processes ensure the efficacy of active ingredients, and precise preparation processes ensure product uniformity and stability. Ultimately, this forms a comprehensive advantage of "comprehensive function, synergistic efficiency, and reliable quality", breaking through the single protection limitations of traditional preparations and providing a more comprehensive solution for cardiovascular and cerebrovascular health and anti-aging protection.

[0088] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axes, wherein the active ingredients consist of a vascular function optimization unit, a cellular energy and antioxidant unit, and a neurofunctional and mitochondrial biosynthesis enhancement unit, characterized in that, The components, by weight, are as follows: The vascular function optimization unit includes 20-60 parts of Ginkgo biloba extract, 20-60 parts of Salvia miltiorrhiza extract, 10-30 parts of American ginseng extract, 10-30 parts of Astragalus membranaceus extract, and 5-15 parts of Hippophae rhamnoides flavonoids; the cellular energy and antioxidant unit includes 5-10 parts of Coenzyme Q10 and 5-10 parts of Astaxanthin; the nerve function and mitochondrial biosynthesis enhancement unit includes 3-5 parts of phosphatidylserine and 0.2-0.3 parts of pyrrolidinequinoline quinone. Among them, the flavonoid content of Ginkgo biloba leaf extract is 24%–30%, with flavonol glycosides accounting for ≥80%, and the lactone content is 5%–7%, with ginkgolide B accounting for ≥40%; the tanshinone IIA in tanshinone extract is ≥0.8%, and salvianolic acid B is ≥5%; the ginsenoside Rg1 in American ginseng extract is ≥2.5%, and Rb1 is ≥2.5%; the phosphatidylserine purity is ≥95%, which can maintain the expression level of PSD95 protein on the postsynaptic membrane of neurons at ≥80%; the pyrroloquinoline quinone purity is ≥99%, which can activate the PGC-1α pathway and promote an increase in mitochondrial DNA copy number at ≥40%.

2. The Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 1, characterized in that, In the vascular function optimization unit, the weight parts of Ginkgo biloba extract are 35-45 parts, the weight parts of Salvia miltiorrhiza extract are 32-40 parts, the weight parts of American ginseng extract are 18-25 parts, the weight parts of Astragalus membranaceus extract are 15-25 parts, and the weight parts of Hippophae rhamnoides flavonoids are 8-12 parts. In the cellular energy and antioxidant unit, the weight parts of coenzyme Q10 are 7-9 parts and the weight parts of astaxanthin are 6-8 parts. In the nerve function and mitochondrial biosynthesis enhancement unit, the weight parts of phosphatidylserine are 3.8-4.5 parts and the weight parts of pyrroloquinoline quinone are 0.24-0.28 parts.

3. The Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 1, characterized in that, The preferred weight ratio of each active ingredient is as follows: 42 parts of Ginkgo biloba extract, 36 parts of Salvia miltiorrhiza extract, 22 parts of American ginseng extract, 20 parts of Astragalus membranaceus extract, 10 parts of Hippophae rhamnoides flavonoids, 8.5 parts of Coenzyme Q10, 7 parts of Astaxanthin, 4.2 parts of Phosphatidylserine, and 0.26 parts of Pyrroloquinoline quinone.

4. The Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 1 or 2, characterized in that, The danshen extract was prepared into a dry powder by reflux extraction with 70%–80% ethanol; the American ginseng extract was prepared into a dry powder by water extraction at 60–70℃ followed by alcohol precipitation; the astragalus extract was prepared into a dry powder by water extraction at 60–70℃ followed by alcohol precipitation; and the sea buckthorn flavonoids were prepared using supercritical fluid extraction. It is produced by extraction.

5. The Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 3, characterized in that, In the cell energy and antioxidant unit, coenzyme Q10 is an oil-soluble crystal with a purity of ≥98%, and astaxanthin is a cell wall-broken extract of Haematococcus pluvialis with astaxanthin ester ≥90%. When the two are combined, ascorbate palmitate is added as a stabilizer, and the amount of ascorbate palmitate added is 0.5% to 1% of the total weight of coenzyme Q10 and astaxanthin.

6. The Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 3, characterized in that, The phosphatidylserine is a purified product of soybean phospholipid enzymatic hydrolysis, and is a low-molecular-weight phospholipid purified by molecular distillation with an average molecular weight of 750-800 Da; the pyrroloquinoline quinone is a colorless crystal prepared by bio-fermentation and purified by HPLC.

7. The Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 3, characterized in that, The dosage form of the formulation is a soft capsule, enteric-coated capsule, or tablet; the contents of the soft capsule contain 10% to 15% medium-chain triglycerides as a dispersion medium; the coating material of the enteric-coated capsule is a mixture of acrylic resin IV and diethyl phthalate in a weight ratio of 9:1, with a coating weight gain of 6% to 7%; the tablet contains 2% to 3% crospovidone as a disintegrant.

8. A method for preparing a Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons as described in any one of claims 1 to 7, characterized in that, Includes the following steps: S1: Accurately weigh all active ingredients according to the weight ratio described in any one of claims 1 to 7; wherein Ginkgo biloba extract, Salvia miltiorrhiza extract, and Panax quinquefolius extract need to be dried in a vacuum drying oven at 65°C for 3 hours in advance, and the moisture content of the material after drying is ≤2%; sea buckthorn flavonoids, coenzyme Q10, and astaxanthin need to be weighed under the protection of inert gas such as nitrogen or argon to avoid oxidation upon contact with air; S2: Place the weighed active ingredients in a V-type mixer, set the speed to 20 r / min and the mixing time to 25 minutes, and stop the machine every 5 minutes to take a sample to check the mixing uniformity until the relative standard deviation (RSD) of the content of all active ingredients is ≤2.5%, and obtain the active ingredient mixture; S3: Add appropriate excipients according to the target dosage form requirements. If preparing soft capsules, first put the active ingredient mixture and medium-chain triglycerides into a high-speed homogenizer at a weight ratio of 1:1.8, set the speed to 8000-10000 r / min, homogenize for 5-8 minutes, and then compress the capsules. If preparing tablets, first premix the active ingredient mixture and microcrystalline cellulose at a weight ratio of 2:1 for 10 minutes, then add starch, crospovidone, and magnesium stearate, granulate, dry at 70℃ for 3 hours, granulate, and then compress the tablets. After tableting, test the dissolution rate of the tablets after 45 minutes to ensure that the dissolution rate is ≥88%.

9. The method for preparing the Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 8, characterized in that, When preparing soft capsules in S3, the capsule material is prepared according to the following weight ratio: gelatin: glycerin: purified water: vitamin E = 1:0.4:1.3:0.002; the capsule material preparation requires first dissolving the gelatin and purified water in a water bath at 55-60℃ for 30-40 minutes, then adding glycerin and vitamin E and continuing to stir for 20 minutes until clear; the shell thickness of the soft capsule is 0.2-0.22mm, and the weight of each capsule contents is 500±20mg; after compression, the soft capsules need to be dried in a ventilated environment at 30-35℃ for 12-16 hours.

10. The method for preparing the Ginkgo biloba compound preparation based on the synergistic protection of blood vessels, mitochondria, and neuronal axons according to claim 8, characterized in that, When preparing tablets in S3, the specific amounts of excipients are 20-22 parts microcrystalline cellulose, 9-10 parts starch, 2.5 parts crospovidone, and 1 part magnesium stearate. During granulation, starch paste is used as a binder. The premixed materials and binder are fed into a vibrating granulator at a weight ratio of 10:3 and granulated using an 18-mesh sieve. After drying, the wet granules need to be granulated through a 16-mesh sieve. After granulation, the tablets are compressed to produce tablets with a weight of 600±30mg per tablet.

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