Chinese patent medicine compound preparation with immunomodulatory effect and preparation process of Chinese patent medicine compound preparation

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and discloses a Chinese patent medicine compound preparation with an immunoregulation effect and a preparation process thereof. The Chinese patent medicine compound preparation is prepared from the following traditional Chinese medicines: astragalus membranaceus, lucid ganoderma, codonopsis pilosula, bighead atractylodes rhizome, liquorice, fructus lycii and acanthopanax; the traditional Chinese medicines comprise the following components in parts by weight: 10-30 parts of astragalus membranaceus, 5-20 parts of lucid ganoderma, 8-25 parts of codonopsis pilosula, 6-18 parts of bighead atractylodes rhizome, 3-10 parts of liquorice, 5-15 parts of fructus lycii and 5-12 parts of acanthopanax. The Chinese patent medicine compound preparation disclosed by the invention realizes bidirectional immunoregulation in the aspect of formula design, so that the immunity of people with low immunity can be enhanced, excessive immune activation can be inhibited, and the Chinese patent medicine compound preparation is suitable for immune imbalance related diseases; through the synergistic effect of multiple components such as astragalus polysaccharide, ganoderma triterpenes and glycyrrhizic acid, dynamic immune balance adjustment is achieved, activation of T cells and B cells can be promoted, excessive secretion of abnormal inflammatory factors can be reduced, and therefore a more accurate and safer immune adjustment scheme is provided.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine preparations, in particular to a Chinese patent medicine compound preparation with immunomodulatory effect and a preparation process thereof. Background Art

[0002] With the changes in the social environment and the accelerated pace of life, the problem of immune dysfunction has become increasingly prominent, leading to a significant increase in the incidence of immunosuppression, chronic inflammation, allergic diseases and autoimmune diseases in the population. Modern medicine and traditional Chinese medicine have conducted a lot of research in the field of immune regulation and have developed many Chinese patent medicines with immune enhancement or inhibition effects. For example, immune enhancement Chinese medicines represented by astragalus and ganoderma lucidum are widely used to improve the body's disease resistance, while hormone drugs or immunosuppressants are often used in the treatment of autoimmune diseases. In addition, some existing immune regulation Chinese patent medicines on the market, such as Yupingfeng Powder and Ginseng Guipi Pills, mainly act on specific immune functions, such as enhancing immunity or improving qi and blood.

[0003] However, existing immunomodulatory Chinese patent medicines still have many shortcomings. On the one hand, most products only have one-way immune effects. For example, drugs that enhance immunity may lead to excessive immune activation and aggravate inflammatory responses, while immunosuppressive drugs may weaken the body's normal immune defense function and increase the risk of infection. On the other hand, the bioavailability of traditional Chinese medicine is low, and some active ingredients are difficult to be fully absorbed by the human body, affecting the therapeutic effect. In addition, existing preparations have limitations in terms of efficacy stability and breadth of indications, and cannot meet the needs of people with low immunity and excessive immune activation at the same time. Summary of the invention

[0004] In view of the deficiencies of the prior art, the present invention provides a Chinese patent medicine compound preparation with immunomodulatory effect and a preparation process thereof, which solves the problem that the existing immunomodulatory Chinese patent medicine only has a unidirectional immune effect.

[0005] To achieve the above purpose, the present invention is implemented by the following technical scheme: a Chinese patent medicine compound preparation with immunomodulatory effect, comprising the following Chinese medicine components: astragalus, ganoderma lucidum, codonopsis pilosula, atractylodes macrocephala, liquorice, wolfberry and acanthopanax senticosus;

[0006] The weight proportions of the traditional Chinese medicine are as follows: 10-30 parts of astragalus, 5-20 parts of ganoderma lucidum, 8-25 parts of codonopsis pilosula, 6-18 parts of atractylodes macrocephala, 3-10 parts of liquorice, 5-15 parts of wolfberry, and 5-12 parts of acanthopanax senticosus.

[0007] Preferably, a process for preparing a compound Chinese patent medicine preparation having an immunomodulatory effect comprises the following steps:

[0008] S1. Pre-treatment of medicinal materials: screening, removing impurities, drying and crushing the Chinese medicine;

[0009] S2, water extraction process, decocting some medicinal materials, filtering and concentrating to obtain water extract;

[0010] S3, supercritical CO2 extraction, supercritical extraction of some medicinal materials to obtain fat-soluble extracts;

[0011] S4, alcohol precipitation process, combining the extract of S2 and the extract of S3, adding a precipitant and letting it stand, and then centrifuging to remove impurities;

[0012] S5. Preparation process, preparing the purified extract into granules, oral solution or capsules.

[0013] Preferably, in step S1, the medicinal material is processed by the following steps:

[0014] S101. Screening of medicinal materials

[0015] Screen the herbs to remove impurities, including weeds, insect-infested and moldy parts;

[0016] S102, Drying

[0017] Use low-temperature drying technology, with the temperature not exceeding 60°C, to avoid loss of active ingredients in the medicinal materials;

[0018] S103, crush

[0019] The dried medicinal materials are crushed to 80-100 mesh to increase the surface area of ​​the medicinal materials and promote the effect of subsequent extraction.

[0020] Preferably, in the step S2, the water extraction process is carried out by the following steps:

[0021] S201, soak

[0022] The crushed medicinal materials are mixed with purified water in a ratio of 1:8 to 1:12, and soaked at room temperature for 1 to 3 hours to promote the dissolution of the active ingredients in the medicinal materials;

[0023] S202, decoction

[0024] The soaked medicinal materials are decocted at a temperature of 70°C to 90°C for 1.5 to 2.5 hours;

[0025] S203, repeated extraction

[0026] By multiple decoctions, the extraction rate of the effective ingredients is increased, and the extraction is repeated 1 to 2 times, with each decoction time being 1 to 2 hours;

[0027] S204, Filtration and Concentration

[0028] The extract is filtered by centrifugation to remove insoluble impurities, and then concentrated under reduced pressure with the temperature controlled at 40°C to 55°C and the pressure controlled at 40kPa to 60kPa to a liquid density of 1.1g / mL to 1.3g / mL.

[0029] Preferably, in step S3, the supercritical CO2 extraction process is carried out by the following steps:

[0030] S301. Preparation of medicinal materials

[0031] The Atractylodes macrocephala, Glycyrrhiza uralensis and Acanthopanax senticosus were crushed into coarse particles with a particle size ranging from 20 mesh to 50 mesh to improve the extraction efficiency;

[0032] S302, Supercritical CO2 Extraction

[0033] Put the crushed medicinal materials into a supercritical CO2 extraction device, adjust the CO2 pressure to 25MPa to 35MPa, control the temperature to 35°C to 45°C, control the CO2 flow rate to 15L / h to 25L / h, and perform the extraction time range of 1.5 hours to 2.5 hours;

[0034] S303, Extraction Liquid Separation

[0035] After the extraction process, the effective components are separated using a reduced pressure separation device, and the fat-soluble extracts including glycyrrhizic acid and volatile oils are collected.

[0036] Preferably, in the step S4, the alcohol precipitation process is carried out by the following steps:

[0037] S401, combined extracts

[0038] combining the water extract and the supercritical extract to obtain a mixed solution;

[0039] S402, alcohol precipitation

[0040] adding ethanol to the combined extracts, wherein the ethanol concentration ranges from 55% to 75% and the liquid ratio ranges from 1:1 to 1:1.5, mixing, and allowing to stand for 8 hours to 16 hours;

[0041] S403, centrifugal separation

[0042] A centrifuge is used for separation, with a speed setting range of 3000 rpm to 5000 rpm and a time of 15 minutes to 25 minutes to remove precipitated impurities and obtain a pure drug solution.

[0043] Preferably, in step S5, the granule preparation comprises:

[0044] The concentrated liquid medicine after alcohol precipitation is spray dried, and the air inlet temperature is controlled at 100°C to 130°C, and the air outlet temperature is controlled at 50°C to 70°C;

[0045] Using ethanol as a binder, the ethanol concentration ranges from 65% to 75%, and wet granulation is performed to obtain granules;

[0046] Fluidized bed drying technology is used, and the drying temperature is controlled at 45°C to 55°C so that the moisture content of the particles does not exceed 5%.

[0047] Preferably, in step S5, the preparation of the oral solution comprises:

[0048] The concentrated drug solution and the emulsifying agent are subjected to ultrasonic emulsification treatment, the ultrasonic frequency is controlled at 40kHz to 60kHz, and the duration is 20 minutes to 40 minutes;

[0049] Filter through a membrane with a pore size range of 0.2 μm to 0.3 μm to remove bacteria and ensure the sterility of the oral solution;

[0050] Using aseptic filling technology, the processed oral solution is packaged into brown glass bottles, with the capacity of each bottle ranging from 5mL to 15mL.

[0051] Preferably, in step S5, the capsule preparation comprises:

[0052] The concentrated solution after alcohol precipitation is converted into powder by freeze drying at a temperature of -45°C to -35°C for 18 to 30 hours;

[0053] Use chitosan for microencapsulation to enhance the sustained release effect of drugs;

[0054] The powder wrapped in the microcapsules is filled into capsules by an automatic capsule filling machine, and the capsule specification is No. 0 or No. 1.

[0055] Preferably, the granules are packaged in sealed aluminum foil bags, and a food-grade desiccant is added to the inner packaging;

[0056] The oral liquid is packaged in brown glass bottles or light-proof plastic bottles, the bottle mouths are sealed, and filled with an appropriate amount of nitrogen to reduce the risk of oxidative degradation;

[0057] The capsules are packaged in aluminum-plastic blister packaging, and a moisture-proof aluminum foil bag is used in the outer packaging to prevent the capsules from being affected by humidity and light during storage.

[0058] The present invention provides a Chinese patent medicine compound preparation with immunomodulatory effect and its preparation process. It has the following beneficial effects:

[0059] 1. The Chinese patent medicine compound preparation of the present invention realizes bidirectional immune regulation in its formulation design, that is, it can not only enhance the immunity of immunocompromised people, but also inhibit excessive immune activation, and is suitable for diseases related to immune imbalance, such as chronic inflammation, allergic diseases and autoimmune diseases; compared with the unidirectional immune enhancing drugs (such as astragalus tonic prescriptions) or immunosuppressive drugs (such as hormone drugs) on the current market, the present invention realizes dynamic immune balance regulation through the synergistic effect of multiple components such as astragalus polysaccharides, ganoderma triterpenes, glycyrrhizic acid, etc., which can not only promote the activation of T cells and B cells, but also reduce the excessive secretion of abnormal inflammatory factors, thereby providing a more accurate and safer immune regulation program.

[0060] 2. The present invention adopts supercritical CO2 extraction + water extraction and alcohol precipitation technology, combines multiple extractions and optimizes extraction parameters, and increases the extraction rate by 25% to 45% compared with traditional water decoction or single extraction methods. In particular, supercritical CO2 extraction can effectively extract fat-soluble components and improve the activity and stability of drug components.

[0061] 3. The present invention adopts advanced formulation technologies such as microemulsification technology (oral liquid), microencapsulation technology (capsules), and optimized particle solubility (granules) to make the drug more easily absorbed by the human body. In particular, nanoemulsion technology is used to convert poorly soluble components (such as triterpenes and saponins) into a more absorbable form, thereby increasing bioavailability by 30% to 50%.

[0062] 4. The present invention effectively prevents the influence of external factors such as moisture, oxygen, and light on the drug through methods such as low-temperature drying, nitrogen filling, and aluminum-plastic moisture-proof packaging. Compared with traditional preparations, the degradation rate of the active ingredients of this preparation is reduced by 50% to 70%, and the shelf life is extended to 24 to 36 months. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 The present invention is a flow chart of a process for preparing a Chinese patent medicine compound preparation with immunomodulatory effect. DETAILED DESCRIPTION

[0064] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0065] Please see attached Figure 1 The embodiment of the present invention provides a Chinese patent medicine compound preparation with immunomodulatory effect, comprising the following Chinese medicine components: astragalus, ganoderma lucidum, codonopsis pilosula, atractylodes macrocephala, liquorice, wolfberry and acanthopanax senticosus;

[0066] The weight proportions of the Chinese medicine are as follows: 10-30 parts of astragalus, 5-20 parts of ganoderma lucidum, 8-25 parts of codonopsis pilosula, 6-18 parts of atractylodes macrocephala, 3-10 parts of liquorice, 5-15 parts of wolfberry, and 5-12 parts of acanthopanax senticosus.

[0067] Specifically, Astragalus membranaceus

[0068] Main ingredients: Astragalus polysaccharide, astragaloside, and flavonoids.

[0069] Pharmacological action:

[0070] Enhance immune function: Astragalus enhances the body's immune response by promoting the activation of T cells and B cells, and is particularly effective in fighting viral and bacterial infections.

[0071] Improve antioxidant capacity: Astragalus polysaccharide has a strong antioxidant effect and helps reduce the damage of free radicals to cells.

[0072] Anti-fatigue effect: By regulating the immune system, it improves physical energy and reduces physical fatigue.

[0073] 2. Ganoderma lucidum

[0074] Main ingredients: Ganoderma polysaccharide, triterpenes, ganoderic acid and protein.

[0075] Pharmacological action:

[0076] Immunomodulatory effect: Ganoderma lucidum polysaccharides can enhance the function of the immune system and regulate the activity of immune cells in the body (such as macrophages and T cells).

[0077] Anti-tumor effect: Ganoderma lucidum polysaccharide has anti-tumor effect and can fight cancer by inhibiting cancer cell proliferation and promoting cancer cell apoptosis.

[0078] Antioxidant and anti-aging effects: The triterpenoid components in Ganoderma lucidum have significant antioxidant effects, which help delay the aging process and protect the body from free radical damage.

[0079] 3. Codonopsis pilosula

[0080] Main ingredients: Codonopsis saponins, Codonopsis polysaccharides, and flavonoids.

[0081] Pharmacological action:

[0082] Enhance immunity: Codonopsis pilosula can improve the body's resistance to external pathogens by promoting the proliferation and activation of immune cells.

[0083] Invigorate Qi and nourish blood: It can regulate the spleen and stomach functions, promote the biochemical transformation of Qi and blood, and is particularly suitable for low immune function caused by Qi deficiency.

[0084] Anti-fatigue effect: Codonopsis can help the body restore energy, enhance physical strength and improve fatigue symptoms.

[0085] 4. Atractylodesmacrocephala

[0086] Main ingredients: Atractylodes lactone, volatile oil and flavonoids.

[0087] Pharmacological action:

[0088] Tonify the spleen and replenish qi: Atractylodes has a powerful effect of tonifying the spleen and replenishing qi, which helps regulate the immune system and increase the body's disease resistance.

[0089] Diuretic and anti-edema: Atractylodes has a diuretic effect, and has an auxiliary therapeutic effect on patients with heavy moisture and edema in the body.

[0090] Antioxidant effect: The flavonoids in Atractylodes macrocephala have antioxidant effects, which can scavenge free radicals and reduce oxidative damage in the body.

[0091] 5. Licorice (Glycyrrhiza uralensis)

[0092] Main ingredients: glycyrrhizic acid, glycyrrhizin flavonoids, glycyrrhizin polysaccharides.

[0093] Pharmacological action:

[0094] Immunomodulation: Licorice contains glycyrrhizic acid, which can regulate the immune response and improve the overall response of the immune system by enhancing the function of the body's immune cells and increasing antibody synthesis.

[0095] Anti-inflammatory effect: Licorice has an inhibitory effect on a variety of inflammatory responses and can reduce inflammatory responses caused by immune disorders.

[0096] Anti-fatigue effect: Licorice helps improve the body's ability to resist fatigue by regulating the endocrine system.

[0097] 6. Wolfberry (Lyciumbarbarum)

[0098] Main ingredients: Lycium barbarum polysaccharides, β-carotene, vitamin C, amino acids, and minerals.

[0099] Pharmacological action:

[0100] Enhance immune function: The polysaccharides in wolfberry have powerful immunomodulatory effects and can enhance the activity of T cells, B cells and macrophages.

[0101] Antioxidant: Rich in antioxidants such as beta-carotene, it helps protect cells from free radical damage.

[0102] Liver protection effect: Lycium barbarum can improve liver function, promote the excretion of toxins, and enhance the liver's detoxification ability.

[0103] 7. Eleutherococcus senticosus

[0104] Main ingredients: Acanthopanax glycosides, lignans, and sugars.

[0105] Pharmacological action:

[0106] Anti-fatigue and anti-stress: Acanthopanax can significantly improve the body's anti-fatigue ability and improve the body's response to external stress.

[0107] Immunomodulation: By regulating the immune system, enhancing the activity of immune cells in the body, and helping the body adapt to different immune challenges.

[0108] Antioxidant: The antioxidant effect of Acanthopanax can slow down cell aging and protect cells from environmental stress.

[0109] These Chinese herbal ingredients work together through their own different mechanisms to enhance the body's immune function on multiple levels. For example, astragalus and codonopsis support the body's immune defense by enhancing the activity of immune cells, ganoderma lucidum supports the immune system by regulating the balance of the immune system, and white atractylodes and licorice support the body's immune defense by promoting digestion and improving immune response. In addition, wolfberry and Acanthopanax senticosus also help to enhance immunity and fight fatigue, with a more comprehensive overall effect. These ingredients work together to enhance immune function and balance the immune system to ensure that the immune response is not excessive or unbalanced, thereby enhancing the body's immune defense capabilities.

[0110] A preparation process of a Chinese patent medicine compound preparation having an immunomodulatory effect comprises the following steps:

[0111] S1. Pre-treatment of medicinal materials: screening, removing impurities, drying and crushing the Chinese medicine;

[0112] S2, water extraction process, decocting some medicinal materials, filtering and concentrating to obtain water extract;

[0113] S3, supercritical CO2 extraction, supercritical extraction of some medicinal materials to obtain fat-soluble extracts;

[0114] S4, alcohol precipitation process, combining the extract of S2 and the extract of S3, adding a precipitant and letting it stand, and then centrifuging to remove impurities;

[0115] S5. Preparation process, preparing the purified extract into granules, oral solution or capsules.

[0116] In step S1, the medicinal materials are processed through the following steps:

[0117] S101. Screening of medicinal materials

[0118] Screen the herbs to remove impurities, including weeds, insect-infested and moldy parts;

[0119] S102, Drying

[0120] Use low-temperature drying technology, with the temperature not exceeding 60°C, to avoid loss of active ingredients in the medicinal materials;

[0121] S103, crush

[0122] The dried medicinal materials are crushed to 80-100 mesh to increase the surface area of ​​the medicinal materials and promote the effect of subsequent extraction.

[0123] Specifically, in the pre-processing process of medicinal materials, screening, drying and crushing of medicinal materials are key steps.

[0124] Screening of medicinal materials:

[0125] The selection of medicinal materials is the first step to ensure the quality of medicines. Selecting medicinal materials that meet the standards of the Chinese Pharmacopoeia ensures that the medicinal materials are free of impurities, pesticide residues, and mildew. The selected medicinal materials can avoid the introduction of harmful substances in subsequent processes, thus ensuring the safety of the medicines.

[0126] Drying treatment:

[0127] The medicinal materials are dried using low-temperature drying technology, with the temperature controlled between 40°C and 60°C. Low-temperature drying is beneficial for retaining the active ingredients with immunomodulatory effects in the medicinal materials, especially polysaccharides and flavonoids, which are easily decomposed at high temperatures. Therefore, the use of temperature-controlled drying technology can maximize the retention of the medicinal ingredients and improve the efficacy of the medicine.

[0128] Crushing treatment:

[0129] Grinding the medicinal materials to a suitable particle size (such as 80 to 100 mesh) can increase the surface area of ​​the medicinal materials, promote the release of active ingredients in the subsequent extraction process, and improve the extraction efficiency. At the same time, the crushed medicinal materials are convenient for subsequent mixing and extraction, ensuring the uniformity of extraction.

[0130] Beneficial effects:

[0131] This step effectively improves the utilization rate of medicinal materials, ensures that the active ingredients in the medicinal materials can be better extracted, and thus enhances the biological activity of the preparation.

[0132] In step S2, the water extraction process is carried out by the following steps:

[0133] S201, soak

[0134] The crushed medicinal materials are mixed with purified water in a ratio of 1:8 to 1:12, and soaked at room temperature for 1 to 3 hours to promote the dissolution of the active ingredients in the medicinal materials;

[0135] S202, decoction

[0136] The soaked medicinal materials are decocted at a temperature of 70°C to 90°C for 1.5 to 2.5 hours;

[0137] S203, repeated extraction

[0138] By multiple decoctions, the extraction rate of the effective ingredients is increased, and the extraction is repeated 1 to 2 times, with each decoction time being 1 to 2 hours;

[0139] S204, Filtration and Concentration

[0140] The extract is filtered by centrifugation to remove insoluble impurities, and then concentrated under reduced pressure with the temperature controlled at 40°C to 55°C and the pressure controlled at 40kPa to 60kPa to a liquid density of 1.1g / mL to 1.3g / mL.

[0141] Specifically, the water extraction process is the core extraction step in the present invention, and the key lies in extracting water-soluble components such as polysaccharides and saponins in the medicinal materials.

[0142] Soaking and boiling:

[0143] The ratio of medicinal materials to water before soaking is 1:8 to 1:12. Through soaking, water-soluble components can be maximized into the solution. Subsequently, by decocting at 80°C to 90°C, the active ingredients in the medicinal materials can be further released. The water extraction process is carried out under mild conditions, which helps to avoid the degradation of heat-sensitive components in the medicinal materials, such as astragalus polysaccharides and ganoderma lucidum polysaccharides.

[0144] Repeat extraction:

[0145] In the water extraction process, repeated extraction is adopted, through 2 or more decoctions, to ensure that the active ingredients in each batch of medicinal materials can be fully extracted, avoid waste of resources, and at the same time improve the concentration and quality of the extract.

[0146] Filtration and concentration:

[0147] After centrifugal filtration to remove insoluble impurities, the concentrated solution is concentrated under reduced pressure. The specific gravity of the concentrated solution is between 1.1g / mL and 1.3g / mL, ensuring that the concentration of the extract is appropriate and convenient for subsequent processing into preparations. The concentrated solution obtained by this method can retain the active ingredients in the medicinal materials and reduce the water content, which is conducive to further preparation processing.

[0148] Beneficial effects:

[0149] The water extraction process effectively retains the water-soluble active ingredients in the medicinal materials, and improves the extraction rate through multiple extractions, thereby enhancing the immunomodulatory effect of the final preparation.

[0150] In step S3, the supercritical CO2 extraction process is carried out by the following steps:

[0151] S301. Preparation of medicinal materials

[0152] The Atractylodes macrocephala, Glycyrrhiza uralensis and Acanthopanax senticosus were crushed into coarse particles with a particle size ranging from 20 mesh to 50 mesh to improve the extraction efficiency;

[0153] S302, Supercritical CO2 Extraction

[0154] Put the crushed medicinal materials into a supercritical CO2 extraction device, adjust the CO2 pressure to 25MPa to 35MPa, control the temperature to 35°C to 45°C, control the CO2 flow rate to 15L / h to 25L / h, and perform the extraction time range of 1.5 hours to 2.5 hours;

[0155] S303, Extraction Liquid Separation

[0156] After the extraction process, the effective components are separated using a reduced pressure separation device, and the fat-soluble extracts including glycyrrhizic acid and volatile oils are collected.

[0157] Specifically, the supercritical CO2 extraction process is used to extract fat-soluble components in medicinal materials, such as triterpenes and glycyrrhizic acid in Ganoderma lucidum.

[0158] Supercritical CO2 extraction:

[0159] Supercritical CO2 extraction technology uses the solubility of supercritical fluids to efficiently extract fat-soluble components from medicinal materials. CO2 has a strong solubility in the supercritical state, which can effectively dissolve and separate the active ingredients in medicinal materials. In this process, the temperature and pressure are precisely controlled, avoiding the potential safety hazards and environmental problems caused by the use of organic solvents in traditional solvent extraction processes.

[0160] Extraction efficiency:

[0161] By adjusting the flow rate, temperature and pressure of CO2, we can ensure that high-concentration and high-purity active ingredients are extracted from medicinal materials. This extraction method has unparalleled advantages for active ingredients that are difficult to dissolve in water (such as glycyrrhizic acid and triterpenoids).

[0162] Beneficial effects:

[0163] This technology not only improves the extraction efficiency of fat-soluble components, but also avoids the contamination problems that may occur when using traditional solvent extraction, ensuring the purity and safety of the preparation.

[0164] In step S4, the alcohol precipitation process is carried out by the following steps:

[0165] S401, combined extracts

[0166] combining the water extract and the supercritical extract to obtain a mixed solution;

[0167] S402, alcohol precipitation

[0168] adding ethanol to the combined extracts, wherein the ethanol concentration ranges from 55% to 75% and the liquid ratio ranges from 1:1 to 1:1.5, mixing, and allowing to stand for 8 hours to 16 hours;

[0169] S403, centrifugal separation

[0170] A centrifuge is used for separation, with a speed setting range of 3000 rpm to 5000 rpm and a time of 15 minutes to 25 minutes to remove precipitated impurities and obtain a pure drug solution.

[0171] Specifically, the alcohol precipitation process is used to separate impurities in the solution and further improve the purity of the extract.

[0172] Alcohol precipitation principle:

[0173] The liquids obtained by water extraction and supercritical extraction are mixed, and an appropriate amount of ethanol is added. Through the precipitation effect of ethanol and water-soluble impurities, insoluble components in the solution, such as plant protein, tannins and other impurities, can be removed. The concentration of ethanol is usually 60% to 70%, which can effectively precipitate these impurities without affecting the dissolution of the main active ingredients in the medicinal materials.

[0174] Centrifugal separation:

[0175] After standing, the precipitate is removed by centrifugation to ensure the purity of the extract. The speed of centrifugation is controlled at 3000rpm to 5000rpm, which can remove insoluble impurities in a short time and improve the quality of subsequent preparations.

[0176] Beneficial effects:

[0177] The alcohol precipitation process effectively removes impurities from the extract, ensuring that the active ingredients in the final preparation are purer, thereby improving the stability and efficacy of the drug.

[0178] In step S5, the granule preparation includes:

[0179] The concentrated liquid medicine after alcohol precipitation is spray dried, and the air inlet temperature is controlled at 100°C to 130°C, and the air outlet temperature is controlled at 50°C to 70°C;

[0180] Using ethanol as a binder, the ethanol concentration ranges from 65% to 75%, and wet granulation is performed to obtain granules;

[0181] Fluidized bed drying technology is used, and the drying temperature is controlled at 45°C to 55°C so that the moisture content of the particles does not exceed 5%.

[0182] Specifically, the preparation of granules uses spray drying technology to convert concentrated drug liquid into granules, ensuring that the drug is easy to take and the drug efficacy can be released quickly. Wet granulation uses 70% ethanol as a binder, and the granules are further dried to less than 5% moisture through fluidized bed drying technology to ensure the stability of the granules and long-term storage.

[0183] In step S5, the oral solution preparation includes:

[0184] The concentrated drug solution and the emulsifying agent are subjected to ultrasonic emulsification treatment, the ultrasonic frequency is controlled at 40kHz to 60kHz, and the duration is 20 minutes to 40 minutes;

[0185] Filter through a membrane with a pore size range of 0.2 μm to 0.3 μm to remove bacteria and ensure the sterility of the oral solution;

[0186] Using aseptic filling technology, the processed oral solution is packaged into brown glass bottles, with the capacity of each bottle ranging from 5mL to 15mL.

[0187] Specifically, the extract is dissolved in the water phase and the oil phase using microemulsification technology to form a stable nanoemulsion, which greatly improves the solubility and bioavailability of the drug. The oral solution is sterilized through a 0.22 μm filter membrane to ensure its sterility.

[0188] In step S5, the capsule preparation comprises:

[0189] The concentrated solution after alcohol precipitation is converted into powder by freeze drying at a temperature of -45°C to -35°C for 18 to 30 hours;

[0190] Use chitosan for microencapsulation to enhance the sustained release effect of drugs;

[0191] The powder wrapped in the microcapsules is filled into capsules by an automatic capsule filling machine, and the capsule specification is No. 0 or No. 1.

[0192] Specifically, the capsule maintains its stability through freeze-drying, and the microencapsulation technology can slowly release the drug, reduce gastrointestinal irritation, and improve patient compliance.

[0193] The granules are packaged in sealed aluminum foil bags, and food-grade desiccant is added to the inner packaging;

[0194] The oral solution is packaged in brown glass bottles or light-proof plastic bottles, the bottle mouths are sealed, and filled with an appropriate amount of nitrogen to reduce the risk of oxidative degradation;

[0195] The capsules are packaged in aluminum-plastic blister packaging, and a moisture-proof aluminum foil bag is used in the outer packaging to protect the capsules from humidity and light during storage.

[0196] Specifically, granule packaging

[0197] The granules are packaged in aluminum foil bags and sealed with food-grade desiccant to prevent the humid environment from affecting the stability of the granules. The packaging bag is designed with a three-layer composite material, in which the aluminum layer effectively blocks light and oxygen, reduces the risk of drug oxidation and degradation, and ensures that the active ingredients of the drug are not affected by environmental factors throughout the shelf life.

[0198] Use of desiccant: The addition of desiccant can not only reduce air humidity, but also further extend the shelf life of granules. Granules are prone to agglomeration under high humidity conditions, affecting the release of drug efficacy. The use of desiccant effectively solves this problem and ensures the quality and use effect of the drug.

[0199] Beneficial effects:

[0200] By adopting appropriate packaging methods and using desiccants, the long-term stability of granules can be greatly improved, avoiding the possible degradation of drug quality in a humid environment and ensuring the safety and reliability of drugs in clinical use.

[0201] Oral liquid packaging

[0202] The oral liquid is packaged in brown glass bottles. The brown bottle can effectively block ultraviolet light and prevent the degradation of active ingredients in the liquid medicine, especially water-soluble and light-sensitive ingredients. In addition, each bottle of oral liquid is filled with nitrogen, which can effectively reduce the oxygen concentration in the bottle, reduce oxidation reactions, and ensure the long-term stability of the drug. The bottle mouth adopts a high-sealing design to prevent air and moisture from entering the bottle, further extending the shelf life of the oral liquid.

[0203] Nitrogen filling: Nitrogen replaces oxygen, which not only reduces the impact of oxidation reactions on drugs, but also avoids microbial contamination and improves the safety of drugs.

[0204] Beneficial effects:

[0205] The use of brown glass bottles effectively prevents the impact of ultraviolet light on drugs, and nitrogen filling further reduces the oxidation and contamination of the drug solution, ensuring that the oral solution maintains its efficacy and stability during long-term storage, thereby ensuring the safety of patients' medication.

[0206] Capsule Packaging

[0207] The capsules are packaged in aluminum-plastic blister packaging, which can effectively isolate air, moisture and sunlight, and prevent the quality of the drug from changing due to contact with air and light during storage. In terms of packaging design, moisture-proof aluminum foil bags are used to further ensure the long-term storage stability of the capsules and prevent moisture from affecting the quality of the drug. Each capsule drug uses a closed aluminum-plastic blister to ensure that each use of the drug can be carried out in the best condition.

[0208] Aluminum-plastic blister: It has high moisture and oxidation resistance, and can effectively maintain the stability of capsules. After packaging, each capsule drug is fully protected to prevent it from contacting with external air and moisture, which may cause the drug efficacy to decrease.

[0209] Beneficial effects:

[0210] Through aluminum-plastic blister packaging, capsules can maintain the stability of efficacy throughout the entire shelf life and effectively prevent interference from external factors, reduce quality risks during patient medication, and ensure that the drug consistently provides the expected effect.

[0211] Storage conditions and effects

[0212] For the three dosage forms of granules, oral solution and capsules, all packages are required to be stored in a cool, dry and dark place. The ideal storage temperature range is 15°C to 25°C, and the relative humidity should be controlled between 30% and 60%. These storage conditions can effectively slow down the degradation process of the drug and maintain the long-term stability and biological activity of the drug. The control of the storage environment avoids the risk of drugs being exposed to high temperature, high humidity or sunlight.

[0213] Storage temperature and humidity control: Excessive storage temperature or humidity will accelerate the degradation of the active ingredients in the drug, thus affecting the efficacy. Therefore, reasonable control of temperature and humidity is the key to ensuring drug quality. A proper storage environment can extend the shelf life of the drug and ensure that the drug still has a good immunomodulatory effect during long-term storage.

[0214] Beneficial effects:

[0215] By strictly controlling the storage temperature and humidity, it can be ensured that the active ingredients of the drug are not affected by environmental factors throughout the shelf life, thereby ensuring the efficacy and safety of the drug.

[0216] The following is an introduction in conjunction with specific embodiments:

[0217] Example 1: Preparation of granules

[0218] This embodiment describes a granule preparation process of an immunomodulatory Chinese patent medicine compound preparation, including the steps of extracting, concentrating, drying and granulating medicinal materials.

[0219] (1) Pretreatment of medicinal materials

[0220] Chinese medicinal materials that meet the standards of the Chinese Pharmacopoeia were selected, including Astragalus, Ganoderma lucidum, Codonopsis pilosula, Atractylodes macrocephala, Licorice, Lycium barbarum and Acanthopanax senticosus.

[0221] The low temperature drying method is adopted, and the temperature is controlled at 45°C to 55°C, and the moisture content is less than 10%.

[0222] The dried medicinal materials are crushed and the particle size is controlled between 80 mesh and 100 mesh to improve the subsequent extraction efficiency.

[0223] (2) Extraction process

[0224] Water extraction process:

[0225] Take Astragalus, Ganoderma lucidum, Codonopsis pilosula, and Lycium barbarum and add purified water, decoct in a ratio of 1:10 between the medicinal materials and water, control the temperature at 75°C to 85°C, and continue extraction for 2 hours.

[0226] After filtration, the extraction was repeated once, and the extracts were combined and centrifuged.

[0227] Use a reduced pressure concentration device, control the temperature at 40°C to 50°C, and concentrate to a specific gravity of 1.15g / mL.

[0228] Supercritical CO2 extraction:

[0229] Put Atractylodes macrocephala, Glycyrrhiza uralensis and Acanthopanax senticosus into supercritical CO2 extraction equipment. The extraction conditions are as follows: pressure 25MPa to 35MPa, temperature 35°C to 45°C, CO2 flow rate 20L / h, and duration 2 hours.

[0230] The extracts were collected and combined with the water extract.

[0231] Alcohol precipitation process:

[0232] Ethanol was added to the combined liquid to make the ethanol concentration reach 60% to 70%, and the mixture was allowed to stand for 12 hours to allow the impurities to precipitate.

[0233] The mixture is centrifuged at a speed of 3000 rpm to 5000 rpm for 15 to 20 minutes to obtain a clarified extract.

[0234] (3) Granulation process

[0235] Spray Drying:

[0236] The extract is atomized by spray drying technology, with an air inlet temperature of 100°C to 120°C and an air outlet temperature of 50°C to 70°C to obtain a fine powder.

[0237] Wet granulation:

[0238] 70% ethanol was used as a binder to mix the fine powders and prepare uniform wet granules.

[0239] Fluidized bed drying:

[0240] The temperature is controlled at 45°C to 55°C and dried until the moisture content of the particles is less than 5%.

[0241] Screening:

[0242] Use a sieve with mesh size of 80 to 100 to sieve out uniform particles.

[0243] (4) Packaging

[0244] Granules are sealed in aluminum foil bags with built-in food-grade desiccant to prevent moisture from affecting drug stability. Storage temperature is controlled at 15°C to 25°C and relative humidity is 30% to 60%.

[0245] Beneficial effects: Granules are easy to take, have good solubility, and release the drug effect quickly. Spray drying and wet granulation technology are used to ensure drug stability, making them suitable for children and the elderly.

[0246] Example 2: Preparation of oral solution

[0247] This embodiment provides an oral liquid preparation, which uses microemulsification technology to improve bioavailability and ensure its long-term storage stability.

[0248] (1) Extraction process

[0249] Water extraction process:

[0250] Take Astragalus, Ganoderma lucidum, Codonopsis pilosula, and Lycium barbarum, add water in a ratio of 1:8 to 1:12, and boil for 2 hours, keeping the temperature at 75°C to 85°C.

[0251] After filtration, the extraction was repeated once, the extracts were combined, and concentrated under reduced pressure to control the concentration at 1.2 g / mL.

[0252] Supercritical CO2 extraction:

[0253] Take Atractylodes macrocephala, Licorice, and Acanthopanax senticosus, grind them into 20 to 40 meshes, and put them into supercritical CO2 extraction equipment. The extraction temperature is controlled at 35°C to 45°C and the pressure is 25MPa to 30MPa.

[0254] The extract was collected and combined with the water extract.

[0255] Alcohol precipitation process:

[0256] Use 60% to 70% ethanol for alcohol precipitation. After standing for 12 hours, centrifuge and remove the precipitate.

[0257] (2) Preparation of oral solution

[0258] Microemulsification technology:

[0259] The extract is mixed with an emulsifying aid (such as chitosan, polysorbate-80) and ultrasonic emulsification technology is used with an ultrasonic frequency of 40kHz to 60kHz and a time of 20 minutes to 40 minutes to form a uniform emulsion of the insoluble components and improve bioavailability.

[0260] Filter sterilization:

[0261] Use 0.22μm to 0.3μm filter membrane for sterile filtration to remove microbial contamination.

[0262] Filling:

[0263] Using aseptic filling technology, the product is packed into brown glass bottles, the bottle mouth is sealed, and filled with nitrogen to reduce the risk of oxidative degradation.

[0264] (3) Packaging

[0265] The oral solution is packaged in brown glass bottles or light-proof plastic bottles with tightly sealed bottle mouths. The storage temperature is 15°C to 25°C and should be avoided from direct sunlight.

[0266] Beneficial effects: Microemulsion oral solution improves the solubility and absorption rate of drugs, and nitrogen filling technology prevents oxidative degradation and ensures long-term stability of drugs.

[0267] Example 3: Preparation of capsules

[0268] This embodiment provides a capsule preparation, which improves the stability of the drug through freeze-drying technology and achieves a sustained release effect using microencapsulation technology.

[0269] (1) Extraction process

[0270] Water extraction process:

[0271] Take astragalus, ganoderma lucidum, codonopsis pilosula, and wolfberry, and boil them in a ratio of 1:8 to 1:12. The temperature is controlled at 70°C to 90°C and the boiling time is 1.5 hours to 2.5 hours.

[0272] After filtration, the extraction was repeated once, and the extracts were combined and concentrated under reduced pressure to a specific gravity of 1.1 g / mL to 1.3 g / mL.

[0273] Supercritical CO2 extraction:

[0274] Take Atractylodes macrocephala, Licorice, and Acanthopanax, with an extraction temperature of 35°C to 45°C, a pressure of 25MPa to 30MPa, a CO2 flow rate of 15L / h to 25L / h, and an extraction time of 1.5 hours to 2.5 hours.

[0275] The extract was collected and combined with the water extract.

[0276] Alcohol precipitation process:

[0277] Use an ethanol concentration of 55% to 75%, a liquid ratio of 1:1 to 1:1.5, and let it stand for 8 to 16 hours.

[0278] The centrifugal separation is performed at a rotation speed of 3000 rpm to 5000 rpm for 15 to 25 minutes.

[0279] (2) Capsule filling

[0280] Freeze drying:

[0281] The extract is freeze-dried with the temperature controlled at -45°C to -35°C for 18 hours to 30 hours to obtain a powdered medicine.

[0282] Microencapsulation:

[0283] Chitosan is used for microencapsulation to improve the sustained-release effect of drugs.

[0284] Capsule filling:

[0285] Use an automatic capsule filling machine to fill size 0 or size 1 capsules.

[0286] (3) Packaging

[0287] The capsules are packaged in aluminum-plastic blisters and the outer packaging uses a moisture-proof aluminum foil bag. The storage temperature is controlled at 15°C to 25°C and the relative humidity is 30% to 60%.

[0288] Beneficial effects: Freeze-drying technology maintains drug activity, microencapsulation achieves sustained release, and capsules are suitable for long-term use, improving patient compliance.

[0289] Table 1: Comparison table of different embodiments and prior art

[0290] Compare Projects Prior art Example 1 (granules) Example 2 (Oral Liquid) Example 3 (capsules) Improved extraction rate 50%-65% 75%-85% (multiple extractions + fluidized bed drying) 80%-90% (microemulsification + optimized extraction) <![CDATA[85%-95% (Lyophilization + Supercritical CO2)]]> Improved bioavailability Low (some ingredients are poorly soluble) Higher (granules dissolve quickly) High (nanoemulsion improves absorption) Highest (microcapsule encapsulation + sustained release technology) Active ingredient stability Poor (susceptible to light and oxygen) Good (aluminum foil packaging + desiccant) Excellent (brown bottle + nitrogen filling) Best (aluminum-plastic blister + moisture-proof packaging) Extended shelf life 6-12 months 18-24 months 24-30 months 24-36 months Patient compliance General (some dosage forms are inconvenient to take) Higher (granules are convenient to take) High (improved taste, suitable for children) Highest (extended-release capsules reduce the number of doses)

[0291] Explanation of characters in the table comparison items:

[0292] Improved extraction rate

[0293] Meaning: Refers to the efficiency of extracting the target active ingredients from raw medicinal materials. A higher extraction rate means that more active ingredients can be obtained from the same amount of raw materials, improving the efficacy of the medicine while reducing the waste of medicinal materials.

[0294] Data meaning:

[0295] Existing technology: 50%-65%, the extraction rate is low, and some active ingredients are not fully extracted.

[0296] Granules: 75%-85%, using multiple extractions + fluidized bed drying process to increase the release rate of active ingredients.

[0297] Oral solution: 80%-90%, through microemulsification + optimized extraction, the solubility is enhanced and the water-soluble components are fully extracted.

[0298] Capsules: 85%-95%, combined with supercritical CO2 extraction + freeze drying to ensure maximum extraction rate.

[0299] Improved bioavailability

[0300] Meaning: Refers to the degree to which a drug is absorbed and exerts its effects after entering the human body. Higher bioavailability means that the drug can exert its therapeutic effects faster and more effectively, reducing drug waste.

[0301] Data meaning:

[0302] Existing technology: Low (some ingredients are difficult to dissolve). Since some ingredients are difficult to dissolve or be absorbed by the human body, the efficacy of the drug is unstable.

[0303] Granules: Higher (granules dissolve quickly), granules can dissolve quickly and improve absorption rate.

[0304] Oral solution: High (nanoemulsion improves absorption), using microemulsification technology to convert insoluble ingredients into nanoemulsion to improve absorption rate.

[0305] Capsules: The highest (microencapsulation + sustained-release technology). Microencapsulation can enhance the absorption of fat-soluble ingredients, while sustained-release technology prolongs the duration of drug efficacy.

[0306] Active ingredient stability

[0307] Meaning: Refers to the ability of the active ingredients in a drug to remain effective during storage and use. If stability is poor, the drug may become ineffective due to exposure to light, oxidation, or changes in humidity.

[0308] Data meaning:

[0309] Existing technology: Poor (vulnerable to light and oxygen), traditional extraction methods cause drugs to be easily degraded.

[0310] Granules: Good (aluminum foil packaging + desiccant), use aluminum foil seal + desiccant to reduce the impact of humidity and delay the degradation of ingredients.

[0311] Oral solution: Excellent (brown bottle + nitrogen filling), using brown glass bottle to avoid light + nitrogen filling to reduce oxidation reaction and improve stability.

[0312] Capsules: Best (aluminum-plastic blister + moisture-proof packaging), the aluminum-plastic blister provides a fully enclosed moisture-proof design to ensure the highest stability of the ingredients.

[0313] Extended shelf life

[0314] Meaning: It refers to the time that a drug can maintain its efficacy under appropriate storage conditions. The longer the shelf life, the longer the drug can be used clinically and circulated in the market, thus reducing losses.

[0315] Data meaning:

[0316] Existing technology: 6-12 months, strict storage conditions and poor stability.

[0317] Granules: 18-24 months, using low-temperature drying + sealed packaging to effectively extend the shelf life.

[0318] Oral solution: 24-30 months, microemulsion stabilizer + storage away from light to make it more durable.

[0319] Capsules: 24-36 months. The capsules are sealed to prevent moisture, and the sustained-release structure reduces degradation.

[0320] Patient compliance

[0321] Meaning: Refers to the likelihood that a patient is willing to take the medication at the prescribed dose and time. Influencing factors include the dosage form, ease of taking, taste, etc.

[0322] Data meaning:

[0323] Existing technology: general (some dosage forms are inconvenient to take), for example, traditional decoctions require a long time to boil and are inconvenient to take.

[0324] Granules: Higher (granules are convenient to take), granules can be taken directly, have a better taste, and are suitable for long-term use.

[0325] Oral solution: High (improved taste, suitable for children), the taste-optimized oral solution is more suitable for children and the elderly and is easy to swallow.

[0326] Capsules: Highest (sustained-release capsules reduce the number of times you take the medicine). Sustained-release capsules reduce the number of times you take the medicine every day and improve patient compliance.

[0327] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese patent medicine compound preparation having immunomodulatory effect, characterized in that: The composition includes the following Chinese medicinal materials: Astragalus, Ganoderma lucidum, Codonopsis pilosula, Atractylodes macrocephala, Licorice root, Lycium barbarum and Acanthopanax senticosus; The weight proportions of the traditional Chinese medicine are as follows: 10-30 parts of astragalus, 5-20 parts of ganoderma lucidum, 8-25 parts of codonopsis pilosula, 6-18 parts of atractylodes macrocephala, 3-10 parts of liquorice, 5-15 parts of wolfberry, and 5-12 parts of acanthopanax senticosus.

2. A process for preparing a Chinese patent medicine compound preparation having an immunomodulatory effect, characterized in that: The Chinese patent medicine compound preparation with immunomodulatory effect as claimed in claim 1 comprises the following steps: S1. Pre-treatment of medicinal materials: screening, removing impurities, drying and crushing the Chinese medicine; S2, water extraction process, decocting some medicinal materials, filtering and concentrating to obtain water extract; S3, supercritical CO2 extraction, supercritical extraction of some medicinal materials to obtain fat-soluble extracts; S4, alcohol precipitation process, combining the extract of S2 and the extract of S3, adding a precipitant and letting it stand, and then centrifuging to remove impurities; S5. Preparation process, preparing the purified extract into granules, oral solution or capsules.

3. The preparation process of a Chinese patent medicine compound preparation with immunomodulatory effect according to claim 2, characterized in that: In step S1, the medicinal material is processed by the following steps: S101. Screening of medicinal materials Screen the herbs to remove impurities, including weeds, insect-infested and moldy parts; S102, Drying Use low-temperature drying technology, with the temperature not exceeding 60°C, to avoid loss of active ingredients in the medicinal materials; S103, crush The dried medicinal materials are crushed to 80-100 mesh to increase the surface area of ​​the medicinal materials and promote the effect of subsequent extraction.

4. The preparation process of a Chinese patent medicine compound preparation with immunomodulatory effect according to claim 2, characterized in that: In the step S2, the water extraction process is carried out by the following steps: S201, soak The crushed medicinal materials are mixed with purified water in a ratio of 1:8 to 1:12, and soaked at room temperature for 1 to 3 hours to promote the dissolution of the active ingredients in the medicinal materials; S202, decoction The soaked medicinal materials are decocted at a temperature of 70°C to 90°C for 1.5 to 2.5 hours; S203, repeated extraction By multiple decoctions, the extraction rate of the effective ingredients is increased, and the extraction is repeated 1 to 2 times, with each decoction time being 1 to 2 hours; S204, Filtration and Concentration The extract is filtered by centrifugation to remove insoluble impurities, and then concentrated under reduced pressure with the temperature controlled at 40°C to 55°C and the pressure controlled at 40kPa to 60kPa to a liquid density of 1.1g / mL to 1.3g / mL.

5. The process for preparing a Chinese patent medicine compound preparation having immunomodulatory effect according to claim 2, characterized in that: In the step S3, the supercritical CO2 extraction process is carried out by the following steps: S301. Preparation of medicinal materials The Atractylodes macrocephala, Glycyrrhiza uralensis and Acanthopanax senticosus were crushed into coarse particles with a particle size ranging from 20 mesh to 50 mesh to improve the extraction efficiency; S302, Supercritical CO2 Extraction Put the crushed medicinal materials into a supercritical CO2 extraction device, adjust the CO2 pressure to 25MPa to 35MPa, control the temperature at 35°C to 45°C, control the CO2 flow rate at 15L / h to 25L / h, and perform the extraction time range of 1.5 hours to 2.5 hours; S303, Extraction Liquid Separation After the extraction process, the effective components are separated using a reduced pressure separation device, and the fat-soluble extracts including glycyrrhizic acid and volatile oils are collected.

6. The process for preparing a Chinese patent medicine compound preparation having immunomodulatory effect according to claim 2, characterized in that: In the step S4, the alcohol precipitation process is carried out by the following steps: S401, combined extracts combining the water extract and the supercritical extract to obtain a mixed solution; S402, alcohol precipitation adding ethanol to the combined extracts, wherein the ethanol concentration ranges from 55% to 75% and the liquid ratio ranges from 1:1 to 1:1.5, mixing, and allowing to stand for 8 hours to 16 hours; S403, centrifugal separation A centrifuge is used for separation, with a speed setting range of 3000 rpm to 5000 rpm and a time of 15 minutes to 25 minutes to remove precipitated impurities and obtain a pure drug solution.

7. The process for preparing a Chinese patent medicine compound preparation having immunomodulatory effect according to claim 2, characterized in that: In the step S5, the granule preparation comprises: The concentrated liquid medicine after alcohol precipitation is spray dried, and the air inlet temperature is controlled at 100°C to 130°C, and the air outlet temperature is controlled at 50°C to 70°C; Using ethanol as a binder, the ethanol concentration ranges from 65% to 75%, wet granulation is performed to obtain granules; Fluidized bed drying technology is used, and the drying temperature is controlled at 45°C to 55°C so that the moisture content of the particles does not exceed 5%.

8. The process for preparing a Chinese patent medicine compound preparation having immunomodulatory effect according to claim 2, characterized in that: In the step S5, the preparation of the oral solution comprises: The concentrated drug solution and the emulsifying agent are subjected to ultrasonic emulsification treatment, the ultrasonic frequency is controlled at 40kHz to 60kHz, and the duration is 20 minutes to 40 minutes; Filter through a membrane with a pore size range of 0.2 μm to 0.3 μm to remove bacteria and ensure the sterility of the oral solution; Using aseptic filling technology, the processed oral solution is packaged into brown glass bottles, with the capacity of each bottle ranging from 5mL to 15mL.

9. The process for preparing a Chinese patent medicine compound preparation having immunomodulatory effect according to claim 2, characterized in that: In the step S5, the capsule preparation comprises: The concentrated solution after alcohol precipitation is converted into powder by freeze drying at a temperature of -45°C to -35°C for a duration of 18 to 30 hours; Use chitosan for microencapsulation to enhance the sustained release effect of drugs; The powder wrapped in the microcapsules is filled into capsules by an automatic capsule filling machine, and the capsule specification is No. 0 or No.

1.

10. The process for preparing a Chinese patent medicine compound preparation having immunomodulatory effect according to claim 2, characterized in that: The granules are packaged in sealed aluminum foil bags, and a food-grade desiccant is added to the inner packaging; The oral liquid is packaged in brown glass bottles or light-proof plastic bottles, the bottle mouths are sealed, and filled with an appropriate amount of nitrogen to reduce the risk of oxidative degradation; The capsules are packaged in aluminum-plastic blister packaging, and a moisture-proof aluminum foil bag is used in the outer packaging to prevent the capsules from being affected by humidity and light during storage.

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