Ginseng, acanthopanax root and aralia elata extract composite effervescent tablet with immune regulation function and preparation method of ginseng, acanthopanax root and aralia elata extract composite effervescent tablet

Abstract

The invention relates to a composite effervescent tablet and a preparation method, in particular to a ginseng, acanthopanax and aralia elata extract composite effervescent tablet with an immune regulation function and a preparation method thereof. In order to solve the problems that in the prior art, only a single polysaccharide is adopted for immunoregulation and the anti-tumor effect is poor, the novel pharmaceutical composition is provided, the three polysaccharides are integrated, comprehensive regulation of an immune system is achieved through the compatibility of ginseng, acanthopanax and aralia elata under the complementary effect, immune defense of a body is enhanced, and the anti-tumor effect is good. And the safety is ensured. The medicine has the main advantages that by tonifying qi and blood, promoting blood circulation and balancing yin and yang, the immune function is optimized, and the side effects such as excessive tonifying or qi stagnation and blood stasis are avoided. Besides, the three components have a synergistic effect through different immunomodulatory mechanisms, so that the immune cell activity is improved, the immune response is enhanced, and blood circulation and cell repair are supported, thereby realizing a comprehensive and durable immune enhancement effect.

Description

Technical Field

[0001] The invention relates to a composite effervescent tablet and a preparation method thereof. Background Art

[0002] Ginseng polysaccharides, Acanthopanax senticosus polysaccharides and Aralia dasyphylla polysaccharides all have significant immunomodulatory and anti-tumor effects. Among them, ginseng polysaccharides can enhance the humoral and cellular immune functions of mice and have an inhibitory effect on tumor metastasis. In the treatment of non-small cell lung cancer, ginseng polysaccharides show good therapeutic effects and reduce adverse reactions by regulating immune cells. Clinical trials have further confirmed that the combination of ginseng polysaccharides and chemotherapy drugs can significantly improve the therapeutic effect of breast cancer and exert anti-cancer effects by downregulating the expression of tumor markers. Acanthopanax senticosus polysaccharides, as the main active ingredient of Acanthopanax senticosus, also show excellent immunomodulatory ability. Studies have shown that Acanthopanax senticosus polysaccharides can significantly improve the phagocytic ability of mouse mononuclear macrophages and enhance humoral immunity. In an immunosuppressive mouse model, Acanthopanax senticosus polysaccharide nanoemulsion stimulates spleen cell proliferation by enhancing immune function. Studies have shown that Aralia dasyphylla polysaccharides can improve the quality of immune organs and the number of lymphocytes in tumor-bearing mice, promote lymphocyte proliferation, and show anti-inflammatory activity and prolonged survival time in a variety of tumor models. Although these polysaccharides have shown therapeutic effects when used alone, the effect of improving immunity when used alone is not significant, and research on the combined use of several polysaccharides is still blank.

[0003] As an emerging drug dosage form, effervescent tablets have many advantages: they are easy to take, especially suitable for patients with dysphagia, and by adding flavoring agents, the taste of effervescent tablets is improved, which is more in line with the taste of modern people. Effervescent tablets dissolve quickly in water, the active ingredients are easy to absorb, and the bioavailability is high, making them effective and effective. Solid effervescent tablets are easy to carry and simple to use. They only need to be added with water, and they are quickly and evenly distributed in water, ensuring the stable effect of the drug. In addition, the improvement of effervescent tablets not only retains the pharmacological effects of traditional Chinese medicine, but also integrates the flavor and nutritional value of food. The products on the market are brightly colored, unique in taste, and have edible value, realizing the dual use of medicine and food, and are widely welcomed by consumers. Therefore, effervescent tablets have broad development potential in the healthcare and food industries. Summary of the invention

[0004] The present invention aims to solve the problem that only a single polysaccharide is used for immunomodulation and anti-tumor effects in the prior art, and proposes a new pharmaceutical composition that combines three polysaccharides in one to optimize immunomodulation and enhance anti-tumor therapeutic effects through synergistic effects.

[0005] The composite effervescent tablet of ginseng, acanthopanacis and elata extracts with immunomodulatory function is prepared from composite polysaccharides, disintegrants, adhesives, lubricants and diluents; the composite polysaccharides are composed of ginseng polysaccharide extracts, acanthopanacis polysaccharide extracts and elata polysaccharide extracts.

[0006] The preparation method of the composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function of the present invention is carried out according to the following steps:

[0007] Step 1: weighing compound polysaccharide, disintegrant, binder, lubricant and diluent as raw materials according to the composition of the compound effervescent tablet;

[0008] Step 2: 50% of the weighed composite polysaccharide, citric acid in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles a;

[0009] Step 3: 50% of the complex polysaccharide, sodium bicarbonate in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles b;

[0010] Step 4: Mix the raw material particles a, raw material particles b and lubricant evenly and press them into tablets to obtain effervescent tablets.

[0011] The principles and beneficial effects of the present invention are:

[0012] 1. The present invention provides a composite polysaccharide effervescent tablet based on ginseng polysaccharide, Acanthopanax senticosus polysaccharide, and Aralia dasyphylla polysaccharide, which is a safe and efficient preparation that can significantly improve the cellular immunity, thymus and spleen index, and macrophage phagocytic ability of mice, and enhance overall immunity. After the combination of multiple polysaccharides, a synergistic effect is achieved to more effectively inhibit tumor growth, protect and repair immune function, and significantly improve the immunity of tumor-bearing mice. In addition, the synergistic effect between different polysaccharide components provides a research reference for future clinical applications. The combined action of these three polysaccharides has a complementary effect, which comprehensively improves the immune regulation function.

[0013] Ginseng has the effects of replenishing vital energy, tonifying the spleen and lungs; Acanthopanax can replenish qi and strengthen the spleen, tonify the kidneys and calm the mind; Aralia elata has the effects of replenishing qi and nourishing yin, clearing away heat and detoxifying. The combination of the three can replenish qi and blood, strengthen the body and eliminate evil, balance yin and yang, and enhance the body's immunity. Ginseng and Acanthopanax can promote the function of immune cells, while Aralia elata can improve the oxygen supply of organs and the transportation of nutrients by promoting blood circulation and qi. The combination of the three can prevent low immunity caused by qi deficiency, and avoid qi stagnation and blood stasis caused by excessive supplementation, ensuring the effectiveness and safety of treatment.

[0014] Ginseng polysaccharides, Acanthopanax senticosus polysaccharides and Aralia elata polysaccharides can achieve complementary effects through multi-target effects:

[0015] First of all, ginseng polysaccharides, with their rich β-D-glucose chains and branched structures, can effectively bind to specific receptors on the surface of immune cells, thereby activating cellular immune responses, including promoting the proliferation and differentiation of T cells, as well as regulating immune balance and preventing excessive immune responses. Acanthopanax senticosus polysaccharides can not only stimulate the activity of immune cells such as macrophages and natural killer cells, and enhance their ability to identify and eliminate pathogens and tumor cells, but also promote the proliferation and differentiation of T cells and B cells, increase the number of immune cells, and strengthen immune responses. At the same time, it also has anti-stress properties, which can help immune cells remain stable when under external pressure. Liaodong Aralia polysaccharides enhance the function of vascular endothelial cells by regulating vascular endothelial growth factor VEGF, promote vasodilation, and thus improve blood circulation and relieve qi stagnation and blood stasis.

[0016] Secondly, the antioxidant properties of ginseng polysaccharides and Acanthopanax senticosus polysaccharides and the anti-inflammatory effects of Aralia dasyphylla polysaccharides help to reduce oxidative stress and inflammatory responses in immune responses. During the immune response, immune cells produce a large number of free radicals and inflammatory mediators. If these substances accumulate too much, they may cause cell damage and tissue inflammation. The sugar units in ginseng polysaccharides and Acanthopanax senticosus polysaccharides, such as glucose, mannose, galactose, etc., can react with free radicals through their hydroxyl groups to remove free radicals. It enables them to remove free radicals in immune cells, thereby protecting cells from oxidative stress. This antioxidant effect helps maintain the normal function of immune cells and prevents them from losing their activity due to oxidative damage. The uronic acid group on the polysaccharide chain of Aralia dasyphylla polysaccharide is the key structure of its anti-inflammatory effect. Uronic acid can bind to inflammatory mediators and inhibit inflammatory responses. It reduces the inflammatory state of tissues by inhibiting the production and release of inflammatory mediators and regulating inflammatory signaling pathways. This anti-inflammatory effect not only helps to protect immune cells from inflammatory damage, but also reduces the damage of immune responses to normal tissues.

[0017] In terms of formulation, the design of this complex polysaccharide effervescent tablet takes into account the optimization of solubility and stability: first, citric acid and sodium bicarbonate are selected as effervescent disintegrants, which quickly produce carbon dioxide in water, promoting the rapid disintegration and dissolution of polysaccharides; also, the loss and oxidation of ingredients in the traditional decoction process are avoided, thereby improving stability; through solubility tests and long-term stability tests, the quality is strictly controlled to ensure the rapid dissolution and stable release of polysaccharide components in the body, thereby improving bioavailability.

[0018] In summary, the combination of ginseng, Acanthopanax senticosus and Aralia dasyphylla achieves comprehensive regulation of the immune system through complementary effects, which not only enhances the body's immune defense but also ensures safety. Its main advantage is to optimize immune function by replenishing qi and blood, promoting blood circulation, and balancing yin and yang, and avoid side effects such as excessive replenishment or qi stagnation and blood stasis. In addition, the three work synergistically through different immune regulation mechanisms to jointly enhance immune cell activity, enhance immune response, and support blood circulation and cell repair, thereby achieving a comprehensive and lasting immune enhancement effect.

[0019] 2. The effervescent tablet of the present invention remains stable under conventional storage conditions, and the polysaccharide component is easily soluble, thereby improving bioavailability.

[0020] 3. The effervescent tablet of the present invention is different from the powdered polysaccharide in the prior art. Instead, the ginseng polysaccharide, Acanthopanax senticosus polysaccharide and Aralia dasyphylla polysaccharide with immunomodulatory function are prepared into the form of effervescent tablets through the process of food processing. This drug dosage form is easier to take, making the three components easier to be absorbed by the human body, thereby enhancing their efficacy. It also improves the taste and promotes the in-depth development of the three medicinal resources.

[0021] 4. Functional evaluation showed that the tumor inhibition rate of the effervescent tablets of the present invention on tumor mice was 53.71%-56.23%.

[0022] 5. The present invention prepares effervescent tablets by separate granulation of acid source and alkali source. First, the acid source and the alkali source are not in direct contact in the early stage of granulation, which avoids the side reactions that may be caused by the mixed granulation of the acid source and the alkali source, such as precipitation or complex formation. Secondly, the mixing is carried out after the particles are dried, which can reduce the adsorption of the auxiliary materials on the effective ingredients of ginseng, Acanthopanax senticosus, and Aralia dasyphylla polysaccharides by the auxiliary materials through mature and stable particle structure, control of moisture and temperature, and delay of contact between the auxiliary materials and the main drug, thereby further improving the content of the main drug composite polysaccharide of the effervescent tablet. The effervescent tablet prepared by the present invention has the characteristics of small size, easy to carry, and convenient to take. DETAILED DESCRIPTION

[0023] The technical solution of the present invention is not limited to the specific implementation modes listed below, but also includes any reasonable combination of the specific implementation modes.

[0024] Specific implementation method 1: In this implementation method, the composite effervescent tablet of ginseng, Acanthopanax and Aralia elata extracts with immunomodulatory function is prepared from composite polysaccharides, disintegrants, adhesives, lubricants and diluents; the composite polysaccharides are composed of ginseng polysaccharide extracts, Acanthopanax polysaccharide extracts and Aralia elata polysaccharide extracts.

[0025] This embodiment has the following beneficial effects:

[0026] 1. This embodiment provides a composite polysaccharide effervescent tablet based on ginseng polysaccharide, Acanthopanax senticosus polysaccharide, and Aralia dasyphylla polysaccharide, which is a safe and efficient preparation that can significantly improve the cellular immunity, thymus and spleen index, and macrophage phagocytosis of mice, and enhance overall immunity. After the combination of multiple polysaccharides, a synergistic effect is achieved to more effectively inhibit tumor growth, protect and repair immune function, and significantly improve the immunity of tumor-bearing mice. In addition, the synergistic effect between different polysaccharide components provides a research reference for future clinical applications. The combined action of these three polysaccharides has a complementary effect, which comprehensively improves the immunoregulatory function.

[0027] Ginseng has the effects of replenishing vital energy, tonifying the spleen and lungs; Acanthopanax can replenish qi and strengthen the spleen, tonify the kidneys and calm the mind; Aralia elata has the effects of replenishing qi and nourishing yin, clearing away heat and detoxifying. The combination of the three can replenish qi and blood, strengthen the body and eliminate evil, balance yin and yang, and enhance the body's immunity. Ginseng and Acanthopanax can promote the function of immune cells, while Aralia elata can improve the oxygen supply of organs and the transportation of nutrients by promoting blood circulation and qi. The combination of the three can prevent low immunity caused by qi deficiency, and avoid qi stagnation and blood stasis caused by excessive supplementation, ensuring the effectiveness and safety of treatment.

[0028] Ginseng polysaccharides, Acanthopanax senticosus polysaccharides and Aralia elata polysaccharides can achieve complementary effects through multi-target effects:

[0029] First of all, ginseng polysaccharides, with their rich β-D-glucose chains and branched structures, can effectively bind to specific receptors on the surface of immune cells, thereby activating cellular immune responses, including promoting the proliferation and differentiation of T cells, as well as regulating immune balance and preventing excessive immune responses. Acanthopanax senticosus polysaccharides can not only stimulate the activity of immune cells such as macrophages and natural killer cells, and enhance their ability to identify and eliminate pathogens and tumor cells, but also promote the proliferation and differentiation of T cells and B cells, increase the number of immune cells, and strengthen immune responses. At the same time, it also has anti-stress properties, which can help immune cells remain stable when under external pressure. Liaodong Aralia polysaccharides enhance the function of vascular endothelial cells by regulating vascular endothelial growth factor VEGF, promote vasodilation, and thus improve blood circulation and relieve qi stagnation and blood stasis.

[0030] Secondly, the antioxidant properties of ginseng polysaccharides and Acanthopanax senticosus polysaccharides and the anti-inflammatory effects of Aralia dasyphylla polysaccharides help to reduce oxidative stress and inflammatory responses in immune responses. During the immune response, immune cells produce a large number of free radicals and inflammatory mediators. If these substances accumulate too much, they may cause cell damage and tissue inflammation. The sugar units in ginseng polysaccharides and Acanthopanax senticosus polysaccharides, such as glucose, mannose, galactose, etc., can react with free radicals through their hydroxyl groups to remove free radicals. It enables them to remove free radicals in immune cells, thereby protecting cells from oxidative stress. This antioxidant effect helps maintain the normal function of immune cells and prevents them from losing their activity due to oxidative damage. The uronic acid group on the polysaccharide chain of Aralia dasyphylla polysaccharide is the key structure of its anti-inflammatory effect. Uronic acid can bind to inflammatory mediators and inhibit inflammatory responses. It reduces the inflammatory state of tissues by inhibiting the production and release of inflammatory mediators and regulating inflammatory signaling pathways. This anti-inflammatory effect not only helps to protect immune cells from inflammatory damage, but also reduces the damage of immune responses to normal tissues.

[0031] In summary, the combination of ginseng, Acanthopanax senticosus and Aralia dasyphylla achieves comprehensive regulation of the immune system through complementary effects, which not only enhances the body's immune defense but also ensures safety. Its main advantage is to optimize immune function by replenishing qi and blood, promoting blood circulation, and balancing yin and yang, and avoid side effects such as excessive replenishment or qi stagnation and blood stasis. In addition, the three work synergistically through different immune regulation mechanisms to jointly enhance immune cell activity, enhance immune response, and support blood circulation and cell repair, thereby achieving a comprehensive and lasting immune enhancement effect.

[0032] 2. The effervescent tablet of this embodiment remains stable under normal storage conditions, and the polysaccharide component is easily soluble, thereby improving bioavailability.

[0033] 3. The effervescent tablet of this embodiment is different from the powdered polysaccharide in the prior art. Instead, the ginseng polysaccharide, Acanthopanax senticosus polysaccharide and Aralia dasyphylla polysaccharide with immunomodulatory function are prepared into the form of effervescent tablets through the process of food processing. This drug dosage form is easier to take, making the three ingredients easier to be absorbed by the human body, thereby enhancing their efficacy. It also improves the taste and promotes the in-depth development of the three medicinal resources.

[0034] 4. Functional evaluation showed that the tumor inhibition rate of the effervescent tablet of this embodiment on tumor-bearing mice was 53.71%-56.23%.

[0035] Specific embodiment 2: This embodiment differs from specific embodiment 1 in that the mass fraction of the composite polysaccharide in the composite effervescent tablet is 13%-16%, the mass fraction of the disintegrant is 40%-60%, the mass fraction of the binder is 1.8%-2.2%, the mass fraction of the lubricant is 1%-4%, and the diluent is the balance.

[0036] Specific implementation method three: This implementation method is different from specific implementation methods one or two in that the mass ratio of ginseng polysaccharide extract, Acanthopanax senticosus polysaccharide extract and Aralia elata polysaccharide extract is 18.7:11.25:100.

[0037] Specific embodiment 4: This embodiment is different from any one of specific embodiments 1 to 3 in that: the disintegrants are citric acid and sodium bicarbonate, sodium bicarbonate is used as the alkali source, citric acid is used as the acid source, and the mass ratio of citric acid to sodium bicarbonate is 0.4-1.2:1.

[0038] Specific implementation mode 5: This implementation mode is different from specific implementation modes 1 to 4 in that: the adhesive is an ethanol solution of polyvinyl pyrrolidone.

[0039] Specific implementation method 6: This implementation method is different from specific implementation method 5 in that the mass fraction of polyvinyl pyrrolidone in the adhesive is 2%-5%.

[0040] Specific implementation method 7: This implementation method is different from any one of specific implementation methods 1 to 6 in that: the lubricant is polyethylene glycol.

[0041] Specific implementation method eight: This implementation method is different from specific implementation method seven in that: the average molecular weight of the polyethylene glycol is 6000.

[0042] Specific implementation method 9: This implementation method is different from any one of specific implementation methods 1 to 8 in that: the diluent is erythritol.

[0043] Specific embodiment 10: The preparation method of the composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function in this embodiment is carried out according to the following steps:

[0044] Step 1: weighing compound polysaccharide, disintegrant, binder, lubricant and diluent as raw materials according to the composition of the compound effervescent tablet;

[0045] Step 2: 50% of the weighed composite polysaccharide, citric acid in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles a;

[0046] Step 3: 50% of the complex polysaccharide, sodium bicarbonate in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles b;

[0047] Step 4: Mix the raw material particles a, raw material particles b and lubricant evenly and press them into tablets to obtain effervescent tablets.

[0048] The design of the composite polysaccharide effervescent tablet of this embodiment takes into account the optimization of solubility and stability: first, citric acid and sodium bicarbonate are selected as effervescent disintegrants, which rapidly generate carbon dioxide in water, promoting the rapid disintegration and dissolution of polysaccharides; and, the loss and oxidation of components in the traditional decoction process are avoided, thereby improving stability; through solubility testing and long-term stability testing, the quality is strictly controlled to ensure the rapid dissolution and stable release of polysaccharide components in the body, thereby improving bioavailability.

[0049] The effervescent tablet of the present embodiment remains stable under conventional storage conditions, and the polysaccharide component is easily soluble, thereby improving bioavailability. The present embodiment prepares the effervescent tablet by separate granulation of acid source and alkali source. First, the acid source and the alkali source are not in direct contact in the early stage of granulation, thereby avoiding the side reactions that may be caused by the mixed granulation of the acid source and the alkali source, such as precipitation generation or complex formation, and secondly, mixing after the particles are dried, the contact of the auxiliary materials with the main drug can be reduced by mature and stable particle structure, controlling moisture and temperature, and delaying the contact of the auxiliary materials with the main drug, thereby reducing the adsorption of the auxiliary materials to the effective ingredients ginseng, Acanthopanax senticosus, and Aralia dasyphylla polysaccharides, further improving the main drug compound polysaccharide content of the effervescent tablet, and the effervescent tablet prepared by the present embodiment has the characteristics of small volume, convenient carrying, and convenient taking.

[0050] Embodiment 1:

[0051] The preparation method of the composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function in this embodiment is carried out according to the following steps:

[0052] Step 1: weighing compound polysaccharide, disintegrant, binder, lubricant and diluent as raw materials according to the composition of the compound effervescent tablet;

[0053] The composite effervescent tablet is prepared from composite polysaccharides, disintegrants, adhesives, lubricants and diluents; in the composite effervescent tablets: the mass fraction of the composite polysaccharide is 15%, the mass fraction of the disintegrant is 50%, the mass fraction of the adhesive is 2%, the mass fraction of the lubricant is 3%, and the mass fraction of the diluent is 30%. The composite polysaccharide is composed of ginseng polysaccharide extract, Acanthopanax senticosus polysaccharide extract and Aralia dasyphylla polysaccharide extract; the mass ratio of ginseng polysaccharide extract, Acanthopanax senticosus polysaccharide extract and Aralia dasyphylla polysaccharide extract is 18.7:11.25:100; the disintegrant is citric acid and sodium bicarbonate, sodium bicarbonate is used as the alkali source, citric acid is used as the acid source, and the mass ratio of citric acid to sodium bicarbonate is 1:1; the adhesive is an ethanol solution of polyvinyl pyrrolidone; the mass fraction of polyvinyl pyrrolidone in the adhesive is 3%; the lubricant is polyethylene glycol; the average molecular weight of the polyethylene glycol is 6000; the diluent is erythritol;

[0054] Step 2: 50% of the weighed composite polysaccharide, citric acid in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles a;

[0055] Step 3: 50% of the complex polysaccharide, sodium bicarbonate in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles b;

[0056] Step 4: Mix the raw material particles a, raw material particles b and lubricant evenly and press them into tablets to obtain effervescent tablets. The weight of each composite effervescent tablet is 1 g.

[0057] Verification experiment:

[0058] The immunomodulatory activity of compound polysaccharide effervescent tablets was studied using the S180 tumor-bearing mouse model. The effects of compound polysaccharide effervescent tablets of ginseng, Acanthopanax senticosus and Aralia elata on the immune function of tumor mice were explored through in vivo immune experiments. The effects of compound polysaccharide effervescent tablets on the immunomodulatory activity of S180 tumor-bearing mouse animal models were studied.

[0059] 1. Experimental groups: Kunming mice were randomly divided into 8 groups according to their weight, namely blank control group, model group, ginseng polysaccharide group, Acanthopanax senticosus polysaccharide group, Aralia elata polysaccharide group, complex polysaccharide group, and complex polysaccharide effervescent tablet group, with 10 mice in each group.

[0060] 2. Dosage: Each group of mice was given the drug by gavage, and the dosage volume was calculated according to body weight. The normal control group was given an equal volume of normal saline, once a day, for 20 consecutive days.

[0061] Blank control group: physiological saline: 0.2 ml / mouse.

[0062] Model group: Normal saline: 0.2 ml / rat.

[0063] Positive drug group: Aidi injection 6.25 mg / (kg·d).

[0064] Ginseng polysaccharide group: 19.64 mg / (kg·d).

[0065] Acanthopanax senticosus polysaccharide group: 11.81 mg / (kg·d).

[0066] Aralia elata polysaccharide group: 105 mg / (kg·d).

[0067] Complex polysaccharide group: 136.45 mg / (kg·d).

[0068] Compound polysaccharide effervescent tablet group: 910 mg / (kg·d).

[0069] 3. Effect of compound polysaccharide effervescent tablets on tumor inhibition rate in S180 tumor-bearing mice

[0070] Tumor inhibition rate: 24 hours after the last administration, the animals were killed by cervical dislocation, the tumors were removed, the mass was weighed, and the tumor inhibition rate was calculated. The calculation formula is as follows:

[0071]

[0072] The results showed that compared with the model group, the inhibitory effect of the compound polysaccharide effervescent tablet group was the most obvious, reaching 54.91%, which was extremely significant compared with the model group, showing the synergistic effect of polysaccharides. The differences in tumor weight and tumor inhibition rate of mice in the compound polysaccharide effervescent tablet group were statistically significant.

[0073] Table 1 Comparison of tumor weight and tumor inhibition rate in mice

[0074]

[0075] Note: Compared with the model group, * P<0.05, ** P<0.01

[0076] 4. Effect of compound polysaccharide effervescent tablets on organ / body weight ratio of S180 tumor-bearing mice

[0077] The experimental results showed that compared with the model group, the spleen / body weight ratio and thymus / body weight ratio of the compound polysaccharide effervescent tablet group were significantly different, indicating that the compound polysaccharide effervescent tablet group can significantly increase the thymus and spleen indexes of immunocompromised mice.

[0078] Table 2 Effects on the thymus and spleen of mice

[0079]

[0080] Note: Compared with the model group, * P<0.05, ** P<0.01; compared with the blank control group, # P<0.05, ## P<0.01

[0081] 5. Effects of compound polysaccharide effervescent tablets on carbon clearance experiment in S180 tumor-bearing mice

[0082] As shown in Table 3, compared with the model group, the compound polysaccharide effervescent tablet group can significantly improve the carbon clearance phagocytosis index of mice, indicating that it has a significant enhancement effect on the carbon clearance function of mice and can effectively improve the phagocytosis index. The compound polysaccharide effervescent tablet group has the most obvious effect on mice. This shows that the compound polysaccharide effervescent tablet can superimpose the effects of each polysaccharide component and can restore the phagocytosis function of mouse macrophages inhibited by tumors to a certain extent.

[0083] Table 3 Effects on carbon clearance capacity of mouse monocytes and macrophages

[0084]

[0085] Note: Compared with the model group, * P<0.05, ** P<0.01; compared with the blank control group, # P<0.05, ## P<0.01

[0086] 6. Effect of compound polysaccharide effervescent tablets on the ability of peritoneal macrophages to phagocytose chicken red blood cells in S180 tumor-bearing mice

[0087] The results are shown in Table 4. Compared with the model group, the compound polysaccharide effervescent tablet group had a significant promoting effect on the phagocytic ability of peritoneal macrophages in mice, and the phagocytic index was much higher than that of the model group. The compound preparation can make the polysaccharide components of various Chinese medicines work synergistically and have a positive effect on the phagocytic ability of peritoneal macrophages in mice.

[0088] Table 4 Effects on the experiment of mouse macrophage phagocytosis of chicken red blood cells

[0089]

[0090] Note: Compared with the model group, * P<0.05, ** P<0.01; compared with the blank control group, # P<0.05, ## P<0.01.

Claims

1. A composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function, characterized in that: The composite effervescent tablet of ginseng, acanthopanacis and elata extracts with immunomodulatory function is prepared from composite polysaccharides, disintegrants, adhesives, lubricants and diluents; the composite polysaccharides are composed of ginseng polysaccharide extracts, acanthopanacis polysaccharide extracts and elata polysaccharide extracts.

2. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 1, characterized in that: The mass fraction of the composite polysaccharide in the composite effervescent tablet is 13%-16%, the mass fraction of the disintegrant is 40%-60%, the mass fraction of the binder is 1.8%-2.2%, the mass fraction of the lubricant is 1%-4%, and the diluent is the balance.

3. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 1, characterized in that: The mass ratio of ginseng polysaccharide extract, Acanthopanax senticosus polysaccharide extract and Aralia elata polysaccharide extract is 18.7:11.25:

100.

4. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 1, characterized in that: The disintegrants are citric acid and sodium bicarbonate, wherein the sodium bicarbonate serves as an alkali source and the citric acid serves as an acid source, and the mass ratio of the citric acid to the sodium bicarbonate is 0.4-1.2:

1.

5. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 1, characterized in that: The adhesive is an ethanol solution of polyvinyl pyrrolidone.

6. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 5, characterized in that: The mass fraction of polyvinyl pyrrolidone in the adhesive is 2%-5%.

7. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 1, characterized in that: The lubricant is polyethylene glycol.

8. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 7, characterized in that: The average molecular weight of the polyethylene glycol is 6000.

9. The composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function according to claim 1, characterized in that: The diluent is erythritol.

10. The method for preparing the composite effervescent tablet of ginseng, Acanthopanax senticosus and Aralia elata extracts with immunomodulatory function as claimed in claim 1, characterized in that: The preparation method is carried out according to the following steps: Step 1: weighing compound polysaccharide, disintegrant, binder, lubricant and diluent as raw materials according to the composition of the compound effervescent tablet; Step 2: 50% of the weighed composite polysaccharide, citric acid in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles a; Step 3: 50% of the complex polysaccharide, sodium bicarbonate in the disintegrant, 50% of the diluent and 50% of the binder are mixed to prepare a soft material, passed through a 20-mesh sieve, then dried at 60° C. for 2 h, and finally passed through a 14-mesh sieve to obtain raw material particles b; Step 4: Mix the raw material particles a, raw material particles b and lubricant evenly and press them into tablets to obtain effervescent tablets.

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