CN111011566A

CN111011566A - Orally disintegrating candy tablet with immunoregulation function

Info

Publication number: CN111011566A
Application number: CN201911082859.0A
Authority: CN
Inventors: 韩宁
Original assignee: Harbin Fanjingyuan Biotechnology Co Ltd
Current assignee: Harbin Fanjingyuan Biotechnology Co Ltd
Priority date: 2019-11-07
Filing date: 2019-11-07
Publication date: 2020-04-17

Abstract

The invention belongs to the field of food processing, and particularly relates to an orally disintegrating candy tablet with an immunoregulation function. The raw materials with the following weight ratio are extracted and then are mixed with auxiliary materials to prepare the feed additive: 2-4 parts of maitake polysaccharide, 1-5 parts of cubilose acid, 1-6 parts of silkworm chrysalis peptide and 2-5 parts of medlar extract. Has the effect of enhancing the immunity of the organism.

Description

Orally disintegrating candy tablet with immunoregulation function

Technical Field

The invention belongs to the field of food processing, and particularly relates to an orally disintegrating candy tablet with an immunoregulation function.

Background

At present, the problems of food safety, air pollution and the like seriously harm the health of people, and meanwhile, the problems of low immunity, memory decline, vision decline, damage caused by overloading of liver, stomach, kidney, lung, heart, brain and other organs, even the incidence of diseases such as infertility, malignant tumor and the like of most people are increased year by year due to excessive smoking, alcoholism, high working and living pressure, poor eating habits and the like.

Therefore, it is very important to provide people with food having an immunoregulatory effect. Many plants used as both medicine and food have an immunoregulation function, so that effective substances are often extracted and combined with other auxiliary materials for use, but the effective substances and the auxiliary materials are usually mixed to play a role in the form of the immunoregulation, and the common dosage forms comprise liquid preparations, tablets, capsules and the like.

The orally disintegrating tablet is a tablet which is not needed to be used with water or is not needed to be chewed with a small amount of water, is placed on the surface of the tongue, is rapidly dissolved or disintegrated in saliva and can enter the stomach to take effect by swallowing power. The orally disintegrating tablet is a new preparation, can be absorbed by sublingual mucosa and directly enters blood, effectively avoids first-pass effect, has small dosage and good safety, is fast to disintegrate, has quick action, and is gradually a focus of attention in the field of health food processing.

For example, patent No. cn201810321554.x provides a functional food containing Cordyceps sinensis and Maitake Mushroom, which is a tablet prepared by mixing Cordyceps militaris powder, Maitake Mushroom powder, desert cistanche powder, Ginseng radix powder, fructus Lycii powder and adjuvants. The invention also provides a preparation method and application of the functional food of cordyceps sinensis and maitake mushroom. The functional food of the cordyceps sinensis and the maitake mushroom has simple components, is completely a medicine-food homologous component, has good taste and no toxic or side effect, can be taken as a health-care product for a long time, and can be used as a dual health-care product for treatment and conditioning. The cordyceps sinensis and maitake mushroom product can improve the immunity of a human body, enhance the physical strength of the human body and inhibit the activity of tumor cells; can effectively reduce the harm of chemotherapy, radiotherapy and operation to the patients and prolong the life cycle of the patients. However, the formula has the defects of high raw material cost and unfavorable absorption due to the type of the preparation.

Patent No. CN201910440842.1 provides an edible composition and a preparation method thereof, wherein the composition comprises the following components in parts by weight: 60-70 parts of lucid ganoderma, 55-65 parts of astragalus membranaceus, 40-50 parts of ginseng, 40-50 parts of poria cocos, 25-35 parts of silkworm chrysalis, 15-25 parts of wolfberry fruits, 10-20 parts of dandelion and 5-15 parts of honey-fried licorice roots, wherein the lucid ganoderma and the astragalus membranaceus are used as monarch drugs, the ginseng and the poria cocos are used as ministerial drugs, the silkworm chrysalis and the wolfberry fruits are used as adjuvant drugs, the dandelion and the honey-fried licorice roots are used as conductant drugs, and the components are compatible with each other, are not added with any preservative or pigment, have no toxic or side effect, are safe and reliable to use; the composition of this document is prepared into an oral preparation after being made into powder, but it is not indicated which oral preparation is.

Disclosure of Invention

The invention provides an orally disintegrating candy tablet with an immunoregulation function to solve the technical problems.

The method is realized by the following technical scheme:

an orally disintegrating candy tablet with immunoregulation function is prepared by extracting the following raw materials in percentage by weight and then mixing with auxiliary materials: 2-4 parts of maitake polysaccharide, 1-5 parts of cubilose acid, 1-6 parts of silkworm chrysalis peptide and 2-5 parts of medlar extract.

The orally disintegrating candy tablet comprises the following raw materials in percentage by weight: 2-3 parts of maitake polysaccharide, 2-3 parts of cubilose acid, 2-5 parts of silkworm chrysalis peptide and 2-4 parts of medlar extract.

Extracting the above raw materials, mixing with carrier to obtain carrier mixture, mixing with adjuvants such as filler, lubricant, disintegrating agent and correctant, and making into food-grade orally disintegrating candy tablet.

The orally disintegrating candy tablet is prepared from the following raw and auxiliary materials in percentage by weight: 0.8-3% of raw material mixture, 5-10% of carrier, 65-85% of carrier filler, 1-5% of lubricant, 2-8% of disintegrant, 4-10% of flavoring agent and 0.5-1.5% of sodium citrate.

The carrier is PVPK30 or PVPK 90;

the filler consists of mannitol and MCC or lactose or sucrose in a mass ratio of 5: 1;

the lubricant is one or two of magnesium stearate and aerosil;

the disintegrating agent is one or more of PVPP, sodium carboxymethylcellulose and sodium carboxymethyl starch;

the flavoring agent can be stevioside, fructo-oligosaccharide, sorbitol, or the like;

preferably, the carrier is PVPK 30; the filler consists of mannitol and lactose in a mass ratio of 5: 1; the lubricant is magnesium stearate; the disintegrating agent is PPVP; the correctant is fructo-oligosaccharide.

The invention also relates to a preparation method of the orally disintegrating candy tablet with the immunoregulation function, which comprises the following steps:

(1) preparation of solid dispersions

Weighing the raw materials and the carrier according to the formula amount, grinding for 20-30min together, then placing in a drier at 50-60 ℃ for balancing for 2-3 days, crushing, and sieving with a 200-mesh sieve to obtain the carrier;

(2) preparation of orally disintegrating tablets

Taking a prescription amount of the solid dispersoid and a proper amount of auxiliary materials, uniformly mixing the solid dispersoid and the auxiliary materials according to an equivalent progressive method, and directly tabletting the powder to obtain the tablet with the pressure of 30-40 mPa.

Has the advantages that:

the method mainly utilizes natural substances from plant bodies to be mixed with food-grade auxiliary materials to obtain the orally disintegrating candy tablets with the immunoregulation effect.

The performance of each raw material adopted by the invention is as follows:

maitake mushroom is a medicinal and edible macrofungi, the fruiting body is rich in amino acids, multiple vitamins, Maitake mushroom Polysaccharide and microelements which are necessary for human body, has high nutritive value, and Maitake Mushroom Polysaccharide (MP) is extracted from Maitake mushroom fruiting body or its mycelium, and has various biological activities of resisting tumor, enhancing organism immunity, etc.

The cubilose is neutral and sweet in nature and taste, cubilose acid, commonly called sialic acid, is a monosaccharide conversion substance, appears in a form combined with protein, is mainly divided into N-acetylneuraminic acid which accounts for 90 percent of sialic acid, has an antiviral effect, and is commonly used for protecting the lung.

The silkworm pupa contains a large amount of protein, can generate active peptide after being hydrolyzed by protease, and has the effects of reducing blood pressure, blood sugar and blood fat, resisting oxidation, inhibiting the propagation of microorganisms such as bacteria, viruses and fungi, resisting fatigue, improving immunity and the like.

From Shen nong Ben Cao Jing (Shen nong's herbal), Gou Qi Zi is listed as the top grade, and has the actions of nourishing liver and kidney, replenishing vital essence and improving eyesight. Cortex Lycii has effects of cooling blood, removing heat, clearing lung-heat, and lowering fire.

The study combined these four substances for the first time and used to enhance immune function in the body. According to the theory of monarch, minister, assistant and guide of traditional Chinese medicines and the theory of nature, taste and channel tropism, the maitake mushroom polysaccharide in the formula is used as a monarch medicine for regulating immunity, the bird nest acid is used as a ministerial medicine, the silkworm chrysalis peptide and the medlar extract are used as an assistant and guide medicine, the four components are mutually coordinated and matched, and the effect is enhanced through the synergistic effect.

The orally disintegrating tablet is absorbed by sublingual mucosa and directly enters blood, so that the first-pass effect is effectively avoided, and the effective substances can play a role, so that the preparation process of the disintegrating tablet is the key for playing the role. The fillers used in the document are carefully screened, so that the problem that some fillers absorb water to agglomerate and slow dissolution is solved, and the fillers are matched with a disintegrating agent, so that the orally disintegrating candy tablet can be rapidly disintegrated while maintaining a good tablet form. The blood is absorbed by the sublingual mucosa to play a role, and the first pass effect of the liver is avoided, so even if the content of the added raw materials is not large, the method improves the utilization rate of the raw materials, and therefore, a good effect is achieved.

In addition, the taste of the raw material substances is covered by adding the flavoring agents, the selected flavoring agents are sweetening agents and are not sugar substances, sugar in the candy tablets is reduced, the taste is ensured, excessive intake of the sugar substances is avoided, and the candy tablets are very friendly to people needing to control the intake of the sugar.

1. Raw material composition screening

In the earlier research, substances with the immunoregulation effect are searched for and comprise cordyceps polysaccharide, ganoderma lucidum polysaccharide, ginseng polysaccharide, maitake polysaccharide, cubilose acid, medlar extract, red date extract, silkworm pupa peptide and the like. Cordyceps sinensis, ganoderma lucidum, ginseng and maitake belong to both medicinal and edible fungi, a plurality of researches on the aspect of regulating human body functions have been carried out for these fungi, but the cost brought by the raw materials is high due to the precious resources, so the cost is controlled by only selecting 1-2 kinds of fungi to be combined, the combination discovers that the matching of the maitake extract and the cordyceps militaris polysaccharide has the same effect of the ganoderma lucidum and the ginseng, particularly the matching of the maitake extract maitake polysaccharide and the silkworm pupa peptide serving as the active ingredient of the silkworm pupa, the phagocytosis percentage is increased by about 20-30% in the determination of the phagocytosis function of mouse abdominal cavity macrophages, and the maitake polysaccharide and the silkworm pupa peptide are selected as the raw materials to be added.

The mixture of the bird's nest, the medlar and the red dates is continuously added to enable the nutrition to be richer, the problem also occurs, the mixture is extremely intolerant to storage, and after the mixed solution of the raw materials is mixed, a large amount of bacterial reproduction is observed under a microscope after the mixed solution is subjected to laboratory conditions for 3 hours. The supposition is that the microorganisms are well survived due to the over-abundant nutrition, which increases the difficulty in the later preparation and preservation process.

By comparing the quality and the effect, the final raw materials comprise the Grifola frondosa polysaccharide, the edible bird's nest acid, the medlar extract and the silkworm pupa peptide, and the dosage of each raw material is further determined by experimental examination.

2. Study on auxiliary materials

Since the present research is intended to develop functional foods having good taste and oral acceptability, consideration is required for the disintegration, sweetness and sourness of orally disintegrating candy tablets, and the like. The compounding of the auxiliary materials was conducted by considering conventionally used carriers (PVPK30, PVPK90, mannitol), fillers (mannitol, MCC, lactose, sucrose, microcrystalline cellulose, calcium sulfate, etc.), lubricants (magnesium stearate, aerosil, talc, etc.), disintegrators (PVPP, sodium carboxymethylcellulose, sodium carboxymethyl starch, microcrystalline cellulose, croscarmellose sodium, etc.), taste correctives (stevioside, fructooligosaccharide, sorbitol, etc.), etc., using hardness, dispersion uniformity, disintegration time, 45-minute dissolution (%) as reference indices.

The result shows that the carrier is selected from PVPK30 or PVPK90, and the dosage is 5-10%; the filler is a mixture of mannitol and MCC or lactose or sucrose (mass ratio is 5:1), and the using amount is 65-85%; the lubricant is magnesium stearate and aerosil, and the using amount is 1-5%; the disintegrating agent adopts PVPP, and the using amount is 2-8%; the flavoring agent is fructo-oligosaccharide with the dosage of 4-10%; the hardness can reach more than 24N, the granules are completely sieved by a 24-mesh sieve and are disintegrated within 1 minute, and the dissolution rate in 45 minutes is more than 90%;

in the research process, the sodium citrate of 0.5-1.5% is added, the indexes are not changed, but the taste of the orally disintegrating candy tablet is improved. Finally, it is preferable that: the carrier is PVPK30, and the using amount is 5-8%; bulking agent is 60% mannitol and 12% MCC; the lubricant is 0.8% of magnesium stearate and 5% of superfine silica gel powder; the disintegrating agent is PPVP 2-5%; the flavoring agent is 4-8% fructo-oligosaccharide; and adding 0.5-1.5% of sodium citrate, wherein the hardness is more than 25N, and the mixture is completely sieved by a 24-mesh sieve and disintegrated within 1 minute, and the dissolution rate in 45 minutes is more than 90%.

Specifically, in the formulation screening process, the inventors mainly consider screening the filler and investigate the filler by using indexes such as dissolution rate of the tablet and dispersion uniformity.

The disintegration time is determined by adopting a static method, 2mL of water with the temperature of 37 ℃ is measured and put into a 10mL measuring cylinder, and the disintegration time is determined from the time when the orally disintegrating tablet contacts with the water until the tablet is completely disintegrated into granules without hard cores.

The dispersion uniformity is inspected by putting the dispersible tablet into 100mL (20 +/-1) DEG C water and shaking, wherein after the dispersible tablet is completely and uniformly dispersed, all particles pass through a No. two standard sieve, and the dispersion time is recorded.

The dissolution rate is measured according to the quality standard (draft) for clinical research, namely the dissolution rate is more than or equal to 85 percent after sampling and measuring for 45 minutes.

The screening results are shown in table 1: (the appropriate amount in the table is the amount for screening mentioned above)

The results show that prescriptions 5-6 are all ideal, with prescription 5 being optimal.

3. Process screening

The preparation process can affect the disintegration time limit, physical properties and the like of the orally disintegrating tablets. Therefore, the indexes of hardness, disintegration time, dispersion uniformity and the like of the dispersible tablets prepared by the following three processes are compared.

The three processes have the same prescription, the formula amount of the Grifola frondosa polysaccharide, the bird's nest acid, the silkworm chrysalis peptide and the medlar extract is selected, and then the main components, namely the extract mixture, account for 3 percent of the whole tablet mass, the PVPK 308 percent, the mannitol 60 percent, the MCC12 percent, the magnesium stearate 0.8 percent, the aerosil 5 percent, the PPVP8 percent, the fructo-oligosaccharide 2 percent and the sodium citrate 1.2 percent.

Process 1.

Grinding the raw materials and the carrier together, sieving the ground raw materials by a 200-mesh sieve to obtain a solid dispersion, taking a proper amount of the solid dispersion and an appropriate amount of auxiliary materials according to a prescription amount, uniformly mixing the solid dispersion and the auxiliary materials by an equivalent progressive method, and directly tabletting the powder to obtain the tablet with the pressure of 30 mPa.

And (5) a process 2.

(1) Preparing a solid dispersion, weighing raw materials and a carrier according to a prescription amount, grinding for 25min together, placing in a 50 ℃ dryer for balancing for 3 days, and crushing to obtain the nano-silver/nano;

(2) the orally disintegrating tablet is prepared by uniformly mixing the solid dispersion and a proper amount of auxiliary materials according to the prescription amount by an equivalent progressive method, and directly tabletting the powder to obtain the orally disintegrating tablet with the pressure of 30 mPa.

And (3) a process.

(1) Preparing a solid dispersion, weighing raw materials and a carrier according to a prescription amount, grinding for 25min together, placing in a 50 ℃ dryer for balancing for 3 days, crushing, and sieving with a 200-mesh sieve to obtain the nano-silver-based nano-particles;

The results of the comparison are shown in Table 2:

the above results show that the best effect is obtained when the orally disintegrating tablet is prepared by the 3 rd process method.

Detailed Description

The following is a detailed description of the embodiments of the present invention, but the present invention is not limited to these embodiments, and any modifications or substitutions in the basic spirit of the embodiments are included in the scope of the present invention as claimed in the claims.

Example 1

The formula of the product is as follows (taking 300mg of each piece as an example):

auxiliary materials selected from the auxiliary materials screened in the research process of the products.

Example 2

(1) Preparation of solid dispersions

Randomly selecting the formula of 1-8 in example 1, weighing 2.4g of the raw material mixture, mixing with 15g of PVPK90, grinding for 25min, balancing in a 55 ℃ dryer for 3 days, crushing, and sieving with a 200-mesh sieve to obtain the product;

(2) preparation of orally disintegrating tablets

Taking the solid dispersion according to the prescription amount, 150g of mannitol, 30g of lactose, 45g of superfine silica gel powder, 24g of sodium carboxymethylcellulose, 30g of fructo-oligosaccharide and 3.6g of sodium citrate, uniformly mixing the solid dispersion and the sodium carboxymethyl cellulose according to an equivalent progressive method, and directly tabletting the powder to obtain the tablet with the pressure of 30 mPa.

Making into dispersible tablet 100 tablets with weight of 300 mg.

Example 3

(1) Preparation of solid dispersions

Randomly selecting the formula of 1-8 in example 1, weighing 9g of the raw material mixture, mixing with 30g of PVPK30, grinding for 20min, balancing in a drier at 60 ℃ for 2 days, crushing, and sieving with a 200-mesh sieve to obtain the product;

(2) preparation of orally disintegrating tablets

Taking the solid dispersion with the prescription amount, 175g of mannitol, 35g of MCC, 30g of magnesium stearate, 6g of PVPP, 12g of stevioside and 3g of sodium citrate, uniformly mixing according to an equivalent progressive method, and directly tabletting the powder to obtain the tablet with the pressure of 35 mPa.

Making into dispersible tablet 100 tablets with weight of 300 mg.

Example 4

(1) Preparation of solid dispersions

Randomly selecting the formula of 1-8 in example 1, weighing 6g of the raw material mixture, mixing with 18g of PVPK30, grinding together for 30min, placing in a drier at 60 ℃ for balancing for 2 days, crushing, and sieving with a 200-mesh sieve to obtain the product;

(2) preparation of orally disintegrating tablets

Taking the solid dispersion according to the prescription amount, 162.5g of mannitol, 32.5g of cane sugar, 37.5g of magnesium stearate, 18g of sodium carboxymethyl starch, 24g of sorbitol and 1.5g of sodium citrate, uniformly mixing according to an equivalent progressive method, and directly tabletting the powder to obtain the tablet with the pressure of 40 mPa.

Making into dispersible tablet 100 tablets with weight of 300 mg.

Example 5

(1) Preparation of solid dispersions

Randomly selecting the formula of 1-8 in example 1, weighing 4.5g of the raw material mixture, mixing with 24g of PVPK90, grinding for 25min, balancing in a 55 ℃ dryer for 3 days, crushing, and sieving with a 200-mesh sieve to obtain the product;

(2) preparation of orally disintegrating tablets

Taking the solid dispersion according to the prescription amount, 150g of mannitol, 30g of cane sugar, 45g of superfine silica gel powder, PVPP 6, 30g of sorbitol and 4.5g of sodium citrate, uniformly mixing the solid dispersion and the cane sugar according to an equivalent progressive method, and directly tabletting the powder to obtain the tablet with the pressure of 35 mPa.

Making into dispersible tablet 100 tablets with weight of 300 mg.

By detection, after the formulas 1-8 of the embodiment 1 are adopted and the processing of the embodiments 2-5 is carried out, the content of the maitake polysaccharide in each tablet is 0.2-0.75mg, and the content of the cubilose acid is 0.52-1.32 mg.

Example 6

1) Preparation of solid dispersions

Weighing the raw material mixture according to the formula of 9-10 in the embodiment 1, mixing the raw material mixture with a proper amount of PVPK90, grinding the mixture for 25min, placing the mixture in a drier at 55 ℃ for balancing for 3 days, crushing the mixture, and sieving the crushed mixture with a 200-mesh sieve to obtain the powder;

(2) preparation of orally disintegrating tablets

Making into dispersible tablet 100 tablets with weight of 300 mg.

According to detection, the content of Grifola frondosa polysaccharide in each of the formulas 9 and 10 is 0.12 mg and 0.89mg, and the content of cubilose acid is 0.45mg and 1.67 mg.

Experimental example 1: stability survey

The stability of the tablets of the preparations prepared in the embodiments 2-5 and 6 is inspected, and the results show that after one year, the content of the active ingredients of the product is not reduced, and various inspections meet the standard requirements of 2015 edition of Chinese pharmacopoeia on the tablets, but the content of the active ingredients of the low formula amount (formula 9) in the embodiment 6 is not ideal.

Experimental example 2: immunoregulation experiment

The experimental method comprises the following steps: 60 healthy Kunming mice were randomly divided into 4 groups, including a blank control group, an immunosuppression model group, an example 2 group, a formula 9 group, a patent number group CN201810321554.X (referred to as a control 1 group), and a patent number group CN201910440842.1 (referred to as a control 2 group), and each group had 10 mice. Except for a blank control group, cyclophosphamide is intraperitoneally injected at a dose of 70mg/kg in the first 5 days of the other 5 groups, the blank group is given with the same dose of normal saline, the groups of example 2, formula 9, control 1 and control 2 are respectively given with disintegrating tablet solutions at a dose of 2.4g/kg on the 6 th day, and all disintegrating tablet solutions are obtained by dissolving disintegrating tablets in normal saline with the mass of 5 times. The stomach is drenched continuously for ten days. The model group and the blank group were each given the same volume of physiological saline. All the medicines are prepared in situ by using normal saline.

Index measurement:

determination of phagocytic function of macrophages in abdominal cavity

1h after the last administration of the mice, 6 mice were taken from each test group, and were subjected to intraperitoneal injection of 0.5ml of a 1% chicken red blood cell suspension, and the mice were sacrificed by cervical dislocation after 1 h. Injecting 200 μ LPBS into abdominal cavity, repeatedly washing, collecting uniform smear of abdominal cavity liquid, incubating in wet box at 37 deg.C for 30min, washing with physiological saline, and performing Gimsa staining microscopy. Each tablet was counted for 200 macrophages, and the percent phagocytosis and phagocytosis index were calculated.

Percent phagocytosis is the number of macrophages phagocytosing red blood cells/200 macrophages

Phagocytosis index-number of phagocytosed erythrocytes/200 macrophages

The results of the experiment are shown in table 1:

compared with a blank control group, the abdominal cavity macrophage phagocytosis rate and the phagocytosis index of the model group mice are remarkably reduced (p is less than 0.05), and compared with the model group, the example 2 group, the formula 10 group and the control 2 group, the phagocytosis rate and the phagocytosis index are increased and have extremely remarkable difference (p is less than 0.01); control 1 group did not have significant difference from blank group (p > 0.05); the phagocytic rate and phagocytic index of the example 2 group were higher than those of the formula 10 group and the control 2 group but the difference was not significant.

Cyclophosphamide is an alkylating agent and has inhibitory effect on both humoral immunity and cellular immunity. In the experiment, cyclophosphamide is used as a medicament for preparing an immunosuppressive model. Macrophages are not only the major component of nonspecific immune responses, but also are effector cells important for the immune monitoring function of the body. The immunoregulation effect of different groups can be reflected to a certain extent by the influence of the phagocytic function of macrophages. The control group 1 was able to increase the decrease in phagocytic ability of macrophages due to cyclophosphamide, indicating that they were able to increase the phagocytic function of peritoneal macrophages to various degrees. The embodiment has the best effect of improving the phagocytic function of abdominal macrophages.

Claims

1. An orally disintegrating candy tablet with an immunoregulation function is characterized by being prepared from the following raw materials in parts by weight through extraction and auxiliary materials: 2-4 parts of maitake polysaccharide, 1-5 parts of cubilose acid, 1-6 parts of silkworm chrysalis peptide and 2-5 parts of medlar extract.

2. The orally disintegrating candy tablet with an immunoregulatory function according to claim 1 wherein the orally disintegrating candy tablet comprises the following raw materials in parts by weight: 2-3 parts of maitake polysaccharide, 2-3 parts of cubilose acid, 2-5 parts of silkworm chrysalis peptide and 2-4 parts of medlar extract.

3. The orally disintegrating candy tablet with immunoregulatory function according to claim 1, wherein the raw materials are extracted and mixed with the carrier uniformly to obtain a raw material carrier mixture, and the raw material carrier mixture is mixed with auxiliary materials such as filler, lubricant, disintegrant, flavoring agent and the like to prepare the food grade orally disintegrating candy tablet.

4. The orally disintegrating candy tablet with immunoregulatory function according to claim 1, wherein the orally disintegrating candy tablet is prepared from the following raw and auxiliary materials in percentage by weight: 0.8-3% of raw material mixture, 5-10% of carrier, 65-85% of carrier filler, 1-5% of lubricant, 2-8% of disintegrant, 4-10% of flavoring agent and 0.5-1.5% of sodium citrate.

5. The orally disintegrating candy tablet having an immunoregulatory function according to claim 1,

the carrier is PVPK30 or PVPK 90;

the lubricant is one or two of magnesium stearate and aerosil;

the flavoring agent can be stevioside, fructo-oligosaccharide, sorbitol, etc.

6. The orally disintegrating candy tablet having an immunoregulatory function according to claim 6 wherein the filler consists of mannitol to lactose in a mass ratio of 5: 1; the lubricant is magnesium stearate; the disintegrating agent is PPVP; the correctant is fructo-oligosaccharide.

7. The orally disintegrating candy tablet having an immunoregulatory function according to claims 1 and 2 which is prepared by the process comprising:

(1) preparation of solid dispersions

(2) preparation of orally disintegrating tablets