CN110881555A

CN110881555A - Dispersible candy tablet with dual-effect of lowering blood pressure

Info

Publication number: CN110881555A
Application number: CN201911082857.1A
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: 2020-03-17

Abstract

The invention belongs to the field of health regulation, and particularly relates to dispersible candy tablets with dual-effect of lowering blood pressure, which are prepared by extracting the following raw materials in parts by weight and then adding auxiliary materials: 0.5-2 parts of bonito, 2-5 parts of chicory, 0.5-2.5 parts of sunflower disc, 1-3 parts of euglena, 0.1-2 parts of lily, 0.5-2 parts of coix seed and 0.5-1.5 parts of dandelion. The invention is prepared by reasonable compatibility and scientific method, so that the product has rapid action, stable effect, convenient use, quick effect and obvious effect of reducing acid and fat.

Description

Dispersible candy tablet with dual-effect of lowering blood pressure

Technical Field

The invention belongs to the field of health regulation, and particularly relates to a dispersible candy tablet with dual-effect of lowering blood pressure.

Background

In the present society, it is not surprising that middle aged and elderly people suffer from hypertension, hyperglycemia and hyperuricemia, which is a new term appearing in our lives. Along with the poor dietary structure (such as the prevalence of diet matching of beer, fried chicken, seafood, crayfish and the like) preference habits of people in recent years, the increase of people with hyperuricemia caused by purine metabolic disorder in vivo due to high living and working pressure, long-term staying up night and the like. According to data statistics, the number of people with high uric acid in China is up to 1.9 hundred million, the high uric acid can cause gout, and the number of gout groups in 2018 exceeds 8500 million people.

Hyperuricemia is a disease of hyperuricemia caused by decreased uric acid excretion or increased uric acid production, and gout is caused by increased uric acid in blood. Moreover, from the plum blossom statistical data in hospitals, a large number of patients suffer from gout and hyperlipidemia, but the acid-lowering drugs and the lipid-lowering drugs need to be taken for a long time and are metabolized on the liver and the kidney, and the metabolic pressure and even damage to the liver and the kidney function can be caused by taking the two drugs simultaneously for a long time, for example, substances for promoting uric acid excretion can interfere the original excretion mechanism of the kidney, the reabsorption of uric acid by the kidney is inhibited, so that a large amount of uric acid is excreted by the kidney, and the kidney is damaged.

At present, the substance combination with the functions of reducing uric acid and hyperlipemia is developed from natural plants, and the substance combination has the functions of protecting liver and kidney while having the functions of reducing both blood sugar and blood fat, but the existing unfavorable development conditions of low efficiency or long treatment time still exist due to the problems of unreasonable component proportion, production process of finished products and the like.

For example, patent No. CN201811219580.8 discloses an effervescent tablet, which comprises active ingredients of chicory extract, gardenia extract, kudzu root extract, ginger extract and auxiliary materials. The preparation method comprises the steps of preparing a chicory extract, a gardenia extract, a kudzu root extract and a ginger extract according to a conventional method, uniformly mixing the 4 extracts, dextrin, soluble starch, sorbitol, aspartame and acesulfame potassium according to a formula proportion, dividing into two parts, respectively mixing with citric acid and sodium bicarbonate, adding ethanol for granulation, sieving by a 20-40-mesh sieve, drying at 40-60 ℃, granulating, mixing, and tabletting. However, the plant extract contains alkaline substances which can react with the effervescent agent to influence the dispersion effect; in addition, the production process of the effervescent tablet needs to control the room temperature (less than 20 ℃) and the relative humidity (less than 25%), the production process is complex, and the requirement on the storage condition is high.

For another example, patent No. CN201710122270.3 discloses an oral liquid for reducing uric acid and blood lipid and a preparation method thereof, wherein the oral liquid is prepared from the following raw materials in parts by weight: 120-125 parts of sunflower disc, 75-80 parts of chicory root, 30-40 parts of rhizoma polygonati, 50-55 parts of corn stigma, 50-55 parts of wolfberry fruit, 30-40 parts of rhizoma smilacis glabrae and 30-40 parts of hawthorn; the preparation method comprises the following steps: (1) crushing a sunflower disc, adding water for soaking, extracting for 515 minutes at normal temperature by using ultrahigh pressure equipment, performing filter pressing, and concentrating filtrate; (2) adding 50% ethanol into the concentrated filtrate, precipitating with ethanol for 12 hr, collecting supernatant, and recovering ethanol to obtain sunflower disc water extract; (3) pulverizing other materials, adding water, reflux extracting, mixing extractive solutions, filtering, standing the filtrate for precipitation, collecting supernatant, and concentrating; (4) mixing the water extract solutions of the sunflower discs, mixing uniformly, adding a proper amount of water to a constant volume of 500ml, filling and sterilizing. The extraction process in this document extracts water-soluble components from plants, which are not as readily absorbed in the body as fat-soluble components, and thus have limited effectiveness and are wasteful of raw materials.

For another example, patent No. CN201610372846.7 provides a special dietary composition containing marine active polypeptide, and its preparation method and application, the composition comprises endothelium corneum gigeriae galli polypeptide 5-75 parts, eel polypeptide 2-51 parts, acanthopanax sessiliflorus extract 2-28 parts, polygonatum odoratum extract 15-31 parts, chicory extract 2-19 parts, and mushroom powder 0.5-15 parts. Adding acceptable adjuvants or food additives into the composition, and making into beverage, granule, or oral liquid. The formula is added with the marine polypeptide in a large proportion, and the addition amount of other raw materials is also high, so that the production cost is high, and the actual production is not facilitated.

Disclosure of Invention

The invention provides a dispersible candy sheet with dual-reduction function for solving the technical problems.

The method is realized by the following technical scheme:

a dispersible candy tablet with dual-effect of lowering blood pressure is prepared from the following raw materials in parts by weight: 0.5-2 parts of bonito, 2-5 parts of chicory, 0.5-2.5 parts of sunflower disc, 1-3 parts of euglena, 0.1-2 parts of lily, 0.5-2 parts of coix seed and 0.5-1.5 parts of dandelion.

The dispersible tablet comprises the following raw materials in percentage by weight: 0.5-1 part of bonito, 2-3 parts of chicory, 1-2 parts of sunflower disc, 1.5-2.5 parts of euglena, 0.5-1.5 parts of lily, 1-1.5 parts of coix seed and 0.8-1.2 parts of dandelion.

Extracting the above raw materials, mixing to obtain raw material mixture, and mixing with filler, binder, lubricant, disintegrant, surfactant and correctant to make into food-grade solid dispersible candy tablet.

In the dispersed candy pieces, the mass percentages of the raw material mixture and the auxiliary materials are as follows: 1-5% of raw material mixture, 60-85% of filler, 5-15% of adhesive, 1-5% of lubricant, 2-8% of disintegrating agent, 1-10% of surfactant and 4-10% of flavoring agent.

In the dispersed candy piece, the weight ratio of the raw material mixture to the auxiliary material is preferably 1: 4-19.

The filler is one or more than two of microcrystalline cellulose, lactose, sucrose, pregelatinized starch and dextrin;

the adhesive is a water solution or an ethanol solution of hydroxypropyl methylcellulose and/or pre-crosslinked starch;

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

the disintegrating agent is one or more than two of low-substituted hydroxypropyl methylcellulose, crospovidone, sodium carboxymethyl starch and croscarmellose sodium;

the surfactant is SDS, or sodium hexadecyl sulfate, or sodium octadecyl sulfate.

The flavoring agent is stevioside, fructo-oligosaccharide or sorbitol;

preferably, the filler is dextrin; the adhesive is an aqueous solution of pre-crosslinked starch; the lubricant is magnesium stearate; the disintegrant is crospovidone; the surfactant is SDS; the flavoring agent is fructo-oligosaccharide.

The preparation method of the dispersible candy tablet with the dual-reduction function comprises the following steps:

1) crushing and mixing: pulverizing the raw material extract with air flow, controlling average particle diameter below 50 μm, and sieving with 80 mesh sieve; sieving the filler, the lubricant and the disintegrant with a 80-mesh sieve respectively, and mixing to obtain mixed powder; 1/2-2/3 mixing the mixed powder with the raw material extract powder by an equivalent incremental method;

2) pulping: adding a surfactant into the adhesive for dissolving, and uniformly mixing to obtain homogenate;

3) and (3) wet granulation: 1) adding the mixed powder into the mixture obtained in the step 2) for homogenizing to prepare a soft material, extruding and sieving by a 20-30-mesh sieve to obtain wet granules, and drying; sieving with 20-30 mesh sieve, and mixing with the rest mixed powder;

4) tabletting: sieving the flavoring agent with a 20-30 mesh sieve, mixing with the granules in 3), and tabletting to obtain candy tablet, or coating to obtain candy tablet.

Has the advantages that:

the preparation for reducing the content of uric acid and blood fat is mainly prepared by mixing natural substances from animal and plant bodies and food-grade auxiliary materials.

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

skipjack: skipjack peptide as main ingredient

Skipjack peptide is an oligopeptide powder, and has the functions of reducing uric acid and relieving gout; prolonging the muscle exercise time; increasing muscle exercise intensity; the inflammation phenomenon is reduced; reducing gastric ulcer symptoms and accelerating wound healing; relieving muscle aging weakness symptoms; enhancing the conduction velocity of the neural response; reducing the damage of myocardial ischemia and cerebral ischemia, if the content is too high, not only increasing the cost of the product, but also not obviously enhancing the effect of reducing uric acid, if the content is too low, the effect of reducing uric acid can not be achieved

Chicory: the extract has obvious effect of reducing uric acid

Is a special plant with two functions of food and medicine, is listed as food with homology of medicine and food by the Ministry of health, and is praised as a green health king by experts of the national nutrition alliance. The chicory contains various nutrient components, so that the chicory has multiple health-care effects of improving the serum uric acid level of a human body, regulating the functions of intestines and stomach, clearing intestines, relaxing bowels, reducing internal heat, moistening dryness, slimming, protecting skin, enhancing the immunity of the human body and the like; meanwhile, abundant potassium can effectively improve oxygen supply of the brain, regulate heart rhythm and the like; most magical are the special ingredients contained in chicory, such as: the aescin, the aescin and the like have obvious application value on gout, hypertension, hyperlipidemia and other diseases.

Sunflower disc: small molecule peptides

The small molecular peptide can degrade the purine ratio in vivo to a relatively normal range, perform gene regulation on the production of uric acid, also can effectively regulate the activity of protease required by the kidney in the uric acid discharge process, and perform effective repair on gene-deleted DNA. And is an inhibitor of inflammatory factors, thereby reducing pain of gout patients, and is the most important component for treating gout in the sunflower disc extract.

Euglena: extract of Gymnodinium

The natural dietary nutrition supplement provides 59 essential nutrient elements for human bodies, such as high-content easily-absorbed vitamins, mineral nutrients, amino acids, unsaturated fatty acids, euglena polysaccharides, chlorophyll, lutein, zeaxanthin, GABA and the like, and has no cell wall, so that the absorption rate is as high as 93.1 percent. The food is listed as a new resource food by China in 5 months in 2013, and has the functions of medicine and food homology: the nutritional requirements of the human body are supplemented and balanced, the recessive hunger is relieved, and the reasonable body form is kept; oxidation resistance and strong free radical removal; removing harmful cholesterol, neutral fat and heavy metal; regulating intestine and stomach, relieving constipation and constipation; relieving chronic fatigue and improving sleep; help alleviate gout; relieving allergic dermatitis; relieving acne; help maintain an alkaline body fluid environment; and (4) resisting aging.

Lily: common formula in traditional Chinese medicine syndrome differentiation for treating gout

Nourishing yin and moistening lung; clearing away heart-fire and tranquilizing. Chronic cough due to yin deficiency; blood in sputum; late stage of febrile disease; restlessness, pavor, insomnia, dreaminess and absentmindedness due to residual heat or emotional disorder; abscess and swelling; and (4) eczema.

Coix seed: because it is sweet and light in flavor, cool in nature, enters spleen, lung and kidney meridians, has the functions of invigorating spleen, tonifying lung, clearing heat and promoting diuresis, and can be used for treating diarrhea, damp arthralgia, spasm of tendons and vessels, difficulty in flexion and extension, edema, beriberi, consumptive lung disease, pulmonary abscess, intestinal abscess, stranguria with turbid urine, leucorrhea with marked discharge

Dandelion: it has bitter and sweet taste and cold property, enters liver and stomach channels, has the functions of clearing heat and detoxicating, inducing diuresis and resolving masses, and is used for treating acute mastitis, lymphadenitis, scrofula, furunculosis and sore, acute conjunctivitis, common cold and fever, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis and urinary tract infection.

The Chinese medicinal composition is prepared by reasonable compatibility and a scientific method, so that the Chinese medicinal composition has the advantages of quick action, stable effect, convenient use, quick response and obvious curative effect, has the functions of clearing heat and removing toxicity, tonifying spleen and lung, purging fire and cooling blood, promoting diuresis and resolving hard mass, has the effects of removing acid and reducing blood fat, is favorable for converting reverse purine, excreting uric acid, reducing blood fat and activating blood, protecting liver and strengthening kidney and delaying senility, has no toxic or side effect, and can be taken for a long time. According to the theory of monarch, minister, assistant and guide of traditional Chinese medicines and the theory of nature, taste and channel tropism, bonito and chicory in the formula are used as monarch medicines for removing acid and reducing fat, sunflower disc is used as a ministerial medicine, lily, coix seed and dandelion are used as assistant and guide medicines, and in order to reduce the invasion of medicine properties to human body, the lily enters lung channel, the coix seed enters kidney channel and the dandelion enters liver channel, so that the body can be protected while treatment is carried out.

In the preparation process, the disintegrant used in the invention has strong water absorption, has the characteristics of water absorption expansion and insolubility, does not form a colloidal solution, and cannot influence the disintegration of the tablet due to the obstruction of the continuous water infiltration, thereby realizing the rapid disintegration. The effective components in the dispersible tablet are water-insoluble substances, and the water-insoluble substances exist in the form of ultrafine particles after being processed by a preparation process, are quickly disintegrated and dissolved out under the action of a disintegrating agent, are uniformly dispersed in digestive juice under the action of physical properties and a surfactant, and improve the concentration of effective substances absorbable by capillary vessels, so that the concentration of the effective substances in blood is improved, the effect is exerted more quickly, and the utilization rate of the effective substances is improved. The significance in practical application is that the amount of active ingredient used is reduced in this process. With consequent reduction in raw material costs.

In addition, the dispersible tablet of the invention is convenient to carry and eat: the common tea, solid beverage and bottled beverage have large volume, need to be taken with water, are inconvenient to take, and are particularly difficult to take for old and patients with swallowing dysfunction. The dispersible tablet has high disintegration speed, can be placed into water to be dispersed into uniform suspension, is convenient to take and is very friendly to people of the type.

The formula components comprise the following contents in the product research process:

1. raw material composition screening

In the earlier research, the bonito peptide is found to have a good uric acid reducing effect, so that the effect foundation of the invention is considered to be that marine substances and traditional Chinese medicine components are combined for use. Therefore, proper components are screened from the plants such as the kudzuvine root, the chicory, the tall gastrodia tuber, the lily bulb, the coix seed, the dandelion, the hawthorn, the honeysuckle and the like, the hyperuricemia is screened and researched by taking the UA level of uric acid, the XOD related to UA metabolism, the ADA activity change and the like as indexes, and the blood fat is screened and researched by taking the TG content as an index.

The screening process comprises the screening of kudzu root, chicory and gastrodia elata and the screening of lily, coix seed, dandelion, hawthorn and honeysuckle. In the screening of pueraria lobata, chicory and gastrodia elata, the acid reducing effect of the combination of extracts of these and bonito peptide was first examined, and it was found that when bonito peptide was combined with extracts of pueraria lobata, chicory and gastrodia elata, respectively, the acid reducing effect of pueraria lobata + bonito peptide (1) and gastrodia elata + bonito peptide (2) was inferior to that of pueraria lobata and gastrodia elata when used alone (UA levels at 7, 14 and 21 days after use were more desirable than those of the 1 and 2 groups when used alone), and the blood lipid level reducing effect of the combinations 1 and 2 was inferior to that of the combination 3 (TG content of the combination 3 rabbit was reduced from 1.52mmol/L to 1.15mmol/L, and the combinations 1 and 2 were reduced to 1.23mmol/L and 1.26mmol/L, respectively). This section therefore selects chicory for incorporation into the study formulation.

In the screening of sunflower discs, lily, coix seeds, dandelion, hawthorn and honeysuckle, firstly, the extracts of the sunflower discs, the lily, the coix seeds, the dandelion, the hawthorn and the honeysuckle are combined with the chicory and the bonito peptide in pairs, and the result shows that a little flocculent precipitate appears in the components containing the hawthorn, so that the hawthorn is removed, the composition containing the honeysuckle has poor acid reducing effect, and the sugar reducing effect does not show obvious advantages of other groups, so the honeysuckle is removed. Secondly, the extracts of the rest components are mixed in equal proportion, the obtained solution is clear, and the effect of reducing blood sugar and acid is slightly stronger (about 10 to 15 percent higher) than that of single use and pairwise matching. Therefore, the researchers further research the mixture ratio of the raw material components to finally obtain the optimal mixture ratio.

2. Study on auxiliary materials

This study is intended to develop functional foods having good taste and oral acceptability, and therefore, consideration is required for the disintegration of the candy tablet, the sweetness and sourness, the sensation of irritation, and the like. The compounding of the auxiliary materials was carried out by studying conventionally used fillers (microcrystalline cellulose, lactose, sucrose, pregelatinized starch, dextrin, calcium sulfate, etc.), binders (an aqueous solution or an ethanol solution of hypromellose and/or pregelatinized starch, starch slurry, etc.), lubricants (magnesium stearate, aerosil, talc), disintegrants (low-substituted hypromellose, crospovidone, sodium carboxymethyl starch, microcrystalline cellulose, croscarmellose sodium, etc.), taste corrigents (stevioside, fructooligosaccharide, sorbitol, etc.), etc., with hardness, dispersion uniformity, dispersion time, 45-minute dissolution (%) as reference indices.

The result shows that the filler is selected from one or two of microcrystalline cellulose, lactose, sucrose, pregelatinized starch and dextrin, and the dosage of the filler is 60-85% of the total amount of each tablet; the adhesive is an aqueous solution or an ethanol solution of hydroxypropyl methylcellulose and/or pre-crosslinked starch, and the dosage of the adhesive is 5-15% of the total amount of each tablet; the lubricant and glidant are magnesium stearate, superfine silica gel powder and silicon dioxide, and the dosage of the lubricant and glidant is 1-5% of the total amount of each tablet; the disintegrant is low-substituted hypromellose, crospovidone, sodium carboxymethyl starch or croscarmellose sodium, and the amount of the disintegrant is 2-8% of the total amount of each tablet; the flavoring agent is stevioside, fructo-oligosaccharide and sorbitol, and the dosage of the flavoring agent is 4-10% of the total amount of each tablet; the hardness can reach more than 24N, the materials are all sieved by a 24-mesh sieve, the materials are dispersed within 4 minutes, and the dissolution rate in 45 minutes is more than 85%;

and in the process of research, we find that the indexes are improved by adding 1-10% of surfactant (SDS, sodium cetyl sulfate or sodium stearyl sulfate). Finally, it is preferable that: the filler is dextrin, and the using amount is 60-85%; the adhesive is aqueous solution of pre-crosslinked starch, and the using amount is 6-10%; the lubricant is 0.5% of magnesium stearate and 4% of superfine silica gel powder; the disintegrating agent is crospovidone with the concentration of 2-8%, the surfactant is SDS with the concentration of 2-8%, the flavoring agent is fructo-oligosaccharide with the concentration of 4-10%, the hardness can reach more than 25N, the components are completely sieved by a 24-mesh sieve and dispersed within 2 minutes, and the dissolution rate in 45 minutes is more than 95%.

Specifically, in the formula screening process, the inventor mainly considers screening the disintegrating agent and considers indexes such as the dissolution rate of the tablet, the dispersion uniformity and the like.

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 1-4 are all ideal, with prescription 2 being optimal.

3. Process screening

When the solid dispersible tablet is prepared, the disintegration and dissolution performance, physical characteristics and the like of the solid dispersible tablet are influenced by slight change of the preparation process. Therefore, the indexes of the dispersible tablets prepared by the following three processes, such as hardness, dissolution rate of the tablets, dispersion uniformity and the like, are compared.

The three processes have the same formula, and are prepared by extracting skipjack, herba Cichorii, receptaculum Helianthi, Euglena, Bulbus Lilii, Coicis semen, and herba Taraxaci into extract mixture, drying into powder, and controlling particle size to 90-150 μm; then the main components, namely the amount of the extraction mixture is 3 percent of the mass of the whole tablet, 69.5 percent of dextrin, 6 percent of the water solution of the pre-crosslinked starch, 0.5 percent of magnesium stearate, 4 percent of superfine silica gel powder, 8 percent of crospovidone, 4 percent of SDS and 1 percent of fructo-oligosaccharide. The adopted preparation process comprises the following steps:

the process 1 comprises the following steps:

1) crushing and mixing: pulverizing the raw material extract with air flow, controlling average particle diameter below 50 μm, and sieving with 80 mesh sieve; respectively sieving dextrin, magnesium stearate, silica gel micropowder and polyvinylpolypyrrolidone with a 80-mesh sieve, and mixing to obtain mixed powder; mixing all the mixed powders with the raw material extract powder by equivalent incremental method;

2) pulping: adding a surfactant into the aqueous solution of the pre-crosslinked starch for dissolving, and uniformly mixing to obtain homogenate;

3) and (3) wet granulation: 1) adding the mixed powder into the mixture obtained in the step 2) for homogenizing to prepare a soft material, extruding and screening the soft material by a 20-mesh sieve to obtain wet granules, and drying; sieving with 20 mesh sieve, and mixing with the rest mixed powder;

4) tabletting: and (3) sieving the fructo-oligosaccharide with a 20-mesh sieve, uniformly mixing with the granules in the step 3), and tabletting to obtain the candy tablets.

And (2) a process:

1) crushing and mixing: pulverizing the raw material extract with air flow, controlling average particle diameter below 50 μm, and sieving with 80 mesh sieve; respectively sieving dextrin, magnesium stearate, silica gel micropowder and polyvinylpolypyrrolidone with a 80-mesh sieve, and mixing to obtain mixed powder; 2/3 mixing the mixed powder with the raw material extract powder and surfactant by equivalent incremental method;

2) pulping: stirring the adhesive evenly to obtain homogenate;

And (3) a process:

1) crushing and mixing: pulverizing the raw material extract with air flow, controlling average particle diameter below 50 μm, and sieving with 80 mesh sieve; respectively sieving dextrin, magnesium stearate, silica gel micropowder and polyvinylpolypyrrolidone with a 80-mesh sieve, and mixing to obtain mixed powder; 2/3 mixing the mixed powder with the raw material extract powder by equivalent incremental method;

The results of the comparison are shown in Table 2:

the above results show that the best results are obtained by the method 3.

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

Randomly selecting the formula of 1-8 in example 1, extracting according to the conventional and same raw material extraction method, pulverizing the extract with air flow, controlling the average particle size below 50 μm, and sieving with 80 mesh sieve; respectively sieving microcrystalline cellulose, magnesium stearate, silica gel micropowder and polyvinylpolypyrrolidone with a 80-mesh sieve, and mixing to obtain mixed powder; 1/2 mixing the mixed powder with the raw material extract powder by equivalent incremental method;

2) pulping: adding SDS into the water solution of hydroxypropyl methylcellulose for dissolving, and uniformly mixing to obtain homogenate;

4) tabletting: sieving stevioside by a sieve of 20 meshes, uniformly mixing with the granules in the step 3), and tabletting to obtain the candy tablets.

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

Example 3

Randomly selecting the formula of 1-8 in example 1, extracting according to the same raw material extraction method, pulverizing the extract with air flow, controlling average particle size below 50 μm, and sieving with 80 mesh sieve; respectively sieving lactose, magnesium stearate, silica gel micropowder and sodium carboxymethyl starch with 80 mesh sieve, and mixing to obtain mixed powder; 2/3 mixing the mixed powder with the raw material extract powder by equivalent incremental method;

2) pulping: adding sodium hexadecyl sulfate into the aqueous solution of the pre-crosslinked starch for dissolving, and uniformly mixing to obtain homogenate;

3) and (3) wet granulation: 1) adding the mixed powder into the mixture obtained in the step 2) for homogenizing to prepare a soft material, extruding and sieving by a 30-mesh sieve to obtain wet granules, and drying; sieving with 20 mesh sieve, and mixing with the rest mixed powder;

4) tabletting: sieving fructo-oligosaccharide with 30 mesh sieve, mixing with the granules in 3), tabletting, and coating to obtain candy tablet.

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

Example 4

Randomly selecting the formula of 1-8 in example 1, extracting according to the same raw material extraction method, pulverizing the extract with air flow, controlling average particle size below 50 μm, and sieving with 80 mesh sieve; respectively sieving dextrin, silica gel micropowder and croscarmellose sodium with 80 mesh sieve, and mixing to obtain mixed powder; 7/12 mixing the mixed powder with the raw material extract powder by equivalent incremental method;

2) pulping: adding sodium octadecyl sulfate into ethanol solution of the pre-crosslinked starch for dissolving, and uniformly mixing to obtain homogenate;

4) tabletting: sieving sorbitol with 30 mesh sieve, mixing with the granules in 3), and tabletting to obtain candy tablet.

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

Example 5

Randomly selecting the formula of 1-8 in example 1, extracting according to the same raw material extraction method, pulverizing the extract with air flow, controlling average particle size below 50 μm, and sieving with 80 mesh sieve; sieving sucrose, silica gel micropowder and polyvinylpolypyrrolidone respectively with a 80-mesh sieve, and mixing to obtain mixed powder; 1/2 mixing the mixed powder with the raw material extract powder by equivalent incremental method;

2) pulping: adding sodium stearyl sulfate into the ethanol solution of hydroxypropyl methylcellulose for dissolving, and mixing uniformly to obtain homogenate;

4) tabletting: sieving stevioside with a 30-mesh sieve, uniformly mixing with the granules in the step 3), tabletting and coating to obtain the candy tablets.

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

By detection, the content range of the bonito peptide in each slice is 0.2-0.75mg after the treatment of the examples 2-5 by adopting the formula 1-8 of the example 1; the main ingredient lactucin of herba Cichorii is 0.52-1.32 mg.

Example 6

In the formulation 9-10 of example 1, after extraction by the same raw material extraction method as in examples 2-5, the extract was pulverized by air flow, and sieved with an 80-mesh sieve with an average particle size of 50 μm or less; sieving sucrose, silica gel micropowder and polyvinylpolypyrrolidone respectively with a 80-mesh sieve, and mixing to obtain mixed powder; 1/2 mixing the mixed powder with the raw material extract powder by equivalent incremental method;

3) and (3) wet granulation: 1) adding the mixed powder into the mixture obtained in the step 2) for homogenizing to prepare a soft material, extruding and sieving by a 30-mesh sieve to obtain wet granules, and drying;

4) tabletting: sieving with 20 mesh sieve, mixing with the rest mixed powder, and tabletting to obtain the final product.

Detection shows that the average content of skipjack peptide in the formulas 9 and 10 is 0.14mg and 0.92mg respectively; the average content of lactucin as main material of herba Cichorii is 0.41mg and 1.58mg respectively.

Experimental example 1: blood uric acid lowering experiment

1. The preparation prepared in the embodiments 2-5 and 6 of the invention is examined on the stability of the tablet, and the result shows that after one year, the content of the active ingredient of the product is not reduced, and various examinations meet the national standard requirements for the tablet, but the content of the active ingredient of the low formula amount (formula 9) in the embodiment 6 is not ideal.

2. The experiment for reducing uric acid is carried out to verify

100 male feeds for Difake quails with high purine content (common feed mixed with yeast 15g kg)^-1·d^-1) Replicate the hyperuricemia model. The groups were randomly divided into 10 groups according to body constitution, namely normal group, model group, positive group, examples 2-5 group, formula 10 group, patent application CN201710122270.3 group and patent application CN201610372846.7 group. The dosage of each group is 3.6 g/kg^-1·d^-1)。

After 3 weeks of administration, quail Uric Acid (UA) level, liver function index glutamic-oxaloacetic transaminase (GOT) level, kidney function index urea nitrogen (BUN) level, and activity changes of UA metabolism related enzymes Xanthine Oxidase (XOD) and Adenosine Deaminase (ADA) are dynamically observed.

The results show that the quail serum UA levels of the positive group and the groups of examples 2-5 on days 7, 14 and 21 are all significantly reduced (P <0.05) compared with the model group, and the difference is obvious; but quail serum UA levels were significantly reduced only on day 21 (P <0.05) in formula 10 group, patent application CN201710122270.3 group, patent application CN201610372846.7 group;

in addition, day 14 positive group, examples 2-5 group quail serum GOT level was significantly reduced (P < 0.05); the GOT level of quail serum in patent application CN201710122270.3 group and patent application CN201610372846.7 group is reduced but not significant;

the quail serum XOD levels of 7 th, 14 th and 21 st positive groups and the quail serum XOD levels of the groups in examples 2 to 5 are all significantly reduced (P < 0.05); the quail serum XOD level is reduced but has no significant difference in patent application CN201710122270.3 group and patent application CN201610372846.7 group;

the day 21 positive group, example 5 group, formula 10 group had significantly reduced serum ADA levels (P < 0.05).

It can be concluded that: the dispersible tablet disclosed by the invention can effectively play a role in reducing the blood-acid, and the blood-acid reducing effect of the examples 2-5 is slightly better than that of the formula 10 and better than that of the patent application CN201710122270.3 group and the patent application CN201610372846.7 group.

Experimental example 2: blood lipid lowering experiment

The experimental rabbit is fed with high-fat feed to cause a hyperlipemia model, and the influence of different samples on the hyperlipemia rabbit is observed by detecting the change conditions of serum lipoprotein, plasma oxygen free radical SOD, MDA, GSH-Px and liver TC content.

The samples were grouped as: normal group, model group, and positive group (30 mg. kg)^-1·d^-1) Examples 2 to 5 groups (4.5 g. kg)^-1·d^-1) Formulation 10 group (4.5 g.kg)^-1·d^-1) Patent application CN201710122270.3 group (4.5 g.kg)^-1·d^-1) Patent application CN201610372846.7 group (4.5 g.kg)^-1·d^-1)。

The results show that the groups of examples 2-5 can significantly reduce the serum TC and LDLc of the hyperlipidemic rabbit (respectively reduced from 4.8mmol/L and 3.4mmol/L to 2.3mmol/L and 1.1mmol/L), also can reduce the MDA level of the plasma (reduced from 12.5mmol/L to 9.1mmol/L), significantly increase the SOD activity of the plasma (increased from 10.8 mu/L to 14.2mmol/L), and significantly reduce the TG content of the liver of the hyperlipidemic rabbit (reduced from 1.51mmol/L to 1.06mmol/L), and no significant difference (P > 0.05) exists between the hypolipidemic effects of the groups. But the data value is more ideal than that of the formula 10 group and is obviously better than that of the prior patent group (the effect is improved by 10-15%).

Claims

1. The dispersible candy tablet with the dual-effect of lowering blood pressure is characterized by being prepared from the following raw materials in parts by weight after extraction and auxiliary materials: 0.5-2 parts of bonito, 2-5 parts of chicory, 0.5-2.5 parts of sunflower disc, 1-3 parts of euglena, 0.1-2 parts of lily, 0.5-2 parts of coix seed and 0.5-1.5 parts of dandelion.

2. The dispersible candy tablet with dual effect of lowering blood pressure according to claim 1, wherein the weight ratio of the raw materials of the dispersible tablet is as follows: 0.5-1 part of bonito, 2-3 parts of chicory, 1-2 parts of sunflower disc, 1.5-2.5 parts of euglena, 0.5-1.5 parts of lily, 1-1.5 parts of coix seed and 0.8-1.2 parts of dandelion.

3. The dispersible candy tablet according to claims 1 and 2, wherein the raw materials are extracted and mixed uniformly to obtain a raw material mixture, and the raw material mixture is mixed with a filler, a binder, a lubricant, a disintegrant, a surfactant and a flavoring agent to prepare the food-grade solid dispersible candy tablet.

4. The dispersible candy sheet with dual effect of lowering blood pressure according to claim 3, wherein the dispersible candy sheet is prepared from the following raw and auxiliary materials by weight percent: 1-5% of raw material mixture, 60-85% of filler, 5-15% of adhesive, 1-5% of lubricant, 2-8% of disintegrating agent, 1-10% of surfactant and 4-10% of flavoring agent.

5. The dispersible candy sheet with dual effect of lowering blood pressure of claim 4, wherein the weight ratio of the raw material mixture to the auxiliary material is 1:4-19 when the dispersible candy sheet is made into a solid dispersion.

6. The discrete confectionery sheet having a dual lowering effect according to claim 4,

the adhesive is a water solution of hydroxypropyl methylcellulose and/or pre-crosslinked starch or ethanol-soluble lubricant is one or two of magnesium stearate and aerosil;

the surfactant is SDS, or sodium hexadecyl sulfate, or sodium octadecyl sulfate;

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

7. The dispersible tablet according to claim 6, wherein the filler is dextrin; the adhesive is an aqueous solution of pre-crosslinked starch; the lubricant is magnesium stearate; the disintegrant is crospovidone; the surfactant is SDS; the correctant is fructo-oligosaccharide.

8. A Shuangjiangdispersible tablet according to claims 1 and 2, which is prepared by the following steps: