Composition, oral tablet as well as preparation method and application of oral tablet

Abstract

The invention discloses a composition, an oral tablet and a preparation method and application thereof, and belongs to the technical field of food and medicine. The composition comprises sodium sulfate, magnesium sulfate and potassium chloride, wherein the weight ratio of the sodium sulfate to the magnesium sulfate to the potassium chloride is (5-10): (1-2): (0.5-1.5); the particle size of the sodium sulfate is less than 700 microns, the purity is not less than 98%, and the moisture content is less than 0.5%; the particle size of the magnesium sulfate is less than 700 microns, the purity is not less than 98.5%, and the moisture content is less than 5.0%; the particle size of the potassium chloride is less than 700 microns, the purity is not less than 98.5%, and the water content is less than 1.0%. The functions of all the components are fully exerted, the intestinal environment is improved, the intestinal health is recovered, and functional constipation is relieved.

Description

Technical Field

[0001] The present application relates to a composition, an oral tablet, a preparation method and application thereof, and belongs to the technical field of food and medicine. Background Art

[0002] Functional constipation is a functional intestinal disease caused by non-organic lesions, with the main symptoms of reduced bowel movements, difficulty in defecation, prolonged defecation cycle, a feeling of incomplete defecation, and dry and hard stools. With the acceleration of the pace of modern life, changes in dietary structure, and the influence of psychological and social factors, the number of patients with chronic constipation is increasing. Long-term constipation can cause abnormal emotions such as anxiety and depression, and can lead to hemorrhoids and increase the risk of tumors and cardiovascular and cerebrovascular diseases. Therefore, it is of great significance to actively carry out research on constipation.

[0003] At present, the main methods for treating functional constipation are conditioning and drug therapy. Conditioning refers to daily adjustment of diet, drinking water and appropriate exercise, and improving constipation symptoms by massaging the abdomen, pressing acupoints, and applying external Shenque. Although this method has certain effects, it has disadvantages such as slow effect and easy rebound. Drug therapy generally uses laxatives such as polyethylene glycol and aloe vera, but long-term use can cause adverse reactions such as abdominal distension, abdominal pain, intestinal nerve damage and colon melanosis, and the side effects are more obvious.

[0004] Probiotics are live microorganisms that can bring health benefits to the host when given in sufficient quantities. When a sufficient number of probiotics pass through the upper digestive tract of the human body and colonize in the large intestine, they will have many beneficial effects, such as regulating the balance of intestinal flora, enhancing the body's immunity, and reducing the risk of diabetes, cardiovascular disease, gastrointestinal diseases and various cancers. However, during processing, storage and human digestion, probiotics are easily affected by 2 , pH value, temperature, moisture, gastric acid and bile salts, resulting in reduced survival rate and vitality, which in turn limits its large-scale application. Summary of the invention

[0005] In order to solve the above problems, a composition, an oral tablet and a preparation method and application thereof are provided, which improve the resistance of probiotics to harsh environments and the survival and colonization in the intestines, and enable the functions of each component in the oral tablets to be fully exerted, thereby improving the intestinal environment, restoring intestinal health, and relieving functional constipation.

[0006] The present invention adopts the following technical solution:

[0007] According to one aspect of the present application, a composition is provided, comprising sodium sulfate, magnesium sulfate and potassium chloride, wherein the weight ratio of the sodium sulfate, magnesium sulfate and potassium chloride is (5-10): (1-2): (0.5-1.5);

[0008] The sodium sulfate has a particle size of less than 700 μm, a purity of not less than 98%, and a moisture content of less than 0.5%;

[0009] The magnesium sulfate has a particle size of less than 700 μm, a purity of not less than 98.5%, and a moisture content of less than 5.0%;

[0010] The potassium chloride has a particle size of less than 700 μm, a purity of not less than 98.5%, and a moisture content of less than 1.0%.

[0011] According to another aspect of the present application, an oral tablet is provided, comprising the above-mentioned composition.

[0012] Optionally, the oral tablet further comprises the following components in parts by weight: 3-8 parts of magnesium oxide, 13-18 parts of embedded probiotics, 17-24 parts of citric acid, 15-22 parts of sugar substitute additives, 5-10 parts of spices, and 28-35 parts of auxiliary materials;

[0013] The embedded probiotics include an inner embedding layer and an outer embedding layer, wherein the inner embedding layer contains probiotics, and the outer embedding layer is wrapped around the outer surface of the inner embedding layer.

[0014] Optionally, the method for preparing the embedded probiotics comprises the following steps:

[0015] S1. Resuspend a single probiotic strain in phosphate buffer and incubate at 35-42°C for 10-20 min, then centrifuge and discard the supernatant;

[0016] S2, mixing the single probiotic suspension and the plant polyphenol solution in a Tris-HCl buffer, and reacting them in a dark environment for 1-3 hours, and then washing them with a phosphate buffer to form an inner embedding layer;

[0017] S3, adding Tween 80 to phosphate buffer and mixing evenly, then adding glycerol and oligosaccharide, and stirring ultrasonically at 60-80°C for 1-2 minutes to obtain solution A; adding Persian gum to phosphate buffer and mixing evenly to obtain solution B; after mixing solution A and solution B evenly, adding protamine, and continuing mixing treatment to obtain solution C;

[0018] S4. Add the inner embedding layer obtained in S2 into solution C, stir and mix for 5-15 minutes, and then freeze-dry to form an outer embedding layer.

[0019] Optionally, in S2, the concentration of the probiotic suspension is 1.2×10 8 -7.6×10 8 CFU / mL;

[0020] The concentration of the plant polyphenol solution is 0.1-1 mg / mL.

[0021] Optionally, the probiotics are bifidobacteria and / or lactobacilli;

[0022] The plant polyphenol is protocatechuic acid, chlorogenic acid or caffeic acid;

[0023] The oligosaccharide is at least one of xylooligosaccharide, galacto-oligosaccharide, fructo-oligosaccharide and lactulose.

[0024] Optionally, in S3, the weight ratio of the oligosaccharide to protamine is 1:(3-8);

[0025] The added weight of the Persian gum is 3-8% of the protamine.

[0026] Optionally, the sugar substitute additive is at least one of xylitol, sorbitol and erythritol;

[0027] The spice is at least one of vanilla, cloves, cinnamon, rose and mint;

[0028] The auxiliary material is at least one of starch, milk powder, maltodextrin, microcrystalline cellulose and magnesium stearate.

[0029] According to another aspect of the present application, a method for preparing an oral tablet is provided, which is used to prepare an oral tablet as described above, comprising the following steps:

[0030] (1) Sodium sulfate, magnesium sulfate, potassium chloride, magnesium oxide, citric acid, sugar substitute additives and spices are respectively passed through a 60-100 mesh sieve, and then mixed uniformly according to a formula ratio to obtain a mixture 1;

[0031] (2) Mixture 1 is put into a fluidized bed one-step granulator for granulation and granulation, with an air intake of 110-120m 3 / h, the air inlet temperature is 50-70°C, the atomization pressure is 1.0-1.2 bar, and the liquid inlet speed is 4-6 mL / min to obtain a mixture 2;

[0032] (3) Mix the mixture 2, the embedded probiotics and the auxiliary materials in accordance with the formula ratio, and then compress the mixture into tablets using a tablet press to obtain oral tablets.

[0033] According to another aspect of the present application, there is provided an application of any of the above-described oral tablets for cleaning the intestine, improving the intestinal environment and alleviating functional constipation, wherein the daily dosage of the oral tablet is 0.1-0.5 g / kg.

[0034] The beneficial effects of this application include but are not limited to:

[0035] 1. In the oral tablets of the present application, sodium sulfate is a bulk laxative, which is not easily absorbed in the intestine. It forms a hypertonic solution in the intestine and absorbs a large amount of water, which increases the volume of the intestinal cavity and increases the pressure, thereby stimulating the intestinal wall, promoting peristalsis and causing diarrhea; magnesium oxide and citric acid react after being dissolved in water to form an osmotic laxative-magnesium citrate, which enhances the bowel cleansing effect and improves the taste; the two cathartic ingredients are used in combination to avoid the user's dependence on a single laxative, and at the same time effectively increase the volume and water content of feces, making feces easier to discharge, and reducing the discomfort of intestinal dryness and constipation.

[0036] 2. In the oral tablets of the present application, the embedded probiotics can adjust the balance of intestinal flora, help the intestines to quickly establish normal and robust flora after a large amount of excretion, reduce the invasion and colonization opportunities of pathogenic bacteria, and play the functions of occupying each other, competing for nutrients, and confronting each other, thereby ensuring that the body is not invaded by pathogenic bacteria; magnesium sulfate and potassium chloride can timely replenish the electrolytes lost by the body during diarrhea and reduce the occurrence of adverse reactions; the addition of sugar substitutes and spices can improve the taste and flavor of oral tablets and increase public acceptance; the molding of oral tablets is guaranteed by the added excipients, and the production efficiency and product quality stability are improved; the components work together to not only relieve functional constipation and achieve intestinal cleansing, but also improve the balance of intestinal flora and the integrity of the intestinal barrier, and promote intestinal health.

[0037] 3. In the oral tablets of the present application, the inner embedding layer is formed by oxidative polymerization of plant polyphenols on the probiotics. When the probiotic cells are exposed to the phenolic solution, the manganese ions released by the probiotic cells act as a catalyst for this process to activate the oxidation of plant polyphenols and induce their polymerization on the surface of the bacteria, wherein the phenolic compounds are oxidized into quinones, followed by cross-coupling reactions and polymerization assembly, which have a good protective effect on the probiotics and improve their survival rate, colonization ability and antioxidant properties in the intestine; oligosaccharides and protamine are compounded to complement each other and are embedded in the inner layer. A stable gel network structure is formed on the outer surface of the inner embedding layer, and Persian gum makes the gel network structure tightly adsorbed on the outer surface of the inner embedding layer to protect the inner embedding layer from damage under harsh conditions. At the same time, the moisture retention ability of Persian gum prevents the embedded probiotics from excessive drying during storage, thereby having better storage stability. In this way, not only the action time of probiotics is increased, but also the body can be supplemented with probiotics and prebiotics at the same time. The two work together to maintain a balance in the intestinal microecological environment, prevent and improve constipation and diarrhea, enhance immunity, and maintain human health.

[0038] 4. The preparation method of the oral tablets of the present application can increase the fluidity and compressibility of the material by one-step granulation in a fluidized bed, and the granulated particles are mixed with the embedded probiotics for tableting, thereby reducing the damage of tableting to the embedded probiotics. Compared with ordinary tablets, the oral tablets prepared by the preparation method of the present application can be directly chewed into pieces in the mouth, resulting in a larger surface area of ​​the product, and it does not need to disintegrate, dissolves faster, and has a higher bioavailability, which is particularly suitable for the elderly and children with poor gastrointestinal function. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0040] Figure 1 This is a diagram showing the effect of relieving constipation according to an embodiment of the present application. DETAILED DESCRIPTION

[0041] The endpoints and any values ​​of the ranges disclosed in this article are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of each range, the endpoint values ​​of each range and the individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed in this article.

[0042] If no specific conditions are specified in the examples, the experiments were carried out under conventional conditions or conditions recommended by the manufacturer. The raw materials or instruments used, if no manufacturer is specified, are all conventional products that can be purchased commercially.

[0043] In the present application, the lactobacillus is at least one of plant lactobacillus, bulgaricus, lactobacillus lactis, and lactobacillus acidophilus; preferably, it is lactobacillus acidophilus, and the strain deposit number of Lactobacillus acidophilus is CGMCC 21371;

[0044] The bifidobacterium is at least one of Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium longum; preferably Bifidobacterium lactis, and the strain collection number of Bifidobacterium lactis is CGMCC 18093.

[0045] Example 1

[0046] A method for preparing an oral tablet comprises the following steps:

[0047] (1) By weight, 25 parts of sodium sulfate (particle size 700 μm, purity 98%, moisture content 0.5%), 4 parts of magnesium sulfate (particle size 700 μm, purity 98.5%, moisture content 5.0%), 2 parts of potassium chloride (particle size 700 μm, purity 98.5%, moisture content 1.0%), 3 parts of magnesium oxide, 17 parts of citric acid, 15 parts of xylitol, 3 parts of vanilla and 2 parts of cinnamon are respectively passed through a 60-mesh sieve and mixed uniformly to obtain a mixture 1;

[0048] (2) Mixture 1 is put into a fluidized bed one-step granulator for granulation and granulation. The air intake volume is 110m 3 / h, the air inlet temperature is 50°C, the atomization pressure is 1.0 bar, and the liquid inlet speed is 4 mL / min to obtain mixed material 2;

[0049] (3) Mixing the mixture 2 with 13 parts of embedded probiotics, 10 parts of maltodextrin, 10 parts of microcrystalline cellulose and 8 parts of magnesium stearate is uniformly mixed, and then compressed by a tablet press to obtain oral tablets;

[0050] The preparation method of embedded probiotics comprises the following steps:

[0051] S1. Resuspend the Lactobacillus acidophilus strain in phosphate buffer and incubate at 35°C for 10 min, then centrifuge at 4000 rpm for 10 min and discard the supernatant;

[0052] S2, the concentration is 1.2×10 8 A suspension of Lactobacillus acidophilus with a concentration of CFU / mL and a protocatechuic acid solution with a concentration of 0.1 mg / mL were mixed in a Tris-HCl buffer and reacted for 1 h in a dark environment. After the reaction, the mixture was washed with a phosphate buffer to form an inner embedding layer.

[0053] S3, adding 1.5wt% Tween 80 to phosphate buffer and mixing evenly, then adding 3wt% glycerol and xylo-oligosaccharide, and stirring ultrasonically at 60°C for 2min to obtain solution A; adding 4wt% Persian gum to phosphate buffer and mixing evenly to obtain solution B; after mixing solution A and solution B evenly, adding protamine, the weight ratio of xylo-oligosaccharide to protamine being 1:3, and continuing the mixing process to obtain solution C;

[0054] S4. Add the inner embedding layer obtained in S2 into solution C, stir and mix for 5 minutes, and then freeze-dry to form an outer embedding layer.

[0055] Example 2

[0056] A method for preparing an oral tablet comprises the following steps:

[0057] (1) By weight, 42 parts of sodium sulfate (particle size 600 μm, purity 98.4%, moisture content 0.2%), 8 parts of magnesium sulfate (particle size 600 μm, purity 98.8%, moisture content 3%), 4 parts of potassium chloride (particle size 600 μm, purity 98.8%, moisture content 0.6%), 5 parts of magnesium oxide, 20 parts of citric acid, 18 parts of erythritol, 3 parts of vanilla, 2 parts of cloves and 3 parts of rose are respectively passed through an 80-mesh sieve and mixed uniformly to obtain a mixture 1;

[0058] (2) Mixture 1 is put into a fluidized bed one-step granulator for granulation and granulation. The air intake volume is 115m 3 / h, the air inlet temperature is 60°C, the atomization pressure is 1.1 bar, and the liquid inlet speed is 5 mL / min to obtain mixture 2;

[0059] (3) Mixing the mixture 2 with 15 parts of embedded probiotics, 10 parts of starch, 8 parts of milk powder, 6 parts of microcrystalline cellulose and 6 parts of magnesium stearate is uniformly mixed, and then compressed by a tablet press to obtain oral tablets;

[0060] The preparation method of embedded probiotics comprises the following steps:

[0061] S1. Resuspend the Lactobacillus acidophilus strain in phosphate buffer and incubate at 38°C for 15 min, then centrifuge at 6000 rpm for 8 min and discard the supernatant;

[0062] The Bifidobacterium lactis strain was resuspended in phosphate buffer and incubated at 40°C for 15 min, then centrifuged at 6000 rpm for 8 min, and the supernatant was discarded;

[0063] S2, the concentration is 7.6×10 8 A suspension of Lactobacillus acidophilus with a concentration of CFU / mL and a chlorogenic acid solution with a concentration of 0.5 mg / mL were mixed in a Tris-HCl buffer and reacted for 2 hours in a dark environment. After the reaction, the mixture was washed with a phosphate buffer to form an inner embedding layer 1;

[0064] The concentration was 7.6×10 8 CFU / mL of Bifidobacterium lactis suspension and 0.5 mg / mL of chlorogenic acid solution were mixed in Tris-HCl buffer and reacted for 2 h in a dark environment. After the reaction, the mixture was washed with phosphate buffer to form an inner embedding layer 2.

[0065] S3, adding 1.5wt% Tween 80 to phosphate buffer and mixing evenly, then adding 3wt% glycerol and oligofructose, and stirring ultrasonically at 70°C for 1.5min to obtain solution A; adding 5wt% Persian gum to phosphate buffer and mixing evenly to obtain solution B; after mixing solution A and solution B evenly, adding protamine, the weight ratio of oligofructose to protamine is 1:5, and continuing the mixing process to obtain solution C;

[0066] S4. Add the inner embedding layer 1 and the inner embedding layer 2 obtained in S2 into solution C, stir and mix for 10 minutes, and then freeze-dry to form an outer embedding layer.

[0067] Example 3

[0068] A method for preparing an oral tablet comprises the following steps:

[0069] (1) By weight, 68 parts of sodium sulfate (particle size of 500 μm, purity of 98.2%, moisture content of 0.3%), 15 parts of magnesium sulfate (particle size of 500 μm, purity of 98.6%, moisture content of 4%), 6 parts of potassium chloride (particle size of 500 μm, purity of 98.6%, moisture content of 0.7%), 8 parts of magnesium oxide, 24 parts of citric acid, 22 parts of sorbitol and 10 parts of mint were respectively passed through a 100-mesh sieve and mixed uniformly to obtain a mixture 1;

[0070] (2) Mixture 1 is put into a fluidized bed one-step granulator for granulation and granulation. The air intake volume is 120m 3 / h, the air inlet temperature is 70°C, the atomization pressure is 1.2 bar, and the liquid inlet speed is 6 mL / min to obtain mixture 2;

[0071] (3) Mixing the mixture 2 with 18 parts of embedded probiotics, 15 parts of starch, 10 parts of microcrystalline cellulose and 10 parts of magnesium stearate is uniformly mixed, and then compressed by a tablet press to obtain oral tablets;

[0072] The preparation method of embedded probiotics comprises the following steps:

[0073] S1. Resuspend the Bifidobacterium lactis strain in phosphate buffer and incubate at 42°C for 20 min, then centrifuge at 8000 rpm for 5 min and discard the supernatant;

[0074] S2, the concentration is 4.5×10 8 CFU / mL of Bifidobacterium lactis suspension and 1 mg / mL of caffeic acid solution were mixed in Tris-HCl buffer and reacted for 3 h in a dark environment. After the reaction, the mixture was washed with phosphate buffer to form an inner embedding layer.

[0075] S3, adding 1.5wt% Tween 80 to phosphate buffer and mixing evenly, then adding 3wt% glycerol and lactulose, and stirring ultrasonically at 80°C for 1 min to obtain solution A; adding 8wt% Persian gum to phosphate buffer and mixing evenly to obtain solution B; after mixing solution A and solution B evenly, adding protamine, the weight ratio of lactulose to protamine is 1:8, and continuing the mixing process to obtain solution C;

[0076] S4. Add the inner embedding layer obtained in S2 into solution C, stir and mix for 15 minutes, and then freeze-dry to form an outer embedding layer.

[0077] Example 4

[0078] The difference from Example 2 is that:

[0079] The preparation method of embedded probiotics comprises the following steps:

[0080] S1. Resuspend the Lactobacillus acidophilus strain in phosphate buffer and incubate at 38°C for 15 min, then centrifuge at 6000 rpm for 8 min and discard the supernatant;

[0081] The Bifidobacterium lactis strain was resuspended in phosphate buffer and incubated at 40°C for 15 min, then centrifuged at 6000 rpm for 8 min, and the supernatant was discarded;

[0082] S2, the concentration is 7.6×10 8 A suspension of Lactobacillus acidophilus with a concentration of CFU / mL and a chlorogenic acid solution with a concentration of 0.5 mg / mL were mixed in a Tris-HCl buffer and reacted for 2 hours in a dark environment. After the reaction, the mixture was washed with a phosphate buffer to form an embedding layer 1;

[0083] The concentration was 7.6×10 8 CFU / mL of Bifidobacterium lactis suspension and 0.5 mg / mL of chlorogenic acid solution were mixed in Tris-HCl buffer and reacted for 2 hours in a dark environment. After the reaction, the mixture was washed with phosphate buffer to form an embedding layer 2.

[0084] Example 5

[0085] The difference from Example 2 is that:

[0086] The preparation method of embedded probiotics comprises the following steps:

[0087] S1. Resuspend the Lactobacillus acidophilus strain in phosphate buffer and incubate at 38°C for 15 min, then centrifuge at 6000 rpm for 8 min and discard the supernatant;

[0088] The Bifidobacterium lactis strain was resuspended in phosphate buffer and incubated at 40°C for 15 min, then centrifuged at 6000 rpm for 8 min, and the supernatant was discarded;

[0089] S2, adding 1.5wt% Tween 80 to phosphate buffer and mixing evenly, then adding 3wt% glycerol and oligofructose, and stirring ultrasonically at 70°C for 1.5min to obtain solution A; adding 5wt% Persian gum to phosphate buffer and mixing evenly to obtain solution B; after mixing solution A and solution B evenly, adding protamine, the weight ratio of oligofructose to protamine is 1:5, and continuing the mixing process to obtain solution C;

[0090] S3. Add the precipitate obtained by centrifugation in S1 into solution C, stir and mix for 10 minutes, and then freeze-dry to form an embedding layer.

[0091] Example 6

[0092] The difference from Example 2 is that:

[0093] In step S2, chlorogenic acid was replaced with salicylic acid.

[0094] Example 7

[0095] The difference from Example 2 is that:

[0096] S3, adding 1.5wt% Tween 80 to phosphate buffer and mixing evenly, then adding 3wt% glycerol and oligofructose, and stirring ultrasonically at 70°C for 1.5min to obtain solution A; adding protamine to solution A, the weight ratio of oligofructose to protamine being 1:5, and continuing the mixing process to obtain solution B;

[0097] S4. Add the inner embedding layer 1 and the inner embedding layer 2 obtained in S2 into solution B, stir and mix for 10 minutes, and then freeze-dry to form an outer embedding layer.

[0098] Example 8

[0099] The difference from Example 2 is that:

[0100] No magnesium oxide was added in step (1).

[0101] Example 9

[0102] The difference from Example 2 is that:

[0103] The weight ratio of fructooligosaccharide to protamine is 1:10.

[0104] Comparative Example 1

[0105] The difference from Example 2 is that:

[0106] Replace the embedded probiotics in step (3) with 7.6×10 8 CFU / g Lactobacillus acidophilus powder and 7.6×10 8 CFU / g lactic acid Bifidobacterium powder, and the preparation method of the embedded probiotics is not disclosed.

[0107] Comparative Example 2

[0108] The difference from Example 2 is that:

[0109] A method for preparing an oral tablet comprises the following steps:

[0110] (1) By weight, 42 parts of sodium sulfate (particle size 600 μm, purity 98.4%, moisture content 0.2%), 8 parts of magnesium sulfate (particle size 600 μm, purity 98.8%, moisture content 3%), 4 parts of potassium chloride (particle size 600 μm, purity 98.8%, moisture content 0.6%), 5 parts of magnesium oxide, 20 parts of citric acid, 18 parts of erythritol, 3 parts of vanilla, 2 parts of cloves and 3 parts of rose are respectively passed through an 80-mesh sieve and mixed uniformly to obtain a mixture 1;

[0111] (2) Mixture 1 is mixed evenly with 15 parts of embedded probiotics, 10 parts of starch, 8 parts of milk powder, 6 parts of microcrystalline cellulose and 6 parts of magnesium stearate, and then compressed by a tablet press to obtain oral tablets.

[0112] The oral tablets obtained by the preparation methods of Examples 1-9 and Comparative Examples 1-2 were tested, and the test methods and results involved are shown below.

[0113] 1. Quality evaluation

[0114] Angle of repose: Weigh 100 g of the material to be tested (except the ingredients containing probiotics) and slowly add it from the top of the funnel. The inclination angle of the conical accumulation formed by the material leaking from the bottom of the funnel on the horizontal plane is the angle of repose.

[0115] Hardness: measured by intelligent hardness tester.

[0116] Friability: Take 10 oral tablets, use a hair dryer to gently blow away the powder on the surface of the tablets, accurately weigh their mass, then place them in a cylinder, rotate them 100 times, take them out, blow away the powder on the surface of the tablets in the same way, then accurately weigh their mass, calculate their lost weight, and calculate their friability.

[0117] Taste rating: 50 subjects were randomly selected to rate the taste or overall taste of the oral tablets, with a good taste and flavor score of 10 points and an unacceptable taste score of 0 points. The average score was taken and the highest score was the best taste.

[0118] Table 1

[0119]

[0120]

[0121] As can be seen from Table 1, the oral tablets obtained by the preparation method of the present application have good mouthfeel and taste, and the surface area increases after chewing and taking, and no disintegration process is required. The effective ingredients can be quickly dissolved, which is beneficial to the dissolution and absorption of each ingredient in the body, thereby greatly reducing the burden on the gastrointestinal tract. Therefore, it is particularly suitable for the elderly, children, people with swallowing disorders and weak gastrointestinal function.

[0122] 2. Determination of viable count

[0123] The number of viable bacteria in the oral tablets obtained by the preparation methods of Examples 1-9 and Comparative Examples 1-2 was detected with reference to GB4789.2-2016, and the results are shown in Table 2 below.

[0124] Table 2

[0125] Test No. Number of viable bacteria (CFU / tablet) Example 1 <![CDATA[0.7×10 8 ]]> Example 2 <![CDATA[6.8×10 8 ]]> Example 3 <![CDATA[3.6×10 8 ]]> Example 4 <![CDATA[5.4×10 6 ]]> Example 5 <![CDATA[2.8×10 6 ]]> Example 6 <![CDATA[6.2×10 7 ]]> Example 7 <![CDATA[4.8×10 7 ]]> Example 8 <![CDATA[6.8×10 8 ]]> Example 9 <![CDATA[0.3×10 8 ]]> Comparative Example 1 <![CDATA[5.8×10 5 ]]> Comparative Example 2 <![CDATA[7.4×10 5 ]]>

[0126] As can be seen from Table 2, the number of viable bacteria in the oral tablets obtained by the preparation methods of Examples 1-3 is relatively high, especially the number of viable bacteria in the oral tablets of Example 3 is higher, which can increase the abundance of beneficial bacteria in the intestine, inhibit the growth of potential pathogenic bacteria, change the composition of intestinal flora, and restore intestinal health.

[0127] 3. Constipation relief efficacy test

[0128] 3.1 ICR male mice were randomly divided into 6 groups, namely, blank control group, model control group (loperamide hydrochloride was dissolved in distilled water at a dose of 1 mg kg), positive control group (polyethylene glycol powder was dissolved in distilled water at a dose of 1 g / kg), low-dose group (the oral tablets in Example 2 were dissolved in distilled water at a dose of 0.1 g / kg), medium-dose group (the oral tablets in Example 2 were dissolved in distilled water at a dose of 0.3 g / kg) and high-dose group (the oral tablets in Example 2 were dissolved in distilled water at a dose of 0.5 g / kg). The blank control group was given an equal volume of distilled water, and the other groups were given the test substances by gavage at 1 mL / 100 g, once a day for 7 consecutive days. After the 7th administration, the mice in each group were fasted for 24 hours, distilled water was given to the blank control group, and 1 mL / 100 g of loperamide hydrochloride solution was given by gavage to the other groups. 30 minutes later, the blank control group and the model control group were given Chinese ink, and the other 4 groups were given Chinese ink containing the corresponding test samples. After 30 minutes, the mice were killed immediately, the intestinal tube from the pylorus to the cecum was removed, the total length of the small intestine and the ink propagation length were measured, and the ink propagation rate of the small intestine P / % was calculated = ink propagation length (cm) / total length of the small intestine (cm) × 100. The ink propagation rate was statistically processed and variance analysis was performed. At the same time, the general condition of the mice was observed, the weight of the mice was recorded, and the biosafety of the product was explored. The results are as follows Figure 1 shown.

[0129] Depend on Figure 1 It can be seen that compared with the model control group, there was no significant difference between the low-dose group and the positive control group, and the ink propulsion rates of the medium and high-dose groups were increased, indicating that the medium and high-dose groups of the sample can promote gastrointestinal motility, among which the high-dose group can significantly improve the intestinal motility of mice and relieve constipation with the best effect; compared with the positive control group, the low-dose group was basically the same, the medium-dose group was better, and the high-dose group had a significant effect on improving intestinal motility.

[0130] The data were expressed as x±s and statistically analyzed using SPSS22.0 software. One-way analysis of variance was used for inter-group comparisons. When the differences between the groups were statistically significant, the least significant difference method was used for pairwise comparisons between the groups, and p<0.05 indicated a significant difference.

[0131] 3.2 Subjects: aged 20-60 years old, with similar constipation degree, and signed informed consent. The subjects were evenly divided into 10 groups, each with 100 people (the age distribution of the subjects in each group was uniform), and the subjects in each group took the oral tablets obtained in Examples 1-9 and Comparative Examples 1-2 orally, two tablets at a time, three times a day; the control group did not take it; the constipation relief rate of each group after taking the corresponding oral tablets for 7 days was calculated (constipation relief rate = number of people with constipation relief / total number of people in the group), and the constipation relief was defecation once a day, and the defecation was smooth and easy, without dry stool and diarrhea, and the results are shown in Table 3.

[0132] Table 3

[0133] Test No. Constipation relief rate (%) Control group 0 Example 1 86.3 Example 2 88.5 Example 3 87.1 Example 4 74.6 Example 5 72.3 Example 6 78.5 Example 7 76.2 Example 8 61.4 Example 9 82.6 Comparative Example 1 65.3 Comparative Example 2 68.5

[0134] It can be seen from Table 3 that the oral tablets obtained by the preparation method of the present application can accelerate the gastrointestinal motility of the body, especially the oral tablets obtained by the preparation method of Examples 1-3, which have a significant effect in relieving functional constipation.

[0135] The above is only the embodiment of the present application, and the protection scope of the present application is not limited by these specific embodiments, but is determined by the claims of the present application. For those skilled in the art, the present application can have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the technical ideas and principles of the present application should be included in the protection scope of the present application.

Claims

1. A composition, characterized in that It comprises sodium sulfate, magnesium sulfate and potassium chloride, wherein the weight ratio of the sodium sulfate, magnesium sulfate and potassium chloride is (5-10):(1-2):(0.5-1.5); The sodium sulfate has a particle size of less than 700 μm, a purity of not less than 98%, and a moisture content of less than 0.5%; The magnesium sulfate has a particle size of less than 700 μm, a purity of not less than 98.5%, and a moisture content of less than 5.0%; The potassium chloride has a particle size of less than 700 μm, a purity of not less than 98.5%, and a moisture content of less than 1.0%.

2. An oral tablet, characterized in that The invention comprises the composition according to claim 1.

3. The oral tablet according to claim 2, characterized in that The oral tablet further comprises the following components in parts by weight: 3-8 parts of magnesium oxide, 13-18 parts of embedded probiotics, 17-24 parts of citric acid, 15-22 parts of sugar substitute additives, 5-10 parts of spices, and 28-35 parts of auxiliary materials; The embedded probiotics include an inner embedding layer and an outer embedding layer, wherein the inner embedding layer contains probiotics, and the outer embedding layer is wrapped around the outer surface of the inner embedding layer.

4. The oral tablet according to claim 3, characterized in that The preparation method of the embedded probiotics comprises the following steps: S1. Resuspend a single probiotic strain in phosphate buffer and incubate at 35-42°C for 10-20 min, then centrifuge and discard the supernatant; S2, mixing the single probiotic suspension and the plant polyphenol solution in a Tris-HCl buffer, and reacting them in a dark environment for 1-3 hours, and then washing them with a phosphate buffer to form an inner embedding layer; S3, adding Tween 80 to phosphate buffer and mixing evenly, then adding glycerol and oligosaccharide, and stirring ultrasonically at 60-80°C for 1-2 minutes to obtain solution A; adding Persian gum to phosphate buffer and mixing evenly to obtain solution B; after mixing solution A and solution B evenly, adding protamine, and continuing mixing treatment to obtain solution C; S4. Add the inner embedding layer obtained in S2 into solution C, stir and mix for 5-15 minutes, and then freeze-dry to form an outer embedding layer.

5. The oral tablet according to claim 4, characterized in that: In S2, the concentration of the probiotic suspension is 1.2×10 8 -7.6×10 8 CFU / mL; The concentration of the plant polyphenol solution is 0.1-1 mg / mL.

6. The oral tablet according to claim 4, characterized in that The probiotics are bifidobacteria and / or lactobacilli; The plant polyphenol is protocatechuic acid, chlorogenic acid or caffeic acid; The oligosaccharide is at least one of xylooligosaccharide, galacto-oligosaccharide, fructo-oligosaccharide and lactulose.

7. The oral tablet according to claim 4, characterized in that In S3, the weight ratio of the oligosaccharide to protamine is 1:(3-8); The added weight of the Persian gum is 3-8% of the protamine.

8. The oral tablet according to claim 3, characterized in that The sugar substitute additive is at least one of xylitol, sorbitol and erythritol; The spice is at least one of vanilla, cloves, cinnamon, rose and mint; The auxiliary material is at least one of starch, milk powder, maltodextrin, microcrystalline cellulose and magnesium stearate.

9. A method for preparing an oral tablet, characterized in that: For preparing an oral tablet as claimed in any one of claims 2 to 8, comprising the following steps: (1) Sodium sulfate, magnesium sulfate, potassium chloride, magnesium oxide, citric acid, sugar substitute additives and spices are respectively passed through a 60-100 mesh sieve, and then mixed uniformly according to a formula ratio to obtain a mixture 1; (2) Mixture 1 is put into a fluidized bed one-step granulator for granulation and granulation, with an air intake of 110-120m 3 / h, the air inlet temperature is 50-70°C, the atomization pressure is 1.0-1.2 bar, and the liquid inlet speed is 4-6 mL / min to obtain a mixture 2; (3) Mix the mixture 2, the embedded probiotics and the auxiliary materials in accordance with the formula ratio, and then compress the mixture into tablets using a tablet press to obtain oral tablets.

10. Use of the oral tablet according to any one of claims 2 to 8 for cleaning the intestinal tract, improving the intestinal environment and relieving functional constipation, wherein the daily dosage of the oral tablet is 0.1-0.5 g / kg.

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