Self-suspending alkaline solid composition as well as preparation method and application thereof

Abstract

The invention provides a self-suspending alkaline solid composition and a preparation method and application thereof, and relates to the technical field of preparation of compositions for inhibiting gastric acid reflux, acidic polysaccharide, konjac glucomannan, sodium bicarbonate, calcium carbonate and acidic slow-release particles are mixed to obtain the solid composition, and when the solid composition is dissolved, the solid composition can be dissolved in water to form the self-suspending alkaline solid composition. The konjac glucomannan provides a macromolecular framework in advance to fix the konjac glucomannan, the acidic sustained-release particles slowly release weak acid, the weak acid reacts with sodium bicarbonate and calcium carbonate to generate carbon dioxide gas and calcium ions, carbon dioxide is wrapped in the viscous liquid, and the calcium ions react with acidic polysaccharide to form gel, so that the viscous liquid has a weak gel structure, and the acidic polysaccharide can form a gel structure. The self-suspension viscous liquid can have good suspension ability under strong acid, weak acid and neutral conditions, and can prevent damage to esophagus caused by reflux of gastric juice.

Description

Technical Field

[0001] The invention belongs to the technical field of compositions for inhibiting gastric acid reflux, and specifically relates to a self-suspending alkaline solid composition and a preparation method and application thereof. Background Art

[0002] Gastroesophageal reflux disease (GERD) is a global health problem. About 30% of adults in the United States experience gastric reflux symptoms once a week; in 2015, the cost of treating GERD and its complications exceeded $18 billion, of which proton pump inhibitors (PPIs) cost $12.4 billion. The proportion of GERD in my country has also increased year by year with economic development, accounting for about 6-15% of the population. PPIs are the first-line drugs for the treatment of peptic ulcers, gastroesophageal reflux disease, Zollinger-Ellison syndrome, and upper gastrointestinal bleeding. A large number of clinical trials have shown that PPIs can achieve an 80% therapeutic effect on the treatment of ulcers and erosive esophagitis (EE); however, in the treatment of refractory GERD and non-erosive reflux disease (NERD), the effectiveness is only about 50%. The next-line treatment for acid reflux is H2 receptor antagonists (H2RA), which also treat symptoms such as heartburn by reducing the acidity of gastric juice. Although PPIs and H2RA reduce the acidity of gastric juice, they have little effect on the frequency and intensity of gastric reflux. Gastric reflux is mainly weak acid or even weak alkaline (pH ≥ 4).

[0003] The harmful components of refluxed gastric juice that damage the esophagus mainly include gastric acid, pepsin, and bile acid; the hydrolytic activity of pepsin is the largest in the pH range of 1.9-3.6. Weak acid reflux still refluxes gastric juice components into the esophagus, and harmful components to the esophageal mucosa, such as pepsin and bile acid, continue to remain in the esophagus. Weak acid reflux still causes heartburn symptoms because weak acid can continue to damage the esophagus. For example, pepsin still has proteolytic activity at pH = 6. Therefore, many patients with gastroesophageal reflux still experience mild heartburn and reflux symptoms after PPI treatment, which is caused by weak acid reflux. It is difficult to effectively control the damage to the esophagus caused by weak acid reflux through drugs, which is one of the reasons why it is difficult to cure gastroesophageal reflux with drugs.

[0004] Alginate antacids, including Gaviscon, are used to treat mild to moderate gastroesophageal reflux, especially for NERD. They prevent or reduce the frequency and intensity of gastric reflux by forming a suspended gel in gastric juice. Since the formation of gel requires strong acidity, the location with the highest acidity in gastric juice is just below the gastroesophageal sphincter, i.e., the "acid bag". Usually, the acidity of the "acid bag" can rise to pH <2.0 after a meal, which is an indispensable condition for the formation of suspended gel by alginate antacids. When people take PPIs / H2RA before meals, the acid production capacity of the stomach is greatly reduced, making the acidity of the gastric juice "acid bag" far lower than the normal pH>2. Therefore, the ability of this type of antacid to produce gel is greatly reduced, or even unable to produce gel, which affects the beneficial effect of the combination of Gaviscon and PPI in treating gastric reflux. Summary of the invention

[0005] In view of this, the present invention provides a self-suspending alkaline solid composition that can self-suspend in both strong acid and weak acid.

[0006] It is also necessary to provide a self-suspending alkaline solid composition and a method for preparing the same.

[0007] There is also a need to provide a use of a self-suspending alkaline solid composition.

[0008] The technical solution adopted by the present invention to solve its technical problem is:

[0009] A self-suspending alkaline solid composition comprises the following components in percentage by mass: 10-40% acidic polysaccharide, 3-10% konjac gum, 10-25% sodium bicarbonate, 10-32% calcium carbonate, and 4-18% acidic slow-release particles;

[0010] The acidic polysaccharide is one or two of sodium alginate, pectin and xanthan gum.

[0011] Preferably, the acidic sustained-release particles are delta-gluconolactone or solid organic acids coated with food-grade wax or fat.

[0012] Preferably, the organic acid is one or more of citric acid, malic acid, tartaric acid, ascorbic acid, succinic acid, alginic acid, hyaluronic acid, polyacrylic acid and polylactic acid.

[0013] Preferably, the invention further comprises 1-15% by weight of a hydrophobic emulsion stabilizer, wherein the hydrophobic emulsion stabilizer is one or more of sucrose fatty acid ester, phospholipid, polyglycerol fatty acid ester and sorbitan monolaurate.

[0014] Preferably, the sweetener or dispersant is further included in an amount of 1-15% by weight, wherein the sweetener or dispersant is one or more of xylitol, mannitol, sucrose, glucose, psicose, and fructose.

[0015] Preferably, the sweetness enhancer is further included in an amount of 0.001-0.006% by mass, wherein the sweetness enhancer is one or more of acesulfame potassium, saccharin sodium, sucralose, aspartame, steviol glycosides, and mogrosides.

[0016] The method for preparing the self-suspending alkaline solid composition as described above comprises the following steps:

[0017] S1: grinding and sieving acidic polysaccharide, konjac gum, sodium bicarbonate and calcium carbonate to obtain a first mixture;

[0018] S2: mixing the first mixture with the acidic sustained-release particles to obtain a self-suspending alkaline solid composition.

[0019] Preferably, the particle size of the first mixture in S1 is ≤0.0750 mm; and the acidic sustained-release particles in S2 are larger than 1 mm.

[0020] Use of the self-suspending alkaline solid composition as described above in gastroesophageal reflux.

[0021] Use of the self-suspending alkaline solid composition as described above in the preparation of gastroesophageal reflux medicines and / or health products.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] The invention provides a self-suspending alkaline solid composition. The solid composition is obtained by mixing acidic polysaccharide, konjac gum, sodium bicarbonate, calcium carbonate and acidic slow-release particles. When the solid composition is dissolved, the konjac gum provides a macromolecular framework in advance to fix the solid composition. The acidic slow-release particles slowly release weak acid. The weak acid reacts with the sodium bicarbonate and the calcium carbonate to generate carbon dioxide gas and calcium ions. The carbon dioxide is wrapped in a viscous liquid. The calcium ions react with the acidic polysaccharide to form a gel. The viscous liquid has a weak gel structure. The self-suspending viscous liquid has good suspension ability under strong acid, weak acid and neutral conditions and can prevent gastric juice reflux from damaging the esophagus. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a test diagram of the suspension performance of Example 1.

[0025] Figure 2 This is a test diagram of the suspension performance of Example 2.

[0026] Figure 3 This is a test diagram of the suspension performance of Example 3.

[0027] Figure 4 This is a test diagram of the suspension performance of Example 4.

[0028] Figure 5 This is a test diagram of the suspension performance of Example 5.

[0029] Figure 6 This is a suspension performance test diagram of Example 6.

[0030] Figure 7 This is a suspension performance test diagram of Example 7.

[0031] Figure 8 This is a suspension performance test diagram of Comparative Example 1. DETAILED DESCRIPTION

[0032] The technical solutions and technical effects of the embodiments of the present invention are further described in detail below in conjunction with the accompanying drawings of the present invention.

[0033] A self-suspending alkaline solid composition comprises the following components in percentage by mass: 10-40% acidic polysaccharide, 3-10% konjac gum, 10-25% sodium bicarbonate, 10-32% calcium carbonate, and 4-18% acidic slow-release particles;

[0034] The acidic polysaccharide is one or two of sodium alginate, pectin and xanthan gum.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] The invention provides a self-suspending alkaline solid composition. The solid composition is obtained by mixing acidic polysaccharide, konjac gum, sodium bicarbonate, calcium carbonate and acidic slow-release particles. When the solid composition is dissolved, the konjac gum provides a macromolecular framework in advance to fix the solid composition. The acidic slow-release particles slowly release weak acid. The weak acid reacts with the sodium bicarbonate and the calcium carbonate to generate carbon dioxide gas and calcium ions. The carbon dioxide is wrapped in a viscous liquid. The calcium ions react with the acidic polysaccharide to form a gel. The viscous liquid has a weak gel structure. The self-suspending viscous liquid has good suspension ability under strong acid, weak acid and neutral conditions and can prevent gastric juice reflux from damaging the esophagus.

[0037] Specifically, the sodium alginate is a sodium salt of a low-viscosity acidic polysaccharide, the guluronic acid content of which is about 60%, and it can neutralize an appropriate amount of gastric acid under gastric acid conditions to form an insoluble alginate gel. In an acidic environment, it can react with calcium carbonate to form a gel with greater strength.

[0038] Xanthan gum is a medium viscosity acidic polysaccharide that is stable to acid, alkali, salt and heat, and can synergize with other polysaccharides to form gels or high viscosity systems.

[0039] Pectin, which refers to low-ester pectin and amino pectin, is an acidic polysaccharide with low viscosity; it reacts with calcium carbonate under acidic conditions to form an insoluble gel.

[0040] Konjac gum is a water-soluble neutral macromolecular polysaccharide that is stable to acid, alkali and heat. It is used as a suspension stabilizer and thickener. It has an excellent sense of fullness and can be used as an intestinal prebiotic.

[0041] Sodium bicarbonate is a weak base that can neutralize gastric acid remaining in the esophagus and gastric acid in gastric juice, while releasing harmless carbon dioxide gas; the gas released in this product is wrapped in a macromolecular gel, making the gel suspended.

[0042] Calcium carbonate is an alkaline insoluble ingredient that can neutralize stomach acid and release calcium ions and carbon dioxide gas when reacting with stomach acid. The calcium ions can react with large molecular acidic polysaccharides to form a gel or further strengthen the gel, and the carbon dioxide is encapsulated in the gel to give the gel a better suspension function. At the same time, calcium carbonate can also serve as a source of calcium needed by the human body.

[0043] Among the above ingredients, 1) the synergistic effect of sodium alginate and amino pectin makes the gel strength and suspension stability formed in the system in an acidic environment better than that of sodium alginate itself, so that the domestic sodium alginate with relatively low guluronic acid can be effectively used in antacid products for gastroesophageal reflux; 2) konjac gum, xanthan gum, pectin and sodium alginate synergistically act in an acidic environment to quickly form a high-viscosity system or weak gel, which helps to protect the gastroesophageal mucosa; 3) calcium carbonate reacts with gastric acid to release calcium ions to strengthen the macromolecular gel structure, and the released carbon dioxide gas helps to suspend the gel; the suspended gel is an important factor for the product to prevent or reduce the reflux of gastric juice into the esophagus; 4) sodium bicarbonate not only neutralizes gastric acid, but also releases carbon dioxide, which helps to suspend the gel.

[0044] Furthermore, the acidic sustained-release particles are δ-gluconolactone or an organic acid coated with food-grade wax or fat; δ-gluconolactone or an organic acid coated with food-grade wax or fat is used as an acidic sustained-release component, so that gluconic acid or an organic acid is slowly released, and then the gluconic acid or an organic acid slowly reacts with sodium bicarbonate or calcium carbonate to generate carbon dioxide, so that the carbon dioxide is as completely coated as possible in the viscous liquid, thereby achieving excellent suspension performance.

[0045] Furthermore, the organic acid refers to one or more of citric acid, malic acid, tartaric acid, ascorbic acid, succinic acid, alginic acid, hyaluronic acid, polyacrylic acid and polylactic acid.

[0046] Furthermore, the invention also comprises 1-15% by weight of a hydrophobic emulsion stabilizer, wherein the hydrophobic emulsion stabilizer is one or more of sucrose fatty acid ester, phospholipid, polyglycerol fatty acid ester, and sorbitan monolaurate.

[0047] Furthermore, it also includes a sweetener or dispersant with a mass percentage of 1-15%, and the sweetener or dispersant is one or more of xylitol, mannitol, sucrose, glucose, psicose, and fructose.

[0048] Furthermore, it also includes 0.001-0.006% by weight of a sweetness enhancer, wherein the sweetness enhancer is one or more of acesulfame potassium, saccharin sodium, sucralose, aspartame, steviol glycosides, and mogrosides.

[0049] Specifically, the acidic polysaccharide, konjac gum, sodium bicarbonate, calcium carbonate, organic acid, hydrophobic emulsion stabilizer, sweetener, dispersant, and sweetness enhancer are all food-grade ingredients.

[0050] The method for preparing the self-suspending alkaline solid composition as described above comprises the following steps:

[0051] S1: grinding and sieving acidic polysaccharide, konjac gum, sodium bicarbonate and calcium carbonate to obtain a first mixture;

[0052] S2: mixing the first mixture with the acidic sustained-release particles to obtain a self-suspending alkaline solid composition.

[0053] Furthermore, the particle size of the first mixture in S1 is ≤0.0750 mm; the acidic sustained-release particles in S2 are larger than 1 mm; and the dissolution rates of the acidic polysaccharides, konjac gum, sodium bicarbonate, calcium carbonate and the acidic sustained-release particles are controlled by the difference in particle size, so that the gas encapsulation effect and the gel formation process are optimal.

[0054] Use of the self-suspending alkaline solid composition as described above in gastroesophageal reflux.

[0055] Use of the self-suspending alkaline solid composition as described above in the preparation of gastroesophageal reflux medicines and / or health products.

[0056] The use of the present invention is described by the following examples.

[0057] Raw material selection criteria:

[0058] Sodium alginate: food grade, G content 60.4%, viscosity (10% aqueous solution, 25°C) 685mPa.s;

[0059] Xanthan gum: food grade, viscosity (1% aqueous solution) is 1485mPa.s;

[0060] Pectin: Aminated pectin food grade, degree of amidation 22%, degree of esterification 27%;

[0061] Konjac gum: food grade, viscosity (1%) 25000mPa.s;

[0062] Light calcium carbonate: food grade;

[0063] Sodium bicarbonate: food grade;

[0064] Sucrose fatty acid ester: food grade, SE15;

[0065] δ-Gluconolactone food grade, particle inner diameter ≥1mm;

[0066] Water: deionized water.

[0067] Embodiment 1:

[0068] 1. The formula is shown in Table 1:

[0069] Table 1

[0070] Composition Dosage Sodium alginate 3.0g Xanthan gum 0.5g Konjac Gum 0.8g Sucrose fatty acid esters 1.0g Sodium bicarbonate 2.0g Light calcium carbonate 2.4g δ-Gluconolactone 1.5g Xylitol 1.2g Acesulfame K 40mg Strawberry solid flavor 0.2g water 80

[0071] 2. Preparation of self-suspending alkaline solid composition:

[0072] Acidic polysaccharide, konjac gum, sodium bicarbonate and calcium carbonate are ground and passed through a 200-mesh sieve to obtain a first mixture; the first mixture is mixed with delta-gluconolactone to obtain a self-suspending alkaline solid composition.

[0073] 3. Suspension test:

[0074] (1) Preparation of suspension: Add the self-suspending alkaline solid composition into water at room temperature and stir rapidly for 10 minutes to allow the materials to be fully dissolved and mixed; obtain a viscous liquid.

[0075] (2) Suspension performance test: 20 mL of the suspension was taken with a syringe and added to the following aqueous solutions preheated to 37°C: a) 100 ml of water, b) 100 ml of 0.01 M HCl, c) 100 ml of 0.04 M HCl; then the solution was kept warm at this temperature and the gel suspension of the solution at different acidities and at different times was observed.

[0076] 4. Test results:

[0077] The suspension conditions of the suspension in 100 ml water (neutral), 100 ml 0.01 M HCl (pH 2), 100 ml 0.04 M HCl (pH 1.4-1.5), and 2 min, 65 min, 130 min, and 270 min are as follows: Figure 1 shown.

[0078] Depend on Figure 1 It can be seen that the viscous suspension liquid can be maintained in neutral pure water for more than 4 hours, and only a small amount of components diffuse into the solution; the viscous suspension liquid can stably exist for a long time in 0.01M HCl solution, with basically no diffusion; the viscous suspension liquid can stably exist for a long time in 0.04M HCl solution.

[0079] Therefore, the suspension conditions of the suspension liquid in water, 0.01M and 0.04M pH aqueous solutions show that the suspension has good suspension ability in acidic gastric juice, and can also maintain good suspension conditions under weak acid and neutral conditions, indicating that the self-suspending alkaline solid composition can be used alone as an antacid, and can also be used in combination with first-line drugs (such as PPIs) for the treatment of gastroesophageal reflux disease in the acidic to neutral range of gastric juice, achieving a dual therapeutic effect.

[0080] Embodiment 2, 3:

[0081] 1. The formula is shown in Table 2:

[0082] Table 2

[0083] Composition / g Example 2 Example 3 Sodium alginate 2.0g 1.0g Xanthan gum 1.0g 1.0g Konjac Gum 0.8g 0.8g Sucrose fatty acid esters 1.0g 1.0g Sodium bicarbonate 2.0g 2.0g Light calcium carbonate 2.4g 2.4g δ-Gluconolactone 1.5g 0.9g Xylitol 1.2g 1.2g Acesulfame K 40mg 40mg Strawberry solid flavor 0.2g 0.2g water 80g 80g

[0084] 2. Preparation of self-suspending alkaline solid composition:

[0085] The preparation method of the self-suspending alkaline solid composition is the same as that in Example 1.

[0086] 3. Suspension test:

[0087] The preparation method and test method are the same as those in the suspension test in Example 1.

[0088] 4. Test results:

[0089] The suspension obtained in Example 2 was suspended in 100 ml of water (neutral), 100 ml of 0.01 M HCl (pH 2), 100 ml of 0.04 M HCl (pH 1.4-1.5), and at 2 min, 60 min, 120 min, and 270 min. Figure 2 shown.

[0090] The suspension obtained in Example 3 was suspended in 100 ml of water (neutral), 100 ml of 0.01 M HCl (pH 2), 100 ml of 0.04 M HCl (pH 1.4-1.5), and at 2 min, 75 min, 150 min, and 240 min. Figure 3 shown.

[0091] Examples 2 and 3 use different amounts of sodium alginate and delta-gluconolactone, and the suspensions of Examples 2 and 3 can still be stable for four hours in 0.04M and 0.01M HCl solutions, indicating that under normal gastric acidity, the sodium alginate combination suspensions prepared in Examples 2 and 3 can be stably suspended in the upper layer of gastric juice to prevent gastric juice reflux.

[0092] Compared with Example 3, the suspension of Example 2 has a longer stability in neutral water. Even if the suspension formula of Example 3 uses a reduced amount of sodium alginate and δ-gluconolactone, the prepared suspension still has good suspension performance in neutral water, and only a small amount of insoluble matter diffuses in neutral water.

[0093] The self-suspending alkaline solid compositions prepared in Examples 2 and 3 can be used alone as antacids, or can be used in combination with first-line drugs for gastric acid reflux.

[0094] Embodiment 4,5:

[0095] 1. The formula is shown in Table 3:

[0096] Table 3

[0097] Composition / g Example 4 Example 5 Pectin 2.0g 1.0g Xanthan gum 0.5g 1.0g Konjac Gum 0.8g 0.5g Sucrose fatty acid esters 1.0g 0.5g Sodium bicarbonate 2.0g 2.0g Light calcium carbonate 2.4g 2.4g δ-Gluconolactone 1.5g 1.5g Xylitol 1.2g 1.2g Acesulfame K 40mg 40mg Strawberry solid flavor 0.2g 0.2g water 80g 80g

[0098] 2. Preparation of self-suspending alkaline solid composition:

[0099] The preparation method of the self-suspending alkaline solid composition is the same as that in Example 1.

[0100] 3. Suspension test:

[0101] The preparation method and test method are the same as those in the suspension test in Example 1.

[0102] 4. Test results:

[0103] The suspension obtained in Example 4 was suspended in 100 ml of water (neutral), 100 ml of 0.01 M HCl (pH 2), 100 ml of 0.04 M HCl (pH 1.4-1.5), and at 2 min, 60 min, 135 min, and 210 min. Figure 4 shown.

[0104] The suspension obtained in Example 5 was suspended in 100 ml of water (neutral), 100 ml of 0.01 M HCl (pH 2), 100 ml of 0.04 M HCl (pH 1.4-1.5), and at 2 min, 60 min, 125 min, and 240 min. Figure 5 shown.

[0105] Example 4 and Example 5 use different amounts of amino pectin instead of sodium alginate, and their suspensions can be stable for more than 3 hours in 0.04M and 0.01M HCl solutions, indicating that under normal gastric acid acidity, the pectin combination suspension can be stably suspended in the upper layer of gastric juice to prevent gastric juice reflux.

[0106] The suspension of Example 4 only slightly diffused in neutral water, and most of the suspension was still suspended on the water surface, indicating that it had good suspension stability.

[0107] The suspension formulation of Example 5 uses reduced amounts of pectin and konjac gum, and the prepared suspension has a certain diffusion in water, indicating that the framework stability is weakened when the amount of konjac gum is reduced.

[0108] Compared with Examples 1-3, Examples 4 and 5 use aminated pectin instead of sodium alginate, and have better stability under weak acid conditions or even in neutral water, indicating that Examples 4 and 5 can be used for gastric reflux, including preventing or reducing weak acid reflux.

[0109] Embodiment 6, 7:

[0110] 1. The formula is shown in Table 4:

[0111] Table 4

[0112]

[0113]

[0114] 2. Preparation of self-suspending alkaline solid composition:

[0115] The preparation method of the self-suspending alkaline solid composition is the same as that in Example 1.

[0116] 3. Suspension test:

[0117] The preparation method and test method are the same as those in the suspension test in Example 1.

[0118] 4. Test results:

[0119] The suspension obtained in Example 6 was suspended in 100 ml of water (neutral), 100 ml of 0.01 M HCl (pH 2), 100 ml of 0.04 M HCl (pH 1.4-1.5), and at 2 min, 60 min, 135 min, and 180 min. Figure 6 shown.

[0120] The suspension obtained in Example 5 was suspended in 100 ml of water (neutral), 100 ml of 0.01 M HCl (pH 2), 100 ml of 0.04 M HCl (pH 1.4-1.5), and at 2 min, 60 min, 120 min, and 240 min. Figure 7 shown.

[0121] Examples 6 and 7 use a combination of sodium alginate and pectin as gel components, and their suspensions can be stable for more than 3 hours in 0.04M and 0.01M HCl solutions, indicating that under normal gastric acid acidity, the pectin combination suspension can be stably suspended in the upper layer of gastric juice to prevent gastric juice reflux.

[0122] The suspensions of Example 6 and Example 7 only slightly diffused in neutral water, and most of the suspensions were still suspended on the water surface, indicating that they had good suspension stability.

[0123] Compared with Examples 1-5, Examples 6 and 7 show that the viscous solution obtained by the synergistic effect of sodium alginate and pectin has better stability in weak acid solutions and pure water, is more durable, can be used alone as an antacid for gastric reflux, and can also be used in combination with first-line drugs to treat gastroesophageal reflux symptoms.

[0124] Comparative Example 1:

[0125] Using Gaviscon Double Action liquid formula, add 15 ml of liquid to 100 ml of 0.04 M HCl, 0.01 M HCl and 100 ml of pure water preheated to 37°C, and let stand for 5 min. The suspension after 30 min is as follows: Figure 8 shown.

[0126] Depend on Figure 8 It can be seen that Gaviscon DA forms a weak suspension gel in 0.04M HCl, and no gel is produced in 0.01M HCl and pure water; therefore, the ability of Gaviscon DA to form a suspension gel under weak acid conditions decreases rapidly with increasing pH, and it is difficult to produce a suspension gel above pH 2.

[0127] Population trials:

[0128] The self-suspending alkaline solid composition was prepared according to Example 1, and each bag sample contained 3.16 g of the self-suspending alkaline solid composition.

[0129] Selection criteria for the trial population: gastric reflux and heartburn more than once a week, symptoms of indigestion and belching, and use of proton pump inhibitors, H2RA or antacids to treat gastroesophageal reflux.

[0130] Exclusion criteria: Excludes patients with esophageal or gastric ulcers and severe gastrointestinal diseases detected by endoscopy; excludes pregnant and lactating women; excludes those with major comprehensive diseases.

[0131] Research evaluation indicators: Determine the effectiveness of the product in treating heartburn and acid reflux; determine the reflux of weak acid in gastric juice into the esophagus under the use of PPI.

[0132] Trial method:

[0133] 1) Before taking, dissolve each bag of product in 20ml of water, stir with a spoon to dissolve, and then take orally.

[0134] 2) The subjects took the medicine half an hour after breakfast, lunch and dinner, and before bedtime.

[0135] 3) Patients who use PPI or H2RA drugs to treat gastroesophageal reflux can use this drink in combination.

[0136] 4) All participants in this trial will complete the gastroesophageal reflux questionnaire every day. After the trial, a comprehensive evaluation of the trial process and results will be conducted.

[0137] Test period: 7 days.

[0138] Test result indicators are determined:

[0139] 1) The effectiveness of the product in treating gastroesophageal reflux: record the number of times the product is used each day, the number of times heartburn and acid reflux occur, and common reflux symptoms such as indigestion and belching.

[0140] 2) Patients who only use antacids to treat reflux symptoms should stop using antacids and use this product instead of antacids; for patients who use PPIs or use this beverage in combination, record the physical reflux symptoms and sleep improvement before and after use.

[0141] 3) Patients used the recall method to record their reflux symptoms in the week before using this product.

[0142] result:

[0143] 20 people participated in this trial. All users of proton pump inhibitors or H2 receptor antagonists (H2RA) were required to use this beverage in combination during the trial, and users of antacids should take this beverage instead. The basic information of the participants is shown in Table 5:

[0144] Table 5

[0145] Total number of people 20 people age 46±14 Male proportion (%) 70 Body mass index (BMI) 26.3 Time since diagnosis of gastroesophageal reflux disease (years) 4.6 Average number of reflux symptoms per week 3.8 Number of people treated with proton pump inhibitors (PPIs) 11 Number of people treated with PPI+antacids 4 Number of people treated with H2RA 2 Number of people using antacids 3

[0146] After one week of testing, all patients completed usage records and a total evaluation form. The symptom indicators are shown in Table 6:

[0147] Table 6

[0148]

[0149] Based on the overall effect evaluation form provided by the users after the trial, the degree of improvement of various symptoms and the improvement of sleep and work concentration were evaluated, as shown in Table 7.

[0150] Table 7

[0151] Overall symptom assessment (20 people) improve Slightly improved No change Condition worsens Heartburn 4 10 6 Acid reflux 13 6 1 indigestion 6 1 Sleep status 3 8 9 Work focus 2 5 13

[0152] As can be seen from Tables 7 and 8, this product can effectively control gastric reflux, including weak acid reflux. Before using this beverage, patients with gastroesophageal reflux had been taking various drugs for the treatment of reflux disease for a long time, and the severity of their symptoms had been controlled to a certain extent; but the above-mentioned perceptible symptoms still occurred. When patients with gastroesophageal reflux use this beverage alone or in combination with medication, the acid reflux symptoms of most patients are further improved, including those using PPIs; and this product basically eliminates the symptoms of indigestion in patients, appropriately improves the sleep quality and work efficiency of some patients, and has no side effects on gastroesophageal reflux symptoms.

[0153] What is disclosed above is only a preferred embodiment of the present invention, which certainly cannot be used to limit the scope of rights of the present invention. A person skilled in the art can understand that all or part of the processes of the above embodiments and equivalent changes made according to the claims of the present invention still fall within the scope of the invention.

Claims

1. A self-suspending alkaline solid composition, characterized in that The invention comprises the following ingredients in percentage by weight: 10-40% acidic polysaccharide, 3-10% konjac gum, 10-25% sodium bicarbonate, 10-32% calcium carbonate, and 4-18% acidic sustained-release particles; The acidic polysaccharide is one or two of sodium alginate, pectin and xanthan gum.

2. The self-suspending alkaline solid composition according to claim 1, characterized in that The acidic sustained-release particles are delta-gluconolactone or solid organic acid wrapped by food-grade wax or fat.

3. The self-suspending alkaline solid composition according to claim 2, characterized in that The organic acid refers to one or more of citric acid, malic acid, tartaric acid, ascorbic acid, succinic acid, alginic acid, hyaluronic acid, polyacrylic acid and polylactic acid.

4. The self-suspending alkaline solid composition according to claim 1, characterized in that It also includes 1-15% by mass of a hydrophobic emulsion stabilizer, wherein the hydrophobic emulsion stabilizer is one or more of sucrose fatty acid ester, phospholipid, polyglycerol fatty acid ester, and sorbitan monolaurate.

5. The self-suspending alkaline solid composition according to claim 1, characterized in that It also includes a sweetener or dispersant with a mass percentage of 1-15%, and the sweetener or dispersant is one or more of xylitol, mannitol, sucrose, glucose, psicose, and fructose.

6. The self-suspending alkaline solid composition according to claim 1, characterized in that It also includes 0.001-0.006% by mass of a sweetness enhancer, wherein the sweetness enhancer is one or more of acesulfame potassium, saccharin sodium, sucralose, aspartame, steviol glycoside, and mogroside.

7. The method for preparing the self-suspending alkaline solid composition according to claim 1, characterized in that: The following steps are involved: S1: grinding and sieving acidic polysaccharide, konjac gum, sodium bicarbonate and calcium carbonate to obtain a first mixture; S2: mixing the first mixture with the acidic sustained-release particles to obtain a self-suspending alkaline solid composition.

8. The method for preparing the self-suspending alkaline solid composition according to claim 7, characterized in that: The particle size of the first mixture in S1 is ≤0.0750 mm; the particle size of the acidic sustained-release particles in S2 is larger than 1 mm.

9. Use of the self-suspending alkaline solid composition according to claim 1 or 7 in gastroesophageal reflux.

10. Use of the self-suspending alkaline solid composition according to claim 1 or 7 in the preparation of gastroesophageal reflux drugs and / or health products.

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