Hawthorn chewable tablet with health-care function and preparation method thereof

Abstract

The invention relates to the technical field of chewable tablets, and discloses a hawthorn chewable tablet with a health-care function and a preparation method thereof, the hawthorn chewable tablet comprises the following raw materials: hawthorn powder, isomaltooligosacharide, erythritol, sweet orange powder, a galangin inclusion compound and a lubricant; wherein the galangin inclusion compound takes a hyperbranched intermediate as a shell and galangin as an inner core, when the chewable tablet enters the stomach through the oral cavity, the pharynx and the esophagus, chitosan in the hyperbranched intermediate can dissolve and release galangin due to the acid environment of gastric juice, so that the slow-release effect is realized, the chitosan has an excellent antibacterial effect, and the galangin inclusion compound can be used for preparing the chewable tablet. The galangin can reduce gastric acid secretion to protect gastric mucosa, so that gastric ulcer is reduced, inflammatory response can be reduced, wound healing at the gastric ulcer is promoted, and a good treatment effect is achieved.

Description

Technical Field

[0001] This invention relates to the field of chewable tablet technology, specifically to a hawthorn chewable tablet with health-promoting functions and its preparation method. Background Technology

[0002] Chewable tablets are tablets that can be swallowed directly after being chewed in the mouth. Compared with other tablets, chewable tablets have advantages such as high bioavailability, convenient administration, and easy portability and storage. In recent years, chewable tablets have attracted much attention from scholars as a new form of confectionery, especially functional chewable tablets, which have become a research hotspot. These chewable tablets have high safety and few side effects. Therefore, many medicinal ingredients have been developed into chewable tablets. Hawthorn is one of the medicinal and edible herbs with multiple pharmacological activities and health benefits. It is rich in nutrients and is known as the "nutritional fruit." In addition, hawthorn has a unique flavor, so it is widely used in chewable tablets to meet people's demand for medicinal ingredients, improve taste, and has high economic and social value. It is a chewable tablet product with a competitive market advantage.

[0003] Gastric ulcer is a multifactorial disease with complex causes, including damage to the gastric mucosa's defense mechanisms caused by factors such as alcohol, Helicobacter pylori infection, drug irritation, and stress responses. This leads to bleeding, erosion, ulceration, inflammatory exudation, and edema of the gastric mucosa. As a chronic disease, gastric ulcer has a high incidence rate, affecting approximately 10% of the world's population at some point in their lives. Most patients experience a long course of illness, sometimes lasting decades. When flare-ups occur, these patients experience rhythmic pain in the upper abdomen, primarily dull, burning, or stabbing. As a common digestive tract disease, its long course and recurrent nature cause significant inconvenience to patients' lives and work. In some cases, it can even progress to precancerous lesions or cancer, endangering life and health. Modern medicine primarily uses chemical drugs for treatment; however, these drugs are highly irritating and often have poor therapeutic effects. Therefore, the development of functional chewable tablets has gradually become a major research direction in the prevention and treatment of gastric ulcers in recent years.

[0004] Patent CN105055355B discloses a hydroxyaluminum montmorillonite chewable tablet, its preparation method, and its application. The chewable tablet prepared by this invention uses hydroxyaluminum montmorillonite as the active pharmaceutical ingredient, with a mass percentage of 50-80%. Suitable pharmaceutical excipients are added to prepare the chewable tablet formulation. After administration through the gastrointestinal tract, the active ingredient neutralizes the pH of the patient's gastric juice and reduces the activity of pepsin, thus relieving stomach pain and promoting the healing of gastric ulcers. It is then excreted through the digestive tract, achieving the purpose of anti-acidity. Therefore, by selectively adding optimized components during the preparation of hawthorn chewable tablets, multifunctional hawthorn chewable tablets can be prepared. Summary of the Invention

[0005] In order to solve the problems mentioned in the background art, the purpose of this invention is to provide a hawthorn chewable tablet with health care function and its preparation method.

[0006] The objective of this invention can be achieved through the following technical solutions: A hawthorn chewable tablet with health benefits comprises the following ingredients in parts by weight: 30-40 parts hawthorn powder, 10-15 parts isomaltooligosaccharide, 15-20 parts erythritol, 8-12 parts sweet orange powder, 3-7 parts galangin inclusion complex, and 1-2 parts lubricant.

[0007] Furthermore, the preparation method of the galangin inclusion complex includes the following steps: S1: Add chitosan to acetic acid solution and stir mechanically until homogeneous. Under continuous nitrogen conditions, add epoxidized soybean oil. After the addition is complete, turn on the heater and control the temperature at 60-70℃. Maintain the temperature for 4-8 hours under continuous stirring, then stop the heating, remove the nitrogen, and discharge the material to obtain the hyperbranched intermediate. S2: Mix the hyperbranched intermediate with deionized water, stir well, add galangin, sonicate for 3-5 hours, filter with a filter membrane, collect the product, and obtain the galangin inclusion complex.

[0008] Furthermore, in step S1, the degree of deacetylation of the chitosan is 80-95%.

[0009] Further, in step S1, the mass fraction of the acetic acid solution is 1-2%.

[0010] It can be inferred that the principle of the above scheme is as follows: In step S1, the amino groups in the chitosan structure can undergo a ring-opening reaction with the epoxy groups in the epoxidized soybean oil structure to obtain a hyperbranched intermediate; In step S2, the hyperbranched intermediate molecule contains a hydrophobic cavity structure, which, with the assistance of ultrasound, effectively encapsulates galangin to obtain a galangin inclusion complex.

[0011] A method for preparing hawthorn chewable tablets with health benefits includes the following steps: (1) Place the hawthorn in a constant temperature box at 60-80℃ and dry for 4-6 hours. Then coarsely grind it at room temperature for 0.5-1.5 minutes. After sieving, grind it at room temperature for 15-25 minutes and pass it through a 150-250 mesh sieve to obtain hawthorn powder. (2) Add hawthorn powder, isomaltooligosaccharide, erythritol, sweet orange powder and galangin inclusion complex into a mixer, stir mechanically until uniform, add wetting agent to adjust the material humidity, and make a soft material that can be dispersed after being kneaded by hand; (3) The prepared soft material is put into a swing pellet mill for granulation. After granulation, it is passed through an 8-12 mesh sieve to obtain wet granules. The wet granules are placed in a forced-air drying oven at 60-70℃ for 1-2 hours to obtain dry granules. (4) Add 1 to 2 parts of lubricant to the dry granules, mix evenly, and feed into a tablet press for tableting. Place the pressed tablets under ultraviolet light for 20 to 30 minutes for sterilization, and package to obtain hawthorn chewable tablets.

[0012] Furthermore, in step (1), the mesh size of the sieve is 70 to 90 mesh.

[0013] Further, in step (2), the wetting agent is ethanol with a mass fraction of 60-70%.

[0014] Furthermore, in step (3), the moisture content of the dry particles is 3-8%.

[0015] Further, in step (4), the lubricant is magnesium stearate.

[0016] The beneficial effects of this invention are: (1) The hawthorn chewable tablets prepared by this invention are made from hawthorn powder, galangin inclusion complex and other raw materials. The components work together to achieve complementary enhancement between the components, significantly improve the treatment effect of gastric ulcer, reduce adverse symptoms and can be used as a health care product for daily use.

[0017] (2) This invention prepares a galangin inclusion complex by encapsulating galangin within the hydrophobic cavity of a hyperbranched intermediate. On the one hand, when the chewable tablet enters the stomach through the mouth, pharynx, and esophagus, the chitosan in the hyperbranched intermediate dissolves and releases galangin due to the acidic environment of the gastric juice, thus achieving a sustained-release effect. Furthermore, chitosan has excellent antibacterial effects, effectively inhibiting the growth of pathogenic bacteria in the stomach, especially showing significant inhibitory effects against Helicobacter pylori. This antibacterial effect not only helps prevent gastric infectious diseases but also... It protects the gastric mucosa and reduces the irritation of gastric acid on the stomach wall. On the other hand, coating galangin can improve its stability. When galangin acts on the stomach, it can reduce gastric acid secretion to protect the gastric mucosa, thereby reducing the occurrence of gastric ulcers and reducing inflammatory response. It can further protect the gastric mucosa, promote wound healing at the site of gastric ulcers, and thus produce good therapeutic effects. It can also prevent problems such as bleeding, erosion, ulceration, inflammatory exudation, and edema of the gastric mucosa caused by gastric ulcers, which bring many inconveniences to the patient's life and work.

[0018] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Detailed Implementation

[0019] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] Example 1 I. Preparation of Galangin Inclusion Complex S1: Add 5g of chitosan with a degree of deacetylation of 90% to a 2% acetic acid solution and stir mechanically until homogeneous. Under continuous nitrogen conditions, add 2.4g of epoxidized soybean oil. After the addition is complete, turn on the heater and control the temperature at 65℃. Maintain this temperature for 6 hours under continuous stirring, then stop the heating, remove the nitrogen, and discharge the material to obtain the hyperbranched intermediate. S2: Mix 5g of hyperbranched intermediate with deionized water, stir well, add 1.2g of galangin, sonicate for 4h, filter with a filter membrane, collect the product, and obtain galangin inclusion complex.

[0021] 5g of the prepared galangin inclusion complex was placed in 50ml of acetone, shaken thoroughly with a vortex mixer, centrifuged and washed, and the supernatant was collected. After removing the solvent by rotary evaporation, the galangin in the supernatant was collected. The encapsulation rate was calculated according to the formula T=[(t1-t2) / t1]×100%, where T is the encapsulation rate (%), t1 is the total mass of galangin (g), and t is the mass of galangin in the supernatant (g). The encapsulation rate of the galangin inclusion complex was calculated to be 75.4%.

[0022] II. Preparation of Hawthorn Chewable Tablets (1) Place the hawthorn in a constant temperature oven at 60℃ and dry for 4 hours. Then coarsely grind it at room temperature for 0.5 minutes, pass it through a 70-mesh sieve, grind it at room temperature for 15 minutes, and pass it through a 150-mesh sieve to obtain hawthorn powder. (2) Add 30g hawthorn powder, 10g isomaltooligosaccharide, 15g erythritol, 8g sweet orange powder and 3g galangin inclusion complex into a mixer, stir mechanically until uniform, add 60% ethanol by mass, adjust the humidity of the material, and make a soft material that can be dispersed after being kneaded by hand. (3) The prepared soft material is put into a swing pellet mill for granulation. After granulation, it is passed through an 8-mesh sieve to obtain wet granules. The wet granules are placed in a 60°C forced-air drying oven for 1 hour to obtain dry granules with a moisture content of 3%. (4) Add 1g of magnesium stearate to the dry granules, mix evenly, and feed into a tablet press for tableting. Place the tablets under a UV lamp for 20 minutes for sterilization, and package to obtain hawthorn chewable tablets.

[0023] Example 2 Preparation of Hawthorn Chewable Tablets (1) Place the hawthorn in a constant temperature oven at 70℃ and dry for 5 hours. Then coarsely grind it at room temperature for 1 minute, pass it through an 80-mesh sieve, grind it at room temperature for 20 minutes, and pass it through a 200-mesh sieve to obtain hawthorn powder. (2) Add 35g hawthorn powder, 12g isomaltooligosaccharide, 18g erythritol, 10g sweet orange powder and 5g galangin inclusion complex to a mixer and stir mechanically until uniform. Add 65% ethanol by mass to adjust the moisture content of the material and make a soft material that can be dispersed after being kneaded by hand. (3) The prepared soft material is put into a swing pellet mill for granulation. After granulation, it is passed through a 10-mesh sieve to obtain wet granules. The wet granules are placed in a 65°C forced-air drying oven for 1.5 hours to obtain dry granules with a moisture content of 5%. (4) Add 1.5g magnesium stearate to the dry granules, mix well, and feed into a tablet press for tableting. Place the tablets under a UV lamp for 25 minutes for sterilization, and package them to obtain hawthorn chewable tablets.

[0024] The preparation method of the galangin inclusion complex is the same as that in Example 1.

[0025] Example 3 Preparation of Hawthorn Chewable Tablets (1) Place the hawthorn in a constant temperature oven at 80℃ for 6 hours, coarsely grind it at room temperature for 1.5 minutes, pass it through a 90-mesh sieve, grind it at room temperature for 25 minutes, and pass it through a 250-mesh sieve to obtain hawthorn powder. (2) Add 40g hawthorn powder, 15g isomaltooligosaccharide, 20g erythritol, 12g sweet orange powder and 7g galangin inclusion complex into a mixer, stir mechanically until uniform, add 70% ethanol by mass, adjust the humidity of the material, and make a soft material that can be dispersed after being kneaded by hand. (3) The prepared soft material is put into a swing pellet mill for granulation. After granulation, it is passed through a 12-mesh sieve to obtain wet granules. The wet granules are placed in a 70°C forced-air drying oven for 2 hours to obtain dry granules with a moisture content of 8%. (4) Add 2g of magnesium stearate to the dry granules, mix well, and feed into a tablet press for tableting. Place the tablets under a UV lamp for 30 minutes for sterilization, and package them to obtain hawthorn chewable tablets.

[0026] The preparation method of the galangin inclusion complex is the same as that in Example 1.

[0027] Comparative Example 1 Preparation of Hawthorn Chewable Tablets (1) Place the hawthorn in a constant temperature oven at 70℃ and dry for 5 hours. Then coarsely grind it at room temperature for 1 minute, pass it through an 80-mesh sieve, grind it at room temperature for 20 minutes, and pass it through a 200-mesh sieve to obtain hawthorn powder. (2) Add 35g hawthorn powder, 12g isomaltooligosaccharide, 18g erythritol and 10g sweet orange powder to a mixer and stir mechanically until uniform. Add 65% ethanol by mass to adjust the moisture content of the material and make a soft material that can be dispersed after being kneaded by hand. (3) The prepared soft material is put into a swing pellet mill for granulation. After granulation, it is passed through a 10-mesh sieve to obtain wet granules. The wet granules are placed in a 65°C forced-air drying oven for 1.5 hours to obtain dry granules with a moisture content of 5%. (4) Add 1.5g magnesium stearate to the dry granules, mix well, and feed into a tablet press for tableting. Place the tablets under a UV lamp for 25 minutes for sterilization, and package them to obtain hawthorn chewable tablets.

[0028] Performance testing Fifty rats weighing 200±5g were randomly divided into five groups: Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, and blank group, with 10 rats in each group. The rats were housed in a laboratory environment at 25℃ for one week. The rats were anesthetized with 10% chloral hydrate solution. A 2cm incision was made along the midline of the abdomen below the xiphoid process. The stomach was then gently pulled out of the abdominal cavity. 0.1mL of acetic acid was applied to the outer side of the stomach for 30 seconds. Excess acetic acid was washed away with sterile saline. The stomach was then gently returned to the abdominal cavity, and the abdominal wall incision was sutured with surgical sutures and disinfected. Except for the blank group, the rats were administered hawthorn chewable tablets prepared in Examples 1-3 and Comparative Example 1 by gavage for 12 consecutive days. The animals were then sacrificed, and the acetic acid was collected. A rat model of acid-induced gastric ulcer was established. The abdominal cavity was opened, the pylorus of the stomach was ligated, and 8 ml of 1% formalin solution was injected into the stomach through the cardia. The cardia was then ligated again. The entire stomach was removed and immersed in formalin solution for half an hour. The stomach was then dissected along the greater curvature, rinsed with cold physiological saline, and dried with filter paper. The gastric tissue was flattened as much as possible and fixed on a flat plate. The maximum long and wide diameters passing through the ulcer center were measured. The product of the long and wide diameters was used to represent the gastric ulcer index. The gastric ulcer index was calculated. The ulcer inhibition rate was calculated using the formula P(%) = (M1-M2) / M1×100%, where M1 is the mean ulcer index of the blank control group, M2 is the mean ulcer index of the experimental group, and P is the ulcer inhibition rate. Specific test results are shown in Table 1. Table 1 - Performance Testing

[0029] Note: Among them a This indicates that compared with the control group, P < 0.05.

[0030] As shown in Table 1, the hawthorn chewable tablets prepared in Examples 1 to 3 have a good effect on treating gastric ulcers in rats; the hawthorn chewable tablets prepared in Comparative Example 1 did not contain galangin inclusion complex, and their therapeutic effect on gastric ulcers in rats was worse compared to the examples.

[0031] The above description is merely an example and illustration of the concept of the present invention. Those skilled in the art can make various modifications or additions to the specific embodiments described or use similar methods to replace them, as long as they do not deviate from the concept of the invention or exceed the scope defined in the claims, they should all fall within the protection scope of the present invention.

Claims

1. A hawthorn chewable tablet with health-promoting functions, characterized in that, The ingredients include the following parts by weight: 30-40 parts hawthorn powder, 10-15 parts isomaltooligosaccharide, 15-20 parts erythritol, 8-12 parts sweet orange powder, 3-7 parts galangin inclusion complex, and 1-2 parts lubricant.

2. The hawthorn chewable tablet with health-promoting function according to claim 1, characterized in that, The preparation method of the galangin inclusion complex includes the following steps: S1: Add chitosan to acetic acid solution and stir mechanically until homogeneous. Under continuous nitrogen conditions, add epoxidized soybean oil. After the addition is complete, turn on the heater and control the temperature at 60-70℃. Maintain the temperature for 4-8 hours under continuous stirring, then stop the heating, remove the nitrogen, and discharge the material to obtain the hyperbranched intermediate. S2: Mix the hyperbranched intermediate with deionized water, stir well, add galangin, sonicate for 3-5 hours, filter with a filter membrane, collect the product, and obtain the galangin inclusion complex.

3. The hawthorn chewable tablet with health-promoting functions according to claim 2, characterized in that, In step S1, the degree of deacetylation of the chitosan is 80-95%.

4. A hawthorn chewable tablet with health-promoting functions according to claim 2, characterized in that, In step S1, the mass fraction of the acetic acid solution is 1-2%.

5. A method for preparing hawthorn chewable tablets with health-promoting functions as described in claim 1, characterized in that, Includes the following steps: (1) Place the hawthorn in a constant temperature box at 60-80℃ and dry for 4-6 hours. Then coarsely grind it at room temperature for 0.5-1.5 minutes. After sieving, grind it at room temperature for 15-25 minutes and pass it through a 150-250 mesh sieve to obtain hawthorn powder. (2) Add hawthorn powder, isomaltooligosaccharide, erythritol, sweet orange powder and galangin inclusion complex into a mixer, stir mechanically until uniform, add wetting agent to adjust the material humidity, and make a soft material that can be dispersed after being kneaded by hand; (3) The prepared soft material is put into a swing pellet mill for granulation. After granulation, it is passed through an 8-12 mesh sieve to obtain wet granules. The wet granules are placed in a forced-air drying oven at 60-70℃ for 1-2 hours to obtain dry granules. (4) Add 1 to 2 parts of lubricant to the dry granules, mix evenly, and feed into a tablet press for tableting. Place the pressed tablets under ultraviolet light for 20 to 30 minutes for sterilization, and package to obtain hawthorn chewable tablets.

6. The method for preparing a hawthorn chewable tablet with health-promoting functions according to claim 5, characterized in that, In step (1), the mesh size of the sieve is 70 to 90 mesh.

7. The method for preparing a hawthorn chewable tablet with health-promoting functions according to claim 5, characterized in that, In step (2), the wetting agent is ethanol with a mass fraction of 60-70%.

8. The method for preparing a hawthorn chewable tablet with health-promoting functions according to claim 5, characterized in that, In step (3), the moisture content of the dry granules is 3-8%.

9. The method for preparing a hawthorn chewable tablet with health-promoting functions according to claim 5, characterized in that, In step (4), the lubricant is magnesium stearate.

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