Stomach-occupying weight-losing device and manufacturing method thereof

Abstract

The invention relates to a weight-losing and stomach-occupying device and a manufacturing method thereof.The weight-losing and stomach-occupying device is arranged in an inhalable mode and comprises a jelly substrate and hydrogel microspheres at least partially wrapped in the jelly substrate, and each hydrogel microsphere comprises a hydrogel microsphere body and a waterproof degradable film wrapping the hydrogel microsphere body; the material of the waterproof degradable film comprises chitosan and sodium alginate, the particle size of the hydrogel microsphere is 300-500 [mu] m, the waterproof degradable film can prevent the volume expansion of the hydrogel microsphere body in the jelly matrix, and the waterproof degradable film can be decomposed in a gastric acid environment to expose the hydrogel microsphere body wrapped in the waterproof degradable film, so that the size of the hydrogel microsphere body is reduced, and the hydrogel microsphere body is protected. The hydrogel microsphere body absorbs water to swell, stomach occupying is achieved, gastric emptying is prolonged, food intake is reduced through stomach occupying, the weight losing effect is achieved, and the weight losing and stomach occupying device is free of a rigid mechanical structure, has the amorphous characteristic, is smaller in compression and stimulation on the stomach, has flavor and can achieve the weight losing function when being taken, and the weight losing and stomach occupying device is suitable for being used for people. And a user can use the device more comfortably, so that the acceptability is higher, and the compliance of the user is improved.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a stomach-occupying weight-loss device and a manufacturing method thereof. Background Art

[0002] As the pressure of life increases, the number of obese people is also increasing. Being overweight or too obese will bring health problems to people. Obesity has become an epidemic, with about 2.1 billion people overweight worldwide. At the same time, obesity and overweight are associated with an increased risk of diseases such as hypertension, dyslipidemia, type 2 diabetes and coronary heart disease. The increase in the prevalence of obesity has spawned many weight loss therapies. Diet control is the most common, which requires a certain amount of willpower and endurance. In reality, patients often give up halfway and fail. Anti-obesity drug therapies such as orlistat are relatively ineffective and have side effects such as tension, irritability and excitement.

[0003] At present, weight loss methods other than dieting and medication are becoming the choice of more and more people. Gastric banding is a surgery used to reduce food intake and absorption. It was once widely used for weight loss, but there are some potential hazards and complications such as dysphagia, gastric wall fistula, displacement and infection of water pump, nausea and vomiting, incision infection, and displacement of gastric banding / water pump. Sleeve gastrectomy and gastric bypass surgery often require surgery on the stomach, which brings a lot of pain to patients and may cause postoperative infection. Intragastric water balloon is a newer surgical method. By placing a regulated water balloon in the stomach using a gastroscope, and then injecting saline to fill the stomach, the stomach capacity is reduced, thereby reducing food intake and producing a feeling of fullness, but complications such as discomfort, nausea and vomiting often occur after use. Therefore, the development of a safe and effective weight loss method with low side effects is the current direction of development.

[0004] In recent years, researchers have further optimized and improved the existing weight loss technology and designed a variety of different forms of weight loss devices, such as expandable weight loss capsules. For example, Chinese patent 201380026831.X discloses an expansion device, which is a triangular expansion device consisting of an external biodegradable membrane, a compartment and a gel compound, and a capsule shell. After the patient takes it, the gel compound in the compartment quickly absorbs water and expands through the external biodegradable membrane to form a three-dimensional triangle, which occupies the stomach and reduces the stomach capacity. Chinese patent 201510670166.9 discloses a gastric volume reduction capsule, which is composed of an outer capsule layer, a built-in capsule, a magnetically controlled switch, and a deflation valve. After the patient takes it, the magnetically controlled switch is remotely controlled by a magnetic sensor, and the inorganic acid salt reacts with the organic acid to expand the capsule, fill part of the patient's stomach cavity, and reduce the stomach volume, thereby achieving the effect of weight loss. The above-mentioned patent solutions all use an expansion device with a certain rigid structure to achieve the stomach occupying effect, but the existence of the rigid structure will inevitably produce a certain mechanical pressure on the stomach, produce continuous stimulation to the stomach, induce patients to have adverse effects such as bloating, nausea, stomach discomfort and even damage, causing pain to patients. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a novel weight-loss device which has good weight-loss effect, little adverse effect and good safety.

[0006] In order to solve the above technical problems, the technical solution adopted by the present invention is:

[0007] A weight-loss stomach-occupying device, which is inhalable, comprises a jelly matrix and a hydrogel microsphere at least partially wrapped in the jelly matrix, wherein the hydrogel microsphere comprises a hydrogel microsphere body and a waterproof degradable film coated outside the hydrogel microsphere body, wherein the material of the waterproof degradable film comprises chitosan and sodium alginate, wherein the particle size of the hydrogel microsphere is 300-500 μm, and the waterproof degradable film can prevent the volume expansion of the hydrogel microsphere body in the jelly matrix. In one embodiment, the jelly matrix comprises carrageenan, pectin, and agar, and the weight percentages of the components in the weight-loss stomach-occupying device are: 20-30% of the hydrogel microsphere, 0.2-0.4% of the carrageenan, 0.2-0.3% of the pectin, 1-2% of the agar, and / or the weight percentage of the chitosan in the hydrogel microsphere is 4-5%, and the weight percentage of the sodium alginate in the hydrogel microsphere is 0.4%-0.6%. That is, the specific proportion of carrageenan, pectin and agar in the jelly matrix makes the overall texture of the jelly matrix softer, suitable for direct inhalation, without chewing, reducing the damage to the hydrogel microspheres when the human body takes the weight loss and stomach device, and in order to make the hydrogel microspheres evenly dispersed and kept suspended in the jelly matrix, pectin is added therein, which is a thickener that can give the hydrogel microspheres a suspended state, and at the same time provide a certain viscosity for the jelly matrix, provide buoyancy for the hydrogel microspheres, and keep the hydrogel microspheres suspended therein without sinking. Carrageenan, pectin and agar are all soluble dietary fibers, have low-calorie properties, and are not absorbed by the human body. The entire jelly matrix formula material is a low-calorie material, and does not bring an additional calorie intake burden to the user when used.

[0008] In one embodiment, the jelly matrix further includes a sweetener, which is sucralose, and the weight percentage of the sweetener in the weight-loss gastric device is 1.5-2%, and / or the jelly matrix further includes vitamin C, and the weight percentage of the vitamin C in the weight-loss gastric device is 1.5-2%. The sweetener is provided to improve the palatability, and the addition of vitamin C allows the user to supplement certain nutrients while losing weight.

[0009] Another technical problem to be solved by the present invention is to provide a method for manufacturing a weight loss and stomach-occupying device, which comprises the following steps:

[0010] S1: dissolving sodium alginate in purified water to obtain a sodium alginate solution; dissolving calcium chloride in purified water to obtain a calcium chloride solution;

[0011] S2: adding sodium alginate solution to the oil phase and mixing to form a W / O type emulsion, and then adding an emulsifier for emulsification;

[0012] S3: adding the calcium chloride solution to the emulsion to form microspheres by cross-linking and curing;

[0013] S4 washing, drying and screening the microspheres to obtain hydrogel microsphere bodies;

[0014] S5: dissolving a waterproof material in an organic solvent, wherein the waterproof material is chitosan and sodium alginate, to obtain a waterproof solution, spraying the waterproof solution on the hydrogel microsphere body, washing the residual organic solvent after drying, and drying again to obtain the hydrogel microsphere with a waterproof and degradable film;

[0015] S6: mixing and dissolving carrageenan, pectin, agar and sweetener to obtain a mixed solution, adding the hydrogel microspheres to the mixed solution, mixing evenly and cooling to obtain the weight loss and stomach-occupying device.

[0016] In one embodiment, the organic solvent is one of acetic acid, malic acid or citric acid.

[0017] In one embodiment, the total concentration of the chitosan and the sodium alginate in the waterproof solution is 1-20%, and / or the weight ratio of the chitosan and the sodium alginate in the waterproof solution is 8-10:0.8-1.2.

[0018] In one embodiment, the total concentration of the chitosan and the sodium alginate in the waterproof solution is 1-5%.

[0019] In one embodiment, the total concentration of the chitosan and the sodium alginate in the waterproof solution is 1%.

[0020] In one embodiment, the mixed solution further contains vitamin C.

[0021] In one embodiment, in step S1, the concentration of the sodium alginate solution is 1% to 5%, and the concentration of the calcium chloride solution is 0.5% to 2%.

[0022] In one embodiment, in step S1, the oil phase is one of liquid paraffin and soybean oil, and / or in step S2, the emulsifier is one of span and cellulose acetate butyrate.

[0023] In one embodiment, the weight percentages of the components in the gastric device are: 20-30% hydrogel microspheres, 0.2-0.4% carrageenan, 0.2-0.3% pectin, 1-2% agar, and 1.5-2% sweetener.

[0024] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0025] 1. The weight loss and stomach-occupying device of the present invention provides a waterproof and degradable film on the hydrogel microspheres. When the hydrogel microspheres are loaded in a jelly matrix, they will not absorb water and swell. However, in a gastric acid environment, the waterproof and degradable film can be decomposed to expose the hydrogel microsphere bodies wrapped therein. The hydrogel microsphere bodies absorb water and swell, thereby occupying the stomach and prolonging gastric emptying. By occupying the stomach and reducing food intake, the weight loss effect is achieved.

[0026] 2. The weight loss and stomach-occupying device of the present invention has no rigid mechanical structure and is amorphous, which results in less pressure and stimulation to the stomach. When taken, it has both flavor and weight loss function, making it more comfortable for users to use, thereby increasing acceptance and improving user compliance.

[0027] 3. The weight loss and stomach-occupying device of the present invention sets the material of the degradable film to include chitosan and sodium alginate. Chitosan is a widely used biomaterial with biodegradability. Chitosan is water-insoluble and is a good waterproof material. It can also dissolve rapidly in an acidic environment. In order to further enhance the waterproof properties of chitosan, sodium alginate is added to chitosan. Chitosan with a large amount of positive charge and alginate with negative charge undergo electrostatic and hydrogen bonding, so that chitosan and sodium alginate molecules are tightly bonded, the composite membrane structure is dense, and the waterproof property is significantly improved.

[0028] 4. The weight loss and stomach-occupying device of the present invention sets the particle size of the hydrogel microspheres to 300-500 μm. The hydrogel microspheres of this specification have better expansion performance and can expand to about 20 times their own volume, thereby achieving a better stomach-occupying effect after entering the human body. DETAILED DESCRIPTION

[0029] The present invention is further described below in conjunction with examples. However, the present invention is not limited to the following examples. The implementation conditions used in the examples can be further adjusted according to the different requirements of specific use, and the implementation conditions not specified are conventional conditions in the industry. The technical features involved in each embodiment of the present invention can be combined with each other as long as they do not conflict with each other. Unless otherwise specified, the reagents in this application can be commercially available or prepared by methods known in the art.

[0030] The weight loss and stomach-occupying device of the present invention is inhalable, comprising a jelly matrix and hydrogel microspheres at least partially wrapped in the jelly matrix, wherein the hydrogel microspheres comprise a hydrogel microsphere body and a waterproof degradable film coated outside the hydrogel microsphere body. The present invention is further described below with specific embodiments.

[0031] Example 1

[0032] The weight loss and stomach-occupying device in Example 1 is prepared by the following method:

[0033] S1: Dissolve 10 g of sodium alginate in 1000 g of purified water to prepare a 1% sodium alginate solution, and weigh 0.5 g of calcium chloride and dissolve it in 100 g of purified water to prepare a 0.5% calcium chloride solution.

[0034] S2: slowly add the sodium alginate solution to the oil phase to form a W / O type emulsion with a water-to-oil ratio of 1:10, wherein the oil phase is liquid paraffin, and in other embodiments the oil phase may also be soybean oil, the temperature is 50-65°C, the stirring speed is 150-240rpm, and after 10 minutes, 3g of the emulsifier Siban is added, and in other embodiments the emulsifier may also be cellulose acetate butyrate, and the emulsification is continued for 15-30 minutes.

[0035] S3 slowly adds 0.5% calcium chloride solution into the oil phase to start the cross-linking reaction, which lasts for 3-4 hours to form microspheres.

[0036] S4: washing, drying and screening the prepared microspheres to obtain hydrogel microsphere bodies with a particle size of 300-500 μm.

[0037] S5: 1g of waterproof material is dissolved in 100g of organic solvent, wherein the waterproof material is 0.9g of chitosan and 0.1g of sodium alginate, and the organic solvent is acetic acid, which may also be malic acid in other embodiments, to obtain a 1% concentration of waterproof material solution. The waterproof material solution is evenly sprayed on the prepared hydrogel microspheres through a fluidized bed, and solidified and dried in the fluidized bed at a drying temperature of 35-45°C for 1-2h. The hydrogel microspheres are washed with purified water to remove the residual organic reagent and dried to obtain hydrogel microspheres with a waterproof and degradable film.

[0038] S6 Weigh 0.1g carrageenan, 0.1g pectin, 0.5g agar and 1g sweetener respectively and mix them to obtain a mixed powder, wherein the sweetener is specifically sucralose. Add the mixed powder to 75-90°C purified water, stir and completely dissolve, add 1g vitamin C, add water to weigh to 40g, and filter aseptically while hot to obtain a mixed solution. When the temperature drops to 40-50°C, weigh 10g of hydrogel microspheres with a waterproof and degradable film, stir and add to the mixed solution, and further mix evenly. Fill, sterilize, and cool to obtain a 50g weight loss and stomach-occupying device. In other embodiments, vitamin C can be omitted, and other nutrients can be provided to replace vitamin C for nutritional supplementation.

[0039] In this embodiment, the weight percentages of the components in the gastric device for weight loss are: 20% hydrogel microspheres, 0.2% carrageenan, 0.2% pectin, 1% agar, 2% sweetener, 2% vitamin C, 4.5% chitosan in the hydrogel microspheres, and 0.05% sodium alginate in the hydrogel microspheres.

[0040] Example 2

[0041] The weight loss and stomach-occupying device in Example 2 is prepared by the following method:

[0042] S1: Dissolve 20g of sodium alginate in 1000g of purified water to prepare a 2% sodium alginate solution, and weigh 1g of calcium chloride and dissolve it in 100g of purified water to prepare a 1% calcium chloride solution.

[0043] S2: slowly add the sodium alginate solution to the oil phase to form a W / O type emulsion with a water-to-oil ratio of 1:10, wherein the oil phase is liquid paraffin, and in other embodiments the oil phase may also be soybean oil, the temperature is 50-65°C, the stirring speed is 150-240rpm, and after 10 minutes, 3g of the emulsifier Siban is added, and in other embodiments the emulsifier may also be cellulose acetate butyrate, and the emulsification is continued for 15-30 minutes.

[0044] S3 slowly adds 1% calcium chloride solution into the oil phase to start the cross-linking reaction, which lasts for 3-4 hours to form microspheres.

[0045] S4: washing, drying and screening the prepared microspheres to obtain hydrogel microsphere bodies with a particle size of 300-500 μm.

[0046] S5: 1g of waterproof material is dissolved in 100g of organic solvent, wherein the waterproof material is 0.9g of chitosan and 0.1g of sodium alginate, and the organic solvent is acetic acid, which may also be malic acid in other embodiments, to obtain a 1% concentration of waterproof material solution. The waterproof material solution is evenly sprayed on the prepared hydrogel microspheres through a fluidized bed, and solidified and dried in the fluidized bed at a drying temperature of 35-45°C for 1-2h. The hydrogel microspheres are washed with purified water to remove the residual organic reagent and dried to obtain hydrogel microspheres with a waterproof and degradable film.

[0047] S6: Weigh 0.1g carrageenan, 0.15g pectin, 0.5g agar and 1g sweetener respectively and mix them to obtain a mixed powder, wherein the sweetener is specifically sucralose. Add the mixed powder to 75-90°C purified water, stir and completely dissolve, add 1g vitamin C, and add water to weigh to 40g, and sterile filter while hot to obtain a mixed solution. When the temperature drops to 40-50°C, weigh 10g of hydrogel microspheres with a waterproof and degradable membrane, stir and add to the mixed solution, and further mix evenly. Fill, sterilize, and cool to obtain a weight loss and stomach-occupying device.

[0048] In this embodiment, the weight percentage of each component in the gastric device for weight loss is: 20% hydrogel microspheres, 0.2% carrageenan, 0.3% pectin, 1% agar, 2% sweetener, 2% vitamin C, the weight percentage of chitosan in the hydrogel microspheres is 4.5%, and the weight percentage of sodium alginate in the hydrogel microspheres is 0.05%.

[0049] Example 3

[0050] The weight loss and stomach-occupying device in Example 3 is prepared by the following method:

[0051] S1: Dissolve 50g of sodium alginate in 1000g of purified water to prepare a 5% sodium alginate solution, and weigh 2g of calcium chloride and dissolve it in 100g of purified water to prepare a 2% calcium chloride solution.

[0052] S2: slowly add the sodium alginate solution to the oil phase to form a W / O type emulsion with a water-to-oil ratio of 1:10, wherein the oil phase is liquid paraffin, and in other embodiments the oil phase may also be soybean oil, the temperature is 50-65°C, the stirring speed is 150-240rpm, and after 10 minutes, 3g of the emulsifier Siban is added, and in other embodiments the emulsifier may also be cellulose acetate butyrate, and the emulsification is continued for 15-30 minutes.

[0053] S3 slowly adds 2% calcium chloride solution into the oil phase to start the cross-linking reaction, which lasts for 3-4 hours to form microspheres.

[0054] S4: washing, drying and screening the prepared microspheres to obtain hydrogel microsphere bodies with a particle size of 300-500 μm.

[0055] S5: 1g of waterproof material is dissolved in 100g of organic solvent, wherein the waterproof material is 0.9g of chitosan and 0.1g of sodium alginate, and the organic solvent is acetic acid, which may also be malic acid in other embodiments, to obtain a 1% concentration of waterproof material solution. The waterproof material solution is evenly sprayed on the prepared hydrogel microspheres through a fluidized bed, and solidified and dried in the fluidized bed at a drying temperature of 35-45°C for 1-2h. The hydrogel microspheres are washed with purified water to remove the residual organic reagent and dried to obtain hydrogel microspheres with a waterproof and degradable film.

[0056] S6: Weigh 0.1g carrageenan, 0.15g pectin, 1g agar and 1g sweetener respectively and mix them to obtain a mixed powder, wherein the sweetener is specifically sucralose. Add the mixed powder to 75-90°C purified water, stir and completely dissolve, add 1g vitamin C, and add water to weigh to 40g, and sterile filter while hot to obtain a mixed solution. When the temperature drops to 40-50°C, weigh 10g of hydrogel microspheres with a waterproof and degradable membrane, stir and add to the mixed solution, and further mix evenly. Fill, sterilize, and cool to obtain a weight loss and stomach-occupying device.

[0057] In this embodiment, the weight percentages of the components in the gastric device for weight loss are: 20% hydrogel microspheres, 0.2% carrageenan, 0.3% pectin, 2% agar, 2% sweetener, 2% vitamin C, 4.5% chitosan in the hydrogel microspheres, and 0.05% sodium alginate in the hydrogel microspheres.

[0058] Performance Testing

[0059] 1. Waterproof performance test

[0060] The waterproof performance of the hydrogel microspheres with waterproof and degradable membranes prepared by the method in Example 1 was tested, and the specific steps and results are as follows:

[0061] Weigh 5 groups of hydrogel microspheres with waterproof and degradable films of different weights and record them as m1. Place the hydrogel microspheres in 500 mL of aqueous solution and soak them for 24 hours. Take out and filter the hydrogel microspheres, remove the moisture on the surface of the hydrogel microspheres and weigh them as m2. Compare whether there is a significant difference between the two values ​​of m1 and m2.

[0062] Table 1

[0063] Serial number m1 m2 Is there a difference 1 1.0g 1.0g no 2 3.1g 3.1g no 3 5.0g 5.1g no 4 8.2g 8.2g no 5 10.1g 10.1g no

[0064] According to the results in Table 1, there is no significant difference in the quality of the hydrogel microspheres before and after immersion, which shows that the hydrogel microspheres with a waterproof and degradable film have good waterproof properties.

[0065] 2. Degradation performance test of waterproof degradation film

[0066] The degradation performance of the hydrogel microspheres with a waterproof and degradable film prepared by the method in Example 1 was tested, and the specific steps and results are as follows:

[0067] Weigh 5 groups of hydrogel microspheres with waterproof and degradable membranes of different weights and record them as m3. Place the hydrogel microspheres in 1L of aqueous solution simulating artificial gastric juice (pH=1.5) and soak them for 5 minutes. Take out and filter the hydrogel microspheres, remove the moisture on the surface of the hydrogel microspheres and weigh them as m4. Compare whether there is any difference between the two values ​​of m3 and m4.

[0068] Table 2

[0069] Serial number m3 m4 Is there a difference 1 1.0g 19.3g yes 2 3.1g 60.4g yes 3 5.3g 99.9g yes 4 8.2g 160.5g yes 5 10.0g 201.1g yes

[0070] According to the results in Table 2, the mass of the hydrogel microspheres undergoes a significant anisotropic change within 5 minutes before and after immersion, indicating that the waterproof and degradable membrane has rapid degradation performance in gastric juice.

[0071] 3. Swelling performance test

[0072] The swelling performance test of the stomach-occupying weight-loss device prepared by the method in Examples 1-3 was conducted, and the specific steps and results are as follows:

[0073] The weight loss device containing 10g of hydrogel microspheres with waterproof and degradable membrane (hereinafter referred to as dry microspheres) was slightly crushed into small pieces, simulated by inhalation, and then added to 1L simulated artificial gastric juice (pH = 1.5) and soaked for 3-4h to dissolve the jelly matrix. The swollen hydrogel microspheres (hereinafter referred to as swollen microspheres) were taken out and filtered, the water on the surface of the swollen microspheres was removed and weighed, and the swelling rate was calculated according to the following formula:

[0074] Swelling rate % = (W 溶胀后微球 -W 干球 ) / W 干球

[0075] Table 3

[0076]

[0077]

[0078] The above results show that the expansion multiple of the dry bulb is about 10 to 20 times, among which the expansion effect of Example 1 is the best. Therefore, the stomach-occupying weight loss device of the present invention has a good swelling rate and can achieve a good stomach-occupying effect.

[0079] Therefore, the stomach-occupying weight-loss device of the present invention can be taken before meals, and each stomach-occupying weight-loss device can be set to 50g. After taking it, the jelly matrix wrapped with hydrogel microspheres decomposes in the gastric acid environment, exposing the hydrogel microspheres wrapped inside, and simultaneously releasing nutrients such as vitamin C for nutritional supplementation, wherein the waterproof and degradable film on the surface of the hydrogel microspheres quickly decomposes in the gastric acid environment, allowing the hydrogel microspheres to contact gastric juice, and the hydrogel microspheres quickly absorb water and swell to 10 to 20 times the original volume, thereby achieving gastric space occupation and prolonging gastric emptying, and achieving the effect of weight loss by occupying the stomach and reducing food intake.

[0080] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A weight loss and stomach-occupying device, characterized in that: The weight loss and stomach-occupying device is inhalable, comprising a jelly matrix and hydrogel microspheres at least partially wrapped in the jelly matrix, the hydrogel microspheres comprising a hydrogel microsphere body and a waterproof degradable film coated outside the hydrogel microsphere body, the material of the waterproof degradable film comprises chitosan and sodium alginate, the particle size of the hydrogel microspheres is 300 to 500 μm, and the waterproof degradable film can prevent the volume expansion of the hydrogel microsphere body in the jelly matrix.

2. The weight loss and stomach-occupying device according to claim 1, characterized in that: The jelly matrix comprises carrageenan, pectin and agar, and the weight percentages of the components in the weight-loss gastric device are as follows: 20-30% of hydrogel microspheres, 0.2-0.4% of carrageenan, 0.2-0.3% of pectin, 1-2% of agar, and / or the weight percentage of chitosan in the hydrogel microspheres is 4-5%, and the weight percentage of sodium alginate in the hydrogel microspheres is 0.4%-0.6%.

3. The weight loss and stomach-occupying device according to claim 2, characterized in that: The jelly matrix further includes a sweetener, which is sucralose, and the weight percentage of the sweetener in the weight-loss gastric device is 1.5-2%, and / or the jelly matrix further includes vitamin C, and the weight percentage of the vitamin C in the weight-loss gastric device is 1.5-2%.

4. A method for manufacturing a weight loss and stomach-occupying device, characterized in that: The following steps are involved: S1: dissolving sodium alginate in purified water to obtain a sodium alginate solution; Dissolve calcium chloride in purified water to prepare a calcium chloride solution; S2: adding sodium alginate solution to the oil phase and mixing to form a W / O type emulsion, and then adding an emulsifier for emulsification; S3: adding the calcium chloride solution to the emulsion to form microspheres by cross-linking and curing; S4 washing, drying and screening the microspheres to obtain hydrogel microsphere bodies; S5: dissolving a waterproof material in an organic solvent, wherein the waterproof material is chitosan and sodium alginate, to obtain a waterproof solution, spraying the waterproof solution on the hydrogel microsphere body, washing the residual organic solvent after drying, and drying again to obtain the hydrogel microsphere with a waterproof and degradable film; S6: mixing and dissolving carrageenan, pectin, agar and sweetener to obtain a mixed solution, adding the hydrogel microspheres to the mixed solution, mixing evenly and cooling to obtain the weight loss and stomach-occupying device.

5. The method for manufacturing the weight loss and stomach-occupying device according to claim 4, characterized in that: The organic solvent is one of acetic acid, malic acid or citric acid.

6. The method for manufacturing the weight loss and stomach-occupying device according to claim 5, characterized in that: The total concentration of the chitosan and the sodium alginate in the waterproof solution is 1-20%, and / or the weight ratio of the chitosan and the sodium alginate in the waterproof solution is 8-10:0.8-1.

2.

7. The method for manufacturing the weight loss and stomach-occupying device according to claim 4, characterized in that: The mixed solution also contains vitamin C.

8. The method for manufacturing the weight loss and stomach-occupying device according to claim 4, characterized in that: In step S1, the concentration of the sodium alginate solution is 1% to 5%, and the concentration of the calcium chloride solution is 0.5% to 2%.

9. The method for manufacturing the weight loss and stomach-occupying device according to claim 4, characterized in that: In step S1, the oil phase is one of liquid paraffin and soybean oil, and / or in step S2, the emulsifier is one of span and cellulose acetate butyrate.

10. The method for manufacturing the weight loss and stomach-occupying device according to claim 4, characterized in that: The weight percentages of the components in the weight-loss gastric device are: 20-30% hydrogel microspheres, 0.2-0.4% carrageenan, 0.2-0.3% pectin, 1-2% agar, and 1.5-2% sweetener.

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