CN116602807B - Capsule type self-produced gas stomach volume-reducing weight-reducing air bag - Google Patents

Abstract

The invention belongs to the technical field of medical appliances, and discloses a capsule type self-produced gas gastric volume-reducing and weight-reducing air bag which sequentially comprises a gastric-soluble capsule layer, an air bag layer and a gas producing agent in the air bag from outside to inside. The invention utilizes a gastric temperature gradient induced gas generating composition as a gas generating agent, which consists of the following components in percentage by mass: 1-20% of component A, 5-30% of component B, 55-95% of component C, 0.05-0.5% of component D and 0.05-0.5% of component E. The component A is selected from the following components: 1, 3-pentafluoropropane-ethanol azeotrope, trans-1-chloro-3, 3-trifluoropropene. The component B is selected from the following components: 1, 3-pentafluorobutane-ethanol azeotrope, or one or two of monofluorotrichloromethane. The component C is selected from the group consisting of: cis-1, 4-hexafluoro-2-butene 1, 3-pentafluorobutane 1-fluoro-1, 1-dichloroethane; component D is a taste alert agent and component E is a color alert agent. The self-produced gas stomach volume-reducing weight-reducing air bag prepared from the organic inert gas generating agent composition has stable property and no harm to human body, can generate more gas with smaller volume, has high gas production volume multiplying power and is convenient for patients to independently swallow.

Description

A capsule-type self-generating gastric volume and weight reduction airbag

Technical Field

The invention relates to the technical field of medical devices, and in particular to a capsule-encapsulated gastric volume-reducing and weight-reducing air bag that expands a gas-generating composition by inducing a gradient in the stomach temperature.

Background technique

The existing treatments for obesity mainly include diet control, exercise weight loss, drug therapy, and surgical treatment. Simply controlling diet and exercising to lose weight requires strong willpower, and most people fail. Although surgery has obvious weight loss effects, it requires a high level of medical skills, and the trauma caused to the patient takes a long time to recover. It is not only expensive, but also causes trauma to the body, which is called "injury to the vital energy" in traditional Chinese medicine, so it is difficult for patients to accept it.

In order to overcome the many drawbacks of existing weight loss methods, many countries have carried out weight loss methods in recent years, which are to place water or air balloons in the stomach to occupy the gastric volume and reduce food intake. This method has been proven to be an effective means of weight loss through a large number of practices. This method connects the balloon to the catheter, and the surgeon implants the empty balloon into the stomach, then injects gas or saline into the balloon to expand the balloon in the stomach, and removes the catheter after completion. The gastric balloon filled with gas or liquid occupies the patient's stomach volume, causing a sense of fullness, thereby reducing food intake and weight loss. This method is a relatively safe and effective medical weight loss treatment technology. Products approved and clinically used in the United States and other countries include ORBERA® and Spatz3. See the literature CHOI S J, CHOI HS. Various intragastric balloons under clinical investigation [J]. Clinical Endoscopy, 2018, 51 (5): 407–415. However, this method has disadvantages: general anesthesia is required for balloon implantation, which can easily cause damage to the throat and esophagus, and the operation is cumbersome, there are risks, and the patient is in pain.

ANNALS OF BIOMEDICAL ENGINEERING, 2021, 49: 1391–1401 reported a swallowable self-gassing weight loss capsule. The gas production mechanism is to place an aqueous solution of an organic acid (such as citric acid) and an alkaline carbonate (such as potassium bicarbonate, sodium bicarbonate) separately into different chambers of an intragastric balloon. After the patient swallows the weight loss capsule into the stomach on his own, a magnetic field is applied in vitro to drive the magnetic valve of the intragastric balloon to open, so that the acid and alkaline reactants come into contact and react, producing carbon dioxide gas to expand the intragastric balloon. This method avoids the pain of surgery, but it also has some disadvantages:

1) Acid-base reactants and water occupy a relatively large volume. According to the data given in the literature: In a capsule with a length of 35mm, a diameter of 12.39mm, and a volume of 4.2mL ( _V1 ), 1.12 grams of acid-base reactants and 1mL of water can be contained. At this time, the gas production is about 120mL ( _V2 ), and the gas production volume ratio _V2 / _V1 is 120/4.2=28.57. If the industry consensus of 400-600mL therapeutic volume is achieved, 4 capsules need to be swallowed at a time. According to a large number of literature records, the number of balloons usually implanted is 1-2. Too small or too many will increase the risk of accidental leakage and pyloric obstruction. (The amount of gas produced by a certain volume of capsule can be described as the gas production volume ratio: _V2 / _V1 , where _V1 is the initial volume of the capsule and _V2 is the volume of the balloon after expansion. A smaller initial volume of the capsule is convenient for autonomous swallowing, and after entering the stomach, it is hoped that it will be filled into a larger balloon.)

2) With existing technology products, if the gas production of the capsule reaches 200mL, according to the chemical equation of the gas production reaction, each capsule needs to contain 1.9 grams of reactants and 1.5mL-2mL of water, plus the volume of the balloon material, the total volume will reach about 7mL (13mm in diameter, 45mm in length). Such a large object is prone to incarceration and obstruction when passing through the throat or esophagus (especially the narrow part of the esophagus). If the gas is accidentally produced at this time, the consequences will be uncontrollable. This makes patients fearful and difficult to accept autonomous swallowing or swallowing failure.

From the above, it can be seen that the existing technology is limited by the gas production capacity of acid-base gas generators. Even if the gas production volume ratio of such capsules is close to the theoretical limit, it is still unable to meet the ideal application requirements due to the limitation of capsule volume.

Therefore, there is a need to improve the self-gas-generating swallowing weight-loss capsule to meet practical needs.

Summary of the invention

In order to address the deficiencies of the prior art, the present invention aims to provide a gastric volume reduction and weight reduction capsule that is safe to use and has a high gas production volume ratio, which is conducive to swallowing by patients and reduces the amount swallowed, thereby meeting treatment needs.

To achieve the purpose of the present invention, the present invention provides a composition for generating gas by inducing a gradient of gas in the stomach temperature as a gas generating agent, and further prepares a capsule-type self-gas generating gastric volume and weight reducing air bag.

The technical solution adopted by the present invention is:

The temperature-induced gradient gas generation composition is composed of the following components, each component is calculated by mass percentage: component A 1%-20%, component B 5%-30%, component C 55%-95%, component D 0.05%-0.5%, component E 0.05%-0.5%.

Preferably, the gas generating composition comprises: component A 1%-10%, component B 5%-20%, component C 70%-90%, component D 0.05%-0.5%, and component E 0.05%-0.5%.

The component A is selected from: any one or two of 1,1,1,3,3-pentafluoropropane-ethanol azeotrope (ethanol mass percentage 1%-20%) and trans-1-chloro-3,3,3-trifluoropropene.

The component B is selected from: any one or two of 1,1,1,3,3-pentafluorobutane-ethanol azeotrope (the mass percentage of ethanol is 1%-20%) and monofluorotrichloromethane.

The component C is selected from any one or more of cis-1,1,1,4,4,4-hexafluoro-2-butene, 1,1,1,3,3-pentafluorobutane, and 1-fluoro-1,1-dichloroethane.

The component D is a taste alerting agent, which is released in the stomach after the airbag is accidentally damaged, and can emit the smell of essential oil through hiccups, indicating that the airbag is damaged. Its material is selected from: any one or more of eugenol, cinnamaldehyde, eucalyptus essential oil, lavender essential oil, basil essential oil, fennel essential oil, peppermint essential oil, rosemary essential oil, and patchouli essential oil.

The component E is a color alerting agent, which is released in the stomach after the airbag is accidentally damaged, and can make the urine blue or purple, indicating that the airbag is damaged. The material is selected from: any one or more of Prussian blue, methylene blue, and anthocyanin.

The sum of the proportions of the various components is A%+B%+C%+D%+E%=100%.

The prepared gas generating agent is placed in the air bag, the excess air is discharged, the air bag is sealed and folded, and the sealed and folded air bag is placed in a gastric soluble pressure-bearing packaging capsule for overall coating and packaging to prepare a gastric soluble gastric volume reduction and weight reduction capsule with temperature-induced gradient gas production. The gastric volume reduction and weight reduction capsule includes, from the outside to the inside, a gastric soluble pressure-bearing capsule layer, an air bag layer, and a gas generating agent in the air bag.

The gastric soluble pressure-bearing capsule layer is made of modified polyhydroxyalkanoate, hydroxypropyl cellulose, polyvinyl pyrrolidone and other animal or plant-derived materials. The shell is evenly distributed with a plurality of air-permeable holes with a diameter of 0.2 mm to 3 mm, which are used to discharge gas when the airbag is overloaded and depressurized, which can meet the pressure relief requirements without reducing the pressure bearing capacity of the capsule.

After the capsule enters the stomach, the gastric-soluble pressure-bearing capsule shell can withstand an expansion pressure of 0.2MPa within 20 minutes. Within 20 to 30 minutes, the capsule disintegrates under the action of gastric juice and releases the air bag.

Optimal solution: Two disposable pressure overload relief safety valves are provided at both ends of the self-generated air bag body (see Figure 2 2-5). The opening pressure is set to 0.2MPa. When the pressure in the bag reaches the set value, one of the overload safety valves automatically opens to release air and relieve pressure, which can prevent pressure overload and accidental expansion caused by staying in the esophagus for too long, and prevent damage to the esophagus. The valve is a bursting disc type (non-reclosing overpressure relief device), and the opening method is a detachment type. The preferred material is a metal film/non-metal composite type. The metal coating not only ensures good barrier properties, but also can be imaged by CT to understand the position and status of the valve and balloon.

The capsule-type self-gas-generating gastric volume reduction and weight loss airbag, after the airbag is folded and packaged, the sum of the volumes of all materials (including packaging materials, balloon materials, and gas generating agents) in the non-gas-generating state is about 2.5mL (V ₁ ), and the size of the encapsulated capsule is: diameter 12mm, length 25mm; the diameter of the airbag after filling is 73mm-75mm, and the volume is about 200mL (V ₂ ). The gas production volume ratio V ₂ /V ₁ can reach 80 (the gas production volume ratio is 2.8 times that of the prior art), and the airbag diameter and the filling amount of the gas generating agent can also be appropriately increased to obtain a larger gas production volume ratio and filling volume. The finished product volume of the "weight loss capsule" of the present invention is less than 1/2 of the existing acid-base reaction type product, which is convenient for patients to swallow independently. Due to the high gas production volume ratio, only two capsules need to be swallowed at a time to meet the treatment needs, which meets the current weight loss treatment needs.

By adopting the simulation device as shown in Figure 4, using the capsule of the present invention, after swallowing simulation enters the stomach, the gastric-soluble pressure-bearing encapsulation capsule layer is disintegrated by the action of gastric acid within a preset time of 20 minutes to 30 minutes, at which time the airbag is released from its restraint, and the gas-generating agent sealed in the airbag induces gradient gasification under the temperature environment of 37°C to 40°C in the human stomach (actually measured by the inventor and confirmed in combination with literature data); the airbag completes the expansion process (see Figure B in Figure 2), occupies the volume in the stomach, reduces food intake, and achieves weight loss treatment.

The principle of the present invention: it belongs to physical gas production, and uses the temperature in the stomach to induce the gradient gasification of the gas generating agent composition (the temperature-expansion volume curve of the gas generating agent of the present invention is shown in Figure 5), and there is no need to match the inflation or chemical reaction device. The utilization rate of the gas generating agent is nearly 100%, and less gas generating agent can produce more gas. The main components of the selected composition are biologically inert compounds, and all components are harmless to the human body. The toxicological data of each component are as follows: 1,1,1,3,3-pentafluoropropane toxicological data: There is no toxicity through the skin route. When rats and mice are exposed to 203,000 ppm or 101,000 ppm of pentafluoropropane, there is no mortality or significant toxicity signs (Toxicological Sciences, 1999, 52(2):289–301). Toxicological data of trans-1-chloro-3,3,3-trifluoropropene: It is non-mutagenic and non-teratogenic. Its toxicity to rodents was negative in the genetic toxicity test. Its toxicity potential to mammals is very low. Male Sprague Dawley rats and female New Zealand rabbits were exposed to 2000, 5000 and 10,000 PPM of trans-1-chloro-3,3,3-trifluoropropene, respectively. After 6 hours of exposure, urine was collected within 48 hours and no toxicants were detected (Toxicology and Applied Pharmacology, 2013, 268: 343–351). Toxicological data of chlorofluoroform: Male and female F-344 rats were exposed to 6 hours/day, 5 days/week, with average levels of 0, 29, 62 and 121 ppm for 13 weeks, and no signs of poisoning were induced (JOURNAL OF THE AMERICAN COLLEGE OFTOXICOLOGY, 1988, 7(5) 663-674). Toxicological data of cis-1,1,1,4,4,4-hexafluoro-2-butene: 4-hour LC50 in rats is 1425 ppm. Fischer-344 rats were exposed to HFIB for 6 hours per day, 5 days/week, with average HFIB concentrations of 3, 10, 30 and 90 ppm for 13 weeks, and no animals died (TOXICOLOGY AND APPLIED PHARMACOLOGY, 1986, 86: 327-340). Toxicological data of 1-fluoro-1,1-dichloroethane: It has very low acute toxicity. No adverse reaction occurs when 2000 mg/kg body weight is applied to rabbit skin. Oral administration of 5000 mg/kg body weight does not cause death or clinical symptoms of toxicity in rats. The 4-hour LC50 in rats is about 62000 ppm. Rats are repeatedly exposed to 2000, 8000 or 20000 ppm for 6 hours/day, 5 days/week, and up to 90 days without significant adverse reactions (Food and Chemical Toxicology, 1995, 33 (6): 483-490). Toxicological data of 1,1,1,3,3-pentafluorobutane: The toxicological indicators are all lower than those of 1-fluoro-1,1-dichloroethane, and it is safer to use in the patent of this invention (JOURNAL OF CELLULAR PLASTICS, 1999, 35: 328-331).

Advantages of the present invention: The main components of this type of composition are organic inert gas generating agents, all of which are stable and harmless to the human body. The gradient gas generation is induced by the temperature in the stomach, which belongs to physical gas generation. The utilization rate of the gas generating agent is nearly 100%, and no byproducts that ineffectively occupy the volume of the capsule are produced. The gas generation volume ratio is high, the gas generation process is gentle and gentle, and the maximum pressure is constant and far lower than carbon dioxide. The gasification temperature range of the gas generating agent is set to 30°C-38°C. At 38°C and 1 standard atmospheric pressure, 1mL of the gas generating agent of the present invention can be gasified into about 200mL of gas, and the gas generation volume ratio is much higher than that of the acid-base reaction type gas generating agent. Therefore, the present invention can make the volume of the weight loss capsule smaller, which is safer and more convenient to use. The schematic diagram of the sample actually produced and packaged after trial production is shown in Figure 1. The actual size is 25mm in length, 12mm in diameter, and the volume is about 2.5mL. The shape is a round-headed columnar body of a common oral capsule, with a short length and a small diameter, which is convenient for autonomous swallowing and easily accepted by patients.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an appearance of a gastric-soluble weight-reducing capsule of the present invention.

Figure 2 is a schematic diagram of the A-A cross-section of the gastric-soluble weight-loss capsule of the present invention before and after the airbag is expanded, 2-1 is the gastric-soluble pressure-bearing packaging capsule, 2-2 is the airbag, 2-3 is the gas generating agent, 2-4 is the exhaust hole, and 2-5 is the overload pressure relief safety valve sheet; Figure A is before the airbag is expanded, and Figure B is after the airbag is expanded.

Fig. 3 is a schematic diagram of the comprehensive detection device for airbags of the present invention, in which 3-1 is a synchronous constant temperature chamber, 3-2 is a constant temperature water bath, 3-3 is water, 3-4 is a precision pressure gauge, 3-5 is a thermometer, 3-6 is a pressure test gas production bottle, 3-7 is an airbag barrier test port, 3-8 is a gas production test bottle, 3-9 is a measuring cylinder (gas production measurement by water displacement method), 3-10 is a material performance test kettle, 3-11 is a membrane material pressure test port, 3-12 is a membrane material barrier test port, 3-13 is an airbag pressure test port, 3-14 is a gastric soluble pressure-bearing packaging capsule test port, and 3-15 is a valve.

Figure 4 is a diagram of the swallowing and intragastric test model device: 4-1 is a constant temperature water bath, 4-2 is water, 4-3 is the esophagus, 4-4 is the weight loss capsule of the present invention entering the esophagus and descending, 4-5 is a simulated stomach, 4-6 is a simulated stomach content (water adjusted to pH=3 with 0.1M hydrochloric acid, carboxymethyl cellulose, milk, vegetable puree, and a preservative mixture), and 4-7 is the airbag of the present invention in a filled and expanded state.

FIG. 5 is a temperature-expansion volume curve of the gas generating agent of the present invention.

FIG. 6 is a temperature-pressure curve of the gas generating agent of the present invention.

Detailed ways

In order to better illustrate the present invention, the present invention is specifically described below in conjunction with embodiments and drawings.

Example 1

The gas generating agent is composed of the following components, each component is expressed in weight percentage:

1,1,1,3,3-pentafluoropropane (97%)-ethanol (3%) azeotrope and trans-1-chloro-3,3,3-trifluoropropene (weight ratio of the two is 1:1) 1%; mixture of chlorofluorotrichloromethane and 1,1,1,3,3-pentafluorobutane (95%)-ethanol (5%) azeotrope (weight ratio of the two is 1:2) 20%; mixture of 1-fluoro-1,1-dichloroethane, 1,1,1,3,3-pentafluorobutane and cis-1,1,1,4,4,4-hexafluoro-2-butene (weight ratio of the three is 4:3:3) 78%; 0.5% eugenol; 0.5% methylene blue. 1.0 mL of the above gas generating agent is placed in the gas generating test bottle 3-8 in Figure 3, and the gas generating capacity is 0 mL when the temperature is below 30°C. The gas production within 2 minutes at 31℃-34℃ is 2.1mL, the gas production within 2-10 minutes at 31℃-34℃ is 9.7mL, the gas production within 2 minutes at 35-38℃ is 158.9mL, and the maximum gas production at 38℃ is 194.0mL.

A PA/EVOH/PE composite film material with a thickness of 0.06 mm was used as the airbag material to make an airbag sample with a capacity of 200 mL. 1.0 g of the above-mentioned gas generating agent was filled into the airbag and tested at a temperature of 39±1°C and simulated gastric environment conditions. The volume of the airbag could remain basically unchanged for 180 days.

The gas generating agent described in Example 1 was subjected to a temperature-pressure test using the device shown in Figure 3. The test conditions were 50% excess gas generating agent, 20°C-50°C, and 1.5 grams of gas generating agent was placed in a pressure test bottle 3-6 with a capacity of 200mL. The maximum pressure measured was 0.0984MPa. The results are shown in Figure 6. The transient temperature rise in the stomach caused by accidentally swallowing hot drinks or food up to 50°C during the retention of the airbag in the stomach can be simulated. It can be known that at the highest temperature that the gastric contents may reach, the minimum expansion pressure that the airbag needs to withstand has practical reference significance for selecting or preparing suitable materials and designing redundant and reliable airbag structural strength.

According to the above test results, the safety of use is explained as follows: the gas generating agent does not vaporize at room temperature below 30°C. During the swallowing process, the gas generating agent enters the stomach through the esophagus within 2 seconds to 15 seconds. According to the measurement in the model, the gas generating agent is gradually heated in the esophagus but does not reach the vaporization temperature as a whole. When the gas generating agent is accidentally retained in the esophagus after swallowing, even if the gas generating agent exceeds the vaporization temperature as a whole, the airbag will not expand because it is encapsulated in a gastric-soluble pressure-bearing capsule.

Further explanation on the safety of use: The gastric-soluble pressure-capsulated capsule can ensure that the self-gas-generating gastric balloon will not accidentally stay in the stomach for too long during storage and when swallowed through the esophagus, and will not gasify and expand when the temperature reaches body temperature. After entering the stomach, the gastric-soluble pressure-capsulated capsule will gradually degrade and collapse within 20 minutes to 30 minutes in an acidic environment of pH=3. The balloon is freed from the pressure constraint, and the gas-generating agent gradually gasifies until the balloon is fully expanded. The diameter of the inflated balloon is 73mm-75mm, and the maximum size of an object that can pass through the pylorus does not exceed 40mm, so a balloon of this diameter can be guaranteed not to pass through the pylorus into the intestine.

The gas generating agent of the above embodiment is used to make a "weight-reducing capsule", in which the material for making the airbag must meet the following conditions: a flexible film material with good barrier properties to the gas generating agent of the present invention, non-toxic and corrosion-resistant, such as PVDC, BOPA, BOPP, BOPET, PVA, EVOH, PE and their multi-layer composite, multi-layer co-extruded, coated materials, etc., preferably BOPA is coated with PVDC material on the inside with a thickness of 0.06 mm.

Usually, a weight loss treatment cycle lasts for 180 days. At the end of treatment (or when necessary), the balloon can be punctured under gastroscopy, and removed under gastroscopy after the gas is discharged. The balloon can also be made of degradable materials. After the treatment cycle is completed, the balloon will degrade and collapse, and the residue will be discharged from the body through the intestines.

Example 2

The gas generating agent is composed of the following components, each component is calculated by weight percentage: trans-1-chloro-3,3,3-trifluoropropene 15%; monochlorotrifluoromethane 15%; 1-fluoro-1,1-dichloroethane 69.8%; fennel essential oil 0.1%; anthocyanin 0.1%. The above composition is used as a gas generating agent.

1.0 g of the above-mentioned gas generating agent was placed into the gas production test bottle 3-8 in Figure 3 for testing. The gas production was 4.8 mL below 30°C, 32.0 mL within 2 minutes at 31°C-34°C, 36.4 mL at 31°C-34°C for 2-10 minutes, 172.5 mL at 35°C-38°C for 2 minutes, and 196.7 mL at 38°C.

Example 3

The gas generating agent is composed of the following components, each component is expressed in weight percentage:

20% of a blend of 1,1,1,3,3-pentafluoropropane (95%)-ethanol (5%) azeotrope and trans-1-chloro-3,3,3-trifluoropropene (weight ratio 1:2); 25% of a blend of 1,1,1,3,3-pentafluorobutane (95%)-ethanol (5%); 54.8% of cis-1,1,1,4,4,4-hexafluoro-2-butene; 0.1% of lavender essential oil; and 0.1% of Prussian blue. The above composition is used as a gas generating agent.

1.0 g of the above-mentioned gas generating agent was placed into the gas production test bottle 3-8 in Figure 3 for testing. The gas production below 30°C was 7.8 mL, the gas production within 2 minutes at 31°C-34°C was 40.0 mL, the gas production at 2-10 minutes at 31°C-34°C was 62.6 mL, the gas production at 2 minutes at 35°C-38°C was 132.8 mL, and the maximum gas production at 38°C was 178.5 mL.

Example 4

Using the model shown in FIG4 , the "gastric-soluble volume-reducing and weight-reducing capsule" prepared by the present invention was flushed into the model stomach through the esophagus with 50 mL of 25° C. warm water, and the preset temperature of the stomach contents was 38° C. After timing, the time for the capsule to be flushed into the stomach through the esophagus with warm water from the upper end of the esophagus was 2 seconds to 5 seconds. After observation by polarized backlight, it was observed that the capsule disintegrated 24 minutes after entering the stomach, and the built-in airbag began to produce gas and expand, and stopped expanding at 265 seconds, and the size was filled to a maximum diameter of 75 mm, with a volume of about 200 mL.

The design parameters for the shell disintegration of gastric-soluble pressure-bearing capsules are: when pH=7, the pressure resistance is 0.2MPa; when pH=3, the gastric environment of 35℃-38℃, the disintegration time is 20 minutes-30 minutes, and the pressure resistance is 0.1MPa within 20 minutes. The safety constraint threshold is set as follows: when the gastric environment pH=3, 46℃, the disintegration time is ≥20 minutes, and the capsule can withstand a pressure of 0.1Mpa within 20 minutes.

Example 5

In a further redundant test, the sample of the gastric volume reduction and weight reduction capsule of the present invention was connected to the test port 3-14 of the airbag comprehensive detection device in Figure 3, and immersed in the simulated gastric content of pH=3. In the temperature range of 38℃-50℃, a point was selected to conduct a pressure bearing time test (the 2-5 overload pressure relief safety valve pieces were placed in a failed state during the test). The gastric-soluble pressure-bearing encapsulated capsule was measured at 46℃ and the pressure inside the capsule was 0.089Mpa. When the constant pressure was maintained for 21 minutes, the capsule collapsed, which was within the preset safety constraint threshold; simulating hypothetical extreme conditions: at 50℃, the pressure inside the capsule was 0.100Mpa, and the constant pressure was maintained for 12 minutes. The capsule collapsed and did not reach the preset safety constraint time threshold. It is reminded that when swallowing the capsule, hot water exceeding 50℃ should not be used for delivery.

The outer layer of the gastric-soluble pressure-bearing capsule was subjected to a pressure resistance test: the gastric-soluble pressure-bearing weight-reducing capsule sample was connected to the test port 3-14 of the airbag comprehensive detection device in Figure 3, and retained in the simulated middle part of the esophagus. Compressed air was filled in through the port 3-13, and the airbag 2-2 in Figure 2 was pressurized. The pressure resistance test of 2-2 was carried out at a temperature of 38°C (the overload pressure relief safety valve piece 2-5 was placed in a failed state during the test). The pressure was set to 0.400Mpa and maintained at a constant pressure for 60 minutes, and the capsule did not burst.

Example 6

Swallowing simulation test: The encapsulated capsules were filled with the following simulated contents: an edible starch film with a volume of 1.5 mL after folding was taken, and 1 mL of vegetable oil was sealed in the starch film. The trial test capsules were made to have the same structure and weight as the capsules of the present invention. The capsules were swallowed voluntarily by the subjects, a total of 5 people, with 50 mL of warm water. Each person swallowed 2 capsules each time, with an interval of 30 seconds between two swallowings. The timing started from the time when the capsules were placed in the mouth. The shortest time for each capsule was 4 seconds and the longest time was 12 seconds. All capsules were swallowed smoothly.

It has been determined that under normal stomach temperature of 38°C, the maximum pressure of the gas-generating agent when gas and liquid coexist is 0.059 MPa and is constant. Even if the overload pressure relief safety valve fails, the airbag will not expand accidentally. Therefore, the capsule of the present invention is very safe during use.

The capsule-type self-gas-generating gastric volume and weight reduction airbag of the present invention is safe, convenient, easy to use, and is conducive to replacing the currently commercially available products.

Claims (2)

1. A self-gas-generating gastric volume-reducing and weight-reducing capsule, comprising, from outside to inside, a gastric-soluble pressure-bearing capsule layer, an air bag layer and a gas-generating agent in the air bag, characterized in that air holes are evenly distributed on the shell of the gastric-soluble pressure-bearing capsule layer; the gas-generating agent is composed of the following components, each component is calculated by mass percentage: component A 1%-20%, component B 15%-25%, component C 54.8%-78%, component D 0.1%-0.5%, component E 0.1%-0.5%, A+B+C+D+E=100%; The component A is a mixture of 1,1,1,3,3-pentafluoropropane-ethanol azeotrope and trans-1-chloro-3,3,3-trifluoropropene, wherein the weight ratio of 1,1,1,3,3-pentafluoropropane-ethanol azeotrope to trans-1-chloro-3,3,3-trifluoropropene is 1:1 or 1:2, and the mass percentage of ethanol in the azeotrope is 3%-5%; or component A is selected from trans-1-chloro-3,3,3-trifluoropropene; The component B is a mixture of 1,1,1,3,3-pentafluorobutane-ethanol azeotrope and monofluorotrichloromethane, the weight ratio of 1,1,1,3,3-pentafluorobutane-ethanol azeotrope to monofluorotrichloromethane is 2: 1, and the mass percentage of the ethanol in the azeotrope is 5%; or the component B is selected from 1,1,1,3,3-pentafluorobutane-ethanol azeotrope, and the mass percentage of the ethanol in the azeotrope is 5%; or the component B is selected from monofluorotrichloromethane; The component C is a mixture of 1-fluoro-1,1-dichloroethane, 1,1,1,3,3-pentafluorobutane and cis-1,1,1,4,4,4-hexafluoro-2-butene, wherein the weight ratio of 1-fluoro-1,1-dichloroethane, 1,1,1,3,3-pentafluorobutane and cis-1,1,1,4,4,4-hexafluoro-2-butene is 4:3:3; or the component C is selected from 1-fluoro-1,1-dichloroethane or cis-1,1,1,4,4,4-hexafluoro-2-butene; The component D is a taste alerting agent, selected from any one or more of eugenol, cinnamaldehyde, eucalyptus essential oil, lavender essential oil, basil essential oil, fennel essential oil, peppermint essential oil, rosemary essential oil, and patchouli essential oil; The component E is a color alerting agent selected from any one or more of Prussian blue, methylene blue, and anthocyanin. 2. The self-generated gastric volume and weight reduction capsule as described in claim 1 is characterized in that a pressure overload relief safety valve is provided at each end of the air bag body.