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

Capsule type self-produced gas stomach volume-reducing weight-reducing air bag Download PDF

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Publication number
CN116602807B
CN116602807B CN202310577291.XA CN202310577291A CN116602807B CN 116602807 B CN116602807 B CN 116602807B CN 202310577291 A CN202310577291 A CN 202310577291A CN 116602807 B CN116602807 B CN 116602807B
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component
gas
reducing
capsule
air bag
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CN116602807A (en
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张勤生
崔学晨
许文俭
白桦
李明彦
俞宏
封雷
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

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

Capsule type self-produced gas stomach volume-reducing weight-reducing air bag
Technical Field
The invention relates to the technical field of medical instruments, in particular to a gastric volume-reducing and weight-reducing air bag which is encapsulated and inflated by utilizing a gastric temperature-induced gradient self-produced gas composition.
Background
The existing obesity treatment methods mainly comprise diet control, exercise weight reduction, drug treatment, operation treatment and the like. The simple diet and exercise weight loss control requires stronger mental control, and most people lose one step. Although the weight reduction effect of the operation is obvious, the operation has high requirements on medical level, has long recovery period of wounds caused to patients, is high in cost, causes body wounds, and is hardly accepted by the patients because of the injury of primordial qi in traditional Chinese medicine.
In order to overcome the defects of the existing weight-reducing method, in recent years, a weight-reducing mode of putting a water sac or an air sac into the stomach to occupy the inner volume of the stomach and reduce the food intake is developed in many countries, and the mode is an effective weight-reducing means proved by a large number of practices. The method is to connect the balloon with the catheter, implant the empty balloon into the stomach by the operator, then inject the gas or normal saline into the balloon, make the balloon expand in the stomach, and pull out the catheter after the completion. The stomach balloon filled with gas or liquid occupies the stomach volume of the patient, causes satiety, and achieves the purpose of reducing food intake and weight. The method is a safer and effective medical weight-reduction treatment technology, and products approved and clinically applied in multiple countries such as the United states have ORBERA ℃ and Spatz3, see document CHOI S J, CHOI H S. Various intragastric balloons under clinical investigation[J].Clinical Endoscopy,2018,51(5):407–415., but the method has the defects: general anesthesia is needed when the saccule is implanted, the damage to the throat and the esophagus is easy to occur, the operation is complicated, the risk exists, and the patient is painful.
ANNALS OF BIOMEDICAL ENGINEERING,2021, 49:1391-1401 reports that the swallowable self-produced weight-reducing capsule has a gas producing mechanism that an organic acid (such as citric acid) aqueous solution and basic carbonate (such as potassium bicarbonate and sodium bicarbonate) are separately placed in different chambers of an intragastric balloon, after a patient independently swallows the weight-reducing capsule into the stomach, a magnetic field is applied in vitro to drive a magnetic valve of the intragastric balloon to make acid and alkali reactants react in contact to generate carbon dioxide gas so as to expand the intragastric balloon, and the method avoids operation pain, but has some disadvantages:
1) The acid-base reactant and water occupy a relatively large volume. Data given in literature: in a capsule of length 35mm, diameter 12.39mm and volume 4.2mL (V 1), 1.12 g of the acid-base reactant and 1mL of water can be contained, the gas yield at this time being about 120mL (V 2), the gas yield volume ratio V 2/V1 being 120/4.2=28.57. If 400-600mL therapeutic effect volume is achieved, 4 capsules need to be swallowed at a time. It is well documented that the number of commonly implanted balloons is 1-2, too small and too large increase the risk of accidental leakage and pyloric obstruction. ( The amount of gas production of a volume of the capsule can be described as the gas production rate: v 2/V1, wherein V 1 is the initial volume of the capsule and V 2 is the volume of the balloon after inflation. Smaller initial capsule volumes facilitate autonomous swallowing, while those that enter the stomach are expected to fill into larger balloons. )
2) With the prior art products, if the gas yield of the capsules reaches 200mL, each capsule needs to contain 1.9 g of reactant and 1.5mL-2mL of water according to the chemical equation of the gas production reaction, and the total volume of the balloon material is about 7mL (the diameter is 13mm and the length is 45 mm), so that large objects easily get into incarceration and obstruction when passing through the throat or esophagus (especially the narrow part of the esophagus), and the unexpected gas production result is uncontrollable at the moment. This creates fear psychology for the patient that is not receptive to spontaneous swallowing or swallowing failure.
From the above, it can be seen that the prior art is limited by the gas generating capability of the acid-base gas generating agent, and even though the gas generating volume ratio of the capsule approaches the theoretical limit, the ideal application requirement cannot be met due to the limitation of the capsule volume.
Therefore, improvements on self-produced gas swallow type weight-losing capsules are needed at present so as to meet the practical demands.
Disclosure of Invention
In order to solve the defects in the prior art, the invention aims to provide the stomach volume-reducing weight-reducing capsule which is safe to use and high in gas production volume multiplying power, is beneficial to patients to swallow, reduces the number of swallows and meets the treatment requirement.
The invention provides a capsule type self-produced gas stomach volume-reducing weight-reducing air bag which uses a temperature-induced gradient gas production composition in the stomach as a gas producing agent.
The technical scheme adopted by the invention is as follows:
the temperature-induced gradient gas production composition comprises 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 preferred gas generating composition comprises the following components: 1% -10% of component A, 5% -20% of component B, 70% -90% 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 (mass percent of ethanol 1% -20%), trans-1-chloro-3, 3-trifluoropropene.
The component B is selected from the following components: 1, 3-pentafluorobutane-ethanol azeotrope (1-20% of ethanol by mass) and 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.
The component D is a flavor alarm, and the air bag is released into the stomach after being accidentally broken, so that essential oil smell can be escaped through hiccup to prompt the breakage of the air bag. The material is selected from the following materials: 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 colored alerter, and the air bag is released into the stomach after being accidentally broken, so that urine can be blue and purple to prompt the air bag to be broken. The material is selected from the following materials: prussian blue, methylene blue, anthocyanin.
The sum of the proportions of the components is A% + B% + C% + D% + E% = 100%.
And (3) placing the prepared gas generating agent into an air bag, discharging redundant air, sealing, folding, and filling the sealed and folded air bag into a gastric-soluble pressure-bearing packaging capsule for integral coating and packaging to prepare the gastric-soluble gastric volume-reducing weight-reducing capsule for temperature-induced gradient gas generation. The stomach volume-reducing weight-reducing capsule sequentially comprises a gastric-soluble pressure-bearing capsule layer, an air sac layer and an air generating agent in the air sac from outside to inside.
The gastric-soluble pressure-bearing capsule layer is made from modified polyhydroxyalkanoate, hydroxypropyl cellulose, polyvinylpyrrolidone and other animal or plant source materials. A plurality of ventilation small holes are uniformly distributed on the shell, the diameters of the small holes are 0.2-3 mm, and the ventilation small holes are used for discharging gas when the air bag is overloaded and depressurized, so that the pressure release requirement can be met, and the pressure bearing capacity of the capsule is not reduced.
After the capsule enters the stomach, the gastric-soluble pressure-bearing capsule shell can bear the expansion pressure of 0.2MPa in 20 minutes, and the capsule is disintegrated under the action of gastric juice within 20 minutes to 30 minutes, so that the air sac is released.
The preferable scheme is as follows: two disposable pressure overload and pressure relief safety valve plates (see figure 2 2-5) are correspondingly arranged at two ends of the self-produced gas bag body, the opening pressure is set to be 0.2MPa, when the pressure in the bag reaches a set value, one of the overload safety valve plates automatically opens and releases the pressure, so that the pressure overload and accidental expansion caused by too long stay in the esophagus can be prevented, the esophagus is prevented from being damaged, the valve is of a bursting disc type (non-reclosing type overpressure relief device), the opening mode is of a falling type, the preferential material is of a metal film/non-metal composite type, the metal coating not only ensures good barrier property, but also can be used for CT imaging, and the positions and states of the valve plates and the sacculus are known.
The capsule type self-produced gas stomach volume-reducing and weight-reducing air bag has the volume of about 2.5mL (V 1) of all materials in the state that the air bag is not produced gas after being folded and packaged (comprising packaging materials, balloon materials and gas producing agents), and the size of the packaged capsule is as follows: diameter 12mm and length 25mm; the diameter of the filled balloon is 73-75 mm and the volume is about 200mL (V 2). The gas generating volume ratio V 2/V1 can reach 80 (the gas generating volume ratio is 2.8 times of the prior art), and the diameter of the air bag and the filling quantity of the gas generating agent can be properly increased so as to obtain larger gas generating volume ratio and filling volume. The volume of the finished product of the weight-reducing capsule is less than 1/2 of that of the existing acid-base reaction type product, so that the weight-reducing capsule is convenient for patients to independently swallow, and can meet the treatment requirement by only swallowing two products at a time due to high gas production volume multiplying power, thereby meeting the current weight-reducing treatment requirement.
Adopting a simulation device as shown in fig. 4, using the capsule of the invention, after the capsule enters the stomach through swallowing simulation, the gastric-soluble pressure-bearing encapsulation capsule layer is decomposed under the action of gastric acid within the preset time of 20 minutes to 30 minutes, at the moment, the air bag releases the restraint, and the gas generating agent sealed in the air bag induces gradient gasification in the human stomach at the temperature of 37 ℃ to 40 ℃ (actually measured by the inventor and confirmed by combining literature data); the balloon completes the inflation process (see the diagram B in fig. 2), occupies the stomach internal volume, reduces diet, and realizes weight reduction treatment.
The principle of the invention is as follows: the method belongs to physical gas production, utilizes 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 is shown in figure 5), does not need to be matched with an inflating or chemical reaction device, has the gas generating agent utilization rate of nearly 100 percent, and can generate more gas with less gas generating agent. The main components of the selected composition are biological inert compounds, and all the components are harmless to human bodies. Toxicology data for each component are as follows: 1, 3-pentafluoropropane toxicology data: the skin route was not toxic, and there was no mortality or significant signs of toxicity when rats and mice were exposed to either 203,000 ppm or 101,000 ppm pentafluoropropane environments (Toxicological Sciences, 1999, 52 (2): 289-301). Trans-1-chloro-3, 3-trifluoropropene toxicology data: non-mutagenic and non-teratogenic, toxicity to rodents was negative in genotoxicity assays, toxicity potential to mammals was very low, male Sprague-Darling rats and female New Zealand rats were exposed to 2000, 5000 and 10,000 PPM of trans-1-chloro-3, 3-trifluoropropene, respectively, and after 6 hours of exposure urine was collected within 48 hours without detection of toxicants (Toxicology AND APPLIED Pharmacology, 2013, 268:343-351). Fluorotrichloromethane toxicology data: 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 without causing signs OF toxicity (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY,1988,7 (5) 663-674). Cis-1, 4-hexafluoro-2-butene toxicology data: the 4 hour LC50 was 1425 ppm in rats. Fischer-344 rats were given average HFIB concentrations of 3, 10, 30 and 90 ppm for 13 weeks at 6 hours, 5 days/week per day, with no animal death (TOXICOLOGY AND APPLIED PHARMACOLOGY,1986, 86:327-340). 1-fluoro-1, 1-dichloroethane toxicology data: has very low acute toxicity, can not cause adverse reaction when being applied to rabbit skin by 2000 mg/kg body weight, can not cause death or clinical symptoms of toxicity when being applied to rats by 5000 mg/kg body weight, has LC50 of about 62000 ppm in 4 hours in the body of the rats, can not cause obvious adverse reaction when being repeatedly exposed to the rats for 6 hours/day, 5 days/week and up to 90 days at 2000, 8000 or 20000ppm (Food AND CHEMICAL Toxicology, 1995, 33 (6): 483-490). 1, 3-pentafluorobutane toxicology data: toxicological related indicators are lower than 1-fluoro-1, 1-dichloroethane, which is safer to use in the present patent (JOURNAL OF CELLULAR PLASTICS,1999, 35:328-331).
The invention has the advantages that: the composition mainly comprises organic inert gas generating agents, all the components are stable in property and harmless to human bodies, gradient gas generation is induced by the temperature in the stomach, the utilization rate of the gas generating agents is close to 100% in physical gas generation, byproducts occupying the capsule volume in an ineffective way are not generated, the gas generating volume ratio is high, the gas generating process is mild and gentle, and the maximum pressure is constant and far lower than that of carbon dioxide. The gasification temperature range of the gas generating agent is set to be 30-38 ℃. At 38 ℃ and 1 standard atmosphere pressure, 1mL of the gas generating agent can be gasified into about 200mL of gas, and the gas generating volume multiplying power is far higher than that of the acid-base reaction type gas generating agent, so that the volume of the weight-reducing capsule can be made smaller, and the weight-reducing capsule is safer and more convenient to use. The actual manufactured and trial-packaged sample is shown in figure 1, the actual size is 25mm in length, 12mm in diameter and about 2.5mL in volume, the appearance is a round-head cylindrical body of a common oral capsule, the length is short, the diameter is small, the capsule is convenient to swallow independently, and the capsule is easy to accept by patients.
Drawings
FIG. 1 is an external appearance of a gastric-soluble weight-loss capsule of the present invention.
FIG. 2 is a schematic view of a section A-A of the gastric-soluble weight-reducing capsule before and after inflation, wherein the section A-A is a section of the gastric-soluble weight-reducing capsule, the section a-1 is a gastric-soluble pressure-bearing encapsulation capsule, the section a-2 is a section a-2 of the balloon, the section a-3 is a section a-3 of the gas generating agent, the section a-4 is a section a-5 of the gas-releasing safety valve plate; wherein before the inflation of the balloon in figure A, the inflation of the balloon in figure B is followed.
FIG. 3 is a schematic diagram of the air bag comprehensive detection device, wherein in the diagram, a 3-1 synchronous thermostatic chamber, a 3-2 thermostatic water bath, 3-3 water, a 3-4 precise pressure gauge, a 3-5 thermometer, a 3-6 pressure test gas producing cylinder, a 3-7 air bag barrier property test port, a 3-8 gas producing amount test cylinder, a 3-9 measuring cylinder (water-displacement gas producing amount meter), a 3-10 material performance test kettle, a 3-11 membrane material pressure-resistant test port, a 3-12 membrane material barrier property test port, a 3-13 air bag pressure-resistant test port, a 3-14 gastric-soluble pressure-bearing encapsulation capsule test port and a 3-15 valve are adopted.
Fig. 4 is a diagram of a swallowing and intragastric test model device: 4-1 of a thermostatic water bath, 4-2 of water, 4-3 of esophagus, 4-4 of weight-reducing capsule of the invention entering the esophagus and descending, 4-5 of simulated stomach, 4-6 of simulated stomach contents (water adjusted to ph=3 with 0.1M hydrochloric acid, carboxymethyl cellulose, milk, vegetable emulsion, preservative mixture), 4-7 of the balloon of the invention in a inflated state.
FIG. 5 is a graph of the temperature versus expansion volume of the gas generant in accordance with the invention.
FIG. 6 is a graph of the temperature versus pressure of the gas generant in accordance with the invention.
Detailed Description
In order to better illustrate the present invention, the present invention will be specifically described with reference to the following examples and the accompanying drawings.
Example 1
The gas generating agent consists of the following components in percentage by weight:
1, 3-pentafluoropropane (97%) -ethanol (3%) azeotrope and trans-1-chloro-3, 3-trifluoropropene (1:1 by weight ratio of the two); 20% of a mixture (1:2 by weight) of monofluorotrichloromethane and 1, 3-pentafluorobutane (95%) -ethanol (5%) azeotrope; 1-fluoro-1, 1-dichloroethane 1, 3-pentafluorobutane and cis-1, 4-hexafluoro-o-i-78% of a 2-butene mixture (weight ratio of the three is 4:3:3); 0.5% eugenol; 0.5% methylene blue. 1.0mL of the gas generating agent is put into a 3-8 gas generating amount test bottle in the figure 3, and the gas generating amount is 0mL below 30 ℃. The gas yield is 2.1mL within 2 minutes at 31-34 ℃, the gas yield is 9.7mL within 2-10 minutes at 31-34 ℃, the gas yield is 158.9mL within 2 minutes at 35-38 ℃, and the maximum gas yield is 194.0mL at 38 ℃.
A PA/EVOH/PE composite film material with the thickness of 0.06mm is used as an air bag material to prepare an air bag sample with the capacity of 200mL, 1.0 g of the air generating agent is filled, and the air bag is tested at the temperature of 39+/-1 ℃ under the condition of simulating the stomach environment, so that the air bag volume can be kept unchanged basically for 180 days.
The gas generating agent described in example 1 was subjected to temperature-pressure test using the apparatus of fig. 3 under conditions that the gas generating agent was excessive by 50%, 20-50 c, and 1.5 g of the gas generating agent was placed in a pressure test flask 3-6 having a capacity of 200mL, and the highest pressure was measured to be 0.0984MPa. The results are shown in FIG. 6. The method simulates the short temperature rise in the stomach caused by accidental swallowing of hot drinks or foods up to 50 ℃ during the retention period of the stomach, so that the minimum inflation pressure which the balloon needs to bear at the highest temperature which can be reached by the stomach content is known, and the method has practical reference significance for selecting or preparing proper materials and designing the structural strength of the balloon with redundancy and reliability.
From the above test results, the following are explained from the safety of use: the gas generating agent is not gasified below the room temperature of 30 ℃, the swallowing process enters the stomach from the esophagus for 2-15 seconds, and the gas generating agent is gradually heated in the esophagus but cannot integrally reach the gasification temperature as measured in a model, when the gas generating agent is accidentally swallowed and stays in the esophagus, even if the gas generating agent integrally exceeds the gasification temperature, the gas bag cannot expand because the gas generating agent is packaged in the gastric-soluble pressure-bearing packaging capsule.
Further description about use safety assurance: the gastric-soluble pressure-bearing encapsulation capsule can ensure that the self-produced gas gastric balloon has overlong accidental retention time during storage and swallowing through esophagus and is not gasified and expanded when the temperature reaches the body temperature. After the gastric-soluble pressure-bearing encapsulation capsule enters the stomach, the gastric-soluble pressure-bearing encapsulation capsule is gradually degraded and collapsed within 20-30 minutes under the pH=3 acidic environment, the pressure-bearing constraint of the air bag is released, and the gas generating agent is gradually gasified until the air bag is fully inflated. The diameter of the inflated balloon is 73-75 mm, and the maximum size of an object through which the pylorus can pass is not more than 40mm, so that the balloon with the diameter can ensure that the pylorus can not pass into the intestinal tract.
The weight-reducing capsule is prepared by using the gas generating agent in the embodiment, wherein the airbag manufacturing material needs to meet the following conditions: the flexible film material with good barrier property, no toxicity and corrosion resistance for the gas generating agent, such as PVDC, BOPA, BOPP, BOPET, PVA, EVOH, PE and multilayer composite, multilayer co-extrusion and coating materials thereof, is preferably coated with PVDC material on the inner side of BOPA, and has the thickness of 0.06 millimeter.
Typically, a weight-loss treatment period is 180 days, and after the treatment is finished (or when needed), the air bag can be punctured under the gastroscope, and the air bag can be taken out under the gastroscope after the air is exhausted. The air bag can also be made of degradable materials, and after the treatment period is completed, the air bag is degraded and collapsed, and the residue is automatically discharged out of the body through the intestinal tract.
Example 2
The gas generating agent consists of the following components in percentage by weight: 15% of trans-1-chloro-3, 3-trifluoropropene; 15% of fluorotrichloromethane; 69.8% of 1-fluoro-1, 1-dichloroethane; 0.1% of fennel essential oil; 0.1% of anthocyanin. The composition is used as a gas generating agent.
1.0 G of the gas generating agent is put into a 3-8 gas generating test bottle in the figure 3 for testing, the gas generating amount is 4.8mL below 30 ℃, the gas generating amount is 32.0 mL within 2 minutes at 31-34 ℃, the gas generating amount is 36.4 mL within 2-10 minutes at 31-34 ℃, the gas generating amount is 172.5 mL within 2 minutes at 35-38 ℃, and the maximum gas generating amount is 196.7 mL at 38 ℃.
Example 3
The gas generating agent consists of the following components in percentage by weight:
A blend of 1, 3-pentafluoropropane (95%) -ethanol (5%) azeotrope and trans-1-chloro-3, 3-trifluoropropene (1:2 by weight); 25% azeotrope of 1, 3-pentafluorobutane (95%) -ethanol (5%); 54.8% of cis-1, 4-hexafluoro-2-butene; 0.1% of lavender essential oil; prussian blue 0.1%. The composition is used as a gas generating agent.
1.0 G of the gas generating agent is put into a 3-8 gas generating test bottle in the figure 3 for testing, the gas generating amount is 7.8 mL below 30 ℃, the gas generating amount is 40.0 mL within 2 minutes at 31-34 ℃, the gas generating amount is 62.6 mL within 2-10 minutes at 31-34 ℃, the gas generating amount is 132.8 mL within 2 minutes at 35-38 ℃, and the maximum gas generating amount is 178.5 mL at 38 ℃.
Example 4
Using the model shown in FIG. 4, the "gastric-soluble volume-reducing weight-reducing capsule" prepared by the present invention was infused into the model stomach via the esophagus with 50mL of warm water at 25℃and the stomach content was preset at 38 ℃. The time that the capsule is flushed into the stomach from the upper end opening of the esophagus through the esophagus by warm water is 2-5 seconds, the capsule is collapsed after 24 minutes after entering the stomach by using polarized light backlight source transillumination observation, at the moment, the built-in air bag starts to produce gas and expand until 265 seconds, the expansion is stopped, the size is full to the maximum diameter of 75mm, and the volume is about 200mL.
The design parameters of the gastric-soluble pressure-bearing encapsulation capsule shell collapse condition are as follows: at ph=7, the withstand voltage is 0.2MPa; the pH=3, the gastric environment at the temperature of 35-38 ℃ and the collapse time of 20-30 minutes, and the pressure resistance of 0.1MPa within 20 minutes. The safety constraint threshold is set as: the time of the collapse is more than or equal to 20 minutes under the conditions that the pH value of the environment in the stomach is=3 and the temperature is 46 ℃, and the pressure resistance of the capsule is 0.1Mpa within 20 minutes.
Example 5
In a further redundancy test, a sample of the gastric volume-and weight-reduction capsule of the present invention was accessed into the test port of the balloon integrated test device 3-14 of fig. 3 and immersed in simulated gastric contents at ph=3. And (3) carrying out pressure-bearing time test by selecting points in the temperature range of 38-50 ℃ (2-5 overload pressure relief safety valve plates are placed in a failure state during test). The gastric-soluble pressure-bearing encapsulation capsule is subjected to disintegration within a preset safety constraint threshold range when the pressure in the capsule is measured to be 0.089Mpa at 46 ℃ and the constant pressure is kept for 21 minutes; simulated hypothetical extreme conditions: when the pressure in the capsule is 0.100Mpa at 50 ℃ and the constant pressure is kept for 12 minutes, the capsule is broken, and the preset safety constraint time threshold is not reached. It is suggested that hot water at a temperature exceeding 50 ℃ should not be used for administration when the capsule is swallowed.
Performing pressure resistance test on the outer layer of the gastric-soluble pressure-bearing capsule: the gastric-soluble pressure-bearing weight-reducing capsule sample is connected to a test port of the air bag comprehensive detection device 3-14 in fig. 3, is retained at the middle section of the simulated esophagus, is filled with compressed air through the port 3-13, pressurizes the air bag 2-2 in fig. 2, performs pressure-bearing test at 38 ℃, and places the overload pressure-relief safety valve plate 2-5 in a failure state during the test. The pressure was set at 0.400Mpa and maintained at constant pressure for 60 minutes without bursting the capsule.
Example 6
Swallowing simulation test: the following simulated contents were filled in the encapsulated capsule: taking an edible starch film with the volume occupied by 1.5mL after folding, sealing 1mL of vegetable oil into the starch film, and making into a test capsule with the same structure and weight as the capsule of the invention, wherein 5 persons independently swallow the test capsule by a subject, taking the test capsule with 50mL of warm water, and the time between two swallowing is 30 seconds each time, starting from the position in an inlet, and the time is 4 seconds each time for the shortest time and 12 seconds each time for the longest time, so that the test capsule can be swallowed smoothly.
According to the measurement, the maximum pressure value of the gas generating agent is 0.059MPa and is constant when the gas and liquid coexist under the condition of normal stomach temperature of 38 ℃, and the gas bag can not be accidentally inflated even if the overload pressure relief safety valve plate fails, so that the capsule is very safe in the use process.
The capsule type self-produced gas stomach volume-reducing weight-reducing air bag is safe, convenient and convenient to use, and is favorable for replacing the current commercial products.

Claims (2)

1. The self-produced gas stomach volume-reducing weight-reducing capsule sequentially comprises a gastric-soluble pressure-bearing capsule layer, an air sac layer and a gas producing agent in the air sac from outside to inside, and is characterized in that ventilation holes are uniformly distributed on a shell of the gastric-soluble pressure-bearing capsule layer; the gas generating agent consists of the following components in percentage by mass: 1% -20% of component A, 15% -25% of component B, 54.8% -78% of component C, 0.1% -0.5% of component D, 0.1% -0.5% of component E, and A+B+C+D+E=100%;
The component A is a mixture of 1, 3-pentafluoropropane-ethanol azeotrope and trans-1-chloro-3, 3-trifluoropropene, wherein the weight ratio of the 1, 3-pentafluoropropane-ethanol azeotrope to the trans-1-chloro-3, 3-trifluoropropene is 1:1 or 1:2, the mass percentage of the ethanol in the azeotrope is 3% -5%; or component A is selected from trans-1-chloro-3, 3-trifluoropropene;
The component B is a mixture of 1, 3-pentafluorobutane-ethanol azeotrope and monofluorotrichloromethane, the weight ratio of the 1, 3-pentafluorobutane-ethanol azeotrope to the monofluorotrichloromethane is 2: 1, the mass percentage of the ethanol in the azeotrope is 5%; or component B is selected from 1, 3-pentafluorobutane-ethanol azeotrope, wherein the mass percentage of the ethanol in the azeotrope is 5%; or component B is selected from monofluorotrichloromethane;
The component C is 1-fluoro-1, 1-dichloroethane 1, 3-pentafluorobutane and cis-1, 4 mixtures of hexafluoro-2-butene, wherein 1-fluoro-1, 1-dichloroethane 1, 3-pentafluorobutane and cis-1, 4 the weight ratio of hexafluoro-2-butene is 4:3:3, a step of; or component C is selected from 1-fluoro-1, 1-dichloroethane or cis-1, 4-hexafluoro-2-butene;
The component D is a taste alerter selected from the group consisting of: 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-developing alerter selected from the group consisting of: prussian blue, methylene blue, anthocyanin.
2. The self-produced gastric volume-reducing weight-reducing capsule of claim 1, wherein two pressure overload pressure-relieving safety valve plates are arranged at two ends of the air bag body respectively.
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