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WO2024240127A1 - Composition autogazeuse à gradient induit par la température et son utilisation - Google Patents

Composition autogazeuse à gradient induit par la température et son utilisation Download PDF

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Publication number
WO2024240127A1
WO2024240127A1 PCT/CN2024/094344 CN2024094344W WO2024240127A1 WO 2024240127 A1 WO2024240127 A1 WO 2024240127A1 CN 2024094344 W CN2024094344 W CN 2024094344W WO 2024240127 A1 WO2024240127 A1 WO 2024240127A1
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component
gas
gas production
pentafluorobutane
ethanol
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PCT/CN2024/094344
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Chinese (zh)
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张勤生
许文俭
崔学晨
李永亮
白桦
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    • 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

Definitions

  • the invention relates to the technical field of medical devices, and in particular to a temperature-induced gradient self-gas-generating composition and an application thereof in a self-expanding medical air bag.
  • Compression is a commonly used treatment method in surgical treatment, and various air bags are commonly used compression devices.
  • air bag compression can effectively stop bleeding; especially for limb trauma bleeding, the use of pneumatic tourniquet compression is the preferred measure for emergency treatment.
  • placing an air bag in the stomach can occupy the gastric volume and reduce food intake, thereby achieving the purpose of weight loss.
  • this method has been clinically applied abroad and has been proven to be a safe, simple and effective means of weight loss.
  • the gas-producing reactants are hydrogen peroxide and ferrous sulfate; CN200420032735.4[P] reports a "stomach automatic inflation weight loss capsule", in which the gas-producing substances are selected from inorganic salts and organic acids, which react in the presence of water.
  • the inorganic salts are potassium carbonate, sodium carbonate, sodium bicarbonate, potassium bicarbonate, etc.
  • the organic acids are acetic acid, citric acid, malic acid, etc.
  • the above patent avoids external inflation and injection of saline, but due to its large size, it is not easy to swallow, chemical reactions occur in the body, there are certain risks, and the gas production reaction is difficult to control in the bladder. Therefore, further improvements are needed to expand the application of such products in human weight loss and surgical treatment.
  • the present invention proposes a temperature-induced gradient self-gas-generating composition, and applies it in gastric filling-type non-drug weight loss treatment or trauma emergency treatment.
  • the technical solution adopted by the present invention is:
  • the temperature-induced gradient self-gassing composition is composed of the following components, each component is expressed in 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%.
  • the preferred components of the self-gassing composition are: 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 and trans-1-chloro-3,3,3-trifluoropropene, wherein the mass percentage of ethanol in the 1,1,1,3,3-pentafluoropropane-ethanol azeotrope is 1%-20%.
  • the component B is selected from: any one or both of 1,1,1,3,3-pentafluorobutane-ethanol azeotrope and monofluorotrichloromethane, wherein the mass percentage of ethanol in the 1,1,1,3,3-pentafluorobutane-ethanol azeotrope is 1%-20%.
  • 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, and 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. Its function is to release it into the stomach after the airbag is accidentally ruptured, and the smell of essential oil can escape through hiccups, indicating that the airbag is damaged.
  • the component E is a color alerting agent, and its material is selected from: any one or more of Prussian blue, methylene blue, and anthocyanin. Its function is to make urine blue after the airbag is accidentally ruptured and released into the stomach, indicating that the airbag is damaged.
  • the prepared gas-generating agent is placed in the airbag, excess air is discharged and the bag is sealed, folded into a specific shape according to different uses, and then packaged as a whole to make a temperature-induced gradient self-gas-generating airbag, which can be used for internal body or limb compression hemostasis or gastric volume and weight reduction.
  • the corresponding volume-reducing and weight-reducing capsule can be further made.
  • the gas-generating agent sealed in the airbag induces gradient gasification under the human stomach temperature of 37°C-40°C.
  • the gastric-soluble encapsulated capsule gradually disintegrates, and the airbag fills and expands to a predetermined volume, occupying the corresponding stomach content, so as to reduce food intake and achieve weight loss.
  • the gas generating agent of the present invention induces gas generation by the temperature in the stomach, belongs to physical gas generation, and does not require a complex gas generating device.
  • Component C and its usage amount can ensure that the gas generating gas balloon in the stomach does not gasify and expand within 2 seconds to 15 seconds during storage and swallowing through the esophagus.
  • the appropriate usage amount of components A and B can ensure that the gas balloon enters the stomach until the gas generating agent is completely gasified, and the expansion diameter reaches 70mm-75mm.
  • the maximum size of an object that can pass through the pylorus does not exceed 40mm, so the air balloon of this diameter can be guaranteed not to enter the intestine through the pylorus.
  • the airbag When used for gastric volume reduction and weight reduction airbags, after the gas generating agent is completely gasified, the airbag is filled and the pressure inside the airbag is kept balanced with or slightly higher than the stomach pressure, with a maximum pressure not exceeding 0.05MPa.
  • the airbag When used for limb compression and hemostasis, after the gas generating agent is completely gasified, the airbag is completely filled, and combined with the strapping tape, the pressure inside the airbag reaches the hemostasis requirement, with a maximum pressure not exceeding 0.1MPa.
  • Principle of the present invention It belongs to physical gas production, and uses the body temperature, body surface temperature and environmental temperature to induce gradient gasification of the gas generating agent composition. It does not 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.
  • Toxicology and Applied Pharmacology, 2013, 268: 343–351 Toxicological data of monofluorotrichloromethane: 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 any signs of poisoning (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, 1988, 7(5)663-674). Cis-1,1,1,4,4,4-hexafluoro-2-butene Toxicological data: 4-hour LC50 in rats is 1425ppm.
  • Fischer-344 rats were exposed to HFIB for 6 hours per day, 5 days per week, with average HFIB concentrations of 3, 10, 30 and 90ppm for 13 weeks, and no animals died (TOXICOLOGY AND APPLIED PHARMACOLOGY, 1986, 86: 327-340).
  • Toxicological data of 1,1,1,3,3-pentafluorobutane Toxicological indicators are all lower than 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).
  • Trans-1-chloro-3,3,3-trifluoropropene has been used in the medical field. See the authorized Chinese invention patent CN201180065331, which records "... Suitable materials to be sprayed include, but are not limited to, cosmetic materials such as deodorants, fragrances, hair sprays, cleaning solvents and lubricants, and medical materials such as antiasthmatics.
  • the term medical material is used in its broadest sense herein to include any and all materials that are effective or at least considered effective in treatment, diagnostic methods, analgesia and similar therapies, thus including, for example, drugs and biologically active substances.
  • MDIs metered dose inhalers
  • the amount of gas produced by a capsule of a certain volume 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.
  • V1 is the initial volume of the capsule
  • V2 is the volume of the balloon after expansion.
  • the smaller initial volume of the capsule is convenient for autonomous swallowing, but after entering the stomach, it is hoped that it will be filled into a larger balloon.
  • the conventional use temperature range of the gas generator of the present invention can be set to 15°C-45°C. At 38°C and 1 standard atmospheric pressure, 1.04 grams of the gas generator of the present invention can be gasified into about 200mL of gas, and the gas production volume ratio is much higher than that of the acid-base reaction type gas generator.
  • the gas generator provided by the present invention can make the packaging size of various air bags smaller, especially the intragastric volume reduction and weight reduction air bags.
  • the smaller volume is convenient for swallowing, and it is safer and more convenient to use.
  • the literature [ANNALS OF BIOMEDICAL ENGINEERING, 2021, 49: 1391–1401], 1.12 grams of acid-base reactants and 1 mL of water can produce 120 mL of gas. (After calculation, the total volume of the acid-base gas generator is about 1.53 mL. When the present invention produces 120 mL of gas, about 0.63 grams of gas generator is required, and the volume is about 0.50 mL, which is about 33% of the total volume of the acid-base reaction type gas generator).
  • the present invention belongs to physical gas production, which uses the body temperature, body surface temperature and ambient temperature to induce gradient gas production of the composition, avoiding chemical reactions and reducing the risk of use.
  • the total volume of all materials is about 2.5mL (V 1 ), and the capsule size is about: diameter 12mm, length 25mm; the diameter of the filled airbag is 73-75mm, and the occupied volume is about 200mL (V 2 ).
  • the gas production volume ratio (V 2 /V 1 ) of the present invention can reach 80 (the gas production volume ratio is 2.4 times that of the prior art), and the filling amount of the gas generating agent can also be appropriately increased to obtain a larger filling volume and gas production volume ratio.
  • the volume of the capsule of the present invention is less than 1/2 of the existing acid-base reaction type product, so that patients can easily swallow it independently. Only 1-2 capsules need to be swallowed at a time to meet the treatment needs, reaching the current common weight loss efficacy volume.
  • 1 is a schematic diagram of a comprehensive detection device for a gas generating agent of the present invention, wherein 1-1 is a synchronous constant temperature chamber; 1-2 is a constant temperature water bath, 1-3 is water, 1-4 is a precision pressure gauge, 1-5 is a pressure test gas generating bottle, 1-6 is an air bag test port, 1-7 is a gas production test bottle (gas production measurement by drainage method), 1-8 is a measuring cylinder, 1-9 is a material test kettle, 1-10 is a membrane material pressure resistance test port, 1-11 is a membrane material barrier property test port, 1-12 is a valve, and 1-13 is a thermometer.
  • 1-1 is a synchronous constant temperature chamber
  • 1-2 is a constant temperature water bath
  • 1-3 water
  • 1-4 is a precision pressure gauge
  • 1-5 is a pressure test gas generating bottle
  • 1-6 is an air bag test port
  • 1-7 is a gas production test bottle (gas production measurement by drainage method)
  • 1-8 is a measuring cylinder
  • 1-9 is a
  • Fig. 2 is a diagram of a swallowing and intragastric test model device, wherein 2-1 is a constant temperature water bath, 2-2 is water, 2-3 is esophagus, 2-4 is a capsule entering the esophagus, 2-5 is stomach, 2-6 is a simulated stomach content, and 2-7 is an air bag in a filled and expanded state.
  • FIG. 3 is a temperature-expansion volume curve of Example 1 of the present invention.
  • FIG. 4 is a temperature-pressure curve of Example 1 of the present invention.
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • 1,1,1,3,3-pentafluoropropane (97%)-ethanol (3%) azeotrope and trans-1-chloro-3,3,3-trifluoropropene (the weight ratio of the two is 1:1) 3%; monofluorotrichloromethane and 1,1,1,3,3-pentafluorobutane (95%)-ethanol (5%) azeotrope (the weight ratio of the two is 1:2) 20%; 1-fluoro-1,1-dichloroethane, 1,1,1,3,3-pentafluorobutane and cis-1,1,1,4,4,4-hexafluoro-2-butene mixture (the weight ratio of the three is 4:3:3) 76%; 0.5% lavender essential oil; 0.5% Prussian blue.
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • 1,1,1,3,3-pentafluoropropane (97%)-ethanol (3%) azeotrope and trans-1-chloro-3,3,3-trifluoropropene (the weight ratio of the two is 1:1) 7%; monofluorotrichloromethane and 1,1,1,3,3-pentafluorobutane (95%)-ethanol (5%) azeotrope (the weight ratio of the two is 1:1) 5%; 1-fluoro-1,1-dichloroethane, 1,1,1,3,3-pentafluorobutane and cis-1,1,1,4,4,4-hexafluoro-2-butene mixture (the weight ratio of the three is 4:3:3) 87%; 0.5% eugenol; 0.5% methylene blue.
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • 1,1,1,3,3-pentafluoropropane (97%)-ethanol (3%) azeotrope and trans-1-chloro-3,3,3-trifluoropropane 10% of 1,1,1,3,3-pentafluorobutane (weight ratio of the two is 1:1); 5% of azeotrope of monofluorotrichloromethane and 1,1,1,3,3-pentafluorobutane (95%)-ethanol (5%) (weight ratio of the two is 1:1); 84% of 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 (weight ratio of the three is 4:3:3); 0.5% of eugenol; 0.5% of methylene blue.
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • the gas generating agent is composed of the following components, each component is expressed in mass percentage:
  • the simulated gastric gas production test was conducted using the swallowing and gastric test model apparatus shown in Figure 2.
  • the gastric contents were water, carboxymethyl cellulose, milk, vegetable puree, and a preservative mixture adjusted to pH 3 with 0.1 M hydrochloric acid.
  • a 200 mL airbag was made of a 0.06 mm thick PA/EVOH/PE composite film material, 1.0 g of the gas generating agent of Example 1 of the present invention was placed in the airbag, the air was removed and sealed, folded, and then placed in a gastric-soluble capsule with a diameter of 12 mm and a length of 25 mm to make a weight loss capsule model, and the capsule was flushed into the model stomach through the esophagus with 50 mL of 25° C. warm water, and the preset temperature of the gastric contents was 38° C.
  • the gas generating agent is composed of the following components (lacking component A), each component is calculated by weight percentage:
  • the gas generating agent is composed of the following components (lacking component B), each component is calculated by weight percentage:
  • 1,1,1,3,3-pentafluoropropane (97%)-ethanol (3%) azeotrope and trans-1-chloro-3,3,3-trifluoropropene (the weight ratio of the two is 1:1) 20%; 1-fluoro-1,1-dichloroethane, 1,1,1,3,3-pentafluorobutane and cis-1,1,1,4,4,4-hexafluoro-2-butene mixture (the weight ratio of the three is 4:3:3) 79.8%; 0.1% lavender essential oil; 0.1% Prussian blue.
  • the gas generating agent does not gasify or gasifies in small amounts at room temperature below 30°C.
  • the gas generating agent is gradually heated in the esophagus within 2 seconds to 15 seconds, and the gasification temperature is not reached as a whole.
  • the gas production continues to increase.
  • a gastric-soluble pressure-bearing packaging capsule can be used to pressure-proof encapsulate the airbag.
  • the preferred gas generating agent components are: A 1%-10%, component B 5%-20%, component C 70%-90%, component D 0.05%-0.5%, component E 0.05%-0.5%.
  • embodiment 5 is preferred.
  • the gas generating agent of the present invention can generate gas in the range of 35°C-40°C in the human stomach within 10 minutes.
  • the volume is filled to about 200 ml and can remain basically unchanged for up to 180 days.
  • a weight loss treatment cycle is 180 days.
  • a needle can be used to pierce the balloon under gastroscopy to extract the gas.
  • the deflated balloon can be grabbed through the gastroscopy and removed.
  • the balloon can also be made of degradable materials.
  • the balloon degrades and collapses, and the gas leaks out.
  • the deflated balloon residue is discharged from the body through the intestine. The possibility of accidental damage to the balloon cannot be ruled out.
  • the gas leaks and the balloon deflates, and the residue can be discharged from the body through the intestine.
  • the leaked gas stays in the stomach for a short time and then quickly discharges itself through the digestive tract.
  • the gas generating agent composition of the present invention can also be made into a self-expanding compression medical air bag for intra-abdominal compression hemostasis, limb compression hemostasis and the like.

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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne une composition autogazeuse à gradient induit par la température, constituée des composants suivants en pourcentage en poids : de 1 % à 20 % du composant A, de 5 % à 30 % du composant B, de 55 % à 95 % du composant C, de 0,05 % à 0,5 % du composant D, et de 0,05 % à 0,5 % du composant E. Le composant A est choisi parmi l'un quelconque ou deux parmi le 1,1,1,3,3-pentafluoropropane-éthanol et le trans-1-chloro -3,3,3-trifluoropropène ; le composant B est choisi parmi l'un quelconque ou deux parmi le 1,1,1,3,3-pentafluorobutane-azéotrope et le monofluorotrichlorométhane ; le composant C est choisi parmi l'un quelconque ou plusieurs parmi le cis-1,1,1,4,4,4-hexafluoro-2-butène, le 1,1,1,3,3-pentafluorobutane et le 1-fluoro-1,1-dichloroéthane ; le composant D est un agent d'amélioration d'arôme et d'alerte ; le composant E est un agent d'amélioration de couleur et d'alerte. La production de gaz à gradient de la composition est induite à l'aide de températures corporelles internes et externes, qui concernent la production de gaz physique, ne nécessite pas de mise en correspondance de n'importe quel dispositif de gonflage ou de production de gaz, permet d'obtenir une efficacité de production de gaz élevée (rapport de volume de production de gaz), et peut mettre en œuvre la production de plus de gaz avec une plus petite quantité d'agent de production de gaz. La composition est transformée en une capsule de réduction de poids ou en un sac d'air médical autoexpansible pour une hémostase par compression intrapéritonéale, une hémostase par compression de membre et d'autres opérations chirurgicales.
PCT/CN2024/094344 2023-05-22 2024-05-21 Composition autogazeuse à gradient induit par la température et son utilisation Pending WO2024240127A1 (fr)

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CN202310577246.4A CN116603067B (zh) 2023-05-22 2023-05-22 一种温度诱导梯度自产气组合物及其应用
CN202310577246.4 2023-05-22

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CN116603067B (zh) * 2023-05-22 2024-04-12 张勤生 一种温度诱导梯度自产气组合物及其应用
CN116602807B (zh) * 2023-05-22 2024-05-28 张勤生 一种胶囊式自产气胃减容减重气囊

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WO2019112768A1 (fr) * 2017-12-07 2019-06-13 Obalon Therapeutics, Inc. Dispositif intragastrique à auto-dégonflage
CN116603067A (zh) * 2023-05-22 2023-08-18 张勤生 一种温度诱导梯度自产气组合物及其应用
CN116602807A (zh) * 2023-05-22 2023-08-18 张勤生 一种胶囊式自产气胃减容减重气囊

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US8703006B2 (en) * 2008-10-28 2014-04-22 Honeywell International Inc. Azeotrope-like compositions comprising 1-chloro-3,3,3-trifluoropropene
CN104000628B (zh) * 2014-05-10 2018-05-22 中南大学湘雅三医院 胃部急救胶囊止血器及止血方法
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AU1801583A (en) * 1982-10-06 1984-04-12 Ainsworth Nominees Pty Ltd Stomach dilator for obesity
CN1653155A (zh) * 2002-03-14 2005-08-10 霍尼韦尔国际公司 五氟丙烷的组合物
CN2754630Y (zh) * 2004-02-06 2006-02-01 兰太富 一种胃内自动充气的减肥胶囊
WO2019112768A1 (fr) * 2017-12-07 2019-06-13 Obalon Therapeutics, Inc. Dispositif intragastrique à auto-dégonflage
CN116603067A (zh) * 2023-05-22 2023-08-18 张勤生 一种温度诱导梯度自产气组合物及其应用
CN116602807A (zh) * 2023-05-22 2023-08-18 张勤生 一种胶囊式自产气胃减容减重气囊

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