WO2022236957A1 - Procédé de préparation d'un hydrogel à rétention gastrique de type gonflant destiné à une intervention contre l'obésité - Google Patents
Procédé de préparation d'un hydrogel à rétention gastrique de type gonflant destiné à une intervention contre l'obésité Download PDFInfo
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- WO2022236957A1 WO2022236957A1 PCT/CN2021/107110 CN2021107110W WO2022236957A1 WO 2022236957 A1 WO2022236957 A1 WO 2022236957A1 CN 2021107110 W CN2021107110 W CN 2021107110W WO 2022236957 A1 WO2022236957 A1 WO 2022236957A1
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- hydrogel
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- swelling
- gastric
- obesity
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Images
Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F251/00—Macromolecular compounds obtained by polymerising monomers on to polysaccharides or derivatives thereof
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F289/00—Macromolecular compounds obtained by polymerising monomers on to macromolecular compounds not provided for in groups C08F251/00 - C08F287/00
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the invention belongs to the technical field of hydrogel materials and physical therapy for obesity intervention, and relates to a preparation method of a swellable gastric retention hydrogel for obesity intervention.
- obesity intervention methods mainly include improving living habits, drug treatment and surgical treatment.
- improving lifestyle habits alone has limited effect on morbid obesity.
- drug therapy has a certain therapeutic effect, it is often accompanied by certain side effects, such as vomiting, diarrhea and endocrine disorders.
- Surgical treatment can effectively reduce weight, but it is not the first choice for obesity treatment due to its large trauma and long recovery period. Therefore, there is an urgent need to develop low-side-effect, non-invasive obesity treatment methods.
- swellable gastric retention carrier for obesity intervention has become a new type of treatment plan.
- the principle is to use the swollen carrier to occupy part of the stomach volume, thereby reducing the patient's food intake.
- the carrier can slow down the emptying of food in the stomach and reduce the patient's desire to eat, thereby achieving weight loss.
- An ideal obesity intervention carrier needs to be swellable, mechanically stable, and degradable to ensure the therapeutic effect and avoid potential risks (such as intestinal obstruction).
- Hydrogel has good biocompatibility and hydrophilicity. Due to its high water content, drying and dehydration can rapidly reduce the volume of the hydrogel carrier, and the hydrogel carrier can quickly expand after absorbing water again, thus realizing the hydrogel gastric retention applications.
- hydrogels such as hydroxypropyl methylcellulose, cellulose, and xanthan gum have the ability to swell in gastric juice and can be degraded and excreted.
- these hydrogels have weak cross-linking strength and mechanical properties, and lack the ability to resist gastric pressure and gastric acid erosion. Therefore, the system has a short residence time and cannot achieve long-term gastric retention.
- researchers try to develop high-strength hydrogels, but high-strength hydrogels face a contradiction between swelling performance and mechanical stability. This is mainly because the mechanical properties of the hydrogel are positively correlated with the molecular chain density, and water swelling will reduce the molecular chain density of the hydrogel, resulting in poor mechanical stability of the gel.
- the invention provides a preparation method of a swellable gastric retention hydrogel for obesity intervention.
- This method can prepare a hydrogel with both swelling and mechanical stability, which can achieve long-term stable gastric retention, and achieve the purpose of obesity intervention by occupying gastric volume and reducing food intake through swelling.
- the hydrogel is biodegradable after staying for a predetermined time, ensuring the safety of discharge.
- a method for preparing a swellable gastric retention hydrogel for obesity intervention comprising the following steps:
- the first step is to prepare the gel precursor
- the material A includes one or a mixture of collagen, chitosan, polylysine, carboxymethyl cellulose, and gelatin, and its concentration is 0.5-50% (w/v).
- the material B includes sodium hyaluronate, sodium alginate, carrageenan, and sodium tripolyphosphate, or a mixture of two or more thereof, and its concentration is 0.5-50% (w/v).
- step 1.3) Add tetramethylethylenediamine and ammonium persulfate to the uniform mixed solution obtained in step 1.2), and stir at 4°C until uniformly obtained to obtain a mixed solution.
- concentration of tetramethylethylenediamine is 0.05- 2.5% (v/v).
- concentration of the ammonium persulfate is 0.05-2.5% (w/v), and the mass ratio of the ammonium persulfate to N,N'-bis(acryloyl)cystamine in step 1.1) is 1:1.
- the second step the formation of the first hydrogel network
- the first network formed is a polyacrylamide network containing disulfide bonds formed by the polymerization of acrylamide; the polyacrylamide network stays in the stomach through swelling, and the swelling mechanism is that the molecular chains are ionized and hydrolyzed in the gastric juice, and the hydrogel
- the ion concentration gradient and osmotic pressure between the gastric juice and the hydrogel swell, and hydrolysis can break the hydrogen bonds in the hydrogel network to promote swelling.
- the third step the formation of the second hydrogel network
- step 3.1) The single-network hydrogel cleaned in step 2.2) is placed in gastric juice, and material A and material B in step 1.2) spontaneously form a second network under gastric juice conditions.
- the second network is formed by ionic cross-linking reaction between material A and material B by gastric acid in gastric juice, the formation of the second network can make up for the molecular chain density reduced by the swelling of the first network, thereby maintaining stable mechanical properties, Achieve long-term gastric retention.
- the volume ratio of ethanol to deionized water is 1:4 ⁇ 1:1.
- the swellable gastric retention hydrogel obtained by the above preparation method can take into account high swelling performance and mechanical stability, and can realize the long-term retention of the hydrogel in the stomach by rapidly swelling and occupying the stomach volume, thereby achieving the purpose of obesity intervention.
- the hydrogel is designed as a double network, the first network can swell in gastric juice, and achieve the purpose of obesity intervention by occupying gastric volume and reducing food intake.
- the decrease in mechanical properties caused by swelling is compensated by the second network, which can be formed spontaneously in gastric juice, that is, a new network can be formed when the hydrogel swells to maintain molecular chain density and maintain mechanical stability.
- the hydrogel can be encapsulated in standard commercial edible capsules for oral administration, and rapidly swells in gastric juice, resisting gastric contraction with constant mechanical properties.
- the hydrogel can achieve long-term stable gastric retention, and the hydrogel can be biodegraded after staying in the stomach for a predetermined time, ensuring the safety of excretion, and is expected to be used for obesity intervention.
- the beneficial effects of the present invention are: the requirements for the instruments and equipment involved in the present invention are simple, the preparation process is simple and controllable, and easy to scale.
- the swollen hydrogel prepared by the invention can stay in the stomach for more than 15 days, and the mechanical properties remain stable during this period. At the same time, the swelling rate of the hydrogel is greater than 1000%, which can achieve both mechanical stability and swelling property. After long-term retention, the hydrogel is biodegradable, ensuring the safety of hydrogel discharge. Therefore, the hydrogel has potential for obesity intervention.
- Figure 1 is the compression performance curve of the hydrogel in Example 1 of the present invention in simulated gastric juice.
- Fig. 2 is an X-ray picture of the hydrogel in Example 1 of the present invention staying in the stomach of a rabbit for 19 days.
- the cylindrical hydrogel obtained by the present invention shrinks from 17 mm to 9.6 mm in diameter after being dried at normal temperature, which is similar to the diameter of No. 000 capsules and meets the requirements for oral administration. After 40 minutes of immersion in simulated gastric juice, the dried hydrogel swelled to the same diameter as the pylorus, indicating that the hydrogel could remain in the stomach within 2-3 hours of gastric emptying.
- FIG. 1 is the compression performance curve of the hydrogel in Example 1 of the present invention in simulated gastric juice, and the specific data are shown in Table 1.
- the stress of the prepared hydrogel is about 38kPa under the condition of 60% strain, and after immersion in simulated gastric juice for 30 days, its stress is about 45kPa, and the swelling rate can reach 1260%.
- the hydrogel can take into account high swelling rate and mechanical stability.
- Fig. 2 is an X-ray picture of the hydrogel prepared in Example 1 of the present invention staying in the stomach of a rabbit for 19 days. It can be seen from the picture analysis that the hydrogel can stay in the stomach for 16 days in a complete form, and then be degraded into fragments. When the size of the fragments is smaller than the diameter of the pylorus, it can be discharged out of the stomach until 19 days. is degraded. Therefore, the hydrogel can achieve long-term stable gastric retention and is biodegradable.
- the cylindrical hydrogel obtained by the present invention shrinks from 16mm to 9.6mm in diameter after being dried at normal temperature, which is similar to the diameter of No. 000 capsule and meets the oral requirements.
- the diameter of the dried hydrogel can be swelled to be consistent with the diameter of the pylorus after immersion in simulated gastric juice for 1 hour, indicating that the hydrogel can remain in the stomach during the gastric emptying time of 2 to 3 hours.
- the stress of the prepared hydrogel is about 45kPa under the condition of 60% strain, and after 30 days of immersion in simulated gastric juice, its stress is 87kPa, the mechanical properties are slightly increased, and the swelling rate can reach 1130%.
- the hydrogel can take into account high swelling rate and mechanical stability.
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Polymers & Plastics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- Mycology (AREA)
- Nutrition Science (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Medicinal Preparation (AREA)
Abstract
L'invention concerne un procédé de préparation d'un hydrogel à rétention gastrique de type gonflant destiné à une intervention contre l'obésité, qui appartient aux domaines techniques des matériaux du type hydrogel et de la thérapie physique par intervention contre l'obésité. L'hydrogel est conçu comme un double réseau pour avoir une bonne performance de gonflement et une bonne stabilité mécanique. Un premier réseau peut gonfler dans les sucs gastriques et permet d'atteindre le but d'une intervention contre l'obésité par occupation du volume de l'estomac et réduction de la quantité de la prise alimentaire. Un second réseau est utilisé pour compenser la dégradation de propriétés mécaniques provoquée par le gonflement du premier réseau. Le second réseau peut se former spontanément dans les sucs gastriques. En d'autres termes, l'hydrogel peut former un nouveau réseau tout en gonflant, ce qui permet de maintenir la densité des chaînes moléculaires et la stabilité mécanique. Les exigences liées au dispositif instrumental impliqué dans le procédé sont simples. Le procédé de préparation est simple, régulable et facile à mettre à l'échelle. L'hydrogel préparé peut être administré par voie orale, gonfle rapidement dans les sucs gastriques et a un taux de gonflement supérieur à 1000 %, et est retenu dans l'estomac pendant plus de 15 jours, période pendant laquelle les propriétés mécaniques sont maintenues stables. Après une rétention à long terme, l'hydrogel peut être biodégradable, ce qui permet d'assurer la sécurité de l'évacuation de l'hydrogel.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110527300.5 | 2021-05-14 | ||
| CN202110527300.5A CN113273692B (zh) | 2021-05-14 | 2021-05-14 | 一种用于肥胖干预的溶胀型胃滞留水凝胶的制备方法 |
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| WO2022236957A1 true WO2022236957A1 (fr) | 2022-11-17 |
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| WO2013103956A1 (fr) * | 2012-01-05 | 2013-07-11 | President And Fellows Of Harvard College | Réseaux imbriqués avec réticulations ioniques et covalentes |
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| CN106750398B (zh) * | 2016-11-25 | 2019-02-19 | 暨南大学 | 载药壳聚糖/海藻酸钠双重交联水凝胶及其制法和应用 |
| CN110835414A (zh) * | 2018-08-17 | 2020-02-25 | 天津大学 | 一种具有pH响应、生物可降解的高强度水凝胶及其制备方法和在胃填充剂中的应用 |
| CN109939066A (zh) * | 2019-03-06 | 2019-06-28 | 华南理工大学 | 基于功能化双网络的刺激响应水凝胶及其制备方法和应用 |
| CN112370417B (zh) * | 2020-11-20 | 2022-10-21 | 湖北科技学院 | 用于基胃滞留剂的双网络水凝胶的预辐射制备方法 |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030232895A1 (en) * | 2002-04-22 | 2003-12-18 | Hossein Omidian | Hydrogels having enhanced elasticity and mechanical strength properties |
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| CN113273692A (zh) | 2021-08-20 |
| CN113273692B (zh) | 2022-10-18 |
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