New material for rapidly repairing mucosal injury of digestive tract

Abstract

The invention relates to the technical field of biomedical materials, and discloses a new material for rapidly repairing mucosal lesions of digestive tracts, which is characterized in that the raw materials comprise a component A, a component B, a component C, a component D and auxiliary materials. Through the synergistic effect of various active components, the composition inhibits the release of inflammatory mediators, reduces oxidative stress injury, accelerates mucous membrane repair, shortens repair time, can maintain the complete form in a complex digestive tract environment, adopts radiation sterilization, avoids the influence of high temperature on the material and the active components, and has a good application prospect. The pore structure and the drug release rate are adjusted through the auxiliary materials, so that continuous release is realized.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedical materials, and in particular to a new material for rapidly repairing digestive tract mucosal damage. Background Art

[0002] Digestive tract mucosal injury is a common clinical pathological condition, which is common in peptic ulcers, inflammatory bowel disease, drug-induced injuries, etc. At present, the clinical treatment methods for digestive tract mucosal injury mainly include drug therapy and endoscopic treatment, but there are problems such as limited treatment effect, long recovery period, and easy recurrence. Therefore, the present invention aims to overcome these defects and provide a new material for rapid repair of digestive tract mucosal injury. Summary of the Invention

[0003] The purpose of the present invention is to provide a new material for quickly repairing digestive tract mucosal damage to solve the problems raised in the above background technology.

[0004] In order to solve the above technical problems, the present invention solves them through the following technical solutions: a new material for rapid repair of digestive tract mucosal damage, characterized in that the raw materials consist of component A, component B, component C, component D and auxiliary materials.

[0005] Preferably, the raw materials include the following components in weight percentage:

[0006] Component A: 15%-25%;

[0007] Component B: 10%-18%;

[0008] Component C: 8%-15%;

[0009] Component D: 5%-12%;

[0010] Excipients: 2%-3%.

[0011] Preferably, the component A is carboxymethyl chitosan, which is used to provide adhesion and form hydrogen bonds and ionic bonds with mucosal surface proteins, so that the material fits tightly to the damaged area. The component B is recombinant human epidermal growth factor, which promotes cell proliferation, differentiation and migration, accelerates mucosal repair, and significantly shortens the repair time.

[0012] Preferably, the component C is a curcumin-β-cyclodextrin inclusion complex, which is used to inhibit the release of inflammatory mediators, reduce oxidative stress damage, and protect cells. The component D is sodium alginate, which forms a gel network by combining with calcium ions to enhance the stability and mechanical strength of the material, so that the material maintains its morphological integrity in the complex environment of the digestive tract.

[0013] Preferably, the excipients are composed of polyethylene glycol-4000 and mannitol. Polyethylene glycol-4000 can effectively reduce the viscosity of the system, making the components more evenly mixed and facilitating the application of the material; while mannitol can adjust the pore structure of the material to achieve precise control of the drug release rate.

[0014] Preferably, the method comprises the following steps:

[0015] S1. Accurately weigh component A, component B, component C, and component D according to the above weight percentages, then add them to a sterile stirring container and mix at a stirring speed of 100-150 rpm for 20-30 minutes to achieve preliminary uniform dispersion of the components;

[0016] S2. Add excipients such as polyethylene glycol-4000 and mannitol, increase the stirring speed to 200-250 rpm, and continue stirring for 30-40 minutes to ensure that the excipients are fully integrated with the active ingredients;

[0017] S3. Transfer the mixed material to a high-pressure homogenizer for homogenization treatment. Perform 2-3 homogenization operations at a temperature of 40-50°C and a pressure of 20-30MPa, each lasting 5-8 minutes, to promote the refinement and uniform dispersion of material particles and improve material stability. Finally, sterilize the material to obtain the new material for rapid repair of digestive tract mucosal damage.

[0018] Preferably, during the homogenization process, the temperature is strictly controlled at 40-50°C. This temperature range can not only ensure that the material has good fluidity and facilitates the smooth homogenization operation, but also avoid the inactivation of active ingredients such as recombinant human epidermal growth factor due to excessively high temperature. The pressure is set to 20-30 MPa, which can effectively break up large particles in the material and form a stable and uniform dispersion system.

[0019] Preferably, the sterilization treatment adopts radiation sterilization. Compared with high-temperature sterilization, radiation sterilization will not have a significant impact on the physical and chemical properties and biological activity of the material, and can ensure the effectiveness and safety of the material.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] 1. The present invention inhibits the release of inflammatory mediators, reduces oxidative stress damage, accelerates mucosal repair, shortens repair time, and can maintain morphological integrity in the complex environment of the digestive tract. Radiation sterilization is used to avoid the impact of high temperature on materials and active ingredients, and the pore structure and drug release rate are adjusted by excipients to achieve sustained release. DETAILED DESCRIPTION

[0022] Unless the context clearly dictates otherwise, unmodified nouns and nouns modified by "the" include singular and plural referents.

[0023] As used in the specification and claims, the terms "comprises," "comprising," "having," "may," "containing," and variations thereof, as used herein, refer to open transitional phrases, terms, or words that require the presence of specified ingredients / steps and permit the presence of other ingredients / steps. However, such descriptions should be interpreted as also describing compositions or methods as "consisting of" and "consisting essentially of" the recited ingredients / steps, which permits the presence of only the specified ingredients / steps and any unavoidable impurities that may result therefrom, and excludes other ingredients / steps.

[0024] The numerical values ​​in the specification and claims of this application should be understood to include the same value when reduced to the same number of significant figures and values ​​that differ from the stated value by less than the experimental error of ordinary measurement techniques of the type described in this application for determining the stated value.

[0025] All ranges disclosed herein are inclusive of the stated endpoints and are independently combinable (eg, the range of "2 grams to 10 grams" includes the endpoints 2 grams and 10 grams, and all intermediate values).

[0026] The terms "about" and "approximately" can be used to include any value that can vary without changing the basic function of the value. When used in conjunction with a range, "about" and "approximately" also disclose the range defined by the absolute values ​​of the two endpoints, for example, "about 2 to about 4" also discloses a range of "2 to 4". In general, the terms "about" and "approximately" can refer to ±10% of the indicated number. However, for temperature, the term "approximately" refers to ±1°C.

[0027] Unless expressly stated otherwise, percentages of elements are to be considered as percentages by weight of the alloy in question.

[0028] The present disclosure may refer to temperatures for certain method steps. It should be noted that these specifications generally refer to the temperature set by the heat source (such as a furnace), and not necessarily the temperature that the heated material must reach.

[0029] An embodiment of the present invention provides a new material for rapidly repairing digestive tract mucosal damage, characterized in that the raw materials consist of component A, component B, component C, component D and auxiliary materials.

[0030] Specifically, the raw materials include the following components in weight percentage:

[0031] Component A: 15%-25%;

[0032] Component B: 10%-18%;

[0033] Component C: 8%-15%;

[0034] Component D: 5%-12%;

[0035] Excipients: 2%-3%.

[0036] Specifically, component A is carboxymethyl chitosan, which is used to provide adhesion and form hydrogen bonds and ionic bonds with mucosal surface proteins, allowing the material to fit tightly to the damaged area. Component B is recombinant human epidermal growth factor, which promotes cell proliferation, differentiation and migration, accelerates mucosal repair, and significantly shortens the repair time.

[0037] Specifically, component C is a curcumin-β-cyclodextrin inclusion complex, which is used to inhibit the release of inflammatory mediators, reduce oxidative stress damage, and protect cells. Component D is sodium alginate, which forms a gel network by combining with calcium ions, enhancing the stability and mechanical strength of the material, allowing the material to maintain its morphological integrity in the complex environment of the digestive tract.

[0038] Specifically, the excipients are composed of polyethylene glycol-4000 and mannitol. Polyethylene glycol-4000 can effectively reduce the viscosity of the system, allowing for more uniform mixing of the components and facilitating material application. Mannitol can also regulate the pore structure of the material, enabling precise control of the drug release rate.

[0039] Specifically, the following steps are included:

[0040] S1. Accurately weigh component A, component B, component C, and component D according to the above weight percentages, then add them to a sterile stirring container and mix at a stirring speed of 100-150 rpm for 20-30 minutes to achieve preliminary uniform dispersion of the components;

[0041] S2. Add excipients such as polyethylene glycol-4000 and mannitol, increase the stirring speed to 200-250 rpm, and continue stirring for 30-40 minutes to ensure that the excipients are fully integrated with the active ingredients;

[0042] S3. Transfer the mixed material to a high-pressure homogenizer for homogenization. Perform 2-3 homogenization operations at a temperature of 40-50°C and a pressure of 20-30 MPa, each lasting 5-8 minutes, to promote the refinement and uniform dispersion of material particles and improve material stability. Finally, sterilize the material to obtain a new material for rapid repair of gastrointestinal mucosal damage.

[0043] Specifically, during the homogenization process, the temperature is strictly controlled at 40-50°C. This temperature range can not only ensure that the material has good fluidity and facilitates the smooth homogenization operation, but also avoid the inactivation of active ingredients such as recombinant human epidermal growth factor due to excessively high temperature. The pressure is set to 20-30MPa, which can effectively break up large particles in the material and form a stable and uniform dispersion system.

[0044] Specifically, the sterilization treatment adopts radiation sterilization. Compared with high-temperature sterilization, radiation sterilization will not have a significant impact on the physical and chemical properties and biological activity of the material, and can ensure the effectiveness and safety of the material.

[0045] The specific steps are as follows: first, 15%-25% of carboxymethyl chitosan, 10%-18% of recombinant human epidermal growth factor, 8%-15% of curcumin-β-cyclodextrin inclusion complex, and 5%-12% of sodium alginate are weighed by weight, and then added into a sterile stirring container, and mixed at a stirring speed of 100-150 rpm for 20-30 minutes to achieve preliminary uniform dispersion of the components, and then polyethylene glycol-4000 and mannitol and other excipients are added, and the stirring speed is increased to 200-250 rpm, and stirring is continued for 30-40 minutes to ensure that the excipients are fully integrated with the active components, and the mixture is transferred to a high-pressure homogenizer for homogenization treatment. At a temperature of 40-50°C and a pressure of 20-30 MPa, 2-3 homogenization operations are performed, each lasting 5-8 minutes, to promote the refinement and uniform dispersion of the material particles and improve the stability of the material, and finally sterilization is performed to obtain a new material for rapid repair of gastrointestinal mucosal damage.

[0046] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A new material for rapid repair of digestive tract mucosal damage, characterized in that: The raw materials consist of component A, component B, component C, component D and auxiliary materials.

2. A new material for rapid repair of digestive tract mucosal damage according to claim 1, characterized in that: The raw materials include the following components in weight percentage: Component A: 15%-25%; Component B: 10%-18%; Component C: 8%-15%; Component D: 5%-12%; Excipients: 2%-3%.

3. The new material for rapid repair of digestive tract mucosal damage according to claim 1, characterized in that: The component A is carboxymethyl chitosan, which is used to provide adhesion and form hydrogen bonds and ionic bonds with mucosal surface proteins, so that the material fits tightly to the damaged area. The component B is recombinant human epidermal growth factor, which promotes cell proliferation, differentiation and migration, accelerates mucosal repair, and significantly shortens the repair time.

4. The new material for rapid repair of digestive tract mucosal damage according to claim 1, characterized in that: The component C is a curcumin-β-cyclodextrin inclusion complex, which is used to inhibit the release of inflammatory mediators, reduce oxidative stress damage, and protect cells. The component D is sodium alginate, which forms a gel network by combining with calcium ions to enhance the stability and mechanical strength of the material, allowing the material to maintain its morphological integrity in the complex environment of the digestive tract.

5. The new material for rapid repair of digestive tract mucosal damage according to claim 1, characterized in that: The excipients are composed of polyethylene glycol-4000 and mannitol. The polyethylene glycol-4000 effectively reduces the viscosity of the system, allowing for more uniform mixing of the components and facilitating material application. Mannitol, on the other hand, regulates the pore structure of the material, enabling precise control of the drug release rate.

6. A new material for rapid repair of digestive tract mucosal damage according to claim 1, characterized in that: The following steps are involved: S1. Accurately weigh component A, component B, component C, and component D according to the above weight percentages, then add them to a sterile stirring container and mix at a stirring speed of 100-150 rpm for 20-30 minutes to achieve preliminary uniform dispersion of the components; S2. Add excipients such as polyethylene glycol-4000 and mannitol, increase the stirring speed to 200-250 rpm, and continue stirring for 30-40 minutes to ensure that the excipients are fully integrated with the active ingredients; S3. Transfer the mixed material to a high-pressure homogenizer for homogenization treatment. Perform 2-3 homogenization operations at a temperature of 40-50°C and a pressure of 20-30MPa, each lasting 5-8 minutes, to promote the refinement and uniform dispersion of material particles and improve material stability. Finally, sterilize the material to obtain the new material for rapid repair of digestive tract mucosal damage.

7. The new material for rapid repair of digestive tract mucosal damage according to claim 1, characterized in that: During the homogenization process, the temperature is strictly controlled at 40-50°C. This temperature range can not only ensure that the material has good fluidity and facilitates the smooth homogenization operation, but also avoid the inactivation of active ingredients such as recombinant human epidermal growth factor due to excessively high temperature. The pressure is set to 20-30MPa, which can effectively break up large particles in the material and form a stable and uniform dispersion system.

8. The new material for rapid repair of digestive tract mucosal damage according to claim 1, characterized in that: The sterilization treatment adopts radiation sterilization. Compared with high-temperature sterilization, radiation sterilization will not have a significant impact on the physical and chemical properties and biological activity of the material, and can ensure the effectiveness and safety of the material.