CN118787730A - Medicine for wound healing and preparation method thereof - Google Patents
Medicine for wound healing and preparation method thereof Download PDFInfo
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- CN118787730A CN118787730A CN202310381637.9A CN202310381637A CN118787730A CN 118787730 A CN118787730 A CN 118787730A CN 202310381637 A CN202310381637 A CN 202310381637A CN 118787730 A CN118787730 A CN 118787730A
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Abstract
The invention provides a pharmaceutical composition for wound healing, in particular to application of interleukin-22 (IL-22) in preparation of a composition or a preparation for wound healing. The inventor surprisingly discovers that the addition of IL-22 can improve the healing rate of the wound surface, shorten the time for healing the wound surface, and is especially suitable for healing the cut wound surface, the burn wound surface and the chronic wound surface, thus being very suitable for preparing the medicine for healing the wound surface.
Description
Technical Field
The invention relates to the field of biological medicine, in particular to a medicine for wound healing and a preparation method thereof.
Background
Wound healing refers to the healing process of the body after the body is subjected to the action of external force and the tissues such as skin are separated or damaged, and comprises the complex combination of regeneration of various tissues and granulation tissue proliferation and scar tissue formation, and the synergistic effect of various processes is shown. The extent of the injury and the regenerative capacity of the tissue determine the manner of repair, the time of healing and the size of the scar. Therefore, the therapeutic principle is to reduce the wound surface (such as a involuted wound), prevent re-injury and promote tissue regeneration as soon as possible.
At present, most of the centralized research on the effect of the growth factors on wound surfaces which are damaged by healing at home and abroad can accelerate the healing of the wound surfaces which are difficult to heal by diabetes, malnutrition, infection, steroid, chemotherapeutics, radiotherapy and the like, but the human body is a complex organism, and the growth factors required by the wound surfaces are not isolated but are mutually intersected. Thus, there is a need in the art to provide more products for wound repair.
Disclosure of Invention
The invention aims to provide a medicine for wound healing and a preparation method thereof.
In a first aspect of the present invention, there is provided a pharmaceutical composition for wound healing, the pharmaceutical composition comprising, or consisting of:
a) Interleukin-22 (IL-22);
b) The cream used as a drug carrier is formed by compounding an oil phase solvent and an aqueous phase solvent; wherein, the mass percentage of the IL-22 in the medicine is as follows: 1-10wt%.
In another preferred embodiment, the mass percentage of the IL-22 in the medicament is 2-7wt%.
In another preferred embodiment, the IL-22 is derived from T cells activated during inflammation.
In another preferred embodiment, the oil phase solvent consists of:
In another preferred embodiment, the oil phase solvent consists of:
In another preferred embodiment, the aqueous phase solvent consists of the following components by volume:
150-300 parts of cream emulsifying agent
20-150 Parts of glycerol
2-20 Parts of nipagin alcohol.
In another preferred embodiment, the aqueous phase solvent consists of the following components by volume:
215-250 parts of cream emulsifying agent
Glycerin 50-100 parts
5-15 Parts of nipagin alcohol.
In another preferred embodiment, the pharmaceutical composition comprises:
In a second aspect of the present invention there is provided a method of preparing a pharmaceutical composition as described in the first aspect, the method comprising the steps of:
a) Preparing an oil phase;
b) Preparing a water phase;
c) Mixing said oil phase and said water phase to form a cream;
d) Adding IL-22 to the cream obtained in step c) to obtain the pharmaceutical composition.
In another preferred embodiment, the method comprises the steps of:
a) Mixing stearic acid, oleum Armeniacae amarum, vaseline, grape seed base oil, and isopropyl myristate (IPM) to obtain oil phase solvent;
b) Mixing the cream emulsifying agent, glycerol and nipagin alcohol to prepare an aqueous phase solvent;
c) Mixing and stirring the oil phase solvent and the water phase solvent of the step a) and the step b) to form a mixed solution; and
D) Adding IL-22 solution into the mixed solution at 30-50deg.C to obtain medicine or preparation containing IL-22.
In another preferred embodiment, the concentration of the nipagin alcohol is 3% -7% by mass.
In another preferred embodiment, the medicament or formulation is for wound healing.
In a third aspect of the present invention there is provided the use of a pharmaceutical composition according to the first aspect for wound healing selected from the group consisting of: a cut wound, a burn wound, a chronic wound, or a combination thereof.
In another preferred embodiment, the chronic wound is a wound with a lesion of more than 6 weeks.
In another preferred embodiment, the chronic wound comprises: chronic wound surface of diabetes, pressure sore, radiotherapy wound surface of cancer patient or their combination.
In another preferred example, the wound healing comprises improving the wound healing rate, shortening the wound healing time and improving the wound healing quality.
It is understood that within the scope of the present invention, the above-described technical features of the present invention and technical features specifically described below (e.g., in the examples) may be combined with each other to constitute new or preferred technical solutions. And are limited to a space, and are not described in detail herein.
Drawings
FIG. 1 shows the IL-22 cream of the invention promoting healing of cut wounds;
FIG. 2 shows the IL-22 cream of the invention promoting healing of burn wounds;
FIG. 3 shows how the IL-22 cream of the invention promotes the healing of diabetic chronic wounds.
Detailed Description
The inventor provides a medicine for wound healing through extensive and intensive research and extensive screening and testing. The inventor surprisingly discovers that the addition of IL-22 can improve the healing rate of the wound surface, shorten the time for healing the wound surface, and is especially suitable for healing the cut wound surface, the burn wound surface and the chronic wound surface, thus being very suitable for preparing the medicine for healing the wound surface. The present invention has been completed on the basis of this finding.
Terminology
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
As used herein, when used in reference to a specifically recited value, the term "about" means that the value can vary no more than 1% from the recited value. For example, as used herein, the expression "about 100" includes 99 and 101 and all values therebetween (e.g., 99.1, 99.2, 99.3, 99.4, etc.).
As used herein, the term "comprising" or "including" can be open, semi-closed, and closed. In other words, the term also includes "consisting essentially of …", or "consisting of …".
As used herein, the term "room temperature" or "normal temperature" refers to a temperature of 4-40 ℃, preferably 25±5 ℃.
Active ingredient
Interleukin-22 (IL-22) is a cytokine produced by activated T cells during inflammation, and affects primarily epithelial cells, hepatocytes, pancreatic acinar cells, and related stem cells through its transmembrane receptor complex consisting of IL-22 receptor 1 (IL-22R 1) and IL-10R 2. IL-22 has been shown to have an effect in promoting tissue regeneration healing in a variety of diseases including liver disease, pancreatic disease, ulcerative colitis, and skin injury.
In the invention, the addition of IL-22 can improve the healing rate of the wound surface and shorten the time for healing the wound surface, and is particularly suitable for healing the cut wound surface, the burn wound surface and the chronic wound surface and very suitable for preparing the medicine for healing the wound surface.
Pharmaceutical composition and use
The pharmaceutical composition of the invention comprises the active ingredients and a pharmaceutically acceptable carrier.
Experiments prove that the active ingredient of the invention can improve the wound healing rate, shorten the wound healing time, and particularly can obviously improve the repair of chronic difficult-to-heal wound, thereby being very suitable for preparing medicines for wound repair.
In the invention, the wound surface refers to a wound formed by the damage of the skin or the loss of skin tissues caused by external factors on the skin of a human body, and the wound surface repair is wound repair. Wounds can be generally classified into acute wounds and chronic wounds according to the healing time. Acute wound mainly refers to sudden injury (such as wound within 7 days after injury), such as abrasion, scratch, puncture, etc.; chronic wound refers to various reasons that acute wound cannot heal according to the normal physiological mechanism of the organism, the wound is not healed, and the reasons for chronic wound include (but are not limited to): lesions caused by pressure causes (such as bedsores), ulcers caused by varicose veins or insufficient arterial blood supply, diabetic ulcers, etc.; or atypical wound surface caused by skin soft tissue infection, vascular inflammation, connective tissue disease, tumor, etc.
Preferably, the wound surface is selected from the group consisting of: cut wound surface, burn wound surface and chronic wound surface.
Cutting wound surface: the cut wound surface is a common wound surface type, and refers to the skin, subcutaneous tissue or deep tissue which is scratched by sharp devices such as a slide, a blade and the like to generate breakage and laceration, so that the wound is tidy, the area is small, but the bleeding is more.
Burn wound surface: the skin tissue is directly or indirectly burned by flame, heat and other external substances; after the heat source is removed, the heat remained on clothes and skin continuously acts on skin tissues, so that the damage degree of burn wound tissues is continuously deepened, and normal tissues are continuously destroyed. Only the data of Shanghai Ruijin hospital burn department show that the number of emergency burn patients is 8-10 ten thousand times per year, and the average number of burn patients is about 250 per day
Chronic wound: wound surface with injury over 6 weeks. Characterized by granulation hyperplasia and wound scar shrinkage. Such as pressure sores, venous ulcers, diabetic ulcers, and the like. The application is characterized by the chronic wound surface of diabetes mellitus, and research is carried out.
In certain embodiments, the pharmaceutical compositions of the present invention may be in solid or liquid form, and in particular, the inventors have found that since interleukin-22 is easily degraded in liquid formulations, optimal therapeutic effects may be achieved when prepared in solid dosage forms, particularly in the case of creams as in the present invention.
The invention also provides a treatment method, which comprises the following steps: the active ingredient described in the present invention is administered to a subject in need of treatment, or the pharmaceutical composition described in the present invention is administered for wound repair.
The main advantages of the invention include:
The invention provides an application of interleukin-22 (IL-22) in preparing a composition or a preparation for wound healing, which can be used for wound healing, has remarkable curative effect, can effectively promote wound healing, improve the wound healing rate, shorten the wound healing time, and has simple administration method, is economical and practical, thus being very suitable for preparing medicines for wound repair.
The invention is further described below in conjunction with the specific embodiments. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. The experimental methods, in which specific conditions are not noted in the following examples, are generally conducted under conventional conditions or under conditions recommended by the manufacturer. Percentages and parts are by weight unless otherwise indicated.
EXAMPLE 1 preparation of IL-22 cream
In this example, an IL-22 cream was prepared by adding IL-22 to a mixed reagent of an oil phase reagent and an aqueous phase reagent.
Preparing an oil phase reagent: stearic acid (60-100 g), sweet almond oil (120-160 ml), vaseline (13-18 g) grape seed base oil (10-20 ml), isopropyl myristate (IPM) (20-60 g);
Preparing an aqueous phase reagent: cream emulsifier (215-250 ml), glycerin (50-100 ml), nipagin alcohol (3% -7%) (5-15 ml), distilled water is supplemented to a predetermined volume;
The oil phase reagent and the water phase reagent are mixed with each other, and then are fully stirred, the temperature is reduced to 30-50 ℃, and the IL-22 solution is added, so that the concentration of the IL-22 is 2-7wt%, and the IL-22 cream is prepared.
EXAMPLE 2 wound healing Rate comparison
In this example, the efficacy of IL-22 cream and blank control cold cream in the model of wound on the circumcision, scald and back skin of diabetic mice was compared, and the possible mechanism was explored by pathological section and molecular experiments.
1. Animal model induction
1.1. Model of scalding: after C57BL/6J mice (8 weeks old) were acclimatized for one week, 200 ul/mouse was intraperitoneally injected with 1% sodium pentobarbital, and after anesthesia, the backs of the mice were dehaired with a shaver. After 2 round copper blocks with the same mass are heated in boiling water for 5 minutes, the round copper blocks are directly placed in a mouse dehairing area for 3 seconds, the mice are scalded without applying any pressure, and two scalding models are manufactured on the back of each mouse.
1.2. And (3) circular cutting model: after C57BL/6J mice (8 weeks old) were acclimatized for one week, 200 ul/mouse was intraperitoneally injected with 1% sodium pentobarbital, and after anesthesia, the backs of the mice were dehaired with a shaver. Molding the mice by using a circular cutter, and manufacturing 2 circular wound surfaces with the diameter of 0.5cm on the back of each mouse;
1.3 diabetic wound: similarly, 6-week-old spontaneous diabetes model mice (db/db mice) were kept for 2 weeks, and after 8 weeks, the blood glucose level of the mice was measured to be between 20mmol/L and 40mmol/L, and the test was continued for one week, which indicated that the diabetes model was successful, and after 4 weeks of further keeping, a circular cut simulated cut model was made on the back.
2. Animal intervention
Cut wound, burn and diabetes chronic wound, each group has 6 wounds, and the intervention is as follows:
control: control group, blank cream without IL-22 added;
Gf group: using an interleukin-22 spray to spray on a wound surface, wherein the group of samples are prepared by dissolving IL-22 in physiological saline to form a solution, wherein the concentration of the IL-22 is the same as that of the ointment of the application;
il-22 cream: uniformly coating on the surface of a wound surface;
The above 3 intervention modes are all used every other day until the wound heals.
3. Wound healing assessment
3.1. The area of the wound surface and the eschar area were analyzed using Adobe Photoshop 2022 and Image-J software, and the percentage of the eschar area to the scald/annular wound surface area was calculated and the differences between the groups were compared.
3.2. At 0,3,5,7 days post-molding, animals were sacrificed using an excess sodium pentobarbital injection. The edge skin tissue is taken and fixed in 10% formalin solution for at least 24h, paraffin embedded and cut into 4um thick sections. HE staining was then performed (short Tian Shengwu, china) using standard procedures. HE sections were panoramically photographed using CASEVIEWER 2.0.0 software (3D Histech) and examined for infiltration of inflammatory cells in skin tissue.
4. Experimental results
4.1IL-22 promotes healing of cut wounds
As shown in FIG. 1, the healing speed of the cut wound surface of the mice after IL-22 cold cream treatment is obviously faster than that of the control group (controls) and GF group, and the wound surface area has obvious statistical difference (p < 0.05) at the eighth day.
4.2IL-22 promotes healing of cut burn wounds
As shown in FIG. 2, the healing rate of the burn wound of the mice after IL-22 cold cream treatment is obviously faster than that of the control group (controls) and GF group, and the mice have obvious statistical difference (p < 0.05) at the 16 th day.
4.3IL-22 promotes healing of diabetic chronic wounds
As shown in FIG. 3, after IL-22 cold cream treatment, dbdb mice (spontaneous diabetes mice) had significantly faster cut wound healing rates than the control (controls) and GF groups, with significant statistical differences in wound healing rates (p < 0.05) at days 8 and 14.
Experiments prove that the IL-22 cream can play a role in regenerating and healing skin injury tissues, has a positive promoting effect on healing of cut wounds, burn wounds and chronic wounds, is very suitable for preparing medicines for healing wounds, and can remarkably improve the healing condition of the wounds especially in the case of preparing the cream.
All documents mentioned in this disclosure are incorporated by reference in this disclosure as if each were individually incorporated by reference. Further, it will be appreciated that various changes and modifications may be made by those skilled in the art after reading the above teachings, and such equivalents are intended to fall within the scope of the application as defined in the appended claims.
Claims (10)
1. A pharmaceutical composition for wound healing, characterized in that the pharmaceutical composition comprises or consists of the following components:
a) Interleukin-22 (IL-22);
b) The cream used as a drug carrier is formed by compounding an oil phase solvent and an aqueous phase solvent; wherein, the mass percentage of the IL-22 in the medicine is as follows: 1-10wt%.
2. The pharmaceutical composition of claim 1, wherein the IL-22 is present in the drug in an amount of 2-7wt%.
3. The pharmaceutical composition of claim 1, wherein the oil phase solvent consists of:
4. The pharmaceutical composition of claim 1, wherein the oil phase solvent consists of:
5. the pharmaceutical composition of claim 1, wherein the aqueous phase solvent consists of the following components by volume:
150-300 parts of cream emulsifying agent
20-150 Parts of glycerol
2-20 Parts of nipagin alcohol.
6. The pharmaceutical composition of claim 1, wherein the aqueous phase solvent consists of the following components by volume:
215-250 parts of cream emulsifying agent
Glycerin 50-100 parts
5-15 Parts of nipagin alcohol.
7. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises:
8. a method of preparing a pharmaceutical composition according to any one of claims 1 to 7, comprising the steps of:
a) Preparing an oil phase;
b) Preparing a water phase;
c) Mixing said oil phase and said water phase to form a cream;
d) Adding IL-22 to the cream obtained in step c) to obtain the pharmaceutical composition.
9. The method of preparing as claimed in claim 8, wherein the method comprises the steps of:
a) Mixing stearic acid, oleum Armeniacae amarum, vaseline, grape seed base oil, and isopropyl myristate (IPM) to obtain oil phase solvent;
b) Mixing the cream emulsifying agent, glycerol and nipagin alcohol to prepare an aqueous phase solvent;
c) Mixing and stirring the oil phase solvent and the water phase solvent of the step a) and the step b) to form a mixed solution; and
D) Adding IL-22 solution into the mixed solution at 30-50deg.C to obtain medicine or preparation containing IL-22.
10. Use of a pharmaceutical composition according to any one of claims 1-7 for wound healing selected from the group consisting of: a cut wound, a burn wound, a chronic wound, or a combination thereof.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310381637.9A CN118787730A (en) | 2023-04-11 | 2023-04-11 | Medicine for wound healing and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310381637.9A CN118787730A (en) | 2023-04-11 | 2023-04-11 | Medicine for wound healing and preparation method thereof |
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