CN108261562A - A kind of Sodium Hyaluronate skin sparing film and its preparation method and application - Google Patents
A kind of Sodium Hyaluronate skin sparing film and its preparation method and application Download PDFInfo
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- CN108261562A CN108261562A CN201710684212.XA CN201710684212A CN108261562A CN 108261562 A CN108261562 A CN 108261562A CN 201710684212 A CN201710684212 A CN 201710684212A CN 108261562 A CN108261562 A CN 108261562A
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- sodium hyaluronate
- skin sparing
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- wound
- skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0023—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0028—Polypeptides; Proteins; Degradation products thereof
- A61L26/0047—Specific proteins or polypeptides not covered by groups A61L26/0033 - A61L26/0042
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/0066—Medicaments; Biocides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/23—Carbohydrates
- A61L2300/232—Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
Abstract
The present invention relates to field of medicaments, disclose one kind and can be used for the minimally invasive post-operative recovery barrier function of beauty, protect the surface of a wound, the Sodium Hyaluronate skin sparing film of healing environment is provided for the surface of a wound, it includes the following components in terms of mass concentration：The Sodium Hyaluronate of 5~20g/L, the recombinant human epidermal growth factor of 0.1~0.5mg/L, the glycerine of 10~30g/L, 0.1~1.0g/L pH adjusting agent, surplus is water for injection, wherein：The molecular weight of the Sodium Hyaluronate is 100~3,000,000 dalton.The covering of the Sodium Hyaluronate skin sparing film as wound in wound healing process, can substitute impaired skin and play temporary barrier action, avoid or control wound infection, be provided with the environment conducive to wound healing.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of skin sparing film and its preparation method and application.
Background technology
With the raising of social standard of living, people are higher and higher to beautiful pursuit, various beauty invasive surgery such as laser etc.
That applies is more and more extensive, and skin different degrees of injury is will also result in while beauty is brought to patient, influences skin screen
Hinder function, so as to cause erythema, even oedema, oozing of blood, furfur, pigmentation, cicatrization etc..Skin barrier is by skin
The common structures such as adipose membrane, cuticula keratin, " sandwich " structure of lipid, brick wall structure, corium mucopolysaccharide, mucopolysaccharide
Into, can resist extraneous noxious stimulus, daylight enter, while have moisturizing and adjust anti-inflammatory effect.Its function includes two aspects：
On the one hand maintain cuticle thickness, ensure structural intergrity, have to extraneous mechanicalness, it is physical, chemically, micro- life such as bacterium
The protective action of object damage；On the other hand water content of stratum corneum is maintained, skin surface adipose membrane is formed, endotrophic object can be prevented
The loss of matter, moisture etc. maintains cutaneous immunisation function.The principle for restoring skin barrier function is to cover one layer of life in skin surface
Object protective film forms package effect, externally resists the injury of extraneous poor environment, bacterium, sensitization source to skin, and it is anti-to reduce inflammation
It should；The complete of moisture, the water for maintaining skin and effect is internally prevented, enhancing stratum corneum flexibility, restores epidermal barrier function, adjust
Epidermis sebum synthesis.
Sodium Hyaluronate is widely present in tissue and cell, is to form human body cell epimatrix and cellular informatics biography
Pass the important component of proteoglycans chain.The good hygroscopicity that Sodium Hyaluronate has, absorbs large quantity of moisture in a dry environment,
In a humid environment, moisture absorption can be automatically reduced, the water content to keep relative stability.Sodium Hyaluronate is polyphosphazene polymer
Object is closed, there is very strong lubricity and film forming, thin film is formed in skin surface, is allowed to generate good smooth and moistening
Sense is played the role of protecting skin.In addition it forms natural aquation envelope barrier in skin surface, can effectively stop bacterium and invades
Enter, generate antibacterial and anti-inflammation functions indirectly.In addition, hyaluronic acid by cell adhesion together, cell metabolism of bringing into normal play and tissue
The effect of water holding makes Skin Cell from invading pathogens, prevents from infecting.
HEGF be the fifties in last century by Cohen and Montalcini when studying mouse nerve growth factor
It was found that a kind of peptide growth factor, be made of 53 amino acid, have the function of widely to stimulate cellular proliferation, exist in recent years
The domestic and international natural epidermal growth factor with recombination has been applied in the clinical medical of cornea, skin injury and gastroenteritic ulcer.
HEGF can enhance movement, merisis and the cytoplasm albumen synthesis capability of cell, promote neovascularization
And the synthesis of nucleic acid, protein, so as to promote the healing of all kinds of surface of a wound by the synthesis of hyperblastosis and important cells interstitial.
Invention content
The problems such as in order to solve fast quick-recovery barrier function and the effective protection surface of a wound after beauty invasive surgery, the present invention mainly carries
One kind has been supplied to can be used for the minimally invasive post-operative recovery barrier function of beauty, has protected the surface of a wound, the hyalomitome of healing environment is provided for the surface of a wound
Sour sodium skin sparing film and its application as the covering of wound, in wound healing process, can substitute impaired skin
Temporary barrier action is played, avoids or control wound infection, is provided with the environment conducive to wound healing.
To achieve these goals, the present invention uses following technical proposal：
A kind of Sodium Hyaluronate skin sparing film, includes the following component in terms of mass concentration：The hyalomitome of 5~20g/L
Sour sodium, the recombinant human epidermal growth factor of 0.1~0.5mg/L, the glycerine of 10~30g/L and 0.1~1.0g/L pH adjusting agent,
Surplus is water for injection.
Preferably, Sodium Hyaluronate skin sparing film of the present invention, wherein, the molecular weight of the Sodium Hyaluronate is
100~3,000,000 dalton.
Preferably, Sodium Hyaluronate skin sparing film of the present invention, wherein, the Sodium Hyaluronate is from animal tissue
Extraction is produced by bacterial fermentation process.
Preferably, Sodium Hyaluronate skin sparing film of the present invention, wherein, the pH adjusting agent is phosphate, citron
It is one or more in hydrochlorate, sodium hydroxide and hydrochloric acid.
A kind of preparation method of Sodium Hyaluronate skin sparing film, includes the following steps：
(1) various components are weighed according to the dosage in formula；
(2) glycerine and pH adjusting agent are added in water for injection, aseptic filtration and high pressure is carried out after being completely dissolved
Steam sterilizing obtains protection membrane matrix；
(3) the protection membrane matrix obtained in step (2) is cooled down, under clean environment, added into the protection membrane matrix
Enter Sodium Hyaluronate and recombinant human epidermal growth factor, and stirred or shaken, until Sodium Hyaluronate is completely dissolved, obtain
Sodium Hyaluronate skin sparing film.
Preferably, the preparation method of Sodium Hyaluronate skin sparing film of the present invention, wherein, in the step (2)
Aseptic filtration using sterilized 0.22 μm of filter core complete；Wherein, the temperature of high pressure steam sterilization is 121 DEG C, the time 30
Minute.
Preferably, the preparation method of Sodium Hyaluronate skin sparing film of the present invention, wherein, in the step (3)
Stirring is completed using agitator tank, and mixing speed is in 200rpm hereinafter, 25 DEG C~40 DEG C of whipping temp；The shaking is using shaking table
It completes, shake speed is in 180rpm hereinafter, 25 DEG C~40 DEG C of temperature of shaking.
In a preferred embodiment, above-mentioned preparation method further include by the Sodium Hyaluronate skin sparing film without
Bacterium it is filling into preparation the step of.
The Sodium Hyaluronate skin sparing film of the present invention is in the minimally invasive post-operative recovery barrier function of beauty, the protection surface of a wound and is
The surface of a wound provides the application in healing environment.
The present invention devises Sodium Hyaluronate and the Sodium Hyaluronate skin of recombinant human epidermal growth factor optimum ratio is protected
Cuticula suitable for the minimally invasive post-operative recovery barrier function of beauty, protects the surface of a wound, healing environment is provided for the surface of a wound.It is the result shows that transparent
Matter acid sodium skin sparing film, which has the diseases such as the erythema, pain, the drying that occur after beauty invasive surgery, to be obviously improved, and is had safely
Effect, has good application prospect in medical cosmetology field.
There are following advantages using the present invention of above-mentioned technical proposal：
The polymer hyaluronic acid sodium raw materials of present invention selection high concentration are aided with the recombinant human epidermal factor, glycerine and pH and adjust
Agent and water for injection composition, are that have passed through to grope many experiments that product formula matches and obtain.Low molecular weight it is transparent
Matter acid is only capable of being formed in low concentration the reticular structure of fragment shape, and can to form covering whole for the hyaluronan molecule of high molecular weight
The reticular structure of a system.High concentration polymer hyaluronic acid sodium solution has stronger film forming, can be formed in wound surface
Natural protection envelope barrier, resists the injury of extraneous bacterium, sensibiligen, prevents from infecting, generates antibacterial and anti-inflammation functions indirectly.It is transparent
Skin wound healing can be obviously promoted after adding recombinant human epidermal growth factor in matter acid sodium solution, the startup surface of a wound is contributed to repair
It is multiple, accelerate wound healing.
Specific embodiment
Further description, but following implementation are made to the technical solution in the present invention below in conjunction with specific embodiments
Example should not be considered as limiting protection scope of the present invention.Other than specified otherwise, instrument used in the following example,
Reagent, material etc. can be obtained by conventional commercial means.
Embodiment 1
A kind of Sodium Hyaluronate skin sparing film and preparation method thereof：
(1) water for injection 1000mL is added in container, then adds in glycerine 10g, disodium hydrogen phosphate 0.50g, phosphorus
Acid dihydride sodium 0.15g carries out aseptic filtration with sterilized 0.22 μm of filter core after being completely dissolved, is placed in high-pressure steam sterilizing pan
In in 121 DEG C sterilize 30 minutes, obtain protection membrane matrix；
(2) said protection film matrix is cooled down, under hundred grades of cleanliness factor environment, protection membrane matrix is first added to agitator tank
In, it is Sodium Hyaluronate degerming the dry powder 5.0g and 0.1mg of 2,860,000 dalton under 25 DEG C of heat-retaining conditions, then by molecular weight
Recombinant human epidermal growth factor is slowly added in agitator tank, and mixing speed is slowly improved to 200rpm, until Sodium Hyaluronate is complete
Fully dissolved obtains Sodium Hyaluronate skin sparing coating solution；
(3) it is aseptically that the progress of above-mentioned solution is filling, it is filling after the completion to get Sodium Hyaluronate skin sparing
Film.
Embodiment 2
A kind of Sodium Hyaluronate skin sparing film and preparation method thereof：
(1) water for injection 1000mL is added in container, then adds in glycerine 20g, disodium hydrogen phosphate 0.50g, phosphorus
Acid dihydride sodium 0.15g carries out aseptic filtration with sterilized 0.22 μm of filter core after being completely dissolved, is placed in high-pressure steam sterilizing pan
In in 121 DEG C sterilize 30 minutes, obtain protection membrane matrix；
(2) said protection film matrix is cooled down, under hundred grades of cleanliness factor environment, protection membrane matrix is first added to agitator tank
In, it is Sodium Hyaluronate degerming the dry powder 10.0g and 0.3mg of 2,040,000 dalton under 25 DEG C of heat-retaining conditions, then by molecular weight
Recombinant human epidermal growth factor is slowly added in agitator tank, and mixing speed is slowly improved to 200rpm, until Sodium Hyaluronate is complete
Fully dissolved obtains Sodium Hyaluronate skin sparing coating solution；
(3) it is aseptically that the progress of above-mentioned solution is filling, it is filling after the completion to get Sodium Hyaluronate skin sparing
Film.
Embodiment 3
A kind of Sodium Hyaluronate skin sparing film and preparation method thereof：
(1) water for injection 1000mL is added in container, then adds in glycerine 30g, disodium hydrogen phosphate 0.50g, phosphorus
Acid dihydride sodium 0.15g carries out aseptic filtration with sterilized 0.22 μm of filter core after being completely dissolved, is placed in high-pressure steam sterilizing pan
In in 121 DEG C sterilize 30 minutes, obtain protection membrane matrix；
(2) said protection film matrix is cooled down, under hundred grades of cleanliness factor environment, protection membrane matrix is first added to agitator tank
In, it is Sodium Hyaluronate degerming the dry powder 20.0g and 0.5mg of 1,160,000 dalton under 25 DEG C of heat-retaining conditions, then by molecular weight
Recombinant human epidermal growth factor is slowly added in agitator tank, and mixing speed is slowly improved to 200rpm, until Sodium Hyaluronate is complete
Fully dissolved obtains Sodium Hyaluronate skin sparing coating solution；
(3) it is aseptically that the progress of above-mentioned solution is filling, it is filling after the completion to get Sodium Hyaluronate skin sparing
Film.
4 properties of product of embodiment detect
Random, double blind control research method is taken, selects patient after 80 laser surgeys, the production of embodiment 1 to 3 is respectively adopted
Product are test group and to have listed medical skin to repair product be that control group is treated, under conditions of constant temperature and humidity, using moral
CK companies of state Multi probe skin measurement system detection skin transepidermal water loss testing result amount and water content of stratum corneum, testing result are shown in
Table 1.The transepidermal water loss amount of skin is higher after laser surgey, and water content of stratum corneum is relatively low, the barrier function damage of skin.By repairing
Test group has improvement with the skin barrier function that control group is damaged after multiple treatment, and the repairing effect of test group is particularly evident.
1 embodiment 1-3 of table and control group skin transepidermal water loss amount and water content of stratum corneum results contrast
Embodiment described above is only that the preferred embodiment of the present invention is described, not to the model of the present invention
It encloses and is defined, under the premise of design spirit of the present invention is not departed from, those of ordinary skill in the art are to the technical side of the present invention
The various modifications and improvement that case is made should all be fallen into the protection domain that claims of the present invention determines.
Claims (9)
1. a kind of Sodium Hyaluronate skin sparing film, which is characterized in that include the following component in terms of mass concentration：5~20g/L
Sodium Hyaluronate, the recombinant human epidermal growth factor of 0.1~0.5mg/L, the glycerine of 10~30g/L and 0.1~1.0g/L
PH adjusting agent, surplus are water for injection.
2. Sodium Hyaluronate skin sparing film according to claim 1, it is characterised in that：The molecular weight of the Sodium Hyaluronate
For 100~3,000,000 dalton.
3. Sodium Hyaluronate skin sparing film according to claim 2, it is characterised in that：The Sodium Hyaluronate is from animal groups
It knits middle extraction or is produced by bacterial fermentation process.
4. Sodium Hyaluronate skin sparing film according to claim 3, it is characterised in that：The pH adjusting agent for phosphate,
It is one or more in citrate, sodium hydroxide and hydrochloric acid.
5. the preparation method of any one of the claim 1-4 Sodium Hyaluronate skin sparing films, which is characterized in that including following
Step：
(1) various components are weighed according to the dosage in formula；
(2) glycerine and pH adjusting agent are added in water for injection, aseptic filtration and high steam is carried out after being completely dissolved
Sterilizing obtains protection membrane matrix；
(3) the protection membrane matrix obtained in step (2) is cooled down, under clean environment, is added in into the protection membrane matrix saturating
Bright matter acid sodium and recombinant human epidermal growth factor, and stirred or shaken, until Sodium Hyaluronate is completely dissolved, obtain transparent
Matter acid sodium skin sparing film.
6. the preparation method of Sodium Hyaluronate skin sparing film according to claim 5, it is characterised in that：The step (2)
In aseptic filtration using sterilized 0.22 μm of filter core complete；Wherein, the temperature of high pressure steam sterilization is 121 DEG C, and the time is
30 minutes.
7. the preparation method of Sodium Hyaluronate skin sparing film according to claim 6, it is characterised in that：The step (3)
In stirring completed using agitator tank, mixing speed is in 200rpm hereinafter, 25 DEG C~40 DEG C of whipping temp；The shaking uses
Shaking table is completed, and shake speed is in 180rpm hereinafter, 25 DEG C~40 DEG C of temperature of shaking.
8. the preparation method of Sodium Hyaluronate skin sparing film according to claim 7, it is characterised in that：The preparation method
The step of further including Sodium Hyaluronate skin sparing film sterile filling into preparation.
9. any one of the claim 1-4 Sodium Hyaluronate skin sparing films are in the minimally invasive post-operative recovery barrier function of beauty, guarantor
The shield surface of a wound and application in healing environment is provided for the surface of a wound.
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| CN201710684212.XA CN108261562A (en) | 2017-08-11 | 2017-08-11 | A kind of Sodium Hyaluronate skin sparing film and its preparation method and application |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109529102A (en) * | 2018-12-29 | 2019-03-29 | 山西纳德西生物科技有限公司 | A kind of medical function dressing and preparation method thereof based on cell culture |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103182070A (en) * | 2013-04-12 | 2013-07-03 | 江苏迪沃生物制品有限公司 | External composition, and preparation and application thereof |
| CN106496599A (en) * | 2016-10-10 | 2017-03-15 | 上海建华精细生物制品有限公司 | High viscosity hyaluronic acid sodium gel and preparation method thereof |
-
2017
- 2017-08-11 CN CN201710684212.XA patent/CN108261562A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103182070A (en) * | 2013-04-12 | 2013-07-03 | 江苏迪沃生物制品有限公司 | External composition, and preparation and application thereof |
| CN106496599A (en) * | 2016-10-10 | 2017-03-15 | 上海建华精细生物制品有限公司 | High viscosity hyaluronic acid sodium gel and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109529102A (en) * | 2018-12-29 | 2019-03-29 | 山西纳德西生物科技有限公司 | A kind of medical function dressing and preparation method thereof based on cell culture |
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