CN105816911A - Repairing gel containing growth factors and preparation method of repairing gel - Google Patents
Repairing gel containing growth factors and preparation method of repairing gel Download PDFInfo
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- CN105816911A CN105816911A CN201610375170.7A CN201610375170A CN105816911A CN 105816911 A CN105816911 A CN 105816911A CN 201610375170 A CN201610375170 A CN 201610375170A CN 105816911 A CN105816911 A CN 105816911A
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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
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/0066—Medicaments; Biocides
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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
- A61L26/0014—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/008—Hydrogels or hydrocolloids
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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
- 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
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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
- 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
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Abstract
The invention belongs to the medicine field, and particularly relates to repairing gel containing growth factors and a preparation method of the repairing gel .The repairing gel is prepared from 0.001%-0.02% of the growth factors, 0.05%-1% of alkaline polysaccharides, 0.5%-2% of a cellulose derivative water-soluble polymer, 0.05%-2% of natural plant polysaccharides, 0.01%-1% of a natural water-soluble polymer of extracellular polysaccharides, 0.1%-2% of carbomer, 12%-40% of a wetting agent, 0.05%-4% of a pH regulating agent, 0.01%-2% of hyaluronic acid, 0.6%-3% of a transdermal absorption agent, 0.1%-0.3% of a penetration enhancer and the balance deionized water .The repairing gel has the excellent antibacterial effect and the good moisture absorption performance and can significantly increase the cure rate of a wound surface, shorten the healing time of the wound surface and prevent scar formation.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of reparation gel containing somatomedin and preparation side thereof
Method.
Background technology
Skin is made up of epidermis, corium and subcutaneous tissue, and its function is that protective inner tissue is damaged from the external world；
Carry out that metabolism such as absorbs, perspires, sebum secreted and row rush down refuse etc.；Skin can also regulate body temperature, sense
By pain, touch, pressure, warm, cold etc. stimulate, and have immunization.People is the most inevitably subject to
The wound that various weights are different, asking it is that wound, natural disaster and ill rear operation wound are often can hardly be avoided.
When skin injury reaches to a certain degree, owing to fibroproliferative reacts, skin ultrastructure will be with cicatrix shape
Become and come to an end.Various body surface cicatrixs all can destroy original skin integrity, damages appearance, brings to patient
The injury of body and mind.While repair in trauma, how to treat its appearance caused destruction always medical domain
One of important subject.
The at present development of new pattern compress and application, skin transplantation, gene therapy, cultivation cell transplantation and artificial
Skin grafting dermepenthesis, the application of cell growth factor and TCM Therapy all occur in that new technology.Traditional dressing energy
Keep the drying property that wound surface is good, but can not effectively stop wound surface infected, and easily glue with planing surface generation
Even, wound surface may be caused during removal the most impaired；Novel synthesis type dressing has good elasticity and breathes freely
Property, but hygroscopicity is bad, may cause forming hydrops at wound surface and causing the breeding of antibacterial.It is applied to clinic
Tissue engineering product there is certain repulsion immunoreation, therapeutic effect is not good enough.
Based on the defect in tradition wound dressing serviceability, in recent years, develop polytype modern times wound
Dressing, wherein the wound dressing Han somatomedin has become as the new highlight of medical dressing field development.It is not only
Overcome the shortcoming that traditional dressing performance is single, and the addition of somatomedin also makes dressing add promotion wound
Face healing, effect of raising wound healing effect.
Chinese patent application 201410438877.9 discloses a kind of wound repair gel containing hexagonal mesoporous silicon
And preparation method thereof, the composition of this invention includes: hexagonal mesoporous silicon, basic fibroblast growth factor
FGF-21, chitosan, surfactant, cosurfactant, glyceryl monostearate, carbomer, pH
Regulator and deionized water.The present invention utilizes hexagonal mesoporous silicon carrying active substance and effective ingredient, can improve
Its stability, and reach slow release effect；Somatomedin can stimulate signaling, merisis and iuntercellular egg
White synthesis, promotes that capillary of skin generates and tissue growth, beneficially scar repairing；Chitosan is to many
Plant antibacterial inhibited, also there is good film property, beneficially wound healing and hemostasis；Should simultaneously
Glyceryl monostearate in system also acts as the effect of skin care.This invention is with carbomer as thickening
Agent, the hexagonal mesoporous silicon utilizing chitosan parcel growth factor-loaded is formed repairs gel, in this reparation gel
Not exclusively running through between somatomedin and glycan substrate, somatomedin is difficult to ooze out and reaches skin surface reparation
Skin, repairing effect is the best；Owing to the viscosity of carbomer gel is bigger, it is difficult to smear, use sense the best.
Therefore, the technical problem existed for above-mentioned prior art, need a kind of repairing effect of proposition badly notable,
The reparation gel containing somatomedin tended to smear out.
Summary of the invention
In order to solve technical problem present in above-mentioned prior art, it is an object of the invention to provide one and contain
Reparation gel of somatomedin and preparation method thereof, this reparation gel has the repairing effect of excellence and antibacterial effect
Really, good moisture pick-up properties and tending to smear out, its can significantly improve wound surface cure rate and shorten wound surface more
The conjunction time, and can the formation of prevention of scar.
The invention provides a kind of reparation gel containing somatomedin, including the component of following mass percent:
0.001～0.02% somatomedin, described somatomedin is selected from recombinant human epidermal growth factor and/or recombined human alkali
Property fibroblast growth factor；
0.05～1% alkaline polysaccharide, described alkaline polysaccharide is selected from chitosan and/or chitosan derivatives；
0.5～2% cellulose derivative water-soluble polymer, described cellulose derivative water-soluble polymer is selected from
One or more in modified Nano microcrystalline Cellulose, sodium carboxymethyl cellulose and hydroxyethyl cellulose；
0.05～2% natural plant polyose, described natural plant polyose is selected from Konjac glucomannan, carrageenan and algaroba
One or more in glue；
0.01～1% natural water-soluble copolymer of extracellular polysaccharide class, described extracellular polysaccharide class water-soluble
Polymer is selected from xanthan gum or gellan gum；
0.1～2% carbomer；
12～40% wetting agent, described wetting agent is selected from polyalcohols；
0.05～6%pH regulator, described pH adjusting agent is in triethanolamine, citric acid and tartaric acid
One or more；
0.6～6% cutaneous permeable agent, described cutaneous permeable agent is selected from Tween 80 and/or azone；
0.1～0.3% penetrating agent, described penetrating agent one in Polyethylene Glycol, polypropylene glycol and polyglycereol
Or it is several；
0.01-2% hyaluronic acid；
40～70% deionized water.
Preferably, described somatomedin is raw by recombinant human epidermal growth factor and recombination human basic fibroblast cell
The long factor presses the weight ratio composition of 1:0.5～1.
Preferably, described somatomedin is raw by recombinant human epidermal growth factor and recombination human basic fibroblast cell
The long factor presses the weight ratio composition of 1:1.
Preferably, described wetting agent is selected from glycerol.
Preferably, described cellulose derivative water-soluble polymer is by modified Nano microcrystalline Cellulose and carboxymethyl
Sodium cellulosate presses the weight ratio composition of 1:0.2～0.5.
Preferably, described cellulose derivative water-soluble polymer is by modified Nano microcrystalline Cellulose and carboxymethyl
Sodium cellulosate presses the weight ratio composition of 1:0.5.
Preferably, the natural water-soluble copolymer of described extracellular polysaccharide class is pressed 1:1～3 by xanthan gum and gellan gum
Weight ratio composition.
Preferably, the natural water-soluble copolymer of described extracellular polysaccharide class is pressed 1:1.5 by xanthan gum and gellan gum
Weight ratio composition.
Preferably, described pH adjusting agent is selected from triethanolamine.
Preferably, described alkaline polysaccharide is selected from carboxymethyl chitosan, and the molecular weight of described carboxymethyl chitosan is
2～4 × 103, substitution value is 80～90%.
Preferably, described natural plant polyose is selected from algaroba glue.
Preferably, described cutaneous permeable agent is selected from Tween 80.
Preferably, described penetrating agent is selected from Polyethylene Glycol.
Correspondingly, present invention also offers the above-mentioned preparation method repairing gel containing somatomedin, it includes
Following steps:
A) take 0.05～1% alkaline polysaccharide join in deionized water, mixing and stirring, obtain 0.5～1wt%
Alkaline polysaccharide solution, take 0.5～2% cellulose derivative water-soluble polymer join in deionized water,
Mixing and stirring, obtains the cellulose derivative water-soluble polymer solution of 0.1～1wt%；By above two
Solution mix homogeneously, swelling, obtain alkaline polysaccharide/cellulose derivative water-soluble polymer support；
B) take 0.1～2% carbomer, join while stirring in deionized water, swelling 12～24h, add
Above-mentioned alkaline polysaccharide/cellulose derivative water-soluble polymer support, stirs 10～15min, continuously adds
0.05～2% natural plant polyose, 0.01～1% natural water-soluble copolymer, 12～40% of extracellular polysaccharide class protect
Humectant, 0.6～6% cutaneous permeable agent, 0.01-2% hyaluronic acid and 0.1～0.3% penetrating agent, stirring
20～35min, adding pH adjusting agent regulation pH is 6.0～7.0, obtains pluralgel；
C) take 0.001～0.02% somatomedin be dissolved in deionized water and be configured to growth factor solution, will grow because of
Sub-solution joins above-mentioned steps B) in gained pluralgel, mix homogeneously, room temperature stands 2～5h, i.e.
?.
Alkaline polysaccharide selects molecular weight to be 2～4 × 103, substitution value is the carboxymethyl chitosan of 80～90%, its
Water solublity is high, has preferable antibiotic property, moisture absorbability and moisture retentivity, film property and biocompatibility, but it resists
Bacterium property and mechanical strength still fail to reach requirement.
Inventor finds to add cellulose derivative water-soluble polymer, is preferably added to modified Nano microcrystalline cellulose
Element forms carboxymethyl chitosan/cellulose derivative water-soluble polymer support, can be obviously improved carboxymethyl shell
The antibacterial ability of polysaccharide and mechanical strength.Trace it to its cause and may is that addition cellulose derivative water-soluble polymeric
Thing can strengthen the interface compatibility of carboxymethyl chitosan gel and other substrate, and makes somatomedin and carboxylic first
Base enclosure polysaccharide gel, completely through getting up to form the antibacterial gel connected altogether, keeps wound to be dried.Cellulose derives
The specific surface area that thing water-soluble polymer is huge can improve the contact area of gel and wound so that antibacterial effect
Can preferably play, and add the structure that cellulose derivative water-soluble polymer can make hydrogel be formed
More fluffy, prevent hydrogel at follow-up freezing (-15 DEG C) the bigger ice crystal of generation by bursting by freezing.
But owing to the addition of cellulose derivative water-soluble polymer causes the viscosity of gel to rise rapidly, smear
Poor performance, adds carbomer, can neutralize the acidity of carboxymethyl chitosan so that it is strand disperse is stretched in pole
Big swelling state forms gel so that the hydrogel formed is homogeneous, it is easy to smear, without greasy feeling,
Good with skin mucosa coupling effect.Three's Synergistic, gives the excellent anti-microbial property of gel, good painting
Smear performance.The addition of sodium carboxymethyl cellulose makes gel have preferably suction while keeping above-mentioned characteristic
Moist, it can adsorb wound surface suppurates, and its collaborative cellulose derivative water-soluble polymer can stably keep wound surface
Be dried, improve repairing effect.
The natural water-soluble copolymer adding natural plant polyose and extracellular polysaccharide class can improve water further
The sense of touch of gel.Owing to the addition of above-mentioned high molecular polymer makes carbomer-carboxymethyl chitosan-cellulose spread out
The viscosity of Biological water soluble polymer gel increases, and causes moisture holding capacity to rise, the nutritional labeling within gel
Fail to ooze out arrival skin surface, therefore add penetrating agent penetrating agent, be preferably added to Polyethylene Glycol, can promote
Internal somatomedin successfully oozes out arrival wound surface surface and plays a role, thus when improve the healing of wound surface
Between.And hyaluronic acid can promote the skin absorption to somatomedin, accelerate wound repairing damage.
Add wetting agent, the healing of wound face can be promoted, the formation of prevention of scar, alleviate wound pain.Respectively
The mutual Synergistic of component, forms one and has the wound repairing ability of excellence, antibacterial ability, good moisture absorption
The reparation gel of performance, it tends to smear out, and has control traumatic infection, accelerates wound healing, prevention
The effect of cicatrization.
Compared with prior art, the reparation gel of the present invention has the advantage that
1) present invention can improve the cure rate of wound surface by the reparation gel that the rational proportion of component prepares,
Shorten the healing time of wound surface, avoid simultaneously and use the drug resistance of antibiotic initiation, superinfection, allergy
The drawbacks such as reaction.
2) good hygroscopicity of the present invention, can absorb the transudate of wound surface, it is allowed to free gas permeates, contemporary
Thank to product to be discharged by gel, and then improve the microenvironment of lesion, promote wound and the reparation of wound surface.
3) present invention have excellence biocidal property, have control traumatic infection, accelerate wound healing,
The effect that prevention of scar is formed.
Detailed description of the invention:
Below by way of the description of detailed description of the invention, the invention will be further described, but this is not to this
Bright restriction, those skilled in the art are according to the basic thought of the present invention, and various modifications may be made or improves,
But without departing from the basic thought of the present invention, the most within the scope of the present invention.
Table 1 embodiment of the present invention 1～7 repairs gel component and consumption (being calculated in mass percent) thereof
Modified Nano microcrystalline Cellulose of the present invention is prepared by following steps:
S1: being joined by cellulosic material in the nitration mixture aqueous solution of organic acid and mineral acid, cellulosic material exists
Solid content in mixed acid liquid is 0.05g/mL, reacts 12h in 60 DEG C, obtains nano micro crystal cellulose suspension；
S2: moved into by above-mentioned suspension in reactor, adds 5mol Ammonium persulfate., stirs 20min at 90 DEG C,
Weigh octadecyl methacrylate soluble in water, instill in reactor with the drop rate of 2 per second,
React 6h at 60 DEG C, obtain the crude product of octadecyl methacrylate-nano micro crystal cellulose polymer,
Wherein octadecyl methacrylate is 1:2 with the mol ratio of nano micro crystal cellulose；
S3: at room temperature toward adding ethyl acetate in above-mentioned crude product, extractive reaction 36h, then at 50 DEG C
Rotary Evaporators extracting 80min removes ethyl acetate, obtains modified Nano microcrystalline Cellulose.
The preparation method of the embodiment of the present invention 1～7 reparation gel:
A) take alkaline polysaccharide and join in deionized water, mixing and stirring, obtain alkaline polysaccharide solution, take
Cellulose derivative water-soluble polymer joins in deionized water, mixing and stirring, obtains cellulose and derives
Thing water-soluble polymer solution；By above two solution mix homogeneously, swelling, obtain alkaline polysaccharide/fiber
Element derivant water-soluble polymer support；
B) take carbomer, join in deionized water while stirring, swelling 24h, add above-mentioned alkalescence many
Sugar/cellulose derivative water-soluble polymer support, stir 15min, continuously add natural plant polyose,
The natural water-soluble copolymer of extracellular polysaccharide class, wetting agent, cutaneous permeable agent, hyaluronic acid and penetrating agent,
Stirring 30min, adding pH adjusting agent regulation pH is 7.0, obtains pluralgel；
C) take somatomedin to be dissolved in deionized water and be configured to growth factor solution, growth factor solution is joined
Above-mentioned steps B) in gained pluralgel, mix homogeneously, room temperature stands 3h, to obtain final product.
Comparative example 1, a kind of reparation gel containing somatomedin
This comparative example 1 provides a kind of wound repair gel containing somatomedin, and it is by following mass percent
Component composition: 0.01% somatomedin, 1% carboxymethyl chitosan, 1% modified Nano microcrystalline Cellulose, 1%
Sodium carboxymethyl cellulose, 0.05% algaroba glue, 0.05% xanthan gum, 0.05% gellan gum, 1.5% carbomer,
10% glycerol, 2% triethanolamine, 1% hyaluronic acid, 3% Tween 80,0.2% Polyethylene Glycol and excess water.
Preparation method is with reference to the embodiment of the present invention 4 preparation method.
Comparative example 1 is with the difference of embodiment 4: change modified Nano microcrystalline Cellulose fine with carboxymethyl
The proportioning of dimension element sodium, specially adds the consumption of sodium carboxymethyl cellulose.
Stability test
Example 1～7 and comparative example 1 repair gel fill in undercoating sealing aluminum pipe, sealing is placed in
Test at 2 DEG C～8 DEG C, respectively at 0th month, 1 month, 3 months, 6 months, 9 months, 12
Individual month, that 18 the end of month detects the outward appearance of gel, loading amount, pH value, biologic activity (%) and antibacterial is total
Number.Testing result is as follows: embodiment 1～7 and the outward appearance of comparative example 1 sample, pH, loading amount, antibacterial
Sum and biologic activity (%) all met the requirements within each stage sealed.
Bacteriostatic test
Subjects: the embodiment of the present invention 1～7 and comparative example 1 gained repair gel.
Test method: use agar diffusion paper disk method and colony counting method to measure gel to strain (large intestine to be measured
Bacillus, staphylococcus aureus, Acinetobacter baumannii, pseudomonas aeruginosa, coagulase-negative Fructus Vitis viniferae
Coccus) fungistatic effect.Preparation is containing 108The bacteria suspension of/mL strain to be measured, is spread evenly across the battalion of solidification
Support agar culture medium planar surface, each flat board 100 μ L；Aseptically gel is uniformly applied to diameter
For on the filter paper that 0.3cm, sterilizing, drying are crossed, by the gel filter paper for preparing (with sterilizing filter paper
For blank) it is affixed on the flat board of coated test strain, on each flat board, scraps of paper repeat number is 4, in
37 DEG C of constant temperature culture 24h, take contact surface culture and make gradient dilution, take 1mL above-mentioned dilution bacteria suspension in
In flat board, use agar pour plate, mixing, to be solidified after be inverted in 37 DEG C of constant temperature culture 24h, calculate
Total plate count, the computational methods of total plate count are with reference to GB 47892-2010, and fungistatic effect is shown in Table 2.
Bacteriostasis rate (%)=(blank total plate count-gel total plate count)/blank total plate count * 100
Table 2 bacteriostatic test result
As seen from Table 2, the bacteriostasis rate of the embodiment of the present invention 1～7 reparation gel infectious bacteria normal to wound surface all exists
More than 90%, each group of fungistatic effect to escherichia coli and staphylococcus aureus is optimum；Above-mentioned 8 groups press down
Bacterium effect is ordered as from high to low: embodiment 4 ＞ embodiment 6 ＞ embodiment 5 ＞ embodiment 2 ＞ embodiment 3
＞ embodiment 7 ＞ embodiment 1 ＞ comparative example 1,4 groups of bacteriostasis rates to strain to be measured of embodiment are the highest, and it presses down
Bacterium effect is best.Comparative example 1 is owing to changing joining of modified Nano microcrystalline Cellulose and sodium carboxymethyl cellulose
Ratio, its gained repairs the fungistatic effect relatively embodiment 4 of gel to be had significantly by low, and comparative example 2 is with real
The fungistatic effect executing example 4 can be seen that, when in formula, modified Nano microcrystalline Cellulose is pressed with sodium carboxymethyl cellulose
Can significantly improve the fungistatic effect of gel when the weight ratio of 1:0.5 compounds, this is likely due to this proportioning can be
Big degree ground increases the contact area of gel and wound surface, thus improves the fungistatic effect of gel；Comparative example
1 and embodiment 2 understand, modified Nano microcrystalline Cellulose and sodium carboxymethyl cellulose are compounding micro-with modified Nano
Crystalline cellulose, sodium carboxymethyl cellulose are compounding with hydroxyethyl cellulose three to be compared, and the former more can improve gel
Fungistatic effect；Comparative example 2 understands with embodiment 3, be used alone algaroba glue with by Konjac glucomannan,
Algaroba glue compounds use and compares, and the gelling performance formed is more preferable；Comparative example 4 and embodiment 7 can
Know, be used alone compared with Polyethylene Glycol compounds use with by Polyethylene Glycol and polyglycereol as penetrating agent, the former
Can improve the bacteriostasis of gel, this explanation is used alone Polyethylene Glycol can be made inside gel as penetrating agent
Nutritional labeling faster, more effectively ooze out, play a role.
Summary test can draw, the embodiment of the present invention 4 repairs gel in stability and fungistatic effect side
All there is prominent performance in face, therefore embodiment 4 is preferred embodiment.
Wound surface is repaiied by different carboxymethyl chitosans, cellulose derivative water-soluble polymer and carbomer proportioning
The impact of multiple gelling performance
This test example, with embodiment 4 as matched group, is provided with 9 kinds of different carboxymethyl chitosans, celluloses and spreads out
1. the reparation gel of Biological water soluble polymer and carbomer proportioning, be respectively labeled as-9. group, investigate it
Impact on stability, sense organ and the bacteriostasis property of pluralgel, proportioning such as table 3.
The different carboxymethyl chitosan of table 3, cellulose derivative water-soluble polymer and carbomer proportioning
Note: stability test, antibacterial test reference stability test and bacteriostatic test method of testing.
Examine repairing the stability of gel, organoleptic properties and bacteriostasis property according to said ratio gained
Survey, result be analyzed as follows:
Organoleptic properties analysis shows, each proportioning gained the most transparent semi-solid of gel outward appearance, homogeneous carefully
Greasy glossy, it is coated with refrigerant sense；The denseness of gel reduces afterwards along with the rising of carbomer addition first increases,
Decrease with the increase of carboxymethyl chitosan addition, cellulose derivative water-soluble polymer addition
Change the denseness of gel is affected little, and denseness height is unfavorable for painting exhibition, more each group, finally draws 1%
The carbomer of carboxymethyl chitosan, 1% cellulose derivative water-soluble polymer and 1.5% compounds gained reparation
Gel has more preferable sensory effects；
Stability analysis shows, each proportioning gained gel, after hermetically storing 18 months, is received without layering and dehydration
Contracting phenomenon, but mildew situation shows, along with carboxymethyl chitosan, carbomer and cellulose derivative water solublity
The addition of polymer is the highest, and gel is less susceptible to mildew, and storage-stable is the best.
Bacteriostasis property analysis shows, the fungistatic effect of gel is along with cellulose derivative water-soluble polymer and carboxylic
The increase of methyl chitosan addition and improve, the fungistatic effect of gel is affected not by the addition of carbomer
Greatly.
Therefore, comprehensive three indexs, draw with 1% cellulose derivative water-soluble polymer, 1.5% cellulose
Derivant water-soluble polymer and 1.5% carbomer compound gained repair gel have more excellent bacteriostasis property,
Organoleptic properties and stability.
Clinical trial
1, data and method
1.1 physical data: Jingzhou City of Hubei Province in May, 2009 is in May, 2012 burned patient 150
Example, male 80 examples, female 70 example, age 7～70 years old, 35 ± 2 years old mean age；Former according to burn and scald
Because being divided into: boiling water burn 68 example, fire burn 82 example；It is divided into according to burn and scald degree: deep II degree of burn and scald
Hinder 90 examples, III degree of burn and scald 60 example.
1.2 packet and medications
Packet: above-mentioned deep II degree of burn and scald 90 example patient is randomly divided into 5 groups, often organizes 18 people, give for each group
Prescription method is as follows:
Embodiment 4 groups: put outward the reparation gel of the embodiment of the present invention 4 preparation on the skin；
Embodiment 5 groups: put outward the reparation gel of the embodiment of the present invention 5 preparation on the skin；
Embodiment 6 groups: put outward the reparation gel of the embodiment of the present invention 6 preparation on the skin；
Embodiment 7 groups: put outward the reparation gel of the embodiment of the present invention 7 preparation on the skin；
Comparative example 1 group: put outward the reparation gel of comparative example 1 of the present invention preparation on the skin；
Above-mentioned III degree of burn and scald 60 example patient being divided into 5 groups, often organizes 12 people, each group medication is as follows:
Embodiment 4 groups: put outward the reparation gel of the embodiment of the present invention 4 preparation on the skin；
Embodiment 5 groups: put outward the reparation gel of the embodiment of the present invention 5 preparation on the skin；
Embodiment 6 groups: put outward the reparation gel of the embodiment of the present invention 6 preparation on the skin；
Embodiment 7 groups: put outward the reparation gel of the embodiment of the present invention 7 preparation on the skin；
Comparative example 1 group: put outward the reparation gel of comparative example 1 of the present invention preparation on the skin；
Medication: under sterile working, by the wound surface routine disinfection of boiling hot burn, first with the povidone iodine of low concentration
Simply clean wound surface with normal saline, remove attachment and the elephant skin that come off, the vesicle tap that tension force is high,
Keep residual epithelium as far as possible, wipe out and come off or downright bad epidermis, the thorough debridement of infective wound surface row, be coated with outside wound surface
Or spray corresponding medicinal liquid, every 3～4 hours 1 time of daytime, every day coating 3～4 times.After medication fully
Expose wound surface, can not cover, prevent from, into water, noting warming winter, each group according to burn and scald area determine to
Dose, can all be as the criterion by flap coverage.
1.3 recovery from illness criterions of therapeutical effect: after medication, swelling disappears, and pain disappears, wound surface is without infecting, under crust more
Closing, have epidermal growth, wound surface is substantially repaired or all repairs.Fully recover from an illness in recording 7d, 14d, 21d after medication
More number, calculates 14d cure rate, recovery from illness number/case total number of persons × 100% in 14d cure rate=14d；
Time needed for the definition complete epithelization of wound surface is healing time, the healing time of record each patient, and right
Healing time carries out t inspection and compares；The wound surface cicatrix situation of record burned patient, record scar
Patient's number of cases, calculates cicatrix rate, patient's number of cases/case total number of persons × 100% of cicatrix rate=scar；
Applied statistics software is analyzed, and has significant difference with p < 0.05, and result of the test is shown in Table 4.
1.4 result of the test.
Table 4 result of the test
As shown in Table 4, on treatment deep II degree and III degree of burn and scald, the embodiment of the present invention 1～3 reparation gel
All achieve the effect of excellence, particularly have notable in terms of improving 14d cure rate and shortening healing time
Progress；From the point of view of the embodiment of the present invention 1～3 repairs the cicatrix rate of gel for treating burn and scald, along with burn and scald
Increasing the weight of of degree, the present invention treat deep II degree and III degree of burn and scald cicatrix rate extremely low, it is clear that reparation of the present invention
Gel staying after treatment burn and scald achieves unforeseeable technique effect in scar problem；And summary is each
Item index, finds that the therapeutic effect of the embodiment of the present invention 4 is optimal.
Claims (10)
1. the reparation gel containing somatomedin, it is characterised in that include following mass percent
Component:
0.001～0.02% somatomedin, described somatomedin is selected from recombinant human epidermal growth factor and/or weight
Group human alkaline fibroblast growth factor；
0.05～1% alkaline polysaccharide, described alkaline polysaccharide is selected from chitosan and/or chitosan derivatives；
0.5～2% cellulose derivative water-soluble polymer, described cellulose derivative water-soluble polymer
One or several in modified Nano microcrystalline Cellulose, sodium carboxymethyl cellulose and hydroxyethyl cellulose
Kind；
0.05～2% natural plant polyose, described natural plant polyose is selected from Konjac glucomannan, carrageenan and Chang Jiao
One or more in locust beam gum；
0.01～1% natural water-soluble copolymer of extracellular polysaccharide class, described extracellular polysaccharide class natural water-soluble
Property polymer selected from xanthan gum or gellan gum；
0.1～2% carbomer；
12～40% wetting agent, described wetting agent is selected from polyalcohols；
0.05～6%pH regulator, described pH adjusting agent is selected from triethanolamine, citric acid and tartaric acid
In one or more；
0.6～6% cutaneous permeable agent, described cutaneous permeable agent is selected from Tween 80 and/or azone；
0.1～0.3% penetrating agent, described penetrating agent is in Polyethylene Glycol, polypropylene glycol and polyglycereol
One or more；
0.01-2% hyaluronic acid；
40～70% deionized water.
2. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described life
The long factor is pressed 1:0.5～1 by recombinant human epidermal growth factor and recombination human basic fibroblast growth factor
Weight ratio composition.
3. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described guarantor
Humectant is selected from glycerol.
4. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described fibre
Dimension element derivant water-soluble polymer is pressed by modified Nano microcrystalline Cellulose and sodium carboxymethyl cellulose
The weight ratio composition of 1:0.2～0.5.
5. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described born of the same parents
The natural water-soluble copolymer of exo polysaccharides class is made up of by the weight ratio of 1:1～3 xanthan gum and gellan gum.
6. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described pH
Regulator is selected from triethanolamine.
7. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described alkali
Property polysaccharide selected from carboxymethyl chitosan, the molecular weight of described carboxymethyl chitosan is 2～4 × 103, substitution value
It is 80～90%.
8. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described sky
So vegetable polysaccharides is selected from algaroba glue.
9. the reparation gel containing somatomedin as claimed in claim 1, it is characterised in that described rush
Penetration enhancer is selected from Polyethylene Glycol.
10. the preparation method repairing gel containing somatomedin, it is characterised in that include following
Step:
A) take 0.05～1% alkaline polysaccharide join in deionized water, mixing and stirring, obtain 0.5～1wt%
Alkaline polysaccharide solution, take 0.5～2% cellulose derivative water-soluble polymer join deionized water
In, mixing and stirring, obtain the cellulose derivative water-soluble polymer solution of 0.1～1wt%；By upper
State two kinds of solution mix homogeneously, swelling, obtain alkaline polysaccharide/cellulose derivative water-soluble polymer and prop up
Frame；
B) take 0.1～2% carbomer, join while stirring in deionized water, swelling 12～24h, add
Enter above-mentioned alkaline polysaccharide/cellulose derivative water-soluble polymer support, stir 10～15min, continue
Add 0.05～2% natural plant polyose, 0.01～1% extracellular polysaccharide class natural water-soluble copolymer,
12～40% wetting agent, 0.6～6% cutaneous permeable agent, 0.01-2% hyaluronic acid and 0.1～0.3% promote to ooze
Agent, stirs 20～35min, and adding pH adjusting agent regulation pH is 6.0～7.0, obtains pluralgel；
C) take 0.001～0.02% somatomedin be dissolved in deionized water and be configured to growth factor solution, will growth
Factor solutions joins above-mentioned steps B) in gained pluralgel, mix homogeneously, room temperature stands 2～5h,
Obtain.
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