CN105287441A - Silica gel scar treatment strip and preparation method thereof - Google Patents
Silica gel scar treatment strip and preparation method thereof Download PDFInfo
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- CN105287441A CN105287441A CN201510789856.6A CN201510789856A CN105287441A CN 105287441 A CN105287441 A CN 105287441A CN 201510789856 A CN201510789856 A CN 201510789856A CN 105287441 A CN105287441 A CN 105287441A
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Abstract
The invention relates to a silica gel scar treatment strip and its preparation method and belongs to the field of medical cosmetology. The silica gel scar treatment strip is composed of three layered structures including an upper layer, a middle layer and a lower layer. The upper layer is a ventilating polyurethane film or silica gel thin film layer; the middle layer is an autoadhesion silica gel layer; and the lower layer is a release protection film layer. Active substances and accessories are added in the autoadhesion silica gel layer. The ventilating polyurethane film or silica gel thin film is tiled on an operating console; the autoadhesion silica gel is uniformly mixed with the active substances and accessories to obtain a mixture; the mixture is uniformly smeared on the ventilating polyurethane film or silica gel thin film; a material obtained is heated to 50-70 DEG C for 15-35 min; the release protection film is pressed and coated and cut to a required specification; and packaging is carried out after passing inspection so as to obtain the product. The product of the invention has good air permeability, has strong skin fitness, is convenient to use and has remarkable effects of treating itching and aching feelings of scar parts and removing scars.
Description
Technical field
The invention belongs to medical and beauty treatment fields, specifically, relate to a kind of Silica hydrogel scar plaster and preparation method thereof.
Background technology
Burn, wound or surgical site infections, patient often forms scar hyperplasia or keloid on surface, wound healing place, and except affecting outward appearance beauty treatment, serious meeting causes the skin diseases such as cicatrix cancer, must, by means restore funcitonss such as operations, bring greatly painful to patient.Therefore, research non-operative treatment prevention of scar hypertrophy becomes the problem that domestic and international the world of medicine pays close attention to jointly.
According to the result of doctor trained in Western medicine research, unanimously think the fibroblast hyperplasia of edge of wound substrate, excessive secretion collagen protein causes scar hyperplasia, and silicone goods can be adopted in non-operative treatment excessively to generate to be suppressed to fibrocyte and to secrete collagen protein.In addition, the 1980s, K.Perkins etc. study discovery, and application organosilicon polymer has control cicatrization, make the effect that cicatrix is softening.Organosilicon polymer and goods thereof are with negative electrostatic field, and the negative electrostatic field that they and contact skin produce can prevent and treat scar hyperplasia.According to one of silica gel scar plaster, the silicon gel formulation of principle development listing be widely used in clinical, obtain certain curative effect.US Patent No. 5895656, Chinese patent ZL01260783.5 all describe a kind of silicagel pad, and it is bonded the silicagel pad forming hollow by two-layer gel silica membrane surrounding, and hollow space fills silicone oil or other can produce the material of electrostatic field.But above-mentioned two patents are all only limitted to silica gel and produce the theory that electrostatic field can soften cicatrix, and must be located with Elastic bandage etc., and patient uses inconvenience.All there are bibliographical information silicone goods countries in the world for the curative effect of control scar hyperplasia.
Therefore, technical problem to be solved by this invention utilizes in Chinese and western medical about the theory of control scar hyperplasia and experience, in applying biological physics in Static Electric Field Theory and pharmaceutics about mechanism that Transdermal absorption is antipruritic, design a kind of can produce stronger electrostatic field, shorten cicatrix soften flatten and fade time, good effect, and can directly stick on cicatrix, use Silica hydrogel scar plaster more easily.
Summary of the invention
In order to overcome Problems existing in background technology, the invention provides a kind of Silica hydrogel scar plaster and preparation method thereof, by using organosilicon polymer, covering above cicatrix more comfortable, simultaneously, add adjuvant, can fibroblast growth be suppressed to, promote infiltration, can enter in scar tissue through skin by potent promotion silicone, enhance the effect of control scar hyperplasia, cicatrix can be shortened and soften the time flattening and fade, improve curative effect; Particularly intermediate layer can form a silicone bank after adding silicone, and silicone slowly infiltrates through in cicatrix by Silica hydrogel semipermeable membrane, depends on Concentraton gradient, constantly spreads, and has more curative effect; Can directly stick on cicatrix, use convenient.
For achieving the above object, the present invention is achieved through the following technical solutions:
A kind of Silica hydrogel scar plaster; described Silica hydrogel scar plaster is made up of upper, middle and lower-ranking structure; upper strata is vapor-permeable type polyurethane film or silica gel thin film layer; middle level is autohension silicon gel layer; lower floor is release protective film; be added with active substance and adjuvant in autohension silicon gel layer, wherein adjuvant comprises penetration enhancer, aromatic and the antipruritic factor.
Described active substance is micromolecule silicone.
Described penetration enhancer is one or more in oleic acid, lanoline, eucalyptus oil, menthol, Camphora, Azone, sodium laurylsulfate, tween 80 and SUNSOFT 700P-2.
Described aromatic is one or more in Oleum menthae, orange peel oil, Oleum Anisi Stellati, Fructus Citri oil, Oleum Menthae Rotundifoliae, oil of Bulbus Allii Cepae.
The described antipruritic factor is one or more in Oleum Terebinthinae, rice oil, black soybean oil.
Also can be scattered in first bright to anaesthesine, dyclonine, ovocaine, diphenhydramine, the power benzene of group in autohension silicon gel layer, expand the therapeutic domain of this kind of medicine, for prevention and the treatment of skin pruritus.
Described Silica hydrogel scar plaster can be made into square, circular or oval, and its effect thickness (i.e. the thickness in upper strata+middle level) is no more than 0.5mm.
A preparation method for Silica hydrogel scar plaster, comprises the following steps:
1) vapor-permeable type polyurethane film or silica gel thin film are laid on operating board;
2) autohension Silica hydrogel is mixed homogeneously with micromolecule silicone and adjuvant;
3) by the autohension Silica hydrogel uniform application of mix homogeneously on vapor-permeable type polyurethane film or silica gel thin film;
4) by step 3) in gains in 50 ~ 70 DEG C heating 15 ~ 35 minutes;
5) release protecting film is overlaid on step 4) surface of gains, cut out to required specification;
6) pack after the assay was approved, obtain this product.
Beneficial effect of the present invention: the present invention, based on autohension technology, integrates scar plaster prepared by short saturating, antipruritic technology, do not need the external world to provide extra adhering pressure, abandoned the use of binder and adhesive plaster, can freely cut out, used more convenient; Scar plaster provided by the invention has good breathability, can ensure the normal water metabolism of skin, does not cause again the discomfort of skin, can stick for a long time and use in skin area while providing cicatrix local wet environment; The present invention incorporates penetration enhancer, makes this treating acne active substance of micromolecule silicone better can penetrate into scar tissue, plays therapeutical effect; Scar plaster provided by the invention has high strength elastic and draftability, and strengthen the parcel to cicatrix and docile ability, the scar tissue for moving parts such as joints has the stronger suitability; Add the antipruritic factor, the local wet environment caused due to long-time docile and scar surface can be suppressed to change and the local pruritus that causes, increase the compliance of patient, improve therapeutic effect; Scar plaster thickness provided by the invention is at about 0.5mm, strong with skin applying force, can not be separated under daily routines amount with scar tissue.
Accompanying drawing explanation
Fig. 1 is composition structure chart of the present invention.
In figure, 1-vapor-permeable type polyurethane film or silica gel thin film layer, 2-autohension silicon gel layer, the release protective film of 3-.
Detailed description of the invention
As shown in Figure 1, a kind of Silica hydrogel scar plaster, described Silica hydrogel scar plaster is made up of upper, middle and lower-ranking structure, upper strata is vapor-permeable type polyurethane film or silica gel thin film layer 1, middle level is autohension silicon gel layer 2, lower floor is release protective film 3, is added with active substance and adjuvant in autohension silicon gel layer 2, and wherein adjuvant comprises penetration enhancer, aromatic and the antipruritic factor; Described active substance is micromolecule silicone, and the addition according to clinical needs is added; Described penetration enhancer is one or more in oleic acid, lanoline, eucalyptus oil, menthol, Camphora, Azone, sodium laurylsulfate, tween 80 and SUNSOFT 700P-2, and its addition and kind depend on clinical needs; Described aromatic is one or more in Oleum menthae, orange peel oil, Oleum Anisi Stellati, Fructus Citri oil, Oleum Menthae Rotundifoliae, oil of Bulbus Allii Cepae, and its addition and kind depend on clinical needs; The described antipruritic factor is one or more in Oleum Terebinthinae, rice oil, black soybean oil, and its addition and kind depend on clinical needs; Also can by anaesthesine, dyclonine, ovocaine, diphenhydramine, the power benzene of group first the medicine such as bright be scattered in autohension silicon gel layer 2, expand the therapeutic domain of this kind of medicine, for prevention and the treatment of skin pruritus; Described Silica hydrogel scar plaster can be made into various shape and all size sizes (2.5 × 12cm, 3 × 9cm, 3 × 12cm, 3 × 18cm, 4 × 30cm, 5 × 7.5cm, 5 × 10cm, 5 × 15cm, 6 × 12cm, 10 × 18cm, 12 × 15cm) such as square, circular, oval, and its effect thickness (i.e. the thickness in upper strata+middle level) is no more than 0.5mm.
A preparation method for Silica hydrogel scar plaster, comprises the following steps:
1) vapor-permeable type polyurethane film or silica gel thin film are laid on operating board;
2) autohension Silica hydrogel is mixed homogeneously with micromolecule silicone and adjuvant;
3) by the autohension Silica hydrogel uniform application of mix homogeneously on vapor-permeable type polyurethane film or silica gel thin film;
4) by step 3) in gains in 50 ~ 70 DEG C heating 15 ~ 35 minutes;
5) release protecting film is overlaid on step 4) surface of gains, cut out to required specification;
6) pack after the assay was approved, obtain this product.
Embodiment 1
Preparation method:
Get the autohension Silica hydrogel of 50% formula ratio to mix homogeneously with the micromolecule silicone in formula and oleic acid, obtain A; The autohension Silica hydrogel remaining 50% formula ratio is mixed homogeneously with the Oleum Terebinthinae in formula, obtains B; By A and B mix homogeneously, after vacuum lower pumping bubble, carefully slowly add Oleum menthae and stir, then gains are spread evenly across on the vapor-permeable type polyurethane film on operating board; heat 18 minutes at 65 DEG C, take out, be cooled to room temperature, coated with release protecting film; compacting, cuts out, packaging.
Embodiment 2
Preparation method:
Get the autohension Silica hydrogel of 50% formula ratio to mix homogeneously with the micromolecule silicone in formula and orange peel oil, Oleum Anisi Stellati, obtain A; The autohension Silica hydrogel remaining 50% formula ratio is mixed homogeneously with the black soybean oil in formula, obtains B; By A and B mix homogeneously, after vacuum lower pumping bubble, carefully add after menthol stirs, be spread evenly across on the silica gel thin film on operating board, heat 25 minutes at 55 DEG C, take out, be cooled to room temperature, coated with release protecting film, compacting, cuts out, packaging.
Embodiment 3
Preparation method:
The autohension Silica hydrogel getting 50% formula ratio is mixed homogeneously with the micromolecule silicone in formula, tween 80, obtains A; The autohension Silica hydrogel remaining 50% formula ratio is mixed homogeneously with the Fructus Citri oil in formula and Oleum Terebinthinae, obtains B; By A and B mix homogeneously, after vacuum lower pumping bubble, carefully add after oil of Bulbus Allii Cepae stirs, be spread evenly across on the vapor-permeable type polyurethane film on operating board; heat 20 minutes at 60 DEG C, take out, be cooled to room temperature, coated with release protecting film; compacting, cuts out, packaging.
Embodiment 4
Recipe ingredient:
Preparation method:
The autohension Silica hydrogel getting 50% formula ratio is mixed homogeneously with the micromolecule silicone in formula, oleic acid, obtains A; The autohension Silica hydrogel remaining 50% formula ratio is mixed homogeneously with the Oleum Terebinthinae in formula, obtains B; By A and B mix homogeneously, after vacuum lower pumping bubble, carefully add after oil of Bulbus Allii Cepae, Oleum menthae and eucalyptus oil stir, be spread evenly across on the vapor-permeable type polyurethane film on operating board; heat 30 minutes at 55 DEG C, take out, be cooled to room temperature, coated with release protecting film; compacting, cuts out, packaging.
Embodiment 5
Recipe ingredient:
Preparation method:
The autohension Silica hydrogel getting 50% formula ratio is mixed homogeneously with the micromolecule silicone in formula, oleic acid, obtains A; The autohension Silica hydrogel remaining 50% formula ratio is mixed homogeneously with the Oleum Terebinthinae in formula, obtains B; By A and B mix homogeneously, after vacuum lower pumping bubble, carefully add after oil of Bulbus Allii Cepae, Oleum menthae and eucalyptus oil stir, be spread evenly across on the silica gel thin film on operating board; heat 30 minutes at 55 DEG C, take out, be cooled to room temperature, coated with release protecting film; compacting, cuts out, packaging.
Clinical trial one: antipruritic scar observation of curative effect
1, test material:
Medicine: Silica hydrogel scar plaster of the present invention;
Control drug: certain domestic scar plaster;
2, diagnostic criteria:
All cases all have cicatrix or hypertrophic cicatrix;
The violent pruritus in skin area local;
3, criterion of therapeutical effect is formulated according to (disease of tcm Standardization of diagnosis and curative effect):
Cure: skin area pruritus pain disappears;
Take a turn for the better: skin area pruritus pain alleviates;
Invalid: skin area pruritus pain does not disappear, and symptom does not control, and even increases the weight of.
4, choose all kinds of scar after the operation patient 100 example, be divided into matched group and treatment group at random; Treatment group 50 example, man 23 example, female 27 example, 1-46 years old ages; Matched group 50 example, man 24 example, female 26 example, 1-48 years old ages; Two groups of no significant difference (P>0.05) in age, sex, the course of disease etc., have comparability.
5, result of the test: suture removing, after wound heals completely, stick in cicatrix affected part, 24h cleans an affected part, and this product need not be cleaned, and 5-7d changes a scar plaster, and treatment comparing result is in table 1.
Table 1 liang group clinical drug comparitive study
Pass through controlled clinical trial, two groups of clinical efficacies are added up, according to healing, take a turn for the better, invalid, always have 100 patients and finally reach evaluation criteria, its effective percentage for the treatment of group is 98%, cure rate 84%, and its effective percentage of matched group is 98%, cure rate is 56%, and treatment group is Be very effective in the symptom for the treatment of cicatrix or hypertrophic cicatrix.
Clinical trial two: scar of dispelling observation of curative effect
This research is that two centers are random, double blinding, placebo clinical research; This research design effective sample number is 117 examples, test group 59 example, and matched group 58 example, considers 10% expulsion rate, and planning into group case load is 130 examples, test group and each 65 examples of placebo group (matched group).
Statistical method analysis adopts SAS9.0 statistical analysis software to calculate, and all statistical test all adopt two-sided test, and P value <0.05 will be considered to checked difference statistical significance; Test group and matched group first carry out statistical analysis with regard to physical data, describe patient's ordinary circumstance, after confirming comparability, carry out clinical efficacy statistical analysis to two groups of cases.Different with problem according to data character, main work is analyzed as follows:
(1) harmonious inspection, whether age of check test group and case in matched group, sex and cicatrix time of origin length equal distribution be balanced, the employing t method of inspection or pearsonx
2the method of inspection.
(2) efficacy analysis, clinical indices according to the rules judges curative effect, to effective percentage and the course for the treatment of degree analyze, analytical method adopts pearsonx
2the method of inspection or the difference between wilcoxon method check test group and matched group have not statistically significant.
(3) if two groups have the factor affected the treatment unbalanced, adopt Multivariate to carry out adjustment to curative effect index and analyze, to confirm curative effect situation.Method adopts orderly logistic analytical method.
In clinical experimental study, object of study sex, at the age, the result of the test that cicatrix life period is compared is in table 2.
Table 2 clinical test results
Note: adopt the t method of inspection, selected object 117 example, come off 13 examples.
Result of the test shows, test group and matched group experimenter sex, age, the more equal not statistically significant of cicatrix life period situation.
Main research grade classification is as follows:
Effective: color and luster (dark red, flushing or purple) shoals, cicatrix hardness (hard, moderate, soft) deliquescing, demarcate clear (clear, fuzzy) with normal skin, subjective symptoms is obviously alleviated.
Effective: color and luster (dark red, flushing or purple) shoals, or cicatrix hardness (hard, moderate, soft) deliquescing, or demarcate clear (clear, fuzzy) with normal skin, or subjective symptoms is obviously alleviated.
Invalid: without changing.
Increase the weight of: color and luster (dark red, flushing or purple) is deepened, cicatrix hardness (hard, moderate, soft) is hardening, and demarcate fuzzy (clear, fuzzy) with normal skin, subjective symptoms obviously increases the weight of.
Each group of subjects uses the effective percentage result of the test after two weeks in table 3.
Table 3 uses the effective percentage result of the test after two weeks
| Group | Invalid | Effectively | Add up to |
| Test group | 0(0.00) | 59(100.00) | 59 |
| Matched group | 29(50.00) | 29(50.00) | 58 |
| Add up to | 29(24.79) | 88(75.21) | 117 |
Note: be percentage rate in bracket, adopt pearsonx
2check to obtain P<0.001
Result of the test shows, and test group uses the effective percentage after two weeks to be 100%, and matched group uses the effective percentage after two weeks to be 50%.
Each group of subjects uses the effective percentage result of the test after 6 months in table 4.
Table 4 uses the effective percentage result of the test after 6 months
| Group | Increase the weight of | Invalid | Effectively | Effective | Add up to |
| Test group | 0(0.00) | 0(0.00) | 19(32.20) | 40(67.80) | 59 |
| Matched group | 0(0.00) | 21(36.21) | 18(31.03) | 19(32.76) | 58 |
| Add up to | 0(0.00) | 21(17.95) | 37(31.62) | 59(50.43) | 117 |
Note: be percentage rate in bracket, adopts logistic analytical method to obtain P<0.001
Result of the test shows, and the obvious effective rate of test group is 67.8%, and effective percentage is 32.2%, and matched group obvious effective rate is 32.76%, and effective percentage is 31.03%.
Through above two clinical trials checking, the curative effect of scar plaster provided by the present invention to the pruritus pain of skin area and scar aspect of dispelling is remarkable; The present invention, based on autohension technology, integrates scar plaster prepared by short saturating, antipruritic technology, does not need the external world to provide extra adhering pressure, abandoned the use of binder and adhesive plaster, can freely cut out, used more convenient; Scar plaster provided by the invention has good breathability, can ensure the normal water metabolism of skin, does not cause again the discomfort of skin, can stick for a long time and use in skin area while providing cicatrix local wet environment; The present invention incorporates penetration enhancer, makes this treating acne active substance of micromolecule silicone better can penetrate into scar tissue, plays therapeutical effect; Scar plaster provided by the invention has high strength elastic and draftability, and strengthen the parcel to cicatrix and docile ability, the scar tissue for moving parts such as joints has the stronger suitability; Add the antipruritic factor, the local wet environment caused due to long-time docile and scar surface can be suppressed to change and the local pruritus that causes, increase the compliance of patient, improve therapeutic effect; Scar plaster thickness provided by the invention is at about 0.5mm, strong with skin applying force, can not be separated under daily routines amount with scar tissue; Supplement and complement each other between the materials such as the micromolecule silicone in the present invention and penetration enhancer, aromatic, the antipruritic factor, enhance the effect of control scar hyperplasia, shorten cicatrix and soften the time flattening and fade, played better therapeutical effect.
What finally illustrate is, above preferred embodiment and accompanying drawing are only in order to illustrate technical scheme of the present invention and unrestricted, although by above preferred embodiment to invention has been detailed description, but those skilled in the art are to be understood that, various change can be made to it in the form and details, and not depart from claims of the present invention limited range.
Claims (8)
1. a Silica hydrogel scar plaster; it is characterized in that: described Silica hydrogel scar plaster is made up of upper, middle and lower-ranking structure; upper strata is vapor-permeable type polyurethane film or silica gel thin film layer; middle level is autohension silicon gel layer; lower floor is release protective film; be added with active substance and adjuvant in autohension silicon gel layer, wherein adjuvant comprises penetration enhancer, aromatic and the antipruritic factor.
2. a kind of Silica hydrogel scar plaster according to claim 1, is characterized in that: described active substance is micromolecule silicone.
3. a kind of Silica hydrogel scar plaster according to claim 1, is characterized in that: described penetration enhancer is one or more in oleic acid, lanoline, eucalyptus oil, menthol, Camphora, Azone, sodium laurylsulfate, tween 80 and SUNSOFT 700P-2.
4. a kind of Silica hydrogel scar plaster according to claim 1, is characterized in that: described aromatic is one or more in Oleum menthae, orange peel oil, Oleum Anisi Stellati, Fructus Citri oil, Oleum Menthae Rotundifoliae, oil of Bulbus Allii Cepae.
5. a kind of Silica hydrogel scar plaster according to claim 1, is characterized in that: the described antipruritic factor is one or more in Oleum Terebinthinae, rice oil, black soybean oil.
6. a kind of Silica hydrogel scar plaster according to claim 1, is characterized in that: also can be scattered in first bright to anaesthesine, dyclonine, ovocaine, diphenhydramine, the power benzene of group in autohension silicon gel layer.
7. a kind of Silica hydrogel scar plaster according to claim 1, is characterized in that: described Silica hydrogel scar plaster is made square, circular or oval, and its effect thickness is no more than 0.5mm.
8. a preparation method for Silica hydrogel scar plaster, comprises the following steps:
1) vapor-permeable type polyurethane film or silica gel thin film are laid on operating board;
2) autohension Silica hydrogel is mixed homogeneously with micromolecule silicone and adjuvant;
3) by the autohension Silica hydrogel uniform application of mix homogeneously on vapor-permeable type polyurethane film or silica gel thin film;
4) gains in step 3) are heated 15 ~ 35 minutes in 50 ~ 70 DEG C;
5) release protecting film is overlaid on the surface of step 4) gains, cuts out to required specification;
6) pack after the assay was approved, obtain this product.
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| CN106361765A (en) * | 2016-08-31 | 2017-02-01 | 广州润虹医药科技有限公司 | Medical silica gel scar treatment strip with package and production technology thereof |
| CN106726140A (en) * | 2016-11-30 | 2017-05-31 | 振德医疗用品股份有限公司 | A kind of Medical silicone gels adhesive tape and preparation method thereof |
| CN110123819A (en) * | 2019-06-03 | 2019-08-16 | 南阳南石医院 | It is a kind of for treating the drug and device of scar |
| CN110833537A (en) * | 2019-11-15 | 2020-02-25 | 三峡大学 | Drug sustained-release material and application thereof to sustained-release material for treating proctitis |
| CN110917179A (en) * | 2019-12-19 | 2020-03-27 | 温州医科大学附属第一医院 | Scar-resistant silicone gel patch and preparation method thereof |
| CN110974537A (en) * | 2019-12-19 | 2020-04-10 | 山东省立医院 | Individual auricle fixator after auricle reconstruction and preparation method thereof |
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| CN106361765A (en) * | 2016-08-31 | 2017-02-01 | 广州润虹医药科技有限公司 | Medical silica gel scar treatment strip with package and production technology thereof |
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| CN110974537B (en) * | 2019-12-19 | 2022-03-29 | 山东第一医科大学附属省立医院(山东省立医院) | Individual auricle fixator after auricle reconstruction and preparation method thereof |
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