Summary of the invention
The objective of the invention is to (1) a kind of 3 D stereo eye mask for the treatment of eye wrinkle-removing is provided; (2) provide a kind of preparation method for the treatment of the 3 D stereo eye mask of eye wrinkle-removing.
The objective of the invention is to realize by following technical method:
(1) a kind of compositions that contains PVAC polyvinylalcohol-124, said composition is composed of the following components by weight percentage:
PVAC polyvinylalcohol-124 5-20%
Fibroblast growth factor 30-40%
0.025% tretinoin 5-10%
Adjuvant 5-20%
Water surplus
Described adjuvant is selected from hyaluronic acid, VitE, VitC, a kind of or its mixture of Flos Carthami alcohol, (cryopreservation).
Said composition is preferably composed of the following components by weight percentage:
PVAC polyvinylalcohol-124 8-17%
Fibroblast growth factor 33-37%
0.025% tretinoin 6-9%
Adjuvant 8-17%
Water surplus
Described adjuvant is selected from hyaluronic acid, VitE, VitC, a kind of or its mixture of Flos Carthami alcohol,
(cryopreservation).
(2) a kind of compositions that contains PVAC polyvinylalcohol-124, said composition is composed of the following components by weight percentage:
PVAC polyvinylalcohol-124 5-20%
Fibroblast growth factor 30-40%
10% glycolic 5-10%
Adjuvant 5-20%
Water surplus
Described adjuvant is selected from hyaluronic acid, VitE, VitC, a kind of or its mixture of Flos Carthami alcohol,
(cryopreservation).
Said composition is preferably composed of the following components by weight percentage:
PVAC polyvinylalcohol-124 8-17%
Fibroblast growth factor 33-37%
10% glycolic 6-9%
Adjuvant 8-17%
Water surplus
Described adjuvant is selected from hyaluronic acid, VitE, VitC, a kind of or its mixture of Flos Carthami alcohol,
(cryopreservation).
(3) a kind of compositions that contains PVAC polyvinylalcohol-124, said composition is composed of the following components by weight percentage:
PVAC polyvinylalcohol-124 5-20%
Fibroblast growth factor 30-40%
12% lactic acid 5-10%
Adjuvant 5-20%
Water surplus
Described adjuvant is selected from hyaluronic acid, VitE, VitC, a kind of or its mixture of Flos Carthami alcohol, (cryopreservation).
Said composition is preferably composed of the following components by weight percentage:
PVAC polyvinylalcohol-124 8-17%
Fibroblast growth factor 33-37%
12% lactic acid 6-9%
Adjuvant 8-17%
Water surplus
Described adjuvant is selected from hyaluronic acid, VitE, Vi tC, a kind of or its mixture of Flos Carthami alcohol, (cryopreservation).
Above-mentioned compositions can be used for the skin of human body according to conventional part, more is applicable to the eye wrinkle-removing film patch of making the controlled release structure.This eye wrinkle-removing film patch comprises the backing layer that is used for load active component, the above-mentioned compositions drug storing layer on backing layer top is laid in, covering being used on the drug storing layer invests the adhesive layer that skin surface PVAC polyvinylalcohol-124 is made with eye wrinkle-removing film patch, cover the adherent layer that the polyester of the silicone-treated on the adhesive layer is made, remove before the use.
The backing layer of being addressed has good barrier for containing the aluminumpolyethylene composite membrane, can prevent the leakage of medicine.
The adherent layer of being addressed is the polyester film of surface through the silicone oil release treatment.
The eye wrinkle-removing film patch preparation method may further comprise the steps:
(1) gluing: PVAC polyvinylalcohol-124 is uniformly coated on the polyester adherent layer that silicone-treated crosses intensive drying;
(2) storage medicine: PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille;
(3) press seal: the gel of pastille quantitatively is added on the above-mentioned film, covers backing film, pressurization is die-cut into suitable size, promptly gets eye wrinkle-removing film patch.
The 3 D stereo eye mask of treatment eye wrinkle-removing
(1) uses the laser three-dimensional scanning technology, at random to the seek medical advice patient of reduce wrinkle of outpatient service, carry out by the three-dimensional configuration scanning of eyebrow to the buccal, three-dimensional configuration with regard to eye socket outer rim and canthus, carry out quantitative analysis, measure, obtain the spherical radian line of eye socket outer rim radian, socket of the eye cheekbone front side angle and palpebra inferior etc.Statistical summary goes out China women's all three-dimensional datas of main eye socket.
Data: 1=122.5 ° ± 6.3 ° of eye socket outer rim arc measurement α, β 1=120.0 ° ± 7.4 °, D1=0.54 ± 0.09cm; 2=155.8 ° ± 7.2 ° of the arc measurement α of cheekbone portion, β 2=155.1 ° ± 5.7 °, D2=1.46 ± 0.24cm; The horizontal turning angle of eyebrow is measured 3=145.5 ° ± 5.4 ° of α;
The horizontal turning angle of outer canthus is measured 4=143.2 ° ± 6.7 ° of α.
(2) according to above-mentioned data: design can cover 3-4 combinations of values of 80% sample, makes three-dimensional stereo model, model according to this, and casting produces the 3 D stereo eye mask.
According to eye socket week three-dimensional data, fashion into as shown in Figure 7 3-D in convex form with PVAC polyvinylalcohol-124, this layer is three-dimensional concavo-convex adhesive layer; On the concavo-convex adhesive layer of three-dimensional outside, cover the three-dimensional concavo-convex drug storing layer of above-mentioned composition; Three-dimensional concavo-convex drug storing layer top covers three-dimensional concavo-convex backing layer; On the concavo-convex adhesive layer inner face of three-dimensional, be covered with the three-dimensional concavo-convex adherent layer that the polyester of silicone-treated is made, remove before the use.
The three-dimensional concavo-convex backing layer of being addressed has good barrier for containing the aluminumpolyethylene composite membrane, can prevent the leakage of medicine.
The three-dimensional concavo-convex adherent layer of being addressed is the polyester film of surface through the silicone oil release treatment.
The preparation method of the 3 D stereo cover of treatment eye wrinkle-removing may further comprise the steps:
(1) moulding: as, to fashion into as shown in Figure 7 3-D in convex form with PVAC polyvinylalcohol-124 according to eye socket week three-dimensional data;
(2) cover adherent layer: on the concavo-convex adhesive layer inner face of three-dimensional, be covered with the three-dimensional concavo-convex adherent layer that the polyester of silicone-treated is made;
(3) storage medicine: PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille;
(4) finished product: on the concavo-convex adhesive layer inner face of three-dimensional, cover gel, the covering backing film of pastille, promptly get the 3 D stereo eye mask for the treatment of eye wrinkle-removing.
Zoopery
1. the heavy Duroc of laboratory animal: 15kg is yellow by the hair piglets, and normal diet is fed can not be point-blank indoor in sunlight.
2. medicine: using polythene alcohol PVA-124 makes gel-type vehicle, medicine: fibroblast growth factor (trade name: Bfgf-ESSEX, be called for short BFGF) and 0.025% Avita Gel, 10% glycolic gel and 12% lactic acid gel.
3. Therapeutic Method: selecting Oculus sus domestica eyelid place skin is the Experimental Area, divides four groups, and (1) matched group sticks PVAC polyvinylalcohol-124 and makes gel.Three groups stick the eye wrinkle-removing film patch that (2) contain PVAC polyvinylalcohol-124, fibroblast growth factor, 0.025% tretinoin respectively in addition; (3) contain the eye wrinkle-removing film patch of PVAC polyvinylalcohol-124, fibroblast growth factor, 10% glycolic; (4) contain the eye wrinkle-removing film patch of PVAC polyvinylalcohol-124, fibroblast growth factor, 12% lactic acid.
4. detection method: behind application treatment, two weeks, January, February, March, skin appearance is observed, got biopsy specimen respectively, formalin fixed, paraffin embedding, section, row HE dyeing.After histological observation and statistical analysis: the HE dyeing, light microscopic is observed the variation of different times piglets epiderm skin cell and papillary layer of corium collagen tissue down.Piglets normal skin group is organized in contrast, and graphical analysis is carried out in the section of each group different times, and the meter skin thickness is analyzed comparison with method of analysis of variance.
5. result:
One. skin tissue morphology is observed
Collagen tissue all has in various degree and thickens in three treatment group papillary layer of corium, and obvious collagen band appears in part, promptly so-called Grenz band, its thickness with the application treatment time and different, arrangement of collagen fibers trends towards neat densification.
Skin tissue morphology changes behind table 1 application treatment
Medicine |
Epidermal area |
Papillary layer of corium |
|
Time |
Cell is arranged |
Tightness degree |
Collagen fiber |
Avita Gel+BFGF |
Two March February in January week |
+ + + + |
± ++ ++ ++ |
++ ++ ++ ++ |
Glycolic gel+BFGF |
Two March February in January week |
+ ++ ++ ++ |
± ++ ++ ++ |
+ + + ++ |
Lactic acid gel+BFGF |
Two March February in January week |
± + + + |
- ++ ++ ++ |
+ + ++ ++ |
Matched group |
Two March in February February in January week |
± - - - - |
- + - - - |
± - - - ± |
Annotate :-not obvious, irregular or disorderly; + neat, tight, clear, obvious
Two. the epidermal area thickness measure
Each treatment group skin epidermis all thickened at one month, trended towards stablizing in two months.Three months very remarkable with normal skin epidermal area difference in thickness, and The results of analysis of variance shows, P<0.05.
(the unit: μ m) of epidermal area thickness measure behind table 1 skin treating
|
Treatment two weeks of back |
January after the treatment |
February after the treatment |
March after the treatment |
Avita Gel+BFGF |
65.0766 |
6 8.9774 |
7 3.9446 |
79.6417 |
Glycolic gel+BFGF |
59.2616 |
67.6826 |
69.4618 |
74.1861 |
Lactic acid gel+BFGF |
59.3276 |
6 3.5744 |
70.3396 |
75.4197 |
Matched group+BFGF |
56.0114 |
55.9411 |
56.8444 |
54.8972 |
(the unit: μ m) of collagen layer thickness measure behind table 2 skin treating
|
Treatment one week of back |
January after the treatment |
February after the treatment |
March after the treatment |
Avita Gel+BFGF |
13.498 8 |
17.138 |
20.482 |
24.402 |
Glycolic gel+BFGF |
11.5191 |
17.414 |
19.712 |
21.374 |
Lactic acid gel+BFGF |
12.174 |
15.509 |
19.219 |
22.874 |
Matched group+BFGF |
9.28 52 |
9.3317 |
9.7421 |
9.5522 |
6. explanation
One. the arranging situation of epidermis cell directly has influence on the outward appearance and the quality of skin, marshalling, the skin smooth exquisiteness that seems.Simultaneously, the tightness degree of cell is related to the moisture-retaining capacity of skin, arranges the moisture content that closely can effectively prevent in the skin and runs off and evaporation, keeps the smooth and elasticity of skin.The observation of each treatment group epidermis cell is found to one to two months, the situation ideal that cell is arranged had the outward appearance and the quality of advantages of good skin.
Two. the hypertrophy of collagen fiber and rearranging, can increase the substrate in the skin corium, improve the elastic fiber quality, improve tiny wrinkle, and the wrinkle in desalination deep, increase the elasticity and the gloss of skin.To the observation of each treatment group collagen tissue, find that papillary layer of corium all has the collagen band to occur or collagen tissue thickens to some extent.
Three. epidermal area thickness has direct influence to skin quality, and epidermal area is blocked up, and it is dark and gloomy, matt that skin seems, epidermal area is thin excessively, and the skin sensitivity degree increases, and easily takes place irritated.The epidermal area of suitable thickness is the key factor that skin keeps optimum state.According to the measurement result of epidermal area thickness, can find after treatment, significantly to increase February the thickness of epidermal area.
Clinical research
Clinical treatment grouping: outpatient service eye wrinkle-removing patient is divided into four groups at random.Organize 1, contain the 3 D stereo cover of the treatment eye wrinkle-removing of PVAC polyvinylalcohol-124, fibroblast growth factor, 0.025% tretinoin; Organize 2, contain the 3 D stereo cover of the treatment eye wrinkle-removing of PVAC polyvinylalcohol-124, fibroblast growth factor, 10% glycolic; Organize 3, contain the 3 D stereo cover of the treatment eye wrinkle-removing of PVAC polyvinylalcohol-124, fibroblast growth factor, 12% lactic acid; Matched group, polyvinyl alcohol+silica gel compound
The clinical treatment method: 1, by doctor's advice, stick wrinkle place near the eyes, about 12 hours every days.As dermatitis appears, the erythema allergy sufferers is picked out experimental group.Observe in addition;
2 followed up a case by regular visits in treatment two weeks, January, February, March, filled in the observation of curative effect table, comprised the subjective curative effect table of doctor's objective determination and patient, the comprehensive statistics curative effect.
The result: pick out 3 erythema allergy sufferers altogether, the curative effect statistics is as follows:
1, curative effect statistics
Table 1: curative effect statistics *
Observing time |
Curative effect |
Grade |
Group 1 |
Group 2 |
Group 3 |
Matched group |
Estimate (example) |
Curative effect rate (%) |
Estimate (example) |
Curative effect rate (%) |
Estimate (example) curative effect rate (%) |
Estimate (example) |
Curative effect rate (%) |
2 weeks |
Effectively |
Wrinkle significantly improves |
12 |
33.75% |
9 |
27.5% |
11 |
31.25% |
0 |
2.5% |
Wrinkle partly improves |
15 |
13 |
14 |
2 |
Invalid |
Wrinkle does not have change |
53 |
66.25% |
58 |
72.5% |
55 68.75% |
78 |
97.50% |
1 month |
Effectively |
Wrinkle significantly improves |
13 |
36.25% |
11 |
32.5% |
10 |
38.75% |
0 |
1.25% |
Wrinkle partly improves |
16 |
15 |
21 |
1 |
Invalid |
Wrinkle does not have change |
51 |
63.75% |
54 |
67.5% |
45 61.25% |
79 |
98.75% |
2 months |
Effectively |
Wrinkle significantly improves |
21 |
51.25% |
21 |
55.0% |
23 |
58.75% |
0 |
1.25% |
Wrinkle partly improves |
20 |
23 |
24 |
1 |
Invalid |
Wrinkle does not have change |
39 |
48.75% |
36 |
45.0% |
33 41.25% |
79 |
98.75% |
3 months |
Effectively |
Wrinkle significantly improves |
42 |
85.00% |
37 |
83.75% |
23 |
77.5% |
0 |
1.25% |
Wrinkle partly improves |
26 |
30 |
39 |
1 |
Invalid |
Wrinkle does not have change |
12 |
15.00% |
13 |
16.25% |
18 22.5% |
79 |
98.75% |
The observation number adds up to (example) |
N=80 |
N=80 |
N=80 |
N=80 |
2, statistical analysis: treatment group and matched group
Table 2. curative effect statistical analysis X
2Check
|
|
Group 1 and matched group | Group | 2 and matched group | Group | 3 and matched group |
|
X
2Value
|
The P value |
X
2Value
|
The P value |
X
2Value
|
The P value |
2 weeks |
26.32 |
<0.01 |
19.61 |
<0.01 |
23.57 |
<0.01 |
1 month |
32.16 |
<0.01 |
24.94 |
<0.01 |
35.15 |
<0.01 |
2 months |
51.65 |
<0.01 |
57.17 |
<0.01 |
62.98 |
<0.01 |
3 months |
114.39 |
<0.01 |
111.41 |
<0.01 |
97.42 |
<0.01 |
2, statistical analysis: treatment group and treatment group are relatively
Table 3. curative effect statistical analysis X
2Check
|
|
Group 1 and group 2 |
Group 1 and group 3 |
Group 2 and group 3 |
|
X
2Value
|
The P value |
X
2Value
|
The P value |
X
2Value
|
The P value |
2 weeks |
0.734 |
p>0.25 |
0.11 |
p>0.5 |
0.27 |
p>0.5 |
1 month |
0.25 |
p>0.5 |
0.93 |
p>0.25 |
0.68 |
p>0.25 |
2 months |
0.23 |
p>0.5 |
0.22 |
p>0.5 |
0.09 |
p>0.5 |
3 months |
0.47 |
p>0.25 |
1.48 |
p>0.25 |
1.00 |
p>0.25 |
The disclosed a kind of eye wrinkle-removing film patch of the present invention, its advantage shows: the drug regimen at skin physiology and the research of pharmacology characteristics, design, act on skin in order, open the skin passage.Medicine and skin condition medicine and micromolecule polypeptide class active substance etc. by the skin barrier regulation and control are formed, and to reach the purpose of Transdermal absorption, treatment skin quality and wrinkle effect are remarkable.
The specific embodiment
Below in conjunction with embodiment the present invention is further described.
Embodiment 1
The component of compositions is as follows:
PVAC polyvinylalcohol-124 5g
Fibroblast growth factor 30g
0.025% tretinoin 10g
VitE、VitC 20g
Water 35g
PVAC polyvinylalcohol-124 is uniformly coated on the polyester adherent layer that silicone-treated crosses intensive drying; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille.The gel of pastille quantitatively is added on the above-mentioned film, covers backing film, pressurization is die-cut into suitable size, promptly gets eye wrinkle-removing film patch.
Embodiment 2
The component of compositions is as follows:
PVAC polyvinylalcohol-124 20g
Fibroblast growth factor 40g
0.025% tretinoin 5g
VitE 5g
Water 30g
According to eye socket week three-dimensional data, fashion into as shown in Figure 7 3-D in convex form with PVAC polyvinylalcohol-124; On the concavo-convex adhesive layer inner face of three-dimensional, be covered with the three-dimensional concavo-convex adherent layer that the polyester of silicone-treated is made; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille; On the concavo-convex adhesive layer inner face of three-dimensional, cover gel, the covering backing film of pastille, promptly get the 3 D stereo eye mask for the treatment of eye wrinkle-removing.
Embodiment 3
The component of compositions is as follows:
PVAC polyvinylalcohol-124 13g
Fibroblast growth factor 35g
0.025% tretinoin 7g
Flos Carthami alcohol 15g
Water 30g
PVAC polyvinylalcohol-124 is uniformly coated on the polyester adherent layer that silicone-treated crosses intensive drying; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille.The gel of pastille quantitatively is added on the above-mentioned film, covers backing film, pressurization is die-cut into suitable size, promptly gets eye wrinkle-removing film patch.
Embodiment 4
The component of compositions is as follows:
PVAC polyvinylalcohol-124 20g
Fibroblast growth factor 40g
10% glycolic 5g
VitE 5g
Water 30g
According to eye socket week three-dimensional data, fashion into as shown in Figure 7 3-D in convex form with PVAC polyvinylalcohol-124; On the concavo-convex adhesive layer inner face of three-dimensional, be covered with the three-dimensional concavo-convex adherent layer that the polyester of silicone-treated is made; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille; On the concavo-convex adhesive layer inner face of three-dimensional, cover gel, the covering backing film of pastille, promptly get the 3 D stereo eye mask for the treatment of eye wrinkle-removing.
Embodiment 5
The component of compositions is as follows:
PVAC polyvinylalcohol-124 13g
Fibroblast growth factor 35g
10% glycolic 7g
Flos Carthami alcohol 15g
Water 30g
PVAC polyvinylalcohol-124 is uniformly coated on the polyester adherent layer that silicone-treated crosses intensive drying; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille.The gel of pastille quantitatively is added on the above-mentioned film, covers backing film, pressurization is die-cut into suitable size, promptly gets eye wrinkle-removing film patch.
Embodiment 6
The component of compositions is as follows:
PVAC polyvinylalcohol-124 5g
Fibroblast growth factor 30g
10% glycolic 10g
VitE、VitC 20g
Water 35g
According to eye socket week three-dimensional data, fashion into as shown in Figure 7 3-D in convex form with PVAC polyvinylalcohol-124; On the concavo-convex adhesive layer inner face of three-dimensional, be covered with the three-dimensional concavo-convex adherent layer that the polyester of silicone-treated is made; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille; On the concavo-convex adhesive layer inner face of three-dimensional, cover gel, the covering backing film of pastille, promptly get the 3 D stereo eye mask for the treatment of eye wrinkle-removing.
Embodiment 7
The component of compositions is as follows:
PVAC polyvinylalcohol-124 5g
Fibroblast growth factor 30g
12% lactic acid 10g
Flos Carthami alcohol 20g
Water 35g
PVAC polyvinylalcohol-124 is uniformly coated on the polyester adherent layer that silicone-treated crosses intensive drying; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille.The gel of pastille quantitatively is added on the above-mentioned film, covers backing film, pressurization is die-cut into suitable size, promptly gets eye wrinkle-removing film patch.
Embodiment 8
The component of compositions is as follows:
PVAC polyvinylalcohol-124 20g
Fibroblast growth factor 40g
12% lactic acid 5g
Flos Carthami alcohol 5g
Water 30g
PVAC polyvinylalcohol-124 is uniformly coated on the polyester adherent layer that silicone-treated crosses intensive drying; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille.The gel of pastille quantitatively is added on the above-mentioned film, covers backing film, pressurization is die-cut into suitable size, promptly gets eye wrinkle-removing film patch.
Embodiment 9
The component of compositions is as follows:
PVAC polyvinylalcohol-124 13g
Fibroblast growth factor 35g
12% lactic acid 7g
Flos Carthami alcohol 15g
Water 30g
According to eye socket week three-dimensional data, fashion into as shown in Figure 7 3-D in convex form with PVAC polyvinylalcohol-124; On the concavo-convex adhesive layer inner face of three-dimensional, be covered with the three-dimensional concavo-convex adherent layer that the polyester of silicone-treated is made; PVAC polyvinylalcohol-124, medicine is water-soluble, fully stir, make the gel of pastille; On the concavo-convex adhesive layer inner face of three-dimensional, cover gel, the covering backing film of pastille, promptly get the 3 D stereo eye mask for the treatment of eye wrinkle-removing.