WO2016052947A1

WO2016052947A1 - Acidic external preparation composition for psoriasis treatment

Info

Publication number: WO2016052947A1
Application number: PCT/KR2015/010191
Authority: WO
Inventors: 김성우; 정세규; 이신희; 김수환
Original assignee: (주)네오팜
Priority date: 2014-09-29
Filing date: 2015-09-25
Publication date: 2016-04-07
Also published as: KR20160037791A

Abstract

The present invention relates to a pharmaceutical composition for psoriasis treatment, wherein the pharmaceutical composition is characterized in that pH is adjusted to acidic by an acidic polymer compound. The present invention provides a novel composition for psoriasis treatment, which is effective in the psoriasis treatment, such as decreasing the thickness of an epidermis layer of the psoriasis-caused skin and increasing and maintaining moisture.

Description

Specification

Name of invention: Acidic external composition for dry treatment

[1] The present invention is a composition for the treatment of psoriasis, which relates to a pharmaceutical composition whose pH is controlled by an acidic polymer compound.

Background

[2] Psoriasis is a chronic inflammatory skin disease, usually in the elbows, knees, scalp, nails, toenails, or torso, and is a chronic skin disease in which the development of silvery-skinned spot papules is characteristic. It may be psoriasis, epidermal psoriasis or pustulic psoriasis, and may occur locally or occur throughout the body, which may lead to severity and may be accompanied by complications.

[3] Research into the causes of psoriasis is being actively conducted, but it is not yet clear.

Genetic, environmental, drug, skin irritation and stress are the main causes, and stimulation of keratinocytes in the skin through various mechanisms of immune substances secreted by immune cells such as skin T cells, dendritic cells, and neutrophils. Psoriasis is thought to be caused by excessive growth and inflammation of keratinocytes.

[4] For the treatment of psoriasis, apply the medicine directly to the affected area or use ultraviolet rays, etc.

Several methods have been used, including photochemical treatments, injections of drugs or oral ingestion, etc. Direct application of drugs that can be tolerated mainly by creams or ointments that contain steroids. Increasing the incidence of skin cancer is also reported in the case of injection or oral infusion therapy, which has been reported to have side effects such as suppression of immune cell activity, cirrhosis of the liver, and fibrosis. Active, but there are no treatments or methods to prevent clear cure and recurrence of psoriasis.

[5] Korean Patent No. 0634397 provides a composition for treating psoriasis, a composition containing several components in a specific ratio, and Korean Patent No. 1374907 provides alpha 2 adrenergic receptors for treating psoriasis-related symptoms. The effectiveness of this drug and its potential as a treatment for psoriasis-related diseases are described.

[6] The present invention is a composition for treating psoriasis by regulating pH to acidity, and the invention of a composition for treating psoriasis by adjusting pH like the present invention is unknown.

[7]

Detailed description of the invention

Technical task

[8] The present invention provides a composition for treating psoriasis, specifically acidic. It is to provide a pharmaceutical external preparation composition of pH 3.0 to 5.0 phosphoric acid by adjusting the pH with a high molecular compound.

Task solution

[9] The present invention provides a pharmaceutical external composition for treating psoriasis containing an acidic polymer compound.

[10] The present invention provides a psoriasis therapeutic pharmaceutical external composition whose pH is controlled to 3.0 to 5.0 by the amount of acidic polymer compound.

[11] The present invention is to adjust the pH of the carbomer (carbomer) having a carboxyl group, to provide a pharmaceutical external composition of pH 3.0-5.0.

Effects of the Invention

[12] Treatment of pharmacological external formulations containing acidic polymer compounds with pH 3.0 to 5.0 Effects of psoriasis on skin thickness reduction by psoriasis, reduction of skin moisture evaporation, increase of skin moisture content and measurement of skin tissue weight You can see that there is. Brief description of the drawings

1 shows the weight change of mice on days 8, 10 and 12.

2 shows changes in the thickness of the back skin of mice on days 8, 10 and 12.

3 shows the change in the thickness of the ear skin of the mouse at 8th, 10th and 12th days.

4 shows changes in skin moisture evaporation of mice on days 8, 10 and 12. FIG.

FIG. 5 shows changes in the skin moisture content of mice on days 8, 10, and 12. FIG.

6 shows a change in the back tissue weight of a mouse.

7 shows the change in the weight of the ear tissue of the mouse. The left bar shows the weight of the left ear.

[20] Figure 8 shows the skin pH change of the mouse

9 shows the results of erythema measurement in the mouse.

10 shows changes in the thickness of the epidermal layer of the mouse and the back tissue.

[23] Figure 11 shows the thickness of the epidermal epidermal layer of the mouse.

12 shows the results of observing the thicknesses of the back tissues (A) and ear tissues (B) of Comparative Example 1. FIG.

FIG. 13 shows the results of observing the thicknesses of the back tissues (A) and ear tissues (B) of Comparative Example 2. FIG.

FIG. 14 shows the results of observing the thicknesses of the back tissues (A) and ear tissues (B) of Example 1. FIG.

FIG. 15 shows the results of observing the thicknesses of the back tissues (A) and ear tissues (B) of Example 2. FIG.

FIG. 16 shows the results of observing the thicknesses of the back tissues (A) and ear tissues (B) of Example 3. FIG.

17 shows the results of observing the thicknesses of the back tissues (A) and ear tissues (B) of Example 4. FIG.

18 shows the results of observing the thicknesses of the back tissues (A) and ear tissues (B) of Example 5. FIG.

Best Mode for Carrying Out the Invention

[31] Hereinafter, the present invention will be described in detail.

Unless otherwise defined, the terms used in this specification should be interpreted as those generally understood by those skilled in the art. BRIEF DESCRIPTION OF THE DRAWINGS The drawings and embodiments of the specification are intended to enable those skilled in the art to easily understand and practice the present invention, and may not omit the subject matter of the drawings and embodiments, and the present invention is not limited to the drawings and embodiments. .

[32] The present invention provides a pharmaceutical external composition for treating psoriasis.

It is a pharmaceutical composition for the treatment of psoriasis containing a high molecular compound, the pH of which is adjusted to 3.0 to 5.0 by the acidic polymer compound.

[33] Psoriasis (prosiasis) is a common condition known as psoriasis and its symptoms.

Psoriasis is a chronic inflammatory skin disease characterized by epidermal growth and inflammation of the dermis, with reddening of the skin at the onset and the appearance of silvery scales on the skin. Eulyang, ulcerative and hemorrhagic dryness.

[34] An acidic polymer compound is a polymer compound containing an acidic functional group.

The acidic polymeric compound is preferably carbomer or carbopol. According to one embodiment of the present invention, acrylic acid is synthesized as a monomer to form a carboxyl group. The pH of the composition can be adjusted according to the amount of carbomer, an acidic polymer compound having

[35] The composition for treating psoriasis for treating psoriasis is a composition having a specific pH, wherein the pH is 3.0 to 5.0, 3.1 to 4.9, 3.2 to 4.8, 3.3 to 4.7, 3.4 to 4.6, 3.5 to 4.5, 3.6 to 4.4, 3.7 to 4.3 , 3.8 to 4.2, 3.9 to 4.1, 3.1 to 3.9, 3.2 to 3.8, 3.3 to 3.7, 3.4 to 3.6. The external composition of the above pH range is applied to psoriasis-induced skin to confirm the psoriasis treatment effect due to the pH drop. can do. If the pH is lower than 3.0, it may cause a cosmetic problem, it is difficult to conduct animal experiments, and even when used as an external preparation, the skin may be adversely affected.

For the treatment of psoriasis, the pH range specified by the Food and Drug Administration's Cosmetic Standards and Test Methods is outside the pH range of 3.0 to 9.0, and external application for skin with a pH of less than 3.0 has no meaning experimentally or commercially.

[36] External preparations are used on the outside of the human body, and may include ointments, lotions, creams, etc., depending on the type of formulation, but are not limited depending on the type, as long as they can be used for external therapy. pH, water content, mass mass should be considered, and can be formulated into oil-based, oil-based, water-based and suspending columns such as petroleum jelly, paraffin, plastic, lard, silicone, vegetable oil, wax, lanolin, etc. It may contain additives such as moisturizers, solubilizers, softening aids, etc. When formulated into lotions, it may be formulated into solution bases, suspension bases and emulsion bases and may contain humectants such as glycerin and glycols.

[37] Psoriasis induction can be carried out by spreading imiquimod creams on the skin. Psoriasis induced by imiquimod has clinical, histological and immunological changes in In the present invention, the psoriasis model induced by imiqui mode was used to check the effect of the external composition for psoriasis treatment, but it is also not limited to this, and can also be applied to the skin of psoriasis patients.

According to an embodiment of the present invention, the external composition for treating psoriasis for acid is decreased in the skin area of the psoriasis-induced skin, the back and ear psoriasis-derived epidermal layer thickness, moisture evaporation, and water content are increased. And the weight loss of psoriasis tissue was able to confirm the effect.

[39] Hereinafter, the present invention will be described in more detail with reference to the external composition for the treatment of psoriasis of the present invention, but the present invention is not limited to the following examples.

[40]

Mode for Carrying Out the Invention

[41] [Examples 1 to 5]

[42] cosmetic preparations for external application of skin

[43] The preparation of external application for skin application is carried out in the form of cream which can be applied to skin.

It was. component of pH 3.5 for external application is the same as Table 1 below, by controlling the carbomer and water ^was used to prepare a dispersible preparation for external use of pH 3.0 ~ 5.0 in the same component.

[44] Table 1

[Table 1]

Content (g) Water 77.70 Glycerin 4.20 Cetearyl alcohol 3.50 Butylene glycol 3.00 Caprylic / capric triglyceride 2.50 Grape seed oil (Vitisinifera seed oil) 2.50 Glyceryl stearate 1.50 Polyglyceryl-10 distearate 1.00

1,2-nucleic acid diol 40% (1,2-Hexanediol), caprylyl glycol 0.60 40% (Caprylyl glycol), tropolone 20% (Tropolone)

Stearic acid 0.90 Camellia oleifera seed oil 0.50 Polyglyceryl-3 methyl Glucose distearate 80% Polyglyceryl-3 0.50 methylglucosedistearate, Glyceryl sterate SE 10%

stearate SE), methylglucose sesquistearate 10% (methyl

glucose sesquistearate)

Dimethicone 0.40 Hydrogenate Poly (C6-14 Olefin)

Myristoyl / palmitoyloxostearamide / arachamide 0.30 MEA (Myristoyl / palmitoyloxostearamide / arachamide MEA)

Xanthan gum 0.05 Tocopheryl acetate 0.10 Methylbenzylmethylbenkimidacolpiperidinylpetanone (Methylbenzylmethy 0.05 lbenzimidazolepiperidinylmethanone)

Phytosterol 0.05 Arginine 0.00 Carbomer 0.20 Ammonium Acryloyldimethyltaurate Vinylpyridone Copolymer 0.05 (Ammonium Acryloyldimethyltaurate / VP Copolymer) ᅵ Total 100

[45] length of guermouse

[46] A 7-week-old female mouse (Balb / c) was prepared for 1 week in constant temperature and humidity conditions for the production of psoriasis-induced mice. (imiquimod, Aldara®) 62.5 mg of 5% cream was also applied to the back and right ear. After 2 days, Imiquimod 5% cream was applied to the back and right ear for 5 days at 62.5 mg daily for 5 days. Body weight, trans epidermal water loss (TEWL), skin moisture (hydration), etc. Psoriasis-induced mice were identified by measuring the skin thickness of the ears.

[47]

[48] Selection of Comparative Examples 1-2 and Examination Examples 1-5

[49] The body weights, skin level evaporation, skin moisture content, and skin thickness of the horn and ears were measured and divided into groups similar to the mean values. A total of 7 groups of 5 mice were used in each group. The normal mouse group vehicle group 1 (Comparative Example 1) and no treatment to the psoriasis-induced mouse

Group 1 (Comparative Example 2), which was treated only with IMQ (Imidazoline quarternary), was designated as a control group, and according to the pH of the acidic external solvent to be treated, pH 3.0 external solvent treatment group (Example 1), ρΗ 3.5 external solvent treatment group (Example 2), pH 4.0 external solvent treatment experimental group (Example 3), pH 4.5 external solvent treatment experimental group (Example 4), and pH 5.0 external solvent treatment experimental group (Example 5) were divided into five different experimental groups.

[50]

[51] Acidic external application for skin application and status check

[52] Starting with the _eighth day of the experiment, apply the external preparation daily for four days in the back and right ear.

The condition was checked by measuring the body weight, skin moisture evaporation, skin moisture and skin thickness of the back and ears at the 8th, 10th, and 12th day of the experiment, and from the 12th day of the end of the experiment, the skin pH and erytheme were measured. ) To confirm the condition.

[53]

[54] Histopathological Confirmation

[55] On the 12th day of the experiment, the mouse was relaxed and the dorsal skin tissue and left and right ear tissues were excised into a 6 mm diameter circle and weighed and fixed in 10% neutral buffered formalin. Blocks were prepared, and cut to 5 um in thickness to proceed with H & E (hematoxylin & eosin) staining. The stained tissue was confirmed by an optical microscope (Figs. 12-18), and the thickness of the epidermis was measured.

[56]

[57] Table 2 [Table 2]

— '-Day 8 Day 10 Day 12 Day 8 Day 10 Day 12 Day 12 Comparative Example 1 20.01 21.08 20.65 Comparative Example 1 19.30 20.11 20.98

1 2 20.11 21.14 22.03 2 2 19.40 21.01 21.21

3 19.89 20.98 21.12 3 19.60 20.21 20.99

4 20.24 21.56 20.88 4 18.90 20.01 21.48

5 19.57 20.88 21.34 5 18.30 19.88 22.20 Average 19.96 21.13 21.20 Average 19.10 20.04 21.37 Standard 0.23 0.23 0.47 Standard 0.46 0.11 0.45

Example 1 18.90 19.98 22.31 Example 1 18.60 19.89 21.56

1 2 19.30 20.10 21.48 2 2 19.70 20.14 20.98

3 20.10 21.03 21.21 3 19.30 20.34 20.77

4 18.10 19.88 21.88 4 19.10 20.45 22.78

5 17.60 19.22 21.56 5 19.10 20.14 21.45 Average 18.80 20.04 21.69 Average 19.16 20.19 21.51 Standard 0.88 0.58 0.38 Standard 0.36 0.19 0.70 Difference

Example 1 18.90 19.88 20.14 Example 1 18.80 20.34 21.81

3 2 19.90 19.99 22.21 4 2 19.40 20.54 21.54

3 19.20 20.87 22.22 3 19.70 20.62 21.03

4 19.60 20.17 22.04 4 19.30 20.81 21.35

5 19.10 20.42 21.08 5 19.40 20.14 21.55 Average 19.34 20.27 21.54 Average 19.32 20.48 21.46 Standard 0.36 0.35 0.82 Standard 0.29 0.23 0.26

Table 2 and Figure 1 show the mouse's weight (g), which showed a slight weight loss in the IMQ-treated group, but not a significant difference.

[59]

[60] Table 3

[Table 3]

—'- ^ Day 8 Day 10 Day 12 Day 8 Day 10 Day 12 Day 12 Comparative Example 1 5.10 6.30 6.40 Comparative Example 1 28.90 31.80 41.20

1 2 6.90 6.70 5.10 2 2 32.80 38.80 40.30

3 2.20 8.10 5.80 3 39.50 35.606 39.90

4 8.80 5.50 5.40 4 33.60 34.20 34.80

5 5.80 7.30 6.10 5 30.30 33.30 38.40 Average 6.36 6.78 5.76 Average 33.02 34.74 38.92 Standard 1.38 0.88 0.47 Standard 3.65 2.38 2.25 Car

Example 1 33.50 29.30 25.30 Example 1 35.40 28.30 20.40

1 2 30.70 28.80 26.70 2 2 33.10 30.10 18.40

3 33.20 27.60 24.30 3 31.20 29.80 21.30

4 36.70 30.10 25.60 4 32.80 28.70 19.10

5 32.00 29.90 24.70 5 35.20 29.30 17.30 Average 33.22 29.14 25.32 Average 33.54 29.24 19.30 Standard Edition 2.00 0.90 0.83 Standard Edition 1.58 0.67 1.42 Car Difference

Example 1 35.80 19.80 15.40 Example 1 34.50 24.50 18.80

3 2 29.80 20.60 18.30 4 2 32.40 23.50 19.10

3 34.20 20.30 19.10 3 32.10 24.90 18.80

4 33.80 19.80 17.30 4 33.10 23.40 18.40

5 30.30 20.70 18.80 5 33.50 23.50 19.30 Average 32.78 20.24 17.78 Average 33.12 23.96 18.88 Standard 2.33 0.38 1.34 Standard 0.85 0.62 0.31 Difference

Table 3 and Figure 2 shows the skin moisture evaporation (g / cnf / hr) in Comparative Example 2 treated IMQ was 5 times more skin moisture evaporation than Comparative Example 1 on day 8, Example 2, Example Near-normal values were seen in 3 and Example 4, and the most effective in Example 3. The significant increase was confirmed in all of Examples 1-5.

[62]

[63] Table 4

[Table 4]

[64]

Table 4 and FIG. 3 show skin moisture content (AU), and Comparative Example 2 treated with IMQ reduced the skin moisture content by three times or more than Comparative Example 1. Example 2, Example 3, and Example A value close to normal was shown in Fig. 4, and the best effect was obtained in Example 3. A significant increase was confirmed in all of Examples 1 to 5.

[66]

[67] Table 5

[Table 5]

8th Day 10th Day 12th Day 8th Day 10th Day 12th Day Comparative Example 1 0.22 0.23 0.24 Comparative Example 1 0.77 0.80 0.79

1 2 0.21 0.21 0.23 2 2 0.68 0.71 0.78

3 0.19 0.22 0.23 3 0.71 0.68 0.76

4 0.21 0.23 0.21 4 0.73 0.66 0.69

5 0.23 0.20 0.22 5 0.69 0.67 0.67 Average 0.21 0.22 0.23 Average 0.72 0.70 0.74 Standard piece 0.01 0.01 0.01 Standard piece 0.03 0.05 0.05 Difference

Example 1 0.68 0.55 0.49 Example 1 0.73 0.51 0.36

1 2 0.69 0.61 0.51 3 2 0.74 0.48 0.33

3 0.71 0.57 0.45 3 0.75 0.48 0.35

4 0.77 0.58 0.53 4 0.81 0.56 0.37

5 0.73 0.60 0.40 5 0.64 0.44 0.41 Average 0.72 0.58 0.48 Average 0.73 0.49 0.36 Standard piece 0.03 0.02 0.05 Standard piece 0.05 0.04 0.03 Difference

Example 1 0.69 0.49 0.33 Example 1 0.68 0.53 0.33

3 2 0.78 0.48 0.31 4 2 0.78 0.51 0.29

3 0.69 0.51 0.35 3 0.81 0.49 0.41

4 0.71 0.44 0.37 4 0.71 0.61 0.44

5 0.77 0.39 0.28 5 0.66 0.58 0.38 Average 0.73 0.45 0.33 Average 0.73 0.54 0.37 Standard piece 0.04 0.04 0.03 Standard piece 0.06 0.04 0.05 Difference

Table 5 and FIG. 4 show round thickness ^ m), and Comparative Example 2 treated with IMQ was three times thicker than Comparative Example 1, and thicknesses close to normal in Examples 2, 3, and 4 The most effective result was shown in Example 3. Significant decrease was confirmed in all of Examples 1-5.

[69]

[70] Table 6

[Table 6]

Left right

Group 8 Day 10 Day 12 Day 8 Day 10 Day 12 Day Comparative Example 1 1 0.07 0.06 0.07 0.07 0.07 0.07

2 0.07 0.07 0.07 0.07 0.07 0.07

3 0.07 0.07 0.07 0.07 0.07 0.07

4 0.07 0.07 0.07 0.07 0.07 0.07

5 0.07 0.07 0.07 0.07 0.06 0.07 Average 0.07 0.07 0.07 0.07 0.07 0.07 Standard deviation 0.00 0.00 0.00 0.00 0.00 0.00 Comparative example 2 1 0.07 0.07 0.07 0.22 0.21 0.24

2 0.07 0.07 0.07 0.23 0.21 0.24

3 0.06 0.07 0.07 0.24 0.25 0.25

4 0.07 0.07 0.07 0.22 0.26 0.23

5 0.07 0.07 0.07 0.24 0.24 0.22 Average 0.07 0.07 0.07 0.23 0.23 0.24 Standard deviation 0.00 0.00 0.00 0.01 0.02 0.01 Example 1 1 0.07 0.06 0.07 0.23 0.21 0.18

2 0.07 0.07 0.07 0.23 0.21 0.18

3 0.07 0.07 0.06 0.21 0.22 0.17

4 0.07 0.07 0.07 0.22 0.21 0.17

5 0.07 0.07 0.07 0.23 0.22 0.16 Average 0.07 0.07 0.07 0.22 0.21 0.17 Standard deviation 0.00 0.00 0.00 0.01 0.00 0.01 Example 2 1 0.07 0.07 0.07 0.24 0.21 0.16

2 0.07 0.07 0.06 0.23 0.20 0.16

3 0.07 0.07 0.07 0.23 0.22 0.14

4 0.07 0.06 0.07 0.21 0.21 0.16

5 0.07 0.07 0.07 0.22 0.19 0.18 Average 0.07 0.07 0.07 0.23 0.21 0.16 Standard deviation 0.00 0.00 0.00 0.01 0.01 0.01 Example 3 1 0.07 0.07 0.07 0.22 0.20 0.15

2 0.06 0.07 0.07 0.24 0.19 0.12

3 0.07 0.07 0.07 0.23 0.20 0.12

4 0.07 0.06 0.07 0.22 0.21 0.13

5 0.07 0.07 0.07 0.21 0.21 0.15 Average 0.07 0.07 0.07 0.22 0.20 0.13 Standard deviation 0.00 0.00 0.00 0.01 0.01 0.01 Example 4 1 0.07 0.06 0.07 0.22 0.20 0.13

2 0.07 0.07 0.07 0.24 0.20 0.14

3 0.07 0.07 0.07 0.25 0.21 0.14

4 0.07 0.07 0.07 0.21 0.20 0.15

5 0.07 0.07 0.07 0.21 0.21 0.15 Average 0.07 0.07 0.07 0.23 0.20 0.14 Standard deviation 0.00 0.00 0.00 0.02 0.00 0.01 Example 5 1 0.07 0.06 0.07 0.21 0.21 0.18

2 0.07 0.07 0.07 0.23 0.21 0.18

3 0.07 0.07 0.07 0.23 0.22 0.19

4 0.07 0.07 0.07 0.24 0.20 0.17

5 0.07 0.07 0.07 0.21 0.19 0.20 Mean 0.07 0.07 0.07 0.22 0.21 0.18 Standard deviation 0.00 0.00 0.00 0.01 0.01 0.01 Table 6 and FIG. 5 measured ear thickness 0 ^ 1) and the left ear was treated as a control. Comparative Example 2 which processed IMQ is 3 times more than Comparative Example 1.

Thickened, closest to normal in Examples 3 and 4, and the most effective in Examples 3. Significant decreases were found in both Examples 1-5.

[72]

[73] Table 7 [Table 7]

Table 7 and Figure 6 show the weight (mg) of the tissues taken after the end of the experiment, and the weight was reduced compared to Comparative Example 2 treated with IMQ in Examples 1 to 5. Example 2, Example 3 and Example The closest normal value was shown in Example 4, and the most effective was obtained in Example 3. A significant decrease was confirmed when compared with Comparative Example 2 in all of Examples 1 to 5.

[75]

Table 8

[Table 8]

Tables 8 and 7 show the weight (mg) obtained after the end of the experiment, and when compared with the right ear, Examples 1 to 5 reduced the weight than Comparative Example 2 treated with 11 ⁽ 3). 2, Examples 3 and 4 showed a near-normal value, and when compared with Comparative Example 2 in all of Examples 1 to 5 was confirmed a significant decrease.

[78]

[79] Table 9

[Table 9]

Table 9 and Figure 8 show the skin pH, the pH was reduced in Examples 1 to 5, except for Example 5 all showed a significant decrease in milk, the value closest to the normal in Example 3 Appeared.

[81]

[82] Table 10

[Table 10]

Table 10 and Figure 9 are measured the degree of erythema using a color difference meter, the degree of flare is hardly distinguished by the naked eye or reduced numerically, the significance was shown in Examples 3 and 4.

[84]

Table 11

[Table 11]

Group point 1 point 2 point 3 point 4 point 5 point 5 Total average comparative example 1 1 11.3 10.3 11.8 12.6 12.2 9.6 11.1

2 13.5 9.7 9.1 11.6 8.4 11.6

3 10.1 10.5 13.4 9.9 12.1 10.5

4 12.4 10.8 11.6 12.3 9.1 11.3

5 11.3 12.1 11.7 11.8 12.3 9.4 Comparative Example 2 1 90.2 77.2 81.5 67.8 98.7 93 75.3

2 96.7 77.1 71.2 78.6 71.7 81.3

3 67.2 65.7 61.8 80.3 61.4 62.5

4 64.5 66.5 68.8 61 66.2 71.2

5 77.3 68.7 90.3 78.4 80.7 81.3 Example 1 1 26.3 24.7 28.9 30.1 33.5 19.1 30.2

2 18.4 28.3 25.3 24.7 21.6 26.9

3 25.3 30.3 34.4 38.9 37.6 33.3

4 35.6 34.2 33.3 32.8 31.8 29.5

5 33.6 37.1 31.2 33 35.7 30.3 Example 2 1 26.8 25.4 21.8 29.4 18.3 15.6 24.8

2 27 27.9 26.8 28.3 30.1 27.4

3 20.5 21.3 25.5 28.9 26.3 27.1

4 22.1 23.3 25.3 18.9 21.3 27.1

5 26.4 25.3 25.5 25.1 27.1 23.3 Example 3 1 21.6 23.1 23.8 22.8 25.1 22.5 23.5

2 28.8 22.7 22.1 22.8 20.8 18.9

3 27.9 16.6 15.3 23.5 25 29.1

4 19.4 26.4 23.9 23.3 23.4 24.1

5 23.4 25.6 27.1 21.3 28.6 25.4 Example 4 1 26.3 25.8 24.1 30.3 33.1 18.9 25.0

2 16.1 29.8 25.3 26.7 26.6 20

3 25.3 30.1 27.4 24.3 25.1 28.3

4 26.4 21.3 25.3 28.1 24.1 20.3

5 20.4 21.3 22.8 25 22.6 28.8 Example 5 1 30.8 32.7 33.4 33.8 30.9 36 32.8

2 35.8 31.3 30.2 30.1 27.2 35.3

3 31.2 30.3 32.1 38.8 29.8 33.3

4 34.4 33.4 34.5 31.7 33.4 36.1

5 30.1 35.3 39.6 28.7 31.5 33.3 Table 11 and Fig. 10 show the thickness of the epidermis (n) through H & E staining. The thickness of the epidermal layer was measured at six different points after photographing the dyed tissue sample. Compared with Comparative Example 2 treated with IMQ, Examples 1 to 5 showed significant decreases, and near-normal values were shown in Examples 3, 4 and 5, and the best effect in Example 3 was obtained. Confirmed. Table 12

[Table 12]

Group point 1 point 1 point 3 point 4 point 5 point 6 Total average comparative example 1 1 9.3 11.4 10.8 11.6 9.1 13.5 10.7

2 11.4 11.6 10.9 8.8 10.6 9.7

3 11.6 10.8 12 11.7 10.4 10.8

4 11.1 12.3 10.8 10.5 9.8 10.6

5 10.4 11.2 10.8 9.4 8.1 10.5 Comparative Example 2 1 63.4 52.1 58.3 54.1 57.1 60.3 53.1

2 48.4 47.1 57.2 52.3 50.4 51.6

3 53.6 53.4 51.8 57.1 58.3 50.4

4 49.6 48.8 50.3 52.7 54.1 50.9

5 52.1 53.7 58.1 45.3 50.3 50.3 Example 1 1 40.3 38.5 35.1 36.4 34.7 33.1 36.7

2 36.3 34.2 31.2 35.3 33.7 33.8

3 30.8 36.9 34.2 41.3 42.6 39.8

4 36.4 35.1 33.8 38.9 38.4 35.3

5 37.8 38.5 39.9 40.5 40.3 38.1 Example 2 1 32.2 31.3 30.5 36 34.5 33.3 32.8

2 35.1 35.2 36.4 37.1 35.2 33.3

3 30.1 28.5 40.3 30.5 31.2 31.2

4 33.4 35.1 30.5 30.9 31.4 33.7

5 29.5 30.4 34.1 32.5 30.3 30 Example 3 1 33.3 32.1 28.9 35.4 30.1 32.7 31.2

2 29.8 30.3 28.7 29.6 30.3 31.5

3 33.2 31.5 30.8 31.6 32 32.8

4 30.7 31.3 29.8 32.3 33.3 31

5 28.5 31.2 30.8 30.7 31.5 30.1 Example 4 1 30.3 28.6 35.4 37.1 33.5 35.1 33.4

2 31.2 33.6 35.1 _. 30.2 30.8 31.7

3 33.5 35.2 35.4 34.3 36.1 40.3

4 30.1 32.3 33.1 32 31.8 32.1

5 35.3 33.4 35.4 31.2 33.3 34.5 Example 5 1 45.3 42 40.3 42.1 38.6 39.5 39.4

2 38.4 35.2 39.4 40.1 41.3 40.4

3 44.3 42.5 38.7 38.8 36.9 37.2

4 38.4 36.9 37.1 40.4 33.8 35.6

5 42.3 39.4 44.4 38.5 35.6 40

Table 12 and FIG. 11 show the thickness of the epidermis mi) through H & E staining. The thickness of the epidermis was measured at six different points after photographing the dyed tissue sample pole. Compared with Comparative Example 2 treated with IMQ, Examples 1 to 5 showed a significant decrease, and the closest normal values were found in Examples 3, 4, and 5, and the highest in Example 3. Excellent effect was confirmed.

[90]

[91] Table 13

[Table 13]

I | *** P <0.00, ** P <0.01, * P <0.05, ns P> 0.05

Table 13 shows the significance of each of the quantitative measurements taken in Comparative Examples 1 and 2 and Examples 1 to 5, in particular, Examples 1 to 5 were more significant at all values compared to Comparative Example 2, which only processed IMQ. Worked.

Claims

Claim

Claim 1 An external composition for treating psoriasis containing an acidic polymer compound and having a pH of 3.0 to 5.0.

[Claim 2] In paragraph 1,

The pH of the external preparation for psoriasis treatment, characterized in that the pH is adjusted according to the content of the polymer.

[Claim 3] In paragraph 2,

The acidic polymer compound is an external preparation for treating psoriasis, which is carbomer or carbopol.

[Claim 4] In any of the preceding paragraphs,

The composition is an external preparation for psoriasis treatment in the form of a lotion, cream, gel, ointment, plaster, emulsion, solution, aerosol and paste.