Preparation for treating psoriasis and application

Abstract

The invention discloses a preparation for treating psoriasis and application. The preparation is prepared from the following raw materials: propylene glycol, halcinonide, fluocinonide acetate, salicylic acid, dimethyl sulfoxide, polyethylene glycol 400, glycerol, borneol, edetate disodium, ethylparaben and ethylparaben. The traditional Chinese medicine composition is reasonable in composition, the treatment effect on psoriasis can be remarkably improved, the problem of pigmentation after treatment can be effectively improved or avoided, and particularly, due to the use of salicylic acid and edetate disodium, it is verified that the traditional Chinese medicine composition has a remarkable curative effect on psoriasis. Salicylic acid and edetate disodium have a synergistic effect on psoriasis treatment effect and pigmentation improvement of the whole medicine system.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a preparation for treating psoriasis and its application. Background Art

[0002] Psoriasis, commonly known as "psoriasis," is a chronic, relapsing, inflammatory skin disease. It has a long course, is prone to recurring attacks, and is relatively difficult to treat. The main characteristic of psoriasis is the appearance of red papules or plaques covered with multiple layers of silvery-white scales with distinct borders, accompanied by varying degrees of itching. In addition, some patients may also experience lesions in areas such as nails and joints. Halcinonide (CAS: 3093-35-4) is a corticosteroid. When applied topically, it can constrict dermal capillaries, inhibit epidermal cell proliferation and regeneration, inhibit fibroblast formation in connective tissue, stabilize intracellular lysosomal membranes, and prevent tissue damage caused by the release of lysosomal enzymes. It has strong anti-inflammatory and anti-allergic effects. It is currently used to treat psoriasis, but the efficacy of halcinonide alone is limited and it can easily cause hyperpigmentation. Summary of the Invention

[0003] Therefore, based on the above background, the present invention provides a preparation and application for treating psoriasis, which, through a reasonable composition, can not only significantly improve the therapeutic efficacy of psoriasis, but also effectively improve or avoid pigmentation problems after treatment.

[0004] The technical solution provided by the present invention is:

[0005] A preparation for treating psoriasis, the composition of its preparation raw materials is as follows:

[0006] Propylene glycol 9.5-25ml, halcinonide 0.05-0.1g, fluocinolone acetonide 0.01-0.05g, salicylic acid 1-5g, dimethyl sulfoxide 4-10ml, polyethylene glycol 4008-15ml, glycerol 3-12ml, borneol 1-3g, disodium edetate 0.01-0.1g, ethylparaben 0.05-0.15g, ethylparaben 0.05-0.15g.

[0007] Preferably, the composition of the raw materials for its preparation is as follows:

[0008] Propylene glycol 15ml, halcinonide 0.1g, fluocinonide 0.05g, salicylic acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 4008ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

[0009] Preferably, the composition of the raw materials for its preparation is as follows:

[0010] Propylene glycol 20ml, halcinonide 0.1g, fluocinonide 0.05g, salicylic acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 40015ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

[0011] Based on the same inventive concept, the present invention also provides the use of the above-mentioned preparation in the preparation of a drug for treating psoriasis.

[0012] Furthermore, the psoriasis is selected from any one of psoriasis vulgaris, psoriasis arthritis, psoriasis pustularis, and psoriasis erythroderma.

[0013] Furthermore, the psoriasis is psoriasis vulgaris.

[0014] Furthermore, the medicine is in the form of an external dosage form.

[0015] Furthermore, the preparation of the drug comprises the following steps:

[0016] 1) Take a portion of propylene glycol, add halcinonide and dissolve it completely, then add edetate disodium and stir until it is completely dissolved;

[0017] 2) taking the remaining amount of propylene glycol and polyethylene glycol, glycerin, and dimethyl sulfoxide, mixing them, adding fluocinonide, salicylic acid, borneol, ethylparaben, ethylparaben, and ethylparaben, and stirring until the mixture is uniform;

[0018] 3) The solution of step 1) and the mixture of step 2) are mixed evenly and homogenized.

[0019] The beneficial effects achieved by the present invention are:

[0020] The present invention, through a reasonable composition, can not only significantly improve the therapeutic efficacy of psoriasis, but also effectively improve or avoid the problem of pigmentation after treatment. In particular, the use of salicylic acid and disodium edetate has been verified to have a synergistic effect on the therapeutic efficacy of psoriasis and its improvement of pigmentation in the entire drug system.

[0021] Figures in the specification

[0022] Attachment Figure 1 These are pictures of the affected area of ​​the patient in typical case 1 before and after treatment. The left is before medication and the right is after medication.

[0023] Attachment Figure 2 These are pictures of the affected area of ​​the patient in typical case 2 before and after treatment. The left is before medication and the right is after medication.

[0024] Attachment Figure 3 These are pictures of the affected area of ​​the patient in typical case 3 before and after treatment. The left is before medication and the right is after medication. DETAILED DESCRIPTION

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0026] Example 1: A drug for treating psoriasis, the composition of its preparation raw materials is as follows:

[0027] Propylene glycol 15ml, halcinonide 0.1g, fluocinonide 0.05g, salicylic acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 4008ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

[0028] Example 2: A drug for treating psoriasis, the composition of its preparation raw materials is as follows:

[0029] Propylene glycol 20ml, halcinonide 0.1g, fluocinonide 0.05g, salicylic acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 40015ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

[0030] The preparation of the medicines of Example 1 and Example 2 comprises the following steps:

[0031] 1) Take a portion of propylene glycol, add halcinonide and dissolve it completely, then add edetate disodium and stir until it is completely dissolved;

[0032] 2) taking the remaining amount of propylene glycol and polyethylene glycol, glycerin, and dimethyl sulfoxide, mixing them, adding fluocinonide, salicylic acid, borneol, ethylparaben, ethylparaben, and ethylparaben, and stirring until the mixture is uniform;

[0033] 3) The solution of step 1) and the mixture of step 2) are mixed evenly and homogenized.

[0034] Comparative Example 1: A drug for treating psoriasis, the composition of its preparation raw materials is shown below:

[0035] Propylene glycol 15ml, halcinonide 0.1g, fluocinonide 0.05g, dimethyl sulfoxide 5ml, polyethylene glycol 4008ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

[0036] Compared with Example 1, this embodiment removes salicylic acid.

[0037] Comparative Example 2: A drug for treating psoriasis, the composition of its preparation raw materials is shown below:

[0038] Propylene glycol 15ml, halcinonide 0.1g, fluocinonide 0.05g, citric acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 4008ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

[0039] Compared with Example 1, salicylic acid in this example is replaced by citric acid, which also has the function of softening keratin and promoting the exfoliation of aged keratin.

[0040] Comparative Example 3: A drug for treating psoriasis, the composition of its preparation raw materials is shown below:

[0041] Propylene glycol 15ml, halcinonide 0.1g, fluocinonide 0.05g, salicylic acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 4008ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

[0042] This embodiment uses disodium EDTA, which can also play a chelating role like disodium edetate, as a replacement.

[0043] The treatments of Comparative Examples 1 to 3 are the same as those of Examples 1 and 2.

[0044] The present invention adopts a rational composition, using halcinonide to treat psoriasis by utilizing anti-inflammatory, immunosuppressive, and anti-proliferative properties. Dimethyl sulfoxide, propylene glycol, polyethylene glycol, and glycerol can be used as solvents. Dimethyl sulfoxide and propylene glycol can increase drug permeability by destroying the lipid structure of the stratum corneum. Borneol can dilate skin capillaries and enhance drug transmembrane transport. It, together with dimethyl sulfoxide and propylene glycol, can play a role in permeation, thereby improving the utilization of effective ingredients such as halcinonide. Glycerol and polyethylene glycol can work together to maintain skin moisture and reduce dryness and desquamation, thereby maintaining skin moisture and reducing dryness and desquamation, thereby enhancing the therapeutic effect. Disodium edetate is a chelating agent that ensures the stability of the drug system and prevents drug degradation. Ethyl paraben and ethyl paraben are preservatives. Salicylic acid can soften and remove hyperkeratotic scales of psoriasis plaques, clear the stratum corneum barrier, and synergize with dimethyl sulfoxide and propylene glycol to increase drug penetration and absorption. The present invention also finds that salicylic acid works synergistically with disodium edetate to enhance the therapeutic effect of the drug system on psoriasis and improve and prevent post-treatment pigmentation.

[0045] Application Verification:

[0046] In April 2024, 67 patients diagnosed with psoriasis vulgaris (all in the active or dormant stage), including 37 males and 30 females, were randomly divided into 4 groups with the informed consent of the patients, namely, the Example group (22 people), the Control group 1 (14 people), the Control group 2 (16 people), and the Control group 3 (15 people), and different drugs were selected for treatment. The Example group was treated with the drug of Example 1, the Control group 1 was treated with the drug of Comparative Example 1, the Control group 2 was treated with the drug of Comparative Example 2, and the Control group 3 was treated with the drug of Comparative Example 3.

[0047] During treatment, apply the medication to the affected area twice a day (morning and evening). Apply directly to the affected area in the morning and wrap the affected area in plastic wrap at night for at least two hours. For psoriasis on the head, apply directly to the affected area without wrapping. For psoriasis on the hands, apply the medication to the affected area with disposable gloves. After 20 consecutive days of treatment, observe the efficacy. Observation indicators: PASI scores before and after treatment; all patients underwent allergy testing before treatment, and treatment was discontinued if any allergic reactions occurred. During the treatment process, no allergic reactions were reported.

[0048] Efficacy criteria:

[0049] Recovery: PASI score improvement rate greater than 90%;

[0050] Markedly effective: PASI score improvement rate is between 60% and 89% (inclusive);

[0051] Effective: PASI score improvement rate is between 20% and 59% (including the end value);

[0052] Ineffective: PASI score improvement rate is less than 20%.

[0053] PASI (Psoriasis Area and Severity Index) is a quantitative tool used to assess the severity of psoriasis. The score is calculated by comprehensively considering the lesion area, erythema, infiltration and scaling.

[0054] The PASI score is based on four dimensions: erythema (redness of the skin), infiltration (thickening of the skin), scaling (degree of scaling), and area of ​​lesion. The first three dimensions are graded on a scale of 0 to 4 (0 = no symptoms, 4 = very severe), while the area score is based on the percentage of skin affected, with a score of 0 to 6 (e.g., 1 = <10% and 6 = ≥90%).

[0055] The total score is the weighted sum of each dimension, and the formula is: PASI total score = erythema score × infiltration score × scaling score × area weight coefficient.

[0056] PASI score improvement rate = (PASI score before treatment - PASI score after treatment) / PASI score before treatment × 100%;

[0057] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0058] The efficacy results are shown in Table 1 below.

[0059] Table 1: Treatment efficacy results

[0060] Group get well Significant effect efficient invalid Total efficiency Example Group 10(45.5％) 8(36.4％) 3(18.18％) 0 100％ Control group 1 1(7.1％) 4(28.5％) 7(50％) 2 85.7％ Control group 2 4(25％) 5(31.2％) 6(37.5％) 1 93.4％ Control group 3 6(40％) 5(33.3％) 4(26.6％) 0 100％

[0061] As can be seen from Table 1, the therapeutic efficacy of the Example group is significantly higher than that of the Control Group 1 and the Control Group 2. Although the statistical efficacy of the Example group and the Control Group 3 is 100%, the cure rate and the marked efficacy of the Example group are higher than those of the Control Group 3, which fully demonstrates that the therapeutic effect of the Example group is superior to that of the Control Group 3. The therapeutic effects of the Example group, the Control Group 2, and the Control Group 3, especially the cure rate and the marked efficacy, show that the therapeutic effect of salicylic acid or edetate disodium is reduced when citric acid or EDTA disodium, which have the same effect, is used to treat psoriasis. This shows that salicylic acid and edetate disodium have a synergistic effect on the entire drug system in the treatment of psoriasis.

[0062] Pigmentation can be reflected by skin color, and the skin color is analyzed by ImageJ software after correcting the photo with Photoshop CS7, and measuring the L* value of the skin in the area. The L* value represents the black and white range of the skin. The larger the L* value, the whiter the skin color, and vice versa. Therefore, for each patient, a photo of the affected area is taken in the same environment after treatment, and the base of the patient's arm (near the armpit) (non-affected area, generally rarely exposed to sunlight and other radiation, which can relatively reflect the patient's true skin color) is photographed in the same environment. The L* value measured based on this photo is referred to as the natural skin L*, and the difference rate between the affected skin L* value and the natural skin L* value is calculated. Specifically: Difference rate = (natural skin L* value - affected skin L* value) * 100% / natural skin L* value.

[0063] Table 2: Comparison of skin L* values ​​in the affected area of ​​pigmentation

[0064] Group Example Group Control group 1 Control group 2 Control group 3 L* value of affected skin 54.47 46.23 49.86 51.64 Natural skin L* value 55.31 55.29 56.44 54.89 Difference rate % 1.52 16.38 11.66 5.92

[0065] As can be seen from the above, the difference between the skin color of the affected area and the natural skin after treatment in the Example group is the smallest, indicating that the pigmentation of the affected area of ​​the Example group is the smallest. The difference in the Control 1 group is the largest, indicating that the pigmentation of the affected area is the largest. By comparing the Control 2 and Control 3 groups with the Example group, it can be seen that when salicylic acid or edetate disodium is used with citric acid or EDTA disodium having the same effect, the pigmentation is more obvious. This shows that salicylic acid and edetate disodium can effectively improve the pigmentation problem after treatment for the entire drug system in the treatment of psoriasis.

[0066] Example 2: Typical Case

[0067] In addition to treating the patients in the example group in the above validation samples, the drug of the present invention has also been used in thousands of patients from 2021 to 2025, and all of them have reported significant effects. The following are typical cases:

[0068] Case 1: Ma, female, 30 years old, before treatment Figure 1 As shown in the left figure, the back of the left hand has skin erythema, peeling and itching. The drug of Example 1 was used for treatment. After 2 days of treatment, itching was significantly relieved. After 5 days, there was no desquamation. After 11 days of treatment, the effect was as follows: Figure 1 As shown in the picture on the right, the symptoms have disappeared, the skin is smooth and fair, and there is no obvious pigmentation.

[0069] Case 2: Liu, female, 59 years old, before treatment Figure 2 As shown in the left figure, the back of his right hand suffers from psoriasis. The affected skin is covered with silvery white scales, accompanied by continuous desquamation and itching. The drug of Example 1 was used for treatment. The itching was significantly relieved after 2 days of medication, and the desquamation stopped after 4 days. The effect was as follows after 17 days. Figure 2 As shown in the right picture, the symptoms disappeared, the skin became smooth, without pigmentation, and basically returned to normal.

[0070] Case 3: Mr. Wang, male, 35 years old, before treatment Figure 3 As shown in the left figure, a large area of ​​red patches appeared on the back of the patient. The red patches were obviously raised and hardened, and it was severely itchy. The drug of Example 1 was used for treatment. The itching stopped after 3 days of medication. After 5 days, the color of the red patches became lighter. After 20 days, the treatment effect was as follows: Figure 3 As shown in the right picture, the symptoms have basically disappeared.

[0071] Case 4: Huang, female, 55 years old, had erythema, desquamation, and itching on her head and limbs before treatment. The itching stopped after 3 days of medication, the desquamation became lighter after 4 days, the erythema began to improve and became lighter in color after 6 days, and the symptoms basically disappeared after 20 days.

[0072] The present invention and its embodiments are described above. Such description is not restrictive. The embodiment shown in the embodiment is only one embodiment of the present invention, and the actual structure is not limited thereto. In short, if a person skilled in the art is inspired by the above, and does not deviate from the purpose of the invention, without creatively designing a structure and embodiment similar to the technical solution, they shall fall within the scope of protection of the present invention.

Claims

1. A preparation for treating psoriasis, characterized in that: The composition of the raw materials for its preparation is as follows: Propylene glycol 9.5-25ml, halcinonide 0.05-0.1g, fluocinolone acetonide 0.01-0.05g, salicylic acid 1-5g, dimethyl sulfoxide 4-10ml, polyethylene glycol 4008-15ml, glycerol 3-12ml, borneol 1-3g, disodium edetate 0.01-0.1g, ethylparaben 0.05-0.15g, ethylparaben 0.05-0.15g.

2. A preparation for treating psoriasis according to claim 1, characterized in that: The composition of the raw materials for its preparation is shown below: Propylene glycol 15ml, halcinonide 0.1g, fluocinonide 0.05g, salicylic acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 4008ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

3. A preparation for treating psoriasis according to claim 1, characterized in that: The composition of the raw materials for its preparation is shown below: The composition of the raw materials for its preparation is shown below: Propylene glycol 20ml, halcinonide 0.1g, fluocinonide 0.05g, salicylic acid 3g, dimethyl sulfoxide 5ml, polyethylene glycol 40015ml, glycerin 10ml, borneol 2g, disodium edetate 0.08g, ethylparaben 0.15g, ethylparaben 0.1g.

4. Use of the preparation according to any one of claims 1 to 3 in the preparation of a medicament for treating psoriasis.

5. The use according to claim 4, characterized in that The psoriasis is selected from any one of psoriasis vulgaris, psoriasis arthritis, psoriasis pustularis, and psoriasis erythroderma.

6. The use according to claim 4, characterized in that The psoriasis is psoriasis vulgaris.

7. The use according to claim 4, characterized in that The medicine is in the form of an external dosage form.

8. The use according to claim 7, characterized in that The preparation of the drug comprises the following steps: 1) Take a portion of propylene glycol, add halcinonide and dissolve it completely, then add edetate disodium and stir until it is completely dissolved; 2) taking the remaining amount of propylene glycol and polyethylene glycol, glycerin, and dimethyl sulfoxide, mixing them, adding fluocinonide, salicylic acid, borneol, ethylparaben, ethylparaben, and ethylparaben, and stirring until the mixture is uniform; 3) The solution of step 1) and the mixture of step 2) are mixed evenly and homogenized.

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