Use of pregnenolone as an active ingredient for the preparation of a medicament for the treatment of psoriasis or atopic dermatitis

Abstract

This invention provides the application of pregnenolone as an active ingredient in the preparation of therapeutic drugs for psoriasis and atopic dermatitis. Through long-term research, the researchers of this invention first discovered and proved that pregnenolone can effectively alleviate the phenotypes of psoriasis and atopic dermatitis in mouse models, demonstrating significant therapeutic effects on both diseases. Furthermore, studies have shown that pregnenolone, whether administered systemically or topically, has significant efficacy in treating psoriasis and atopic dermatitis, exhibiting broad application prospects and considerable value for widespread application. Since pregnenolone is a naturally occurring component in mammals, it has fewer side effects on humans, thus reducing research and development costs and manufacturing costs.

Description

Technical Field

[0001] This invention relates to the field of skin disease treatment technology, and in particular to the use of pregnenolone as an active ingredient in the preparation of therapeutic drugs for psoriasis or atopic dermatitis. Background Technology

[0002] Psoriasis is a common, chronic, relapsing skin disease mediated by the immune system. Clinically, it mainly manifests as erythema or scaling, localized or widespread. Its histopathology is specific, showing excessive proliferation of epidermal keratinocytes, hyperkeratosis with parakeratosis, acanthosis, and sparse perivascular inflammatory cell infiltration in the superficial dermis. The incidence of psoriasis in the general population is 0.1%–3%, and its pathogenesis is complex and prone to recurrence.

[0003] Atopic dermatitis, also known as atopic eczema or hereditary allergic dermatitis, is a chronic, relapsing inflammatory skin disease characterized by dry skin, itching, and eczematous rashes. The etiology of this disease is not yet clear, but it is currently believed to be closely related to the following factors: Genetic factors: Genetic factors can affect the skin's barrier function and immune function. For example, a family history of allergic diseases significantly increases the probability of developing this disease; Immune abnormalities: Many immune cells and their produced cytokines, chemokines, and pro-inflammatory molecules can participate in the pathogenesis; Abnormal skin barrier function: Disruption of the skin barrier function can lead to increased skin permeability and excessive loss of water through the skin surface, resulting in dry skin, desquamation, and easier entry of viruses or allergens into the body, inducing or aggravating immune and inflammatory responses.

[0004] Currently, there are still relatively few drugs available for treating the aforementioned skin diseases, making the search for a new drug with good efficacy of great significance. Summary of the Invention

[0005] Based on this, the present invention provides the application of pregnenolone as an active ingredient in the preparation of a therapeutic drug for psoriasis or atopic dermatitis.

[0006] The present invention also provides a therapeutic agent for psoriasis or atopic dermatitis, comprising pregnenolone as an active ingredient and pharmaceutically acceptable excipients.

[0007] In one embodiment, the therapeutic agent is an injectable agent, an oral agent, or a topical agent.

[0008] In one embodiment, the pregnenolone in the therapeutic drug has a mass percentage of not less than 0.5%.

[0009] In one embodiment, the dosage form of the therapeutic agent is an injection, gel, lotion, liniment, tincture, oil, ointment, paste, patch, or film.

[0010] In one embodiment, the excipients are selected from one or more of solvents, propellants, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, stabilizers, flavoring agents, preservatives, fragrances, penetration enhancers, pH adjusters, and plasticizers.

[0011] In one embodiment, the solvent is selected from one or more of ethanol and physiological saline.

[0012] In one embodiment, the preservative is selected from one or more of sorbic acid, methyl sorbate, methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, sodium methylparaben, benzoic acid, and benzyl alcohol.

[0013] In one embodiment, the emulsifier is selected from one or more of the following: polyoxyethylene hydrogenated castor oil, hydrogenated soybean lecithin, lanolin, glyceryl stearate, sorbitan sesquioleate, cetyl alcohol, stearyl alcohol, cetearyl alcohol, castor oil, and palmitate.

[0014] The above-described solution of the present invention has the following beneficial effects:

[0015] Through long-term research, the researchers of this invention first discovered and proved that pregnenolone can effectively alleviate the phenotypes of psoriasis and atopic dermatitis in mouse models, demonstrating significant therapeutic effects on both diseases. This invention provides a new use for pregnenolone, offering a novel drug for treating psoriasis and atopic dermatitis. Studies have shown that pregnenolone, whether administered systemically or topically, has significant efficacy in treating psoriasis and atopic dermatitis, exhibiting broad application prospects and considerable value for widespread application. Furthermore, since pregnenolone is a naturally occurring component in mammals, it has fewer side effects on humans, reducing research and manufacturing costs. Attached Figure Description

[0016] Figure 1 These are photographs of the skin lesions on the backs of mice in groups 1 to 8 of Example 1 of this invention;

[0017] Figure 2 The image shows the PASI scores of the skin lesions on the backs of mice in groups 1 to 8 of Example 1 of this invention from day 1 to day 6.

[0018] Figure 3 The PASI score of the dorsal skin lesions of mice in groups 1 to 8 in Example 1 of this invention on day 6;

[0019] Figure 4 HE staining micrographs of the skin lesions on the backs of mice in groups 1-8 of Example 1 of this invention on day 6;

[0020] Figure 5 These are photographs of the skin lesions on the backs of mice in groups 1 to 8 of Example 2 of this invention;

[0021] Figure 6 The image shows the PASI scores of the skin lesions on the backs of mice in groups 1 to 8 of Example 2 of this invention from day 1 to day 6.

[0022] Figure 7 The PASI score of the dorsal skin lesions of mice in groups 1 to 8 in Example 2 of this invention on day 6;

[0023] Figure 8 HE staining micrographs of the skin lesions on the backs of mice in groups 1-8 of Example 2 of this invention on day 6;

[0024] Figure 9 These are photographs of ear skin lesions in groups 1 to 8 of Example 3 of the present invention;

[0025] Figure 10 This is a graph showing the thickness change of the ear skin lesions in groups 1 to 8 of the present invention from day 1 to day 9.

[0026] Figure 11 The thickness of the ear skin lesions in mice in groups 1 to 8 of Example 3 of this invention on the ninth day;

[0027] Figure 12 HE staining micrographs of ear skin lesions in mice of groups 1-8 in Example 3 of this invention on the ninth day;

[0028] Figure 13 These are photographs of ear skin lesions in groups 1 to 8 of Example 4 of the present invention;

[0029] Figure 14 This is a thickness diagram of the ear skin lesions of mice in groups 1 to 8 of Example 4 of the present invention from day 1 to day 9;

[0030] Figure 15 The thickness of the ear skin lesions in mice in groups 1 to 8 of Example 4 of this invention on the ninth day;

[0031] Figure 16 HE staining micrographs of ear skin lesions in mice of groups 1 to 8 in Example 4 of this invention on the ninth day. Detailed Implementation

[0032] To make the technical problems, solutions, and advantages of this invention clearer, a detailed description will be provided below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0033] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other. Unless otherwise specified, the reagents and instruments used in the embodiments are conventional choices in the art. Experimental methods not specifying specific conditions in the embodiments are implemented according to conventional conditions, such as those described in literature, books, or methods recommended by the manufacturer.

[0034] the term

[0035] The PASI (Psoriasis Area and Severity Index) score assesses the severity and area of ​​psoriasis lesions in patients using a comprehensive evaluation method. The final score is calculated using a specific formula and is commonly used to assess the severity of psoriasis vulgaris; it is an internationally recognized scoring standard for psoriasis lesion severity.

[0036] HE staining, or hematoxylin-eosin staining, is a commonly used staining method in paraffin sectioning. Hematoxylin is an alkaline staining solution, which primarily colors the chromatin in the cell nucleus and nucleic acids in the cytoplasm with a purple-blue hue; eosin is an acidic dye, which primarily colors the components in the cytoplasm and extracellular matrix with a red hue. HE staining is the most basic and widely used technique in histology, embryology, and pathology teaching and research.

[0037] "Pharmaceutical acceptable excipients" refers to pharmaceutical excipients that are appropriate for administration to patients within the bounds of reasonable medical judgment and that are commensurate with a reasonable benefit / risk ratio.

[0038] One embodiment of the present invention provides the application of pregnenolone as an active ingredient in the preparation of a therapeutic drug for psoriasis or atopic dermatitis.

[0039] Pregnenolone is an endogenous steroid hormone and a precursor to progestins, mineralocorticoids, glucocorticoids, androgens, estrogens, and neuroactive steroids. Pregnenolone is primarily synthesized in the adrenal glands, brain, and gonads (testes and ovaries), and its application as an active ingredient in the treatment of psoriasis and atopic dermatitis is currently undocumented. Through systematic mechanistic exploration and verification, the inventors have demonstrated that pregnenolone plays a crucial role in regulating the pathological pathways of psoriasis and atopic dermatitis, a significant research conclusion based on the inventors' systematic scientific research. This invention provides the first-ever verification of pregnenolone and its oral, injectable, and topical formulations, demonstrating its effective relief of psoriasis and atopic dermatitis.

[0040] An embodiment of the present invention provides a treatment for psoriasis or atopic dermatitis, comprising pregnenolone as an active ingredient and pharmaceutically acceptable excipients.

[0041] In a specific example, the treatment drug can be injected, taken orally, or applied topically, all of which can have a therapeutic effect.

[0042] In one specific example, the mass percentage of pregnenolone in the treatment drug is not less than 0.5%. Optionally, the mass percentage of pregnenolone in the treatment drug is 0.5% to 99%, 0.5% to 50%, etc. It is understood that the specific concentration can be adjusted as needed according to the condition or individual circumstances, for example, 0.5%, 1.0%, etc., and is not limited thereto.

[0043] In a specific example, the dosage form of the therapeutic drug may be an injection, gel, lotion, liniment, tincture, oil, ointment, paste, patch, or film, which may be adjusted as needed.

[0044] In a specific example, the excipients are selected from one or more of the following: solvents, propellants, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, stabilizers, flavoring agents, preservatives, fragrances, penetration enhancers, pH adjusters, and plasticizers. It is understood that different excipients can be selected and combined according to the needs of dosage form preparation.

[0045] In a specific example, the solvent is selected from one or more of ethanol and saline, for example, dissolved in saline to prepare an injection.

[0046] Optionally, the preservative is selected from one or more of sorbic acid, methyl sorbate, methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, sodium methylparaben, benzoic acid, and benzyl alcohol.

[0047] Optionally, the emulsifier is selected from one or more of the following: polyoxyethylene hydrogenated castor oil, hydrogenated soybean lecithin, lanolin, glyceryl stearate, sorbitan sesquioleate, cetyl alcohol, stearyl alcohol, cetearyl alcohol, castor oil, and palmitate.

[0048] Optionally, the disintegrant is selected from one or more of croscarmellose sodium, carboxymethyl starch sodium, croscarmellose polyvinylpyrrolidone, or low-substituted hydroxypropyl cellulose. Optionally, the colorant is selected from one or more of carbon black, iron black, iron brown, iron red, and titanium dioxide.

[0049] The following are specific examples.

[0050] Example 1: Systemic administration of pregnenolone significantly inhibited psoriasis.

[0051] 1. Experimental Methods

[0052] Forty-eight 8-week-old female Balb / c mice were randomly divided into eight groups (n=6 per group):

[0053] OVX group: Under isoflurane gas anesthesia, all mice except the sham control group underwent bilateral ovariectomy to remove the ovaries.

[0054] Fake control group: underwent surgery, but did not have their ovaries removed.

[0055] Pregnenolone (Preg) was purchased from Selleck and is soluble in ethanol. It was further diluted to the working concentration in sterile water before use.

[0056] IMQ modeling for psoriasis: A 2.5cm x 3.5cm area was shaved on the back, and 62.5mg of imiquimod (IMQ) was applied daily.

[0057] The treatments for each group of mice are shown in the table below:

[0058]

[0059] Groups 1-4 received no topical IMQ treatment. Group 5 was the sham-operated group (simultaneously receiving sterile water injection and topical IMQ to create a psoriatic dermatitis model); Group 6 was the OVX group (simultaneously receiving sterile water injection and topical IMQ); Group 7 was the OVX group (simultaneously receiving low-dose Preg injection and topical IMQ); and Group 8 was the OVX group (simultaneously receiving high-dose Preg injection and topical IMQ). After 5-7 days of continuous treatment, the Psoriasis Skin Lesion Area and Severity Index (PASI) was used to assess the psoriasis-like symptoms in the mice. The mice were then weighed and photographed. They were subsequently euthanized, and the back lesions were used for HE staining to assess epidermal thickness and keratinocyte proliferation. The spleens of the mice were also weighed and photographed.

[0060] The PASI scoring principle is as follows: Daily assessment of the severity of skin inflammation, including measurement of skin thickness, crusting, and erythema. A 5-point scale (0-4) is used for scoring.

[0061] Skin thickness (infiltration): 0: smooth skin without wrinkles; 1: slight wrinkles appear at the edge of the treatment area; 2: slight wrinkles appear on the entire treatment area; 3: the wrinkles in the treatment area become more pronounced; 4: based on a score of 3, the mouse shows signs of weight loss or poor condition.

[0062] Scaling: 0: Smooth skin without scales; 1: Slight scaling appears on the skin in the treatment area; 2: The skin in the treatment area is completely covered with scales; 3: The scaling in the treatment area becomes more severe; 4: Based on a score of 3, the mouse shows signs of weight loss or poor condition.

[0063] Erythema: 0: Smooth skin; 1: Slight redness in the treated area; 2: The entire treated area turns red; 3: The redness in the treated area deepens further; 4: Based on a score of 3, the mouse exhibits weight loss or poor condition.

[0064] Overall score: The sum of scores for skin thickness, crusting, and erythema.

[0065] 2. Results

[0066] like Figure 1 The images show photographs of the dorsal skin lesions of mice in groups 1-8. It is evident that the IMQ group exhibits significantly more erythema, thickening, and scaling compared to the non-IMQ group, demonstrating the successful induction of the psoriasis model. Furthermore, the dorsal skin lesions in the OVX+IMQ group showed more severe inflammation than those in the sham surgery+IMQ group, indicating that postmenopausal sex hormone decline can exacerbate psoriasis. In the OVX+injection group, the Preg injection group showed significantly reduced erythema, infiltration, and thickening compared to the sterile water injection group, indicating that Preg can effectively treat psoriasis. Within-group comparisons within the Preg group showed that high-dose Preg (10 mg / kg / d) resulted in less inflammation than low-dose Preg (1 mg / kg / d), indicating that higher Preg doses are more effective in inhibiting IMQ-induced psoriatic inflammation. In conclusion, systemic administration of Preg can significantly inhibit postmenopausal IMQ-induced psoriasis-like inflammation.

[0067] like Figure 2 The image shows the PASI scores of the skin lesions on the backs of mice in groups 1-8 from day 1 to day 6. Figure 3 The results show the PASI scores of the dorsal skin lesions of mice in groups 1-8 on day 6. It can be seen that the Prec systemic administration can effectively treat psoriasis, and the higher the dose, the better the effect.

[0068] like Figure 4 The image shown is a HE staining micrograph of the skin lesions on the back of mice in groups 1-8 on day 6, further demonstrating that Preg systemic administration can significantly and effectively improve psoriatic skin lesions.

[0069] Example 2: Topical application of pregnenolone significantly inhibited psoriasis.

[0070] 1. Experimental Methods

[0071] Forty 8-week-old female Balb / c mice were randomly divided into 8 groups (n=5 per group), as shown in the table below:

[0072] Group Sham surgery group Group OVX technique group 1 Sham surgery group + IMQ 5 OVX procedure + IMQ 2 Sham surgery group + IMQ + BASE 6 OVX procedure group + IMQ + BASE 3 Sham surgery group + IMQ + 0.5% Preg 7 OVX procedure + IMQ + 0.5% Prescription 4 Sham surgery group + IMQ + 1.0% Preg 8 OVX procedure + IMQ + 1.0% Prescription

[0073] Pregnenolone (Preg) was purchased from Selleck, dissolved in ethanol, and then prepared into gel formulations with mass concentrations of 0.5% and 1.0%. The Base group is the blank matrix group.

[0074] IMQ modeling for psoriasis: A 2.5cm x 3.5cm area was shaved on the back, and 62.5mg of imiquimod (IMQ) was applied daily.

[0075] Groups 1-4 underwent sham surgery, while groups 5-8 underwent OVX surgery. Psoriasis-like dermatitis modeling began 7 weeks post-surgery. In the morning, groups 1-8 received topical imiquimod at 62.5 mg / day. 4-6 hours later, groups 2 and 6 received 62.5 mg of a blank matrix, groups 3 and 7 received 0.5% Preg gel, and groups 4 and 8 received 1.0% Preg gel. 5-7 days after modeling, the Psoriasis Skin Lesion Area and Severity Index (PASI) was used to assess psoriasis-like symptoms on the back of the mice. The mice were then weighed and photographed. They were subsequently euthanized, and the back lesions were used for HE staining to assess epidermal thickness and keratinocyte proliferation. The spleens of the mice were also weighed and photographed.

[0076] 2. Results

[0077] like Figure 5 The images show photographs of skin lesions on the backs of mice in groups 1-8. The IMQ group exhibits significant erythema, thickening, and scaling, confirming the successful induction of the psoriasis model. Regardless of whether OVX surgery was performed, there was no significant difference in skin lesions between the IMQ + topical BASE group and the IMQ group, indicating that the pure gel has no significant therapeutic effect on psoriasis. However, the addition of Preg significantly improved skin lesions in the IMQ + Preg group, and higher Preg concentrations resulted in better therapeutic effects. Furthermore, the effect of Preg was more pronounced in the OVX group.

[0078] like Figure 6 The image shows the PASI scores of the skin lesions on the backs of mice in groups 1-8 from day 1 to day 6. Figure 7 The image shows the PASI scores of the skin lesions on the back of mice in groups 1-8 on day 6. It can be seen that topical treatment with Preg can also effectively treat psoriasis, and the higher the dose, the better the effect.

[0079] like Figure 8 The image shown is a HE staining micrograph of the skin lesions on the back of mice in groups 1-8 on day 6, further demonstrating that topical administration of Preg can significantly and effectively improve the skin lesions of psoriasis.

[0080] Example 3: Systemic administration of pregnenolone significantly inhibited atopic dermatitis.

[0081] 1. Experimental Methods

[0082] Forty-eight 8-week-old female Balb / c mice were randomly divided into eight groups (n=6 per group):

[0083] OVX group: Under isoflurane gas anesthesia, all mice except the sham control group underwent bilateral ovariectomy to remove the ovaries.

[0084] Fake control group: underwent surgery, but did not have their ovaries removed.

[0085] Pregnenolone (Preg) was purchased from Selleck and is soluble in ethanol. It was further diluted to the working concentration in sterile water before use.

[0086] Atopic dermatitis modeling: Mice in the modeling group were administered 20 μL of calcipotriol (MC903) per ear per day.

[0087] The treatments for each group of mice are shown in the table below:

[0088] Group No modeling Group MC903 mold 1 Sham surgery group + sterile water injection 5 Sham surgery group + sterile water injection 2 OVX group + sterile water injection 6 OVX group + sterile water injection 3 OVX low-dose Prec (1 mg / kg / day) 7 OVX low-dose Prec (1 mg / kg / day) 4 OVX high-dose Prec (10 mg / kg / day) 8 OVX high-dose Prec (10 mg / kg / day)

[0089] Groups 1-4 were not treated with MC903. Group 5 was the sham-operated group (simultaneously receiving sterile water injection and topical application of MC903 to create an atopic dermatitis model); Group 6 was the OVX group (simultaneously receiving sterile water injection and topical application of MC903); Group 7 was the OVX group (simultaneously receiving low-dose Preg injection and topical application of MC903); Group 8 was the OVX group (simultaneously receiving high-dose Preg injection and topical application of MC903). The treatment was continued for 7-9 days, and the thickness of the ear lesions was measured daily. Mice were then weighed and photographed, followed by euthanasia. Ear lesions were collected for HE staining to examine epidermal thickness and keratinocyte proliferation. The spleens of the mice were also collected, weighed, and photographed.

[0090] 2. Results

[0091] like Figure 9 The images show photographs of ear lesions in mice from groups 1 to 8. It is evident that the MC903 group exhibits significantly more erythema, edema, thickening, and scaling compared to the non-MC903 group, demonstrating the successful induction of the atopic dermatitis model. Furthermore, the ear lesions in the OVX+MC903 group showed more severe inflammation than those in the sham surgery+MC903 group, indicating that postmenopausal sex hormone decline can exacerbate atopic dermatitis. In the OVX+injection group, the Preg injection group showed significantly reduced erythema, infiltration, and thickening compared to the sterile water injection group, indicating that Preg can effectively treat atopic dermatitis. Within-group comparisons within the Preg group, the high-dose Preg (10 mg / kg / d) showed milder inflammation than the low-dose Preg (1 mg / kg / d), indicating that higher Preg doses have a better effect on inhibiting MC903-induced atopic dermatitis inflammation. In conclusion, systemic administration of Preg can significantly inhibit postmenopausal MC903-induced atopic dermatitis-like inflammation.

[0092] like Figure 10 The figure shows the thickness changes of ear skin lesions in mice from day 1 to day 9 for groups 1 to 8. Figure 11 The thickness of the ear skin lesions in mice from groups 1 to 8 on day 9 shows that Prec systemic administration can effectively treat atopic dermatitis, and the higher the dose, the better the effect.

[0093] like Figure 12 The image shown is a HE staining micrograph of the ear skin lesions of mice in groups 1-8 on the ninth day, further demonstrating that systemic administration of Preg can effectively improve the skin lesions of atopic dermatitis.

[0094] Example 4: Topical application of pregnenolone significantly inhibited atopic dermatitis.

[0095] 1. Experimental Methods

[0096] Forty 8-week-old female Balb / c mice were randomly divided into 8 groups (n=5 per group), as shown in the table below:

[0097] Group Sham surgery group Group OVX technique group 1 Sham surgery group + MC903 5 OVX treatment kit + MC903 2 Sham surgery group + MC903 + BASE 6 OVX treatment kit + MC903 + BASE 3 Sham surgery group + MC903 + 0.5% Preg 7 OVX procedure + MC903 + 0.5% Preg 4 Sham surgery group + MC903 + 1.0% Preg 8 OVX treatment kit + MC903 + 1.0% Prescription

[0098] Pregnenolone (Preg) was purchased from Selleck, dissolved in ethanol, and then prepared into gel formulations with mass concentrations of 0.5% and 1.0%. The Base group is the blank matrix group.

[0099] Atopic dermatitis modeling with MC903: Mice in the modeling group were administered 20 μL of calcipotriol (MC903) per ear per day for 9 consecutive days.

[0100] Groups 1-4 underwent sham surgery, while groups 5-8 underwent OVX surgery. Atopic dermatitis-like dermatitis modeling began in the 7th week post-surgery. In the morning, groups 1-8 received 20 μL of calcipotriol (MC903) applied to their ears. Four to six hours later, groups 2 and 6 received a blank matrix, groups 3 and 7 received 0.5% Preg gel, and groups 4 and 8 received 1.0% Preg gel. Ear thickness was measured daily to assess atopic dermatitis-like symptoms in mice. Mice were then weighed, photographed, and euthanized. Ear lesions were collected for HE staining to examine epidermal thickness and immune cell infiltration.

[0101] 2. Results

[0102] like Figure 13The images show photographs of ear skin lesions in groups 1-8 of mice. The MC903 group exhibits significant erythema, edema, scaling, and thickening, confirming the successful induction of the atopic dermatitis model. Regardless of whether OVX surgery was performed, there was no significant difference in skin lesions between the MC903 + topical BASE group and the MC903 group, indicating that pure gel has no significant therapeutic effect on atopic dermatitis. However, with the addition of Preg, the skin lesions in the MC903 + Preg group showed significant improvement, and the higher the Preg concentration, the better the therapeutic effect. Furthermore, the effect of Preg was more pronounced in the OVX group.

[0103] like Figure 14 The image shown depicts the thickness of ear skin lesions in mice from day 1 to day 9 for groups 1 to 8. Figure 15 The thickness of ear skin lesions in mice from groups 1 to 8 on day 9 shows that topical administration of PREc can effectively treat atopic dermatitis, and the higher the dose, the better the effect.

[0104] like Figure 16 The image shown is a HE staining micrograph of ear skin lesions in mice from groups 1 to 8 on day 9, further demonstrating that topical administration of PREc can effectively improve atopic dermatitis-like skin lesions.

[0105] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. Application of pregnenolone as the sole active ingredient in the preparation of therapeutic drugs for atopic dermatitis.

2. The application according to claim 1, characterized in that, The therapeutic drug includes pregnenolone as the active ingredient and pharmaceutically acceptable excipients.

3. The application according to claim 2, characterized in that, The therapeutic drugs are injectable drugs, oral drugs, or topical drugs.

4. The application according to claim 2, characterized in that, In the therapeutic drug, the mass percentage of the pregnenolone is not less than 0.5%.

5. The application according to claim 2, characterized in that, The dosage form of the therapeutic drug is an injection, gel, lotion, liniment, tincture, oil, ointment, paste, patch, or film.

6. The application according to claim 2, characterized in that, The excipients are selected from one or more of the following: solvents, propellants, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, stabilizers, flavoring agents, preservatives, fragrances, penetration enhancers, pH adjusters, and plasticizers.

7. The application according to claim 6, characterized in that, The solvent is selected from one or more of ethanol and physiological saline.

8. The application according to claim 6, characterized in that, The preservative is selected from one or more of sorbic acid, methyl sorbate, methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, sodium methylparaben, benzoic acid, and benzyl alcohol.

9. The application according to claim 6, characterized in that, The emulsifier is selected from one or more of the following: polyoxyethylene hydrogenated castor oil, hydrogenated soybean lecithin, lanolin, glyceryl stearate, sorbitan sesquioleate, cetyl alcohol, stearyl alcohol, cetearyl alcohol, castor oil, and palmitate.

10. The application according to claim 6, characterized in that, The disintegrant is selected from one or more of croscarmellose sodium, carboxymethyl starch sodium, croscarmellose polyvinylpyrrolidone or low-substituted hydroxypropyl cellulose.

Images