Traditional Chinese medicine composition for treating psoriasis, preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating psoriasis, a preparation method and application thereof. The raw material composition comprises, in mass parts, 10-30 parts of schizonepeta, 10-30 parts of moxa leaf, and 10-30 parts of rhizoma alocasia. Animal experiments show that the traditional Chinese medicine composition can promote the repair of skin barrier function and reduce the skin lesion symptoms of psoriasis-like mice, which indicates that the traditional Chinese medicine composition has a good therapeutic effect on psoriasis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating psoriasis, its preparation method, and its application. Background Technology

[0002] Psoriasis is a common and stubborn chronic inflammatory autoimmune skin disease, induced by a combination of genetic and environmental factors. Clinically, it is characterized by erythema and scaling, and its condition is complex, prone to recurrence, and difficult to cure. The global incidence of psoriasis is 2-3%, and is showing an upward trend. Mild cases affect patients' physical and mental health and work / studies, while severe cases can lead to various complications impacting quality of life and even life itself.

[0003] Currently, the most widely used drugs for treating psoriasis in clinical practice include glucocorticoids and vitamin D3 derivative compound preparations. These drugs mainly improve psoriasis symptoms by inhibiting epidermal proliferation and anti-inflammatory effects, but they are prone to drug resistance and dependence, and have side effects such as easy relapse or rebound after discontinuation of the drug.

[0004] Traditional Chinese medicine (TCM) is easily accepted by patients due to its fewer side effects and better safety profile. While some topical TCM preparations are available on the market for psoriasis and have shown some efficacy, their results are still not satisfactory to patients. Therefore, developing new, safe, and effective TCM treatments for psoriasis has significant social and clinical implications. Summary of the Invention

[0005] The first objective of this invention is to provide a traditional Chinese medicine composition for treating psoriasis; the second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition; and the third objective of this invention is to provide the application of the traditional Chinese medicine composition.

[0006] According to a first aspect of the present invention, a traditional Chinese medicine composition for treating psoriasis is provided, wherein the raw materials comprising, by weight, are: 10-30 parts of Schizonepeta tenuifolia, 10-30 parts of Artemisia argyi, and 10-30 parts of Acorus tatarinowii.

[0007] This invention suggests that the most common clinical syndrome of psoriasis is blood-heat syndrome. Blood heat leads to blood stasis and deficiency, but blood deficiency also leads to blood stasis. Prolonged blood stasis can also generate heat, which circulates without breaking down, resulting in the mutual binding of blood stasis and heat, obstruction of meridians, and abnormal qi and blood.

[0008] This invention uses the principles of clearing heat, removing dampness and detoxifying, promoting blood circulation, dispelling wind and relieving itching, so as to clear heat and cool blood without causing stagnation.

[0009] This formula uses Schizonepeta tenuifolia as the principal herb. Schizonepeta tenuifolia is pungent and slightly bitter, enters the lung and liver meridians, and enters the blood level. It clears blood heat without causing coldness, and also enters the qi level of the Foot Jueyin meridian, where it excels at dispelling wind-evil. Artemisia argyi is the assistant herb. Artemisia argyi is pungent, bitter, and warm, enters the liver and spleen meridians, regulates qi and blood circulation, and is also good at relieving itching. Combined with the principal herb Schizonepeta tenuifolia, it enhances the effects of clearing blood heat and dispelling wind-evil. Acorus tatarinowii is the adjuvant herb. Acorus tatarinowii is pungent, bitter, and warm, enters the heart and stomach meridians, transforms dampness, promotes qi circulation, invigorates blood, and dispels wind. It assists the principal and assistant herbs in their functions of transforming dampness, detoxifying, dispelling wind, and relieving itching. The entire formula works synergistically to clear heat, eliminate dampness, dispel wind, and relieve itching.

[0010] The specific sources of the active pharmaceutical ingredients in this invention are as follows:

[0011] Catnip: The above-ground parts of *Schizonepeta tenuifolia* Briq., a plant belonging to the genus *Schizonepeta* in the family Lamiaceae.

[0012] Artemisia argyi Levl. et Vant., a plant belonging to the genus Artemisia in the family Asteraceae.

[0013] Sweet flag (Acorus tatarinowii): The dried rhizome of Acorus tatarinowii Schott., a plant belonging to the genus Acorus in the family Araceae.

[0014] In some embodiments, the raw material composition by weight includes: 20 parts of catnip, 20 parts of mugwort, and 20 parts of acorus.

[0015] According to a second aspect of the present invention, a topical medicine for treating psoriasis is provided, comprising the above-described traditional Chinese medicine composition for treating psoriasis, and pharmaceutically acceptable excipients.

[0016] In some embodiments, the dosage form of the topical medicine is a lotion, liniment, ointment, or gel.

[0017] According to a third aspect of the present invention, a method for preparing the above-described topical medication for treating psoriasis is provided. When the topical medication is a lotion, the preparation method includes the following steps:

[0018] Mix the raw materials according to the formula, add 8-12 times the weight of water and soak for 1-2 hours, then heat to boiling, maintain a gentle boil for 10-20 minutes, filter to obtain the filtrate, which is the final product.

[0019] According to a fourth aspect of the present invention, the use of the above-described traditional Chinese medicine composition for treating psoriasis in the preparation of a medicament for treating skin barrier dysfunction is provided.

[0020] According to a fifth aspect of the present invention, the use of the above-described traditional Chinese medicine composition for treating psoriasis in the preparation of a medicament for treating psoriasis is provided.

[0021] According to a sixth aspect of the present invention, the use of the above-described topical medicine for treating psoriasis in the preparation of a medicine for treating skin barrier dysfunction is provided.

[0022] According to a seventh aspect of the present invention, the use of the above-described topical medicine for treating psoriasis in the preparation of a medicine for treating psoriasis is provided.

[0023] The beneficial effects of this invention include:

[0024] (1) Animal experiments have shown that the traditional Chinese medicine composition of the present invention can alleviate the skin lesion symptoms of psoriasis-like mice by promoting the repair of skin barrier function. This suggests that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on psoriasis.

[0025] (2) In the traditional Chinese medicine composition of the present invention, Schizonepeta tenuifolia, Artemisia argyi and Acorus tatarinowii work together to relieve exterior symptoms, promote rash eruption and remove dampness. It can effectively repair the skin barrier function, has a significant effect on treating psoriasis, and is safe and has no toxic side effects. Attached Figure Description

[0026] Figure 1 The results of the effect of the psoriasis formula on the skin lesions induced by imiquimod in animal experiments of the present invention are shown in the figure. (a)-(e) are the skin lesion manifestations on the back of mice in each group after the last administration; (f) is the line graph of the skin inflammation PASI score of mice in each group during the experiment; (g) is the bar graph of the skin inflammation PASI score of mice in each group on the last day of the experiment. In the figure, ** indicates that compared with the model group, P<0.01.

[0027] Figure 2 The figures show the effects of the psoriasis formula of the present invention on the morphological characteristics of skin lesions in imiquimod-induced psoriasis-like model mice in animal experiments. In the figures, (a) represents the pathological examination of skin lesions in the control group mice; (b) represents the pathological examination of skin lesions in the model group mice; (c) represents the pathological examination of skin lesions in the positive group mice; (d) represents the pathological examination of skin lesions in the low-dose group of the psoriasis formula mice; and (e) represents the pathological examination of skin lesions in the high-dose group of the psoriasis formula mice.

[0028] Figure 3 The figure shows the effect of the psoriasis formula of the present invention on the skin barrier function of imiquimod-induced psoriasis-like model mice in animal experiments. In the figure, (a) is a comparison of transepidermal water loss (TEWL) of mice in each group; (b) is a comparison of skin barrier function index of mice in each group. Note: Compared with the IMQ group, * indicates P<0.05; ** indicates P<0.01; *** indicates P<0.001. Detailed Implementation

[0029] The present invention will now be described in further detail with reference to the embodiments and accompanying drawings.

[0030] Example 1

[0031] The lotion for treating psoriasis in this embodiment consists of the following raw materials: 20g of Schizonepeta tenuifolia, 20g of Artemisia argyi, and 20g of Acorus tatarinowii.

[0032] For example, its preparation method includes the following steps:

[0033] Mix the raw materials according to the specified ratio, add 2L of water, soak for 2 hours, heat to boiling, maintain a gentle boil for 10 minutes, filter to obtain the filtrate, and cool to about 45℃. When using, first fumigate and wash the affected area, then wipe the affected area, apply a wet compress to the affected area, and gently massage with your hands, once a day.

[0034] In addition, the lotion for treating psoriasis of the present invention can also be prepared according to methods in the prior art, which will not be listed here.

[0035] Example 2

[0036] The lotion for treating psoriasis in this embodiment consists of the following raw materials: 30g of Schizonepeta tenuifolia, 10g of Artemisia argyi, and 10g of Acorus tatarinowii.

[0037] Its preparation method is the same as that of Example 1.

[0038] Example 3

[0039] The lotion for treating psoriasis in this embodiment consists of the following raw materials: 10g of Schizonepeta tenuifolia, 30g of Artemisia argyi, and 30g of Acorus tatarinowii.

[0040] Its preparation method is the same as that of Example 1.

[0041] To demonstrate the therapeutic effect of the traditional Chinese medicine composition for treating psoriasis of the present invention (hereinafter referred to as the psoriasis formula) on psoriasis, the following animal experiments were conducted.

[0042] 1. Grouping, modeling, and drug administration methods

[0043] (1) Grouping

[0044] Fifty SPF-grade male BALB / c mice, weighing 18-22g and aged 6-9 weeks, were purchased from the Guangdong Provincial Medical Animal Experiment Center. They were randomly divided into five groups: control group (Ctrl group), model group (IMQ group), positive control group (DTM group), low-dose psoriasis formula group (YXBF-L group), and high-dose psoriasis formula group (YXBF-H group), with 10 mice in each group.

[0045] (2) Modeling and drug administration

[0046] Methods for establishing an imiquimod-induced psoriasis-like mouse model: One day before the experiment, the hair on a 2cm × 3cm area of ​​the mouse's back was shaved off using electric clippers, and then depilatory cream was applied to remove the remaining hair. Except for the control group, mice in other groups had 62.5mg of 5% imiquimod ointment applied to the shaved area every morning for 6 consecutive days.

[0047] Mice in the control and model groups were treated with 0.1 mL of 0.9% saline solution at the hair removal site every afternoon. Mice in the positive control group were treated with 50 mg of compound dexamethasone acetate cream at the hair removal site every afternoon. Mice in the low-dose psoriasis treatment group were treated with 0.1 mL of a concentrated solution (0.3 g crude drug / mL) obtained from the psoriasis treatment lotion of Example 1 at the hair removal site every afternoon. Mice in the high-dose psoriasis treatment group were treated with 0.1 mL of a concentrated solution (0.5 g crude drug / mL) obtained from the psoriasis treatment lotion of Example 1 at the hair removal site every afternoon. It should be noted that the drug concentration used in animal experiments is different from that used in humans. The drug concentration used in mice is about 9 times that in humans. Therefore, the psoriasis treatment lotion prepared in Example 1 was concentrated before being administered to mice.

[0048] Mice in each group were treated with the drug for 6 consecutive days, and treatment was stopped on the 7th day. Observation showed obvious erythema, scaling, and thickening of the skin on the back of the model group mice, indicating successful modeling. After deep anesthesia, the mice were sacrificed by cervical dislocation, and a 0.5cm × 0.5cm area of ​​skin lesion from the hairless area on the back was taken, fixed with 4% paraformaldehyde, embedded in paraffin, and kept for later use.

[0049] 2. Results of therapeutic efficacy evaluation

[0050] (1) The psoriasis formula improved the skin lesions in imiquimod-induced psoriasis-like model mice.

[0051] During the administration period, the total score of psoriasis-like changes on the back of mice in each experimental group (scaling + erythema + thickening of skin lesions, 0-12) was statistically analyzed and a trend graph was plotted according to the Area and Severity Index (PASI) scoring criteria for clinical psoriasis (as shown in Table 1) to observe the dynamic changes of skin lesions in mice.

[0052] Table 1. Psoriasis Area and Severity Index (PASI) Scoring Criteria

[0053]

[0054] On the third day after applying imiquimod ointment, mice developed psoriasis-like symptoms such as redness and scaling, which continued to worsen. The effects of the psoriasis formula on the imiquimod-induced skin lesions in mice are as follows: Figure 1As shown in the figure, (a)-(e) are the skin lesions on the back of mice in each group after the last administration; (f) is the line graph of the PASI score of skin inflammation in each group of mice during the experiment; (g) is the bar graph of the PASI score of skin inflammation in each group of mice on the last day of the experiment. In the figure, ** indicates that compared with the model group, P<0.01.

[0055] from Figure 1 It can be seen that the control group mice had smooth backs without erythema, scales, or thickening, and their total PASI score remained around 0. Compared with the control group, the model group mice had bright red to purplish-red backs, significantly thickened and wrinkled skin, increased skin lesions, and were covered with thick, layered scales, with some scale shedding. Their total PASI score was significantly higher than that of the control group (P<0.01), indicating that imiquimod successfully induced a psoriasis-like model in mice. The positive group mice still had scales on their skin lesions, but the scales showed a significant reduction compared to the model group, the thickening of the lesions was greatly improved, and most of the erythema had subsided and lightened in color. Compared with the model group, the psoriasis-like skin lesions in mice in the low-dose and high-dose psoriasis formula groups were significantly alleviated, as shown by: the erythema color lightening, changing from red to light pink, and some of it disappearing; the scale area significantly reduced, the scales becoming fragmented and easily detached; and the infiltration thickness of the skin lesions also improved. This indicates that the psoriasis formula of the present invention can effectively alleviate the imiquimod-induced psoriasis-like skin lesion state in mice.

[0056] Comparing the intervention effects of the two dosage groups of the psoriasis formula, the high-dose group of the psoriasis formula showed a more significant effect in improving the degree of erythema, scaling, and infiltration thickness of mouse skin lesions. Furthermore, the PASI total score showed that the high-dose group of the psoriasis formula had a lower PASI total score than the low-dose group, indicating that the topical treatment of psoriasis with the 0.5g / mL dose of the psoriasis formula was more effective than the 0.3g / mL dose.

[0057] In general, after the last administration, the model group showed typical psoriasis symptoms such as thickened skin, scaling, and redness. Both compound dexamethasone acetate cream and the psoriasis formula of the present invention could significantly inhibit and alleviate psoriasis-related symptoms. Among them, the mice treated with compound dexamethasone acetate cream had significantly thinner skin and decreased mental state and activity, but these problems did not exist after using the psoriasis formula of the present invention.

[0058] (2) The psoriasis formula improved the morphological changes of skin lesions in imiquimod-induced psoriasis-like model mice.

[0059] After HE staining, the skin lesions of mice in each group were observed and compared under a light microscope on day 7 of the experiment for histopathological analysis.

[0060] The effects of the psoriasis formula on the morphology of skin lesions in imiquimod-induced psoriasis-like mouse models are as follows: Figure 2As shown in the figure, (a) represents the pathological examination of skin lesions in the control group mice; (b) represents the pathological examination of skin lesions in the model group mice; (c) represents the pathological examination of skin lesions in the positive group mice; (d) represents the pathological examination of skin lesions in the low-dose group of the psoriasis formula mice; and (e) represents the pathological examination of skin lesions in the high-dose group of the psoriasis formula mice.

[0061] from Figure 2 It can be seen that the control group mice had an intact stratum corneum, normal cell morphology, thin epidermis, and no thickening or inflammatory infiltration. The model group mice showed parakeratosis, increased number of epidermal prickle cells, thickened prickle cell layer, and significant inflammatory cell infiltration. Compared with the model group, the positive control group, the low-dose psoriasis formula group, and the high-dose psoriasis formula group showed significantly reduced epidermal thickness, significantly reduced number of epidermal prickle cells, and significant improvements in parakeratosis and inflammatory infiltration. This indicates that the psoriasis formula of the present invention can effectively inhibit the pathological state of the epidermis at the site of psoriasis-like mouse lesions, and the efficacy of the 0.5 g / mL dose of the psoriasis formula is superior to that of the 0.3 g / mL dose.

[0062] (3) Effect of the psoriasis formula on skin barrier function in imiquimod-induced psoriasis-like model mice

[0063] The skin condition of mice in each group was assessed daily using a skin testing instrument. The measured indicators included transepidermal water loss (TEWL) (g / m²). 2 •h) and skin barrier function index (%).

[0064] The effects of the psoriasis formula on skin barrier function in imiquimod-induced psoriasis-like mouse models are as follows: Figure 3 As shown in the figure, (a) is a comparison of transdermal water loss (TEWL) among the groups of mice; (b) is a comparison of skin barrier function index among the groups of mice; Note: Compared with the IMQ group, * indicates P<0.05; ** indicates P<0.01; *** indicates P<0.001.

[0065] from Figure 3 As can be seen, compared with the control group, the transepidermal water loss (TEWL) of the model group mice was significantly increased (P<0.001), and the skin stratum corneum barrier function index was significantly decreased (P<0.01). The transepidermal water loss was significantly reduced and the skin stratum corneum barrier function index was significantly increased in the positive group, the low-dose psoriasis formula group, and the high-dose psoriasis formula group (P<0.01). This indicates that the psoriasis formula of the present invention can effectively inhibit transepidermal water loss and enhance the skin stratum corneum barrier function. Among these, the 0.5 g / mL dose of the psoriasis formula showed better effects in inhibiting transepidermal water loss and enhancing the skin stratum corneum barrier function.

[0066] In summary, the traditional Chinese medicine composition of this invention can alleviate skin lesions in psoriasis-like mice by promoting the repair of skin barrier function. This suggests that the traditional Chinese medicine composition of this invention has a good therapeutic effect on psoriasis.

[0067] The above descriptions are merely some embodiments of the present invention. Those skilled in the art can make various modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the scope of protection of the present invention.

Claims

1. A topical traditional Chinese medicine composition for treating psoriasis, characterized in that, The raw material composition by weight is: 10-30 parts of catnip, 10-30 parts of mugwort, and 10-30 parts of acorus.

2. The topical traditional Chinese medicine composition for treating psoriasis according to claim 1, characterized in that, The raw material composition by weight is: 20 parts of catnip, 20 parts of mugwort, and 20 parts of acorus.

3. A topical medication for treating psoriasis, characterized in that, Its composition is the topical traditional Chinese medicine composition for treating psoriasis as described in claim 1 or 2, and pharmaceutically acceptable excipients.

4. The topical medication for treating psoriasis according to claim 3, characterized in that, The dosage form of the topical medication is a lotion, liniment, ointment, or gel.

5. The method for preparing the topical medication for treating psoriasis according to claim 4, characterized in that, When the topical medication is a lotion, its preparation method includes the following steps: Mix the raw materials according to the formula, add 8-12 times the weight of water and soak for 1-2 hours, then heat to boiling, maintain a gentle boil for 10-20 minutes, filter to obtain the filtrate, which is the final product.

6. The use of the topical traditional Chinese medicine composition for treating psoriasis according to claim 1 or 2 in the preparation of a medicament for treating skin barrier dysfunction caused by psoriasis.

7. The use of the topical traditional Chinese medicine composition for treating psoriasis according to claim 1 or 2 in the preparation of a medicament for treating psoriasis.

8. The use of the topical medicine for treating psoriasis according to claim 3 or 4 in the preparation of a medicine for treating skin barrier dysfunction caused by psoriasis.

9. The use of the topical medicine for treating psoriasis according to claim 3 or 4 in the preparation of a medicine for treating psoriasis.

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