A traditional Chinese medicine composition for treating psoriasis, a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating psoriasis and a preparation method and application thereof, and belongs to the technical field of medicines. The traditional Chinese medicine composition comprises an oral composition and an external use composition. The oral composition comprises Huangqi, Huangbai, Huanglian, Tufuling, Zhizi, Longdan, Mianbudixie, Pailan, Zexie, Kuqian, Cangzhu, Lianqiao and Haitongpi. The external use composition comprises Huanglian, Huangbai, Huangqi, Xishengcao, Baishaxieshecao, Tufuling, Kuqian and Cangzhu. The external use composition is applied to the surface of the diseased skin during the oral administration of the oral composition. After the oral composition and the external use composition are used in combination, the symptoms of psoriasis such as erythema, scales and thickening can be obviously relieved, the curative effect is remarkable, the external use composition can cooperate with the oral composition, the oral composition has better treatment effect, and the oral composition and the external use composition have a synergistic effect. The traditional Chinese medicine composition has definite curative effect, low recurrence rate and small side effect, provides a favorable means for clinically treating psoriasis, and is convenient for large-scale popularization.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a traditional Chinese medicine composition for treating psoriasis, its preparation method, and its application. Background Technology

[0002] Psoriasis is a common, chronic, relapsing, inflammatory, systemic disease characterized by scaly, erythematous patches or plaques on the skin, often accompanied by itching and pain. Psoriasis is prone to relapse and difficult to treat, severely impacting patients' physical and mental health and quality of life.

[0003] Currently, treatment for psoriasis mainly involves topical medications and biologics. Topical medications include keratolytic agents, antibiotics, and corticosteroids; biologics include adalimumab and infliximab. While both can achieve some therapeutic effect in the early stages, long-term use results in significant side effects and a high relapse rate. Therefore, it is essential to explore a highly effective and safe drug treatment for psoriasis.

[0004] Based on this, this application utilizes traditional Chinese medicine theory to treat psoriasis through a combination of Chinese herbal medicines. It demonstrates significant advantages in alleviating patients' clinical symptoms, reducing recurrence rates, and minimizing side effects, with an efficacy rate approaching 100%. This is a clinically valuable treatment method for psoriasis that is suitable for large-scale promotion. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating psoriasis, which, based on the theory of traditional Chinese medicine, treats psoriasis through the combination of traditional Chinese medicines. It shows significant advantages in relieving patients' clinical symptoms, reducing recurrence rate and reducing side effects, thereby overcoming the shortcomings of existing clinical treatments for psoriasis.

[0006] To solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for treating psoriasis, including an oral composition comprising the following raw materials by weight: Scutellaria baicalensis 20-40g, Phellodendron chinense 20-40g, Coptis chinensis 10-30g, Smilax glabra 30-50g, Gardenia jasminoides 15-35g, Gentiana scabra 15-35g, Dioscorea hypoglauca 10-30g, Eupatorium fortunei 10-30g, Alisma plantago-aquatica 5-15g, Sophora flavescens 10-30g, Atractylodes lancea 10-30g, Forsythia suspensa 20-40g, and Erythrina variegata 40-60g.

[0007] The oral composition contains the following ingredients: Scutellaria baicalensis: bitter, cold. Enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. Clears heat and dries dampness, drains fire and detoxifies, stops bleeding, and calms the fetus. Used for carbuncles and boils. Phellodendron chinense: bitter, cold. Enters the kidney and bladder meridians. Clears heat and dries dampness, drains fire and eliminates steaming heat, detoxifies and heals sores. Used for boils, carbuncles, eczema, and damp sores. Coptis chinensis: bitter, cold. Enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. Clears heat and dries dampness, drains fire and detoxifies. Used for carbuncles and boils; externally for eczema and damp sores. Smilax glabra: sweet, bland, neutral. Enters the liver and stomach meridians. Detoxifies, eliminates dampness, and promotes joint mobility. Gardenia jasminoides: bitter, cold. Enters the heart, lung, and triple burner meridians. Drains fire and eliminates irritability, clears heat and promotes diuresis, cools blood and detoxifies; externally used to reduce swelling and relieve pain. Gentiana scabra: bitter, cold. Enters the liver and gallbladder meridians. Clears heat and dries dampness, drains liver and gallbladder fire. Used for eczema and itching. *Dioscorea hypoglauca*: Bitter, neutral. Enters the kidney and stomach meridians. Promotes diuresis and removes turbidity, dispels wind and relieves numbness. *Eupatorium fortunei*: Pungent, neutral. Enters the spleen, stomach, and lung meridians. Aromatically transforms dampness, invigorates the spleen and stomach, releases exterior pathogens and relieves summer heat. Has anti-inflammatory and antibacterial effects. *Alisma plantago-aquatica*: Sweet, bland, cold. Enters the kidney and bladder meridians. Promotes diuresis and removes dampness, clears heat, transforms turbidity and lowers lipids. Has anti-inflammatory, immunomodulatory, and anti-allergic effects. *Sophora flavescens*: Bitter, cold. Enters the heart, liver, stomach, large intestine, and bladder meridians. Clears heat and dries dampness, kills parasites. Used for eczema, wet sores, itchy skin, scabies, and leprosy. *Atractylodes lancea*: Pungent, bitter, warm. Enters the spleen, stomach, and liver meridians. Dries dampness and strengthens the spleen, dispels wind and cold, improves eyesight. Used to treat skin diseases and tinea pedis. *Forsythia suspensa*: Bitter, slightly cold. Enters the lung, heart, and small intestine meridians. Clears heat and detoxifies, reduces swelling and dissipates nodules. Used for carbuncles, scrofula, mastitis, acute and chronic urticaria, eczema, herpes zoster, etc. Erythrina bark: pungent, bitter, neutral. Enters the liver and kidney meridians. Dispels wind and dampness, unblocks meridians, and relieves pain. Used to treat rheumatic pain, lower back and knee pain; externally used to treat scabies and eczema.

[0008] Further improvements are made to the oral composition, which comprises the following ingredients by weight: 30g Scutellaria baicalensis, 30g Phellodendron chinense, 20g Coptis chinensis, 40g Smilax glabra, 25g Gardenia jasminoides, 25g Gentiana scabra, 20g Dioscorea hypoglauca, 20g Eupatorium fortunei, 10g Alisma plantago-aquatica, 20g Sophora flavescens, 20g Atractylodes lancea, 30g Forsythia suspensa, and 50g Erythrina variegata.

[0009] A further improvement is made to the preparation method of the oral composition as follows: Scutellaria baicalensis, Phellodendron chinense, Coptis chinensis, Smilax glabra, Gardenia jasminoides, Gentiana scabra, Dioscorea hypoglauca, Eupatorium fortunei, Alisma plantago-aquatica, Sophora flavescens, Atractylodes lancea, Forsythia suspensa, and Erythrina variegata are weighed according to the raw material ratio, mixed, and decocted three times with water. Each time, the amount of water added is 8 times the total weight of the raw materials, and the decoction times are 2 hours, 1.5 hours, and 1.5 hours respectively. The filtrates are collected and combined, and then concentrated to a relative density of 1.12 at 60°C. Purified water is added to the obtained concentrate to a final volume of 1000 mL, and the concentrate is dispensed in 200 mL portions to obtain the oral composition.

[0010] In a further improvement, the traditional Chinese medicine composition for treating psoriasis of the present invention also includes a topical composition, which comprises the following raw materials by weight: Coptis chinensis 3-8g, Phellodendron chinense 3-8g, Scutellaria baicalensis 3-8g, Siegesbeckia orientalis 3-8g, Hedyotis diffusa 3-8g, Smilax glabra 3-8g, Sophora flavescens 3-8g, and Atractylodes lancea 3-8g.

[0011] The topical composition is applied to the affected skin surface during the administration of the oral composition.

[0012] According to the description in "Theoretical Parallel Texts", the method of internal treatment is the same as the method of external treatment. In the external application composition, Coptis chinensis, Phellodendron chinense, and Scutellaria baicalensis are the principal herbs for clearing heat from the upper, middle, and lower jiaos. Hedyotis diffusa is the assistant herb for its immunosuppressive and inflammatory effects. Siegesbeckia orientalis has a hormone-like anti-inflammatory effect when applied externally and is an adjuvant herb. Smilax glabra, Sophora flavescens, and Atractylodes lancea are adjuvant herbs for their diuretic and anti-inflammatory effects. All the herbs work together to control infiltrative inflammation.

[0013] Further improvements are made to the topical composition, which includes the following ingredients by weight: 5g each of Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea.

[0014] Further improvements are made by preparing the external composition as follows: Weigh out the following medicinal materials according to the raw material ratio: Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea. Mix them and decoct twice with water, adding water at 8 times and 6 times the total weight of the raw materials respectively. The decoction times are 2 hours and 1 hour respectively. Collect and combine the filtrates, concentrate the filtrate to 100 mL, and dispense into 20 mL portions to obtain the external composition.

[0015] As a further improvement of the present invention, the present invention also provides a method for preparing a traditional Chinese medicine composition for treating psoriasis. The traditional Chinese medicine composition adopts the above-mentioned traditional Chinese medicine composition for treating psoriasis, including the oral composition and the topical composition. The preparation method of the oral composition is as follows: weigh out the following medicinal materials according to the raw material ratio: Scutellaria baicalensis, Phellodendron chinense, Coptis chinensis, Smilax glabra, Gardenia jasminoides, Gentiana scabra, Dioscorea hypoglauca, Eupatorium fortunei, Alisma plantago-aquatica, Sophora flavescens, Atractylodes lancea, Forsythia suspensa, and Erythrina variegata. Mix them and decoct them three times with water. Each time, the amount of water added is 8 times the total weight of the raw materials. The decoction time is 2h, 1.5h, and 1.5h respectively. Collect and combine the filtrates and concentrate the filtrate to a relative density of 1.12 at 60°C. Add purified water to the obtained concentrate to a volume of 1000mL and dispense it in 200mL portions to obtain the oral composition.

[0016] The preparation method of the external composition is as follows: Weigh out the medicinal slices of Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea according to the raw material ratio, mix them, add water and decoct twice, adding water at 8 times and 6 times the total weight of the raw materials respectively, and decoct for 2 hours and 1 hour respectively. Collect and combine the filtrates, concentrate the filtrate to 100 mL, and dispense into 20 mL portions to obtain the external composition.

[0017] As another improvement of the present invention, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating psoriasis.

[0018] With this design, the present invention has at least the following advantages:

[0019] This invention relates to a traditional Chinese medicine composition based on TCM theory. Through the combination of herbal ingredients, it treats psoriasis and demonstrates significant advantages in alleviating clinical symptoms, reducing recurrence rates, and minimizing side effects. Furthermore, the combined use of oral and topical compositions achieves synergistic effects, resulting in even more significant therapeutic efficacy. This provides a more effective treatment method for psoriasis in current clinical practice and is easily scalable for widespread application. Attached Figure Description

[0020] The above is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0021] Figure 1 This is a graph showing the effects of different experimental groups on rat skin lesions in the pharmacological test of the herbal composition of this invention. In the graph, a is the blank group, b is the model group, c is the positive control group, d is the oral administration group, and e is the combined oral and topical administration group.

[0022] Figure 2 This is a graph showing the HE staining results of rat skin after treatment in the pharmacological test of the herbal composition of this invention. In the graph, a is the blank group, b is the model group, c is the positive control group, d is the oral administration group, and e is the combined oral and topical administration group.

[0023] Figure 3 These are before-and-after treatment effect diagrams of a typical clinical case 6 of the traditional Chinese medicine composition of this invention.

[0024] Figure 4 These are before-and-after treatment effect diagrams of a typical clinical case 13 using the traditional Chinese medicine composition of this invention.

[0025] Figure 5 These are before-and-after treatment effect diagrams of a typical clinical case 15 using the traditional Chinese medicine composition of this invention.

[0026] Figure 6 These are before-and-after treatment effect diagrams of clinical typical case 37 of the traditional Chinese medicine composition of this invention. Detailed Implementation

[0027] Example 1

[0028] Preparation of oral compositions

[0029] (1) Formula

[0030] Ingredients include: 30g Scutellaria baicalensis, 30g Phellodendron chinense, 20g Coptis chinensis, 40g Smilax glabra, 25g Gardenia jasminoides, 25g Gentiana scabra, 20g Dioscorea hypoglauca, 20g Eupatorium fortunei, 10g Alisma plantago-aquatica, 20g Sophora flavescens, 20g Atractylodes lancea, 30g Forsythia suspensa, and 50g Erythrina variegata.

[0031] (2) Manufacturing method

[0032] Weigh out the following medicinal materials according to the above formula: Scutellaria baicalensis, Phellodendron chinense, Coptis chinensis, Smilax glabra, Gardenia jasminoides, Gentiana scabra, Dioscorea hypoglauca, Eupatorium fortunei, Alisma plantago-aquatica, Sophora flavescens, Atractylodes lancea, Forsythia suspensa, and Erythrina variegata. Mix them together, then add water equivalent to 8 times their total weight for the first time, decoct for 2 hours, collect the filtrate, add water equivalent to 8 times their total weight to the residue, decoct for 1.5 hours, collect the filtrate, add water equivalent to 8 times their total weight to the residue, decoct for 1.5 hours, collect the filtrate, combine it with the filtrates obtained from the first two decoctions, concentrate to a relative density of 1.12 at 60°C, add purified water to the concentrate to a total volume of 1000 mL, and fill into 200 mL bags to obtain the oral composition 1.

[0033] Example 2

[0034] Preparation of oral compositions

[0035] (1) Formula

[0036] Ingredients include: 20g Scutellaria baicalensis, 20g Phellodendron chinense, 10g Coptis chinensis, 30g Smilax glabra, 15g Gardenia jasminoides, 15g Gentiana scabra, 10g Dioscorea hypoglauca, 10g Eupatorium fortunei, 5g Alisma plantago-aquatica, 10g Sophora flavescens, 10g Atractylodes lancea, 20g Forsythia suspensa, and 40g Erythrina variegata.

[0037] (2) Manufacturing method

[0038] Weigh out the following medicinal materials according to the above formula: Scutellaria baicalensis, Phellodendron chinense, Coptis chinensis, Smilax glabra, Gardenia jasminoides, Gentiana scabra, Dioscorea hypoglauca, Eupatorium fortunei, Alisma plantago-aquatica, Sophora flavescens, Atractylodes lancea, Forsythia suspensa, and Erythrina variegata. Mix them together, then add water equivalent to 8 times their total weight for the first time, decoct for 2 hours, collect the filtrate, add water equivalent to 8 times their total weight to the residue, decoct for 1.5 hours, collect the filtrate, add water equivalent to 8 times their total weight to the residue, decoct for 1.5 hours, collect the filtrate, combine it with the filtrates obtained from the first two decoctions, concentrate to a relative density of 1.12 at 60°C, add purified water to the concentrate to a total volume of 1000 mL, and fill into 200 mL bags to obtain the oral composition 2.

[0039] Example 3

[0040] Preparation of oral compositions

[0041] (1) Formula

[0042] Ingredients include: Scutellaria baicalensis 40g, Phellodendron chinense 40g, Coptis chinensis 30g, Smilax glabra 50g, Gardenia jasminoides 35g, Gentiana scabra 35g, Dioscorea hypoglauca 30g, Eupatorium fortunei 30g, Alisma plantago-aquatica 15g, Sophora flavescens 30g, Atractylodes lancea 30g, Forsythia suspensa 40g, Erythrina variegata 60g.

[0043] (2) Manufacturing method

[0044] Weigh out the following medicinal materials according to the above formula: Scutellaria baicalensis, Phellodendron chinense, Coptis chinensis, Smilax glabra, Gardenia jasminoides, Gentiana scabra, Dioscorea hypoglauca, Eupatorium fortunei, Alisma plantago-aquatica, Sophora flavescens, Atractylodes lancea, Forsythia suspensa, and Erythrina variegata. Mix them together, then add water equivalent to 8 times their total weight for the first time, decoct for 2 hours, collect the filtrate, add water equivalent to 8 times their total weight to the residue, decoct for 1.5 hours, collect the filtrate, add water equivalent to 8 times their total weight to the residue, decoct for 1.5 hours, collect the filtrate, combine it with the filtrates obtained from the first two decoctions, concentrate to a relative density of 1.12 at 60°C, add purified water to the concentrate to a total volume of 1000 mL, and fill into 200 mL bags to obtain the oral composition 3.

[0045] Example 4

[0046] Preparation of topical compositions

[0047] (1) Formula

[0048] Ingredients include: Coptis chinensis 5g, Phellodendron chinense 5g, Scutellaria baicalensis 5g, Siegesbeckia orientalis 5g, Hedyotis diffusa 5g, Smilax glabra 5g, Sophora flavescens 5g, Atractylodes lancea 5g.

[0049] (2) Manufacturing method

[0050] Weigh out the following medicinal materials according to the above formula: Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea. Mix them together, add water equivalent to 8 times their total weight, decoct for 2 hours, collect the filtrate, add water equivalent to 6 times their total weight to the residue, decoct for 1 hour, collect the filtrate, combine it with the filtrate obtained from the first decoction, concentrate the filtrate to 100 mL, and fill into 20 mL bags to obtain the external composition 1.

[0051] Example 5

[0052] Preparation of topical compositions

[0053] (1) Formula

[0054] Ingredients include: Coptis chinensis 3g, Phellodendron chinense 3g, Scutellaria baicalensis 3g, Siegesbeckia orientalis 3g, Hedyotis diffusa 3g, Smilax glabra 3g, Sophora flavescens 3g, Atractylodes lancea 3g.

[0055] (2) Manufacturing method

[0056] Weigh out the following medicinal materials according to the above formula: Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea. Mix them together, add water equivalent to 8 times their total weight, decoct for 2 hours, collect the filtrate, add water equivalent to 6 times their total weight to the residue, decoct for 1 hour, collect the filtrate, combine it with the filtrate obtained from the first decoction, concentrate the filtrate to 100 mL, and fill into 20 mL bags to obtain the external composition 2.

[0057] Example 6

[0058] Preparation of topical compositions

[0059] (1) Formula

[0060] Ingredients include: 8g each of Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea.

[0061] (2) Manufacturing method

[0062] Weigh out the following medicinal materials according to the above formula: Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea. Mix them together, add water equivalent to 8 times their total weight, decoct for 2 hours, collect the filtrate, add water equivalent to 6 times their total weight to the residue, decoct for 1 hour, collect the filtrate, combine it with the filtrate obtained from the first decoction, concentrate the filtrate to 100 mL, and fill into 20 mL bags to obtain the external composition 3.

[0063] Results Examples

[0064] (I) Animal experiments on pharmacodynamics

[0065] (1) Laboratory animals

[0066] Thirty male SD rats, aged 6-8 weeks and weighing approximately 180-200g, were selected. All animals were kept at a standard temperature of 23±2℃ and under a 12-hour light-dark cycle, with free access to food and water.

[0067] (2) Experimental methods

[0068] The rats underwent hair removal treatment on their backs. First, a pet hair clipper was used to remove the hair, and then Veet hair removal spray was used to thoroughly remove the fine hair on the backs, resulting in smooth skin measuring 3×3cm. The treated rats were then fed normally for 2 days to eliminate any potential impact of the hair clipper and hair removal spray on the rats' back skin.

[0069] Rats were randomly divided into 4 groups of 6 rats each. All treatments began on the day of application of IMQ cream (day 0) and were administered once daily for 10 consecutive days. On day 11, the PAS I score was performed on the affected skin of the rats.

[0070] (a) Control group: Water was applied to the bare skin on the back of rats daily;

[0071] (b) Model group: 62.5 mg of 5% imiquimod (IMQ) cream was applied to the bare skin on the back of rats daily, and then applied with an appropriate amount of water 4 hours later;

[0072] (c) Positive drug (calcipotriol) group: 62.5 mg of 5% IMQ cream was applied to the bare skin on the back of rats daily, and calcipotriol cream was applied evenly 4 hours later.

[0073] (d) Oral administration group: 62.5 mg of 5% IMQ cream was applied to the bare skin on the back of rats daily. Four hours after application, rats were given oral composition 1 by gavage daily.

[0074] (e) Combined oral and topical administration group: 62.5 mg of 5% IMQ cream was applied to the bare skin on the back of rats daily. Four hours after application, the rats were given oral composition 1 by gavage daily, and the topical composition 1 was applied evenly to the bare skin on the back of the rats.

[0075] During the experiment, changes in the rats' skin were observed. After the experiment, the rats were euthanized by cervical dislocation, and the skin lesions on their backs were collected for HE staining.

[0076] (3) Experimental Results

[0077] The severity of skin inflammation on the back of rats was assessed using the Psoriasis Clinical Area and Severity Index (PASI), which included erythema, thickness, and scaling. Scores indicated severity: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (extremely severe). Results are attached. Figure 1 See Table 1 below. Pathological sections of the skin from rats in each experimental group were prepared and stained with hematoxylin and eosin (HE). The results are attached. Figure 2 As shown.

[0078] Table 1. PASI scores of psoriasis in rats of each experimental group.

[0079]

[0080] Combined with Table 1, Figure 1 and Figure 2 It can be seen that the model group rats developed erythema and skin lesions, such as... Figure 1 As shown in b, the average PAS I score is greater than 2, indicating moderate inflammation, with increased inflammatory cell infiltration, such as... Figure 2 The increase in small blue vesicles (marked by arrows) in b indicates a significant inflammatory response in the skin of the rats in the model group, demonstrating the success of the psoriasis model constructed using imiquimod. In both the positive drug group and the oral administration group, skin erythema and lesions improved after drug administration. Figure 1 As shown in c and 1d, the average PASI score decreased to 1.57 and 1.32, respectively, indicating mild inflammation, and inflammatory cell infiltration was reduced. Figure 2 The decrease in blue vesicles in c and 2d indicates that the oral administration group achieved efficacy that was essentially the same as or better than the positive control group. From... Figure 1 As clearly shown in e, 2e, and Table 1, after the experiment, the rats in the combined oral and topical administration group had smooth skin, no obvious erythema, no damage, and a reduced average PASI score of 0.18. Furthermore, inflammatory cell infiltration was significantly reduced, and the inflammatory response essentially disappeared. This indicates that the combined administration of the oral and topical compositions significantly improved imiquimod-induced psoriatic-like skin lesions in rats, alleviating symptoms such as erythema, scaling, and thickening, demonstrating a significant therapeutic effect on psoriasis. The topical composition synergistically enhanced the oral composition, resulting in a superior therapeutic effect; the two have a synergistic effect.

[0081] (II) Clinical Cases

[0082] (1) Source of cases

[0083] Select patients with psoriasis treated at the Yizhiwen Traditional Chinese Medicine Hospital outpatient clinic from July 2021 to July 2023.

[0084] (2) Diagnostic criteria

[0085] Referring to the relevant criteria for psoriasis vulgaris in *Chinese Clinical Dermatology*, the condition is characterized by red papules on the scalp, trunk, and extensor surfaces of the limbs; well-defined borders but irregular shapes; thick, silvery-white scales on the surface, which gradually enlarge and merge into patches or plaques; significant infiltration at the base of the rash, with small bleeding points visible upon scraping off the erythema membrane; and itching. The severity is graded according to the Psoriasis Area and Severity Index (PASI): >12 points for severe; 6–12 points for moderate; <6 points for mild.

[0086] (3) Inclusion criteria

[0087] Thirty-eight patients meeting the above diagnostic and syndrome differentiation criteria were selected, aged 3-80 years, including 26 males and 12 females. All patients had not received any related treatment within one month prior to enrollment and had signed informed consent forms.

[0088] (4) Exclusion criteria

[0089] Patients diagnosed with Yang deficiency syndrome according to Traditional Chinese Medicine were screened out and excluded from the treatment observation scope.

[0090] (5) Test drug and administration regimen

[0091] Of the 38 patients, 19 took oral composition 1 daily for at least 14 consecutive days; the other 19 patients took oral composition 1 daily and applied topical composition 1 daily for at least 14 consecutive days.

[0092] (6) Efficacy evaluation criteria

[0093] The observation indicator was the condition of the skin lesions, and the PAS I scoring method was used to assess the area and severity of the skin lesions.

[0094] The lesion area was scored on a 7-point scale based on whether it was located on the head and face, trunk, upper limbs, or lower limbs: none (0 points), <10% (1 point), 10%–29% (2 points), 30%–49% (3 points), 50%–69% (4 points), 70%–89% (5 points), and 90%–100% (6 points). The percentage of the body surface area occupied by each location was as follows: head and face 10%, trunk 30%, upper limbs 20%, and lower limbs 40%.

[0095] The severity of skin lesions was assessed using three indicators: erythema, infiltration, and scaling. Each indicator was scored on a 5-point scale: none (0 points), mild (1 point), moderate (2 points), severe (3 points), and extremely severe (4 points).

[0096] PAS I score = Head area score × Head severity score (erythema + infiltration + scaling) × 0.1 + Upper limb area score × Upper limb severity score (erythema + infiltration + scaling) × 0.2 + Trunk area score × Trunk severity score (erythema + infiltration + scaling) × 0.3 + Lower limb area score × Lower limb severity score (erythema + infiltration + scaling) × 0.4.

[0097] The efficacy criteria were based on the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Edition)" and combined with the PAS I score. The efficacy index was calculated using the nimodipine method.

[0098] The efficacy index = (PASI score before treatment - PAS I score after treatment) / PAS I score before treatment × 100%.

[0099] Cure: Skin lesions have basically subsided, symptoms have disappeared, and the efficacy index is ≥95%;

[0100] Significant effect: Most skin lesions subside, clinical symptoms are significantly relieved, 70% ≤ efficacy index < 95%;

[0101] Effective: Skin lesions partially subside, symptoms improve, 50% ≤ efficacy index < 70%;

[0102] Ineffective: Skin lesions do not significantly subside, symptoms do not improve or even worsen, efficacy index <50%.

[0103] (7) Treatment effect

[0104] Based on the above dosing regimen, the efficacy evaluation criteria and disease status of the patients were statistically analyzed, and the results are shown in Tables 2, 3, and 4 below.

[0105] Table 2 Statistical results of basic information of each clinical case

[0106]

[0107]

[0108]

[0109]

[0110]

[0111] Table 3. Statistical results of clinical efficacy of different dosing regimens in each case.

[0112]

[0113] Table 4 Comparison of PAS I scores before and after treatment with different dosing regimens (mean ± SD)

[0114]

[0115]

[0116] As shown in Tables 2, 3, and 4 above, both the oral administration group and the combined oral and topical administration group of the herbal composition of this invention achieved significant therapeutic effects on psoriasis, with an effective rate of 100%. Furthermore, the PASI scores after treatment were significantly lower than the pre-treatment PASI scores, demonstrating a clear difference. The tables also show that the combined administration group, using both the oral and topical compositions, achieved superior therapeutic effects. For example, the cure rate of the combined administration group was significantly higher than that of the oral administration group, and the PASI score after treatment in the combined administration group was significantly lower than that in the oral administration group. This result is consistent with the pharmacodynamic experimental results, further proving that the topical composition synergistically enhances the therapeutic effect of the oral composition, demonstrating a synergistic effect between the two.

[0117] (8) Typical Cases

[0118] This example illustrates the skin changes before and after treatment in four typical cases of patients in clinical practice, such as... Figure 3 Table 2 shows the before-and-after skin effect images of Case 6 in the treatment. Figure 4 The table shows the before-and-after skin effects of case 13 in Table 2. Figure 5 The table shows the before-and-after skin effects of Case 15 in Table 2. Figure 6 The before-and-after skin effects of treatment in case 37 in Table 2 are shown.

[0119] from Figures 3 to 6 It is evident that after using the oral composition and the combined oral and external compound composition of the traditional Chinese medicine composition of this invention, regardless of whether the affected area is the upper limb, lower limb or trunk, the patient's erythema and scaling will subside, the rash will fall off, and the plaque will disappear, which will greatly relieve the patient's symptoms and reduce the patient's suffering, and has significant therapeutic effect.

[0120] Furthermore, follow-up of 38 patients in this embodiment revealed no side effects or recurrence. The herbal composition for treating psoriasis of this invention, based on traditional Chinese medicine theory, utilizes a combination of oral and topical application. It demonstrates significant advantages in treating psoriasis, alleviating clinical symptoms, reducing recurrence rates, and minimizing side effects. It is a clinically valuable treatment for psoriasis and is suitable for large-scale application.

[0121] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications, equivalent changes, or alterations made by those skilled in the art using the disclosed technical content shall fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating psoriasis, characterized in that, It is made from an oral composition and a topical composition, wherein the oral composition is composed of the following raw materials in parts by weight: Scutellaria baicalensis 30 g, Phellodendron chinense 30 g, Coptis chinensis 20 g, Smilax glabra 40 g, Gardenia jasminoides 25 g, Gentiana scabra 25 g, Dioscorea hypoglauca 20 g, Eupatorium fortunei 20 g, Alisma plantago-aquatica 10 g, Sophora flavescens 20 g, Atractylodes lancea 20 g, Forsythia suspensa 30 g, Erythrina variegata 50 g; The external composition consists of the following raw materials in parts by weight: Coptis chinensis 5 g, Phellodendron chinense 5 g, Scutellaria baicalensis 5 g, Siegesbeckia orientalis 5 g, Hedyotis diffusa 5 g, Smilax glabra 5 g, Sophora flavescens 5 g, Atractylodes lancea 5 g. The topical composition is applied to the affected skin surface during the administration of the oral composition.

2. The traditional Chinese medicine composition for treating psoriasis according to claim 1, characterized in that, The oral composition is prepared as follows: Scutellaria baicalensis, Phellodendron chinense, Coptis chinensis, Smilax glabra, Gardenia jasminoides, Gentiana scabra, Dioscorea hypoglauca, Eupatorium fortunei, Alisma plantago-aquatica, Sophora flavescens, Atractylodes lancea, Forsythia suspensa, and Erythrina variegata are weighed according to the raw material ratio. The mixture is then decocted three times with water, each time adding 8 times the total weight of the raw materials. The decoction times are 2 hours, 1.5 hours, and 1.5 hours respectively. The filtrates are collected and combined, and then concentrated to a relative density of 1.12 at 60°C. Purified water is added to the concentrate to a final volume of 1000 mL, and the concentrate is dispensed in 200 mL portions to obtain the oral composition.

3. The traditional Chinese medicine composition for treating psoriasis according to claim 1, characterized in that, The preparation method of the external composition is as follows: Weigh out the medicinal slices of Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea according to the raw material ratio, mix them, add water and decoct twice, adding water at 8 times and 6 times the total weight of the raw materials respectively, and decoct for 2 hours and 1 hour respectively. Collect and combine the filtrates, concentrate the filtrate to 100 mL, and dispense into 20 mL portions to obtain the external composition.

4. A method for preparing a traditional Chinese medicine composition for treating psoriasis as described in claim 1, characterized in that, The oral composition is prepared as follows: Scutellaria baicalensis, Phellodendron chinense, Coptis chinensis, Smilax glabra, Gardenia jasminoides, Gentiana scabra, Dioscorea hypoglauca, Eupatorium fortunei, Alisma plantago-aquatica, Sophora flavescens, Atractylodes lancea, Forsythia suspensa, and Erythrina variegata are weighed according to the raw material ratio. The mixture is then decocted three times with water, each time adding 8 times the total weight of the raw materials. The decoction times are 2 hours, 1.5 hours, and 1.5 hours respectively. The filtrates are collected and combined, and then concentrated to a relative density of 1.12 at 60°C. Purified water is added to the concentrate to a final volume of 1000 mL, and the concentrate is dispensed in 200 mL portions to obtain the oral composition. The preparation method of the external composition is as follows: Weigh out the medicinal slices of Coptis chinensis, Phellodendron chinense, Scutellaria baicalensis, Siegesbeckia orientalis, Hedyotis diffusa, Smilax glabra, Sophora flavescens, and Atractylodes lancea according to the raw material ratio, mix them, add water and decoct twice, adding water at 8 times and 6 times the total weight of the raw materials respectively, and decoct for 2 hours and 1 hour respectively. Collect and combine the filtrates, concentrate the filtrate to 100 mL, and dispense into 20 mL portions to obtain the external composition.

5. The use of a traditional Chinese medicine composition for treating psoriasis according to any one of claims 1 to 3 in the preparation of a medicament for treating psoriasis.

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