New use of traditional Chinese medicine composition for preparing a medicament for treating psoriasis

Abstract

The application relates to the field of traditional Chinese medicines, and particularly relates to application of a traditional Chinese medicine composition in preparation of medicines for preventing and treating psoriasis, wherein the traditional Chinese medicine composition is prepared from raw medicinal materials in the following proportions by weight: Euphorbia helioscopia 10-50 parts, prepared Pinellia ternata 5-30 parts, Gnaphalium affine 5-25 parts, Reineckia 5-25 parts, raw ginger 5-25 parts, Ramulus Cinnamomi 2-20 parts, Radix Scophulariae 2-20 parts, Radix Ginseng 2-20 parts and Radix Glycyrrhizae 2-20 parts.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically, it relates to a new use of a traditional Chinese medicine composition. Background Technology

[0002] Psoriasis is a chronic, immune-mediated inflammatory skin disease that affects the quality of life and mental health of approximately 150 million adults and children worldwide. Clinically, the main features of psoriasis are erythema, thickened skin, and scaling. The different sites and symptoms of psoriasis often have a detrimental impact on patients' quality of life and physical and mental health. The pathogenesis of psoriasis is very complex, and its mechanisms are not yet fully understood. Current research suggests that the overactivation of the partially adaptive immune system mediated by IL-23 / Th17 cells is the core of the pathogenesis of psoriasis. Currently, there is no specific drug for psoriasis, and current clinical drugs have drawbacks such as toxic side effects, drug resistance, and high costs. Therefore, seeking safer, more effective, and more economical drug treatments for psoriasis based on targeting the immune microenvironment remains a hot research topic. Summary of the Invention

[0003] The purpose of this invention is to provide a new use for a traditional Chinese medicine composition.

[0004] The first aspect of the present invention is to provide an application of a traditional Chinese medicine composition in the preparation of an anti-psoriasis drug, the traditional Chinese medicine composition being made from the following raw materials in parts by weight: 10-50 parts of Euphorbia helioscopia, 5-30 parts of processed Pinellia ternata, 5-25 parts of Hedyotis diffusa, 5-25 parts of Cynanchum paniculatum, 5-25 parts of fresh ginger, 2-20 parts of Cinnamomum cassia, 2-20 parts of Scutellaria baicalensis, 2-20 parts of ginseng, and 2-20 parts of Glycyrrhiza uralensis.

[0005] In a preferred embodiment, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts of Euphorbia helioscopia, 15 parts of processed Pinellia ternata, 10 parts of Hedyotis diffusa, 10 parts of Cynanchum paniculatum, 10 parts of fresh ginger, 6 parts of cinnamon twig, 6 parts of Scutellaria baicalensis, 6 parts of ginseng, and 6 parts of licorice.

[0006] Details of various aspects of the invention will be described in detail in the following sections. The features, objects, and advantages of the invention will become more apparent from the following description and the claims. Attached Figure Description

[0007] Figure 1 The traditional Chinese medicine composition significantly inhibited imiquimod-induced psoriatic dermatitis in mice.

[0008] CON: Normal group; ZQT: Traditional Chinese medicine prescription group

[0009] Figure 2 The traditional Chinese medicine composition significantly inhibited imiquimod-induced psoriasis-like skin thickening in mice.

[0010] CON: Normal group; ZQT: Traditional Chinese medicine prescription group Detailed Implementation

[0011] The traditional Chinese medicine composition of the present invention consists of Euphorbia helioscopia L., Processed Pinellia ternata, Chinese Sage Herb, Cynanchum glaucescens, Fresh ginger, Cassia twig, Scutellaria baicalensis, Ginseng, and Liquorice.

[0012] Among them, Euphorbia helioscopia L. is the whole herb of Euphorbia helioscopia, a plant of the Euphorbiaceae family. It has a pungent and bitter taste and is cool in nature. It has the functions of promoting diuresis and reducing swelling, dispersing nodules, and killing parasites. It is used to treat edema, ascites due to liver cirrhosis, psoriasis, etc.

[0013] Processed Pinellia ternata is the dried tuber of Pinellia ternata (Thunb.) Breit., a plant in the Araceae family. It has a pungent taste and warm properties. It functions to dry dampness and resolve phlegm, relieve nausea and vomiting, and dissipate lumps and nodules. It is used to treat damp phlegm, cold phlegm, cough with excessive phlegm, phlegm-induced dizziness and palpitations, wind-phlegm dizziness, phlegm-induced headache, vomiting and nausea, chest and epigastric fullness, and globus hystericus.

[0014] Chinese Sage Herb (Salvia chinensia Benth.) is the whole herb of the plant in the Lamiaceae family. It has a pungent and bitter taste and is slightly cold in nature. It possesses the effects of clearing heat and detoxifying, promoting blood circulation and regulating qi, and relieving pain. It is used to treat acute and chronic hepatitis, abdominal distension and pain, damp-heat leukorrhea, mastitis, boils, esophageal obstruction, phlegm and asthma, scrofula, etc.

[0015] Baiqian (Cynanchum glaucescens) is the dried rhizome and root of *Cynanchum stauntonii* (Decne.) Schltr. ex Lévl. or *Cynanchum glaucescens* (Decne.) Hand.-Mazz., belonging to the Asclepiadaceae family. It has a pungent and bitter taste and is slightly warm in nature. It has the effects of lowering qi, resolving phlegm, and relieving cough. It is used to treat lung qi stagnation, cough with excessive phlegm, chest fullness, and shortness of breath.

[0016] Fresh ginger is the fresh rhizome of *Ginger*, a perennial herbaceous plant belonging to the ginger family (Zingiberaceae). It has a pungent taste and slightly warm properties. It has the effects of relieving exterior syndromes and dispelling cold, warming the middle jiao and stopping vomiting, warming the lungs and stopping cough, and detoxifying. It is used for colds due to wind-cold, spleen and stomach cold syndrome, vomiting due to stomach cold, cough due to lung cold, and detoxifying fish and crab poisoning.

[0017] Cinnamon twig (Cassia twig) is the dried young branch of Cinnamomum cassia (L.) D. Don, a plant in the Lauraceae family. It has a pungent, sweet, and warm nature. It possesses the functions of inducing sweating and relieving muscle tension, warming and unblocking the meridians, assisting yang and promoting qi circulation, and calming and descending qi. It is commonly used for colds due to wind-cold, abdominal pain due to cold, amenorrhea due to blood stasis, joint pain, phlegm retention, edema, and palpitations.

[0018] Scutellaria baicalensis is the root of Scutellaria baicalensis Georgi, a plant in the Lamiaceae family. It has a bitter taste and is cold in nature. It possesses the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is used to treat damp-heat syndrome, summer-heat syndrome with chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, blood-heat vomiting and nosebleeds, carbuncles and boils, and threatened abortion.

[0019] Ginseng is the root of Panax ginseng CAMey. (P. schin-seng Nees), a plant belonging to the genus Panax in the family Araliaceae. It has a sweet and slightly bitter taste and is warm in nature. It possesses the effects of greatly replenishing vital energy, consolidating the body's foundation, promoting the production of body fluids, and calming the mind. It is used to treat various conditions of insufficient qi, blood, and body fluids, including those caused by overexertion, weakness, and prolonged deficiency.

[0020] Licorice is the root and rhizome of *Glycyrrhiza uralensis* Fisch., a plant belonging to the genus *Glycyrrhiza* in the legume family. It has a sweet taste and neutral properties. It possesses the functions of harmonizing the stomach and relieving spasms, moistening the lungs, detoxifying, and harmonizing other medicinal ingredients. It is used to treat spleen and stomach weakness.

[0021] Based on the clinical application of this traditional Chinese medicine composition, the inventors constructed a mouse psoriasis model to study and explore the therapeutic effect of this traditional Chinese medicine composition on psoriasis. The research results of this invention confirm that this traditional Chinese medicine composition has a significant therapeutic effect on psoriasis and can effectively guide clinical medication.

[0022] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions or as recommended by the manufacturer. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to the methods of this invention. The preferred embodiments and materials described herein are for illustrative purposes only.

[0024] The features mentioned above in this invention, or the features mentioned in the embodiments, can be combined arbitrarily. All features disclosed in this patent specification can be used in any compositional form, and each feature disclosed in the specification can be replaced by any alternative feature that provides the same, equivalent, or similar purpose. Therefore, unless otherwise specified, the disclosed features are merely general examples of equivalent or similar features.

[0025] Example 1: Preparation of Traditional Chinese Medicine Composition

[0026] Euphorbia helioscopia 30g, processed Pinellia ternata 15g, Hedyotis diffusa 10g, Cynanchum paniculatum 10g, fresh ginger 10g, Scutellaria baicalensis 6g, ginseng 6g, cinnamon twig 6g, licorice root 6g.

[0027] Weigh all the medicinal materials and soak them in purified water for 1 hour. After soaking, boil the liquid and decoct for 2 hours. Filter the decocted liquid through a 200-mesh sieve and repeat the decoction-filtration process twice. Mix and concentrate the liquids obtained from the three decoctions, and after cooling, dispense them into portions and freeze at -80°C. Before freeze-drying, remove the pre-frozen liquid and place it in a freeze dryer to prepare freeze-dried Zeqi Tang powder.

[0028] Seven doses of traditional Chinese medicine composition were prepared according to the above preparation method for subsequent experimental verification.

[0029] Example 2: Experimental study on the relief of psoriasis-like skin lesions by traditional Chinese medicine composition

[0030] Experimental animals: C57 / 6J mice

[0031] Experimental drugs: The traditional Chinese medicine composition was prepared according to Example 1.

[0032] Experimental Methods: Male C57 / 6J mice weighing 16-18g were randomly divided into a model group and a traditional Chinese medicine (TCM) composition group. After shaving the backs of mice in both groups, 62.5mg of imiquimod was applied topically to the backs once daily for 7 consecutive days to induce psoriatic lesions. The TCM composition group received 200μl of the TCM composition via gavage, while the model group received 200μl of normal drinking water via gavage. The progression of erythema and scaling on the backs of the mice was observed daily, and a PASI score of 0-4 was used based on symptom severity, with 0 points for asymptomatic cases and 4 points for extremely severe cases.

[0033] Statistical methods: GraphPad Prism 9 was used for statistical analysis. The Shapiro-Wilk (SW) test was used to determine if the distribution was normal. If the distribution was normal, the results were expressed as x±s. One-way classification ANOVA was used, and the LSD test was employed to compare differences between groups. If the distribution was not normal, the Kruskal-Wallis H rank-sum test was used for statistical analysis.

[0034] Experimental results: as shown in Table 1. Figure 1 As shown, compared with the model group mice, the PASI scores of the main psoriatic manifestations of erythema and scaling on the back skin of the mice in the traditional Chinese medicine composition group were significantly lower, and this was statistically significant (P < 0.05). This indicates that the traditional Chinese medicine composition significantly alleviates psoriatic dermatitis in mice.

[0035] Table 1. Effects of Traditional Chinese Medicine Formulas on Psoriasis

[0036] Group quantity PASI score for erythema PASI score for scales Model group 10 3.90±0.21 4.00±0.00 Traditional Chinese Medicine Formula Group 10 1.40±0.52*** 2.90±0.39***

[0037] Note: ***, P < 0.001 compared to the model group.

[0038] Example 3: Experimental study on the inhibition of inflammatory secretion of IL17 and IL23 in psoriatic skin by a traditional Chinese medicine composition.

[0039] Experimental animals: C57 / 6J mice

[0040] Experimental drugs: The traditional Chinese medicine composition was prepared according to Example 1.

[0041] Experimental Methods: Male C57 / 6J mice weighing 16-18g were randomly divided into a model group and a traditional Chinese medicine (TCM) composition group. After shaving the backs of mice in both groups, 62.5mg of imiquimod was applied topically to the backs once daily for 7 consecutive days to induce psoriatic lesions. The TCM composition group received 200μl of the TCM composition via gavage, while the model group received 200μl of normal drinking water via gavage. After the experiment, the mice were euthanized, and skin from the psoriatic lesions on the backs was excised. The skin was homogenized in PBS containing 1μg / L of a protease inhibitor, and the supernatant was collected. The levels of IL17A and IL23 in the skin and serum were detected using an ELISA kit, and the results were analyzed using a microplate reader.

[0042] Statistical methods: GraphPad Prism 9 was used for statistical analysis. The Shapiro-Wilk (SW) test was used to determine if the distribution was normal. If the distribution was normal, the results were expressed as x±s. One-way classification ANOVA was used, and the LSD test was employed to compare differences between groups. If the distribution was not normal, the Kruskal-Wallis H rank-sum test was used for statistical analysis.

[0043] Experimental results: such as Figure 2 As shown in Table 2, compared with the model group mice, the inflammatory thickening of the skin in the traditional Chinese medicine composition group was significantly alleviated, and the levels of psoriatic pathological markers IL17 and IL23 in the skin were significantly reduced, demonstrating a significant inhibitory effect on psoriasis (P < 0.05). Therefore, the traditional Chinese medicine composition significantly inhibits the pathological secretion of inflammatory IL17 and IL23 in psoriatic skin.

[0044] Table 2. Effects of Traditional Chinese Medicine Formula on Inhibiting Pathological Secretion of IL17 and IL23 in Psoriatic Skin

[0045] Group quantity IL17 level (pg / ml) IL23 level (pg / ml) Model group 10 219.80±1.12 1087.00±1.24 Traditional Chinese Medicine Formula Group 10 122.50±1.13*** 989.00±1.55***

[0046] Note: ***, P < 0.001 compared to the model group.

[0047] Example 4: Comparative Study of Traditional Chinese Medicine Composition and Individual Formulas

[0048] Experimental animals: C57 / 6J mice

[0049] Experimental drugs: The traditional Chinese medicine composition was prepared according to Example 1.

[0050] Formula 1: Ingredients: Prepared Pinellia ternata 15 parts, Hedyotis diffusa 10 parts, Cynanchum paniculatum 10 parts, fresh ginger 10 parts, Scutellaria baicalensis 6 parts, ginseng 6 parts, cinnamon twig 6 parts, licorice root 6 parts

[0051] Formula 2 consists of the following ingredients: Euphorbia helioscopia 30 parts, Hedyotis diffusa 10 parts, Cynanchum paniculatum 10 parts, fresh ginger 10 parts, Scutellaria baicalensis 6 parts, ginseng 6 parts, cinnamon twig 6 parts, and licorice root 6 parts.

[0052] Formula 3 consists of: 30 parts Euphorbia helioscopia, 15 parts prepared Pinellia ternata, 10 parts Cynanchum paniculatum, 10 parts fresh ginger, 6 parts Scutellaria baicalensis, 6 parts ginseng, 6 parts cinnamon twig, and 6 parts licorice root.

[0053] Formula 4 consists of the following ingredients: Euphorbia helioscopia 30 parts, processed Pinellia ternata 15 parts, Hedyotis diffusa 10 parts, fresh ginger 10 parts, Scutellaria baicalensis 6 parts, ginseng 6 parts, cinnamon twig 6 parts, and licorice root 6 parts.

[0054] Formula 5 consists of the following ingredients: Euphorbia helioscopia 30 parts, processed Pinellia ternata 15 parts, Hedyotis diffusa 10 parts, Cynanchum paniculatum 10 parts, Scutellaria baicalensis 6 parts, Panax ginseng 6 parts, Cinnamomum cassia 6 parts, Glycyrrhiza uralensis 6 parts.

[0055] Formula 6 consists of the following ingredients: Euphorbia helioscopia 30 parts, processed Pinellia ternata 15 parts, Hedyotis diffusa 10 parts, Cynanchum paniculatum 10 parts, fresh ginger 10 parts, ginseng 6 parts, cinnamon twig 6 parts, and licorice root 6 parts.

[0056] Formula 7 consists of the following ingredients: Euphorbia helioscopia 30 parts, processed Pinellia ternata 15 parts, Hedyotis diffusa 10 parts, Cynanchum paniculatum 10 parts, fresh ginger 10 parts, Scutellaria baicalensis 6 parts, Cinnamomum cassia 6 parts, Glycyrrhiza uralensis 6 parts.

[0057] Formula 8 consists of the following ingredients: Euphorbia helioscopia 30 parts, processed Pinellia ternata 15 parts, Hedyotis diffusa 10 parts, Cynanchum paniculatum 10 parts, fresh ginger 10 parts, Scutellaria baicalensis 6 parts, ginseng 6 parts, and licorice root 6 parts.

[0058] Formula 9 consists of the following ingredients: Euphorbia helioscopia 30 parts, processed Pinellia ternata 15 parts, Hedyotis diffusa 10 parts, Cynanchum paniculatum 10 parts, fresh ginger 10 parts, Scutellaria baicalensis 6 parts, ginseng 6 parts, and cinnamon twig 6 parts.

[0059] Preparation method of the disassembled drug: It was prepared according to the method in Example 1.

[0060] Experimental Methods: Male C57 / 6J mice weighing 16-18g were randomly divided into four groups: normal group, model group, traditional Chinese medicine (TCM) composition group, and groups of disassembled prescriptions (1, 2, 3, 4, 5, 6, 7, 8, and 9). Mice in the model group, TCM composition group, and all disassembled prescription groups were shaved on their backs and then given 62.5mg of imiquimod applied topically once daily for 7 consecutive days to induce psoriatic lesions. The TCM composition group and all disassembled prescription groups were administered 200μl of their respective TCM composition via gavage, while the model group received 200μl of normal drinking water via gavage. The progression of erythema and scaling on the backs of the mice was observed daily, and a PASI score of 0-4 was used based on symptom severity, with 0 points for asymptomatic cases and 4 points for extremely severe cases.

[0061] Statistical methods: GraphPad Prism 9 was used for statistical analysis. The Shapiro-Wilk (SW) test was used to determine if the distribution was normal. If the distribution was normal, the results were expressed as x±s. One-way classification ANOVA was used, and the LSD test was employed to compare differences between groups. If the distribution was not normal, the Kruskal-Wallis H rank-sum test was used for statistical analysis.

[0062] Experimental Results: As shown in Table 3, compared with the model group mice, the psoriasis-like dermatitis in the traditional Chinese medicine composition group was significantly reduced, and the difference was statistically significant (P < 0.05). Although the psoriasis-like dermatitis in the fractional formula groups 1, 2, 3, 4, and 5 was reduced, their psoriasis severity scores were still higher than those in the traditional Chinese medicine composition group, and their therapeutic effects on psoriasis were inferior to those of the traditional Chinese medicine composition group (P < 0.05).

[0063] Table 3. The effect of traditional Chinese medicine formulas and their components on inhibiting psoriatic dermatitis.

[0064] Group quantity PASI score for erythema PASI score for scales Model group 10 3.80±0.42 4.00±0.00 Traditional Chinese Medicine Formula Group 10 1.95±0.55*** 2.65±0.41*** Dismantling Group 1 10 3.45±0.50 3.60±0.46 2 sets of demolition 10 3.70±0.48 3.35±0.47 3 groups of demolition 10 3.50±0.53 3.65±0.47 4 groups of demolition 10 2.25±0.42 3.55±0.50 5 groups of demolition 10 2.85±0.24 3.25±0.42 6 groups of demolition 10 3.35±0.47 3.45±0.50 7 demolition groups 10 3.35±1.41 3.65±0.47 8 groups of demolition 10 3.35±0.47 3.45±0.44 9 groups of demolition 10 2.9±0.39 3.25±0.42

[0065] Note: ***, P < 0.001 compared to the model group.

[0066] The various aspects of this invention have been described above. However, it should be understood that, without departing from the spirit of this invention, those skilled in the art can make equivalent changes and modifications, which also fall within the scope of the appended claims.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating psoriasis, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-50 parts of Euphorbia helioscopia, 5-30 parts of processed Pinellia ternata, 5-25 parts of Hedyotis diffusa, 5-25 parts of Cynanchum paniculatum, 5-25 parts of fresh ginger, 2-20 parts of Cinnamomum cassia, 2-20 parts of Scutellaria baicalensis, 2-20 parts of Panax ginseng, and 2-20 parts of Glycyrrhiza uralensis.

2. The application as described in claim 1, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts of Euphorbia helioscopia, 15 parts of processed Pinellia ternata, 10 parts of Hedyotis diffusa, 10 parts of Cynanchum paniculatum, 10 parts of fresh ginger, 6 parts of cinnamon twig, 6 parts of Scutellaria baicalensis, 6 parts of ginseng, and 6 parts of licorice.

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