Traditional Chinese medicine composition for clearing heat and promoting diuresis, medicinal preparation and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for clearing heat and promoting diuresis, a pharmaceutical preparation and a preparation method thereof. The traditional Chinese medicine composition comprises the following components: herba violae, honeysuckle, bistort rhizome, dandelion, scorpio, scutellaria baicalensis, oriental wormwood, fructus forsythiae and moutan bark. The pharmaceutical preparation comprises the effective components of the traditional Chinese medicine composition. The traditional Chinese medicine composition and the medicinal preparation for clearing heat and promoting diuresis provided by the invention have the effects of clearing away heat and toxic materials, and removing dampness and relieving itching, and can be used for treating damp-heat accumulation skin syndromes, such as palmoplantar skin lesion, pustules, scorching fever, pruritus or pain, periodic attack, entanglement and difficulty in healing, accompanied erythema, scales, blisters, dry or sticky and uncomfortable stool, yellow urine, bitter mouth, thirst without drinking, red tongue, thin, yellow or greasy fur, and the like. The pulse slip number or the soft number; and the traditional Chinese medicine composition has a good treatment effect on acute heat skin diseases such as palmoplantar pustulosis and the like with the syndromes.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and in particular relates to a traditional Chinese medicine composition for clearing away heat and dampness, a pharmaceutical preparation and a preparation method thereof. Background Art

[0002] Psoriasis, commonly known as "psoriasis," is an immune-mediated, chronic, relapsing, inflammatory, and systemic disease induced by a combination of genetic and environmental factors. Pustular psoriasis is a specific type of psoriasis, and palmoplantar pustulosis (PPP) is a specific type of localized pustular psoriasis, accounting for approximately 1% of all psoriasis cases, with a prevalence of 0.12%. PPP typically presents with sterile pustules on the palms and soles, with keratinization, scaling, and possible pruritus and pain. The condition often recurs. It primarily develops in adults aged 20 to 60 years, rarely affecting children. Female patients are more common, with only 10% to 30% being male. A family history of psoriasis is present in 10% to 25% of cases. Multiple comorbidities may occur. Its etiology and pathogenesis remain unclear, but may be related to genetic, environmental, and immune factors. Although PPP lesions are small in size, they severely restrict patients' daily activities and impose a significant psychological burden.

[0003] There is currently no specific treatment for PPP. Localized pustular psoriasis is primarily treated with topical Western medications, commonly including topical corticosteroids (TCS) and vitamin D derivatives. Long-term use of TCS can cause skin pigmentation changes, skin atrophy, and capillary dilation. These adverse reactions limit long-term medication use and reduce patient compliance. Furthermore, nonstandard treatment results in suboptimal outcomes for some patients, leading to chronic disease progression. If patients fail to receive timely and effective treatment, their symptoms will continue to worsen and may develop other complications, severely impacting their health and quality of life.

[0004] Therefore, it is urgent to develop a drug suitable for treating PPP. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the present invention aims to provide a traditional Chinese medicine composition and pharmaceutical preparation for clearing heat and removing dampness, and a preparation method thereof. The traditional Chinese medicine composition and pharmaceutical preparation have the effects of clearing heat and detoxifying, removing dampness and relieving itching, and have a good therapeutic effect on acute febrile skin diseases such as palmoplantar pustulosis.

[0006] To achieve this object, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for clearing away heat and dampness, the traditional Chinese medicine composition comprising the following components:

[0008] Honeysuckle, Bistort, Taraxacum, Viola yedoensis, Scorpio, Scutellaria baicalensis, Artemisia capillaris, Forsythia suspensa, and Paeonia suffruticosa bark.

[0009] In some embodiments of the present invention, the traditional Chinese medicine composition further comprises one or more of the following components:

[0010] Red peony root, lithospermum officinale, raw rehmannia root, poria, sophora flavescens, stir-fried atractylodes macrocephala, radix polygoni multiflori, white peony root, plantain, oriental water plantain and tangerine peel.

[0011] In some embodiments of the present invention, the Chinese medicine composition comprises the following components:

[0012] Honeysuckle, Bistort, Taraxacum, Viola yedoensis, Scorpio, Scutellaria baicalensis, Artemisia capillaris, Forsythia suspensa, Paeonia suffruticosa, Red Peony Root, Rehmannia glutinosa, Poria, Sophora flavescens, and Lithospermum officinale.

[0013] In some embodiments of the present invention, the Chinese medicine composition comprises the following components:

[0014] Honeysuckle, Polygonum multiflorum, Dandelion, Viola yedoensis, Scorpio, Scutellaria baicalensis, Artemisia capillaris, Forsythia suspensa, Paeonia suffruticosa moutan bark, Paeonia lactiflora, Rehmannia root, Poria, Sophora flavescens, stir-fried Atractylodes macrocephala, Radix Dipterocarpa, Dictamni bark, Plantain, Alisma orientalis, and Tangerine peel.

[0015] In the present invention, when the Chinese medicine composition contains one or more of the following components, the weight parts of the components are:

[0016] 20-40 parts of honeysuckle, 20-40 parts of polygonum multiflorum, 10-30 parts of dandelion, 10-30 parts of viola yedoensis, 2-12 parts of scorpio, 5-25 parts of scutellaria, 5-25 parts of capillaries, 5-25 parts of forsythia, 10-30 parts of peony bark, 5-25 parts of red peony root, 5-25 parts of lithospermum officinale, 5-25 parts of raw rehmannia root, 10-30 parts of poria, 5-25 parts of sophora flavescens, 10-30 parts of stir-fried atractylodes, 5-25 parts of radix polygoni multiflori, 5-25 parts of dittany bark, 5-25 parts of plantain, 5-25 parts of oriental rhizome, and 3-20 parts of dried tangerine peel.

[0017] Preferably, the ingredients are: 25-35 parts of honeysuckle, 25-35 parts of polygonum multiflorum, 15-25 parts of dandelion, 15-25 parts of viola yedoensis, 4-8 parts of scorpion, 10-20 parts of scutellaria, 10-20 parts of capillaris, 10-20 parts of forsythia, 15-25 parts of moutan bark, 10-20 parts of red peony root, 10-20 parts of lithospermum officinale, 10-20 parts of raw rehmannia root, 15-25 parts of poria, 10-20 parts of sophora flavescens, 15-25 parts of stir-fried atractylodes, 10-20 parts of radix polygoni multiflori, 10-20 parts of dittany bark, 10-20 parts of plantain, 10-20 parts of oriental rhizome, and 5-15 parts of dried tangerine peel.

[0018] More preferably, it is: 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of scorpion, 15 parts of scutellaria, 15 parts of capillaris, 15 parts of forsythia, 20 parts of peony bark, 15 parts of red peony root, 15 parts of lithospermum officinale, 15 parts of raw rehmannia root, 20 parts of poria, 15 parts of sophora flavescens, 20 parts of stir-fried atractylodes, 15 parts of radix polygoni multiflori, 15 parts of dittany bark, 15 parts of plantain, 15 parts of rhizoma alismatis, and 10 parts of dried tangerine peel.

[0019] It should be noted that the above-mentioned component content refers to the content of the component when it is contained in the traditional Chinese medicine composition. In the present invention, honeysuckle, bistort, dandelion, Viola yedoensis, scorpion, scutellaria, capillaris, forsythia and peony bark are the basic formula, and the component contents are as described above. The weight parts of other components besides the basic formula are all weight parts relative to the basic formula with the above-mentioned ratio. For example:

[0020] For the basic prescription, the weight proportions of its components can be 20-40 parts of honeysuckle, 20-40 parts of polygonum multiflorum, 10-30 parts of dandelion, 10-30 parts of viola yedoensis, 2-12 parts of whole scorpion, 5-25 parts of scutellaria, 5-25 parts of capillaries, 5-25 parts of forsythia and 10-30 parts of peony bark; preferably 25-35 parts of honeysuckle, 25-35 parts of polygonum multiflorum, 15-25 parts of dandelion, 15-25 parts of viola yedoensis, 4-8 parts of whole scorpion, 10-20 parts of scutellaria, 10-20 parts of capillaries, 10-20 parts of forsythia and 15-25 parts of peony bark; more preferably 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of whole scorpion, 15 parts of scutellaria, 15 parts of capillaries, 15 parts of forsythia and 20 parts of peony bark.

[0021] When the traditional Chinese medicine composition includes honeysuckle, bistort, dandelion, Viola yedoensis, scorpion, scutellaria, capillaris, forsythia, moutan bark, red peony root, raw rehmannia root, poria, sophora flavescens and lithospermum erythrorhizon, the weight proportions of the components can be 20-40 parts of honeysuckle, 20-40 parts of bistort, 10-30 parts of dandelion, 10-30 parts of viola yedoensis, 2-12 parts of scorpion, 5-25 parts of scutellaria, 5-25 parts of capillaris, 5-25 parts of forsythia, 10-30 parts of moutan bark, 5-25 parts of red peony root, 5-25 parts of raw rehmannia root, 10-30 parts of poria, 5-25 parts of sophora flavescens and 5-25 parts of lithospermum erythrorhizon; preferably 25-35 parts of honeysuckle, 20-40 parts of bistort, 10-30 parts of dandelion, 10-30 parts of viola yedoensis, 2-12 parts of scorpion, 5-25 parts of scutellaria, 5-25 parts of capillaris, 5-25 parts of forsythia root, 10-30 parts of moutan bark, 5-25 parts of red peony root, 5-25 parts of raw rehmannia root, 10-30 parts of poria, 5-25 parts of sophora flavescens and 5-25 parts of lithospermum erythrorhizon; More preferably, 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of whole scorpion, 15 parts of scutellaria, 15 parts of capillaries, 15 parts of forsythia, 20 parts of peony bark, 15 parts of red peony root, 15 parts of raw rehmannia root, 20 parts of poria, 15 parts of sophora flavescens and 15 parts of lithospermum officinale; more preferably, 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of whole scorpion, 15 parts of scutellaria, 15 parts of capillaries, 15 parts of forsythia, 20 parts of peony bark, 15 parts of red peony root, 15 parts of raw rehmannia root, 20 parts of poria, 15 parts of sophora flavescens and 15 parts of lithospermum officinale.

[0022] When the traditional Chinese medicine composition includes honeysuckle, bistort, dandelion, Viola yedoensis, scorpion, scutellaria, capillaris, forsythia, moutan bark, red peony root, raw rehmannia root, poria, sophora flavescens, stir-fried atractylodes, radix ophiopogonis, white peony root, plantain, oriental rhizome and tangerine peel, the weight proportions of the components can be 20-40 parts of honeysuckle, 20-40 parts of bistort, 10-30 parts of dandelion, 10-30 parts of Viola yedoensis, 2-12 parts of scorpion, 5-2 parts of scutellaria. 5 parts, Artemisia capillaris 5-25 parts, Forsythia suspensa 5-25 parts, Paeonia suffruticosa 10-30 parts, Red Peony Root 5-25 parts, Rehmannia glutinosa 5-25 parts, Poria 10-30 parts, Sophora flavescens 5-25 parts, Stir-fried Atractylodes macrocephala 10-30 parts, Dipterocarpus radix 5-25 parts, Dictamni 5-25 parts, Plantago asiatica 5-25 parts, Alisma orientalis 5-25 parts and Tangerine peel 3-20 parts; preferably 25-35 parts of Honeysuckle, 25-35 parts of Bistorta ginseng, Taraxacum mongolicum 15-25 parts, 15-25 parts of Viola yedoensis, 4-8 parts of Scorpio, 10-20 parts of Scutellaria baicalensis, 10-20 parts of Artemisia capillaris, 10-20 parts of Forsythia suspensa, 15-25 parts of Paeonia suffruticosa, 10-20 parts of Red Peony Root, 10-20 parts of Rehmannia glutinosa, 15-25 parts of Poria, 10-20 parts of Sophora flavescens, 15-25 parts of Stir-fried Atractylodes macrocephala, 10-20 parts of Radix Dipterocarpae, 10-20 parts of Dictamni Cortex, 10-20 parts of Plantago, 10-20 parts of Alisma orientalis More preferably, it is 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of scorpion, 15 parts of scutellaria, 15 parts of capillaris, 15 parts of forsythia, 20 parts of peony bark, 15 parts of red peony root, 15 parts of raw rehmannia, 20 parts of poria, 15 parts of sophora flavescens, 20 parts of stir-fried atractylodes, 15 parts of radix polygoni multiflori, 15 parts of dittany peel, 15 parts of plantain, 15 parts of rhizoma alismatis and 10 parts of tangerine peel.

[0023] In the present invention, the weight proportion of the honeysuckle can be any value within 20-40 parts, for example, it can be 20 parts, 22 parts, 23 parts, 25 parts, 26 parts, 28 parts, 30 parts, 32 parts, 33 parts, 35 parts, 36 parts, 38 parts or 40 parts, etc.

[0024] The weight proportions of the bistort can be any value within 20-40 parts, for example, 20 parts, 22 parts, 23 parts, 25 parts, 26 parts, 28 parts, 30 parts, 32 parts, 33 parts, 35 parts, 36 parts, 38 parts or 40 parts, etc.

[0025] The weight proportion of the dandelion can be any value within 10-30 parts, for example, it can be 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts, 25 parts, 26 parts, 28 parts or 30 parts, etc.

[0026] The weight proportion of the Viola yedoensis can be any value within 10-30 parts, for example, it can be 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts, 25 parts, 26 parts, 28 parts or 30 parts.

[0027] The weight proportions of the whole scorpion can be any value within 2-12 parts, for example, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts or 12 parts.

[0028] The weight proportion of the scutellaria baicalensis can be any value within 5-25 parts, for example, it can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts.

[0029] The weight proportions of the Artemisia capillaris can be any value within 5-25 parts, for example, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts, etc.

[0030] The weight proportion of the Forsythia suspensa can be any value within 5-25 parts, for example, it can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts.

[0031] The weight proportion of the peony bark can be any value within 10-30 parts, for example, it can be 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts, 25 parts, 26 parts, 28 parts or 30 parts, etc.

[0032] The weight proportions of the red peony root can be any value within 5-25 parts, for example, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts, etc.

[0033] The weight proportion of the lithospermum erythrorhizon can be any value within 5-25 parts, for example, it can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts.

[0034] The weight proportion of the raw Rehmannia root can be any value within 5-25 parts, for example, it can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts.

[0035] The weight proportions of the Poria cocos can be any value within 10-30 parts, for example, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts, 25 parts, 26 parts, 28 parts or 30 parts, etc.

[0036] The weight proportions of the Sophora flavescens can be any value within 5-25 parts, for example, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts, etc.

[0037] The weight proportions of the stir-fried Atractylodes macrocephala can be any value within 10-30 parts, for example, it can be 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts, 25 parts, 26 parts, 28 parts or 30 parts, etc.

[0038] The weight proportion of the Radix Dichroae can be any value within the range of 5-25 parts, for example, it can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts.

[0039] The weight proportion of the Dictamnus cortex can be any value within the range of 5-25 parts, for example, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts.

[0040] The weight proportion of the plantain can be any value within the range of 5-25 parts, for example, it can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts, etc.

[0041] The weight proportions of the rhizoma alismatis can be any value within 5-25 parts, for example, it can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 23 parts or 25 parts, etc.

[0042] The weight proportion of the dried tangerine peel can be any value within 3-20 parts, for example, can be 3 parts, 4 parts, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts or 20 parts etc.

[0043] Traditional Chinese Medicine (TCM) considers the human body an organic whole, emphasizing its integrity, unity, and its interrelationship with nature. However, when it comes to skin diseases, syndrome differentiation and treatment are somewhat unique, often focusing on the local issues while neglecting the overall picture, which can negatively impact treatment effectiveness. TCM syndrome differentiation and treatment are based on the differentiation of internal organs, complementing internal fundamental conditioning with external symptomatic treatment to ultimately achieve a cure.

[0044] From a Traditional Chinese Medicine (TCM) perspective, PPP is caused by spleen deficiency and dampness accumulation, which transforms into toxic heat over time. This internally generated dampness and heat, which accumulate over time, transforms into heat and accumulates in the skin. Because the spleen governs the limbs and muscles, toxic heat is released through the meridians, leading to pustules that often appear on the palms and soles. The sticky, lingering dampness is difficult to heal, leading to recurring symptoms and frequent pustules.

[0045] The present invention adopts the above-mentioned traditional Chinese medicine components for scientific compatibility to obtain a traditional Chinese medicine composition for clearing away heat and dampness.

[0046] In the traditional Chinese medicine composition of the present invention, honeysuckle, bistort, dandelion, Viola yedoensis, and scorpion are the main ingredients. The sweet and cold properties of honeysuckle and dandelion, along with the bitter, pungent, and cold properties of bistort and Viola yedoensis, are used to clear away heat and toxicity. The bistort, dandelion, Viola yedoensis, and scorpion dissipate the accumulation of heat and toxicity. The light and dispersing properties of honeysuckle and the pungent and cold properties of bistort and Viola yedoensis are used to disperse and expel pathogenic factors. These five ingredients work together to regulate both qi and blood, achieving the effects of clearing heat, detoxifying, and dispersing pathogenic factors.

[0047] Forsythia suspensa and Scutellaria baicalensis serve as assistants. Forsythia suspensa is a "holy medicine for treating sores in the twelve meridians," dispersing blood stagnation and Qi accumulation, purging heart fire and removing dampness and heat from the spleen and stomach. Scutellaria baicalensis has a soothing nature that dispels pathogenic factors, and a bitter and neutral flavor that dries up dampness. These two, as assistants, not only aid the main herb in strengthening its heat-clearing, detoxifying, and stagnation-dispersing effects, but also assist in dispersing and drying dampness, leaving the heat and toxic pathogens with no dampness to cling to.

[0048] Lithospermum officinale, raw rehmannia root, peony bark, red peony root, stir-fried atractylodes macrocephala, Poria cocos, radix polygoni multiflori, Artemisia capillaris, plantain, and tangerine peel are used as adjuvants. Lithospermum officinale, raw rehmannia root, peony bark, and red peony root, with their cold nature and ability to cool blood, can remove the firewood from under the cauldron and cut off the heat at its roots; stir-fried atractylodes macrocephala, tangerine peel, Poria cocos, radix polygoni multiflori, plantain, and Artemisia capillaris are used to dry, penetrate, and remove existing dampness and turbidity, and strengthen the spleen and earth to eliminate the source of dampness; Lithospermum officinale promotes blood circulation and detoxifies, peony bark promotes blood circulation and removes blood stasis, and red peony root disperses evil and circulates blood to nourish, dispersing stagnation and giving rise to new blood; raw rehmannia nourishes yin and produces body fluid, Poria cocos strengthens the spleen and calms the heart, and stir-fried atractylodes strengthens the spleen and protects the vital energy, strengthening the vital energy to drive out evil, and radix polygoni multiflori resolves turbidity and dispels wind to urgently treat the symptoms, eliminating evil and stagnating the vital energy. These 10 ingredients are auxiliary ingredients that directly target the root cause of the disease, which is excessive heat and dampness in the blood, liver and spleen. They cool the invisible heat in the blood, eliminate the visible dampness, strengthen the weak spleen, and replenish the depleted yin and fluid, so as to achieve the goal of treating both the symptoms and the root cause.

[0049] Dictamni bark, Alisma orientalis, and Sophora flavescens serve as the guiding herbs. Dictamni bark, with its skin reaching the skin, clears heat and dampness, dispels wind and detoxifies, allowing the medicine to reach the affected area. Alisma orientalis and Sophora flavescens clear heat, promote urination, and allow the pathogenic factors to escape. Sophora flavescens also has insecticide and antipruritic properties. These three herbs serve as guiding herbs, harmonizing the overall formula's aromas, ensuring the smooth flow of medicinal energy, expelling the pathogen, and promoting recovery.

[0050] The Chinese medicinal composition has the effects of clearing away heat and detoxifying, removing dampness and relieving itching, and can be used for damp-heat accumulation in the skin, which is characterized by skin lesions and pustules on the palms and soles, burning, itching or pain, periodic attacks, lingering and difficult to heal, accompanied by erythema, scales, blisters, dry or sticky stools, yellow urine, bitter taste in the mouth, thirst without desire to drink, red tongue, thin yellow or greasy fur, and slippery or weak pulse; as well as acute febrile skin diseases such as palmoplantar pustulosis with the above symptoms.

[0051] In a second aspect, the present invention provides a use of the traditional Chinese medicine composition as described in the first aspect in preparing a medicine for clearing away heat and removing dampness.

[0052] In a third aspect, the present invention provides a pharmaceutical preparation for clearing away heat and removing dampness, the pharmaceutical preparation comprising the effective ingredients of the traditional Chinese medicine composition as described in the first aspect.

[0053] In some embodiments of the present invention, the pharmaceutical preparation further comprises an excipient.

[0054] In some embodiments of the present invention, the pharmaceutical preparation is in the form of tablets, capsules, granules or oral liquids.

[0055] In a fourth aspect, the present invention provides a method for preparing the pharmaceutical preparation according to the third aspect, the preparation method comprising the following steps:

[0056] (1) extracting the Chinese medicine composition according to the first aspect with water to obtain a water extract;

[0057] (2) preparing the aqueous extract into the dosage form of the pharmaceutical preparation.

[0058] In some embodiments of the present invention, the amount of water used in the water extraction in step (1) is 1-5 times the mass of the traditional Chinese medicine composition.

[0059] In some embodiments of the present invention, the water extraction method in step (1) is: decocting at least 2 times (for example, 2 times, 3 times, 4 times, 5 times, etc.), each time decocting for 20-60 minutes (for example, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes or 60 minutes, etc.) after the water boils.

[0060] In the present invention, there is no particular limitation on the method for preparing the aqueous extract into the dosage form of the pharmaceutical preparation in step (2), and those skilled in the art can select the method according to the conventional dosage form of the pharmaceutical preparation.

[0061] For example, when the pharmaceutical preparation is a granule, the method for preparing the granule may be:

[0062] The aqueous extract is concentrated to a relative density of 1.02-1.10 at 50° C., the supernatant is collected, and the concentrate is further concentrated to a relative density of 1.05-1.20 at 60° C. The obtained concentrate is mixed with steviol glycoside and dextrin, and granulated in one step.

[0063] Compared with the prior art, the present invention has the following beneficial effects:

[0064] 1. The Chinese medicine composition provided by the present invention has the effects of clearing away heat and detoxifying, removing dampness and relieving itching, and can be used for damp-heat accumulation in the skin, with symptoms of palmoplantar skin lesions, pustules, burning, itching or pain, periodic attacks, lingering and difficult to heal, accompanied by erythema, scales, blisters, dry or sticky stools, yellow urine, bitter taste in the mouth, thirst without desire to drink, red tongue, thin yellow or greasy fur, slippery or rapid pulse; as well as acute febrile skin diseases such as palmoplantar pustulosis with the above symptoms, and has a good therapeutic effect.

[0065] 2. The pharmaceutical preparation provided by the present invention has a simple prescription, a simple production process, few toxic and side effects, is convenient to administer, is easy to manufacture, and has low cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Figure 1 This is a diagram showing the effect of treating Case 1 with the heat-clearing and dampness-removing decoction provided in Example 3 at different times;

[0067] Figure 2 The diagram shows the effect of treating Case 2 with the heat-clearing and dampness-removing decoction provided in Example 3 for different treatment times. DETAILED DESCRIPTION

[0068] The technical solution of the present invention is further described below by way of specific embodiments. It should be understood by those skilled in the art that the specific embodiments are merely to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0069] Example 1

[0070] This embodiment provides a traditional Chinese medicine composition for clearing away heat and removing dampness, comprising the following components in parts by weight:

[0071] 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of scorpio, 15 parts of scutellaria, 15 parts of artemisia capillaris, 15 parts of forsythia and 20 parts of moutan bark.

[0072] This embodiment also provides a decoction for clearing away heat and removing dampness, and its preparation method is as follows:

[0073] According to the ratio of the traditional Chinese medicine composition provided in this example, 30g of honeysuckle, 30g of polygonum multiflorum, 20g of dandelion, 20g of viola yedoensis, 6g of scorpion, 15g of scutellaria baicalensis, 15g of capillaris, 15g of forsythia suspensa and 20g of peony bark were taken, water was added until it was about 3cm higher than the raw materials, soaked for 30 minutes, and decocted twice. The first decoction time was 30 minutes after the water boiled, and the second decoction time was 20 minutes after the water boiled using less water than the first time. The two medicinal liquids were combined to obtain 400mL of a decoction for clearing heat and dampness.

[0074] Example 2

[0075] This embodiment provides a traditional Chinese medicine composition for clearing away heat and removing dampness, comprising the following components in parts by weight:

[0076] 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of scorpio, 15 parts of scutellaria, 15 parts of capillaries, 15 parts of forsythia, 20 parts of peony bark, 15 parts of red peony root, 15 parts of lithospermum officinale, 15 parts of raw rehmannia root, 20 parts of tuckahoe and 15 parts of sophora flavescens.

[0077] This embodiment also provides a decoction for clearing away heat and removing dampness, and its preparation method is as follows:

[0078] According to the ratio of the traditional Chinese medicine composition provided in this embodiment, 30g of honeysuckle, 30g of polygonum multiflorum, 20g of dandelion, 20g of viola yedoensis, 6g of scorpion, 15g of scutellaria baicalensis, 15g of capillaris, 15g of forsythia, 20g of moutan bark, 15g of red peony root, 15g of lithospermum officinale, 15g of raw rehmannia root, 20g of poria and 15g of sophora flavescens were taken, water was added to about 3cm above the raw materials, soaked for 30 minutes, and decocted twice. The first decoction time was 30 minutes after the water boiled, and the second decoction time was 20 minutes after the water boiled using less water than the first time. The two medicinal liquids were combined to obtain 400mL of a decoction for clearing heat and dampness.

[0079] Example 3

[0080] This embodiment provides a traditional Chinese medicine composition for clearing away heat and removing dampness, comprising the following components in parts by weight:

[0081] 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of scorpio, 15 parts of scutellaria, 15 parts of capillaries, 15 parts of forsythia, 20 parts of peony bark, 15 parts of red peony root, 15 parts of raw rehmannia, 20 parts of poria, 15 parts of sophora flavescens, 20 parts of stir-fried atractylodes, 15 parts of radix polygoni multiflori, 15 parts of dittany bark, 15 parts of plantain, 15 parts of rhizoma alismatis, and 10 parts of dried tangerine peel.

[0082] This embodiment also provides a decoction for clearing away heat and removing dampness prepared using the Chinese medicine composition of this embodiment, and the preparation method thereof is as follows:

[0083] According to the ratio of the traditional Chinese medicine composition provided in this embodiment, 30g of honeysuckle, 30g of polygonum multiflorum, 20g of dandelion, 20g of viola yedoensis, 6g of scorpion, 15g of scutellaria, 15g of capillaris, 15g of forsythia, 20g of moutan bark, 15g of red peony root, 15g of raw rehmannia, 20g of poria, 15g of sophora flavescens, 20g of stir-fried atractylodes, 15g of radix polygoni multiflori, 15g of dittany, 15g of plantain, 15g of oriental rhizome and 10g of tangerine peel were taken, water was added to about 3cm above the raw materials, soaked for 30 minutes, and decocted twice. The first decocting time was 30 minutes after the water boiled, and the second time used less water than the first time and decocted for 20 minutes after the water boiled. The two medicinal liquids were combined to obtain 400mL of a decoction for clearing heat and dampness.

[0084] Clinical efficacy test

[0085] In order to investigate the clinical efficacy of the drug of the present invention in treating palmoplantar pustulosis, patients with palmoplantar pustulosis were selected for clinical efficacy observation.

[0086] 1.1 Diagnostic criteria

[0087] The diagnosis can be made based on the history of disease, clinical symptoms, medication history and laboratory tests.

[0088] Characteristics of palmoplantar pustulosis:

[0089] (1) Mostly limited to the palms and soles, with numerous yellowish pustules ranging in size from pinhead to millet-sized, with a red base, often occurring in batches on the thenar and hypothenar eminences or on the soles of the feet;

[0090] (2) After about 1-2 weeks, the pus scars rupture, become indurated, and scales are shed. Later, small pustules appear under the scales, sometimes mild and sometimes severe.

[0091] (3) Conscious itching or pain. Sometimes there may also be low-grade fever or general discomfort. The nails are often affected, appearing cloudy and thick with ridges.

[0092] (4) Psoriatic lesions are often seen on other parts of the patient's body;

[0093] (5) Some patients first develop symptoms on the palms and soles, and then develop generalized symptoms after repeated attacks.

[0094] With reference to the Clinical Edition of Traditional Chinese Medicine Dermatology and Venereology edited by Fan Ruiqiang, the TCM diagnosis and differentiation criteria for this disease are summarized as follows:

[0095] Damp-heat accumulation in the skin syndrome:

[0096] Main symptoms: ① Skin lesions are mostly seen on the palms and soles, and may even extend to the elbows; ② There are many pustules, accompanied by erythema and scales; ③ Burning, itching or pain; ④ Periodic attacks, lingering and difficult to heal; ⑤ May be accompanied by blisters, exudation and erosion.

[0097] Secondary symptoms: ① Dry or sticky stool; ② Yellow urine; ③ Bitter taste in the mouth; ④ Thirst without desire to drink; ⑤ Red tongue with thin yellow or greasy coating; ⑥ Slippery or rapid pulse.

[0098] Requirements for syndrome differentiation: Patients who have the above main symptoms ①②, 1 of ③-⑤, and 3 secondary symptoms can be diagnosed with this syndrome.

[0099] 1.2 Case data

[0100] A retrospective analysis was conducted on 60 patients with palmoplantar pustulosis who were consulted from 2021 to 2023, including 15 males and 45 females with a disease course of 3 months to 11 years and an age range of 20 to 60 years.

[0101] 1.3 Grouping

[0102] The patients were randomly divided into 3 groups (20 patients in each group), and were treated clinically with the heat-clearing and dampness-removing decoctions provided in Examples 1-3.

[0103] 1.4 Treatment

[0104] The patient orally takes the heat-clearing and dampness-removing decoction of the present invention, 2 times a day, 200 mL each time, one month as a course of treatment, and takes it continuously for 3 months. The patient goes to the hospital for treatment on a monthly basis and is followed up at the 3rd month.

[0105] 1.5 Efficacy evaluation criteria

[0106] Cured: all pustular lesions disappear or the disappearance area is greater than 90%;

[0107] Markedly effective: the area of ​​pustular lesions subsided by 61-90%;

[0108] Improvement: The area of ​​pustular lesions subsided by 21-60%;

[0109] Ineffective: The area of ​​pustular lesions subsided ≤ 20%.

[0110] 1.6 Treatment Effect

[0111] The statistical results of clinical treatment effects are shown in Table 1 below.

[0112] Table 1

[0113]

[0114] The safety statistics are shown in Table 2 below.

[0115] Table 2

[0116]

[0117]

[0118] Combining the efficacy and safety analysis, it can be seen that Example 3 is the most preferred solution.

[0119] 1.7 Typical Cases

[0120] The following are the conditions of two recovered patients treated with the decoction for clearing away heat and removing dampness according to Example 3:

[0121] Case 1

[0122] Wang Moumou, male, 22 years old. Diagnosis: Damp-heat accumulation in the skin; palmoplantar pustulosis. Patient self-report: Medical history of 6 years, symptoms include swollen and painful skin rash on the hands and feet for several years, erythema, peeling, pustules, red papules on the skin, and pus heads. In September 2021, he visited a city hospital and was diagnosed with palmoplantar pustulosis by Western medicine. On October 5, 2021, he started to take the Chinese medicine of the present invention orally. When he was re-examined in January 2022 (3 months of treatment), the patient had significantly improved, the pustules gradually shrank, and the skin lesions gradually returned to normal.

[0123] Case 2

[0124] Wang Moumou, female, 26 years old. Diagnosis: Damp-heat accumulation in the skin; palmoplantar pustulosis. Patient self-report: In September 2022, blister-like pustules grew on the fingers. The local hospital examined and prescribed Western medicine for eczema, but the condition did not improve and even became worse. In March 2023, a Chinese medicine hospital in Beijing diagnosed palmoplantar pustulosis. The pustules on both hands and feet were scaly and cracked. They would crack and bleed, and the itching was severe, making it difficult to fall asleep. On April 13, 2023, the Chinese medicine of the present invention was taken orally. After taking the medicine, no pustules appeared, the peeling was reduced, and the sleep improved. In July 2023, the patient was re-examined (after 3 months of treatment). The scales were basically shed, the pustules gradually shrank, and gradually returned to normal skin.

[0125] Figure 1 These are the results of treatment of Case 1 with the heat-clearing and dampness-removing decoction provided in Example 3 at 0 months (initial) and 3 months; Figure 2 These are the therapeutic effects of the heat-clearing and dampness-removing granules provided in Example 3 for Case 2 at 0 months (initial), 2 months, and 3 months.

[0126] As can be seen from the figure, after 3 months of treatment with the decoction for clearing away heat and removing dampness provided in Example 3, the area of ​​the patient's palmoplantar pustules was significantly reduced and the severity was significantly alleviated, indicating that the pharmaceutical preparation for clearing away heat and removing dampness provided by the present invention has a good therapeutic effect on palmoplantar pustulosis.

[0127] It should be noted that, in this document, the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0128] The foregoing description is intended only to provide specific embodiments of the present disclosure, intended to enable those skilled in the art to understand and implement the present disclosure. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present disclosure. Therefore, the present disclosure is not intended to be limited to the embodiments described herein, but rather to be construed in the broadest manner consistent with the principles and novel features disclosed herein.

Claims

1. A Chinese medicine composition for clearing away heat and dampness, characterized in that: The Chinese medicine composition comprises the following components: Honeysuckle, Bistort, Taraxacum, Viola yedoensis, Scorpio, Scutellaria baicalensis, Artemisia capillaris, Forsythia suspensa, and Paeonia suffruticosa bark.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition further comprises one or more of the following components: Red peony root, lithospermum officinale, raw rehmannia root, poria, sophora flavescens, stir-fried atractylodes macrocephala, radix polygoni multiflori, white peony root, plantain, oriental water plantain and tangerine peel.

3. The Chinese medicine composition according to claim 2, characterized in that The Chinese medicine composition comprises the following components: Honeysuckle, Bistort, Taraxacum, Viola yedoensis, Scorpio, Scutellaria, Artemisia capillaris, Forsythia suspensa, Paeonia suffruticosa, Paeonia lactiflora, Rehmannia root, Poria, Sophora flavescens, and Lithospermum officinale; Alternatively, the following components are included: honeysuckle, polygonum multiflorum, dandelion, viola yedoensis, scorpion, scutellaria baicalensis, capillaris, forsythia suspensa, peony bark, red peony root, raw rehmannia root, poria, sophora flavescens, stir-fried atractylodes, radix polygoni multiflori, bark of dittany, plantain, oriental rhizome and tangerine peel.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that When the Chinese medicine composition contains one or more of the following components, the weight proportions of the components are: 20-40 parts of honeysuckle, 20-40 parts of bistort, 10-30 parts of dandelion, 10-30 parts of viola yedoensis, 2-12 parts of scorpion, 5-25 parts of scutellaria, 5-25 parts of capillaries, 5-25 parts of forsythia, 10-30 parts of peony bark, 5-25 parts of red peony root, 5-25 parts of lithospermum officinale, 5-25 parts of raw rehmannia root, 10-30 parts of poria, 5-25 parts of sophora flavescens, 10-30 parts of stir-fried atractylodes, 5-25 parts of radix polygoni multiflori, 5-25 parts of dittany bark, 5-25 parts of plantain, 5-25 parts of oriental rhizome, 3-20 parts of dried tangerine peel; Preferably: 25-35 parts of honeysuckle, 25-35 parts of bistort, 15-25 parts of dandelion, 15-25 parts of viola yedoensis, 4-8 parts of scorpion, 10-20 parts of scutellaria, 10-20 parts of capillaries, 10-20 parts of forsythia, 15-25 parts of peony bark, 10-20 parts of red peony root, 10-20 parts of lithospermum officinale, 10-20 parts of raw rehmannia root, 15-25 parts of poria, 10-20 parts of sophora flavescens, 15-25 parts of stir-fried atractylodes, 10-20 parts of radix polygoni multiflori, 10-20 parts of divaricate bark, 10-20 parts of plantain, 10-20 parts of oriental rhizome, 5-15 parts of dried tangerine peel; More preferably, it is: 30 parts of honeysuckle, 30 parts of polygonum multiflorum, 20 parts of dandelion, 20 parts of viola yedoensis, 6 parts of scorpion, 15 parts of scutellaria, 15 parts of capillaris, 15 parts of forsythia, 20 parts of peony bark, 15 parts of red peony root, 15 parts of lithospermum officinale, 15 parts of raw rehmannia root, 20 parts of poria, 15 parts of sophora flavescens, 20 parts of stir-fried atractylodes, 15 parts of radix polygoni multiflori, 15 parts of dittany bark, 15 parts of plantain, 15 parts of rhizoma alismatis, and 10 parts of dried tangerine peel.

5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in preparing a medicine for clearing away heat and removing dampness.

6. A medicinal preparation for clearing away heat and dampness, characterized in that The pharmaceutical preparation comprises the active ingredients of the traditional Chinese medicine composition according to any one of claims 1 to 4.

7. The pharmaceutical preparation according to claim 6, characterized in that The pharmaceutical preparation further includes an excipient.

8. The pharmaceutical preparation according to claim 6 or 7, characterized in that The dosage form of the pharmaceutical preparation is tablet, capsule, granule or oral solution.

9. A method for preparing the pharmaceutical preparation according to any one of claims 6 to 8, characterized in that: The preparation method comprises the following steps: (1) extracting the Chinese medicine composition according to any one of claims 1 to 4 with water to obtain a water extract; (2) preparing the aqueous extract into the dosage form of the pharmaceutical preparation.

10. The preparation method according to claim 9, characterized in that The amount of water used in the water extraction in step (1) is 1-5 times the mass of the traditional Chinese medicine composition; Preferably, the water extraction method in step (1) is: decocting at least twice, each time decocting for 20-60 minutes after the water boils.

Images