A kind of Xiaofeng Zhiyang granules for treating wind-heat type eczema

Abstract

The application discloses a kind of treating wind heat type eczema's Qufeng Zhiyang granules, contain bamboo leaf 30-50 parts, Ophiopogon 20-30 parts, Huangqi 15-25 parts, Cape jasmine 20-30 parts, Lily 15-25 parts, Shengdi 20-30 parts, Lianqiao 18-22 parts, Honeysuckle 20-30 parts, Xuan 20-30 parts, Purple grass 18-22 parts, Alisma 15-25 parts, Plantago 20-30 parts, Fuling 18-22 parts, Baizhu 15-25 parts, Guizhi 10-20 parts, Amomum 18-22 parts, Red flower 20-30 parts, Red Shaor 15-25 parts, Tao Ren 18-22 parts, Danshen 15-25 parts, Huangqi 20-30 parts, Dangshen 20-30 parts, Jiegeng 15-25 parts, Banxia 15-25 parts, can clear heart fire, blood detoxification, dispel wind and clear heat and dampness, spleen dampness, blood circulation, lung qi, lung yin, lung, wind heat type eczema treatment, effect is remarkable, and its preparation method is disclosed.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a wind-heat type eczema relief and antipruritic granule and its preparation method. Background Technology

[0002] Dermatitis eczema is a skin inflammation characterized by intense itching, caused by a variety of internal and external factors. It is a disease triggered by allergic irritants. While eczema may be caused by a humid environment, it is not solely due to this factor. It can be triggered by diet or contact with certain substances, and frequent scratching and irritation can worsen the symptoms. Clinically, eczema is classified into three stages: acute, subacute, and chronic. The acute stage tends to be exudative, while the chronic stage is characterized by infiltration and thickening. Some patients present directly with chronic eczema. The lesions are polymorphic, symmetrical, itchy, and prone to recurrence. Due to the complex etiology of eczema, it is prone to recurrence even after treatment, making it difficult to cure completely. Because the clinical morphology and location vary, medication varies from person to person. Application number 202211083554.3, invention title: A traditional Chinese medicine composition for treating eczema, its preparation method and application, provides a traditional Chinese medicine composition for treating eczema, comprising the following medicinal ingredients in parts by weight: 3-8 parts of Sophora flavescens, 1-4 parts of Phellodendron chinense, 1-4 parts of Kochia scoparia, 1-4 parts of Dictamnus dasycarpus, 1-4 parts of Gentiana scabra, 1-4 parts of Plantago asiatica (processed with salt), 1-4 parts of Alisma plantago-aquatica (processed with salt), 1-4 parts of Smilax glabra, 1-4 parts of Gardenia jasminoides, 1-4 parts of Scutellaria baicalensis, 1-4 parts of Sanguisorba officinalis, 1-4 parts of Rehmannia glutinosa, 1-4 parts of Paeonia suffruticosa, 1-4 parts of Paeonia lactiflora, 1-4 parts of stir-fried Pheretima aspergillum, 1-4 parts of stir-fried Tribulus terrestris, and 0.5-3 parts of Cicadae periostracum. This traditional Chinese medicine composition has no toxic side effects and has a significant therapeutic effect on eczema. Furthermore, compared to the low-dose and high-dose groups, the medium-dose group of the traditional Chinese medicine composition of this invention shows a more significant therapeutic effect on eczema. The preparation method of this traditional Chinese medicine preparation is unique, employing different treatments for different raw materials. Extensive research has proven that this preparation method is more conducive to preserving the content of effective substances. However, this invention does not target specific syndrome types for symptomatic treatment, thus its reliability is questionable. Traditional Chinese medicine classifies eczema into three types: damp-heat, wind-heat, and blood deficiency with wind-dryness. The damp-heat type is mainly characterized by erythema, papules, exudation, erosion, and crusting. The wind-heat type presents with erythema, papules, scaling, and even fissures, accompanied by burning sensation and intense itching; both of these types of eczema belong to acute eczema. Chronic eczema is mainly characterized by thickened skin, lichenification, some papules, scaling, fissures, skin pigmentation, and itching; this is diagnosed as the blood deficiency with wind-dryness type in traditional Chinese medicine. Among these, the wind-heat type is the most common. Summary of the Invention

[0003] The purpose of this invention is to address the shortcomings of existing technologies by proposing a wind-relieving and itch-relieving granule for treating wind-heat type eczema and its preparation method.

[0004] To achieve the above objectives, the present invention adopts the following technical solution:

[0005] A granule for treating wind-heat type eczema, comprising the following ingredients in parts by weight: bamboo leaves 30-50 parts, ophiopogon japonicus 20-30 parts, scutellaria baicalensis 15-25 parts, gardenia 20-30 parts, lily bulb 15-25 parts, rehmannia glutinosa 20-30 parts, forsythia suspensa 18-22 parts, honeysuckle 20-30 parts, scrophularia ningpoensis 20-30 parts, lithospermum erythrorhizon 18-22 parts, alisma plantago-aquatica 15-25 parts, plantain seed 20-30 parts, poria cocos 18-22 parts, atractylodes macrocephala 15-25 parts, cinnamon twig 10-20 parts, amomum villosum 18-22 parts, safflower 20-30 parts, red peony root 15-25 parts, peach kernel 18-22 parts, salvia miltiorrhiza 15-25 parts, astragalus membranaceus 20-30 parts, codonopsis pilosula 20-30 parts, platycodon grandiflorus 15-25 parts, and pinellia ternata 15-25 parts.

[0006] The wind-heat type eczema-relieving and antipruritic granules are prepared from the following raw materials in parts by weight: bamboo leaves 40 parts, ophiopogon japonicus 25 parts, scutellaria baicalensis 20 parts, gardenia 25 parts, lily bulb 20 parts, rehmannia glutinosa 25 parts, forsythia suspensa 20 parts, honeysuckle 25 parts, scrophularia ningpoensis 25 parts, gromwell root 20 parts, alisma plantago-aquatica 20 parts, plantain seed 25 parts, poria cocos 20 parts, atractylodes macrocephala 20 parts, cinnamon twig 15 parts, amomum villosum 20 parts, safflower 25 parts, red peony root 20 parts, peach kernel 20 parts, salvia miltiorrhiza 20 parts, astragalus membranaceus 25 parts, codonopsis pilosula 25 parts, platycodon grandiflorus 20 parts, and pinellia ternata 20 parts.

[0007] The preparation method of the wind-heat type eczema-relieving and antipruritic granules includes the following steps:

[0008] S1: Weigh each component according to the formula, pick out the raw materials of each component, wash them and dry them, and set them aside for later use;

[0009] S2: Add 2 to 5 times the amount of water to Forsythia, Honeysuckle, Safflower, Red Peony Root, and Peach Kernel, soak for 40 to 80 minutes, then extract the volatile oil by steam distillation for 3 hours, collect the volatile oil, and keep the residue for later use.

[0010] S3: Take the dregs obtained in step S2, add other Chinese medicinal herbs, add 8 to 12 times the amount of water, decoct for 1 to 3 hours, filter to obtain the decoction, add 8 to 12 times the amount of water to the dregs, decoct for 1 to 3 hours, filter to obtain the decoction, and combine the two decoctions.

[0011] S4: Concentrate the decoction to a relative density of 1.20-1.30 at 25°C, and spray dry to obtain extract powder;

[0012] S5: Take the volatile oil obtained in step S2 and encapsulate it with cyclodextrin;

[0013] S6: The extract powder obtained in step S4 and the volatile oil cyclodextrin inclusion complex prepared in step S5 are combined with excipients to prepare granules.

[0014] In the preparation method of the wind-heat type eczema relief and itch-relieving granules, in step S2, forsythia, honeysuckle, safflower, red peony root, and peach kernel are added to 4 times the amount of water and soaked for 60 minutes.

[0015] The method for preparing the wind-heat type eczema relief and itch-relieving granules involves adding water twice in step S3, with the amount being 10 times the normal volume, and then decocting for 2 hours.

[0016] The wind-heat relieving and itching-relieving granules for treating wind-heat type eczema have a relative density of 1.25 in S4 during the preparation method.

[0017] The application of the wind-heat type eczema-relieving and antipruritic granules in the preparation of eczema treatment drugs.

[0018] Bamboo leaves are the leaves of *Phyllostachys nigra* (Lodd. ex Lindl.) Munro var. *henonis* (Mitf.) Stapf et Rendle, belonging to the Poaceae family. They are distributed in Shandong, Henan, and areas south of the Yangtze River. They have the effects of clearing heat and relieving irritability, promoting body fluid production, and promoting urination. They are used for feverish thirst, infantile convulsions, cough with vomiting and nosebleeds, scanty dark urine, and oral ulcers.

[0019] Ophiopogon japonicus is the dried tuberous root of the plant Ophiopogon japonicus, belonging to the Liliaceae family. It has the effects of nourishing yin and moistening the lungs, benefiting the stomach and promoting the production of body fluids, clearing the heart and relieving irritability, and moistening the intestines and promoting bowel movements.

[0020] Scutellaria baicalensis has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It can be used to treat damp-heat syndrome, lung-heat cough, blood-heat bleeding, carbuncles and boils, and threatened abortion. Scutellaria baicalensis is the dried root of Scutellaria baicalensis, a plant in the Lamiaceae family.

[0021] Gardenia is the fruit of the gardenia plant, belonging to the Rubiaceae family. Gardenia fruit is a traditional Chinese medicine, a resource that can be used for both medicinal and edible purposes, and has effects such as protecting the liver, promoting bile secretion, lowering blood pressure, calming the nerves, stopping bleeding, and reducing swelling.

[0022] Lily refers to the dried, fleshy scales of the lily plant *Lilium lancifolium* Ker Gawl. or *Liliumpumilum Redouté*. It has the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind. Lily is commonly used to treat dry cough due to yin deficiency, hemoptysis due to overwork, restlessness and palpitations, insomnia and excessive dreaming, and mental confusion.

[0023] Rehmannia root is the dried tuberous root of Rehmannia glutinosa, a perennial herb of the Scrophulariaceae family. It cools the blood and clears heat, nourishes yin and tonifies the kidneys, and promotes the production of body fluids and quenches thirst. It is often used to treat symptoms such as heat entering the blood level, bone steaming fever, dry and sore throat, and blood in sputum.

[0024] Forsythia is the fruit of the forsythia plant, belonging to the Oleaceae family. It belongs to the category of heat-clearing and detoxifying drugs. Its medicinal properties are bitter and slightly cold, and it enters the lung, heart, and small intestine meridians. It has the functions of clearing heat and detoxifying, reducing swelling and dissipating nodules, and dispersing wind-heat.

[0025] Honeysuckle is the dried flower bud or unopened flower of *Lonicera japonica* Thunb., a plant belonging to the genus *Lonicera* in the family Caprifoliaceae. It has heat-clearing and detoxifying properties. It is used to treat febrile diseases, dysentery due to heat toxicity, carbuncles, boils, scrofula, and hemorrhoids.

[0026] Scrophularia is the root of Scrophularia ningpoensis and Scrophularia ningpoensis var. chinensis, belonging to the Scrophulariaceae family. It is sweet, bitter, and salty in taste, slightly cold in nature, and enters the lung, stomach, and kidney meridians. It has the functions of clearing heat and cooling blood, purging fire and detoxifying, and nourishing yin. It is mainly used for treating abdominal pain, pericardial effusion, yin deficiency due to febrile diseases, constipation due to fluid depletion, bone steaming pain, eye irritation and sore throat, fatigue, and diphtheria swelling.

[0027] Lithospermum erythrorhizon is the dried root of plants in the Boraginaceae family, such as Lithospermum erythrorhizon, Lithospermum sibiricum, or Lithospermum mongholicum. It has the effects of cooling the blood, promoting blood circulation, detoxifying, and relieving rashes. It can be used for measles or febrile diseases with rashes.

[0028] Alisma orientalis (Sam.) Juzep., a plant in the Alismataceae family, is a dried tuber. It has diuretic, dampness-removing, and heat-clearing properties. It is used to treat urinary difficulty, edema, vomiting, diarrhea, phlegm retention, beriberi, gonorrhea, and hematuria.

[0029] Plantain seeds are the dried, mature seeds of Plantago asiatica L. or Plantago depressa Willd., belonging to the Plantaginaceae family. They have the effects of clearing heat and promoting diuresis, relieving strangury, eliminating dampness and stopping diarrhea, clearing the liver and improving eyesight, and clearing the lungs and resolving phlegm. They can be used to treat heat accumulation in the bladder, difficulty urinating, and painful urination.

[0030] Poria cocos is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf, belonging to the Polyporaceae family. It has diuretic and dampness-removing properties, and also strengthens the spleen and replenishes qi. Poria cocos can be used to treat symptoms such as edema, damp-heat, and spleen and stomach weakness.

[0031] Atractylodes macrocephala is the dried rhizome of the plant Atractylodes macrocephala Koidz., belonging to the Asteraceae family. It is used to invigorate the spleen and replenish qi, dry dampness and promote diuresis, stop sweating, and calm the fetus. It can be used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0032] Cinnamon twigs are the tender branches of the cinnamon tree (Cinnamomum cassia), a plant in the Lauraceae family. They have the effects of inducing sweating to relieve exterior syndromes, warming and unblocking the meridians, and warming yang and transforming qi.

[0033] Amomum villosum Lour., Amomum villosum Lour. var. xanthioides TLWu et Senjen, or Amomum longiligulare TLWu are all plants belonging to the ginger family. Amomum villosum Lour., Amomum villosum Lour. var. xanthioides TLWu et Senjen are also mentioned. Amomum villosum Lour. has a fragrant aroma and is beneficial to the spleen and stomach. It excels at resolving dampness, invigorating the spleen, regulating qi, harmonizing the stomach, warming the middle jiao, and dispelling cold. It is considered an excellent medicine for resolving dampness, regulating qi, invigorating the spleen, and harmonizing the stomach.

[0034] Safflower is the dried flower of *Carthamus tinctorius* L., a plant in the Asteraceae family. It has the effects of promoting blood circulation, regulating menstruation, removing blood stasis, and relieving pain. It can be used to treat dysmenorrhea, postpartum abdominal pain, chest tightness (chest pain), rib pain (pain in the hypochondriac region), and injuries from falls and blows.

[0035] Red peony root is the dried root of Paeonia lactiflora or Paeonia veitchii, both belonging to the Ranunculaceae family. It has the following effects and uses: 1. Nourishing Yin and promoting blood circulation, relieving pain, cooling blood and reducing swelling. 2. Treating coagulation disorders, high blood lipids, traumatic injuries, carbuncles, abdominal pain, and rib pain.

[0036] Peach kernel is the dried, mature seed of *Prunus persica* (L.) Batsch or *Prunus davidiana* (Carr.) Franch., both belonging to the Rosaceae family. It invigorates blood circulation, removes blood stasis, and moistens the intestines to relieve constipation. It is used for amenorrhea, dysmenorrhea, abdominal masses, traumatic injuries, and constipation due to intestinal dryness.

[0037] Danshen is the dried root and rhizome of *Salvia miltiorrhiza* Bge., a plant in the Lamiaceae family. It has the effects of promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain; it also has the effects of clearing heat and detoxifying, and improving cardiovascular health.

[0038] Astragalus is the root of *Astragalus memeranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao or *A. membranaceus* (Fisch.) Bge., belonging to the genus *Astragalus* of the legume family. It has the effects of strengthening the spleen and replenishing the middle jiao, raising yang and lifting prolapse, benefiting wei qi and consolidating the exterior, promoting diuresis, and promoting tissue regeneration and detoxification. It is mainly used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, and spontaneous sweating due to qi deficiency.

[0039] Codonopsis pilosula is the dried root of Codonopsis pilosula, Codonopsis lanceolata, or Codonopsis chuanxiong, all belonging to the Campanulaceae family. It has a sweet taste and neutral properties. It tonifies the middle energizer and replenishes qi, quenches thirst, strengthens the spleen and lungs, nourishes blood and generates fluids. It is used for spleen and lung qi deficiency, poor appetite and fatigue, cough and wheezing, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to fluid depletion, and internal heat and thirst.

[0040] Platycodon grandiflorus (Jacq.) A.Dc., a plant in the Campanulaceae family, is the dried root of the plant. It is used to clear lung heat, expel phlegm, and drain pus. It is used to treat coughs due to external pathogens, sore throat, lung abscess with purulent sputum, chest fullness and rib pain, and dysentery with abdominal pain.

[0041] Pinellia ternata is a perennial herb belonging to the genus Pinellia of the family Araceae. This invention uses ginger-processed Pinellia ternata, which has the functions of drying dampness and resolving phlegm, relieving nausea and vomiting, and is suitable for those with spleen deficiency causing excessive phlegm and vomiting, or those with cold phlegm causing cough and nausea.

[0042] Wind-heat eczema is an allergic reaction of the skin caused by the invasion of wind-heat pathogens. Clinically, it generally manifests as papules, vesicles, and itching. Main clinical symptoms: rapid onset, predominantly red papules, widespread throughout the body, flushed and scaly, with itching, often scratched and bleeding, but with minimal exudation. This type is commonly seen in acute papular eczema and some subacute eczema. Tongue and pulse: red tongue with a thin white or thin yellow coating, and a wiry and rapid pulse. The *Huangdi Neijing Suwen* (Yellow Emperor's Inner Classic - Basic Questions) states, "All pain, itching, and sores belong to the heart." Qing dynasty scholar Gao Shizong, in his *Huangdi Suwen Zhijie* (Straightforward Explanation of the Yellow Emperor's Inner Classic), explains: "The pericardium meridian originates in the chest, runs along the chest to the ribs, and enters the elbow and lower arm. Body heat is due to the fire qi floating to the surface. Bone pain is caused by the fire floating externally, not warming the interior, thus causing it to spread. Prolonged body heat will linger in the skin and meridians, forming spreading sores." Therefore, heat in the heart meridian is primarily caused by emotional distress, irritability, and anxiety, leading to qi stagnation and fire. The heart governs fire and blood vessels; internal heart fire causes heat in the blood, which manifests on the skin. Therefore, the treatment involves clearing the heart, cooling the blood, and detoxifying.

[0043] The Qing dynasty scholar Li Wen recorded in his "Extensive Commentary on the Essentials of the Golden Chamber" that "Infiltrated sores are characterized by dampness and oozing, where pus and fluid flow, leading to ulceration and sores, hence the name 'Infiltrated Sores.' They are caused by the accumulation of damp heat." The appropriate treatment is to dispel wind, clear heat, and promote diuresis.

[0044] The *Suwen Zhizhen Dayao Lun* states, "All swelling and fullness due to dampness belong to the spleen." This means that all diseases related to dampness are inseparable from spleen damage. The spleen governs transformation and transportation; it is responsible for the transport and distribution of all the essential nutrients and dampness products in the body. When the spleen is damaged, it is unable to transform the nutrients received by the body into essential substances and distribute them throughout the body, thus affecting the generation of blood and qi, leading to a state of spleen deficiency. Repeated occurrences of this can result in a deficiency of the body's vital energy, causing the illness to become chronic. If the transformation and transportation of dampness is disrupted, the body's fluids stagnate, forming phlegm and other pathological products. Prolonged stagnation can generate heat, and this internal damp-heat, under the influence of external pathogens, manifests as eczema. Therefore, eczema is rooted in internal spleen deficiency and internal dampness, while external pathogenic factors such as wind, cold, heat, and dampness are the superficial manifestations. When the spleen yang is weak, water and dampness cannot be transported, and dampness is generated internally in the spleen. The spleen governs the muscles, and dampness infiltrates the spleen, causing damp sores. When dampness and heat combine and infiltrate the body, it becomes a widespread condition. It is necessary to invigorate qi, strengthen the spleen, and eliminate dampness.

[0045] Eczema is a common and refractory skin disease in clinical practice. It has an unpredictable course, is prone to recurrence, and is difficult to cure. Traditional Chinese medicine believes that "prolonged illness inevitably leads to blood stasis" and "stubborn diseases are mostly due to blood stasis." Prolonged illness enters the collaterals, resulting in poor blood circulation, blood stasis obstructing the collaterals, and malnourishment of the skin. "When blood flows smoothly, wind will naturally subside." Therefore, blood-activating and stasis-removing drugs are used for treatment.

[0046] Traditional Chinese medicine believes that the lungs govern the dispersing and dispersing of qi, and are externally connected to the skin and hair. The essence of food and water transformed by the spleen is distributed throughout the body via the dispersing and dispersing function of the lungs to warm and nourish the skin. If the dispersing and dispersing function of the lungs is disordered and the skin does not receive the nourishment of the essence of food and water, the skin's self-protection function will decline, leading to various skin diseases. It is necessary to replenish lung qi, replenish lung yin, and cleanse the lungs.

[0047] This invention uses bamboo leaves, ophiopogon japonicus, scutellaria baicalensis, gardenia, lily bulb, and rehmannia glutinosa to clear heart fire, cool blood, and detoxify, as the principal herbs; forsythia suspensa, honeysuckle, scrophularia ningpoensis, gromwell root, alisma plantago-aquatica, and plantain seed to dispel wind, clear heat, and promote diuresis, as the assistant herbs; poria cocos, atractylodes macrocephala, cinnamon twig, and amomum villosum to strengthen the spleen and promote diuresis; safflower, red peony root, peach kernel, and salvia miltiorrhiza to invigorate blood and remove blood stasis, as the adjuvant herbs; and astragalus membranaceus, codonopsis pilosula, platycodon grandiflorus, and pinellia ternata to tonify lung qi, nourish lung yin, and clear lung heat, as the guiding herbs. The formula contains bamboo leaves, ophiopogon japonicus, scutellaria baicalensis, gardenia, lily bulb, rehmannia glutinosa, forsythia suspensa, honeysuckle, scrophularia ningpoensis, gromwell root, alisma plantago-aquatica, plantain seed, poria cocos, atractylodes macrocephala, cinnamon twig, amomum villosum, safflower, red peony root, peach kernel, salvia miltiorrhiza, astragalus membranaceus, codonopsis pilosula, platycodon grandiflorus, and pinellia ternata. It can clear heart fire, cool blood and detoxify, dispel wind and clear heat and promote diuresis, strengthen spleen and promote diuresis, invigorate blood and remove blood stasis, replenish lung qi, replenish lung yin, and clear lung heat. It has a significant effect in treating wind-heat type eczema. Detailed Implementation

[0048] The present invention will be further described 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. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0049] Example 1: Take 40g of bamboo leaves, 25g of Ophiopogon japonicus, 20g of Scutellaria baicalensis, 25g of Gardenia jasminoides, 20g of Lilium brownii, 25g of Rehmannia glutinosa, 20g of Forsythia suspensa, 25g of Lonicera japonica, 25g of Scrophularia ningpoensis, 20g of Lithospermum erythrorhizon, 20g of Alisma plantago-aquatica, 25g of Plantago asiatica, 20g of Poria cocos, 20g of Atractylodes macrocephala, 15g of Cinnamomum cassia, 20g of Amomum villosum, 25g of Carthamus tinctorius, 20g of Paeonia lactiflora, 20g of Prunus persica, 20g of Salvia miltiorrhiza, 25g of Astragalus membranaceus, 25g of Codonopsis pilosula, 20g of Platycodon grandiflorus, and 20g of Pinellia ternata. The preparation method includes the following steps:

[0050] S1: Weigh each component according to the formula, pick out the raw materials of each component, wash them and dry them, and set them aside for later use;

[0051] S2: Add forsythia, honeysuckle, safflower, red peony root, and peach kernel to 4 times the amount of water and soak for 60 minutes. Then extract the volatile oil by steam distillation for 3 hours. Collect the volatile oil and keep the residue for later use.

[0052] S3: Take the dregs obtained in step S2, add other Chinese medicinal herbs, add 10 times the amount of water, decoct for 2 hours, filter to obtain the decoction, add 10 times the amount of water to the dregs, decoct for 2 hours, filter to obtain the decoction, and combine the two decoctions.

[0053] S4: Concentrate the decoction to a relative density of 1.25 at 25°C, and spray dry to obtain extract powder;

[0054] S5: Take the volatile oil obtained in step S2 and encapsulate it with cyclodextrin;

[0055] S6: The extract powder obtained in step S4 and the volatile oil cyclodextrin inclusion complex prepared in step S5 are combined with excipients to prepare granules.

[0056] Example 2:

[0057] Take 30g of bamboo leaves, 30g of Ophiopogon japonicus, 15g of Scutellaria baicalensis, 30g of Gardenia jasminoides, 15g of Lilium brownii, 30g of Rehmannia glutinosa, 18g of Forsythia suspensa, 30g of Lonicera japonica, 20g of Scrophularia ningpoensis, 22g of Lithospermum erythrorhizon, 15g of Alisma plantago-aquatica, 30g of Plantago asiatica, 18g of Poria cocos, 25g of Atractylodes macrocephala, 10g of Cinnamomum cassia, 22g of Amomum villosum, 20g of Carthamus tinctorius, 25g of Paeonia lactiflora, 18g of Prunus persica, 25g of Salvia miltiorrhiza, 20g of Astragalus membranaceus, 30g of Codonopsis pilosula, 15g of Platycodon grandiflorus, and 25g of Pinellia ternata. The preparation method includes the following steps:

[0058] S1: Weigh each component according to the formula, pick out the raw materials of each component, wash them and dry them, and set them aside for later use;

[0059] S2: Add forsythia, honeysuckle, safflower, red peony root, and peach kernel to twice the amount of water and soak for 80 minutes. Then extract the volatile oil by steam distillation for 3 hours. Collect the volatile oil and keep the residue for later use.

[0060] S3: Take the dregs obtained in step S2, add other Chinese medicinal herbs, add 8 times the amount of water, decoct for 3 hours, filter to obtain the decoction, add 8 times the amount of water to the dregs, decoct for 3 hours, filter to obtain the decoction, and combine the two decoctions.

[0061] S4: Concentrate the decoction to a relative density of 1.20 at 25°C, and spray dry to obtain extract powder;

[0062] S5: Take the volatile oil obtained in step S2 and encapsulate it with cyclodextrin;

[0063] S6: The extract powder obtained in step S4 and the volatile oil cyclodextrin inclusion complex prepared in step S5 are combined with excipients to prepare granules.

[0064] Example 3:

[0065] Take 50g of bamboo leaves, 20g of Ophiopogon japonicus, 25g of Scutellaria baicalensis, 20g of Gardenia jasminoides, 25g of Lilium brownii, 20g of Rehmannia glutinosa, 22g of Forsythia suspensa, 20g of Lonicera japonica, 30g of Scrophularia ningpoensis, 18g of Lithospermum erythrorhizon, 25g of Alisma plantago-aquatica, 20g of Plantago asiatica, 22g of Poria cocos, 15g of Atractylodes macrocephala, 20g of Cinnamomum cassia, 18g of Amomum villosum, 30g of Carthamus tinctorius, 15g of Paeonia lactiflora, 22g of Prunus persica, 15g of Salvia miltiorrhiza, 30g of Astragalus membranaceus, 20g of Codonopsis pilosula, 25g of Platycodon grandiflorus, and 15g of Pinellia ternata. The preparation method includes the following steps:

[0066] S1: Weigh each component according to the formula, pick out the raw materials of each component, wash them and dry them, and set them aside for later use;

[0067] S2: Add 5 times the amount of water to forsythia, honeysuckle, safflower, red peony root, and peach kernel, soak for 40 minutes, and then extract the volatile oil by steam distillation for 3 hours. Collect the volatile oil and keep the residue for later use.

[0068] S3: Take the dregs obtained in step S2, add other Chinese medicinal herbs, add 12 times the amount of water, decoct for 1 hour, filter to obtain the decoction, add 8 times the amount of water to the dregs, decoct for 3 hours, filter to obtain the decoction, and combine the two decoctions.

[0069] S4: Concentrate the decoction to a relative density of 1.20 at 25°C, and spray dry to obtain extract powder;

[0070] S5: Take the volatile oil obtained in step S2 and encapsulate it with cyclodextrin;

[0071] S6: The extract powder obtained in step S4 and the volatile oil cyclodextrin inclusion complex prepared in step S5 are combined with excipients to prepare granules.

[0072] Example 4: Effects of histamine phosphate on a guinea pig model of rash and itching

[0073] Thirty guinea pigs weighing 280-320g, half male and half female, were randomly divided into a model group, the Example 1 group of this invention, and a positive control drug, Fuyang Granules group (Fuyang Granules were produced by Sichuan Dikang Pharmaceutical Co., Ltd., National Drug Approval Number Z51021686, Production Batch Number 20220509). The Example 1 group and the positive control drug Fuyang Granules group were administered 5g of raw drug / kg orally, while the model group was given an equal amount of distilled water, once a day for 4 consecutive days. One hour after administration on day 3, the fur on the right hind foot of each group of guinea pigs was shaved. One hour after administration on day 4, the shaved area on the right hind foot was scratched with coarse sandpaper, covering an area of ​​approximately 0.8 square centimeters. At the wound site, 0.05 ml of 0.01% histamine phosphate was administered per guinea pig. Subsequently, the concentration was increased by 0.02%, 0.03%, 0.04%, etc., every 3 minutes, with each increase being 0.05 ml per guinea pig, until the guinea pig turned back to lick the right hind foot. The total amount of histamine phosphate (micrograms) administered when the guinea pig turned back to lick the right hind foot was taken as the pruritus threshold. The pruritus threshold values ​​of each group were recorded and compared. The t-test was used to compare whether the pruritus threshold values ​​of each administration group were statistically significant compared with the model group. The results are shown in Table 1.

[0074] Table 1. Effects of this invention on the histamine-induced guinea pig tetany model.

[0075]

[0076] Compared with the model group, * p < 0.05; ** p < 0.01; Compared with the positive drug group, # p < 0.05

[0077] The results showed that the pruritus threshold of histamine phosphate in the first embodiment of the present invention and the positive drug pruritus granules group could significantly increase the pruritus threshold, which was significantly different from that of the model group. Moreover, the effect of the first embodiment of the present invention was better than that of the positive drug group.

[0078] Example 5:

[0079] Thirty male mice weighing 18-22g were randomly divided into a model group, the Example 1 group of this invention, and a positive drug Fuyang Granules group (Fuyang Granules were produced by Sichuan Dikang Pharmaceutical Co., Ltd., National Drug Approval Number Z51021686, Production Batch Number 20220509). The Example 1 group and the positive drug Fuyang Granules group were administered 2g of raw drug / kg orally, while the model group received an equal volume of distilled water, once daily for 3 consecutive days. Forty-five minutes after administration on the fourth day, a circular filter paper soaked in xylene was applied tightly to the right ear of the mouse for 15 seconds to induce inflammation. The mice were sacrificed 20 minutes later, and ear pieces were taken from the same location on both ears using an ear-swelling device. The weight of the ear pieces was measured using an analytical balance, and the weight difference between the two ears was calculated. A t-test was used to compare the degree of ear swelling in each treatment group with that in the model group to determine if there was a statistically significant difference. The results are shown in Table 2.

[0080] Table 2. Effects of the present invention on xylene-induced ear swelling in mice.

[0081]

[0082] Compared with the model group, * p < 0.05; ** p < 0.01; Compared with the positive control group, # p < 0.05; ## p < 0.01

[0083] The results showed that both the Example 1 group and the positive drug Fuyang granule group of the present invention had a significant inhibitory effect on xylene-induced ear swelling in mice, and there was a significant difference compared with the model group.

[0084] Example 6: Clinical Study

[0085] This study included 80 patients who visited the Dermatology Department of Nanjing Municipal Hospital of Traditional Chinese Medicine between December 2022 and December 2023. The diagnosis of wind-heat type eczema was based on the diagnostic criteria in *New Edition of Traditional Chinese Surgery*, published by the People's Military Medical Publishing House: Main symptoms: rapid onset, predominantly red papules, widespread throughout the body, flushed with scaling, itching, often scratched and bleeding, with minimal exudation; this type is commonly seen in acute papular eczema and some subacute eczema. Tongue and pulse: red tongue with a thin white or thin yellow coating, and a wiry and rapid pulse. The diagnosis was wind-heat type eczema.

[0086] Inclusion criteria: (1) meeting the Western medicine diagnostic criteria for eczema; (2) meeting the diagnostic criteria for wind-heat type eczema; (3) being between 18 and 65 years of age; (4) obtaining informed consent from the subject; (5) having a total skin lesion area of ​​less than 30% of the body surface area.

[0087] Exclusion criteria: (1) Those with serious systemic diseases, such as those undergoing systemic treatment for malignant tumors; (2) Women who are trying to conceive, pregnant, breastfeeding, or taking contraceptives for a long time; (3) Those with mental illness, intellectual disability, or communication disorders; (4) Those who are allergic to traditional Chinese medicine or levocetirizine hydrochloride tablets; (5) Those who have used glucocorticoids or immunosuppressants within 2 weeks; (6) Those whose skin lesions are located in delicate areas of the skin, such as the vulva, perianal area, and eyelids; and those whose total skin lesion area is greater than 30% of the body surface area and who need to receive other or combined treatments.

[0088] Exclusion and dropout criteria: (1) Patients with poor compliance who request to withdraw, are lost to follow-up midway, or whose initial data collection is incomplete; (2) Patients whose skin lesions increase and itching worsens during treatment, and who need to receive other or systemic treatments according to the attending physician's judgment; (3) Patients who experience serious adverse reactions or other clear adverse events after receiving treatment during the trial, and whose physical condition is no longer suitable for continuing to receive the trial.

[0089] Handling of excluded and dropped cases: (1) If a patient withdraws from the study on their own, they or their family members should be called in time to record the specific reasons, medication, and current condition of the patient, and to assess whether they can continue to complete the efficacy evaluation; (2) If a patient has a serious adverse reaction, they should be treated in time, the study should be stopped, and all questionnaires and forms should be kept intact for future verification.

[0090] Randomization: Patients were numbered according to their order of visit using a random number table. Eighty patients meeting the inclusion criteria were randomly divided into a control group (levocetirizine hydrochloride tablets, 5mg once daily) and a treatment group (Example 1 of this invention, daily dosage: bamboo leaves 40g, ophiopogon japonicus 25g, scutellaria baicalensis 20g, gardenia 25g, lily bulb 20g, rehmannia glutinosa 25g, forsythia suspensa 20g, honeysuckle 25g, scrophularia ningpoensis 25g, lithospermum erythrorhizon 20g, alisma plantago-aquatica 20g, plantain seed 25g, poria cocos 20g, atractylodes macrocephala 20g, cinnamon twig 15g, amomum villosum 20g, safflower 25g, red peony root 20g, peach kernel 20g, salvia miltiorrhiza 20g, astragalus membranaceus 25g, codonopsis pilosula 25g, platycodon grandiflorus 20g, pinellia ternata 20g). Both groups received treatment for 7 days as one course, for a total of two courses. The treatment effect was evaluated after two courses. Before and after treatment, the same physician inquired about and recorded the patient's basic information, EASI score, pruritus score, TCM syndrome score, DLQI score, and any adverse reactions, and completed the corresponding questionnaire. After treatment, the efficacy index was calculated and the efficacy was evaluated.

[0091] The Area and Severity of Eczema Lesions (EASI) score is composed of a severity score for lesions. Clinically, the following four indicators need to be scored: erythema (E), edema / papules (I), exudation / crusting (Ef), and epidermal peeling / scratching (C). Each indicator is divided into 4 grades, as shown in Table 3.

[0092] Table 3: Eczema Lesion Area and Severity (EASI) Scoring Table

[0093]

[0094] EASI scoring method: The total score is calculated using the following method, as detailed in Table 4.

[0095] Table 4 EASI Scoring Calculation Method

[0096]

[0097] Itching severity scoring: The visual analog scale (VAS) was used to score the patients' itching severity, with a score range of 0-10. Patients selected a number to represent their perceived itching severity, with higher scores indicating more severe itching (see Table 5 for details). Since itching is a subjective experience and most patients reported varying degrees of itching between day and night, the scoring was uniformly conducted at night while the patient was resting quietly.

[0098] Table 5 Itching Intensity Scoring Table

[0099]

[0100] Efficacy evaluation criteria: Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," the efficacy index was calculated using the nimodipine method. Calculation formula: Efficacy index (EASI score reduction rate) = (EASI score before treatment - EASI score after treatment) / EASI score before treatment × 100%. Cure: EASI score reduction of ≥95%; disappearance of itching symptoms; Significant improvement: EASI score reduction of 60%~94%; significant improvement in itching severity; Effective: EASI score reduction of 30%~59%; relative reduction in itching severity; Ineffective: score reduction <30%; no significant reduction in itching severity. Total effective rate: Total effective rate = (Number of cured cases + Number of significantly effective cases + Number of effective cases) / Total number of cases × 100%.

[0101] Comparing the efficacy of the two groups, the treatment group had 3 cured cases, 25 cases with significant improvement, 10 cases with improvement, and 2 cases with no effect, with a total effective rate of 95.0%. The control group had 0 cured cases, 8 cases with significant improvement, 19 cases with improvement, and 13 cases with no effect, with a total effective rate of 67.5%. The efficacy scores of the treatment group were significantly lower than those of the control group, and the differences were statistically significant (P < 0.05). This indicates that the present invention is more effective than levocetirizine hydrochloride tablets in improving the severity, itching, and symptoms of eczema. It also confirms that the present invention, compared with the treatment principle of Western medicine antihistamines, can better help patients improve skin lesions, regulate their constitution, and restore their health. The efficacy is definite and worthy of promotion and use in clinical practice.

[0102] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A wind-dispelling and itch-relieving granule for treating wind-heat type eczema, characterized in that, It is prepared from the following raw materials in parts by weight: bamboo leaves 30-50 parts, ophiopogon japonicus 20-30 parts, scutellaria baicalensis 15-25 parts, gardenia 20-30 parts, lily bulb 15-25 parts, rehmannia glutinosa 20-30 parts, forsythia suspensa 18-22 parts, honeysuckle 20-30 parts, scrophularia ningpoensis 20-30 parts, gromwell root 18-22 parts, alisma plantago-aquatica 15-25 parts, plantain seed 20-30 parts, poria cocos 18-22 parts, atractylodes macrocephala 15-25 parts, cinnamon twig 10-20 parts, amomum villosum 18-22 parts, safflower 20-30 parts, red peony root 15-25 parts, peach kernel 18-22 parts, salvia miltiorrhiza 15-25 parts, astragalus membranaceus 20-30 parts, codonopsis pilosula 20-30 parts, platycodon grandiflorus 15-25 parts, and pinellia ternata 15-25 parts.

2. The wind-dispelling and itch-relieving granules for treating wind-heat type eczema as described in claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: bamboo leaves 40 parts, ophiopogon japonicus 25 parts, scutellaria baicalensis 20 parts, gardenia 25 parts, lily bulb 20 parts, rehmannia glutinosa 25 parts, forsythia suspensa 20 parts, honeysuckle 25 parts, scrophularia ningpoensis 25 parts, gromwell root 20 parts, alisma plantago-aquatica 20 parts, plantain seed 25 parts, poria cocos 20 parts, atractylodes macrocephala 20 parts, cinnamon twig 15 parts, amomum villosum 20 parts, safflower 25 parts, red peony root 20 parts, peach kernel 20 parts, salvia miltiorrhiza 20 parts, astragalus membranaceus 25 parts, codonopsis pilosula 25 parts, platycodon grandiflorus 20 parts, and pinellia ternata 20 parts.

3. The wind-dispelling and itch-relieving granules for treating wind-heat type eczema as described in claim 1, characterized in that, The preparation method includes the following steps: S1: Weigh each component according to the formula, pick out the raw materials of each component, wash them and dry them, and set them aside for later use; S2: Add 2 to 5 times the amount of water to Forsythia, Honeysuckle, Safflower, Red Peony Root, and Peach Kernel, soak for 40 to 80 minutes, then extract the volatile oil by steam distillation for 3 hours, collect the volatile oil, and keep the residue for later use. S3: Take the dregs obtained in step S2, add other Chinese medicinal herbs, add 8 to 12 times the amount of water, decoct for 1 to 3 hours, filter to obtain the decoction, add 8 to 12 times the amount of water to the dregs, decoct for 1 to 3 hours, filter to obtain the decoction, and combine the two decoctions. S4: Concentrate the decoction to a relative density of 1.20-1.30 at 25°C, and spray dry to obtain extract powder; S5: Take the volatile oil obtained in step S2 and encapsulate it with cyclodextrin; S6: The extract powder obtained in step S4 and the volatile oil cyclodextrin inclusion complex prepared in step S5 are combined with excipients to prepare granules.

4. The wind-dispelling and itch-relieving granules for treating wind-heat type eczema as described in claim 3, characterized in that, In step S2 of the preparation method, forsythia, honeysuckle, safflower, red peony root, and peach kernel are added to 4 times the amount of water and soaked for 60 minutes.

5. The wind-dispelling and itch-relieving granules for treating wind-heat type eczema as described in claim 3, characterized in that, In the preparation method, the amount of water added twice in step S3 is 10 times the amount of water, and the decoction is carried out for 2 hours.

6. The wind-dispelling and itch-relieving granules for treating wind-heat type eczema as described in claim 3, characterized in that, In the preparation method, the relative density of S4 is 1.

25.

7. The use of the wind-heat type eczema-relieving and antipruritic granules as described in claim 1 in the preparation of eczema-treating drugs.

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