A traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method thereof and application in treatment of psoriasis

Abstract

The application discloses a traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method of the traditional Chinese medicine composition and the traditional Chinese medicine preparation and application of the traditional Chinese medicine composition in treating psoriasis. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: medicinal materials with heat-clearing and blood-cooling effects 15-25 parts, medicinal materials with qi-tonifying and spleen-strengthening effects 20-30 parts, medicinal materials with blood-activating and stasis-removing effects 10-20 parts, medicinal materials with food-digesting and stomach-strengthening effects 6-15 parts, medicinal materials with spleen-strengthening and dampness-removing effects 6-15 parts and medicinal materials with heart-soothing and spirit-quieting effects 6-15 parts. The medicinal materials with heat-clearing and blood-cooling effects are one of Rhizoma Coptidis and Aloe. The medicinal materials with qi-tonifying and spleen-strengthening effects are Radix Ginseng and Radix Glycyrrhizae. The traditional Chinese medicine composition and the traditional Chinese medicine preparation have the effects of stable curative effect, high safety, good long-term drug tolerance and obviously reduced long-term recurrence rate, and have a good application prospect.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, its preparation method, and its application in the treatment of psoriasis, belonging to the field of psoriasis treatment. Background Technology

[0002] Psoriasis, also widely known as "cowhide rash," is a common chronic, relapsing inflammatory skin disease. It typically manifests as localized or widespread scaly erythematous plaques or patches, and its etiology is related to the combined effects of genetic and environmental factors. Common types include plaque psoriasis, psoriatic arthritis, erythrodermic psoriasis, and pustular psoriasis, with plaque psoriasis accounting for the vast majority. Currently, there are approximately 7 million psoriasis patients in my country (prevalence rate of 0.47%), with over 60% experiencing moderate to severe cases. 41.2% of these patients are young adults aged 18-35, indicating a trend towards younger onset.

[0003] Currently, clinical Western medicine treatment mainly relies on hormone drugs, immunosuppressive drugs, and biological agents. Although these can relieve symptoms in the short term, the relapse rate is high after stopping the medication, long-term use can easily lead to drug resistance, and there are obvious adverse reactions.

[0004] Traditional Chinese medicine (TCM) theory holds that psoriasis is caused by multiple factors leading to deficiency of blood and qi, internal heat in the blood, dryness and wind, and malnourishment of the skin. As the disease progresses, various symptoms often intertwine, transform into one another, and are mutually causal. However, current TCM treatments for psoriasis often suffer from limitations such as simplistic syndrome differentiation, repetitive medication approaches, and an overemphasis on symptomatic relief. The formulation of prescriptions lacks a holistic perspective and fails to address the transformation of symptoms and the consolidation of therapeutic effects. This results in unsatisfactory cure and relapse rates, frequently exhibiting effective but incomplete cures, and rapid relapse after discontinuation of medication. Therefore, exploring a treatment method that is both effective and safe, while also significantly reducing the relapse rate, is of great clinical significance. Summary of the Invention

[0005] Purpose of the invention: The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition that can effectively treat psoriasis.

[0006] Another technical problem that this invention aims to solve is to provide a traditional Chinese medicine preparation.

[0007] Another technical problem that this invention aims to solve is to provide a method for preparing a traditional Chinese medicine preparation.

[0008] The final technical problem to be solved by the present invention is to provide the application of the said traditional Chinese medicine composition or preparation in the treatment of psoriasis.

[0009] Technical solution: To solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: The herb has the effects of clearing heat and cooling blood (15-25 parts), the herb has the effects of invigorating qi and strengthening the spleen (20-30 parts), the herb has the effects of promoting blood circulation and removing blood stasis (10-20 parts), the herb has the effects of promoting digestion and strengthening the stomach (6-15 parts), the herb has the effects of strengthening the spleen and removing dampness (6-15 parts), and the herb has the effects of calming the mind and soothing the nerves (6-15 parts). The herb with the effects of clearing heat and cooling blood is one of Coptis chinensis or Aloe vera, and the herb with the effects of invigorating qi and strengthening the spleen is ginseng and licorice.

[0010] The medicinal materials with the effect of promoting blood circulation and removing blood stasis include one or more of the following: Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, Prunus persica, Carthamus tinctorius, Curcuma longa, Crataegus pinnatifida, or Salvia miltiorrhiza.

[0011] The medicinal materials with digestive and stomach-strengthening effects include one or more of the following: chicken gizzard lining, medicated leaven, malt, or radish seeds.

[0012] The medicinal materials with spleen-strengthening and dampness-removing effects include one or more of Atractylodes macrocephala, Poria cocos, Poria cocos sclerotium, or Coix lacryma-jobi.

[0013] The medicinal materials with calming and soothing effects include one or more of the following: jujube seed, albizia bark, schisandra fruit, or polygala root.

[0014] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: The herb has the effects of clearing heat and cooling blood (15-22 parts), the herb has the effects of invigorating qi and strengthening the spleen (22-30 parts), the herb has the effects of promoting blood circulation and removing blood stasis (10-15 parts), the herb has the effects of promoting digestion and strengthening the stomach (6-12 parts), the herb has the effects of strengthening the spleen and removing dampness (6-12 parts), and the herb has the effects of calming the mind and soothing the nerves (10-15 parts). The herb with the effects of clearing heat and cooling blood is one of Coptis chinensis or Aloe vera, and the herb with the effects of invigorating qi and strengthening the spleen is ginseng and licorice.

[0015] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: The herb has the effects of clearing heat and cooling blood (15-20 parts), the herb has the effects of invigorating qi and strengthening the spleen (24-30 parts), the herb has the effects of promoting blood circulation and removing blood stasis (12-15 parts), the herb has the effects of promoting digestion and strengthening the stomach (6-10 parts), the herb has the effects of strengthening the spleen and removing dampness (6-10 parts), and the herb has the effects of calming the mind and soothing the nerves (12-15 parts). The herb with the effects of clearing heat and cooling blood is one of Coptis chinensis or Aloe vera, and the herb with the effects of invigorating qi and strengthening the spleen is ginseng and licorice.

[0016] The present invention also provides a traditional Chinese medicine preparation containing the aforementioned traditional Chinese medicine composition.

[0017] The present invention also provides a method for preparing traditional Chinese medicine preparations, comprising the following steps: preparing the preparation by adding or not adding excipients from the decoction obtained by decocting and filtering the traditional Chinese medicine combination drugs with water or the fine powder obtained by pulverizing the traditional Chinese medicine.

[0018] The dosage form of the preparation is a decoction, oral liquid, ointment, granules, pills or capsules.

[0019] The present invention also provides the use of the traditional Chinese medicine composition or the traditional Chinese medicine preparation in the preparation of a medicament for treating psoriasis.

[0020] The psoriasis of the present invention includes psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and erythrodermic psoriasis.

[0021] The details of the active pharmaceutical ingredient in this invention are as follows: Coptis chinensis is derived from the dried rhizomes of Coptis chinensis, Coptis triangularis, or Coptis yunnanensis, all belonging to the Ranunculaceae family. It possesses the effects of clearing heat and drying dampness, purging fire and detoxifying, and cooling the blood. It is used for damp-heat diarrhea, abdominal pain, tenesmus, and bloody stools; for damp-heat fullness, vomiting, acid reflux, bloating, nausea, and heartburn; for damp-heat jaundice, eczema, and damp sores; for excessive heart fire, irritability, insomnia, mouth ulcers, palpitations, and restlessness; for febrile diseases with heat entering the pericardium, causing irritability and delirium; for blood-heat causing hematemesis and epistaxis; for liver fire causing red, swollen, and painful eyes, stomach fire causing toothache, and stomach heat causing thirst; it can also treat boils, carbuncles, and other skin abscesses caused by heat toxins.

[0022] Aloe vera is the concentrated and dried juice of Aloe barbadensis or Aloe ferox, both belonging to the lily family. It has laxative, liver-cleansing, and insecticidal effects. It is used for constipation due to heat accumulation, excessive heart and liver fire, irritability, and insomnia; for constipation with dark urine, dizziness, headache, irritability, and convulsions due to excessive liver fire; and for infantile malnutrition due to intestinal parasites, characterized by abdominal pain, sallow complexion, and emaciation.

[0023] Ginseng is derived from the dried root and rhizome of Panax ginseng, a plant belonging to the genus Panax in the family Araliaceae. It possesses numerous health benefits, including replenishing vital energy, restoring pulse and consolidating the body, tonifying the spleen and lungs, promoting body fluid production and nourishing blood, calming the mind and improving intelligence, and warming and tonifying kidney qi. It is used for conditions of vital energy depletion leading to collapse, such as weakness and exhaustion, profuse sweating, severe bleeding, chronic illness leading to exhaustion, weak breathing, cold limbs, and weak pulse; for spleen deficiency with poor appetite, fatigue, loose stools, and emaciation; for lung deficiency with cough and asthma, shortness of breath, spontaneous sweating, and weak cough and asthma; for febrile diseases causing fluid depletion, dry mouth and thirst, and excessive sweating; for chronic illness with qi and blood deficiency and sallow complexion; for heart and spleen deficiency with palpitations, insomnia, dreaminess, forgetfulness, neurasthenia, and excessive thinking; and also for kidney deficiency with aversion to cold, impotence, cold uterus, and premature aging.

[0024] Licorice is derived from the dried roots and rhizomes of the legumes *Glycyrrhiza uralensis*, *Glycyrrhiza inflata*, and *Glycyrrhiza glabra*. It possesses the functions of invigorating qi and strengthening the middle jiao, clearing heat and detoxifying, relieving spasms and pain, and harmonizing other herbs. It is used for spleen and stomach weakness, poor appetite, fatigue, and loose stools; for palpitations, chest tightness, shortness of breath, irregular pulse, and arrhythmia; for sore throat, mouth ulcers, skin sores and carbuncles, and eczema; for abdominal and limb cramps and pain; and can moderate the harshness of hot and cold herbs and detoxify minor drug toxicity.

[0025] Angelica sinensis is derived from the dried root of the angelica sinensis plant (Apiaceae family). It has the effects of nourishing blood and regulating menstruation, promoting blood circulation and relieving pain, and moistening the intestines and promoting bowel movements. This herb is pungent and warm in nature, making it a key medicine for promoting blood circulation and removing blood stasis. It is used for various symptoms of blood deficiency, including blood deficiency and blood stasis, irregular menstruation, amenorrhea, and dysmenorrhea; it is also used for abdominal pain due to deficiency and cold, traumatic injuries, carbuncles and sores, and wind-cold arthralgia; it can also be used for constipation due to blood deficiency and intestinal dryness.

[0026] Chuanxiong (Ligusticum striatum) is derived from the dried rhizome of the plant Ligusticum striatum, belonging to the Apiaceae family. It possesses the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain. This herb is pungent and warming, capable of both promoting blood circulation and removing blood stasis, as well as regulating qi and relieving pain, thus being considered a "qi-regulating herb within the blood." It is used for chest pain, liver qi stagnation, stomach pain, and traumatic injuries; for menstrual cramps, amenorrhea, postpartum lochia retention, and lower abdominal pain due to blood stasis; for headaches caused by wind-cold, wind-heat, wind-dampness, blood deficiency, and blood stasis; and also for wind-cold-dampness arthralgia, joint pain, numbness of limbs, and difficulty in flexion and extension.

[0027] Red peony root is derived from the dried root of *Paeonia lactiflora* or *Paeonia veitchii*, both belonging to the Ranunculaceae family. It possesses properties such as clearing heat and cooling the blood, dispersing blood stasis and relieving pain. This herb is bitter and cold, entering the liver meridian and blood level, and has the function of promoting blood circulation, dispersing blood stasis, and relieving pain. It is used for epidemic rashes, hematemesis and epistaxis due to blood heat; for red and swollen eyes, carbuncles and sores; for liver stagnation and hypochondriac pain, amenorrhea and dysmenorrhea, and traumatic injuries.

[0028] Peach kernels are the dried, mature seeds of peach or wild peach, plants belonging to the Rosaceae family. They have the effects of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma. They are used for amenorrhea, dysmenorrhea, postpartum lochia retention, and lower abdominal pain due to blood stasis; for traumatic injuries, swelling and pain due to blood stasis; for constipation due to intestinal dryness and fluid deficiency, constipation in the elderly and postpartum women with blood deficiency; and also for cough, asthma, and lung qi stagnation.

[0029] Safflower is the dried flower of *Carthamus tinctorius*, a plant in the Asteraceae family. It has the effects of promoting blood circulation, regulating menstruation, removing blood stasis, and relieving pain. It is used for amenorrhea due to blood stasis, dysmenorrhea, postpartum lochia retention, and lower abdominal pain due to blood stasis; for chest pain due to blood stasis, rib pain due to blood stasis, and hemiplegia; for abdominal masses and blood stasis lumps; for traumatic injuries, bruises, swelling, and pain due to blood stasis; and for rashes due to heat stagnation and blood stasis, with dark and difficult-to-penetrate rashes.

[0030] Turmeric is derived from the dried tuberous roots of *Curcuma longa*, *Curcuma zedoaria*, *Curcuma fangchi*, or *Curcuma zedoaria*, all belonging to the ginger family. It possesses the effects of promoting blood circulation and relieving pain, regulating qi and relieving depression, clearing heat from the heart and cooling the blood, and promoting bile secretion and reducing jaundice. It is used for chest and rib pain due to liver qi stagnation, breast distension and pain; dysmenorrhea due to qi stagnation and blood stasis, amenorrhea, and postpartum abdominal pain due to blood stasis; emotional depression, chest tightness with frequent sighing accompanied by chest and rib pain; delirium due to febrile diseases, epilepsy with phlegm retention, delirium, restlessness, insomnia, palpitations, and mania; bleeding due to blood heat, hematemesis, epistaxis, and retrograde menstruation; and jaundice due to damp-heat in the liver and gallbladder, hypochondriac fullness and distension, and gallstones.

[0031] Hawthorn comes from the dried ripe fruits of the plants Crataegus pinnatifida Bge. var. major N.E. Br. or Crataegus pinnatifida Bge. It has the effects of promoting digestion and strengthening the stomach, promoting blood circulation and removing stasis. It is used for abdominal distension, belching, anorexia, nausea and fullness caused by overeating meat; for diarrhea due to indigestion, dysentery abdominal pain, and hernia pain with a feeling of heaviness and swelling; for dysmenorrhea, amenorrhea, retention of lochia after childbirth, and pain in the lower abdomen due to blood stasis; it is also used for conditioning coronary heart disease, chest tightness and pain, hyperlipidemia, and arteriosclerosis.

[0032] Salvia miltiorrhiza comes from the dried roots and rhizomes of the plant Salvia miltiorrhiza Bunge of the Labiatae family. It has the effects of promoting blood circulation to remove blood stasis, dredging the channels to stop pain, clearing the heart to remove vexation, cooling the blood to dissipate carbuncles, etc. It is used for chest pain due to chest impediment, chest tightness and palpitations, stabbing pain in the epigastrium and abdomen, traumatic injury, swelling and pain due to blood stasis; for various gynecological disorders with blood stasis such as irregular menstruation, dysmenorrhea, amenorrhea, and abdominal pain due to postpartum blood stasis; for heat entering the nutrient and blood aspects, restlessness and insomnia, heart and spleen deficiency, palpitation and anxiety, and dreamy sleep; for carbuncles and sores caused by heat-toxin, subcutaneous nodules, and abdominal masses; it is commonly used in modern times for conditioning coronary heart disease, angina pectoris, sequelae of cerebral infarction, hyperlipidemia, microcirculation disorders, and chronic diseases of liver depression and blood stasis.

[0033] Endothelium Corneum Gigeriae Galli comes from the dried inner wall of the gizzard of the domestic chicken of the Phasianidae family. It has the effects of promoting digestion and strengthening the stomach, astringing essence and arresting seminal emission, etc. It is used for abdominal distension due to indigestion, acid regurgitation, anorexia, and infantile malnutrition; for insufficiency of kidney qi, spermatorrhea, slippery spermatorrhea, enuresis in children, and frequent nocturia; for calculus stranguria syndrome and gallstones.

[0034] Medicated Leaven comes from a fermented leaven prepared by mixing flour, wheat bran with drugs such as almonds, adzuki beans, Artemisia annua, Polygonum hydropiper, and Xanthium sibiricum, etc. and fermenting them. It has the effects of promoting digestion and regulating the stomach, strengthening the spleen and resolving accumulation. It is used for food retention, fullness and distension in the epigastrium and abdomen, acid regurgitation, nausea and vomiting, anorexia; for weakness of the spleen and stomach, abdominal distension after eating, poor appetite, and loose stools.

[0035] Fructus Hordei Germinatus comes from the mature fruits of the plant Hordeum vulgare L., which are obtained by germination and drying. It has the effects of promoting digestion and strengthening the stomach, reducing lactation and relieving breast distension, soothing the liver and relieving depression. It is used for food retention, fullness and distension in the epigastrium and abdomen, belching and poor appetite, indigestion; for weakness of the spleen and stomach, poor appetite, abdominal distension after meals, and loose stools. It is used for weaning in women, excessive accumulation of milk, and breast distension; it is also used for liver qi stagnation, chest and hypochondriac distension and fullness, belching, and discomfort in the epigastrium and hypochondrium.

[0036] Semen Raphani comes from the dried mature seeds of the plant Raphanus sativus L. of the Cruciferae family. It has the effects of promoting digestion to relieve distension, descending qi to resolve phlegm. It is used for fullness and distension in the epigastrium and abdomen, acid regurgitation, nausea and vomiting, anorexia, abdominal distension and constipation; for phlegm-dampness obstructing the lungs, cough with profuse sputum, chest tightness and wheezing, profuse sputum and chest tightness, restlessness when sitting or lying; for qi stagnation in the intestines and stomach, obstruction of the qi movement in the internal organs, and constipation.

[0037] Atractylodes macrocephala is derived from the dried rhizome of the plant Atractylodes macrocephala in the Asteraceae family. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used for symptoms of spleen and stomach weakness such as fatigue, loss of appetite, abdominal distension, emaciation, and indigestion; for edema due to spleen deficiency and internal dampness retention, difficulty urinating, excessive phlegm, and sticky, unformed stools; for spontaneous sweating due to qi deficiency, shortness of breath, fatigue, and weak defensive qi; and for fetal restlessness, weak spleen and stomach during pregnancy, nausea, poor appetite, and unstable fetal qi caused by spleen deficiency and qi weakness.

[0038] Poria cocos is derived from the dried sclerotium of the fungus Poria cocos (family Polyporaceae). It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. It is used for edema of the limbs and scanty urination; for weakness of the spleen and stomach, poor appetite and abdominal distension, loose stools, chronic diarrhea, internal phlegm and dampness, heaviness of the body, and a thick, greasy tongue coating; for phlegm and dampness disturbing the upper body, dizziness, chest and rib distension, palpitations, and chest tightness; for palpitations, insomnia, dreaminess, forgetfulness, and easy startling caused by deficiency of both heart and spleen and insufficient qi and blood; and also for timidity and restless sleep due to heart deficiency.

[0039] Poria cocos extract is derived from the white part of the sclerotium of the fungus Poria cocos, which contains pine roots. It has the effects of strengthening the spleen and promoting diuresis, calming the mind and soothing the nerves. It is used for palpitations, restlessness at night, excessive dreaming and easy awakening, forgetfulness, timidity and easy fright; for spleen and stomach weakness, poor appetite and fatigue, loose stools, and heaviness in the limbs; and for deficiency syndromes with difficulty urinating and mild edema.

[0040] Job's tears (Coix seed) is the dried, mature seed of the grass *Coix lacryma-jobi*. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stopping diarrhea. It is used for loose stools, abdominal distension, heaviness of the body, thick and greasy tongue coating, loss of appetite, edema, and difficulty urinating due to spleen deficiency and dampness; for damp-heat arthralgia, swollen and painful joints, and difficulty in flexion and extension; for lung abscess with cough and purulent sputum, and for intestinal abscess with dull pain in the right lower abdomen and damp-heat stagnation in the intestines; and for warts, nodules, and flat warts caused by phlegm-dampness and damp-heat stagnation.

[0041] Sour jujube seed is the dried, mature seed of the sour jujube plant (Ziziphus jujuba var. spinosa). It has the effects of nourishing the heart and liver, calming the mind and soothing the nerves, and astringing sweat and promoting body fluid production. It is used for insomnia, excessive dreaming, palpitations, restlessness, forgetfulness, and easy startling; for spontaneous sweating due to qi deficiency, night sweats due to yin deficiency, and excessive sweating due to prolonged illness and physical weakness; it is also used for yin deficiency and fluid depletion, dry mouth and throat, and thirst due to deficiency heat.

[0042] Albizia bark is derived from the dried bark of the Albizia julibrissin tree, a legume. It has the effects of relieving depression and calming the mind, promoting blood circulation and reducing swelling. It is used for emotional depression, anxiety, chest tightness, irritability, insomnia, restlessness, forgetfulness, and irritability; for injuries from falls and blows, sprains and fractures, and swelling and pain due to blood stasis; for lung abscess with chest pain and coughing up purulent sputum; and also for skin sores, carbuncles, boils, and carbuncles with redness, swelling, heat, and pain.

[0043] Schisandra chinensis is derived from the dried, ripe fruit of the Schisandra chinensis plant, belonging to the Magnoliaceae family. It possesses astringent and consolidating properties, replenishes qi and promotes the production of body fluids, and tonifies the kidneys and calms the mind. It is used for deficiency of both lung and kidney, persistent cough, and shortness of breath due to deficiency; it can also treat chronic cough due to lung qi deficiency; spontaneous sweating, night sweats, thirst due to fluid depletion, and diabetes; seminal emission, chronic diarrhea; and palpitations, insomnia, and forgetfulness caused by disharmony between the heart and kidneys and deficiency of yin and blood.

[0044] Polygala tenuifolia is derived from the dried root of Polygala tenuifolia or Polygala ovoidea, plants belonging to the Polygalaceae family. It has the effects of calming the mind and improving intelligence, resolving phlegm and clearing the orifices, and reducing swelling and abscesses. It is used for palpitations, insomnia, excessive dreaming, easy startling, forgetfulness, poor concentration, hot flashes, irritability, and weakness in the lower back and knees due to disharmony between the heart and kidneys; for palpitations, irritability, mental confusion, epilepsy, and loss of consciousness due to phlegm obstructing the heart orifices; for cough with excessive phlegm and thick, difficult-to-expectorate phlegm; and also for sores, carbuncles, and breast swelling and pain.

[0045] Mechanism explanation of the present invention: Group 1: In this invention, Coptis chinensis is bitter and cold, entering the heart and liver meridians to purge heat and cool the blood; Aloe vera is bitter and cold, clearing liver fire and relieving irritability and heat. Blood stagnation and heat, if prolonged, can lead to dryness. Therefore, one of these two herbs is selected as the principal herb, using its bitter and cold properties to purge heat and cool the blood, cutting off the source of dryness.

[0046] The second group: In this invention, ginseng is sweet and warm, tonifying the qi of the spleen and lungs; licorice is sweet and readily enters the middle jiao, benefiting qi and tonifying the spleen. The two herbs work together to tonify qi and strengthen the spleen, nourishing the source of qi and blood production, and supporting the body's vital energy, serving as assistant herbs.

[0047] The third group: In this invention, Angelica sinensis nourishes and invigorates blood, serving as a key herb for promoting blood circulation and removing blood stasis; Ligusticum chuanxiong promotes qi and invigorates blood, acting as a qi-regulating herb within the blood; Paeonia lactiflora, bitter and cold, enters the liver meridian and blood level, possessing the function of invigorating blood and removing blood stasis; Prunus persica enters the heart and liver meridian and blood level, effectively draining blood stasis and possessing strong blood-activating and stasis-removing power; Carthamus tinctorius invigorates blood and unblocks the meridians to resolve stagnation and eliminate spots; Curcuma longa enters the liver meridian and blood level, both cooling the blood and invigorating blood and qi; Crataegus pinnatifida, warm in nature, enters the liver meridian and blood level, promoting qi and removing blood stasis; Salvia miltiorrhiza, slightly cold and mild in nature, effectively invigorates blood and removes blood stasis, promoting new blood production without harming the body's vital energy. Prolonged heat leads to blood stasis and meridian obstruction; one or more herbs from this group are selected to invigorate blood, remove blood stasis, and unblock the meridians.

[0048] Group 4: In this invention, chicken gizzard lining aids digestion and eliminates food stagnation, strengthening the spleen and stomach; medicated leaven aids digestion and harmonizes the stomach, strengthens the spleen and stops diarrhea; malt strengthens the stomach and aids digestion, while also soothing the liver and relieving depression; radish seed aids digestion, eliminates food stagnation, promotes qi circulation and relieves bloating. One or more ingredients from this group can be selected to aid digestion, strengthen the stomach, and assist the spleen and stomach in their digestive functions.

[0049] Group 5: In this invention, Poria cocos strengthens the spleen and replenishes the middle jiao, promotes diuresis and eliminates dampness; Poria cocos sclerotium strengthens the spleen, promotes diuresis, and calms the mind; Atractylodes macrocephala invigorates qi, strengthens the spleen, and dries dampness; Coix lacryma-jobi strengthens the spleen, promotes diuresis and eliminates dampness. One or more herbs from this group are selected to strengthen the spleen, eliminate dampness, and assist the spleen and stomach in their digestive functions.

[0050] Group Six: In this invention, jujube seed nourishes heart yin, benefits liver blood, calms the mind, astringes sweat, and generates fluids; albizia bark soothes the mind and calms the spirit, effectively relieving liver stagnation and harmonizing the five internal organs; schisandra fruit calms the mind and soothes the spirit, and tonifies the heart and kidneys; polygala root calms the mind and soothes the spirit, and harmonizes the heart and kidneys. When heat disturbs the mind and spirit, depleting yin and blood, the mind and spirit become malnourished. One or more herbs from this group are selected to calm the mind and soothe the spirit, and nourish heart yin.

[0051] Select one or more herbs from each of the four groups from the third to the sixth group above to serve as adjuvant herbs; when used together, these herbs work together to clear heat and cool the blood, invigorate qi and strengthen the spleen, promote blood circulation and remove spots, so that blood heat is cleared, blood deficiency is replenished, stagnation is dispersed, the body's vital energy is supported, and all symptoms are eliminated.

[0052] Beneficial Effects: Compared with existing technologies, this invention has the following significant advantages: This invention treats psoriasis from the perspective of Traditional Chinese Medicine (TCM), combining the disease's development and transformation with a balance of eliminating pathogenic factors and strengthening the body's resistance. Its core treatment principle is to clear heat and cool the blood, invigorate qi and strengthen the spleen, supplemented by a treatment plan that promotes blood circulation and removes blood stasis, aids digestion and harmonizes the stomach, strengthens the spleen and eliminates dampness, and calms the mind and soothes the nerves. Clinically proven, this treatment for psoriasis has stable efficacy, high safety, good long-term tolerability, and significantly reduces the long-term recurrence rate, showing promising application prospects. Attached Figure Description

[0053] Figure 1 Photos of Case 1 before and after treatment; Figure 2 Photos of Case 2 before and after treatment; Figure 3 Photos of Case 3 before and after treatment; Figure 4 Photos of Case 4 before and after treatment; Figure 5 Photos of Case 5 before and after treatment; Figure 6 Photos of Case 6 before and after treatment; Figure 7 Photos of Case 7 before and after treatment; Figure 8 Photos of Case 8 before and after treatment; Figure 9 Photos of Case 9 before and after treatment; Figure 10 Photos of Case 10 before and after treatment; Figure 11 Photos of Case 11 before and after treatment; Figure 12 Photos of Case 12 before and after treatment; Figure 13 Photos of Case 13 before and after treatment; Figure 14 Photos of Case 14 before and after treatment; Figure 15Photos of Case 15 before and after treatment; Figure 16 Photos of Case 16 before and after treatment; Figure 17 Photos of Case 17 before and after treatment; Figure 18 Photos of Case 18 before and after treatment; Figure 19 Photos of Case 19 before and after treatment; Figure 20 Photos of Case 20 before and after treatment; Figure 21 Photos of Case 21 before and after treatment; Figure 22 Photos of Case 22 before and after treatment; Figure 23 Photos of Case 23 before and after treatment; Figure 24 Photos of Case 24 before and after treatment; Figure 25 Photos of Case 25 before and after treatment; Figure 26 Photos of Case 26 before and after treatment; Figure 27 Photos of Case 27 before and after treatment; Figure 28 Photos of Case 28 before and after treatment; Figure 29 Photos showing the recurrence of symptoms in Case 28 after treatment; Figure 30 Photos of Case 29 before and after treatment; Figure 31 Photos of Case 30 before and after treatment; Figure 32 Photos of Case 31 before and after treatment; Figure 33 Photos of Case 32 before and after treatment; Figure 34 Photos showing the recurrence of symptoms in Case 32 after treatment; Figure 35 Photos of Case 33 before and after treatment; Figure 36 Photos of Case 34 before and after treatment; Figure 37 Photos of Case 35 before and after treatment; Figure 38 Photos showing the recurrence of symptoms in Case 35 after treatment; Figure 39 Photos of Case 36 before and after treatment; Figure 40 Photos showing the recurrence of symptoms in Case 36 after treatment; Figure 41 Photos of Case 37 before and after treatment; Figure 42 Photos showing the recurrence of symptoms in Case 37 after treatment; Figure 43 Photos of Case 38 before and after treatment; Figure 44 Photos of Case 39 before and after treatment; Figure 45 Photos showing the recurrence of symptoms in Case 39 after treatment; Figure 46 Photos of Case 40 before and after treatment; Figure 47 Photos showing the recurrence of symptoms in Case 40 after treatment; Figure 48 Photos of Case 41 before and after treatment; Figure 49 This is a photo of Case 41 after relapse following treatment. Detailed Implementation

[0054] The technical solution of the present invention will be further described below with reference to the accompanying drawings. All patient cases provided in this invention meet the Western medicine diagnostic criteria for psoriasis in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and are cases accumulated by the applicant in the course of long-term diagnosis and treatment.

[0055] Example 1: Preparation of a decoction of traditional Chinese medicine composition Drug composition: Coptis chinensis 15 parts, ginseng 11 parts, licorice 11 parts, chuanxiong rhizome 4 parts, angelica sinensis 4 parts, red peony root 4 parts, malt 12 parts, atractylodes macrocephala 5 parts, poria cocos 5 parts, schisandra chinensis 10 parts.

[0056] Preparation method: Weigh the above-mentioned raw materials in the corresponding weight proportions, grind them into coarse powder for later use. Weigh 18 grams of coarse powder, add 300 ml of water and soak for 30 minutes. After boiling, simmer over low heat until 150 ml remains. Collect the first decoction. Add another 300 ml of water to the dregs, boil again, and simmer over low heat until 150 ml remains. Collect the second decoction. Mix the two decoctions together to obtain the final product.

[0057] Example 2: Preparation of a decoction of traditional Chinese medicine composition Drug composition: Coptis chinensis 15 parts, ginseng 10 parts, licorice 10 parts, turmeric 10 parts, red peony root 10 parts, radish seed 6 parts, poria cocos 3 parts, atractylodes macrocephala 3 parts, jujube seed 3 parts, polygala tenuifolia 3 parts.

[0058] Preparation method: Same as in Example 1.

[0059] Example 3: Preparation of Traditional Chinese Medicine Composition Granules Composition of medicinal materials: Coptis chinensis 20g, ginseng 12g, licorice 12g, angelica sinensis 10g, safflower 10g, medicated leaven 10g, poria cocos 6g, coix seed 6g, albizia bark 6g, schisandra chinensis 6g.

[0060] Preparation method: Weigh the raw materials of the above corresponding weight, add 1000ml of water and soak for 30 minutes, boil and simmer for 60 minutes, collect the first decoction, add 800ml of water to the residue, boil and simmer for 40 minutes, collect the second decoction, mix the two decoctions and add 20ml of honey, evaporate under reduced pressure to a paste, add 10g of maltodextrin to prepare a soft material, extrude granulate and dry to obtain the final product.

[0061] Example 4: Preparation of Traditional Chinese Medicine Composition Granules Composition of medicinal materials: Coptis chinensis 25g, ginseng 15g, licorice 15g, salvia miltiorrhiza 10g, peach kernel 10g, radish seed 15g, coix seed 5g, poria cocos 5g, poria cocos sclerotium 5g, jujube seed 15g.

[0062] Preparation method: Same as in Example 3.

[0063] Example 5: Preparation of Traditional Chinese Medicine Composition Pills Composition of medicinal materials: 20g aloe vera, 15g ginseng, 15g licorice, 5g salvia miltiorrhiza, 5g turmeric, 5g peach kernel, 12g chicken gizzard lining, 6g poria cocos, 6g atractylodes macrocephala, 12g jujube seed.

[0064] Preparation method: Weigh the above-mentioned raw materials of corresponding weight, crush them and pass them through a 150-mesh sieve to obtain fine powder of traditional Chinese medicine for later use. Take 5 grams of dextrin, dissolve it in a small amount of warm water, pour in an equal amount of boiling water and stir until it becomes a semi-transparent thick paste. Add the thick paste to the powder in batches, stir and knead to form pills, extrude to form pills, and dry at low temperature to obtain the final product.

[0065] Example 6: Preparation of Traditional Chinese Medicine Composition Pills Composition of medicinal materials: 22g aloe vera, 15g ginseng, 15g licorice, 10g hawthorn, 6g malt, 6g radish seed, 5g Poria cocos, 5g Atractylodes macrocephala, 15g Schisandra chinensis.

[0066] Preparation method: Same as in Example 5.

[0067] Example 7

[0068] 112 patients with psoriasis vulgaris were selected as clinical observation cases. Their ages ranged from 18 to 70 years, with an average age of 34.08 years. There were 67 males and 45 females. The duration of the disease ranged from 1 month to 45 years, with an average duration of 85.67 months.

[0069] All patients met the Western medicine diagnostic criteria for psoriasis vulgaris in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0070] The herbal decoction of the composition described in Example 1 was taken twice daily, 150 ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0071] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0072] Observation results: Among 112 patients: 79 cases were cured (70.54%), 20 cases showed significant improvement (17.86%), 11 cases were effective (9.82%), and 2 cases were ineffective (1.79%). The overall effective rate was 98.21%. Among them, 28 cases (35.44%) were cured within one course of treatment, 43 cases (54.43%) were cured within one to two courses of treatment, and 8 cases (10.13%) were cured within two to three courses of treatment. The shortest recovery time was 1 month and the longest was 9 months. The average recovery time was 4.5 months.

[0073] Follow-up at 1, 3, and 6 months after discontinuation of medication revealed that only a few cases experienced mild recurrence of skin lesions, while the rest remained stable. One case of mild relapse was observed within 6 months of discontinuation of medication in recovered patients, resulting in a relapse rate of 1.49%.

[0074] A small number of patients experienced mild diarrhea and abdominal pain during medication, which all subsided on their own. There were no obvious adverse reactions, no abnormal liver or kidney function, and the medication was safe.

[0075] Conclusion: After treatment, the symptoms of erythema, scaling, and itching were significantly reduced or disappeared, with a total effective rate of 98.21%. The recurrence rate within 6 months of follow-up was 1.49%. There were no obvious adverse reactions, and no abnormalities were found in liver and kidney function. The medication was safe and the patient's compliance was good.

[0076] Case 1 Male, 48 years old, with a 20-year history of illness. Diagnosis: Psoriasis vulgaris.

[0077] like Figure 1 As shown, before treatment: generalized erythema and scaling all over the body, bright red in color, with severe itching; The herbal decoction of the composition described in Example 1 was taken twice daily, 150 ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0078] After treatment: erythema and scaling completely subsided, no new skin lesions appeared, and itching disappeared; Therapeutic effect assessment: Cured.

[0079] No recurrence was observed during the 6-month follow-up period.

[0080] No significant discomfort was observed during the entire course of medication, and no abnormalities were found in liver and kidney function.

[0081] Case 2 Male, 27 years old, with a disease course of 2 years. Diagnosis: Psoriasis vulgaris.

[0082] like Figure 2 As shown, before treatment: widespread erythema and scaling all over the body, bright red in color, with severe itching.

[0083] The herbal decoction of the composition described in Example 1 was taken twice daily, 150 ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0084] After treatment: erythema and scaling completely subsided, no new skin lesions appeared, and itching disappeared.

[0085] Therapeutic effect assessment: Cured.

[0086] No recurrence was observed during the 6-month follow-up period.

[0087] No significant adverse reactions were observed during medication use, and no abnormalities in liver or kidney function were observed; the medication was well tolerated.

[0088] Case 3 Male, 52 years old, with a disease course of 27 years, diagnosed with psoriasis vulgaris.

[0089] like Figure 3 As shown, before treatment: widespread erythema and scaling all over the body, bright red in color, with severe itching.

[0090] The herbal decoction of the composition described in Example 1 was taken twice daily, 150 ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no concurrent medications were used.

[0091] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and itching symptoms disappeared.

[0092] Therapeutic effect assessment: Cured.

[0093] No recurrence was observed during the 6-month follow-up period.

[0094] No obvious discomfort was observed during medication, liver and kidney function were normal, and overall compliance was good.

[0095] Case 4 Female, 51 years old, with a disease course of 12 years, diagnosed with psoriasis vulgaris.

[0096] like Figure 4 As shown, before treatment: multiple erythematous patches and scales on the limbs and trunk, bright red in color, with moderate itching.

[0097] The herbal decoction of the composition described in Example 1 was taken twice daily, 150 ml each time. A course of treatment consisted of three months, with no modifications based on the patient's condition and no concurrent medications.

[0098] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and itching disappeared.

[0099] Therapeutic effect assessment: Cured.

[0100] No recurrence was observed during the 6-month follow-up period.

[0101] The patient experienced mild abdominal pain during medication, which subsided on its own. There were no other adverse reactions, and liver and kidney function remained normal.

[0102] Case 5 Male, 34 years old, with a disease course of 3 years. Diagnosis: Psoriasis vulgaris.

[0103] like Figure 5 As shown, before treatment: generalized erythema and scaling all over the body, bright red in color, with severe itching; The herbal decoction of the composition described in Example 1 was taken twice daily, 150 ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0104] After treatment: erythema and scaling completely subsided, no new skin lesions appeared, and itching disappeared.

[0105] Therapeutic effect assessment: Cured.

[0106] No recurrence was observed during the 6-month follow-up period.

[0107] No significant discomfort was observed during the entire course of medication, and no abnormalities were found in liver and kidney function.

[0108] Example 8 Fifty-seven patients with erythrodermic psoriasis were selected as clinical observation cases, aged 10 to 65 years, with an average age of 33.75 years. There were 35 males and 22 females, with a disease duration of 6 months to 30 years, and an average disease duration of 81.33 months.

[0109] All patients met the Western medicine diagnostic criteria for erythrodermic psoriasis in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0110] The herbal composition pills of Example 5 were taken twice daily, 9 grams each time, with the dosage reduced for children. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0111] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0112] Observation results: Among 57 patients: 39 cases were cured (68.42%), 14 cases showed significant improvement (24.56%), 3 cases were effective (5.26%), and 1 case was ineffective (1.75%). The overall effective rate was 98.25%. Among them, 7 cases (17.95%) were cured within one course of treatment, 24 cases (61.54%) were cured within 1-2 courses of treatment, 6 cases (15.38%) were cured within 2-3 courses of treatment, and 2 cases (5.13%) were cured within 3-4 courses of treatment. The shortest treatment time was two months, and the longest was 12 months. The average cure time was 4.85 months.

[0113] Follow-up at 1, 3, and 6 months after discontinuation of medication showed that only a few cases experienced mild recurrence of skin lesions, while the rest remained stable. No relapses were observed in recovered cases during the 6-month follow-up period after discontinuation of medication.

[0114] A small number of patients experienced mild diarrhea and abdominal pain during medication, which all subsided on their own. There were no obvious adverse reactions, no abnormal liver or kidney function, and the medication was safe.

[0115] Conclusion: After treatment, the symptoms of erythema, scaling, and itching were significantly reduced or disappeared, with a total effective rate of 98.25%. No recurrence was observed within 6 months of follow-up after recovery. There were no obvious adverse reactions, and liver and kidney function were normal. The medication was safe and the patient had high compliance.

[0116] Case 6 Male, 51 years old, with a disease duration of 25 years. Diagnosis: Erythrodermic psoriasis.

[0117] like Figure 6 As shown, before treatment: the whole body was diffusely red and covered with silvery-white flaky scales, with no exudation or erosion.

[0118] The herbal composition pills from Example 5 were taken twice daily, 9 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0119] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and itching disappeared.

[0120] Therapeutic effect assessment: Cured.

[0121] No recurrence was observed during the 6-month follow-up period.

[0122] No obvious discomfort was observed during medication, and liver and kidney function remained normal.

[0123] Case 7 Male, 48 years old, with a 20-year history of illness. Diagnosis: Erythrodermic psoriasis.

[0124] like Figure 7 As shown, before treatment: generalized erythema covered with silvery-white bran-like scales, no exudation, erosion, or joint deformity.

[0125] The herbal composition pills from Example 5 were taken twice daily, 9 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0126] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and itching disappeared.

[0127] Therapeutic effect assessment: Cured.

[0128] No recurrence was observed during the 6-month follow-up period.

[0129] No significant adverse reactions were observed throughout the course of medication, and liver and kidney function remained normal, with good patient compliance.

[0130] Case 8 Female, 10 years old, with a disease course of 4 years, diagnosed as erythrodermic psoriasis.

[0131] like Figure 8 As shown, before treatment: diffuse erythema all over the body, covered with silvery-white scales, no exudation, and no erosion.

[0132] The herbal composition pills of Example 5 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy based on clinical symptoms.

[0133] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and itching disappeared.

[0134] Therapeutic effect assessment: Cured.

[0135] No recurrence was observed during the 6-month follow-up period.

[0136] The patient experienced mild diarrhea during medication, which resolved on its own. There were no other adverse reactions, and liver and kidney function remained normal.

[0137] Example 9 Fifty-nine patients with psoriatic arthritis were selected as clinical observation cases. Their ages ranged from 18 to 65 years, with an average age of 35.26 years. There were 35 males and 24 females. The duration of the disease ranged from 6 months to 35 years, with an average duration of 97.89 months.

[0138] All patients met the Western medicine diagnostic criteria for psoriatic arthritis in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0139] The herbal composition granules from Example 3 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0140] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0141] Observation results: Among 59 patients: Of the 41 cases (69.49%) that were cured, 12 cases (20.34%) that showed significant improvement, 5 cases (8.47%) that were effective, and 1 case (1.69%) that was ineffective, the overall effective rate was 98.31%. Among them, 6 cases (14.63%) were cured within one course of treatment, 29 cases (70.73%) were cured within one to two courses of treatment, and 6 cases (14.63%) were cured within two to three courses of treatment. The shortest treatment time was 2 months, the longest was 9 months, and the average treatment time was 4.78 months.

[0142] Follow-up of all cases at 1, 3, and 6 months after discontinuation of medication showed that only a few cases experienced mild recurrence of skin lesions, while the rest remained stable. No recurrence was observed in recovered cases during the 6-month follow-up period after discontinuation of medication.

[0143] A small number of patients experienced mild diarrhea and abdominal pain during medication, which all subsided on their own. There were no obvious adverse reactions, no abnormal liver or kidney function, and the medication was safe.

[0144] Conclusion: After treatment, the symptoms of erythema, scaling, itching and joint swelling were significantly reduced or disappeared, with a total effective rate of 98.31%. No recurrence was observed within 6 months of follow-up after recovery. There were no obvious adverse reactions, and liver and kidney function were normal. The medication was safe and the patient had high compliance.

[0145] Case 9 Male, 39 years old, with a disease course of 13 years, diagnosed with psoriatic arthritis.

[0146] like Figure 9 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, significant swelling and pain in the finger joints, and stiffness and deformity of the distal joint of the right little finger.

[0147] The herbal composition granules from Example 3 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0148] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and joint swelling and pain disappeared.

[0149] Therapeutic effect assessment: Cured.

[0150] No recurrence was observed during the 6-month follow-up period.

[0151] The patient experienced mild abdominal pain during medication, which subsided on its own. There were no other adverse reactions, and liver and kidney function remained normal.

[0152] Case 10 Male, 36 years old, with a disease course of 25 years, diagnosed with psoriatic arthritis.

[0153] like Figure 10 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, swelling and pain in the finger joints, but no joint stiffness or deformity.

[0154] The herbal composition granules from Example 3 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0155] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and joint swelling and pain disappeared.

[0156] Therapeutic effect assessment: Cured.

[0157] No recurrence was observed during the 6-month follow-up period.

[0158] No significant adverse reactions were observed during medication, and liver and kidney function remained normal, indicating good tolerability.

[0159] Case 11 Male, 57 years old, with a disease course of 35 years, diagnosed with psoriatic arthritis.

[0160] like Figure 11 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, swelling, pain, stiffness, and deformity of the finger joints.

[0161] The herbal composition granules from Example 3 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0162] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and joint swelling and pain disappeared.

[0163] Therapeutic effect assessment: Cured.

[0164] No recurrence was observed during the 6-month follow-up period.

[0165] No significant adverse reactions were observed throughout the course of medication, and no abnormalities were found in liver and kidney function.

[0166] Example 10 Thirty-two patients with pustular psoriasis were selected as clinical observation cases. Their ages ranged from 6 to 60 years, with a mean age of 29.23 years. There were 19 males and 13 females. The duration of the disease ranged from 6 months to 30 years, with a mean duration of 72.78 months.

[0167] All patients met the Western medicine diagnostic criteria for pustular psoriasis in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0168] The herbal decoction of Example 2 was taken twice daily, 150ml each time, with the dosage reduced for children. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0169] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0170] Observation results: Among 32 patients: Of the 20 cases (62.5%) that were cured, 10 cases (31.25%) that showed significant improvement, 2 cases (6.25%) that showed improvement, and 0 cases that showed no improvement, the overall effective rate was 100%. Among them, 2 cases (10.00%) were cured within one course of treatment, 13 cases (65.00%) were cured within one to two courses of treatment, 3 cases (15.00%) were cured within two to three courses of treatment, and 2 cases (10.00%) were cured within three to four courses of treatment. The shortest treatment time was 2 months, the longest was 12 months, and the average treatment time was 4.97 months.

[0171] Follow-up of all cases at 1, 3, and 6 months after discontinuation of medication showed that only a few cases experienced mild recurrence of skin lesions, while the rest remained stable. No recurrence was observed in recovered cases during the 6-month follow-up period after discontinuation of medication.

[0172] A small number of patients experienced mild diarrhea and abdominal pain during medication, which all subsided on their own. There were no obvious adverse reactions, no abnormal liver or kidney function, and the medication was safe.

[0173] Conclusion: After treatment, the symptoms of erythema, scaling, and pustules were significantly reduced or disappeared, with a total effective rate of 100%. No recurrence was observed during the 6-month follow-up period. There were no obvious adverse reactions, and no abnormalities were found in liver and kidney function. The medication was safe and the patient had high compliance.

[0174] Case 12 Male, 14 years old, with a disease course of 4 years, diagnosed as pustular psoriasis.

[0175] like Figure 12 As shown, before treatment: multiple erythematous patches on the limbs and trunk, with millet-like pustules and yellowish-white scales.

[0176] The herbal decoction of Example 2 was taken twice daily, 150 ml each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0177] After treatment: all erythema, scaling and pustules subsided, leaving only light brown pigmentation spots.

[0178] Therapeutic effect assessment: Cured.

[0179] No recurrence was observed during the 6-month follow-up period.

[0180] No significant adverse reactions were observed during medication, and liver and kidney function remained normal, indicating good tolerability.

[0181] Case 13 Female, 11 years old, disease course 5 years, diagnosis: pustular psoriasis.

[0182] like Figure 13 As shown, before treatment: multiple erythema and pustules on the limbs and trunk, with yellowish-white scales.

[0183] The herbal decoction of Example 2 was taken twice daily, 100ml each time. A course of treatment lasted three months, with no modifications or combination therapy based on clinical symptoms.

[0184] After treatment: the erythema, scales, and pustules all subsided, leaving only light brown pigmentation spots.

[0185] Therapeutic effect assessment: Cured.

[0186] No recurrence was observed during the 6-month follow-up period.

[0187] The patient experienced mild abdominal pain during medication, which subsided on its own. No abnormalities were observed in liver and kidney function, and the medication was well tolerated.

[0188] Case 14 Male, 6 years old, with a disease course of 6 months, diagnosed as pustular psoriasis.

[0189] like Figure 14 As shown, before treatment: multiple erythema on the head, face, limbs, and trunk, millet-like pustules, and yellowish-white scales.

[0190] The herbal decoction of Example 2 was taken twice daily, 100ml each time. A course of treatment lasted three months, with no modifications or combination therapy based on clinical symptoms.

[0191] After treatment: all erythema, scaling, and pustules subsided, leaving only light-colored depigmented spots.

[0192] Therapeutic effect assessment: Cured.

[0193] No recurrence was observed during the 6-month follow-up period.

[0194] No obvious discomfort was observed during medication, and liver and kidney function were normal, indicating good tolerance.

[0195] Example 11 Sixty-two patients with psoriasis vulgaris were selected as clinical observation cases. Their ages ranged from 18 to 70 years, with an average age of 35.19 years. There were 39 males and 23 females. The duration of the disease ranged from 1 month to 40 years, with an average duration of 78.76 months.

[0196] All patients met the Western medicine diagnostic criteria for psoriasis vulgaris in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0197] The herbal composition granules from Example 4 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0198] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0199] Observation results: Among 62 patients: Of the 11 cases treated, 44 (70.97%) were cured, 11 (17.74%) showed significant improvement, 6 (9.68%) showed improvement, and 1 (1.61%) showed no improvement; the overall effective rate was 98.39%. Among these, 14 (31.82%) recovered within one course of treatment, 24 (54.55%) recovered within one to two courses, and 6 (13.64%) recovered within two to three courses. The shortest recovery time was 2 months, and the longest was 9 months. The average recovery time was 4.64 months.

[0200] Follow-up at 1, 3, and 6 months after discontinuation of medication showed that only a few cases experienced mild recurrence of skin lesions, while the rest remained stable. No relapses were observed in recovered cases during the 6-month follow-up period after discontinuation of medication.

[0201] A small number of patients experienced mild diarrhea and abdominal pain during medication, which all subsided on their own. There were no obvious adverse reactions, no abnormal liver or kidney function, and the medication was safe.

[0202] Conclusion: After treatment, the symptoms of erythema, scaling, and itching were significantly reduced or disappeared, with a total effective rate of 98.39%. No recurrence was observed during the 6-month follow-up period after recovery. There were no obvious adverse reactions during the medication process, and no abnormalities were found in liver and kidney function. The medication was safe and the patient's compliance was good.

[0203] Case 15 Male, 38 years old, with a 7-year history of illness, diagnosed as psoriasis vulgaris.

[0204] like Figure 15 As shown, before treatment: widespread erythema and scaling all over the body, bright red in color, with severe itching.

[0205] The herbal composition granules from Example 4 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no concurrent medications were used.

[0206] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and itching symptoms disappeared.

[0207] Therapeutic effect assessment: Cured.

[0208] No recurrence was observed during the 6-month follow-up period.

[0209] No obvious discomfort was observed during medication, liver and kidney function were normal, and overall compliance was good.

[0210] Case 16 Male, 36 years old, with a disease course of 25 years, diagnosed with psoriasis vulgaris.

[0211] like Figure 16 As shown, before treatment: widespread erythema and scaling all over the body, bright red in color, with itching.

[0212] The herbal composition granules from Example 4 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications based on symptoms and no concurrent medications.

[0213] After treatment: all erythema and scaling subsided, no new skin lesions appeared, and itching disappeared.

[0214] Therapeutic effect assessment: Cured.

[0215] No recurrence was observed during the 6-month follow-up period.

[0216] No obvious discomfort was observed during medication, and liver and kidney function remained normal.

[0217] Case 17 Female, 24 years old, with a disease course of 6 years. Diagnosis: Psoriasis vulgaris.

[0218] like Figure 17 As shown, before treatment: generalized erythema and scaling all over the body, with severe itching; The herbal composition granules from Example 4 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0219] After treatment: erythema and scaling completely subsided, no new skin lesions appeared, and itching disappeared.

[0220] Therapeutic effect assessment: Cured.

[0221] No recurrence was observed during the 6-month follow-up period.

[0222] No significant discomfort was observed during the entire course of medication, and no abnormalities were found in liver and kidney function.

[0223] Example 12 Sixty-eight patients with psoriasis vulgaris were selected as clinical observation cases, aged 10 to 75 years, with an average age of 32.13 years. There were 41 males and 27 females, with a disease duration of 1 month to 40 years, and an average disease duration of 81.32 months.

[0224] All patients met the Western medicine diagnostic criteria for psoriasis vulgaris in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0225] The herbal composition pills of Example 6 were taken twice daily, 9 grams each time, with the dosage reduced for children. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0226] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0227] Observation results: Among 68 patients: Of the 12,47 cases (69.12%) were cured, 12 cases (17.65%) showed significant improvement, 8 cases (11.76%) showed improvement, and 1 case (1.47%) showed no improvement; the overall effective rate was 98.53%. Among these, 15 cases (31.91%) were cured within one course of treatment, 25 cases (53.19%) within one to two courses, 6 cases (12.77%) within two to three courses, and 1 case (2.13%) within three to four courses. The shortest recovery time was one month, and the longest was 11 months. The average recovery time was 4.77 months.

[0228] Follow-up at 1, 3, and 6 months after discontinuation of medication showed that only a few cases experienced mild recurrence of skin lesions, while the rest remained stable. No relapses were observed in recovered patients during the 6-month follow-up period after discontinuation of medication.

[0229] A small number of patients experienced mild diarrhea and abdominal pain during medication, all of which resolved spontaneously. No abnormalities were found in liver or kidney function, indicating good safety of the medication.

[0230] Conclusion: After treatment, the symptoms of erythema, scaling, and itching were significantly reduced or disappeared, with a total effective rate of 98.53%. No recurrence was observed during the 6-month follow-up. There were no obvious adverse reactions, and liver and kidney function were normal. The medication was safe and the patients had good compliance.

[0231] Case 18 Male, 12 years old, with a disease course of 2 years. Diagnosis: Psoriasis vulgaris.

[0232] like Figure 18 As shown, before treatment: multiple erythema and scaling all over the body, with itching; The herbal composition pills of Example 6 were taken twice daily, 6 grams each time. A course of treatment lasted three months, with no modifications or combination therapy based on clinical symptoms.

[0233] After treatment: erythema and scaling completely subsided, no new skin lesions appeared, and itching disappeared.

[0234] Therapeutic effect assessment: Cured.

[0235] No recurrence was observed during the 6-month follow-up period.

[0236] The patient experienced mild diarrhea during medication, which resolved on its own. There were no other adverse reactions, and liver and kidney function remained normal.

[0237] Case 19 Male, 14 years old, with a disease course of 2 years. Diagnosis: Psoriasis vulgaris.

[0238] like Figure 19 As shown, before treatment: multiple erythema and scaling all over the body, with itching; The herbal composition pills of Example 6 were taken twice daily, 9 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0239] After treatment: The erythema and scaling completely subsided, with no new skin lesions, and only light brown pigmentation spots remained.

[0240] Therapeutic effect assessment: Cured.

[0241] No recurrence was observed during the 6-month follow-up period.

[0242] No obvious discomfort was observed during medication, and liver and kidney function remained normal.

[0243] Case 20 Male, 18 years old, with a disease course of 1 year. Diagnosis: Psoriasis vulgaris.

[0244] like Figure 20 As shown, before treatment: multiple erythema and scaling all over the body, with itching; The herbal composition pills of Example 6 were taken twice daily, 9 grams each time. A course of treatment lasted three months, with no modifications or combination therapy performed based on clinical symptoms.

[0245] After treatment: erythema and scaling completely subsided, no new skin lesions appeared, and itching disappeared.

[0246] Therapeutic effect assessment: Cured.

[0247] No recurrence was observed during the 6-month follow-up period.

[0248] No significant discomfort was observed during the entire course of medication, and no abnormalities were found in liver and kidney function.

[0249] Comparative Example 1 In Example 1, the principal herb Coptis chinensis was replaced with Lithospermum erythrorhizon, which also has the effect of clearing heat and cooling blood. The assistant herbs and adjuvant herbs remained unchanged, as did the dosage and preparation method.

[0250] Drug composition: 15 parts of Lithospermum erythrorhizon, 11 parts of ginseng, 11 parts of licorice, 4 parts of Ligusticum chuanxiong, 4 parts of Angelica sinensis, 4 parts of Paeonia lactiflora, 12 parts of malt, 5 parts of Atractylodes macrocephala, 5 parts of Poria cocos, and 10 parts of Schisandra chinensis.

[0251] Sixty-five patients with psoriasis vulgaris were selected as clinical observation cases. Their ages ranged from 18 to 65 years, with an average age of 30.16 years. There were 36 males and 29 females. The duration of the disease ranged from 1 month to 35 years, with an average duration of 83.26 months.

[0252] All patients met the Western medicine diagnostic criteria for psoriasis vulgaris in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0253] Dosage: 150ml twice daily. One course of treatment is three months. No modifications or combination therapy are recommended based on clinical symptoms.

[0254] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0255] Observation results: Among 65 patients: 19 cases were cured (29.23%), 14 cases showed significant improvement (21.54%), 17 cases were effective (26.15%), and 15 cases were ineffective (23.08%). The overall effective rate was 76.92%. Among them, 3 cases (15.79%) were cured within 1 course of treatment, 6 cases (31.58%) were cured within 1-2 courses of treatment, 6 cases (31.58%) were cured within 2-3 courses of treatment, and 4 cases (21.05%) were cured within 3-4 courses of treatment. The shortest recovery time was 3 months and the longest was 12 months. The average recovery time was 6.93 months.

[0256] Follow-up at 1, 3, and 6 months after discontinuation of medication revealed that approximately one-third of cases experienced recurrence of skin lesions, while the remaining cases remained stable. Two recovered patients relapsed within 6 months of follow-up, resulting in a relapse rate of 10.53%.

[0257] No significant adverse reactions or abnormal liver and kidney function were observed during medication, indicating good safety.

[0258] Conclusion: In this comparative study, after adjusting the principal drug to other herbs with similar heat-clearing and blood-cooling effects, the overall effective rate decreased from 98.21% to 76.92%, the cure rate decreased from 70.54% to 29.23%, the average cure time increased from 4.5 months to 6.93 months, and the number of cases with recurrent skin lesions increased significantly at 1, 3, and 6 months after drug withdrawal. The recurrence rate at 6 months of follow-up increased from 1.49% to 10.53%.

[0259] The results of this comparative observation demonstrate that the principal herb in the herbal composition of this invention cannot be arbitrarily replaced with other herbs of the same or different effects; otherwise, the overall effective rate and cure rate will decrease significantly, the average cure time will increase significantly, and the number of cases of recurrent skin lesions will increase significantly at 1, 3, and 6 months after discontinuation of the drug, with a significantly increased recurrence rate at 6 months of follow-up.

[0260] Case 21 Male, 45 years old, with a disease course of 6 years, diagnosed as psoriasis vulgaris.

[0261] like Figure 21 As shown, before treatment: multiple erythema on the limbs and trunk, fine scales, and significant itching.

[0262] The herbal decoction containing the replaced principal drug from Example 1 was taken twice daily, 150 ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0263] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0264] Efficacy assessment: Ineffective.

[0265] After a 6-month follow-up, the condition showed no improvement.

[0266] No significant adverse reactions were observed during medication, and liver and kidney function remained normal.

[0267] Case 22 Male, 43 years old, with a disease course of 3 years, diagnosed as: psoriasis vulgaris.

[0268] like Figure 22 As shown, before treatment: multiple erythema and scaling all over the body, with significant itching.

[0269] The herbal decoction containing the replaced principal drug from Example 1 was taken twice daily, 150 ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0270] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0271] Efficacy assessment: Ineffective.

[0272] After a 6-month follow-up, the condition showed no improvement.

[0273] No significant adverse reactions were observed during medication, and liver and kidney function remained normal.

[0274] Case 23 Male, 44 years old, with a disease course of 12 years, diagnosed with psoriasis vulgaris.

[0275] like Figure 23 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, with significant itching.

[0276] The herbal decoction containing the replaced principal drug from Example 1 was taken twice daily, 150 ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0277] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0278] Efficacy assessment: Ineffective.

[0279] After a 6-month follow-up, the condition showed no improvement.

[0280] No significant adverse reactions were observed during medication, and liver and kidney function remained normal.

[0281] Comparative Example 2 In Example 1, the assistant herbs ginseng and licorice were replaced with astragalus and yam, which also have the effect of invigorating qi and strengthening the spleen. The principal herbs and adjuvant herbs remained unchanged, as did the dosage and preparation method.

[0282] Drug composition: Coptis chinensis 15 parts, Astragalus membranaceus 11 parts, Dioscorea opposita 11 parts, Ligusticum chuanxiong 4 parts, Angelica sinensis 4 parts, Paeonia lactiflora 4 parts, Hordeum vulgare 12 parts, Atractylodes macrocephala 5 parts, Poria cocos 5 parts, Schisandra chinensis 10 parts.

[0283] Sixty-seven patients with psoriasis vulgaris were selected as clinical observation cases. Their ages ranged from 18 to 65 years, with an average age of 31.87 years. There were 39 males and 28 females. The duration of the disease ranged from 2 months to 35 years, with an average duration of 80.78 months.

[0284] All patients met the Western medicine diagnostic criteria for psoriasis vulgaris in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0285] Dosage: 150ml twice daily. One course of treatment is three months. No modifications or combination therapy are recommended based on clinical symptoms.

[0286] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0287] Observation results: Among 67 patients: 19 cases were cured (28.36%), 15 cases showed significant improvement (22.39%), 17 cases were effective (25.37%), and 16 cases were ineffective (23.88%). The overall effective rate was 76.12%. Among them, 3 cases (15.79%) were cured within 1 course of treatment, 5 cases (26.32%) were cured within 1-2 courses of treatment, 6 cases (31.58%) were cured within 2-3 courses of treatment, and 5 cases (26.32%) were cured within 3-4 courses of treatment. The shortest recovery time was 2 months and the longest was 11.5 months. The average recovery time was 6.97 months.

[0288] Follow-up at 1, 3, and 6 months after discontinuation of medication showed that approximately one-third of cases experienced recurrence of skin lesions, while the remaining cases remained stable. Among the recovered patients, 3 relapsed within 6 months of discontinuation of medication, representing a relapse rate of 15.79%. During the course of medication, about half of the patients experienced diarrhea and abdominal pain, which were relieved after taking the traditional Chinese medicine after meals. There were no other adverse reactions or abnormal liver and kidney function, and the medication was safe.

[0289] Conclusion: In this comparative study, after adjusting the assistant herbs to other herbs with the same qi-tonifying and spleen-strengthening effects, the overall effective rate decreased from 98.21% to 76.12%, the cure rate decreased from 70.54% to 28.36%, and the average cure time increased from 4.5 months to 6.97 months. The number of patients experiencing gastrointestinal reactions during medication significantly increased, and the number of cases with recurrent skin lesions at 1, 3, and 6 months after discontinuation of medication significantly increased. The recurrence rate within 6 months of follow-up increased from 1.49% to 15.79%.

[0290] The results of this comparative observation demonstrate that the herbal medicine composition of the present invention cannot be arbitrarily replaced with other herbs of the same or different effects. Otherwise, it will lead to a significant decrease in the overall effective rate and cure rate, a significant increase in the average cure time, a significant increase in patients with gastrointestinal reactions during medication, a significant increase in cases of recurrent skin lesions during follow-up at 1, 3, and 6 months after stopping medication, and a significant increase in the recurrence rate within 6 months of follow-up.

[0291] Case 24 Male, 41 years old, with a disease course of 15 years, diagnosed with psoriasis vulgaris.

[0292] like Figure 24 As shown, before treatment: multiple erythema all over the body, fine scales, and significant itching.

[0293] The herbal decoction containing the replaced herbal medicine from Example 1 was taken twice daily, 150ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0294] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0295] Efficacy assessment: Ineffective.

[0296] After a 6-month follow-up, the condition showed no improvement.

[0297] Mild diarrhea and abdominal pain occurred during medication, which were relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0298] Case 25 Male, 47 years old, with a disease course of 4 years, diagnosed as: psoriasis vulgaris.

[0299] like Figure 25 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, with significant itching.

[0300] The herbal decoction containing the replaced herbal medicine from Example 1 was taken twice daily, 150ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0301] After treatment: The affected area expanded, the symptoms of erythema and scaling did not improve significantly, and the itching did not subside.

[0302] Efficacy assessment: Ineffective.

[0303] After a 6-month follow-up, the condition showed no improvement.

[0304] Mild diarrhea and abdominal pain occurred during medication, which were relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0305] Case 26 Male, 31 years old, with a disease course of 1 year, diagnosed with psoriasis vulgaris.

[0306] like Figure 26 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, bright red in color, with significant itching.

[0307] The herbal decoction containing the replaced herbal medicine from Example 1 was taken twice daily, 150ml each time. A course of treatment consisted of three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0308] After treatment: The affected area increased, the symptoms of erythema and scaling did not improve significantly, and the itching did not lessen.

[0309] Efficacy assessment: Ineffective.

[0310] After a 6-month follow-up, the condition showed no improvement.

[0311] Mild diarrhea and abdominal pain occurred during medication, which were relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0312] Comparative Example 3 A total of 225 patients with psoriasis vulgaris were selected as clinical observation cases. Their ages ranged from 10 to 70 years, with an average age of 33.25 years. There were 126 males and 99 females. The duration of the disease ranged from 1 month to 35 years, with an average duration of 82.25 months.

[0313] All patients met the Western medicine diagnostic criteria for psoriasis vulgaris in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018 Complete Version)" and were excluded from the following groups: those with severe heart, liver and kidney diseases, immunodeficiency, and pregnant or lactating women.

[0314] The 225 patients were randomly divided into five groups: control group 1, control group 2, control group 3, control group 4 and control group 5, with 45 patients in each group.

[0315] The herbal decoction from Example 1 was prepared by keeping the principal and assistant herbs, dosages, and preparation methods unchanged. After adjusting the compatibility of the adjuvant herbs, it was divided into five groups: Group 1: Remove medicinal herbs with blood-activating and stasis-removing effects. Drug composition: Coptis chinensis 15 parts, ginseng 11 parts, licorice 11 parts, malt 12 parts, Atractylodes macrocephala 5 parts, Poria cocos 5 parts, Schisandra chinensis 10 parts.

[0316] Group 2: Remove herbs that have digestive and stomach-strengthening effects. Drug composition: Coptis chinensis 15 parts, ginseng 11 parts, licorice 11 parts, chuanxiong rhizome 4 parts, angelica sinensis 4 parts, red peony root 4 parts, atractylodes macrocephala 5 parts, poria cocos 5 parts, schisandra chinensis 10 parts.

[0317] Group 3: Remove herbs with spleen-strengthening and dampness-removing effects. Drug composition: Coptis chinensis 15 parts, ginseng 11 parts, licorice 11 parts, chuanxiong rhizome 4 parts, angelica sinensis 4 parts, red peony root 4 parts, malt 12 parts, schisandra chinensis 10 parts.

[0318] Group 4: Remove herbs with calming and soothing effects. Drug composition: Coptis chinensis 15 parts, ginseng 11 parts, licorice 11 parts, chuanxiong rhizome 4 parts, angelica sinensis 4 parts, red peony root 4 parts, malt 12 parts, atractylodes macrocephala 5 parts, poria cocos 5 parts.

[0319] Group 5: Do not remove any medicinal materials with any effects, but add medicinal materials with heat-clearing and dampness-drying effects (6 parts of Sophora flavescens and 6 parts of Dictamnus dasycarpus).

[0320] Drug composition: Coptis chinensis 15 parts, ginseng 11 parts, licorice 11 parts, Ligusticum chuanxiong 4 parts, Angelica sinensis 4 parts, Paeonia lactiflora 4 parts, malt 12 parts, Atractylodes macrocephala 5 parts, Poria cocos 5 parts, Schisandra chinensis 10 parts, Sophora flavescens 6 parts, Dictamnus dasycarpus 6 parts.

[0321] The five groups of drugs were administered to control group 1, control group 2, control group 3, control group 4 and control group 5 respectively.

[0322] Dosage: 150ml twice daily. Reduce dosage for children. One course of treatment is three months. No adjustments should be made based on clinical symptoms. No combination of medications is permitted.

[0323] Refer to the clinical efficacy evaluation criteria for psoriasis: Cure: The skin lesions have completely subsided and the symptoms have disappeared; Significant effect: Skin lesions subsided by ≥70%, and symptoms of itching and scaling were significantly relieved; Effective: Skin lesions subside in 30%–70% of cases, and clinical symptoms improve; Ineffective: Skin lesions subside by less than 30%, symptoms show no significant improvement or even worsen.

[0324] Observation results: In control group 1 (medicinal herbs with blood-activating and stasis-removing effects were removed): 7 cases were cured (15.56%), 8 cases showed significant improvement (17.78%), 12 cases were effective (26.67%), and 18 cases were ineffective (40.00%). The overall effective rate was 60.00%. Follow-up at 1, 3, and 6 months after discontinuation of medication showed that approximately one-third of cases experienced recurrent skin lesions. Two cases relapsed within 6 months, resulting in a relapse rate of 28.57%.

[0325] About one-third of the patients experienced diarrhea and abdominal pain during the medication period. The symptoms were relieved after taking the traditional Chinese medicine after meals. There were no abnormalities in liver and kidney function, and the medication was safe.

[0326] Case 27 Male, 42 years old, with a disease course of 8 years, diagnosed with psoriasis vulgaris.

[0327] like Figure 27 As shown, before treatment: multiple erythema all over the body, obvious infiltration, dark red color, fine scales, and obvious itching.

[0328] The patient was given a decoction of the first group of herbs (without herbs that promote blood circulation and remove blood stasis), 150ml twice daily. One course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0329] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0330] Efficacy assessment: Ineffective.

[0331] After a 6-month follow-up, the condition showed no improvement.

[0332] No significant adverse reactions were observed during medication, and liver and kidney function remained normal.

[0333] Case 28 Male, 53 years old, with a disease course of 25 years, diagnosed as: psoriasis vulgaris.

[0334] like Figure 28 As shown, before treatment: multiple erythema and obvious infiltration on the limbs and trunk, with severe itching.

[0335] The patient was given a decoction of the first group of herbs (without herbs that promote blood circulation and remove blood stasis), 150ml twice daily. One course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0336] After treatment: The erythema completely subsided, leaving only a few scales, with no new skin lesions and no itching.

[0337] Therapeutic effect assessment: Significantly effective.

[0338] After a 6-month follow-up, the condition showed significant recurrence. Figure 29 As shown, multiple erythema recurred on the limbs and trunk.

[0339] The patient experienced mild abdominal pain during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0340] Case 29 Female, 32 years old, with a disease course of 15 years, diagnosed with psoriasis vulgaris.

[0341] like Figure 30 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, with significant itching.

[0342] The patient was given a decoction of the first group of herbs (without herbs that promote blood circulation and remove blood stasis), 150ml twice daily. One course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0343] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0344] Efficacy assessment: Ineffective.

[0345] After a 6-month follow-up, the condition showed no improvement.

[0346] The patient experienced mild diarrhea during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0347] In control group 2 (medicinal herbs with digestive and stomach-strengthening effects were removed): Eight cases (17.78%) were cured, nine cases (20.00%) showed significant improvement, 13 cases (28.89%) showed improvement, and 15 cases (33.33%) showed no improvement. The overall effective rate was 66.67%. Follow-up at 1, 3, and 6 months after discontinuation of medication showed that approximately one-third of cases experienced recurrent skin lesions. Three cases relapsed within 6 months, resulting in a relapse rate of 37.50%.

[0348] About half of the patients experienced diarrhea and abdominal pain during the medication period. The symptoms were relieved after taking the traditional Chinese medicine after meals. There were no abnormalities in liver and kidney function, and the medication was safe.

[0349] Case 30 Male, 25 years old, with a disease course of 6 years, diagnosed as psoriasis vulgaris.

[0350] like Figure 31 As shown, before treatment: multiple erythema all over the body, fine scales, and significant itching.

[0351] The second group of herbal decoctions (containing herbs with digestive and stomach-strengthening effects) was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0352] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0353] Efficacy assessment: Ineffective.

[0354] After a 6-month follow-up, the condition showed no improvement.

[0355] The patient experienced mild diarrhea during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0356] Case 31 Male, 48 years old, with a disease course of 20 years, diagnosed with psoriasis vulgaris.

[0357] like Figure 32 As shown, before treatment: multiple erythema and fine scales on the limbs and trunk, bright red in color, with obvious itching.

[0358] The second group of herbal decoctions (containing herbs with digestive and stomach-strengthening effects) was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0359] After treatment: There was no change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0360] Efficacy assessment: Ineffective.

[0361] After a 6-month follow-up, the condition showed no improvement.

[0362] The patient experienced mild abdominal pain during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0363] Case 32 Male, 52 years old, with a disease course of 7 years, diagnosed as psoriasis vulgaris.

[0364] like Figure 33 As shown, before treatment: multiple erythema and scaling all over the body, with severe itching.

[0365] The second group of herbal decoctions (containing herbs with digestive and stomach-strengthening effects) was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0366] After treatment: more than 80% of the skin lesions subsided, the symptoms of erythema and scaling were significantly improved, and the itching was significantly reduced.

[0367] Therapeutic effect assessment: Significantly effective.

[0368] After a 6-month follow-up, the condition showed significant recurrence. Figure 34 As shown, multiple erythema and scaling reappeared all over the body.

[0369] The patient experienced mild abdominal pain during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0370] In control group 3 (medicinal herbs with spleen-strengthening and dampness-removing effects were removed): Six cases (13.33%) were cured, eight cases (17.78%) showed significant improvement, fourteen cases (31.11%) showed improvement, and seventeen cases (37.78%) showed no improvement. The overall effective rate was 62.22%. Follow-up at 1, 3, and 6 months after discontinuation of medication showed that approximately one-third of cases experienced recurrent skin lesions. Two cases relapsed within 6 months, resulting in a relapse rate of 33.33%.

[0371] About half of the patients experienced diarrhea and abdominal pain during the medication period. The symptoms were relieved after taking the traditional Chinese medicine after meals. There were no abnormalities in liver and kidney function, and the medication was safe.

[0372] Case 33 Male, 20 years old, with a disease course of 7 years, diagnosed as psoriasis vulgaris.

[0373] like Figure 35 As shown, before treatment: multiple erythema and scaling all over the body, with significant itching.

[0374] The patient was given a decoction of the third group of Chinese herbal medicines (without herbs that have spleen-strengthening and dampness-removing effects), 150ml twice daily. One course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0375] After treatment: The affected area increased, the symptoms of erythema and scaling did not improve, and the itching did not lessen.

[0376] Efficacy assessment: Ineffective.

[0377] After a 6-month follow-up, the condition showed no improvement.

[0378] The patient experienced mild abdominal pain during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0379] Case 34 Male, 26 years old, with a disease course of 10 years, diagnosed with psoriasis vulgaris.

[0380] like Figure 36 As shown, before treatment: multiple erythema and scaling all over the body, with significant itching.

[0381] The patient was given a decoction of the third group of Chinese herbal medicines (without herbs that have spleen-strengthening and dampness-removing effects), 150ml twice daily. One course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0382] After treatment: There was no change in the area of ​​skin lesions, no improvement in erythema and scaling symptoms, and no relief from itching.

[0383] Efficacy assessment: Ineffective.

[0384] After a 6-month follow-up, the condition showed no improvement.

[0385] The patient experienced mild diarrhea during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0386] Case 35 Male, 45 years old, with a disease course of 1 year, diagnosed with psoriasis vulgaris.

[0387] like Figure 37 As shown, before treatment: widespread erythema and scaling all over the body, with significant itching.

[0388] The patient was given a decoction of the third group of Chinese herbal medicines (without herbs that have spleen-strengthening and dampness-removing effects), 150ml twice daily. One course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combination of medications.

[0389] After treatment: The affected area decreased by more than 95%, leaving only a few erythema and scales, and light brown pigmentation spots. There was no itching.

[0390] Therapeutic effect assessment: Significantly effective.

[0391] After a 6-month follow-up, the condition showed significant recurrence. Figure 38 As shown, the patient has widespread erythema and scaling all over the body, and the condition recurs.

[0392] The patient experienced mild abdominal pain during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0393] In control group 4 (medicinal herbs with calming and tranquilizing effects were removed): Six cases (13.33%) were cured, nine cases (20.00%) showed significant improvement, fourteen cases (31.11%) showed improvement, and sixteen cases (35.56%) showed no improvement. The overall effective rate was 64.44%. Follow-up at 1, 3, and 6 months after discontinuation of medication showed that approximately one-third of cases experienced recurrent skin lesions. Two cases relapsed within 6 months, resulting in a relapse rate of 33.33%.

[0394] About one-third of the patients experienced diarrhea and abdominal pain during the medication period. The symptoms were relieved after taking the traditional Chinese medicine after meals. There were no abnormalities in liver and kidney function, and the medication was safe.

[0395] Case 36 Male, 56 years old, with a disease course of 20 years, diagnosed with psoriasis vulgaris.

[0396] like Figure 39 As shown, before treatment: multiple erythema and scaling all over the body, with significant itching.

[0397] The fourth group of traditional Chinese medicine decoctions (excluding those with calming and soothing effects) was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications based on clinical symptoms and no combination of medications.

[0398] After treatment: The erythema completely subsided, leaving only a small amount of scales and light brown pigmentation spots. There was no itching.

[0399] Therapeutic effect assessment: Significantly effective.

[0400] After a 6-month follow-up, the condition showed significant recurrence. Figure 40As shown, multiple erythema and scaling reappeared.

[0401] No significant adverse reactions were observed during medication, and liver and kidney function remained normal.

[0402] Case 37 Female, 14 years old, with a disease course of 6 years, diagnosed as: psoriasis vulgaris.

[0403] like Figure 41 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, with mild itching.

[0404] The fourth group of traditional Chinese medicine decoctions (excluding those with calming and soothing effects) was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications based on clinical symptoms and no combination of medications.

[0405] After treatment: more than 90% of the skin lesions subsided, leaving only a few erythema and scales, with no itching.

[0406] Therapeutic effect assessment: Significantly effective.

[0407] After a 6-month follow-up, the condition showed significant recurrence. Figure 42 As shown, multiple erythema and scaling reappeared.

[0408] The patient experienced mild diarrhea during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0409] Case 38 Male, 45 years old, with a disease course of 10 years, diagnosed with psoriasis vulgaris.

[0410] like Figure 43 As shown, before treatment: widespread erythema and scaling all over the body, with significant itching.

[0411] The fourth group of traditional Chinese medicine decoctions (excluding those with calming and soothing effects) was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications based on clinical symptoms and no combination of medications.

[0412] After treatment: There was no significant change in the area of ​​skin lesions, no significant improvement in erythema and scaling symptoms, and no relief from itching.

[0413] Efficacy assessment: Ineffective.

[0414] After a 6-month follow-up, the condition showed no improvement.

[0415] The patient experienced mild abdominal pain during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0416] In control group 5 (without removing any medicinal materials, but adding 6 portions of Sophora flavescens and 6 portions of Dictamnus dasycarpus for their heat-clearing and dampness-drying effects): 11 cases were cured (24.44%), 10 cases showed significant improvement (22.22%), 10 cases showed improvement (22.22%), and 14 cases showed no improvement (31.11%). The overall effective rate was 68.89%. Follow-up at 1, 3, and 6 months after discontinuation of medication showed that approximately one-third of cases experienced recurrence of skin lesions. Two cases relapsed within 6 months, with a relapse rate of 18.18%. About one-third of the patients experienced diarrhea and abdominal pain during the medication period. The symptoms were relieved after taking the traditional Chinese medicine after meals. There were no abnormalities in liver and kidney function, and the medication was safe.

[0417] Case 39 Male, 48 years old, with a disease course of 25 years, diagnosed with psoriasis vulgaris.

[0418] like Figure 44 As shown, before treatment: multiple erythema and scaling all over the body, with significant itching.

[0419] The fifth group of traditional Chinese medicine decoctions was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0420] After treatment: The erythema completely subsided, leaving only a few scales and light brown pigmentation spots. There was no itching.

[0421] Therapeutic effect assessment: Significantly effective.

[0422] After a 6-month follow-up, the condition showed significant recurrence. Figure 45 As shown, multiple erythema and scaling reappeared, and the condition recurred.

[0423] The patient experienced mild diarrhea during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0424] Case 40 Female, 43 years old, with a disease course of 20 years, diagnosed with psoriasis vulgaris.

[0425] like Figure 46 As shown, before treatment: multiple erythema and scaling on the limbs and trunk, with significant itching.

[0426] The fifth group of traditional Chinese medicine decoctions was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0427] After treatment: The erythema completely subsided, leaving only a few scales and light white depigmented patches. There was no itching.

[0428] Therapeutic effect assessment: Significantly effective.

[0429] After a 6-month follow-up, the condition showed significant recurrence. Figure 47 As shown, multiple erythema and scaling reappeared, and the condition recurred.

[0430] No significant adverse reactions were observed during medication, and liver and kidney function remained normal.

[0431] Case 41 Male, 17 years old, with a disease course of 4 years, diagnosed as: psoriasis vulgaris.

[0432] like Figure 48 As shown, before treatment: multiple erythema and scaling all over the body, with significant itching.

[0433] The fifth group of traditional Chinese medicine decoctions was taken twice daily, 150ml each time. A course of treatment lasted three months, with no modifications or additions based on clinical symptoms, and no combined medications were used.

[0434] After treatment: all erythema and scaling subsided, leaving light brown pigmentation spots. There were no new skin lesions or itching.

[0435] Therapeutic effect assessment: Cured.

[0436] After a 6-month follow-up, the condition clearly relapsed. Figure 49 As shown, multiple erythema and scaling reappeared.

[0437] The patient experienced mild abdominal pain during medication, which was relieved after taking the traditional Chinese medicine after meals. No abnormalities were found in liver and kidney function.

[0438] Conclusion: With the principal and assistant herbs, dosage, and preparation method remaining unchanged in the herbal composition of this invention, the overall effective rate of the five control groups decreased from 98.21% before adjustment to 60.00%, 66.67%, 62.22%, 64.44%, and 68.89%, respectively, and the cure rate decreased from 70.54% before adjustment to 15.56%, 17.78%, 13.33%, 13.33%, and 24.44%, respectively. The number of patients experiencing gastrointestinal reactions during medication significantly increased. The number of cases of recurrent skin lesions at 1, 3, and 6 months after discontinuation of medication in the five control groups was significantly higher than before adjustment. The recurrence rate at 6 months of follow-up increased from 1.49% before adjustment to 28.57%, 37.50%, 33.33%, 33.33%, and 18.18%, respectively.

[0439] The results of this comparative observation demonstrate that the fixed compatibility structure between the principal and assistant herbs and the adjuvant herbs in the herbal composition of this invention has a synergistic effect, enhancing efficacy, reducing adverse reactions, and lowering the recurrence rate. Deleting any adjuvant herb with a specific effect or adding an adjuvant herb with a different type of effect disrupts the fixed compatibility structure and synergistic relationship between the principal and assistant herbs, leading to a significant decrease in the overall effective rate and cure rate, a significant increase in patients experiencing gastrointestinal reactions during medication, a significant increase in cases of recurrent skin lesions at 1, 3, and 6 months after discontinuation of medication, and a significantly higher recurrence rate at 6 months of follow-up.

[0440] In summary, the principal herb in the herbal composition of this invention clears heat and cools the blood, the assistant herb invigorates qi and strengthens the spleen, and the adjuvant herbs promote blood circulation, remove blood stasis, aid digestion, strengthen the spleen and eliminate dampness, and calm the mind and soothe the nerves. This fixed compatibility structure has the good effects of enhancing efficacy, reducing adverse reactions, stabilizing the condition, and significantly reducing the relapse rate after drug withdrawal. The compatibility relationship between the principal, assistant, adjuvant, and adjuvant herbs has obvious synergistic effects and its compatibility structure should not be arbitrarily changed. Replacing the principal herb with other herbs of the same or different efficacy, replacing the assistant herb with other herbs of the same or different efficacy, deleting any adjuvant herb with any efficacy, replacing any adjuvant herb with other herbs of the same or different efficacy, or adding adjuvant herbs with other different efficacy will all destroy the fixed compatibility structure of the entire formula, leading to many adverse effects such as decreased efficacy, significantly increased gastrointestinal adverse reactions, decreased condition stability after drug withdrawal, and significantly increased relapse rate.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is made from the following ingredients in parts by weight: 15-25 parts of herbs with heat-clearing and blood-cooling effects, 20-30 parts of herbs with qi-tonifying and spleen-strengthening effects, 10-20 parts of herbs with blood-activating and stasis-removing effects, 6-15 parts of herbs with digestive and stomach-strengthening effects, 6-15 parts of herbs with spleen-strengthening and dampness-removing effects, and 6-15 parts of herbs with calming and soothing effects; the herbs with heat-clearing and blood-cooling effects are either Coptis chinensis or Aloe vera, and the herbs with qi-tonifying and spleen-strengthening effects are ginseng and licorice.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The medicinal materials with the effect of promoting blood circulation and removing blood stasis include one or more of the following: Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, Prunus persica, Carthamus tinctorius, Curcuma longa, Crataegus pinnatifida, or Salvia miltiorrhiza.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The medicinal materials with digestive and stomach-strengthening effects include one or more of the following: chicken gizzard lining, medicated leaven, malt, or radish seeds.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The medicinal materials with spleen-strengthening and dampness-removing effects include one or more of Atractylodes macrocephala, Poria cocos, Poria cocos sclerotium, or Coix lacryma-jobi.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The medicinal materials with calming and soothing effects include one or more of the following: jujube seed, albizia bark, schisandra fruit, or polygala root.

6. The traditional Chinese medicine composition according to any one of claims 1 to 5, characterized in that, It is made from the following ingredients in parts by weight: 15-22 parts of medicinal materials with heat-clearing and blood-cooling effects, 22-30 parts of medicinal materials with qi-tonifying and spleen-strengthening effects, 10-15 parts of medicinal materials with blood-activating and stasis-removing effects, 6-12 parts of medicinal materials with digestive and stomach-strengthening effects, 6-12 parts of medicinal materials with spleen-strengthening and dampness-removing effects, and 10-15 parts of medicinal materials with calming and soothing effects; the medicinal material with heat-clearing and blood-cooling effects is one of Coptis chinensis or Aloe vera, and the medicinal material with qi-tonifying and spleen-strengthening effects is ginseng and licorice.

7. The traditional Chinese medicine composition according to any one of claims 1 to 6, characterized in that, It is made from the following ingredients in parts by weight: 15-20 parts of herbs with heat-clearing and blood-cooling effects, 24-30 parts of herbs with qi-tonifying and spleen-strengthening effects, 12-15 parts of herbs with blood-activating and stasis-removing effects, 6-10 parts of herbs with digestive and stomach-strengthening effects, 6-10 parts of herbs with spleen-strengthening and dampness-removing effects, and 12-15 parts of herbs with calming and soothing effects; the herbs with heat-clearing and blood-cooling effects are either Coptis chinensis or Aloe vera, and the herbs with qi-tonifying and spleen-strengthening effects are ginseng and licorice.

8. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine composition comprising any one of claims 1 to 7.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The dosage forms of the traditional Chinese medicine preparations are decoctions, oral liquids, ointments, granules, pills, or capsules.

10. The method for preparing the traditional Chinese medicine preparation according to claim 8 or 9, characterized in that, The process includes the following steps: preparing the decoction obtained by decocting and filtering the traditional Chinese medicine combination drugs according to any one of claims 1 to 7, or the fine powder of traditional Chinese medicine obtained by pulverizing, with or without the addition of excipients.

11. The use of the traditional Chinese medicine composition according to any one of claims 1 to 7 or the traditional Chinese medicine preparation according to claim 8 or 9 in the preparation of a medicament for treating psoriasis, wherein preferably, the psoriasis includes psoriasis vulgaris, psoriatic arthritis, pustular psoriasis or erythrodermic psoriasis.

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