A traditional Chinese medicine composition for treating chronic urticaria and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating chronic urticaria, which is prepared from the following components in parts by weight: rehmannia 6-30 parts, radix scutellariae 3-18 parts, angelica 3-18 parts, red peony root 3-18 parts, white peony root 5-18 parts, chuanxiong 3-12 parts, sophora 6-18 parts, radix codonopsis 6-20 parts, radix astragali 6-30 parts, white atractylodes 6-30 parts, poria 6-30 parts, siler 3-15 parts, salvinia 3-15 parts, luyetong 3-12 parts, salix 3-20 parts, dark plum 3-18 parts and licorice 3-18 parts. The medicine is prepared from pure traditional Chinese medicines, and has the advantages of exact curative effect, low recurrence rate and no obvious toxic side effect by clearing heat and blood, nourishing blood and dispelling wind, and tonifying kidney and benefiting qi according to the pathogenesis characteristics of chronic urticaria.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically, it relates to a traditional Chinese medicine composition for treating chronic urticaria and its application. Background Technology

[0002] Chronic urticaria is a skin condition characterized by recurrent episodes of wheals and angioedema lasting more than six weeks, occurring at least twice a week. While not life-threatening, the intense itching, recurrent attacks, and persistent nature of the condition significantly impact patients' quality of life. Currently, modern medicine treats chronic urticaria primarily according to authoritative guidelines such as the "Chinese Guidelines for the Diagnosis and Treatment of Urticaria," and commonly used medications include second-generation non-sedating antihistamines (such as cetirizine and loratadine). However, the following significant limitations exist in clinical practice: First, approximately 40% to 50% of patients cannot fully control their symptoms with conventional doses of antihistamines, and even when the dose is increased 2 to 4 times, some patients still experience poor symptom control. Second, long-term use of antihistamines may cause dry mouth, fatigue, drowsiness, or potential liver and kidney burden, and for chronic patients requiring long-term medication, drug safety is an important consideration. Third, although biologics such as omalizumab are effective for refractory cases, they are expensive, require injection, and some patients do not respond, making them difficult to use as a first-line treatment option. Fourth, current treatments mostly aim to "control symptoms" and are difficult to fundamentally regulate the patient's disordered immune status, resulting in a high relapse rate after discontinuation of medication.

[0003] Traditional Chinese medicine (TCM) has accumulated rich experience in treating chronic urticaria, believing that the disease is often related to factors such as "inherent deficiency, weak defensive qi, and subsequent invasion of wind-evil, or combined with blood heat, blood deficiency, and blood stasis." Treatment emphasizes syndrome differentiation and overall regulation. Compared with simple antihistamine therapy, TCM's advantage lies in its ability to control acute symptoms, improve the patient's constitution, and reduce the risk of recurrence by strengthening the body's resistance and eliminating pathogenic factors, thus reducing the risk of recurrence. Furthermore, TCM has good drug safety and is suitable for long-term treatment. However, existing TCM treatments still have room for improvement: most existing proprietary Chinese medicines or empirical formulas tend to focus on "dispelling wind and clearing heat" or "cooling blood and relieving itching," targeting only the symptoms of "excessive symptoms" while neglecting the root cause of recurrent chronic urticaria—namely, the "deficiency of the root" due to "deficiency of spleen and lung qi and instability of defensive qi." Therefore, they are often effective in the early stages, but the long-term effects are not lasting. Although some formulas take into account both supporting the body's resistance and eliminating pathogenic factors, they fail to fully coordinate the relationship between clearing heat and cooling blood, nourishing blood and dispelling wind, and nourishing the kidneys and replenishing qi in the drug combination. In particular, there are deficiencies in nourishing blood and promoting blood circulation to help dispel wind, tonifying both the spleen and kidneys to consolidate the root, and using both dispersing and astringing methods to prevent damage to the body's resistance. This results in poor adaptability for patients with long disease courses and weak constitutions, and unstable long-term efficacy.

[0004] Patent application CN118717839A discloses a traditional Chinese medicine composition for treating chronic urticaria of the liver stagnation and blood deficiency type, which consists of the following parts by weight: Angelica sinensis 6-12 parts, Paeonia lactiflora 20-40 parts, Atractylodes macrocephala 6-12 parts, Saposhnikovia divaricata 20-30 parts, Bombyx mori 6-12 parts, Tribulus terrestris 20-40 parts, Spatholobus suberectus 6-12 parts, Zaocys dhumnades 10-20 parts, calcined dragon bone 20-40 parts, calcined oyster shell 20-40 parts, Astragalus membranaceus 10-20 parts, Codonopsis pilosula 6-12 parts, Cynanchum paniculatum 10-20 parts, and Glycyrrhiza uralensis 6-12 parts. Patent application CN117919357A discloses a traditional Chinese medicine composition for treating chronic urticaria, comprising the following parts by weight: Artemisia capillaris 10-20 parts, Pogostemon cablin 40-50 parts, Bombyx mori excrement 15-25 parts, Cinnamomum cassia 25-35 parts, Cicadae periostracum 2-8 parts, Poria cocos 5-15 parts, Atractylodes macrocephala 5-15 parts, Amomum villosum 1-5 parts, and Citrus reticulata peel 2-8 parts. Currently published literature on traditional Chinese medicine for treating urticaria mainly focuses on dispelling wind and cold, clearing heat and promoting diuresis, or sedative and calming the mind. It does not adequately address the common pathological characteristics of chronic urticaria patients, such as internal heat in the blood, weak defensive qi, leading to repeated invasion of wind pathogens and a complex mixture of deficiency and excess. Therefore, there is an urgent need for a comprehensive traditional Chinese medicine compound that can quickly control the itching symptoms of wheals, and also rapidly control the symptoms and reduce the long-term recurrence rate through cooling the blood, detoxifying, and regulating qi and blood. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for treating chronic urticaria.

[0006] Another object of the present invention is to provide the use of the traditional Chinese medicine composition in the preparation of a medicament for treating chronic urticaria.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic urticaria, comprising the following components in parts by weight: 6-30 parts Rehmannia glutinosa, 3-18 parts Scutellaria baicalensis, 3-18 parts Angelica sinensis, 3-18 parts Paeonia lactiflora, 5-18 parts Paeonia lactiflora, 3-12 parts Ligusticum chuanxiong, 6-18 parts Sophora japonica, 6-20 parts Codonopsis pilosula, 6-30 parts Astragalus membranaceus, 6-30 parts Atractylodes macrocephala, 6-30 parts Poria cocos, 3-15 parts Saposhnikovia divaricata, 3-15 parts Spirodela polyrhiza, 3-12 parts Liquidambar formosana, 3-20 parts Salix babylonica, 3-18 parts Prunus mume, and 3-18 parts Glycyrrhiza uralensis.

[0009] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 15 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 9 parts Angelica sinensis, 9 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 9 parts Ligusticum chuanxiong, 12 parts Sophora japonica, 15 parts Codonopsis pilosula, 15 parts Astragalus membranaceus, 12 parts Atractylodes macrocephala, 15 parts Poria cocos, 9 parts Saposhnikovia divaricata, 9 parts Spirodela polyrhiza, 6 parts Liquidambar formosana, 15 parts Salix babylonica, 9 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

[0010] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 6 parts Rehmannia glutinosa, 3 parts Scutellaria baicalensis, 3 parts Angelica sinensis, 3 parts Paeonia lactiflora, 5 parts Paeonia lactiflora, 3 parts Ligusticum chuanxiong, 6 parts Sophora japonica, 6 parts Codonopsis pilosula, 6 parts Astragalus membranaceus, 6 parts Atractylodes macrocephala, 6 parts Poria cocos, 3 parts Saposhnikovia divaricata, 3 parts Spirodela polyrhiza, 3 parts Liquidambar formosana, 3 parts Salix babylonica, 3 parts Prunus mume, and 3 parts Glycyrrhiza uralensis.

[0011] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 30 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 18 parts Angelica sinensis, 9 parts Paeonia lactiflora, 15 parts Paeonia lactiflora, 12 parts Ligusticum chuanxiong, 9 parts Sophora japonica, 15 parts Codonopsis pilosula, 30 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 30 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 15 parts Salix babylonica, 12 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

[0012] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 9 parts Rehmannia glutinosa, 6 parts Scutellaria baicalensis, 6 parts Angelica sinensis, 6 parts Paeonia lactiflora, 6 parts Paeonia veitchii, 6 parts Ligusticum chuanxiong, 9 parts Sophora japonica, 9 parts Codonopsis pilosula, 9 parts Astragalus membranaceus, 9 parts Atractylodes macrocephala, 12 parts Poria cocos, 6 parts Saposhnikovia divaricata, 6 parts Spirodela polyrhiza, 6 parts Liquidambar formosana, 6 parts Salix babylonica, 6 parts Prunus mume, and 6 parts Glycyrrhiza uralensis.

[0013] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 27 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 15 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Paeonia veitchii, 12 parts Ligusticum chuanxiong, 12 parts Sophora japonica, 15 parts Codonopsis pilosula, 24 parts Astragalus membranaceus, 24 parts Atractylodes macrocephala, 30 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 15 parts Salix babylonica, 12 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

[0014] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 12 parts Rehmannia glutinosa, 9 parts Scutellaria baicalensis, 9 parts Angelica sinensis, 9 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 6 parts Ligusticum chuanxiong, 9 parts Sophora japonica, 12 parts Codonopsis pilosula, 12 parts Astragalus membranaceus, 12 parts Atractylodes macrocephala, 12 parts Poria cocos, 9 parts Saposhnikovia divaricata, 9 parts Spirodela polyrhiza, 6 parts Liquidambar formosana, 12 parts Salix babylonica, 9 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

[0015] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 24 parts Rehmannia glutinosa, 15 parts Scutellaria baicalensis, 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 10 parts Ligusticum chuanxiong, 15 parts Sophora japonica, 20 parts Codonopsis pilosula, 24 parts Astragalus membranaceus, 30 parts Atractylodes macrocephala, 30 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 18 parts Salix babylonica, 15 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

[0016] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 18 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 12 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Paeonia lactiflora, 10 parts Ligusticum chuanxiong, 15 parts Sophora japonica, 18 parts Codonopsis pilosula, 18 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 18 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 9 parts Liquidambar formosana, 18 parts Salix babylonica, 12 parts Prunus mume, and 12 parts Glycyrrhiza uralensis.

[0017] Preferably, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 21 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 12 parts Angelica sinensis, 9 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 9 parts Ligusticum chuanxiong, 12 parts Sophora japonica, 15 parts Codonopsis pilosula, 15 parts Astragalus membranaceus, 12 parts Atractylodes macrocephala, 15 parts Poria cocos, 9 parts Saposhnikovia divaricata, 9 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 12 parts Salix babylonica, 9 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

[0018] In a second aspect, the present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating chronic urticaria.

[0019] A third aspect of the present invention provides a pharmaceutical preparation made from the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0020] The dosage form of the pharmaceutical preparation is decoction, granules, decocted medicine, tablets, capsules, oral liquid, mixture or syrup.

[0021] In a fourth aspect, the present invention provides the use of the pharmaceutical preparation in the preparation of a medicament for treating chronic urticaria.

[0022] In the traditional Chinese medicine composition of the present invention, Rehmanniae Radix acts as the monarch drug, which can clear heat and cool blood, nourish yin and promote the production of body fluids, directly reduce blood heat, address yin impairment due to long-term illness, and nourish yin to suppress fire. Scutellariae Radix, Sophorae Flos, and Paeoniae Radix Rubra collectively serve as minister drugs. Scutellariae Radix, bitter and cold in nature, directly reduces heat, and is good at clearing heat in the upper energizer and the blood system; when combined with raw Rehmanniae Radix, it enhances the effect of clearing heat and cooling blood. Sophorae Flos is good at cooling blood and purging fire, which can assist raw Rehmanniae Radix and Scutellariae Radix in clearing and resolving heat in the blood system, and is used to improve manifestations such as wheals and pruritus on the skin caused by blood heat. Paeoniae Radix Rubra clears heat and cools blood, activates blood circulation and dissipates stasis, so that blood heat is cleared and blood circulation is unobstructed, preventing stasis from being accumulated due to long-term blood heat. The three drugs act synergistically to assist the monarch drug in clearing heat, cooling blood and resolving stagnation. Astragali Radix, Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, Poria, Angelicae Sinensis Radix, Paeoniae Radix Alba, Chuanxiong Rhizoma, Saposhnikoviae Radix, Spirodelae Herba, Liquidambaris Fructus, Tamaricis Cacumen, and Mume Fructus collectively serve as adjuvant drugs. The first group of adjuvant drugs: Astragali Radix, Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, and Poria, draw the meaning of the Four Gentlemen Decoction that tonifies qi and invigorates the spleen, to tonify qi and secure the exterior, targeting the root of qi deficiency caused by long-term consumption of qi due to blood heat. Astragali Radix is the main drug for tonifying qi and securing the exterior; when combined with Saposhnikoviae Radix, it draws the meaning of the Jade Screen Powder that tonifies qi and secures the exterior to prevent pathogenic factors from invading, so as to strengthen defensive qi to resist external pathogenic factors. Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, and Poria invigorate the spleen and tonify qi, generating the source of qi and blood production. In view of the present invention's recognition that long-term blood heat can consume healthy qi, qi-tonifying and spleen-invigorating effects are supplemented while clearing heat and cooling blood, so as to clear heat without damaging healthy qi, and address the evolution process of the pathogenesis from excess to deficiency. The second group of adjuvant drugs: Angelicae Sinensis Radix, Paeoniae Radix Alba, and Chuanxiong Rhizoma, draw the effect of the Four Substances Decoction that nourishes blood and activates blood circulation, targeting the pathogenesis that long-term blood heat consumes yin and blood, and wind pathogens are prone to move when blood deficiency fails to nourish. Angelicae Sinensis Radix tonifies and activates blood, Paeoniae Radix Alba nourishes blood and astringes yin, and Chuanxiong Rhizoma moves qi and activates blood; when combined with the monarch drug raw Rehmanniae Radix and the minister drug Paeoniae Radix Rubra, they perform the functions of nourishing blood, cooling blood and activating blood. Long-term blood heat will inevitably damage yin and blood, and wind pathogens are prone to move when blood deficiency fails to nourish. Therefore, Angelicae Sinensis Radix and Paeoniae Radix Alba are used to nourish blood and harmonize nutrient, and Chuanxiong Rhizoma is used to activate blood and move qi, so that blood is harmonized and wind is naturally alleviated. Blood deficiency will aggravate wind generation, nourishing blood can extinguish internal wind, and activating blood can unblock the collaterals. The third group of adjuvant drugs: Saposhnikoviae Radix dispels wind and releases the exterior, overcomes dampness and relieves pruritus, and disperses wind pathogens in the muscular exterior to improve wheals and pruritus. Spirodelae Herba disperses wind-heat, promotes eruption of papules and relieves pruritus, assisting Saposhnikoviae Radix and Tamaricis Cacumen to disperse wind-heat in the muscular exterior, so that pathogenic factors have an opportunity to be expelled outward. Liquidambaris Fructus dispels wind and unblocks the collaterals, promotes diuresis and unblocks meridians, which can not only assist in dispelling wind and relieving pruritus, but also address dampness, so that the whole formula dispels wind without stagnation. Tamaricis Cacumen assists Saposhnikoviae Radix, Spirodelae Herba and Liquidambaris Fructus in enhancing the effects of dispelling wind and promoting eruption of papules, and is especially suitable for patients with recurrent wheals that are difficult to erupt. Mume Fructus astringes floating wind-heat, prevents excessive consumption of qi and yin due to excessive pungent dispersion, and at the same time, when combined with Glycyrrhizae Radix et Rhizoma and Paeoniae Radix Alba, produces yin with the sour-sweet property to nourish yin fluid. Glycyrrhizae Radix et Rhizoma acts as the conductant drug, harmonizing all the drugs. Meanwhile, it tonifies qi and harmonizes the middle energizer, assisting the qi-tonifying effects of Astragali Radix, Codonopsis Radix and the like.

[0023] The nature, flavor, channel tropism, efficacy and indications of the traditional Chinese medicine raw materials of the present invention are as follows:

[0024] Rehmanniae Radix: Nature, flavor and channel tropism: sweet, cold; attributive to the heart, liver and kidney channels; Efficacy: clearing heat and cooling blood, nourishing yin and promoting the production of body fluids. Indications: invasion of heat into nutrient-blood, macules caused by warm toxin, hematemesis and epistaxis, yin impairment due to febrile disease, crimson tongue with polydipsia, constipation due to fluid consumption, yin deficiency fever, bone steaming and consumptive fever, internal heat and consumptive thirst.

[0025] Scutellaria baicalensis: Properties and Channels: Bitter, cold; Enters the Lung, Gallbladder, Spleen, Large Intestine, and Small Intestine channels; Functions: Clears heat and dries dampness, drains fire and detoxifies, stops bleeding, and calms the fetus. Indications: Damp-heat syndrome, summer-dampness syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, cough due to lung heat, high fever and thirst, hematemesis due to blood heat, carbuncles and boils, and threatened abortion.

[0026] Angelica sinensis: Properties and channels: sweet, pungent, warm; enters the liver, heart, and spleen channels; Functions: nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, moistens the intestines and promotes bowel movement. Indications: blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, traumatic injuries, carbuncles and sores.

[0027] Red peony root: Properties and channels: bitter, slightly cold; enters the liver channel; Functions: clears heat and cools the blood, disperses blood stasis and relieves pain. Indications: febrile diseases with rashes, hematemesis and epistaxis, red and swollen eyes, liver stagnation and hypochondriac pain, amenorrhea and dysmenorrhea, abdominal masses and pain, traumatic injuries, carbuncles and sores.

[0028] White peony root: Properties and channels: bitter, sour, slightly cold; enters the liver and spleen channels; Functions: nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, calms liver yang. Indications: blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms and pain, headache and dizziness.

[0029] Chuanxiong (Ligusticum striatum): Properties and Channels Entered: Pungent, warm; Enters the Liver, Gallbladder, and Pericardium channels; Functions: Activates blood circulation and promotes qi circulation, dispels wind and relieves pain. Indications: Chest pain, stabbing pain in the chest and hypochondrium, swelling and pain from falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal masses and pain, headache, and rheumatic pain.

[0030] Sophora japonica flower buds: Properties and channels: bitter, slightly cold; enters the liver and large intestine channels; Functions: cools the blood and stops bleeding, clears liver heat and drains fire. Indications: hematochezia, hemorrhoidal bleeding, bloody dysentery, metrorrhagia, hematemesis, epistaxis, red eyes due to liver heat, headache and dizziness.

[0031] Codonopsis pilosula: Properties and channels: sweet, neutral; enters the spleen and lung channels; Functions: tonifies the middle energizer and replenishes qi, strengthens the spleen and benefits the lungs. Indications: weakness of the spleen and lungs, shortness of breath and palpitations, poor appetite and loose stools, wheezing and cough due to deficiency, and internal heat and thirst.

[0032] Astragalus: Properties and Channels Entered: Sweet, slightly warm; Enters the Spleen and Lung channels; Functions: Tonifies Qi and raises Yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, promotes tissue regeneration and detoxification. Indications: Qi deficiency and fatigue, poor appetite and loose stools, sinking of middle Qi, spontaneous sweating due to exterior deficiency, edema due to Qi deficiency, and flaccidity due to blood deficiency.

[0033] Atractylodes macrocephala: Properties and channels: bitter, sweet, warm; enters the spleen and stomach channels; Functions: strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. Indications: spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0034] Poria cocos: Properties and channels: sweet, bland, neutral; enters the heart, lung, spleen, and kidney channels; Functions: promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Indications: edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0035] Fangfeng (Saposhnikovia divaricata): Properties and Channels: Pungent, sweet, slightly warm; enters the bladder, liver, and spleen channels; Functions: dispels wind and releases the exterior, eliminates dampness and relieves pain, stops spasms. Indications: common cold with headache, rheumatic pain, urticaria with itching, tetanus.

[0036] Duckweed: Properties and Channels Entered: Pungent, Cold; Enters the Lung Channel; Functions: Disperses wind-heat, promotes rash eruption, and promotes urination. Indications: Incomplete measles eruption, itchy rubella, edema with scanty urine.

[0037] Lulutong (Luffa cylindrica): Properties and Channels Entered: Bitter, neutral; Enters the Liver and Kidney channels; Functions: Dispels wind and activates collaterals, promotes diuresis, and regulates menstruation. Indications: Joint pain, numbness and contracture, edema and abdominal distension, insufficient lactation, and amenorrhea.

[0038] West River Willow: Properties and Channels Entered: Sweet, pungent, neutral; Enters the Heart, Lung, and Stomach channels; Functions: Releases exterior pathogens and promotes rash eruption, dispels wind and eliminates dampness. Indications: Incomplete measles eruption, rheumatic pain.

[0039] Ume (dried plum): Properties and channels: sour, astringent, neutral; enters the liver, spleen, lung, and large intestine channels; Functions: astringes the lungs, astringes the intestines, promotes the production of body fluids, and expels roundworms. Indications: used for chronic cough due to lung deficiency, chronic diarrhea and dysentery, thirst due to deficiency heat, and vomiting and abdominal pain due to roundworm infestation.

[0040] Licorice: Properties and Channels Entered: Sweet, neutral; Enters the Heart, Lung, Spleen, and Stomach channels; Functions: Tonifies the spleen and replenishes qi, clears heat and detoxifies, resolves phlegm and relieves cough, alleviates spasms and pain, and harmonizes other herbs. Indications: Weakness of the spleen and stomach, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and reduces the toxicity and harshness of other drugs.

[0041] By adopting the above technical solution, the present invention has the following advantages and beneficial effects:

[0042] Based on long-term clinical observation of chronic urticaria, this invention breaks through the traditional single understanding of "wind-evil as the cause," proposing the core pathogenesis of "blood heat generating wind, spleen and lung qi deficiency, and kidney yin deficiency." It reveals the vicious cycle of "blood heat-qi deficiency-yin injury," establishing the treatment principle of "clearing heat and cooling blood, nourishing blood and dispelling wind, and tonifying the kidney and replenishing qi." This overcomes the limitations of existing treatments that either focus too much on clearing heat and dispelling wind while neglecting the body's vital energy, or focus too much on replenishing qi and consolidating the exterior while failing to cool blood and clear heat. It both interrupts "deficiency caused by heat" and prevents "heat generated by deficiency," embodying the holistic view of "treating both the root cause and the symptoms," and providing a solid theoretical basis for formula formulation.

[0043] This invention uses Rehmannia glutinosa as the principal ingredient to clear heat, cool the blood, nourish yin, and generate fluids, addressing both the symptoms of blood heat and the underlying cause of yin deficiency due to prolonged illness. Scutellaria baicalensis, Sophora japonica, and Paeonia lactiflora are used as assistant ingredients to clear heat, purge fire, cool the blood, and disperse blood stasis, assisting the principal ingredient in clearing heat from the blood. Codonopsis pilosula, Astragalus membranaceus, Atractylodes macrocephala, and Poria cocos are added to invigorate qi, strengthen the spleen, consolidate the exterior, and support the body's resistance; Angelica sinensis and Paeonia lactiflora nourish the blood and regulate qi; Ligusticum chuanxiong invigorates blood and promotes qi circulation; Saposhnikovia divaricata, Spirodela polyrhiza, Salix babylonica, and Liquidambar formosana dispel wind, promote rash eruption, unblock the meridians, and relieve itching; Prunus mume astringes and generates fluids, providing a balance of dispersion and astringency. Glycyrrhiza uralensis is used as the guiding ingredient to harmonize the various herbs. The entire formula clears heat and cools the blood to treat the symptoms, invigorates qi and nourishes yin and blood to treat the root cause, and also dispels wind and relieves itching, embodying a treatment that addresses both the root cause and the symptoms, potentially reducing disease recurrence and improving disease stability after discontinuation of medication.

[0044] The medicines selected in this invention are all traditional Chinese medicines. The formula combines tonification and purgation, eliminating pathogens without harming the body's vital energy. The medicines are mild, safe, and have no obvious toxic side effects. They are suitable for long-term treatment of patients with chronic urticaria who have "blood heat combined with qi and yin deficiency".

[0045] The traditional Chinese medicine composition of the present invention is composed of Chinese medicinal materials and does not contain chemically synthesized drug components. It works by clearing heat and cooling blood, nourishing blood and dispelling wind, and tonifying the kidney and replenishing qi. It targets the pathogenesis of chronic urticaria, which is characterized by "deficiency of the root and excess of the branch". It has the characteristics of reasonable formulation, relatively mild medicinal properties, and taking into account both eliminating pathogens and supporting the body's resistance. It is suitable for the treatment and conditioning of patients with chronic urticaria with blood heat and deficiency of both qi and yin. Detailed Implementation

[0046] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0047] Example 1

[0048] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 6g, Scutellaria baicalensis 3g, Angelica sinensis 3g, Paeonia lactiflora 3g, Paeonia veitchii 5g, Ligusticum chuanxiong 3g, Sophora japonica 6g, Codonopsis pilosula 6g, Astragalus membranaceus 6g, Atractylodes macrocephala 6g, Poria cocos 6g, Saposhnikovia divaricata 3g, Spirodela polyrhiza 3g, Liquidambar formosana 3g, Salix babylonica 3g, Prunus mume 3g, Glycyrrhiza uralensis 3g.

[0049] Example 2

[0050] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 30g, Scutellaria baicalensis 12g, Angelica sinensis 18g, Paeonia lactiflora 9g, Paeonia veitchii 15g, Ligusticum chuanxiong 12g, Sophora japonica 9g, Codonopsis pilosula 15g, Astragalus membranaceus 30g, Atractylodes macrocephala 15g, Poria cocos 30g, Saposhnikovia divaricata 12g, Spirodela polyrhiza 12g, Liquidambar formosana 12g, Salix babylonica 15g, Prunus mume 12g, and Glycyrrhiza uralensis 9g.

[0051] Example 3

[0052] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 9g, Scutellaria baicalensis 6g, Angelica sinensis 6g, Paeonia lactiflora 6g, Paeonia veitchii 6g, Ligusticum chuanxiong 6g, Sophora japonica 9g, Codonopsis pilosula 9g, Astragalus membranaceus 9g, Atractylodes macrocephala 9g, Poria cocos 12g, Saposhnikovia divaricata 6g, Spirodela polyrhiza 6g, Liquidambar formosana 6g, Salix babylonica 6g, Prunus mume 6g, Glycyrrhiza uralensis 6g.

[0053] Example 4

[0054] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 27g, Scutellaria baicalensis 12g, Angelica sinensis 15g, Paeonia lactiflora 12g, Paeonia veitchii 15g, Ligusticum chuanxiong 12g, Sophora japonica 12g, Codonopsis pilosula 15g, Astragalus membranaceus 24g, Atractylodes macrocephala 24g, Poria cocos 30g, Saposhnikovia divaricata 12g, Spirodela polyrhiza 12g, Liquidambar formosana 12g, Salix babylonica 15g, Prunus mume 12g, and Glycyrrhiza uralensis 9g.

[0055] Example 5

[0056] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 12g, Scutellaria baicalensis 9g, Angelica sinensis 9g, Paeonia lactiflora 9g, Paeonia veitchii 12g, Ligusticum chuanxiong 6g, Sophora japonica 9g, Codonopsis pilosula 12g, Astragalus membranaceus 12g, Atractylodes macrocephala 12g, Poria cocos 12g, Saposhnikovia divaricata 9g, Spirodela polyrhiza 9g, Liquidambar formosana 6g, Salix babylonica 12g, Prunus mume 9g, Glycyrrhiza uralensis 9g.

[0057] Example 6

[0058] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 24g, Scutellaria baicalensis 15g, Angelica sinensis 15g, Paeonia lactiflora 15g, Paeonia veitchii 12g, Ligusticum chuanxiong 10g, Sophora japonica 15g, Codonopsis pilosula 20g, Astragalus membranaceus 24g, Atractylodes macrocephala 30g, Poria cocos 30g, Saposhnikovia divaricata 12g, Spirodela polyrhiza 12g, Liquidambar formosana 12g, Salix babylonica 18g, Prunus mume 15g, and Glycyrrhiza uralensis 9g.

[0059] Example 7

[0060] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 18g, Scutellaria baicalensis 12g, Angelica sinensis 12g, Paeonia lactiflora 12g, Paeonia veitchii 15g, Ligusticum chuanxiong 10g, Sophora japonica 15g, Codonopsis pilosula 18g, Astragalus membranaceus 18g, Atractylodes macrocephala 15g, Poria cocos 18g, Saposhnikovia divaricata 12g, Spirodela polyrhiza 12g, Liquidambar formosana 9g, Salix babylonica 18g, Prunus mume 12g, Glycyrrhiza uralensis 12g.

[0061] Example 8

[0062] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 21g, Scutellaria baicalensis 12g, Angelica sinensis 12g, Paeonia lactiflora 9g, Paeonia veitchii 12g, Ligusticum chuanxiong 9g, Sophora japonica 12g, Codonopsis pilosula 15g, Astragalus membranaceus 15g, Atractylodes macrocephala 12g, Poria cocos 15g, Saposhnikovia divaricata 9g, Spirodela polyrhiza 9g, Liquidambar formosana 12g, Salix babylonica 12g, Prunus mume 9g, Glycyrrhiza uralensis 9g.

[0063] Example 9

[0064] A traditional Chinese medicine composition for treating chronic urticaria is made from the following components by weight: Rehmannia glutinosa 15g, Scutellaria baicalensis 12g, Angelica sinensis 9g, Paeonia lactiflora 9g, Paeonia veitchii 12g, Ligusticum chuanxiong 9g, Sophora japonica 12g, Codonopsis pilosula 15g, Astragalus membranaceus 15g, Atractylodes macrocephala 12g, Poria cocos 15g, Saposhnikovia divaricata 9g, Spirodela polyrhiza 9g, Liquidambar formosana 6g, Salix babylonica 15g, Prunus mume 9g, Glycyrrhiza uralensis 9g.

[0065] It should be noted that the traditional Chinese medicine compositions provided in Examples 1-9 can all be decocted into a soup using conventional methods.

[0066] Example 10

[0067] Tablet preparation:

[0068] Take any of the traditional Chinese medicine compositions given in Examples 1-9, decoct twice with water. For the first decoction, add 10 times the amount of water and decoct for 2 hours. For the second decoction, add 8 times the amount of water and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 (60°C). Spray dry to obtain a dry extract powder. Add starch and microcrystalline cellulose, mix well, granulate with 85% ethanol, dry, granulate, add magnesium stearate, mix well, and compress into tablets to obtain tablets.

[0069] Example 11

[0070] Preparation of capsules:

[0071] Take any of the traditional Chinese medicine compositions given in Examples 1-9, decoct twice with water. For the first decoction, add 10 times the amount of water and decoct for 2 hours. For the second decoction, add 8 times the amount of water and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 (60°C). Spray dry to obtain a dry extract powder. Add starch and microcrystalline cellulose, mix well, granulate with 85% ethanol, dry, granulate, add magnesium stearate, mix well, and fill into capsules to obtain capsules.

[0072] Example 12

[0073] Preparation of granules:

[0074] Take any of the traditional Chinese medicine compositions given in Examples 1-9, decoct twice with water. For the first decoction, add 12 times the amount of water and decoct for 2 hours. For the second decoction, add 10 times the amount of water and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 (60°C). Add dextrin, spray dry, and obtain a dry extract powder. Add sucrose powder, mix well, granulate with 85% ethanol, dry, and granulate to obtain granules.

[0075] Example 13

[0076] Preparation of the mixture:

[0077] Take any of the traditional Chinese medicine compositions given in Examples 1 to 9, add water and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 2 hours. Add 8 times the amount of water for the second decoction and decoct for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.05 to 1.10 (60°C). Add pharmaceutical excipients, mix well, and package to obtain the compound.

[0078] Example 14

[0079] Preparation of oral liquid:

[0080] Take any of the traditional Chinese medicine compositions given in Examples 1 to 9, prepare a paste according to the method of Example 12, add flavoring agents (such as sucrose and honey) and preservatives, mix well, filter, dispense into oral liquid bottles, sterilize, and obtain oral liquid.

[0081] Example 15

[0082] Preparation of syrup:

[0083] Take any of the traditional Chinese medicine compositions given in Examples 1 to 9, prepare a clear extract according to the method of Example 12, add sucrose, heat to dissolve, filter, add preservative, mix well, and package to obtain a syrup.

[0084] Precautions during preparation:

[0085] The traditional Chinese medicine composition of this invention contains volatile components (such as Saposhnikovia divaricata and Lemna minor) and heat-sensitive components (such as glycosides in Rehmannia glutinosa). When preparing solid dosage forms, the following precautions should be taken: low-temperature techniques (such as vacuum concentration, spray drying, or freeze drying) should be used during the concentration and drying processes, with the temperature controlled below 60°C to avoid loss or destruction of the active ingredients. If pills are required, the above-mentioned extract can be mixed with an appropriate amount of refined honey and prepared using conventional pan-frying or molding methods.

[0086] Example 16

[0087] 1. Research Subjects

[0088] We collected data from patients with chronic urticaria who visited the dermatology outpatient department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, between January 2023 and January 2026.

[0089] 2. Selection Criteria

[0090] 2.1 Diagnostic criteria

[0091] The diagnostic criteria for chronic urticaria were based on the "Guidelines for the Diagnosis and Treatment of Urticaria in China (2022 Edition)".

[0092] Main symptoms

[0093] (1) Red, light red or pale white edematous wheals appear all over the body or in local areas, accompanied by itching. They can gradually subside within 24 hours, with or without angioedema, and leave no pigmentation after they subside.

[0094] (2) When other systems are involved, corresponding symptoms may be present, such as cough, fever, irritability, loss of appetite, abdominal pain, etc.

[0095] (3) The onset of wheals may or may not have a clear cause.

[0096] (4) Continuous or intermittent attacks, with ≥2 attacks per week for more than 6 weeks.

[0097] (5) Skin scratching may be positive.

[0098] 2.2 Inclusion criteria:

[0099] (1) Meets the diagnostic criteria for chronic urticaria;

[0100] (2) Age 18-70 years old, gender not limited;

[0101] (3) Voluntary participation in this study.

[0102] 2.3 Exclusion criteria:

[0103] (1) Urticaria that is induced by various underlying diseases or does not recur after the removal of the identifiable precipitating factor;

[0104] (2) Has received treatment with medication, acupuncture, or other methods within the past two weeks;

[0105] (3) Patients with serious heart, liver, kidney or other organ diseases that affect the evaluation of treatment efficacy;

[0106] (4) Allergy to the drugs used in this study;

[0107] (5) Pregnant or lactating women;

[0108] (6) Other circumstances will be determined by the researcher as unsuitable for participation in this study.

[0109] 3. Treatment methods

[0110] Treatment group: According to the quality of Example 9, the components were mixed, decocted twice with water. The first decoction was made with 10 times the amount of water and decocted for 2 hours. The second decoction was made with 8 times the amount of water and decocted for 1.5 hours. The decoctions were combined, filtered, and concentrated to obtain a soup. One dose was taken twice a day, morning and evening, with each dose being 150-200 ml. Treatment lasted for 8 weeks.

[0111] Control group: Oral administration of cetirizine hydrochloride tablets (Aobiqing, Chengdu Lier Pharmaceutical Co., Ltd.), 10mg each time, once every night, for 8 weeks.

[0112] 4. Indicators for monitoring therapeutic effects

[0113] 4.1 Urticaria Control Efficacy: The Urticaria Control Scale (UCT) was used to evaluate the patients' control status before treatment and at week 8 of treatment. The UCT score includes four components: wheals, pruritus, sleep, and quality of life, using a 5-point scoring system with a total score of 0-16. UCT score <12: poor control; 12-15: good control; 16: complete control.

[0114] Overall control rate = [(Number of cases with full control + Number of cases with partial control) / Total number of cases] × 100%.

[0115] 4.2 Observation of quality of life: Before treatment and after 8 weeks of treatment, the quality of life assessment questionnaire for patients with chronic urticaria (CU-Q2oL) was used to evaluate the patients. CU-Q2oL mainly involves itching, sleep, skin lesions, life limitations, and appearance. The total score is 0 to 100 points. The higher the score, the greater the impact on the patient's life.

[0116] 4.3 Recurrence: Patients with a UCT score ≥12 after treatment were followed up for 3 months. The recurrence rate of the two groups was calculated as follows: recurrence rate = number of cases recurring during the follow-up period / [(number of cases with complete control + number of cases with partial control)] × 100%.

[0117] 4.4 Adverse reactions: Observe the adverse reactions such as skin erythema, desquamation, dizziness, nausea, vomiting, abdominal pain and diarrhea in the two groups of patients during the treatment process.

[0118] 5. Results

[0119] 5.1 General Information

[0120] A total of 61 patients who met the inclusion criteria were enrolled and divided into two groups based on the medication dosage:

[0121] Treatment group: 31 cases, with a mean age of 44.61±11.32 years, including 16 females, and a mean course of disease of 12.42±4.98 months.

[0122] Control group: 30 cases, with a mean age of 43.93±20.14 years, including 18 females, and a mean disease duration of 11.67±4.74 months.

[0123] There were no statistically significant differences in age and gender between the two groups of patients (P>0.05), making them comparable. The results are shown in Table 1.

[0124] Table 1 Comparison of general information between the two groups of cases

[0125]

[0126] 5.2 Comparison of therapeutic effects

[0127] The overall clinical control rate in the treatment group was 93.55%, while that in the control group was 73.33%. The P-values ​​are shown in Table 2.

[0128] Table 2 Comparison of overall clinical control rates between the two groups of cases

[0129]

[0130] 5.2.1 Comparison of urticaria control

[0131] There was no statistically significant difference in UCT scores between the two groups before treatment. After treatment, the UCT score of the treatment group was significantly higher than that of the control group, and the difference was statistically significant, indicating that the treatment method in the treatment group was superior to that in the control group. The results are shown in Table 3.

[0132] Table 3 Comparison of UCT before and after treatment in the two groups of cases ( )

[0133]

[0134] 5.2.2 Comparison of Quality of Life

[0135] Both groups showed a significant decrease in CU-Q2oL scores after treatment. Intergroup comparisons showed that the decrease in CU-Q2oL scores in the treatment group was significantly greater than that in the control group, and the difference was statistically significant. This indicates that the treatment method in the treatment group was superior to that in the control group. The results are shown in Table 4.

[0136] Table 4 Comparison of CU-Q2OL before and after treatment in the two groups of cases ( )

[0137]

[0138] 5.2.3 Comparison of recurrence rates

[0139] In the treatment group, 29 patients were followed up, with 1 patient experiencing a relapse, resulting in a relapse rate of 3.45%. In the control group, 22 patients were followed up, with 7 patients experiencing a relapse, resulting in a relapse rate of 31.82%. The results are shown in Table 5.

[0140] Table 5 Comparison of recurrence rates between the two groups of cases

[0141]

[0142] 5.3 Safety Evaluation

[0143] During the treatment, none of the experimental subjects showed obvious allergies, adverse reactions, or toxic side effects, proving that the traditional Chinese medicine composition of the present invention is safe and reliable with no toxic side effects during application.

[0144] 6 Conclusions

[0145] The results of this study show that the traditional Chinese medicine composition provided by this invention has unique advantages in the treatment of chronic urticaria: (1) It has a definite curative effect and a rapid onset of action: after treatment, the patients' UCT scores increased significantly and their CU-Q2oL scores decreased significantly, with a total effective rate of 93.55%. (2) It has a low recurrence rate: only 1 patient in the treatment group relapsed after treatment, with a recurrence rate of 3.45%. (3) It has high safety and good tolerability: no adverse reactions were observed in the patients, and the safety was good.

[0146] In summary, the traditional Chinese medicine composition of the present invention can effectively control the symptoms of chronic urticaria and improve the quality of life of patients through its effects of clearing heat and cooling blood, nourishing blood and dispelling wind, and tonifying the kidney and replenishing qi. It also has a low recurrence rate and high safety, and has important clinical application value.

[0147] Example 17

[0148] Patient Zhu, female, 33 years old. Chief complaint: Paroxysmal nocturnal itching for more than 2 months. Present illness: For more than 2 months, the patient developed nocturnal itching without any obvious cause. During an attack, the skin would become raised at the scratching site, and the rash was mostly seen in the limbs. She experienced fatigue and weakness, slept relatively well, had one bowel movement per day, and irregular menstruation. She had a history of urticaria but no history of drug allergies. Physical examination: No obvious primary rash, dermatographia (+), dark red tongue with teeth marks on the edges, thin white coating, and thready pulse. Western medicine diagnosis: Chronic urticaria; Traditional Chinese medicine diagnosis: Urticaria (syndrome: blood heat combined with qi and yin deficiency). She was given a decoction prepared according to the components of Example 9 (one dose per day, taken warm twice a day, morning and evening). After taking 14 doses, she returned for a follow-up visit and reported that the severity of nocturnal itching had decreased. After taking another 14 doses, the frequency and severity of nocturnal itching attacks were significantly improved, and the pulse was thready on the left cun position. After continuing consolidation treatment for 4 weeks, all symptoms basically disappeared, the tongue turned pale red, and the pulse gradually became more normal. Three months after stopping the medication, the condition did not recur.

[0149] Example 18

[0150] Patient Shi, female, 37 years old. Chief complaint: Persistent rash all over the body for more than 3 months. Present illness: One month ago, the patient developed a generalized red rash without any obvious cause, which appeared and disappeared intermittently and was itchy during flare-ups. She had previously taken cetirizine (3 tablets daily) which controlled the rash, but later switched to ebastine (2 tablets daily) which was ineffective. The rash occurred at night but did not affect sleep. She had bowel movements every two days, and her menstruation came early and the rash worsened during menstruation. No significant past medical history, no history of drug allergies. Physical examination: Scattered red edematous erythema all over the body, deep red tongue with cracks and teeth marks, thin and scanty coating, and a thready pulse on the left. Western medicine diagnosis: Chronic urticaria; Traditional Chinese medicine diagnosis: Urticaria (syndrome: blood heat with deficiency of both qi and yin). She was given a decoction prepared according to the components of Example 2 (1 dose daily, taken warm twice a day, morning and evening). After 14 doses of medication, the frequency of rash flare-ups decreased, itching lessened, and nighttime flare-ups reduced. After another 14 doses, no new rashes appeared, the rash did not worsen during menstruation, menstruation returned to normal, the red tongue with shallower fissures, and the tongue coating became thin and white. Treatment continued for 8 weeks, and clinical symptoms completely disappeared, with no itching or other discomfort. The tongue was pale red with teeth marks on the edges, the coating was thin and white, and the pulse was more moderate than before. No recurrence was observed during a 2-month follow-up.

[0151] Example 19

[0152] Patient Shen, female, 68 years old. Chief complaint: Persistent rash all over the body for over 9 months. Present illness: Nine months ago, the patient developed a red rash all over her body after consuming seafood. The rash appeared intermittently, mainly on the limbs, and occurred daily. She is currently being treated with oral cetirizine tablets, but the rash continues to occur daily, severely affecting her sleep. Allergen testing at another hospital indicated an allergy to multiple edible proteins, which she is currently avoiding as prescribed. Bowel movements are normal. She has a history of asthma. Physical examination: No obvious primary skin lesions were observed. Tongue was red with teeth marks and a thin coating. Pulse was thready in the right Guan position and left Chi position. Western medicine diagnosis: Chronic urticaria. Traditional Chinese medicine diagnosis: Urticaria (syndrome of blood heat and deficiency of both Qi and Yin). She was prescribed a decoction prepared according to the components in Example 5 (one dose daily, taken warm twice a day). After 14 doses, she returned for a follow-up visit; the rash had largely subsided. The patient continued taking 14 doses (one dose every two days, taken warm in the evening). The condition remained stable with no new flare-ups; the tongue was pale red, and other symptoms remained the same. A three-month follow-up after discontinuation of medication showed stable condition and no recurrence.

[0153] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic urticaria, characterized in that, It is made from the following components in parts by weight: Rehmannia glutinosa 6-30 parts, Scutellaria baicalensis 3-18 parts, Angelica sinensis 3-18 parts, Paeonia lactiflora 3-18 parts, Paeonia veitchii 5-18 parts, Ligusticum chuanxiong 3-12 parts, Sophora japonica 6-18 parts, Codonopsis pilosula 6-20 parts, Astragalus membranaceus 6-30 parts, Atractylodes macrocephala 6-30 parts, Poria cocos 6-30 parts, Saposhnikovia divaricata 3-15 parts, Spirodela polyrhiza 3-15 parts, Liquidambar formosana 3-12 parts, Salix babylonica 3-20 parts, Prunus mume 3-18 parts, Glycyrrhiza uralensis 3-18 parts.

2. The traditional Chinese medicine composition for treating chronic urticaria according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 15 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 9 parts Angelica sinensis, 9 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 9 parts Ligusticum chuanxiong, 12 parts Sophora japonica, 15 parts Codonopsis pilosula, 15 parts Astragalus membranaceus, 12 parts Atractylodes macrocephala, 15 parts Poria cocos, 9 parts Saposhnikovia divaricata, 9 parts Spirodela polyrhiza, 6 parts Liquidambar formosana, 15 parts Salix babylonica, 9 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition for treating chronic urticaria according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 6 parts Rehmannia glutinosa, 3 parts Scutellaria baicalensis, 3 parts Angelica sinensis, 3 parts Paeonia lactiflora, 5 parts Paeonia veitchii, 3 parts Ligusticum chuanxiong, 6 parts Sophora japonica, 6 parts Codonopsis pilosula, 6 parts Astragalus membranaceus, 6 parts Atractylodes macrocephala, 6 parts Poria cocos, 3 parts Saposhnikovia divaricata, 3 parts Spirodela polyrhiza, 3 parts Liquidambar formosana, 3 parts Salix babylonica, 3 parts Prunus mume, and 3 parts Glycyrrhiza uralensis. Alternatively, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 30 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 18 parts Angelica sinensis, 9 parts Paeonia lactiflora, 15 parts Paeonia veitchii, 12 parts Ligusticum chuanxiong, 9 parts Sophora japonica, 15 parts Codonopsis pilosula, 30 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 30 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 15 parts Salix babylonica, 12 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

4. The traditional Chinese medicine composition for treating chronic urticaria according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 9 parts Rehmannia glutinosa, 6 parts Scutellaria baicalensis, 6 parts Angelica sinensis, 6 parts Paeonia lactiflora, 6 parts Paeonia veitchii, 6 parts Ligusticum chuanxiong, 9 parts Sophora japonica, 9 parts Codonopsis pilosula, 9 parts Astragalus membranaceus, 9 parts Atractylodes macrocephala, 12 parts Poria cocos, 6 parts Saposhnikovia divaricata, 6 parts Spirodela polyrhiza, 6 parts Liquidambar formosana, 6 parts Salix babylonica, 6 parts Prunus mume, and 6 parts Glycyrrhiza uralensis. Alternatively, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 27 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 15 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Paeonia veitchii, 12 parts Ligusticum chuanxiong, 12 parts Sophora japonica, 15 parts Codonopsis pilosula, 24 parts Astragalus membranaceus, 24 parts Atractylodes macrocephala, 30 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 15 parts Salix babylonica, 12 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

5. The traditional Chinese medicine composition for treating chronic urticaria according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 12 parts Rehmannia glutinosa, 9 parts Scutellaria baicalensis, 9 parts Angelica sinensis, 9 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 6 parts Ligusticum chuanxiong, 9 parts Sophora japonica, 12 parts Codonopsis pilosula, 12 parts Astragalus membranaceus, 12 parts Atractylodes macrocephala, 12 parts Poria cocos, 9 parts Saposhnikovia divaricata, 9 parts Spirodela polyrhiza, 6 parts Liquidambar formosana, 12 parts Salix babylonica, 9 parts Prunus mume, and 9 parts Glycyrrhiza uralensis. Alternatively, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 24 parts Rehmannia glutinosa, 15 parts Scutellaria baicalensis, 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 10 parts Ligusticum chuanxiong, 15 parts Sophora japonica, 20 parts Codonopsis pilosula, 24 parts Astragalus membranaceus, 30 parts Atractylodes macrocephala, 30 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 18 parts Salix babylonica, 15 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

6. The traditional Chinese medicine composition for treating chronic urticaria according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 18 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 12 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Paeonia veitchii, 10 parts Ligusticum chuanxiong, 15 parts Sophora japonica, 18 parts Codonopsis pilosula, 18 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 18 parts Poria cocos, 12 parts Saposhnikovia divaricata, 12 parts Spirodela polyrhiza, 9 parts Liquidambar formosana, 18 parts Salix babylonica, 12 parts Prunus mume, and 12 parts Glycyrrhiza uralensis. Alternatively, the traditional Chinese medicine composition for treating chronic urticaria is made from the following components in parts by weight: 21 parts Rehmannia glutinosa, 12 parts Scutellaria baicalensis, 12 parts Angelica sinensis, 9 parts Paeonia lactiflora, 12 parts Paeonia lactiflora, 9 parts Ligusticum chuanxiong, 12 parts Sophora japonica, 15 parts Codonopsis pilosula, 15 parts Astragalus membranaceus, 12 parts Atractylodes macrocephala, 15 parts Poria cocos, 9 parts Saposhnikovia divaricata, 9 parts Spirodela polyrhiza, 12 parts Liquidambar formosana, 12 parts Salix babylonica, 9 parts Prunus mume, and 9 parts Glycyrrhiza uralensis.

7. The use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating chronic urticaria.

8. A pharmaceutical preparation, characterized in that, It is made from the traditional Chinese medicine composition as described in any one of claims 1 to 6 and pharmaceutically acceptable excipients.

9. The pharmaceutical preparation according to claim 8, characterized in that, The dosage form of the pharmaceutical preparation is decoction, granules, decocted medicine, tablets, capsules, oral liquid, mixture or syrup.

10. Use of the pharmaceutical preparation of claim 8 or 9 in the preparation of a medicament for treating chronic urticaria.

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