Traditional Chinese medicine composition for treating and preventing recurrence of atopic dermatitis

Abstract

The recurrence rate of atopic dermatitis is extremely high, the recurrence rate of moderate and severe atopic dermatitis is 37-53% every year, and the living quality of patients is greatly affected. The invention provides the traditional Chinese medicine composition for treating atopic dermatitis by taking'spleen strengthening, kidney nourishing, yin nourishing and dryness moistening 'as a core treatment rule, and the traditional Chinese medicine composition can relieve skin itch, promote skin lesion fading and reduce the recurrence rate. The traditional Chinese medicine composition accords with the idea of'prevention of disease 'of traditional Chinese medicine, has important value in chronic disease management, and has good effectiveness and safety through clinical verification. Meanwhile, the application of the invention can reduce the medical expenditure of disease recurrence, and has good economic value. At present, no medicine for controlling atopic dermatitis or eczema relapse exists in the market, and the research of the project proves that the traditional Chinese medicine composition has a remarkable curative effect on prevention of atopic dermatitis relapse.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating atopic dermatitis. BACKGROUND

[0002] Atopic dermatitis, also known as atopic eczema or atopic eczema, is a chronic inflammatory skin disease characterized by eczema-like skin rash and stubborn itching. Atopic dermatitis is divided into infant period, childhood, adolescence and adult period, and old age according to age, and is more common in infants and young children, and is characterized by alternating remission and recurrence (Atopic dermatitis [J]. Lancet. 2016; 387(10023): 1109-1122.). The incidence of infant period accounts for 50% of all patients.

[0003] Atopic dermatitis in the infant period is mainly heart fire, fetal heat, stagnation of fire, and fire stagnation of the skin; while atopic dermatitis in the childhood, adolescence and adult period, and old age often occurs in the elbow fossa, popliteal fossa, etc., which is consistent with the description of "four flexural eczema" in "Jingzong Jinjian": "Four flexural eczema exists in the flexures of the legs and feet, and occurs every month, which is like tinea, and is caused by wind evil invading the skin. It is extremely itchy, and the skin is broken and weeps, which is like tinea. "In ancient Chinese medicine, atopic dermatitis has no clear corresponding disease name, but according to its characteristics, symptoms, etc., it can be classified into "four flexural eczema", "milk tinea", "fetal sore", etc. "Zhuobing Yuanhou Lun" records: "Small children's face tinea, skin like shell error, dry, called milk tinea." Traditional Chinese medicine calls this stage "milk tinea". When ancient medical scholars described the pathogenesis of atopic dermatitis, they summarized that the internal and external factors acted together, the external wind, damp and heat evil, and the internal spleen, lung and heart were related, and were affected by diet, parental inheritance and other factors. "Shengji Zonglu" records: "Small children have wind and heat, and the spleen and lung are not beneficial, or the damp evil invades the skin, and the blood and qi are stagnant, and the skin is thick, then it changes into various tinea", which shows that the pathogenesis of this disease is mainly wind, damp and heat evil, and weak spleen and lung. The research of Wang Ruoyi et al. thinks that the occurrence of atopic dermatitis is related to deficiency of spleen and stomach, damp and cold evil in the body, and qi stagnation (Thinking about the syndrome differentiation and treatment of atopic dermatitis from the theory of zang-fu wind and dampness [J]. Global Traditional Chinese Medicine, 2020, 13(2): 282-284.). Professor Zhang Zhili thinks that the occurrence of atopic dermatitis is closely related to the function of the spleen and stomach, and the core pathogenesis of the disease is spleen deficiency and dampness stagnation (Jingcheng Dayi Zhang Zhili [M]. People's Medical Publishing House 2020: 55.). When modern Chinese medicine scholars describe the etiology and pathogenesis of atopic dermatitis, they can be classified as congenital deficiency, internal generation of dampness and heat due to spleen deficiency, and external invasion of wind, damp and heat evil, and think that the main pathological factors of this disease are wind, damp and heat evil, which are closely related to the five zang organs (Systematic evaluation of the efficacy and safety of traditional Chinese medicine in the treatment of atopic dermatitis [J]. Chinese Journal of Immunology, 2019, 35(24): 3054-3059.) In recent years, the incidence of atopic dermatitis has been increasing, and the State Administration of Traditional Chinese Medicine points out that the treatment of this disease is similar to acute, subacute and chronic eczema, and is treated according to syndrome differentiation. Patent CN114504619A discloses a traditional Chinese medicine composition for treating atopic dermatitis, which is composed of wild chrysanthemum, honeysuckle, sophora, atractylodes, cork tree, cumin, groundcherry, white pyrethrum, white atractylodes, and radix paeoniae. The treatment effect of the composition is remarkable. In patent CN116459322A, a group of traditional Chinese medicine components are provided, which are composed of 10 kinds of medicines such as raw land, yam, cortex, poria cocos, ephedra, raw gypsum, white bark, raw yam, radix scrophulariae and angelica. The SCORAD score total score decreases more significantly, indicating that the disease remission of the treatment group is more significant after 4 weeks. In addition to the above-mentioned internal treatment of traditional Chinese medicine, external treatment of traditional Chinese medicine such as traditional Chinese medicine ointment, medicine bath, acupuncture and other methods can directly stimulate the skin lesions of patients and mobilize the body function to achieve the effect of strengthening the body resistance and eliminating evil.

[0004] Although there is no cure for atopic dermatitis at present, there are still some treatment methods and self-care measures that can relieve the symptoms of atopic dermatitis. However, due to the quite complex nature of atopic dermatitis, there is no single treatment method suitable for treating all or most patients with atopic dermatitis. Even though there are a variety of treatment methods that can control the symptoms of atopic dermatitis, the disease will recur within a few weeks after treatment stops in most patients. Liu Yun selected 60 cases of adult atopic dermatitis patients and divided them into two groups, one group was treated with loratadine tablets, and the other group was treated with angelica root decoction combined with yin-nourishing and dryness-moistening medicine. The angelica root decoction was decocted to 300 mL and taken orally, twice a day. The results showed that the recurrence rate of the treatment group was 20.00%, which was lower than that of the control group (54.16%) (Clinical observation on treating adult atopic dermatitis (blood deficiency and dryness) with blood-nourishing and dryness-moistening method combined with medicine bath[D]. Jiangxi University of Traditional Chinese Medicine, 2019.). The recurrence of atopic dermatitis is not simply a "reappearance of skin symptoms", but a continuous destruction to the patient's physiology, psychology and sociality.

[0005] Therefore, while exploring the treatment of atopic dermatitis, attention should also be paid to how to reduce the recurrence rate of the disease. SUMMARY

[0006] The present application takes "invigorating the spleen and nourishing the kidney, nourishing yin and moistening dryness" as the core principle, and provides a traditional Chinese medicine composition for treating atopic dermatitis. The traditional Chinese medicine composition can relieve skin itching, promote skin lesion regression and reduce the recurrence rate. Based on this, the present application is completed.

[0007] In a first aspect, the present application provides a traditional Chinese medicine composition, which is composed of the following weight parts of traditional Chinese medicines: The monarch medicine is selected from one or more of 2.5-50 parts of radix codonopsis and / or 5-50 parts of atractylodes. the ministerial medicinal is selected from one or more of 10-50 parts of raw Rehmannia root, 5-30 parts of Chinese yam and / or 5-50 parts of white peony root; the auxiliary medicinal is selected from one or more of 5-50 parts of hawthorn fruit, 5-30 parts of dried tangerine or orange peel, 5-50 parts of dogwood fruit, 5-50 parts of angelica root, 5-50 parts of cassia twig, 10-50 parts of poria, 5-30 parts of Chinese medicinal leaven, 5-50 parts of barley malt, 5-20 parts of siler root, 5-30 parts of milk vetch root and / or 5-100 parts of sugar; the ministerial medicinal is 5-30 parts of prepared licorice root.

[0008] Preferably, the traditional Chinese medicinal composition is selected from the following traditional Chinese medicinals in the following proportions by weight: the monarch medicinal is selected from one or more of 5-25 parts of codonopsis root and / or 10-25 parts of atractylodes root; the ministerial medicinal is selected from one or more of 10-25 parts of raw Rehmannia root, 5-20 parts of Chinese yam and / or 10-25 parts of white peony root; the auxiliary medicinal is selected from one or more of 10-25 parts of hawthorn fruit, 10-15 parts of dried tangerine or orange peel, 10-25 parts of dogwood fruit, 5-30 parts of angelica root, 10-25 parts of cassia twig, 10-30 parts of poria, 10-15 parts of Chinese medicinal leaven, 5-20 parts of barley malt, 5-10 parts of siler root, 5-15 parts of milk vetch root and / or 10-50 parts of sugar; the ministerial medicinal is 5-15 parts of prepared licorice root.

[0009] More preferably, the traditional Chinese medicinal composition is selected from the following traditional Chinese medicinals in the following proportions by weight: the monarch medicinal is selected from one or more of 10-20 parts of codonopsis root and / or 15-20 parts of atractylodes root; the ministerial medicinal is selected from one or more of 15-25 parts of raw Rehmannia root, 5-15 parts of Chinese yam and / or 15-20 parts of white peony root; the auxiliary medicinal is selected from one or more of 15-20 parts of hawthorn fruit, 5-15 parts of dried tangerine or orange peel, 5-20 parts of dogwood fruit, 5-20 parts of angelica root, 5-20 parts of cassia twig, 10-20 parts of poria, 5-15 parts of Chinese medicinal leaven, 5-30 parts of barley malt, 5-8 parts of siler root, 5-15 parts of milk vetch root and / or 15-25 parts of sugar; the ministerial medicinal is 10-15 parts of prepared licorice root.

[0010] In one specific embodiment of the present application, the traditional Chinese medicinal composition is made from the following traditional Chinese medicinals: 2.5-50 parts of codonopsis root, 5-50 parts of atractylodes root, 5-50 parts of white peony root, 10-50 parts of raw Rehmannia root, 5-30 parts of Chinese yam, 5-30 parts of dried tangerine or orange peel, 5-50 parts of hawthorn fruit, 5-30 parts of prepared licorice root and 5-100 parts of sugar.

[0011] In one embodiment of the present application, the Chinese medicine composition is made of the following Chinese medicines: 2.5-50 parts of Radix Codonopsis, 5-50 parts of Rhizoma Atractylodis Macrocephalae, 5-50 parts of Radix Paeoniae Alba, 10-50 parts of Radix Rehmanniae, 5-30 parts of Rhizoma Polygonati, 10-50 parts of Poria, 5-30 parts of Pericarpium Citri Reticulatae Viride, 5-50 parts of Fructus Crataegi, 5-30 parts of Radix Glycyrrhizae Praeparata, and 5-100 parts of Glycine.

[0012] In one embodiment of the present application, the Chinese medicine composition is made of the following Chinese medicines: 2.5-50 parts of Radix Codonopsis, 5-50 parts of Rhizoma Atractylodis Macrocephalae, 5-50 parts of Radix Paeoniae Alba, 10-50 parts of Radix Rehmanniae, 5-30 parts of Rhizoma Polygonati, 10-50 parts of Poria, 5-30 parts of Pericarpium Citri Reticulatae Viride, 5-50 parts of Fructus Crataegi, 5-30 parts of Radix Glycyrrhizae Praeparata, 5-20 parts of Radix Saposhnikoviae, 5-30 parts of Radix Astragali, and 5-100 parts of Glycine.

[0013] In one embodiment of the present application, the Chinese medicine composition is made of the following Chinese medicines: 2.5-50 parts of Radix Codonopsis, 5-50 parts of Rhizoma Atractylodis Macrocephalae, 5-50 parts of Radix Paeoniae Alba, 10-50 parts of Radix Rehmanniae, 5-30 parts of Rhizoma Polygonati, 10-50 parts of Poria, 5-30 parts of Pericarpium Citri Reticulatae Viride, 5-50 parts of Fructus Crataegi, 5-30 parts of Radix Glycyrrhizae Praeparata, 5-20 parts of Radix Saposhnikoviae, 5-30 parts of Radix Astragali, 5-50 parts of Ramulus Cinnamomi, 5-30 parts of Massa Medicata Fermentata, 5-50 parts of Fructus Mume, 5-50 parts of Fructus Corni, 5-50 parts of Angelica sinensis, and 5-100 parts of Glycine.

[0014] In the second aspect, the present application provides a Chinese medicine preparation made of a Chinese medicine composition, wherein the Chinese medicine composition is made of the following Chinese medicines in the following proportions: The monarch drug is selected from one or more of 2.5-50 parts of Radix Codonopsis and / or 5-50 parts of Rhizoma Atractylodis Macrocephalae; The minister drug is selected from one or more of 10-50 parts of Radix Rehmanniae, 5-30 parts of Rhizoma Polygonati, and / or 5-50 parts of Radix Paeoniae Alba; The assistant drug is selected from one or more of 5-50 parts of Fructus Crataegi, 5-30 parts of Pericarpium Citri Reticulatae Viride, 5-50 parts of Fructus Corni, 5-30 parts of Angelica sinensis, 5-50 parts of Ramulus Cinnamomi, 10-50 parts of Poria, 5-50 parts of Massa Medicata Fermentata, 5-50 parts of Fructus Mume, 5-20 parts of Radix Saposhnikoviae, 5-30 parts of Radix Astragali, and / or 5-100 parts of Glycine; The guide drug is 5-30 parts of Radix Glycyrrhizae Praeparata.

[0015] Further, the Chinese medicine preparation is one of granules, decoction, capsules, powder, tablets, paste, pills, or pills.

[0016] Preferably, the Chinese medicine preparation is a paste, and the preparation method of the paste comprises the following steps: S01, soaking each paste (50 parts of medicinal decoction pieces) with 6-8 times the amount of water; S02, decocting the soaked slices in S01 for 1-2 hours, filtering out the medicinal juice, adding 6-8 times amount of water to re-decoct, mixing the medicinal juice obtained from the two decocting processes, and heating the mixed medicinal liquid to concentrate into a clear paste; S03, adding honey to the clear paste obtained from S02, further heating to concentrate into a paste, and dispensing the obtained paste.

[0017] Further, the traditional Chinese medicine preparation contains pharmaceutically acceptable excipients required by the corresponding preparation.

[0018] Still further, the excipients are medicinal excipients that have the effects of enhancing the efficacy, reducing the toxicity, and / or alleviating the side effects of the main drugs.

[0019] In a third aspect, the present application provides the use of the traditional Chinese medicine composition of the first aspect in the preparation of a medicament for treating skin diseases, wherein the traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by weight: the monarch drug is selected from one or both of 2.5-50 parts of radix codonopsis and / or 5-50 parts of atractylodes macrocephala koidz; the ministerial drug is selected from one or more of 10-50 parts of raw rehmannia, 5-30 parts of polygonatum sibiricum, and / or 5-50 parts of radix paeoniae alba; the assistant drug is selected from one or more of 5-50 parts of hawthorn, 5-30 parts of citrus reticulata, 5-50 parts of dogwood fruit, 5-50 parts of angelica sinensis, 5-50 parts of cassia twig, 10-30 parts of poria cocos, 5-30 parts of divine powder, 5-30 parts of barley malt, 5-20 parts of saposhnicovia divaricata, 5-30 parts of astragalus membranaceus, and / or 5-100 parts of honey; the guide drug is 5-30 parts of honey-fried licorice.

[0020] Further, the skin diseases include one or more of eczema, dermatitis, atopic dermatitis, allergic dermatitis, urticaria, and / or psoriasis.

[0021] Still further, the atopic dermatitis includes simple atopic dermatitis and mixed atopic dermatitis.

[0022] Further, the atopic dermatitis is of the syndrome of spleen deficiency and blood dryness in traditional Chinese medicine.

[0023] In a fourth aspect, the present application provides the use of the traditional Chinese medicine composition of the first aspect in the preparation of a medicament for preventing and treating the recurrence of skin diseases, wherein the traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by weight: the monarch drug is selected from one or both of 2.5-50 parts of radix codonopsis and / or 5-50 parts of atractylodes macrocephala koidz; the ministerial drug is selected from one or more of 10-50 parts of raw rehmannia, 5-30 parts of polygonatum sibiricum, and / or 5-50 parts of radix paeoniae alba; The adjuvant is selected from one or more of 5-50 parts of hawthorn, 5-30 parts of dried tangerine or orange peel, 5-50 parts of dogwood fruit, 5-50 parts of angelica, 5-50 parts of cassia twig, 10-30 parts of poria, 5-30 parts of divine elixir, 5-30 parts of malt, 5-20 parts of siler, 5-30 parts of milk vetch and / or 5-100 parts of sugar; The medicine is 5-30 parts of fried licorice.

[0024] Further, the skin disease includes one or more of eczema, dermatitis, atopic dermatitis, allergic dermatitis, urticaria and / or psoriasis.

[0025] Still further, the atopic dermatitis includes simple atopic dermatitis and mixed atopic dermatitis.

[0026] Further, the TCM syndrome of atopic dermatitis is spleen deficiency and blood dryness.

[0027] The medicinal properties and effects of each traditional Chinese medicinal material in the present application Codonopsis: sweet, nature. Return to spleen, lung meridian. Has the function of spleen and lung, blood, and the function of generating fluid. Used for spleen and lung deficiency, food less and tired, cough and shortness of breath, blood deficiency, pale, palpitation and shortness of breath, dry mouth and thirst, internal heat and thirst.

[0028] White atractylodes: bitter, sweet, warm. Return to spleen and stomach meridian. Has the function of spleen and qi, dryness and water, stop sweating, and the function of fetal movement. Used for spleen deficiency, abdominal distension, diarrhea, dizziness, edema, sweating, and unstable fetus.

[0029] Raw Rehmannia: sweet, bitter, cold. Return to heart, liver and kidney meridian. Has the function of clearing heat and blood, nourishing yin and generating fluid. Used for heat into the blood, warm toxin rash, hematemesis and metrorrhagia, heat disease and dry mouth, dry mouth and constipation, yin deficiency fever, bone heat and internal heat.

[0030] White peony root: bitter, sour, slightly cold. Return to liver and spleen meridian. Has the function of blood and menstruation, yin and sweating, liver and pain, and the function of liver and yang. Used for blood deficiency and yellow, irregular menstruation, sweating, night sweat, hypochondriac pain, abdominal pain, and headache and dizziness.

[0031] Hawthorn: sour, sweet, slightly warm. Return to spleen, stomach and liver meridian. Has the function of food digestion and stomach, blood stasis, turbidity and lipid reduction. Used for meat accumulation, stomach and stomach distension, diarrhea and abdominal pain, blood stasis, postpartum obstruction, heart and abdominal pain, chest pain, and high blood lipids. The function of Jiaoshansan is enhanced. Used for meat accumulation and diarrhea.

[0032] Dried tangerine or orange peel: bitter, pungent, warm. Return to lung and spleen meridian. Has the function of regulating qi and spleen, drying wet and reducing phlegm. Used for abdominal distension, food less and diarrhea, cough and phlegm.

[0033] Cortex Eucommiae: Sour and astringent in flavor, slightly warm in nature. It is attributed to the liver and kidney meridians. It has the functions of tonifying liver and kidney, astringing and consolidating. It is used for dizziness, tinnitus, soreness of waist and knees, impotence, spermatorrhea, enuresis, frequent micturition, metrorrhagia, leukorrhagia, profuse sweating, and internal heat with polydipsia.

[0034] Cassia Bark: Pungent and sweet in flavor, warm in nature. It is attributed to the heart, lung, and bladder meridians. It has the functions of inducing perspiration to relieve the exterior, warming channels and vessels, assisting yang and transforming qi, and descending and calming the lung. It is used for common cold due to wind-cold, cold pain in the abdomen, blood cold with amenorrhea, arthralgia, phlegm retention, edema, palpitation, and mania.

[0035] Medicated Leaven: Sweet, pungent, and warm in nature, it is attributed to the spleen and stomach meridians. Because of the pungent flavor, it can help to disperse and digest food, and because of the sweet flavor, it can also warm the spleen and stomach, and harmonize the center. It is used for food stagnation, diarrhea, and stomachache.

[0036] Poria: Sweet, bland, and neutral in nature, it is attributed to the heart, lung, spleen, and kidney meridians. It has the functions of promoting water metabolism and removing dampness, and it can also invigorate the spleen and calm the heart. It is used for spleen deficiency with poor appetite, diarrhea, restlessness, palpitation, insomnia, edema, and oliguria.

[0037] Malt: Sweet and neutral in nature, it is attributed to the spleen and stomach meridians. It has the functions of promoting digestion, invigorating the spleen, and relieving abdominal distention. It is used for food stagnation, abdominal pain, spleen deficiency with poor appetite, breast distention, and stomachache.

[0038] Szechwan Lovage Root: Slightly warm in nature, it is attributed to the bladder, liver, and spleen meridians. It has the functions of dispelling wind and relieving the exterior, relieving dampness and pain, and stopping convulsions. It is used for external wind, arthralgia due to wind-dampness, tetanus, infantile convulsion, and urticaria.

[0039] Radix Astragali: Slightly warm in nature, it is attributed to the spleen and lung meridians. It has the functions of tonifying qi, raising yang, stopping sweating, promoting water metabolism, and removing dampness. It is used for chronic diarrhea, prolapse of the uterus, polyhidrosis, urticaria, edema, dizziness, and palpitation.

[0040] Rhizoma Polygonati: Neutral in nature, it is attributed to the spleen, lung, and kidney meridians. It has the functions of tonifying qi and yin, invigorating the spleen and lung, and tonifying the kidney. It is used for poor appetite, fatigue, dry mouth, dry stool, dry cough, little sputum, soreness of the waist and knees, and dizziness.

[0041] Angelica: Warm in nature, it is attributed to the liver, heart, and spleen meridians. It has the functions of tonifying blood, regulating menstruation, and relieving pain. It is used for dizziness, palpitation, insomnia, dry skin, irregular menstruation, and dry stool.

[0042] Sugar: Sweet in flavor, warm in nature, it is attributed to the spleen, stomach, and lung meridians. It has the functions of tonifying the spleen and qi, relieving pain, and relieving cough. It is used for the spleen deficiency due to overstrain, abdominal pain, dry cough, hemoptysis, thirst, sore throat, and constipation.

[0043] Radix Glycyrrhizae: sweet, flat. Belongs to heart, lung, spleen, stomach meridian. It has the function of invigorating the spleen and stomach, benefiting qi and restoring pulse. It is used for weakness of the spleen and stomach, lassitude, fatigue, palpitation, pulse knot.

[0044] Principle of the present application Treatment method: invigorating the spleen and nourishing the kidney, nourishing yin and moistening dryness.

[0045] The present application takes Radix Codonopsis and Atractylodes as the monarch drug, invigorating the spleen and benefiting qi, tonifying middle qi and producing blood; Radix Rehmanniae, Radix Paeoniae Alba and Polygonatum as the ministerial drug, nourishing the kidney and yin, nourishing blood and producing fluid; Crataegus, Pericarpium Citri Reticulatae and Sugar as the auxiliary drug, regulating qi and invigorating the spleen, eliminating food retention and invigorating the stomach; Radix Glycyrrhizae as the ministerial drug, regulating all drugs and invigorating the middle energizer.

[0046] If the patient is accompanied by allergic rhinitis and is prone to repeated exogenous, add Radix Saposhnikoviae and Radix Astragali to benefit qi and tonify the lung; if the patient has poor appetite, is prone to abdominal pain and abdominal distension, and has dry skin, add Semen Pruni, Fructus Rosae Laevigatae, Ramulus Cinnamomi, Poria, Radix Angelicae Sinensis and Fructus Corni. Among them, Semen Pruni and Fructus Rosae Laevigatae invigorate the spleen and eliminate stagnation; Ramulus Cinnamomi warms the meridians, disperses cold, regulates the ying and wei, and invigorates the middle energizer, Poria, Radix Angelicae Sinensis and Fructus Corni nourish blood and the kidney, invigorate the spleen and calm the heart, and moisten dryness and relieve itching.

[0047] Beneficial effects Atopic dermatitis has a very high recurrence rate, and the annual recurrence rate of moderate to severe atopic dermatitis is 37-53%, which greatly affects the quality of life of patients. The traditional Chinese medicine composition of the present application can significantly reduce the recurrence of atopic dermatitis, relieve symptoms such as poor diet, dry or loose stool, dry skin, desquamation, and itching, and other symptoms of patients.

[0048] Therefore, the traditional Chinese medicine composition of the present application has the advantages of reducing disease recurrence and improving the clinical symptoms of spleen deficiency and blood dryness in patients, can moisturize the skin, and relieve itching. The present application is in line with the concept of “preventing disease before it occurs” in traditional Chinese medicine, and has important value in chronic disease management. It has been clinically proven to have good effectiveness and safety. At the same time, the application of the present application can reduce the medical expenses for disease recurrence, and has good economic value. At present, there is a lack of drugs to control the recurrence of atopic dermatitis or eczema in the market, and the traditional Chinese medicine composition provided by the present application has significant effects in preventing the recurrence of atopic dermatitis. DETAILED DESCRIPTION

[0049] The specific embodiments of the present application will be further described below. It should be noted that the description of these embodiments is used to help understand the present application, but does not constitute a limitation on the present application. In addition, the technical features involved in the following embodiments can be combined with each other as long as they do not conflict with each other.

[0050] The experimental methods in the following examples are all conventional methods unless otherwise specified. The test materials used in the following examples are all commercially available unless otherwise specified.

[0051] In the following examples of the present application, the crude drugs are all common Chinese medicinal materials available on the market, and the single-ingredient Chinese medicinal granules are all common Chinese medicinal granules available on the market.

[0052] Terminology The "clear paste" in the present application is a form of Chinese medicinal preparation, which refers to a high-concentration semi-liquid or thick paste-like substance formed after decoction and concentration of medicinal materials, and is commonly used in the production of traditional paste prescriptions or Chinese patent medicines. The clear paste has the characteristics of concentrated efficacy, easy preservation and administration, and is suitable for the conditioning of chronic diseases or the improvement of specific symptoms.

[0053] The "flag hanging" in the present application refers to the process in which, during the decoction of a paste prescription or a gum preparation, when the medicinal liquid is concentrated to a certain extent, the medicinal liquid is scooped up with a stirring tool (such as a bamboo piece or a spatula), and the medicinal liquid will hang on the tool like a flag, falling in a sheet shape instead of rapidly dripping. The flag hanging is one of the important indicators for judging whether the decoction of a paste prescription or a gum preparation is successful.

[0054] Example 1 Chinese medicinal composition 1.1 Chinese medicinal composition Chinese medicinal composition 1: Dangshen 5g, Baizhu 10g, Baishao 10g, Shengdi 10g, Huangjing 15g, Chenpi 10g, Shanzha 10g, Zhigancao 6g, and Miansu 10g.

[0055] Chinese medicinal composition 2: Dangshen 8g, Baizhu 10g, Baishao 10g, Shengdi 10g, Huangjing 15g, Fuling 10g, Chenpi 10g, Shanzha 10g, Zhigancao 6g, and Miansu 10g.

[0056] Chinese medicinal composition 3: Dangshen 10g, Baizhu 10g, Baishao 10g, Shengdi 10g, Fuling 10g, Huangjing 10g, Shanzha 10g, Zhigancao 6g, Chenpi 6g, Fangfeng 10g, Huangqi 10g, and Miansu 10g.

[0057] Chinese medicinal composition 4: Dangshen 10g, Baizhu 10g, Baishao 10g, Shengdi 10g, Huangjing 10g, Fuling 10g, Shanzha 10g, Zhigancao 6g, Chenpi 6g, Fangfeng 10g, Huangqi 10g, Guizhi 10g, Danggui 10g, Shanyurou 10g, Shencu 10g, Maiya 10g, and Miansu 15g.

[0058] 1.2 Preparation method of paste prescription Each paste side (50 pairs of decoction amount) is immersed with 6-8 times the amount of water for ≥8 hours. After boiling with strong fire, use low heat to cook for about 2 hours, filter out the medicinal juice, add 6 times the amount of water, boil with strong fire, then use low heat to cook for about 1 hour. Mix the medicinal juices obtained from the two decoctions, and filter after standing or use a 100-mesh sieve. Heat and concentrate the filtered medicinal liquid, continuously stir and concentrate until it becomes thick and thick into a "clear paste". Add honey while hot and stir well, then heat with low heat; stop heating when "water droplets form beads", and put into vacuum bags. Each bag contains 20 ml, and each 2 bags are 1 pair of decoction amount.

[0059] Example 2 Clinical study Research method A prospective, randomized, controlled, small sample study design was used.

[0060] Design scheme Research object This topic selects children with atopic dermatitis (four wind) of spleen deficiency and blood dryness syndrome who have recovered clinically (the researcher's overall assessment is less than or equal to 1, that is, IGA≤1, for 2 weeks) in the outpatient department of Beijing Hospital of Chinese Medicine of Capital Medical University as the research object.

[0061] 2. Diagnostic criteria (1) Western medicine diagnostic criteria: Refer to Hanifin-Rajka diagnostic criteria.

[0062] (2) TCM diagnostic criteria: Refer to "Expert Consensus on Diagnosis and Treatment of Atopic Dermatitis in TCM" (2013) and "Sincere Great Doctor Zhang Zhili".

[0063] Spleen deficiency and dampness accumulation: Children with thin body, pale or white face, dry skin and scaling all over the body, poor appetite or unappetizing food, loose or sticky stool, and fatigue can be accompanied by fatigue. Pale or pale red tongue, white fur, and thin and slow pulse or fingerprint color.

[0064] 3. Inclusion criteria (1) Patients who meet the above clinical diagnostic criteria of atopic dermatitis in western medicine (reach IGA≤1 point) are cured; (2) Meet the syndrome differentiation criteria of spleen deficiency and blood dryness syndrome in TCM; (3) Age 2 to 18 years old, gender unrestricted; (4) Good compliance, can cooperate with the collection of clinical data; (5) No systematic application of hormones, immunosuppressants, biological agents or small molecule drugs in the past 3 months, and no ultraviolet therapy in the past 4 weeks; (6) No systemic use of antihistamines in the past 2 weeks; (7) Obtain the patient and guardian permission, sign the informed consent form (8 years old by the guardian to sign, 8 years old by the patient and guardian to sign), volunteers, informed consent process in line with the provisions of the drug clinical trial management standard.

[0065] 4. Exclusion criteria (1) Combined with any other skin disease that may interfere with the evaluation of the test results; (2) Combined with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and autoimmune diseases, skin tumor diseases, and patients with mental illness; (3) Patients with relatively severe skin infections or systemic infections; (4) Patients with a history of allergy to any component of the study drug; (5) Patients who cannot accept oral Chinese medicine ointment treatment; (6) Patients participating in other drug clinical trials.

[0066] 5. Case exclusion / dropout criteria (1) Excluded if found not to meet the inclusion criteria after inclusion; (2) Cases not taking the medicine as specified in the trial protocol, included but not taking the medicine; (3) Patients lost to follow-up are considered to have dropped out.

[0067] 6. Termination criteria (1) Serious adverse reactions, allergic reactions occur during the clinical trial; (2) If it is found during the study that the drug used is not only ineffective in improving symptoms, but also further aggravates the condition; (3) Major errors in trial design; (4) Significant bias in the implementation process, which cannot evaluate the efficacy of the drug; (5) The researcher considers it necessary to terminate the trial from a medical point of view.

[0068] 7. Prohibited combination therapy Patients receiving trial research are prohibited from using systemic glucocorticoids, non-steroidal immunosuppressants, antihistamines, and prohibited from using ultraviolet light therapy (long wave or medium wave ultraviolet light) treatment. If the patient combines other drugs during the trial research process, it needs to be recorded in time, and if it has an impact on the trial, it will be excluded.

[0069] 8. Intervention measures (1) Test group: oral ointment (using the Chinese medicine composition ointment prepared in Example 1). Adopt age stratification method: 2-7 years old, 1 bag per day; 8-11 years old, 2 bags per day; 12-18 years old, 3 bags per day, for 4 weeks.

[0070] (2) Control group: do not take any medicine.

[0071] (3) Basic treatment: both groups of children and families adopt health education, diet care, repair skin barrier and moisturizing (emollient) basic treatment measures.

[0072] (4) Record the recurrence of patients during treatment and 12 weeks after follow-up after treatment.

[0073] (5) Recurrence determination: if the ADCT score is ≥7 within 16 weeks, it is determined to be recurrence.

[0074] 9. Efficacy evaluation Efficacy index: atopic dermatitis control scale (ADCT) Table 1 Atopic dermatitis control scale (ADCT) Results From January 2025 to July 2025, 170 cases of IGA≤1 for more than 2 weeks were recruited in Beijing Hospital of Chinese Medicine Affiliated to Capital Medical University. The patients were diagnosed as atopic dermatitis recurrence after clinical evaluation of IGA≤1 for more than 2 weeks after treatment with traditional Chinese medicine and external medicine. The patients in this study were randomly divided into control group and test group by random number table. The test group was given traditional Chinese medicine ointment for 4 weeks, and the control group was not intervened. The recurrence of patients during treatment and 12 weeks after treatment was compared. This study finally completed 165 cases of case collection; 132 cases in the test group and 33 cases in the control group. There were 62 males and 70 females in the treatment group, with an average age of (8.42±3.54) years and an average disease duration of (4.85±3.01) years. There were 15 males and 18 females in the control group, with an average age of (7.98±4.34) years and an average disease duration of (4.08±2.85) years. There was no significant difference in general data between the two groups (P>0.05). The test group was treated with ointment prepared according to Example 1, and the control group was not given intervention measures. Follow-up was conducted for 12 weeks, and recurrence was used as the endpoint of this study. The recurrence rates of the two groups were compared.

[0075] Table 2 Comparison of recurrence between the two groups before and after treatment Table 3 Comparison of recurrence between the two groups before and after treatment The test results are shown in Table 2. It is found by 16-week disease recording of the patients that there are 19 relapse patients in the test group, and the relapse rate is 14.4%; there are 8 relapse patients in the control group, and the relapse rate is 24.2%, P<0.05, and the difference has statistical significance. In addition, compared with the control group, the relapse rates of the patients taking the traditional Chinese medicine composition 1, the traditional Chinese medicine composition 2, the traditional Chinese medicine composition 3 and the traditional Chinese medicine composition 4 are all significantly lower than those of the control group (see Table 3). The above-mentioned clinical test results show that oral administration of the traditional Chinese medicine composition paste provided by the application can better prolong the stable period and reduce the relapse rate. No adverse reactions occur, and it is safe and effective. It has a good market application prospect.

Claims

1. A traditional Chinese medicine composition, which is composed of the following traditional Chinese medicines in parts by weight: the monarch drug is selected from one or more of 2.5-50 parts of radix codonopsis and / or 5-50 parts of rhizoma atractylodis macrocephalae; the ministerial drug is selected from one or more of 10-50 parts of radix rehmanniae, 5-30 parts of rhizoma polygonati and / or 5-50 parts of radix paeoniae alba; the auxiliary drug is selected from one or more of 5-50 parts of fructus crataegi, 5-30 parts of pericarpium citri reticulatae, 5-50 parts of fructus corni, 5-50 parts of angelica sinensis, 5-50 parts of ramulus cinnamomi, 10-50 parts of poria cocos, 5-30 parts of massa medicata fermentata, 5-50 parts of malt, 5-20 parts of sileris divaricatae, 5-30 parts of radix astragali and / or 5-100 parts of honey; the guide drug is 5-30 parts of honey-fried licorice.

2. The traditional Chinese medicine composition of claim 1, which is composed of the following traditional Chinese medicines in parts by weight: the monarch drug is selected from one or more of 5-25 parts of radix codonopsis and / or 10-25 parts of rhizoma atractylodis macrocephalae; the ministerial drug is selected from one or more of 10-25 parts of radix rehmanniae, 5-20 parts of rhizoma polygonati and / or 10-25 parts of radix paeoniae alba; the auxiliary drug is selected from one or more of 10-25 parts of fructus crataegi, 10-15 parts of pericarpium citri reticulatae, 10-25 parts of fructus corni, 5-30 parts of angelica sinensis, 10-25 parts of ramulus cinnamomi, 10-30 parts of poria cocos, 10-15 parts of massa medicata fermentata, 5-20 parts of malt, 5-10 parts of sileris divaricatae, 5-15 parts of radix astragali and / or 10-50 parts of honey; the guide drug is 5-15 parts of honey-fried licorice.

3. The traditional Chinese medicine composition of claim 1, which is composed of the following traditional Chinese medicines in parts by weight: the monarch drug is selected from one or more of 10-20 parts of radix codonopsis and / or 15-20 parts of rhizoma atractylodis macrocephalae; the ministerial drug is selected from one or more of 15-25 parts of radix rehmanniae, 5-15 parts of rhizoma polygonati and / or 15-20 parts of radix paeoniae alba; the auxiliary drug is selected from one or more of 15-20 parts of fructus crataegi, 5-15 parts of pericarpium citri reticulatae, 5-20 parts of fructus corni, 5-20 parts of angelica sinensis, 5-20 parts of ramulus cinnamomi, 10-20 parts of poria cocos, 5-15 parts of massa medicata fermentata, 5-30 parts of malt, 5-8 parts of sileris divaricatae, 5-15 parts of radix astragali and / or 15-25 parts of honey; the guide drug is 10-15 parts of honey-fried licorice.

4. The traditional Chinese medicine composition of claim 1, consisting of the following traditional Chinese medicines: 2.5-50 parts of radix codonopsis, 5-50 parts of rhizoma atractylodis macrocephalae, 5-50 parts of radix paeoniae alba, 10-50 parts of radix rehmanniae, 5-30 parts of rhizoma polygonati, 5-30 parts of pericarpium citri reticulatae, 5-50 parts of fructus crataegi, 5-30 parts of honey-fried licorice and 5-100 parts of honey; the traditional Chinese medicine composition is composed of 2.5-50 parts of radix codonopsis, 5-50 parts of rhizoma atractylodis macrocephalae, 5-50 parts of radix paeoniae alba, 10-50 parts of radix rehmanniae, 5-30 parts of rhizoma polygonati, 10-50 parts of poria cocos, 5-30 parts of pericarpium citri reticulatae, 5-50 parts of fructus crataegi, 5-30 parts of honey-fried licorice and 5-100 parts of honey; the traditional Chinese medicine composition is composed of 2.5-50 parts of radix codonopsis, 5-50 parts of rhizoma atractylodis macrocephalae, 5-50 parts of radix paeoniae alba, 10-50 parts of radix rehmanniae, 5-30 parts of rhizoma polygonati, 10-50 parts of poria cocos, 5-30 parts of pericarpium citri reticulatae, 5-50 parts of fructus crataegi, 5-30 parts of honey-fried licorice, 5-20 parts of sileris divaricatae, 5-30 parts of radix astragali and 5-100 parts of honey; The traditional Chinese medicine composition is composed of 2.5-50 parts of radix codonopsis, 5-50 parts of rhizoma atractylodis macrocephalae, 5-50 parts of radix paeoniae alba, 10-50 parts of radix rehmanniae, 5-30 parts of polygonatum, 10-50 parts of poria cocos, 5-30 parts of citrus reticulata, 5-50 parts of hawthorn, 5-30 parts of licorice, 5-20 parts of saposhnikovia divaricata, 5-30 parts of astragalus, 5-30 parts of asarum, 5-50 parts of wheat germ, 5-50 parts of dogwood fruit, 5-50 parts of angelica and 5-100 parts of sugar.

5. A traditional Chinese medicine preparation made of a traditional Chinese medicine composition, the traditional Chinese medicine composition being composed of the following traditional Chinese medicines in the following amounts by weight: the monarch drug being selected from one or more of 2.5-50 parts of radix codonopsis and / or 5-50 parts of rhizoma atractylodis macrocephalae; the ministerial drug being selected from one or more of 10-50 parts of radix rehmanniae, 5-30 parts of polygonatum and / or 5-50 parts of radix paeoniae alba; the auxiliary drug being selected from one or more of 5-50 parts of hawthorn, 5-30 parts of citrus reticulata, 5-50 parts of dogwood fruit, 5-30 parts of angelica, 5-50 parts of asarum, 10-50 parts of poria cocos, 5-50 parts of asarum, 5-50 parts of wheat germ, 5-20 parts of saposhnikovia divaricata, 5-30 parts of astragalus and / or 5-100 parts of sugar; the guide drug being 5-30 parts of licorice; the traditional Chinese medicine preparation being one of granules, decoction, capsules, powder, tablets, paste, pills or pills.

6. The traditional Chinese medicine preparation of claim 5, the preparation method of the paste comprising the following steps: S01, soaking each paste (50 doses of medicinal decoction pieces) with 6-8 times the amount of water; S02, decocting the soaked medicinal decoction pieces in S01 for 1-2 hours, filtering out the medicinal juice, adding 6-8 times the amount of water for re-decocting, mixing the medicinal juice obtained from the two decocting processes, and heating and concentrating the mixed medicinal liquid into a clear paste; S03, adding sugar to the clear paste obtained in S02, further heating and concentrating the paste, and then packaging the obtained paste.

7. Use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for treating skin diseases, the traditional Chinese medicine composition being composed of the following traditional Chinese medicines in the following amounts by weight: the monarch drug being selected from one or more of 2.5-50 parts of radix codonopsis and / or 5-50 parts of rhizoma atractylodis macrocephalae; the ministerial drug being selected from one or more of 10-50 parts of radix rehmanniae, 5-30 parts of polygonatum and / or 5-50 parts of radix paeoniae alba; the auxiliary drug being selected from one or more of 5-50 parts of hawthorn, 5-30 parts of citrus reticulata, 5-50 parts of dogwood fruit, 5-50 parts of angelica, 5-50 parts of asarum, 10-30 parts of poria cocos, 5-30 parts of asarum, 5-30 parts of wheat germ, 5-20 parts of saposhnikovia divaricata, 5-30 parts of astragalus and / or 5-100 parts of sugar; the guide drug being 5-30 parts of licorice.

8. The use of claim 7, wherein the skin diseases include one or more of eczema, dermatitis, atopic dermatitis, allergic dermatitis, urticaria and / or psoriasis; the atopic dermatitis includes simple atopic dermatitis and mixed atopic dermatitis; and the atopic dermatitis is of the spleen deficiency and blood dryness syndrome in traditional Chinese medicine.

9. Use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for preventing and treating recurrence of skin diseases, the traditional Chinese medicine composition being composed of the following traditional Chinese medicines in the following amounts by weight: The monarch drug is selected from one or both of 2.5-50 parts of radix codonopsis and / or 5-50 parts of atractylodes macrocephala koidz; The minister drug is selected from one or more of 10-50 parts of raw rehmannia, 5-30 parts of polygonatum, and / or 5-50 parts of radix paeoniae alba; The assistant drug is selected from one or more of 5-50 parts of hawthorn, 5-30 parts of citrus reticulata, 5-50 parts of dogwood fruit, 5-50 parts of angelica sinensis, 5-50 parts of cassia twig, 10-30 parts of poria cocos, 5-30 parts of divine powder, 5-30 parts of barley malt, 5-20 parts of sileris divaricata, 5-30 parts of radix astragali, and / or 5-100 parts of sugar; The auxiliary drug is 5-30 parts of fried licorice.

10. The use according to claim 9, wherein the skin disease comprises one or more of eczema, dermatitis, atopic dermatitis, allergic dermatitis, urticaria, and / or psoriasis; the atopic dermatitis comprises simple atopic dermatitis and mixed atopic dermatitis; and the atopic dermatitis is of the spleen deficiency and blood dryness syndrome in traditional Chinese medicine.

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