WO2024000914A1 - 一种治疗皮肤病的中药组合物及其制备方法 - Google Patents

一种治疗皮肤病的中药组合物及其制备方法 Download PDF

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WO2024000914A1
WO2024000914A1 PCT/CN2022/124230 CN2022124230W WO2024000914A1 WO 2024000914 A1 WO2024000914 A1 WO 2024000914A1 CN 2022124230 W CN2022124230 W CN 2022124230W WO 2024000914 A1 WO2024000914 A1 WO 2024000914A1
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medicine
traditional chinese
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chinese medicine
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徐佳
王萍
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首都医科大学附属北京中医医院
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/35—Caprifoliaceae (Honeysuckle family)
    • A61K36/355—Lonicera (honeysuckle)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/734—Crataegus (hawthorn)
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/752—Citrus, e.g. lime, orange or lemon
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/808—Scrophularia (figwort)
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/8998—Hordeum (barley)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates to a traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating skin diseases and a preparation method thereof.
  • the treatment methods are often based on strengthening the spleen and dispersing conduction, clearing heat and removing dampness, strengthening the spleen and removing dampness, and nourishing blood and moisturizing. ; Professor Chen dacan believes that heart-fire and spleen deficiency are the dominant pathogenesis of this disease, and spleen deficiency runs through the entire course of the disease.
  • the clinical treatment method is to cultivate soil and clear the heart (strengthen the spleen and clear the heart); Professor Huang Yaozhou believes that evil fire disturbing the heart is the main pathogenesis of the disease, and advocates the emphasis on important towns. Soothing drugs treat this disease.
  • atopic dermatitis is a skin disease with a genetic tendency. Genetic family history is closely related to the onset of the disease. If your parents have atopic diseases (allergic rhinitis, asthma, etc.) or are allergic Physical constitution will greatly increase the risk of atopic dermatitis in their children.
  • the concept of innate endowment in traditional Chinese medicine can summarize the overall influence of individual innate genetic factors and various other innate factors in modern medical research. Endowment comes from innate essence, which is endowed by parents, and the kidney is the place where essence is stored. Li Zhongzi, a doctor in the Ming Dynasty, clearly stated that "kidney is the foundation of innateness". From the perspective of the viscera system, the genetic material must be kidney essence.
  • the function of the kidney is to determine the human body.
  • the root of the strength of innate endowment is that AD patients have insufficient kidney essence, biased endowment, and obvious genetic tendencies.
  • CN110025705A discloses a traditional Chinese medicine composition for treating atopic dermatitis.
  • the formula of the traditional Chinese medicine composition is 70-90 parts by weight of Atractylodes rhizome, 70-90 parts by weight of tangerine peel, 70-90 parts by weight of Magnolia officinalis, and 110-125 parts by weight of Angelica dahurica.
  • 110-125 parts by weight of Poria cocos 110-125 parts by weight of Poria bark, 70-90 parts by weight of raw Pinellia ternata, 5-15 parts by weight of licorice extract, 0.5-1.2 parts by volume of patchouli oil and 0.2 parts by volume of perilla leaf oil. -0.6 parts by volume.
  • CN108853272A discloses an external ointment for treating atopic dermatitis, which is composed of the following parts by weight: 60-80 parts of Lithospermum charcoal, 70-90 parts of Cortex Phellodendron, 300-400 parts of winter melon seed oil, 20-30 parts of safflower, Made of 30-50 parts of Purple Flower Dips and 60-80 parts of beeswax; it has the effects of clearing away heat and detoxifying, reducing swelling and relieving itching, moistening dryness and promoting muscle growth.
  • the above-mentioned drugs only focus on the symptoms of the disease and do not pay attention to the cause, pathogenesis and syndrome differentiation treatment of the disease.
  • the inventor has explored and studied the etiology and pathogenesis of this disease through many years of clinical experience, combined with the genetic perspective of traditional Chinese medicine, the physiology of the five internal organs of children and other characteristics, and proposed that insufficient kidney water and excessive heart fire are the core pathogenesis of atopic dermatitis.
  • the methods of nourishing kidney water, clearing heart fire, and regulating gastrointestinal function have achieved good clinical results in the treatment of atopic dermatitis.
  • the object of the present invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for treating skin diseases, especially for the pathogenesis of atopic dermatitis, so as to "nourish the congenital deficiency of kidney water, clear the heart fire, and guide the accumulation of spleen and stomach.”
  • “Stagnation” is the core treatment principle. It provides a traditional Chinese medicine composition for the treatment of eczema, dermatitis, especially atopic dermatitis. It can quickly reduce skin lesions and relieve itching. It can significantly reduce the number of glucocorticoid ointments and avoid long-term external use. Side effects caused by corticosteroid creams.
  • the invention provides a traditional Chinese medicine composition for treating skin diseases, which is made of the following traditional Chinese medicines in parts by weight:
  • the monarch medicine consists of the following medicines: 10-30 parts of raw rehmannia root, 5-25 parts of gardenia;
  • the ministerial drug is composed of the following drugs A or B: A is: 5-20 parts of Scrophulariaceae, 5-15 parts of bamboo leaves; B is: 5-20 parts of Scrophulariaceae, 5-15 parts of bamboo leaves, and selected from the group consisting of: 5-15 parts of chicken gizzard, 5-10 parts of betel nut, one or two kinds.
  • the adjuvant medicine consists of the following drugs C or D: C is: 5-20 parts of Uncaria, 10-30 parts of Imperata rhizome, and 5-15 parts of Hawthorn; D is: 5-20 parts of Uncaria, 10-30 parts of Imperata rhizome. 30 parts, 5-15 parts of hawthorn, and selected from 5-15 parts of honeysuckle, 5-15 parts of malt, 5-15 parts of bone bark, 1-5 parts of rush, 5-30 parts of purslane, 5-15 parts One or more parts of Forsythia suspensa, 5-30 parts of oysters, 5-15 parts of tangerine peel or 5-15 parts of Poria cocos.
  • the traditional Chinese medicine composition is preferably made from the following parts by weight of traditional Chinese medicine:
  • the monarch medicine consists of the following medicines: 10-30 parts of Rehmannia glutinosa, more preferably 15, 20, 25 parts, 5-25 parts of Gardenia, more preferably 10, 15, 20 parts;
  • the ministerial drug is composed of the following drug A: wherein A is: 5-20 parts of Scrophulariaceae, more preferably 10, 15, 20 parts, 5-15 parts of Pale Bamboo Leaf, more preferably 5, 10, 15 parts;
  • the adjuvant medicine is composed of the following medicine C: wherein C is: 5-20 parts of Uncaria rhynchophora, more preferably 10, 15, 20 parts, 10-30 parts of Imperata rhizome, more preferably 10, 15, 20, 25 parts, 5-25 parts of Hawthorn 15 parts, more preferably 10 or 15 parts.
  • the traditional Chinese medicine composition of the present invention is preferably made from the following parts by weight of traditional Chinese medicine:
  • the monarch medicine consists of the following medicines: 10-30 parts of raw rehmannia root, 5-25 parts of gardenia;
  • the ministerial medicine is composed of the following medicine A: wherein A is: 5-20 parts of Scrophulariaceae, 5-15 parts of Phyllostachys sibiricum;
  • the adjuvant medicine is composed of the following medicine D: wherein D is: 5-20 parts of Uncaria rhynchophora, 10-30 parts of Imperata rhizome, 5-15 parts of hawthorn, 5-15 parts of tangerine peel and 5-15 parts of Poria. Among them, 10 and 15 parts of tangerine peel are more preferred, and 10 and 15 parts of Poria are more preferred.
  • the monarch medicine consists of the following medicines: 10-30 parts of raw rehmannia root, 5-25 parts of gardenia;
  • the ministerial medicine is composed of the following medicine B: wherein B is: 5-20 parts of Scrophulariaceae, 5-15 parts of bamboo Leaf, 5-15 parts of Gallus gallus gallus L. and 5-10 parts of Betel nut;
  • the adjuvant medicine is composed of the following drugs D: where D is: 5-20 parts of Uncaria rhynchophora, 10-30 parts of Imperata rhizome, 5-15 parts of hawthorn, 5-15 parts of honeysuckle, 5-15 parts of Diguchi bark, and 1 part of rush. -5 parts, purslane 5-30 parts, oysters 5-30 parts.
  • the monarch medicine consists of the following medicines: 10-30 parts of raw rehmannia root, 5-25 parts of gardenia;
  • the ministerial medicine is composed of the following medicine B: wherein B is: 5-20 parts of Scrophulariaceae, 5-15 parts of bamboo Leaf, 5-15 parts of Gallus gallus gallus L. and 5-10 parts of Betel nut;
  • the adjuvant medicine is composed of the following medicine D: wherein D is: 5-20 parts of Uncaria striata, 10-30 parts of Imperata cognac, 5-15 parts of hawthorn, 5-15 parts of honeysuckle, 5-15 parts of malt, and 5-15 parts of Digupi. 15 parts, rush 1-5 parts, purslane 5-30 parts, forsythia 5-15 parts, oyster 5-30 parts.
  • the monarch medicine consists of the following medicines: 10-30 parts of raw rehmannia root, 5-25 parts of gardenia;
  • the ministerial medicine is composed of the following medicine B: wherein B is: 5-20 parts of Scrophulariaceae, 5-15 parts of bamboo Leaf, 5-15 parts of Gallus gallus gallus L. and 5-10 parts of Betel nut;
  • the adjuvant medicine is composed of the following medicine D: wherein D is: 5-20 parts of Uncaria striata, 10-30 parts of Imperata cognac, 5-15 parts of hawthorn, 5-15 parts of honeysuckle, 5-15 parts of malt, and 5-15 parts of Digupi. 15 parts, 1-5 parts of rush, 5-30 parts of purslane, 5-15 parts of forsythia, 5-30 parts of oyster, 5-15 parts of tangerine peel and 5-15 parts of Poria.
  • D is: 5-20 parts of Uncaria striata, 10-30 parts of Imperata cognac, 5-15 parts of hawthorn, 5-15 parts of honeysuckle, 5-15 parts of malt, and 5-15 parts of Digupi. 15 parts, 1-5 parts of rush, 5-30 parts of purslane, 5-15 parts of forsythia, 5-30 parts of oyster, 5-15 parts of tangerine peel and 5-15 parts of Poria.
  • the above-mentioned traditional Chinese medicine composition of the present invention also includes 5-15 parts of licorice.
  • the traditional Chinese medicine composition of the present invention is selected from the group consisting of decoction, granule, tablet, capsule, oral liquid, pill and ointment.
  • the present invention also provides a preparation method of the above-mentioned traditional Chinese medicine composition, which is prepared by adding water or alcohol solution to each traditional Chinese medicine and extracting it.
  • the alcohol is one of methanol, ethanol, propanol or butanol, preferably ethanol.
  • the present invention also provides the use of traditional Chinese medicine compositions in preparing medicines for skin diseases, such as eczema, dermatitis, atopic dermatitis, allergic dermatitis, drug eruption or urticaria. Eczema or atopic dermatitis is preferred.
  • the inventor discovered through long-term clinical practice of traditional Chinese medicine that the disease is caused by congenital deficiency of kidney essence, resulting in endowment intolerance.
  • the fetus may have residual fever.
  • Children have a pure yang body.
  • the heart is often surplus, the spleen is often deficient, the liver is often surplus, and the lungs are often deficient. Therefore, there is heat in the five zangs, especially heart heat.
  • the treatment is to nourish the congenital kidney water deficiency, clear the heart fire, and lead to the stagnation of the spleen and stomach.
  • Rehmannia glutinosa and Gardenia are used as monarch medicines to nourish kidney water, nourish yin and cool blood, clear away heart fire, and clear triple burner; Scrophulariaceae and Fragrant bamboo leaves are used as ministerial medicines, which can clear away heat and nourish yin and cool blood, clear away heart fire, nourish yin and facilitate urination; use hawthorn.
  • Uncaria, and Imperata cognac roots are used as adjuvants, which can clear away heat, remove accumulation, guide stagnation in the intestines and stomach, clear away heat, relieve wind, cool blood, and relieve itching.
  • the traditional Chinese medicine composition of the present invention can significantly improve recurrent erythema, edema, papules, and blisters on the face, neck, antecubital fossa, popliteal fossa, trunk, etc., and some skin lesions are eroded and exuded, and some skin lesions are rough or mossy. changes, itching is obvious, etc. At the same time, symptoms such as irritability, dry mouth, poor sleep, restless sleep, and dry stools can be reduced.
  • the traditional Chinese medicine composition of the present invention has the effect of quickly reducing skin lesions and relieving itching, can significantly reduce the dosage of glucocorticoid ointment, and avoid side effects caused by long-term external use of glucocorticoid ointment.
  • the drug has a good safety profile.
  • Rehmannia glutinosa 15g Gardenia 15g, Scrophulariaceae 15g, bamboo leaves 10g, Uncaria 10g, Imperata root 15g, Hawthorn 15g.
  • a prospective, randomized, single-blind, controlled research design was adopted to conduct a standardized clinical study on patients with atopic dermatitis (four-curved wind) with water deficiency, heart, and fire syndrome to verify the efficacy of the optimized TCM treatment plan for atopic dermatitis.
  • Main symptoms Recurrent erythema, edema, papules, and blisters on the face, neck, antecubital fossa, popliteal fossa, or trunk, etc., some skin lesions are eroded and exuded, some skin lesions are rough or lichenified, and itching is obvious, etc. .
  • the diagnosis can be made if the main symptom + the above two secondary symptoms are present.
  • Treatment grouping Divide subjects into treatment groups and control groups.
  • Randomization scheme The computer randomly generates a random number, and the researcher receives the medicine according to the random number in the order in which the subjects are enrolled. After checking the prescription and registering it, the drug distributor will distribute the corresponding drugs and emphasize the precautions for medication use, and the subject will sign to receive the medicine.
  • Sample size This study is an exploratory study. Based on clinical experience and considering the clinical dropout rate of 20%, the total number of cases in the trial is 66 (30 cases in the treatment group and 30 cases in the control group).
  • Oral medicine Take the medicine of Example 2 orally, half an hour after meals, once in the morning and once in the evening.
  • Topical drugs Give Elosone cream (Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval No. H19991418) for external use, and apply a thin layer to the affected skin to cover evenly. For the first 2 weeks, apply Elosone cream once a day for topical use. After 2 weeks, gradually reduce the frequency and quantity of use according to the condition of the skin lesions. For external use, avoid facial and body folds.
  • Control group Ailosone cream (Bayer Pharmaceuticals (Shanghai) Co., Ltd., National Drug Approval No. H19991418) was given for external use, and the skin of the affected area was evenly covered with a thin layer. In the first 2 weeks, Elosone Cream is used once a day. After 2 weeks, the frequency and quantity of use are gradually reduced according to the condition of the skin lesions. For external use, avoid facial and body folds.
  • Duration of treatment 4 weeks. Patients were reviewed every 1 week to record the degree of improvement. Provide health education to children and their families. They are advised to avoid spicy and cold foods, avoid scalding the affected area with hot water, and use regular external emollients.
  • the SCORAD score proposed by the European Atopic Dermatitis Study Group is currently the most widely used disease severity scale in clinical research and practice. It mainly includes the scope of skin lesions (A), the severity of skin lesions (B) and the patient's subjective symptoms. (C). The details are as follows (see Table 1 for details):
  • the front of the human body 4.5% of the head, 18% of the trunk, 4.5% of the upper limbs (unilateral), 9% of the lower limbs (unilateral); the calculation method for the back of the human body is the same as the front; in addition, the vulva is 1 %, the total score is 100 points.
  • Severity of skin lesions Divide the severity of skin lesions into four levels: none, mild, moderate, and severe, and use four scores from 0 to 3 for evaluation. Mainly by evaluating the skin lesions for erythema, papules/edema, crusting, lichenification/hypertrophy, exfoliation, and dry skin in non-lesional areas.
  • Subjective symptoms Evaluate the average level of itching in the past 3 days and the average level of sleep impact in the past 3 nights based on the patient's actual situation, and use a visual analog scale (see Appendix 1 for details) for scoring.
  • the scoring criteria are as follows: 0 means no obvious itching; ⁇ 3 means there is itching, but it is tolerable and will not affect sleep; 4-6 means there is moderate itching, which is still tolerable but will affect sleep; 7-10 points indicate severe itching, which is intolerable to the patient and difficult to sleep.
  • the patients After the treatment, the patients returned the distributed Elosone, and the researchers recorded the weight of the patients' remaining medication.
  • Concomitant medication If combined with other medications, it must be recorded in time. If it has an impact on the test, it will be eliminated.
  • the facility has a system for counting the remaining prescription drugs. After the trial, the researcher is responsible for counting the number of remaining prescription drugs for the subjects under their responsibility to supervise the subjects' medication compliance.
  • Safety indicators include: vital signs (body temperature, heart rate, respiration, blood pressure), blood, urine, and stool routine, electrocardiogram, liver function [alanine aminotransferase (ALT), aspartate aminotransferase (AST)], kidney function [ Burea nitrogen (BUN), serum creatinine (Cr)], and other possible adverse reactions
  • Total effective rate [(number of recovered cases + number of markedly effective cases + number of effective cases)/total number of cases] ⁇ 100%.
  • Statistical analysis will be performed using SPSS 22.0 statistical analysis software. All statistical tests were two-sided, and a P value less than or equal to 0.05 was considered statistically significant. Count data were expressed using the chi-square test, measurement data were expressed as mean ⁇ standard deviation (x ⁇ s), intra-group comparisons were made using paired samples t-test, and inter-group comparisons were made using independent samples t-test; clinical efficacy comparisons were made using rank sum test of hierarchical data. ; Correlation analysis uses Pearson correlation test for comparison.
  • Case data were collected from patients in the Dermatology Clinic of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University. After the patient case report form (CRF) is completed, the data will be entered and checked twice by two different entry personnel. A total of 65 patients were enrolled, 5 patients dropped out due to being unable to come to the hospital due to the epidemic, and 60 cases were finally included in the statistics. Among them, there were 30 cases in the treatment group and 30 cases in the control group.
  • CRF patient case report form
  • Baseline data Among the 60 patients, there were 34 males and 26 females, with an average age of 8.31 ⁇ 4.80 years and an average disease duration of 64.50 ⁇ 61.31 months.
  • the chi-square test was performed on the gender of the treatment group and the control group before treatment, and the independent sample t test was performed on the patient's age and disease course, which showed that there was no significant difference between the two groups.
  • the total effective rate of the treatment group was 93.33%, and that of the control group was 83.33%. There was no statistically significant difference in the effective rate between the two groups after treatment (P>0.05). The effective rate in the treatment group was 80.00%, and the effective rate in the control group was 43.33%. The difference in effective rate after treatment between the two groups was statistically significant (P ⁇ 0.05). See Table 3.
  • the traditional Chinese medicine composition of the present invention has the effect of quickly reducing skin lesions and relieving itching, and can significantly reduce the dosage of glucocorticoid ointment (first-line medication for atopic dermatitis), and avoid long-term external use of glucocorticoid ointment. and cause side effects. At the same time, it has good security.
  • glucocorticoid ointment first-line medication for atopic dermatitis
  • eczema in children or adolescents on the market. This project study confirmed the significant efficacy of the traditional Chinese medicine composition of the present invention in treating atopic dermatitis.
  • Rehmannia glutinosa 15g Gardenia 15g, Scrophulariaceae 15g, bamboo leaves 10g, Uncaria 10g, Imperata root 15g, Hawthorn 15g.
  • Main symptoms Recurrent erythema, edema, papules, and blisters on the face, neck, antecubital fossa, popliteal fossa, or trunk, etc., some skin lesions are eroded and exuded, some skin lesions are rough or lichenified, and itching is obvious, etc. .
  • the total effective rate in the treatment group was 87.5%, with 1 case cured, 4 cases markedly effective, 2 cases effective, and 1 case ineffective.
  • Main symptoms Recurrent erythema, edema, papules, and blisters on the face, neck, antecubital fossa, popliteal fossa, or trunk, etc., some skin lesions are eroded and exuded, some skin lesions are rough or lichenified, and itching is obvious, etc. .
  • the total effective rate in the treatment group was 87.5%, with 1 case cured, 4 cases markedly effective, 2 cases effective, and 1 case ineffective.
  • Main symptoms Recurrent erythema, edema, papules, and blisters on the face, neck, antecubital fossa, popliteal fossa, or trunk, etc. Some skin lesions are obviously eroded and exuded, some skin lesions are rough or lichenified, and itching is severe. wait.
  • the total effective rate in the treatment group was 83.33%, with 1 case cured, 3 cases markedly effective, 2 cases effective, and 1 case ineffective.
  • the score before treatment was 8.43 ⁇ 3.67, and the score after treatment was 2.11 ⁇ 5.98. Comparing the itching scores before and after treatment, the t test showed that the itching scores decreased after treatment, and the difference was statistically significant (P ⁇ 0.001).
  • Main symptoms Recurrent erythema, edema, papules, and blisters on the face, neck, antecubital fossa, popliteal fossa, or trunk, etc. Some skin lesions are obviously eroded and exuded, some skin lesions are rough or lichenified, and itching is severe. wait.
  • the total effective rate in the treatment group was 90.00%, 2 cases were cured, 7 cases were markedly effective, 1 case was effective, and 0 cases were ineffective.

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Abstract

一种治疗皮肤病的中药组合物，其君药由下述药物组成：生地10-30 份、栀子5-25份；臣药由下述药物A或B组成：其A为：玄参5-20份、淡竹叶5-15 份，其B为：玄参5-20份、淡竹叶5-15 份以及选自5-15份鸡内金、5-10份槟榔中的一种或两种；佐药由下述药物C或D组成：其C为：钩藤5-20份、白茅根10-30份、山楂5-15 份，其D为：钩藤5-20份、白茅根10-30份、山楂5-15份以及选自5-15份金银花、5-15份麦芽、5-15份地骨皮、1-5份灯芯草、5-30份马齿苋、5-15份连翘、5-30份牡蛎、5-15份陈皮或5-15份茯苓中的一种或多种。该中药组合物能有效治疗特应性皮炎、湿疹、过敏性皮炎、药疹、荨麻疹等皮肤病。

Description

一种治疗皮肤病的中药组合物及其制备方法 技术领域
本发明涉及一种中药,尤其涉及的是一种治疗皮肤病的中药组合物及其制备方法。
背景技术
现代医家对特应性皮炎研究较多，但大多主要从心、脾论治。如赵炳南老专家认为特应性皮炎多因禀赋不耐，脾失健运，湿热内生，感受风湿热邪，郁于肌腠而发病；由于反复发作，缠绵不已，致使脾虚血燥，肌肤失养。治疗多从湿论治，或健脾利湿或健脾润燥；张志礼教授在治疗中重视脾胃的作用，治疗多采用健脾消导、清热利湿或健脾除湿、养血润肤为法；陈达灿教授认为心火脾虚是本病的主导病机，脾虚贯穿整个病程，临床采用培土清心(健脾清心)为法治疗；黄尧洲教授认为邪火扰心是疾病的主要病机，主张重用重镇安神的药物治疗本病。
目前研究已证实特应性皮炎是一种具有遗传倾向的皮肤疾病，遗传家族史与本病发病有密切关系，若父母患有特应性疾病(过敏性鼻炎、哮喘等病)或为过敏性体质，则会大大增加其子女患特应性皮炎的风险。中医学中的先天禀赋这一概念即可概括现代医学研究中个体与生俱来的遗传因素及其他各种先天因素的总体影响。禀赋来源于先天之精，禀受于父母，而肾为藏精之处，明代医家李中梓明确提出”肾为先天之本“，遗传物质从脏腑系统论当属肾精，肾的功能是决定人体先天禀赋强弱的根本，故AD患者肾精不足，禀赋偏颇，有明显的遗传倾向。许多医家着眼于AD发病遗传背景，已总结出先天禀赋不足是发病的根本原因，却未重视先天禀赋与先天之本肾脏之间的关联，没有从肾精不足论治本病，这是十分遗憾的。
CN110025705A公开了一种治疗特应性皮炎的中药组合物，所述中药组合物的配方为苍术70-90重量份、陈皮70-90重量份、厚朴70-90重量份、白芷110-125重量份、茯苓110-125重量份、大腹皮110-125重量份、生半夏70-90重量份、甘草浸膏5-15重量份、广藿香油0.5-1.2体积份和紫苏叶油0.2-0.6体积份。该药物内服起到湿滞得消、气机通畅，外用够起到止痒、消红肿、滋润患处的功效。CN108853272A公开了一种治疗特应性皮炎的外用药膏，由以下重量份数计的：紫草炭60-80份、黄柏70-90份、冬瓜子油300-400份、红花20-30份、紫花地丁30-50份和蜂蜡60-80份制成；具有清热解毒，消肿止痒，润燥生 肌之功效。但上述药物仅是关注了该病的症状，并未关注疾病的病因病机以及辨证治疗。
发明人通过多年临证经验，结合中医遗传学观点、小儿五脏生理等特点对本病的病因病机进行探索和研究，提出肾水不足、心火亢盛是特应性皮炎的核心病机，采用滋肾水、清心火、理肠胃的方法治疗特应性皮炎取得良好临床效果。
发明内容
本发明目的在于克服现有技术的不足，提供一种治疗皮肤病的中药组合物，尤其是针对特应性皮炎的病机，以“滋先天之肾水不足，清心火之有余，导脾胃之积滞”为核心治则，提供一种治疗湿疹、皮炎尤其是特应性皮炎的中药组合物，快速减轻皮损、缓解瘙痒的作用，可明显减少糖皮质激素药膏的用药数量，避免因长期外用糖皮质激素药膏而引起的副作用。
本发明是通过以下技术方案实现的：
本发明提供一种治疗皮肤病的中药组合物，其由下列重量份中药制成：
君药由下述药物组成：生地10-30份，栀子5-25份；
臣药由下述药物A或B组成：其中A为：玄参5-20份，淡竹叶5-15份；其中B为：玄参5-20份，淡竹叶5-15份，以及选自5-15份鸡内金、5-10份槟榔中的一种或两种。
佐药由下述药物C或D组成：其中C为：钩藤5-20份，白茅根10-30份，山楂5-15份；其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，以及选自5-15份金银花、5-15份麦芽、5-15份地骨皮、1-5份灯芯草、5-30份马齿苋、5-15份连翘、5-30份牡蛎、5-15份陈皮或5-15份茯苓中的一种或多种。
或者所述中药组合物优选，其由下列重量份中药制成：
君药由下述药物组成：生地10-30份，更优选15、20、25份，栀子5-25份，更优选10、15、20份；
臣药由下述药物A组成：其中A为：玄参5-20份，更优选10、15、20份，淡竹叶5-15份，更优选5、10、15份；
佐药由下述药物C组成：其中C为：钩藤5-20份，更优选10、15、20份，白茅根10-30份，更优选10、15、20、25份，山楂5-15份，更优选10、15份。
或者本发明所述中药组合物优选，其由下列重量份中药制成：
君药由下述药物组成：生地10-30份，栀子5-25份；
臣药由下述药物A组成：其中A为：玄参5-20份，淡竹叶5-15份；
佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，陈皮5-15份和茯苓5-15份。其中陈皮更优选10、15份，茯苓更优选10、15份
或者本发明所述的中药组合物，其由下列重量份中药制成：
君药由下述药物组成：生地10-30份，栀子5-25份；
臣药由下述药物B组成：其中B为：玄参5-20份，淡竹叶5-15份，鸡内金5-15份和槟榔5-10份；
佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，金银花5-15份，地骨皮5-15份，灯芯草1-5份，马齿苋5-30份，牡蛎5-30份。
或者本发明所述的中药组合物，其由下列重量份中药制成：
君药由下述药物组成：生地10-30份，栀子5-25份；
臣药由下述药物B组成：其中B为：玄参5-20份，淡竹叶5-15份，鸡内金5-15份和槟榔5-10份；
佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，金银花5-15份，麦芽5-15份，地骨皮5-15份，灯芯草1-5份，马齿苋5-30份，连翘5-15份，牡蛎5-30份。
或者本发明所述的中药组合物，其由下列重量份中药制成：
君药由下述药物组成：生地10-30份，栀子5-25份；
臣药由下述药物B组成：其中B为：玄参5-20份，淡竹叶5-15份，鸡内金5-15份和槟榔5-10份；
佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，金银花5-15份，麦芽5-15份，地骨皮5-15份，灯芯草1-5份，马齿苋5-30份，连翘5-15份，牡蛎5-30份，陈皮5-15份和茯苓5-15份。
同时本发明上述中药组合物还包括5-15份的甘草。
本发明中药组合物选自汤剂、颗粒剂、片剂、胶囊剂、口服液、丸剂、膏剂中的一种。
本发明还提供上述中药组合物的制备方法，将各中药加水或醇溶液提取制得。
所述醇为甲醇、乙醇、丙醇或丁醇中的一种，优选乙醇。
本发明还提供中药组合物在制备皮肤病药物中的用途，所述皮肤病为湿疹、皮炎、特应性皮炎、过敏性皮炎、药疹或荨麻疹。优选湿疹、或特应性皮炎。
对于湿疹、特应性皮炎，发明人在长期的中医临床实践发现，该病为先天肾精不足，而致禀赋不耐。又因妈妈妊娠期间或母乳期间，饮食不当，过失肥甘厚味或滋补之品，导致胎有遗热。小儿为纯阳之体，心常有余，脾常不足，肝常有余，肺常不足。故五藏有热，尤以心热为甚，加之饮食不节，过食油炸、肥甘厚味，而致脾土壅滞，胃肠积滞，聚湿化热，加重心之热邪，脾之湿邪。心火移入小肠，肾主二阴，热移于肾，燔灼肾水，加重肾阴不足，肾水不能上滋心火，故见红斑，瘙痒，心烦，眠差，大便干，舌红。湿热外发肌肤，故见糜烂、渗出。饮食不当，胃肠积滞，湿热内生，故见苔白或白厚，脉滑。故治疗以滋先天之肾水不足，清心火之有余，导脾胃之积滞。
辨证：肾阴不足，心火炽盛，肠胃积滞
治法：滋肾水，清心火，理肠胃
具体地本发明，以生地、栀子为君药，滋肾水、滋阴凉血，清心火、清三焦；以玄参、淡竹叶为臣药，清热滋阴凉血，清心火滋阴利小便；以山楂、钩藤、白茅根为佐药，清热消积导滞理肠胃，清热息风凉血止痒。
对于肠胃积滞盛者，进一步加入炒鸡内金消积运脾、焦槟榔行气导滞，作为臣药，玄参、淡竹叶相互配伍。脾胃虚弱者，进一步加入佐药陈皮、茯苓或焦麦芽；热毒盛者，加入金银花、马齿苋、连翘，虚热者加入地骨皮，心烦者，加灯芯草、牡蛎。并根据情况加入使药甘草。
本发明中药组合物能显著改善面部、颈部、肘窝、腘窝或躯干部等部位反复发作的红斑、水肿，或丘疱疹、水疱，部分皮损糜烂渗出，部分皮损粗糙或呈苔藓化，瘙痒明显等。同时减少心烦，口干，眠差，睡卧不安，大便干的病症。
因而，本发明中药组合物具有快速减轻皮损、缓解瘙痒的作用，可明显减少糖皮质激素药膏的用药数量，避免因长期外用糖皮质激素药膏而引起的副作用。同时，药物具有良好的安全性。目前，市场上缺乏儿童或青少年口服治疗特应性皮炎或湿疹的药物，本项目研究证实本发明中药组合物在治疗特应性皮炎方面的 显著疗效
具体实施方式
下面对本发明的实施例作详细说明，以下实施例在以本发明技术方案为前提下进行实施，给出了详细的实施方式和具体的操作过程，但本发明的保护范围不限于下述的实施例。
实施例1：
生地15g，栀子15g，玄参15g，淡竹叶10g，钩藤10g，白茅根15g，山楂15g。
(1)将各原料药粉碎，然后加水煎煮两次，第一次加原料药总重量的10倍量水，武火煎煮沸腾10分钟，再用文火煎煮20分钟，过滤，得第一次煎煮液和药渣；
(2)药渣加原料药总重量的12倍量水，武火煎煮至沸腾，再用文火煎煮20分钟，过滤，得第二次煎煮液；
(3)合并两次煎煮液，浓缩即得汤剂。
实施例2：
生地15g，栀子6g，玄参15g，淡竹叶6g，钩藤10g，白茅根15g，炒山楂6g，陈皮10g，茯苓10g。
将各原料药粉碎成40目颗粒，加10倍量水浸泡半小时后，加热煎煮1小时，过滤，收集滤液，药渣再加入12倍量的水提取1小时，过滤，收集滤液，将第一次和第二次的滤液合并浓缩，加入蔗糖制成口服液。
实施例3：
生地20g，栀子10g，玄参15g，淡竹叶10g，鸡内金10g，槟榔5g，钩藤10g，白茅根15g，山楂15g，金银花10g，地骨皮10g，灯芯草3g，马齿苋10g，牡蛎10g。
(1)将各原料药粉碎，然后加水煎煮三次，第一次加原料药总重量的10倍量水，武火煎煮沸腾10分钟，再用文火煎煮20分钟，过滤，得第一次煎煮液和药渣；
(2)药渣加原料药总重量的10倍量水，武火煎煮至沸腾，再用文火煎煮20分钟，过滤，得第二次煎煮液；
(3)药渣加原料药总重量的8倍量水，武火煎煮至沸腾，再用文火煎煮20分钟，过滤，得第二次煎煮液；
(4)合并三次煎煮液，浓缩即得汤剂。
实施例4：
生地20g，栀子10g，玄参10g，淡竹叶8g，鸡内金10g，槟榔5g，钩藤10g，白茅根15g，山楂10g，金银花10g，麦芽5g，地骨皮10g，灯芯草3g，马齿苋15g，连翘10g，牡蛎15g。
除牡蛎外，将各原料药粉碎成40目颗粒，加10倍量的60％乙醇加热回流提取1.5小时，过滤，收集滤液，药渣再加入10倍量的70％乙醇加热回流提取1小时，过滤，收集滤液，将第一次和第二次的滤液合并浓缩，干燥后粉碎，加入糊精制成颗粒。
实施例5：
生地15g，栀子8g，玄参10g，淡竹叶8g，鸡内金10g，槟榔5g，钩藤10g，白茅根15g，山楂8g，金银花10g，麦芽5g，地骨皮10g，灯芯草3g，马齿苋30g，连翘10g，牡蛎30g，陈皮10g，茯苓10份。
除牡蛎外，将各原料药粉碎成40目颗粒，加8倍量的65％乙醇加热回流提取2小时，过滤，收集滤液，药渣再加入10倍量的775％乙醇加热回流提取1小时，过滤，收集滤液，将第一次和第二次的滤液合并浓缩，干燥后粉碎，加入糊精制成颗粒。
临床研究
(一)研究方案
1.研究方法
采用前瞻性、随机、单盲、对照的研究设计，对特应性皮炎(四弯风)水亏心火证患者，进行规范化临床研究特应性皮炎中医治疗优化方案的疗效验证。
2.设计方案
(1)研究对象
本研究选取首都医科大学附属北京中医医院皮肤科和北京市怀柔区中医医院皮肤科门诊特应性皮炎(四弯风)水亏心火证患者作为研究对象。
(2)诊断标准
1)西医诊断标准：参照《中国特应性皮炎诊疗指南2020版》《中国临床皮肤病学》中特应性皮炎临床诊断标准。
2)中医诊断标准：参考《精诚大医张志礼》《特应性皮炎中医诊疗方案专家共识》(中国中西医结合皮肤性病学杂志，2013年)、《中医病症诊断疗效标准》(国家中医药行业标准)拟定：
水亏心火证：
主症：面部、颈部、肘窝、腘窝或躯干部等部位反复发作的红斑、水肿，或丘疱疹、水疱，部分皮损糜烂渗出，部分皮损粗糙或呈苔藓化，瘙痒明显等。
次症：心烦，口干，眠差，睡卧不安，大便干，舌红或舌尖红或有芒刺，苔腻，脉偏数。
主症+以上两项次症者，即可诊断。
4)纳入标准
①符合上述西医特应性皮炎临床诊断标准；
②符合水亏心火证的辨证标准；
③年龄在2岁至18岁，性别不限；
④依从性较好，能够配合采集临床资料；
⑤近2周内未系统应用过激素、抗组胺药物或免疫抑制剂等药物治疗；
⑥本人或获得监护人许可，签署知情同意书(由监护人代签)，志愿受试，知情同意过程符合GCP的规定。
同时符合上述条件者，符合纳入标准，纳入本研究。
4)排除标准
①近2周内系统应用过激素、抗组胺药物或免疫抑制剂等药物治疗者；
②合并其他任何可能干扰试验结果评价的皮肤疾病者；
③合并有心脑血管、肝、肾和造血系统等严重原发性疾病及自身免疫性疾病、皮肤瘤疾病者，患有精神病者；
④合并较为严重的皮肤感染或全身感染的患者；
⑤对研究药物任一成分有过敏史的患者；
⑥不能接受中药汤药治疗的患者；
⑦正在参加其他药物临床试验的患者。
符合上述任何一项者，即符合排除标准，对患者予以排除，不纳入本研究。
5)剔除标准
①不符合纳入标准而被误纳入者；
②治疗过程中使用其他药物或治疗方案治疗，影响疗效判定者。
6)脱落标准
①进入试验治疗，但最终未坚持完成临床观察者；
②治疗期间未定期复诊，随访时因各种原因失访者；
③在治疗过程中不愿意继续进行临床试验者。
7)全面中止标准
①在临床试验过程中发生严重不良反应、过敏反应者；
②在研究过程中，若发现所用药物对症状改善不仅无效，反而进一步加重病情；或试验设计方案存在重大失误；或在实施过程中产生的偏差较大，无法评价药物疗效时；
③研究者从医学角度考虑受试验者有必要终止者。
(3)临床研究方案
1)治疗分组：将受试者分为治疗组与对照组。
2)随机方案：计算机随机产生随机号，研究者按受试者入组的顺序根据随机号领取药品。发药人员核对处方并登记后，发放相应药物，并强调用药注意事项，受试者签字领药。
3)抽样方法：将入选病例以1:1比例随机分配到试验组和对照组。
4)样本大小：本研究为探索性研究，根据临床经验，考虑到临床脱失率为20％，试验总例数为66例(治疗组30例，对照组30例)。
5)治疗方法
治疗组：
内服药物：口服实施例2药物，饭后半小时口服，早晚各一次。
外用药物：给予艾洛松乳膏(拜耳医药(上海)有限公司，国药准字H19991418)外用，患处皮肤外涂薄层均匀覆盖。前2周外用艾洛松乳膏每日1次，2周后根据皮损情况逐渐减少使用次数和数量。药物外用避开面部和身体皱褶部位。
对照组：给予艾洛松乳膏(拜耳医药(上海)有限公司，国药准字H19991418)外用，患处皮肤外涂薄层均匀覆盖。前2周艾洛松乳膏每日1次，2周后根据皮损情况逐渐减少使用次数和数量。药物外用避开面部和身体皱褶部位。
疗程：4周。每1周患者复诊记录病情改善程度。对患儿及家属进行健康宣教，嘱忌辛辣刺激性和生冷性饮食，避免热水烫洗患处，常规外用润肤剂。
6)盲法：
取药：患者家属按照随机号在临床研究药物窗口领取药品，由专人发放药物并登记。
7)疗效评价
①主要疗效指标——SCORAD评分
欧洲特应性皮炎研究组所提出的SCORAD评分是目前临床研究和实践中应用最广泛的疾病严重程度量表，主要包括皮损范围(A)、皮损严重程度(B)及患者的主观症状(C)。具体如下(详见表1)：
A.计算皮损范围：人体前面：头部4.5％，躯干部18％，上肢(单侧)4.5％，下肢(单侧)9％；人体后面计算方法与前面相同；另外,外阴部为1％，总分共计100分。
B.皮损严重程度：将皮损严重程度分为无、轻度、中度、重度四个等级，运用0-3的四个分值进行估分。主要通过评估皮损处的红斑、丘疹/水肿、结痂、苔藓样变/肥厚、表皮剥脱以及非皮损处的皮肤干燥情况。
C.主观症状(瘙痒及睡眠影响程度)：结合患者实际情况进行评估过去3天瘙痒的平均水平和评估过去3晚影响睡眠的平均程度，采用视觉模拟标尺(详见附录1)进行评分。评分标准具体如下：0分为无明显瘙痒；﹤3分为有瘙痒感，但是可以忍受，且不会影响睡眠；4-6分为存在中度瘙痒感，仍可以忍受，但会影响睡眠；7-10分为瘙痒感重，患者不可以忍受，难以入睡。
SCORAD评分的计算公式：A/5+7B/2+C。
表1 SCORAD评分评估量表
Figure PCTCN2022124230-appb-000001
Figure PCTCN2022124230-appb-000002
②次要疗效指标
A评价艾洛松使用数量
治疗结束后，患者将发放的艾洛松交回，由研究人员记录患者剩余药物的重量。
③研究评价指标
合并用药：如合并其他用药需及时记录，如对试验有影响，则予以剔除。
依从性：临床试验过程中设施剩余处方药物清点制度，试验结束后由研究者负责清点所负责的受试者剩余处方药物数量，以监督受试者的用药依从性。
④安全性指标安全性指标包括：生命体征(体温、心率、呼吸、血压)，血、尿、便常规，心电图，肝功能[谷丙转氨酶(ALT)、谷草转氨酶(AST)]、肾功能[尿素氮(BUN)、血肌酐(Cr)]，以及其它可能出现的其他不良反应
(4)疗效评价标准
依据《中药新药临床研究指导原则》(中国医药科技出版社：2002，5.)拟定。
计算公式(尼莫地平法)为：疗效指数＝[(治疗前SCORAD总分－治疗后SCORAD总分)/治疗前SCORAD总分]×100％。
疗效评定：
临床痊愈：皮疹基本消退，症状消失，疗效率≥90％；
显效：皮疹大部分消退，症状明显改善，60％≤疗效率<90％；
有效：皮疹部分消退，症状有所改善，20％≤疗效率<60％；
无效：皮疹消退不明显，症状无减轻甚至加重，疗效率<20％；
总有效率＝[(痊愈例数+显效例数+有效例数)/病例总数]×100％。
(5)研究总结
所有符合试验方案、依从性好、试验期间未服禁止用药、完成CRF规定填写内容的病例，或服用试验用药数量在80％～120％者，对其疗效进行符合方案数据集统计分析。
(6)统计分析及内容
统计分析将采用SPSS 22.0统计分析软件进行计算。所有的统计检验均采用双侧检验，P值小于或等于0.05将被认为所检验的差别有统计意义。计数资料采用卡方检验，计量资料使用均数±标准差(x±s)表示，组内比较采用配对样本t检验，组间比较使用独立样本t检验；临床疗效比较采用等级资料的秩和检验；相关性分析采用Pearson相关性检验进行比较。
(二)研究结果
1.病例数据病例采集首都医科大学附属北京中医医院皮肤科门诊的患者。患者病例报告表(CRF)填写完成后，由两名不同录入人员对数据进行先后两次录入并核对。共65例患者入组，5例因疫情原因不能来院而脱落，最终纳入统计病例60例。其中，治疗组30例，对照组30例。
2.基线资料60例患者中，男性34例，女性26例，平均年龄8.31±4.80岁，平均病程64.50±61.31月。治疗前治疗组和对照组的性别进行卡方检验，对患者年龄、病程进行独立样本t检验均提示两组间无显著差异。
3.疗效评价
1)SCORAD评分
比较治疗前后SCORAD评分总分，经配对t检验可知，治疗组和对照组治疗前后SCORAD评分总分均下降，差异有统计学意义(P＜0.05)，而治疗组SCORAD评分总分下降更为明显，差异有统计学意义(P＜0.001)，提示治疗4周后治疗组患者病情缓解更加显著。见表2.
表2.治疗前后SCORAD评分比较
Figure PCTCN2022124230-appb-000003
注：治疗后，治疗组与对照组比较，P﹥0.05。
2)SCORAD评分疗效评价
治疗组总有效率为93.33％，对照组总有效率为83.33％，两组之间治疗后有效率差异无统计学意义(P﹥0.05)。治疗组显效率为80.00％，对照组显效率为43.33％，两组之间治疗后显效率差异有统计学意义(P＜0.05)。见表3.
表3.治疗前后SCORAD疗效比较
Figure PCTCN2022124230-appb-000004
3)瘙痒改善情况
比较治疗前后瘙痒评分总，经配对t检验可知，治疗组和对照组治疗前后瘙痒评分均下降，差异有统计学意义(P＜0.05)，而治疗组瘙痒评分下降更为明显，差异有统计学意义(P＜0.001)。治疗后，治疗组瘙痒评分优于对照组，组间差异有统计学意义(P＜0.05)。见表4。
表4.治疗前后瘙痒评分比较
Figure PCTCN2022124230-appb-000005
Figure PCTCN2022124230-appb-000006
注：治疗后，治疗组与对照组比较，P<0.05。
4)使用激素药膏的数量。
本次研究，治疗组和对照组每位患者均共发放艾洛松6支(每支5克)，治疗4周后，回收剩余的艾洛松，治疗组剩余15.72±3.28，对照组剩余1.39±2.66经统计组间差异有统计学意义(P＜0.001)。治疗组在使用艾洛松数量方面明显少于对照组。
4.不良反应
治疗组中有一例出现腹泻，详细询问情况后，考虑与患者食用冷饮有关，叮嘱其不得食用生冷，饭后服用中药后腹泻缓解。对照组未出现不良反应。
(三)结论
通过本次临床研究，显示本发明中药组合物具有快速减轻皮损、缓解瘙痒的作用，可明显减少糖皮质激素药膏(特应性皮炎一线用药)的用药数量，避免因长期外用糖皮质激素药膏而引起的副作用。同时，具有良好的安全性。目前，市场上缺乏儿童或青少年口服治疗特应性皮炎或湿疹的药物，本项目研究证实本发明中药组合物在治疗特应性皮炎方面的显著疗效。
临床病例
实验例1：
生地15g，栀子15g，玄参15g，淡竹叶10g，钩藤10g，白茅根15g，山楂15g。
2)中医诊断标准：参考《精诚大医张志礼》《特应性皮炎中医诊疗方案专家共识》(中国中西医结合皮肤性病学杂志，2013年)、《中医病症诊断疗效标准》(国家中医药行业标准)拟定：
水亏心火证：
主症：面部、颈部、肘窝、腘窝或躯干部等部位反复发作的红斑、水肿，或丘疱疹、水疱，部分皮损糜烂渗出，部分皮损粗糙或呈苔藓化，瘙痒明显等。
次症：心烦，口干，眠差，睡卧不安，大便干，舌红或舌尖红或有芒刺，苔白厚或腻，脉偏数。
此类患者红斑、水肿更加明显，舌苔白厚或腻。
共观察8例患者，男性4例，女性4例，平均年龄12.13±8.10岁，平均病程86.24±55.21月。
疗效评价
1)SCORAD评分
比较治疗前后SCORAD评分总分，治疗前62.31±9.96，治疗后18.00±8.42.经t检验可知，治疗前后SCORAD评分总分均下降，差异有统计学意义(P＜0.05)，提示治疗4周后治疗组患者病情缓解更加显著。
2)SCORAD评分疗效评价
治疗组总有效率为87.5％，治愈1例，显效4例，有效2例，无效1例。
3)瘙痒改善情况
治疗前评分6.44±2.76，治疗后评分2.89±4.91。比较治疗前后瘙痒评分，经t检验可知，治疗后瘙痒评分下降，差异有统计学意义(P＜0.05)。
实验例2：
生地20g，栀子10g，玄参15g，淡竹叶10g，鸡内金10g，槟榔5g，钩藤10g，白茅根15g，山楂15g，金银花10g，地骨皮10g，灯芯草3g，马齿苋10g，牡蛎10g。
水亏心火证：
主症：面部、颈部、肘窝、腘窝或躯干部等部位反复发作的红斑、水肿，或丘疱疹、水疱，部分皮损糜烂渗出，部分皮损粗糙或呈苔藓化，瘙痒明显等。
次症：心烦，口干，眠差，睡卧不安，消谷善饥，大便干，舌红或舌尖红或有芒刺，苔白厚或白厚腻，脉偏数。
此类患者消谷善饥明显。皮损红斑、水肿更加明显，舌苔白厚或白厚腻
共观察8例患者，男性5例，女性3例，平均年龄6.34±7.20岁，平均病程55.45±32.77月。
疗效评价
1)SCORAD评分
比较治疗前后SCORAD评分总分，治疗前65.87±7.46，治疗后15.27±6.49。 经t检验可知，治疗前后SCORAD评分总分均下降，差异有统计学意义(P＜0.001)，提示治疗4周后治疗组患者病情缓解更加显著。
2)SCORAD评分疗效评价
治疗组总有效率为87.5％，治愈1例，显效4例，有效2例，无效1例。
3)瘙痒改善情况
治疗前评分6.89±3.46，治疗后评分2.67±5.33。比较治疗前后瘙痒评分，经t检验可知，治疗后瘙痒评分下降，差异有统计学意义(P＜0.05)。
实验例3：
生地20g，栀子10g，玄参10g，淡竹叶8g，鸡内金10g，槟榔5g，钩藤10g，白茅根15g，山楂10g，金银花10g，麦芽5g，地骨皮10g，灯芯草3g，马齿苋15g，连翘10g，牡蛎15g。
水亏心火证：
主症：面部、颈部、肘窝、腘窝或躯干部等部位反复发作的红斑、水肿，或丘疱疹、水疱，部分皮损糜烂渗出明显，部分皮损粗糙或呈苔藓化，瘙痒剧烈等。
次症：心烦，口干，眠差，睡卧不安，小便短赤，大便秘结，舌红或舌尖红或有芒刺，苔白厚或白厚腻，脉偏数
此类患者瘙痒剧烈。皮损较为广泛，色红肿胀。部分皮损糜烂渗出明显。小便短赤，大便秘结，舌苔白厚或白厚腻
共观察6例患者，男性3例，女性3例，平均年龄8.27±6.44岁，平均病程75.22±38.69月。
疗效评价
1)SCORAD评分
比较治疗前后SCORAD评分总分，治疗前68.78±9.66，治疗后15.23±5.72。经t检验可知，治疗前后SCORAD评分总分均下降，差异有统计学意义(P＜0.001)，提示治疗4周后治疗组患者病情缓解更加显著。
2)SCORAD评分疗效评价
治疗组总有效率为83.33％，治愈1例，显效3例，有效2例，无效1例。
3)瘙痒改善情况
治疗前评分8.43±3.67，治疗后评分2.11±5.98。比较治疗前后瘙痒评分，经t检验可知，治疗后瘙痒评分下降，差异有统计学意义(P＜0.001)。
实验例4：
生地15g，栀子8g，玄参10g，淡竹叶8g，鸡内金10g，槟榔5g，钩藤10g，白茅根15g，山楂8g，金银花10g，麦芽5g，地骨皮10g，灯芯草3g，马齿苋30g，连翘10g，牡蛎30g，陈皮10g，茯苓10份。
水亏心火证：
主症：面部、颈部、肘窝、腘窝或躯干部等部位反复发作的红斑、水肿，或丘疱疹、水疱，部分皮损糜烂渗出明显，部分皮损粗糙或呈苔藓化，瘙痒剧烈等。
次症：心烦，口干，夜不能寐，小便短赤，大便秘结，舌红或舌尖红或有芒刺，苔白厚或白厚腻，脉偏数
此类患者瘙痒剧烈，夜不能寐。皮损较为广泛，色红肿胀。部分皮损糜烂渗出明显。小便短赤，大便秘结，舌苔白厚或白厚腻
共观察10例患者，男性5例，女性5例，平均年龄8.33±6.25岁，平均病程66.54±39.21月。
疗效评价
1)SCORAD评分
比较治疗前后SCORAD评分总分，治疗前68.99±9.87，治疗后14.62±6.43。经t检验可知，治疗前后SCORAD评分总分均下降，差异有统计学意义(P＜0.001)，提示治疗4周后治疗组患者病情缓解更加显著。
2)SCORAD评分疗效评价
治疗组总有效率为90.00％，治愈2例，显效7例，有效1例，无效0例。
3)瘙痒改善情况
治疗前评分9.73±4.42，治疗后评分2.51±5.34。比较治疗前后瘙痒评分，经t检验可知，治疗后瘙痒评分下降，差异有统计学意义(P＜0.001)。

Claims (10)

  1. 一种治疗皮肤病的中药组合物，其特征在于：其由下列重量份中药制成：
    君药由下述药物组成：生地10-30份，栀子5-25份；
    臣药由下述药物A或B组成：其中A为：玄参5-20份，淡竹叶5-15份；其中B为：玄参5-20份，淡竹叶5-15份，以及选自5-15份鸡内金、5-10份槟榔中的一种或两种。
    佐药由下述药物C或D组成：其中C为：钩藤5-20份，白茅根10-30份，山楂5-15份；其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，以及选自5-15份金银花、5-15份麦芽、5-15份地骨皮、1-5份灯芯草、5-30份马齿苋、5-15份连翘、5-30份牡蛎、5-15份陈皮或5-15份茯苓中的一种或多种。
  2. 根据权利要求1所述的中药组合物，其特征在于：其由下列重量份中药制成：君药由下述药物组成：生地10-30份，栀子5-25份；
    臣药由下述药物A组成：其中A为：玄参5-20份，淡竹叶5-15份；
    佐药由下述药物C组成：其中C为：钩藤5-20份，白茅根10-30份，山楂5-15份。
  3. 根据权利要求1所述的中药组合物，其特征在于：其由下列重量份中药制成：君药由下述药物组成：生地10-30份，栀子5-25份；
    臣药由下述药物A组成：其中A为：玄参5-20份，淡竹叶5-15份；
    佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，陈皮5-15份和茯苓5-15份。
  4. 根据权利要求1所述的中药组合物，其特征在于：其由下列重量份中药制成：君药由下述药物组成：生地10-30份，栀子5-25份；
    臣药由下述药物B组成：其中B为：玄参5-20份，淡竹叶5-15份，鸡内金5-15份和槟榔5-10份；
    佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，金银花5-15份，地骨皮5-15份，灯芯草1-5份，马齿苋5-15份，牡蛎5-15份。
  5. 根据权利要求1所述的中药组合物，其特征在于：其由下列重量份中药制成：君药由下述药物组成：生地10-30份，栀子5-25份；
    臣药由下述药物B组成：其中B为：玄参5-20份，淡竹叶5-15份，鸡内金5-15 份和槟榔5-10份；
    佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，金银花5-15份，麦芽5-15份，地骨皮5-15份，灯芯草1-5份，马齿苋5-15份，连翘5-15份，牡蛎5-15份。
  6. 根据权利要求1所述的中药组合物，其特征在于：其由下列重量份中药制成：君药由下述药物组成：生地10-30份，栀子5-25份；
    臣药由下述药物B组成：其中B为：玄参5-20份，淡竹叶5-15份，鸡内金5-15份和槟榔5-10份；
    佐药由下述药物D组成：其中D为：钩藤5-20份，白茅根10-30份，山楂5-15份，金银花5-15份，麦芽5-15份，地骨皮5-15份，灯芯草1-5份，马齿苋5-30份，连翘5-15份，牡蛎5-30份，陈皮5-15份和茯苓5-15份。
  7. 根据权利要求1-6任意一项所述的中药组合物，其特征在于：所述中药组合物选自汤剂、颗粒剂、片剂、胶囊剂、口服液、丸剂、膏剂中的一种。
  8. 根据权利要求1-6任意一项所述的中药组合物的制备方法，其特征在于：将各中药加水或醇溶液提取制得。
  9. 根据权利要求8所述的制备方法，其特征在于：所述醇为甲醇、乙醇、丙醇或丁醇中的一种，优选乙醇。
  10. 根据权利要求1-6任意一项所述的中药组合物在制备皮肤病药物中的用途，其特征在于，所述皮肤病为湿疹、皮炎、特应性皮炎、过敏性皮炎、药疹或荨麻疹。
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