WO2018035706A1 - 特应性皮炎中药制剂、制备方法及其用途 - Google Patents

特应性皮炎中药制剂、制备方法及其用途 Download PDF

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WO2018035706A1
WO2018035706A1 PCT/CN2016/096343 CN2016096343W WO2018035706A1 WO 2018035706 A1 WO2018035706 A1 WO 2018035706A1 CN 2016096343 W CN2016096343 W CN 2016096343W WO 2018035706 A1 WO2018035706 A1 WO 2018035706A1
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atopic dermatitis
juice
chinese medicine
medicine preparation
thyme
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PCT/CN2016/096343
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English (en)
French (fr)
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谭健
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谭健
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Priority to CN201680021077.4A priority Critical patent/CN107635573A/zh
Priority to PCT/CN2016/096343 priority patent/WO2018035706A1/zh
Publication of WO2018035706A1 publication Critical patent/WO2018035706A1/zh

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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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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)
    • A61K36/74—Rubiaceae (Madder family)
    • A61K36/746—Morinda
    • 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

Definitions

  • the invention relates to a traditional Chinese medicine preparation for atopic dermatitis, a preparation method and the use thereof, and an effective medicine for treating dermatological diseases such as atopic dermatitis, which combines the medicinal characteristics of the berry juice, the scented grass leaf and the thyme leaves, and is prepared.
  • atopic dermatitis which combines the medicinal characteristics of the berry juice, the scented grass leaf and the thyme leaves, and is prepared.
  • External application of drugs for the treatment of atopic dermatitis caused by asthma such as atopic dermatitis, provides a possible way to cure atopic dermatitis.
  • Atopic dermatitis is a chronic, relapsing, inflammatory skin disease.
  • the onset of the disease includes all ages, but usually occurs in infancy. Before the age of 1 year, the disease accounts for about 50% of all patients, and some patients can be extended to adulthood. In developed countries, the prevalence of children with this disease can be as high as 10% to 20%. In China, the prevalence of atopic dermatitis has gradually increased over the past 20 years. In 2012, the epidemiological survey in Shanghai showed that the prevalence of children aged 3 to 6 years was 8.3%, and the prevalence of urban children was significantly higher than that in rural areas.
  • atopic dermatitis The incidence of atopic dermatitis is closely related to genetic and environmental factors. Parents and other family members who have a history of allergic disease have a significantly increased risk of developing the disease. Statistics show that about 60% of patients have a family history of allergies, such as atopic dermatitis, allergic asthma, allergic rhinitis, allergic conjunctivitis. Some patients, especially severe atopic dermatitis, may have elevated serum total IgE, and about 40% to 60% of patients have elevated peripheral blood eosinophils. Some patients have obvious allergic effects of heterologous proteins, such as allergic proteins (meat, eggs, milk, nuts, etc.) or inhalations (dust mites, house dust mites, etc.).
  • atopic dermatitis The clinical manifestations of atopic dermatitis are diverse, the most basic features are dry skin, chronic eczema-like dermatitis and severe itching. Most of the disease occurs in infants and young children, and some can occur in children and adults. Infancy (birth to 2 years old): manifested as infant eczema, mostly distributed on the cheeks, forehead and scalp, the rash can be dry or exuded. Childhood (2 to 12 years old): It usually evolves from infancy or does not occur through infancy. Most occur in the elbow fossa, axillary fossa and calf extension, with subacute and chronic dermatitis as the main manifestations, the rash is often dry and hypertrophic, with obvious mossy changes.
  • Atopic dermatitis is a chronic recurrent disease. So far, there is no medicine or method that can be completely cured in medicine. The purpose of treatment is only to alleviate or eliminate clinical symptoms. Western medicine has more treatments for AD, but it has a large side effect and a high proportion of recurrence in the short term.
  • Atopic dermatitis drugs include antihistamines, and oral antihistamines help alleviate skin inflammation and itching. Some popular antihistamines include: loratadine, cetirizine hydrochloride, fexofenadine, and the like.
  • the main side effects of internal antihistamines are (but not limited to) lethargy (more common in first-generation antihistamines) and drug resistance. The main side effect of topical use is that the skin develops an allergic reaction to those drugs, such as rash.
  • glucocorticoid also known as adrenocortical hormone
  • Glucocorticoid is a kind of steroid hormone secreted by the adrenal cortex bundle. It can also be synthesized by chemical methods. The main products include hydrogenation.
  • Cortisone, dexamethasone, betamethasone, beclomethasone, etc. glucocorticoids have a strong anti-inflammatory effect at higher doses, can protect the body from inflammatory reactions, and can also suppress immune response, Anti-shock.
  • glucocorticoids have obvious side effects, which can cause metabolic disorders, leading to side effects such as fat accumulation on the face and abdomen, thinning of the skin, osteoporosis, hyperglycemia, hyperlipidemia, and growth and development; and can also damage the digestive tract. Causes ulcers and hemorrhage; in addition, glucocorticoids also have an adverse effect on the nervous system, and inhibit the immune response, not only makes the infection easy to occur, but also masks the symptoms of the infection after the infection, resulting in the illusion of "the world is peaceful.” At the same time, after the withdrawal of hormones, the delayed response of the central nervous system, there will be too low levels of hormones in the body.
  • Calcineurin inhibitors including tacrolimus ointment and pimecrolimus cream, etc.: These drugs have selective inhibitory effects on T lymphocytes, have strong anti-inflammatory effects, and are suitable for serious and routine conditions. Therapy is not easy to control Patient. However, in recent years, it has been found that its long-term application may cause liver, kidney toxicity, neurotoxicity and vascular disease of transplanted kidney. The blood pressure and renal function should be closely monitored during the administration, and the condition is easy to repeat after stopping the drug.
  • the anti-microbial preparation may be a substance produced during the growth and reproduction of certain microorganisms, and the antibiotics used for treating the disease are directly extracted therefrom; and artificially synthesized or partially artificially synthesized.
  • antibiotics including penicillins and cephalosporins, aminoglycosides, macrolides, echinocandins, cyclosporine and tetracyclines.
  • Antibiotics are used to treat a variety of non-viral infections. However, many side effects have appeared in clinical use, and the problem of bacterial fungal resistance is particularly serious. For atopic dermatitis, antibiotics are mainly induced by heavier patients, especially those with exudative skin lesions, due to bacterial or fungal colonization or secondary infections that can induce or aggravate the condition.
  • topical drugs such as zinc oxide oil (paste) agent, black bean distillate ointment, etc. have certain curative effect on atopic dermatitis, physiological sodium chloride solution, 1% to 3% boric acid solution and other wet compress drugs for atopic dermatitis Exudation in the acute phase has a certain effect, and Doxepin cream and some non-steroidal anti-inflammatory drugs have an antipruritic effect.
  • Physical therapy includes phototherapy and ultraviolet therapy. These treatments have limited effects, and UV therapy is not suitable for infants under 6 years of age.
  • March 2009 the European Atopic Dermatitis Task Force and the European Society of Dermatology and Sexually Transmitted Diseases Eczema Working Group issued a guideline for the diagnosis and treatment of atopic dermatitis, reaffirming that the goal of treatment is only to maintain a long-term good condition in patients with atopic dermatitis. ease.
  • the 2014 edition of the Chinese Atopic Dermatitis Treatment Guide recommends that patients should actively cooperate with the doctor's treatment, and pay attention to protection in all aspects of “clothing, food, housing, transportation, washing”, and try to avoid contact-induced factors that increase the disease. Long term follow-up. In general, the current Western medicine only stays at the level of mitigation and control. Many patients have long suffered from the pain of not being relieved and the side effects of drugs.
  • Atopic dermatitis is similar to "milk mites”, “wet sores”, “soaked sores”, and “four bends” in Chinese medicine.
  • the patient's symptoms are complex, all of which are multi-certificate and have no single syndrome.
  • Most doctors believe that atopic dermatitis is closely related to spleen, heart and liver. Wet, wind, heat and phlegm are the main manifestations, while spleen deficiency and wetness run through. The disease is always.
  • the present invention integrates the medicinal characteristics of the beautiful juice, the scented grass leaf and the thyme leaves, and is made into an external application.
  • Noni non-named Morinda Citrifolia
  • Noni fruit trees are grown in tropical and subtropical countries and regions such as the South Pacific Islands, the Philippines, Hawaii, Hainan Island and Taiwan. Among them, the high quality and excellent noni fruit are mainly from the South Pacific Islands, where the scenery is beautiful, the air is fresh, and there are blue waters. Soft beaches and verdant greens, no industry, no pollution.
  • Noni is rich in more than 200 nutrients, including 13 vitamins (A, B, C, E, etc.), 16 minerals (potassium, sodium, zinc, calcium, iron, magnesium, phosphorus, copper, selenium, etc.) , 8 kinds of rare elements, including more than 20 kinds of amino acids (the most powerful combination of amino acids in plants), and more than 10 kinds of anti-oxidation substances. It also contains a variety of alkaloids, polysaccharides, and a variety of enzymes and other medically valuable ingredients.
  • Noni juice has the strongest antioxidant activity compared to the three most powerful antioxidants currently known, vitamin C, pure grape seed powder and Pycnogenol.
  • the antioxidant effect of Noni juice is 2.8 times that of vitamin C, 1.2 times that of pure grape seed powder, and 1.4 times that of Pycnogenol.
  • the United States Pharmacopoeia describes Noni's anti-bacterial, anti-viral, anti-fungal, and immune-enhancing functions.
  • NONI the orange leaf pae.
  • Chinese medicine the root of the orange leaf scorpion is dried and used as a medicine. Its main performance is dehumidification and is often used to treat eczema and bruises.
  • the main constituents of Morinda citrifolia are similar to those of the genus Basil, which is also of the genus Rubiaceae. Therefore, the performance of Morinda citrifolia can be compared with that of the Chinese herbal medicine, which is extremely important and often used.
  • Bayu Tian the interpretation of Bayu Tian is quite detailed. It is a sedge family, mainly distributed in Guangdong, Hainan and Taiwan.
  • Bayu Tian is often used for strong bones, rheumatism, phlegm and urinary incontinence, uterine deficiency, calming the heart, treating edema, treating athlete's foot, blood, phlegm and cough, treating kidney deficiency, weakness, spleen and rheumatism Diseases, neurasthenia, insomnia, women's infertility and other diseases have the effect of improving immune function and prolonging life.
  • Stinky grass also known as Smelly, small vanilla or Nepeta
  • Stinky grass is the whole grass of the musk plant.
  • Stinky grass is a perennial herb with a height of up to 1 meter and a strong odor.
  • the base is lignified, the whole plant is hairless and has glandular spots.
  • Leaves alternate, 2 to 3 pinnately compound, lobed to deeply divided, 5–15 cm long, lobes obovate-oblong, obovate or valvate, 1–2 cm long, entire or slightly dentate . Cymes terminal or axillary; flowers golden yellow, ca.
  • Odor grass contains volatile oil containing indolone-2, undecane-2, sterol-2, undecanol-2 and their acetates, casein, ⁇ - and ⁇ -pinene, linalool , terpenes, camphorenes, limonenes, cymenesin, etc.
  • biopterin musk scent, vanilla wood, scorpion, scorpion, 6-methoxy white sorghum, tin sage, succulent yam, yam, yam, yam, yam Pyridone, N-methylpralatstin, Ribaridine, muskidine and their quaternary ammonium ions, 2-(4-(3,4-methyldioxyphenyl)butyl) -4-quinolone and the like. Also contains bergamot lactone, psoralen, xanthotoxin, umbelliferone, scutellaria, sylvestris, scented horse, scented scent, scented, scented, parsley, pan Angelica and so on.
  • the efficacy of odor grass is many, including hurricane, antipyretic, diuretic, blood circulation, detoxification, swelling; treatment of cold and fever, rheumatism and bone pain, convulsions in children, dysuria, diarrhea, belching, women's amenorrhea, bruises, Hot sores, eczema, etc. It can be taken orally (1 ⁇ 3 money), or it can be applied externally, such as sputum application, sputum juice or nasal congestion.
  • the total sputum contained in the scented grass has the effect of releasing the smooth sputum.
  • the bergamot lactone, psoralen, and pepper toxin contained in the scented scented scented grass can cause photoallergic effects on the skin, and in vitro, it has the effect of killing tumor cells.
  • Furan coumarins also have a photosensitizing effect on bacteria: in the presence of these substances, such as simultaneous exposure, can cause bacterial death.
  • psoralen and xanthotoxin 100 ⁇ g/ml
  • umbelliferone has antibacterial activity against Brucella
  • psoralen is used with ultraviolet light.
  • the furan coumarin contained in the scented grass has anti-inflammatory and anti-histamine effects.
  • Isoflavone has a moderate protective effect on experimental ulcer in rats.
  • Yinzhi has a paralyzing effect on muscles, and involving the heart muscle can cause a progressive decline in blood pressure in mammals.
  • odorous grass has certain toxicity.
  • the volatile oil contained in the scented grass has unpleasant odor and irritation. It can be used directly on the skin to cause burning, redness and even blistering. The dosage must be controlled during oral administration.
  • Guangxi The Chinese Medicine Journal states: "Pregnant women should not take it.”
  • Thyme also known as ground pepper, ground pepper, mountain pepper, mountain pepper, thyme, etc.
  • the thyme is native to North Africa, Europe and Asia. The whole grass of the thyme of the Labiatae family. Thyme stalks are stalk-like, rooting everywhere, more branched, lower lignified, reddish brown, squid straight, 3 to 15 cm high, with strong aroma. Leaves opposite; small, oblong or ovate, as long as 15 mm, as long as 7 mm, entire, blunt, base pubescent, shortly stalked.
  • the small nut is oval and is located at the bottom of the Cebu. Thyme grows on dry hillside sand texture and is mainly distributed in Inner Mongolia, Gansu, Shaanxi and Northeast China. Harvested from June to July, dry or fresh
  • Thyme contains volatile oil and has the best content when flowering. Its main components are thyme (Thymol), baicalein, glucoside, luteolin-7-glucoside, apigenin and other flavonoids, carvacrol, Linalolol pair - cymbidium A variety of compounds such as p-Cymol. Have antitussive, anti-inflammatory, antiseptic and other effects. Excessive amount of irritant, can make the liver degeneration.
  • Thyme has a fragrant smell. It has been used as a spice vegetable and honey plant in people's lives. It is one of the natural flavors that humans have applied since ancient times. As early as in the Yuan Dynasty, China used thyme as a spice for the seasoning. In the Yuan Dynasty, the Complete Works of Home Affairs, remember to use thyme to add hump and camel hooves. Li Shizhen's "Compendium of Materia Medica" records: 'Taste Weixin, the natives cook boiled lamb, sweet and thyme'.
  • thyme powder When cooking seafood, meat, fish and other foods, you can add a little thyme powder to remove the astringency and increase the flavor of the dishes; The addition of thyme to pickles and kimchi enhances their fragrance and grassy aroma.
  • the natural antiseptic effect of thyme also makes it a green and harmless spice additive for meat sauces, sausages, clams and kimchi.
  • the cheese and wine made by the Romans are used as seasonings, and thyme is a must-have spice for French cuisine.
  • the International Standard Organization announced that thyme could be used as a food spice.
  • Thyme can treat a variety of diseases, with a sweet and medicinal taste.
  • the medicinal records of thyme in China can be traced back to the Northern Song Dynasty. All kinds of Chinese medicine classics have been recorded.
  • "Shaanxi Chinese Herbal Medicine” records that it can cure indigestion, body pain, hurricane analgesia, abdominal distension, toothache, cold stomach pain; "Jiayou Materia Medica” said that its main drenching swelling and pain;
  • "Xinjiang Chinese Herbal Medicine Handbook” record The treatment of colds, hurricanes, spleen and digestion, cough and phlegm, warming and dispelling cold, "Shaan Gan, Ningqing, Chinese Herbal Medicine” recorded the stomach vomiting and clearing heat and heat;
  • “Chinese Medicine Map” recorded that it has a town ⁇ , drive the wind, strong role, attending inflammation, spastic cough, whooping cough, sore throat. Modern medicinal use is a fresh or dry sample of the aboveground part or whole grass,
  • Thyme essential oil contains 20 to 54% of thymol, which has antibacterial function and is used to prepare mouthwash, antifungal fungi and anti-cough or bronchitis drugs. Many disinfectants also contain thymol.
  • thyme essential oils Prior to the development of modern antibiotics, thyme essential oils were used to make applicator bandages with bactericidal, palliative, expectorant and calming effects. Chewing thyme can calm your emotions. Thyme decoction or extract can be used as a protective agent for bronchitis or other respiratory diseases and an analgesic for neuritis or spinal radiculitis.
  • the invention provides a traditional Chinese medicine preparation for atopic dermatitis, a preparation method and the use thereof, and is an effective treatment traditional Chinese medicine for dermatological diseases such as atopic dermatitis, which utilizes the medicinal characteristics of the beautiful juice, the grass leaf and the thyme leaves.
  • the prepared external application is effective for treating dermatological diseases such as atopic dermatitis caused by asthma.
  • the atopic dermatitis traditional Chinese medicine preparation of the invention comprises: 10 parts of the noni juice fermentation raw juice according to the volume, 1 part of the scented grass leaf juice and 0.5 part of the thyme leaf juice, and the noni juice fermentation raw juice is The fresh and mature noni fruit is washed and dried, placed in a closed container at a temperature of 25 ° C to 35 ° C for 3 months, naturally fermented, and filtered to obtain a noni fruit fermented raw juice;
  • the atopic dermatitis Chinese medicine preparation of the present invention wherein the berry comprises: noni fruit grown from the South Pacific Islands, the Philippines, Hawaii, Hainan Island, Taiwan, the tropics or the subtropics;
  • the atopic dermatitis Chinese medicine preparation of the present invention wherein: the scented grass leaf is a scented grass leaf produced in China or around the world; and the thyme leaves are thyme leaves produced from China or around the world;
  • a preparation method of a traditional dermatitis traditional Chinese medicine preparation of the present invention comprises the steps of: washing and drying fresh and mature noni fruit, and placing it in a closed container at a temperature of 25 ° C to 35 ° C for 3 months, thereby making it Natural fermentation, filtration to obtain noni fruit fermentation juice; the selected fresh grass leaves and thyme leaves are washed, disinfected, juiced and filtered with water to obtain odor grass leaf juice and thyme leaf juice; according to the formula volume Comparing, respectively, 10 parts of noni juice fermentation raw juice, 1 part of odor grass leaf juice and 0.5 parts of thyme leaf juice are uniformly mixed, and then a traditional dermatitis Chinese medicine preparation is obtained;
  • atopic dermatitis Chinese medicine preparation is a medicine for treating atopic dermatitis
  • the invention relates to the use of a traditional Chinese medicine preparation for atopic dermatitis, wherein the auxiliary material is starch, sorbitol, maltose, glucose, sucrose, lactose, silicon derivative, cellulose and its derivative, gelatin, glycerin and talc. a mixture of one or more of powder, calcium carbonate, calcium hydrogencarbonate, distilled water, cyclodextrin;
  • atopic dermatitis Chinese medicine preparation of the present invention wherein the medicine for treating atopic dermatitis is a suppository, a soft plaster, a cream, a spray, a drop, a patch, a tablet, a sugar-coated tablet Enteric coated tablets, capsules, hard capsules, soft capsules, oral liquids, buccal agents, granules, granules, pills, powders, granules, powders or injections.
  • the atopic dermatitis traditional Chinese medicine preparation of the invention combines the medicinal characteristics of the succulent juice, the scented grass leaf and the thyme leaves, and will strengthen the spleen, improve the immune function, perform the gas osmosis, the hurricane, the blood circulation, the calming, the swelling and detoxification, and the sterilization.
  • Anti-bacterial, anti-viral, anti-fungal, detoxification, cell tissue repair and activation, and regenerative functions are combined to cure the symptoms and solidify.
  • the externally applied drugs can effectively treat skin diseases such as atopic dermatitis caused by asthma. Stubborn.
  • the atopic dermatitis traditional Chinese medicine preparation of the invention comprises: 10 parts of the noni juice fermentation raw juice according to the volume, 1 part of the scented grass leaf juice and 0.5 part of the thyme leaf juice, and the noni juice raw juice is the fresh mature noni If it is cleaned and dried, it is placed in a closed container at a temperature of 25 ° C to 35 ° C for 3 months to be naturally fermented, and filtered to obtain a noni fruit fermented raw juice.
  • the fruit includes: from the South Pacific Islands, the Philippines. , Hawaii, Hainan Island, Taiwan Bay, tropical or subtropical noni fruit, scented grass leaves are produced from China or around the world; thyme leaves are thyme leaves from China or around the world.
  • the preparation method of the atopic dermatitis traditional Chinese medicine preparation of the present invention comprises the steps of: washing and drying fresh and mature noni fruit, and placing it in a closed container at a temperature of 25 ° C to 35 ° C for 3 months to naturally ferment. Filtering the raw juice of Noni fruit; washing the selected fresh grass leaves and thyme leaves with water, disinfecting, juicing and filtering to obtain the grass leaf juice and thyme leaf juice; according to the volume ratio of the formula, 10 parts of noni juice fermentation juice, 1 part of scented grass leaf juice and 0.5 parts of thyme leaf juice were uniformly mixed, respectively, to obtain a traditional dermatitis Chinese medicine preparation.
  • the atopic dermatitis traditional Chinese medicine preparation is a medicine for treating atopic dermatitis
  • the traditional Chinese medicine preparation for atopic dermatitis accounts for 10-90% of the medicine for treating atopic dermatitis
  • the rest is an auxiliary material
  • the auxiliary material is pharmacy.
  • Acceptable carriers such as starch, sorbitol, maltose, glucose, sucrose, lactose, silicon derivatives, cellulose and its derivatives, gelatin, glycerin, talc, calcium carbonate, calcium bicarbonate, distilled water, cyclodextrin a mixture of one or more of the compounds for treating atopic dermatitis as a suppository, a soft plaster, a cream, a spray, a drop, a patch, a tablet, a sugar-coated tablet, an enteric coated tablet, a capsule, Hard capsules, soft capsules, oral liquids, buccal agents, granules, granules, pills, powders, granules, powders or injections.
  • the invention is treated with the new formula external application of the invention, a total of 5 courses, each course of 7 days.
  • the first course of treatment the enlargement of the dermatitis coverage was suppressed, the exudation was alleviated, and the mossy appearance was relieved; after the second course of treatment, there was almost no exudation, the mossy appearance was further relieved, and the dry and hypertrophic peripheral skin began to fall off;
  • the exudation completely stopped, covering the new skin, the moss-like changes disappeared, and the hypertrophic peripheral skin further fell off;
  • the fourth course of treatment After the new skin grows completely, the mossy appearance disappears, the peripheral skin of the hypertrophy is basically completed, and the symptoms of atopic dermatitis disappear; after the fifth course of treatment, the process of consolidation and maintenance, after the course of treatment, the patient's atopic dermatitis The symptoms disappeared completely, and the original dermatitis returned to normal skin. 8 months after the external application of the new formula of
  • atopic dermatitis Chinese medicine preparation, preparation method and use thereof of the present invention can be produced in the industry and have the effect of atopic dermatitis.

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Abstract

一种特应性皮炎中药制剂，包括按照体积计算的诺丽果汁发酵原汁10份、臭草叶汁1份和百里香叶汁0.5份，诺丽果汁发酵原汁是将新鲜成熟的诺丽果清洗晾干，在250℃～350℃温度下的密闭容器内放置3个月，使其自然发酵，过滤制得诺丽果发酵原汁。所述制剂综合了诺丽果汁、臭草叶和百里香叶的药性特征，将健脾、提高免疫功能、行气渗湿、祛风、活血、镇定、消肿解毒、杀菌、抗细菌、抗病毒、抗霉菌、排毒、细胞组织修复活化及其再生功能等药性融合在一起，既治标又固本，制成的外敷药可有效治疗哮喘引发的特应性皮炎等皮肤病顽症。

Description

特应性皮炎中药制剂、制备方法及其用途 技术领域
本发明涉及特应性皮炎中药制剂、制备方法及其用途，它是治疗特应性皮炎等皮肤病顽症有效药物，它综合了渃丽果汁，臭草叶和百里香叶的药性特征，制成的外敷药有效治疗哮喘引发的特应性皮炎等皮肤病顽症，为根治特应性皮炎提供了一种可能的途径。
背景技术
特应性皮炎(atopic dermatitis，AD)是一种慢性、复发性、炎症性皮肤病。该病发病者包括各个年龄阶段，但通常初发于婴儿期，1岁前发病者约占全部患者的50％，部分患者病情可以迁延到成年。在发达国家该病儿童患病率可高达10％～20％。在中国，20年来特应性皮炎的患病率也在逐步上升，2012年上海地区流行病学调查显示，3～6岁儿童患病率达8.3％，城市儿童患病率显著高于农村。
特应性皮炎的发病与遗传和环境等因素关系密切。父母亲等家族成员有过敏性疾病史者，患该病的概率显著增加。统计表明，约60％的患者有家族过敏史，如家族成员中有特应性皮炎、过敏性哮喘、过敏性鼻炎、过敏性结膜炎等。部分患者特别是重度特应性皮炎可有血清总IgE升高，约40％～60％患者有外周血嗜酸性粒细胞升高。部分患者有明显的异种蛋白过敏，如对部分食物蛋白(肉、蛋、奶、坚果等)或吸入物(粉尘螨、屋尘螨等)过敏。
遗传因素主要影响皮肤屏障功能与免疫平衡，本病患者往往有Th2为主介导的免疫学异常，还有如表皮中丝聚蛋白减少或缺失等问题，减弱或破坏皮肤屏障功能。环境因素包括环境变化、生活方式改变、过度洗涤、感染原和变应原等。此外，心理因素(如精神紧张、焦虑、抑郁等)也在特应性皮炎的发病中发挥一定作用。
特应性皮炎确切发病机制尚不清楚。一般认为是在遗传因素基础上，由于变应原进入和微生物定植(如金黄色葡萄球菌和马拉色菌)，形成皮肤免疫异常反应和炎症，引发皮疹和瘙痒，而搔抓和过度洗涤等不良刺激又可进一步加重皮肤炎症。
特应性皮炎的临床表现多种多样，最基本的特征是皮肤干燥、慢性湿疹样皮炎和剧烈瘙痒。该病大多数初发于婴幼儿期，部分可发生于儿童和成人期。婴儿期(出生至2岁)：表现为婴儿湿疹，多分布于两面颊、额部和头皮，皮疹可干燥或渗出。儿童期(2～12岁)：多由婴儿期演变而来，也可不经过婴儿期而发生。多发生于肘窝、腘窝和小腿伸侧，以亚急性和慢性皮炎为主要表现，皮疹往往干燥肥厚，有明显苔藓样变。青年与成人期(12岁以上)：皮损与儿童期类似，也以亚急性和慢性皮炎为主，主要发生在肘窝、腘窝、颈前等部位，也可发生于躯干、四肢、面部、手背，大部分呈干燥、肥厚性皮炎损害，部分患者也可表现为痒疹样皮疹。
特应性皮炎是慢性复发性疾病，到目前为止，医学上还没有能够完全根治的药物或方法，治疗的目的仅仅是缓解或消除临床症状。西医对AD的治疗方法较多，但副作用大，短期内复发比例高。特应性皮炎药物包括抗组胺药，口服抗组胺药帮助减轻引起的皮肤炎症瘙痒。一些流行的抗组胺药包括：氯雷他定，盐酸西替利嗪，非索非那定等。內用抗組胺药的主要副作用有(但不限於)嗜睡(較常見於第一代抗組織胺)和耐药现象，外用的主要副作用是皮膚對那些藥物產生過敏反應，例如出疹。
大多数情况下，特应性皮炎的治疗是通过在皮肤外用药物的应用完成。这些外敷药主要有：糖皮质激素(又名腎上腺皮質激素)软膏或霜剂，糖皮质激素是由肾上腺皮质束状带分泌的一类甾体激素，也可由化学方法人工合成，主要产品包括氢化可的松、地塞米松、倍他米松、倍氯米松等，糖皮质激素在较大剂量下有很强大的抗炎作用，能保护机体不受炎症反应的侵害，同时还能够抑制免疫反应、抗休克。但糖皮质激素有明显的副作用，会引起代谢紊乱，导致如脂肪堆积在脸和腹部、皮肤变薄、骨质疏松、高血糖、高血脂、影响生长发育等副作用；同时也可以损伤消化道，造成溃疡和出血；此外，糖皮质激素还对神经系统有不良影响，并且抑制了免疫反应，不仅使感染容易发生，在感染发生之后还掩盖感染的症状，造成“天下太平”的假象。同时，撤掉服用激素后，中枢神经的滞后反应，会出现体内激素水平过低的情况。现代医疗指南指出原则上尽量不用或少用此类药物，只有在感染造成的炎性反应非常严重以至于威胁到患者生命的情况下，才可以短期大剂量使用糖皮质激素缓解症状。
钙调神经磷酸酶抑制剂，包括他克莫司软膏和吡美莫司乳膏等：此类药物对T淋巴细胞有选择性抑制作用，有较强的抗炎作用，适用于病情严重且常规疗法不易控制 的患者。但近年来发现其长期应用可出现肝、肾毒性、神经毒性和移植肾的血管病变，用药期间要密切监测血压和肾功能，而且，停药后病情易反复。
抗微生物制剂(抗生素)，可以是某些微生物生长繁殖过程中产生的一种物质，用于治病的抗生素除由此直接提取外；还有完全用人工合成或部分人工合成的。抗生素种类较多，包括青霉素类和头孢菌素类，氨基糖苷类，大环内酯类，棘白菌素类，环孢霉素和四环素类等。抗生素用于治疗各种非病毒感染的药物。但是在临床使用中已经显现了许多副作用，细菌真菌抗药性的问题尤其严重。对于特应性皮炎，由于细菌、真菌定植或继发感染可诱发或加重病情，抗生素主要于较重患者尤其是有渗出皮损病情的控制。
其他外用药如氧化锌油(糊)剂、黑豆馏油软膏等对特应性皮炎也有一定疗效效，生理氯化钠溶液、1％～3％硼酸溶液及其他湿敷药物对于特应性皮炎急性期的渗出有一定疗效，多塞平乳膏和部分非甾体抗炎药物具有止痒作用。
物理疗法包括光疗和紫外线疗法。这些疗法效果局限，而紫外线疗法不适用于6岁以下婴幼儿。2009年3月，欧洲特应性皮炎特别工作组和欧洲皮肤病和性病学会湿疹工作组发布的特应性皮炎诊断和治疗指南，重申治疗的目标仅仅为保持特应性皮炎患者病情的长期良好缓解。中国特应性皮炎诊疗指南2014版建议，患者应当积极配合医生的治疗，并在“衣、食、住、行、洗”各方面注意防护，尽量避免接触诱发疾病加重的因素，应定期复诊和长期随访。总体而言，目前的西医仅仅停留在减轻和控制层面上，许多患者长期忍受着病痛不得缓解以及药物毒副作用的双重折磨。
特应性皮炎与中医中的“奶癣”、“湿疮”、“浸淫疮”、“四弯风”等相类似。患者征候表现复杂，均为多证相兼，无单一证型，多数医家认为特应性皮炎与脾、心、肝关系密切，湿、风、热、瘀为其主要表现，而脾虚湿盛贯穿该病始终。
近年来，随着中医药研究的进一步深入，中医药作为一种潜在的有效治疗方法，逐渐获得国际认同。1992～1995年，Sheehan等人先后在《英国皮肤病杂志》等发表了中医药治疗特应性皮炎的临床对照试验，显示在红斑和皮炎面积改善方面，中药治疗的优势显著，随访一年大约一半患者受益，有近20％患者痊愈，没有复发迹象。美国、日本、英国的特应性皮炎诊疗指南中均认为中医药疗法是应对特应性皮炎诊疗困境中可选择的方法。欧洲特应性皮炎特别工作组1991年也开始对中医药治疗特应性皮 炎的潜在作用和安全性进行了系统评价，认为特别是对部分难治性顽固特应性皮炎患者，其短期和远期的疗效均令人鼓舞，是可以选择的治疗方法。但是，迄今为止还没有副作用小，能完全根治和控制特应性皮炎复发的有效药物和治疗手段。为此，本发明综合渃丽果汁，臭草叶和百里香叶的药性特征，制成的外敷药。诺丽果(NONI，学名Morinda Citrifolia)保健功效多，有“巴戟天屬的女王”和“天賜之果”之称。诺丽果树生长在南太平洋群岛，菲律宾，夏威夷，海南岛和台湾等热带和亚热带国家和地区，其中高质量优异诺丽果主要来自南太平洋群岛，那里风景优美，空气清新，有着湛蓝的海水、细软的沙滩和青翠欲滴的绿色，没有工业，没有污染。
诺丽果富含200多种营养成分，包括13种维生素(A、B、C、E等)，16种矿物质(钾、钠、锌、钙、铁、镁、磷、铜、硒等)，8种稀有元素，包括9种必需氨基酸在内的20多种氨基酸(是植物中含氨基酸种类最多的超强组合)，10多种具抗氧化作用的物质。还含有多种生物碱、多醣体、多种酵素等极具医学价值的成分。
医学研究表明，同三种目前已知最强有力的抗氧化剂，即维生素C、纯葡萄籽粉和碧容健，相比，诺丽果汁的抗氧化作用最强。诺丽果汁的抗氧化作用是维生素C的2.8倍，是纯葡萄籽粉的1.2倍，是碧容健的1.4倍。
生物专家提出，如果三种重要的植物性营养素类别多醣体、抗氧化剂、生物碱同时大量出现在一个天然植物果实中，就可说是革命性发现。营养学家夏普提出，诺丽果内的营养成分创造出颇具威力的协同效应，也就是组合的威力远胜于单一成分的功效。海尼克博士发现诺丽果所含的化合物赛洛宁可迅速重建修复细胞组织、排除废物与毒素及活化健全细胞组织，参与细胞代谢、修复和再生活动的全过程，帮助非正常细胞恢复正常功能。
《美国药典》介绍诺丽有抗细菌，抗病毒，抗霉菌，提高免疫力等功能。
《中国本草图录》中详细介绍了诺丽(NONI)的各种资讯，书中将诺丽(NONI)称之为橘叶巴戟。中国医药学中以橘叶巴戟的根晒干入药，称之为海巴戟。其主要的性能就在除湿壮骨，因而常常被用来治疗湿疹和跌打损伤。海巴戟的主要成分和同属茜草科的巴戟天相类似，因此海巴戟的性能又能与中草药上极为重要并常应用的巴戟天相提并论。在《中医大辞典》中对巴戟天的解说颇为详尽，其为茜草科，主要分布在广东、海南和台湾等地，其根含有维生素C、矿物质和多醣体，也含有与海巴戟相同的 檄树等成分。巴戟天常被用于壮筋骨、祛风湿、治阳痿和小便失禁、子宫虚寒，定心气、疗水肿、治脚气、补血、化痰止咳，治肾虚腰脚无力、萎脾瘫痪、风湿骨病、神经衰弱、失眠、妇女不育等病，有提高免疫功能，延年益寿的作用。
臭草，又名臭艾，小香草或荊芥七，是蕓香科植物蕓香的全草。臭草为多年生草本，高可達1米，有強烈氣味。基部木質化，全株無毛，有腺點。葉互生，2～3回羽狀復葉，全裂至深裂，長5～15厘米，裂片倒卵狀長圓形、倒卵形或匙形，長1～2厘米，全緣或微有鈍齒。聚傘花序頂生或腋生；花金黃色，直徑約1～2厘米；萼片4～5，細小，宿存；花瓣4～5，邊緣細撕裂狀；雄蕊8～10，花初開時與花瓣對生的4枚貼伏於花瓣上，與萼片對生的4枚較長，斜出外露，盛開時全部雄蕊並列一起且等長；心皮3～5，上部離生；花盤有腺點。蒴果4～5室，成熟時開裂。種子腎形，黑色。花期春季。
臭草含揮發油，內含壬酮-2，十一酮-2，壬醇-2,十一醇-2和它們的乙酸酯，案葉素，α-和β-蒎烯，芳樟醇，莰烯，樟腦烯，檸檬烯，對聚傘花素等。還含生物堿：蕓香堿，香草木寧堿，茵芋堿，6-甲氧基白鮮堿，加錫彌羅果堿，山小橘堿，γ-崖椒堿，蕓香寧堿，蕓香吖啶酮，N-甲基坡拉特德斯明，日巴裏尼定，蕓香裏尼定和它們的季銨離子，2-(4-(3，4-甲二氧基苯)丁基)-4-喹諾酮等。还含佛手柑內酯，補骨脂素，花椒毒素，傘形花內酯，東莨菪素，異虎耳草靠，蕓香馬扔，蕓香枯亭，蕓香扔，異歐芹屬素乙，潘當歸素等。
臭草的功效多，包括祛風，退熱，利尿，活血，解毒，消腫；治感冒發熱，風濕骨痛，小兒驚風，小便不利，泄瀉，疝氣，婦女經閉，跌打損傷，熱毒瘡瘍，濕疹等。可煎湯內服(1～3钱)，也可搗敷、搗汁調敷或塞鼻等外用。《生草藥性備要》记载臭草可："消百毒腫，散大瘡，理蛇傷"；《南寧市藥物誌》："退熱祛風，利尿消腫，治小兒發熱驚風，風濕骨痛"；《廣西中藥志》："治瘴瘧、熱毒瘡瘍及一切跌打損傷。外敷蜈蚣咬傷"；《中國藥植圖鑒》："治經閉不調，疝痛"；《廣西植物名錄》："祛風解毒，涼血散瘀。治感冒發熱，月經不調，衄血，牙痛，癤腫，蛇咬傷”。《福建中草藥》记载：治小兒濕疹-鮮臭草莖，葉二至三錢。綠豆三錢。開水泡服。
臭草中所含的總堿有解除平滑嘰痊攣的作用。臭草中所含呋喃香豆精類的佛手柑內酯、補骨脂素、花椒毒素等均可引起光過敏的對皮膚的作用，在體外，有殺滅腫瘤細胞的作用。呋喃香豆精類對細菌也有光敏作用：即在這些物質存在時，如同時曝光，可引起細菌死亡。在體外試驗中，補骨脂素、花椒毒素(100微克/毫升)對人型結核桿菌有抑制作用，傘形花內酯對布魯氏桿菌有抗菌作用，補骨脂素如與紫外線同用，可滅活某些DNA病毒及RNA病毒。另外，臭草中所含呋喃香豆精，山小橘堿有抗炎及抗組織胺作用。異虎耳草素對大鼠的實驗性潰瘍有中度的保護作用。茵芋堿對肌肉有麻痹作用，累及心肌可引起哺乳動物的血壓進行性下降。
另一方面，臭草有一定的毒性，臭草所含揮發油，有難聞的氣味和刺激性，直接用於皮膚可引起燒灼感、發紅甚至起泡；内服时必须控制用量；同时，《廣西中藥誌》注明：“孕婦忌服”。
百里香，又称地椒、地花椒、山椒、山胡椒、麝香草等，是一種採擇自百里香属品種植物、具有烹飪和藥用價值的香草，百里香原产北非、欧洲及亚洲温带。为唇形科植物百里香的全草。百里香茎匍匐状，随处生根，多分枝，下部木质化，红棕色，花枝直上，高3～15厘米，有强烈芳香气。叶对生；细小，长椭圆形或卵形，长达15毫米，宽达7毫米，全缘，钝头，基部具刚毛，有短柄。花小，紫红色，簇集枝端，形成轮伞花穗：萼绿色，萼筒钟形，先端5裂，喉部有毛；花冠唇形，下唇3裂；雄蕊4，2强；雌蕊1。小坚果椭圆形，位于宿萼的底部。百里香生长于干燥山坡砂质地，在中国主要分布于内蒙古、甘肃、陕西、东北等地。6～7月采收，阴干或鲜用
百里香含挥发油，以花盛时含量最好。其主要成分为百里香酚(Thymol)、黄芩素、葡萄糖苷、木犀草素-7-葡萄糖苷、芹菜素等黄酮成分、香荆芥酚(Carvacrol)、芳樟醇(Linalool)对-聚伞花素(p-Cymol)等多种化合物。有镇咳、消炎、防腐等作用。超量有较强刺激性，可使肝脏变性。
百里香具有芳香的气味，很早的时候就作为一种香料蔬菜、蜜源植物出现在人们的生活中，是人类从古至今应用的天然的调味香料之一。中国早在元朝就有用百里香作调味香料的记载，元朝的《居家必用事類全集》中，記有用百里香加入駝峰駝蹄调味。李时珍《本草纲目》记载：‘味微辛，土人以煮羊肉食，香美麝香草’。在烹调海鲜、肉类、鱼类等食品时，可加入少许百里香粉，以除去腥味，增加菜肴的风味； 腌菜和泡菜时加入百里香，能提高它们的清香和草香味年，百里香的天然防腐作用还使其成为肉酱、香肠、焖肉和泡菜的绿色无害的香料添加剂。在国外，罗马人制作的奶酪和酒都用它作调味料，百里香还是法国菜必备的香料。1970年，国际标准化组织(International Standard Organization)公布百里香可以用作食物香辛料。
百里香可治疗多种疾病，气味甜而又似药草味。百里香在中国的药用记载可追溯到北宋。各种中医典籍都有所记载。《陕西中草药》记录了它可治消化不良、周身疼痛、祛风镇痛、小腹胀满、牙痛、治胃寒痛；《嘉佑本草》谓其主淋炸肿痛；《新疆中草药手册》记录了治感冒、祛风、健脾消食、止咳化痰、温中散寒作用、《陕甘宁青中草药选》记录了胃止呕和清暑解热；《中国药植图鉴》记载其具有镇痉、驱风、强壮作用，主治炎症、痉挛性咳嗽、百日咳、喉头肿痛。现代药用是用其地上部分或全草的鲜样或阴干样，有祛风、止痛的功能。
百里香精油含有的20至54％的百里酚成分，具有防菌功能而被用於調配漱口水、抗灰甲真菌藥和抗咳嗽或支氣管炎藥，不少消毒劑亦含有百里酚。在現代抗生素研發以前，麝香草精油會被用於製作塗藥繃帶，有殺菌、緩解痙孿、祛痰劑和鎮定作用。嚼食麝香草則可以撫平情緒。百里香煎剂或流浸膏可作为支气管炎或其它呼吸道疾患的保护剂及神经炎或脊神经根炎的止痛剂。
发明内容
本发明提供一种特应性皮炎中药制剂、制备方法及其用途，它是特应性皮炎等皮肤病顽症的有效治疗中医药，它运用了渃丽果汁，臭草叶和百里香叶的药性特征，制成的外敷药有效治疗哮喘引发的特应性皮炎等皮肤病顽症。
为了完成本申请的发明目的，本发明采用以下技术方案：
本发明的一种特应性皮炎中药制剂，其中：它包括：按照体积计算的诺丽果汁发酵原汁10份、臭草叶汁1份和百里香叶汁0.5份，诺丽果汁发酵原汁是将新鲜成熟的诺丽果清洗晾干，在25℃～35℃温度下的密闭容器内放置3个月，使其自然发酵，过滤制得诺丽果发酵原汁；
本发明的一种特应性皮炎中药制剂，其中：所述渃丽果包括：来自生长于南太平洋群岛，菲律宾，夏威夷，海南岛、台湾、热带或亚热带的诺丽果；
本发明的一种特应性皮炎中药制剂，其中：所述臭草叶是产自中国或世界各地的臭草叶；所述百里香叶是产自中国或世界各地的百里香叶；
本发明的一种特应性皮炎中药制剂的制备方法，它包括以下步骤：将新鲜成熟的诺丽果清洗晾干，在25℃～35℃温度下的密闭容器内放置3个月，使其自然发酵，过滤制得诺丽果发酵原汁；将选好的新鲜臭草叶和百里香叶分别用清水洗净、消毒、榨汁和过滤得到臭草叶汁和百里香叶汁；按配方的体积比,分别将诺丽果汁发酵原汁10份、臭草叶汁1份和百里香叶汁0.5份均匀混合后，得到特应性皮炎中药制剂；
本发明的一种特应性皮炎中药制剂的用途，其中：所述特应性皮炎中药制剂是用于治疗特应性皮炎的药物；
本发明的一种特应性皮炎中药制剂的用途，其中：所述特应性皮炎中药制剂在治疗特应性皮炎的药物中占10-90％，其余为辅料；
本发明的一种特应性皮炎中药制剂的用途，其中：所述的辅料为淀粉、山梨醇、麦芽糖、葡萄糖、蔗糖、乳糖、硅衍生物、纤维素及其衍生物、明胶、甘油、滑石粉、碳酸钙、碳酸氢钙、蒸馏水、环糊精中的一种或几种的混合物；
本发明的一种特应性皮炎中药制剂的用途，其中：所述治疗特应性皮炎的药物为栓剂、软硬膏剂、霜剂、喷雾剂、滴剂、贴剂、片剂、糖衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、丹剂、粉剂或注射剂。
本发明的特应性皮炎中药制剂综合了渃丽果汁，臭草叶和百里香叶的药性特征，将健脾、提高免疫功能、行氣滲濕、祛風、活血、鎮定、消腫解毒、杀菌、抗细菌、抗病毒、抗霉菌、排毒、细胞组织修复活化及其再生功能等药性融合在一起，既治标又固本，制成的外敷药可有效治疗哮喘引发的特应性皮炎等皮肤病顽症。
具体实施方式
本发明的特应性皮炎中药制剂包括：按照体积计算的诺丽果汁发酵原汁10份、臭草叶汁1份和百里香叶汁0.5份，诺丽果汁发酵原汁是将新鲜成熟的诺丽果清洗晾干，在25℃～35℃温度下的密闭容器内放置3个月，使其自然发酵，过滤制得诺丽果发酵原汁，渃丽果包括：来自生长于南太平洋群岛，菲律宾，夏威夷，海南岛、台 湾、热带或亚热带的诺丽果，臭草叶是产自中国或世界各地的臭草叶；百里香叶是产自中国或世界各地的百里香叶。
本发明的特应性皮炎中药制剂的制备方法，它包括以下步骤：将新鲜成熟的诺丽果清洗晾干，在25℃～35℃温度下的密闭容器内放置3个月，使其自然发酵，过滤制得诺丽果发酵原汁；将选好的新鲜臭草叶和百里香叶分别用清水洗净、消毒、榨汁和过滤得到臭草叶汁和百里香叶汁；按配方的体积比,分别将诺丽果汁发酵原汁10份、臭草叶汁1份和百里香叶汁0.5份均匀混合后，得到特应性皮炎中药制剂。
本发明特应性皮炎中药制剂是用于治疗特应性皮炎的药物，所述特应性皮炎中药制剂在治疗特应性皮炎的药物中占10-90％，其余为辅料，辅料为药学上可接受的载体，如淀粉、山梨醇、麦芽糖、葡萄糖、蔗糖、乳糖、硅衍生物、纤维素及其衍生物、明胶、甘油、滑石粉、碳酸钙、碳酸氢钙、蒸馏水、环糊精的一种或几种的混合物，治疗特应性皮炎的药物为栓剂、软硬膏剂、霜剂、喷雾剂、滴剂、贴剂、片剂、糖衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、丹剂、粉剂或注射剂。
治疗特应性皮炎的药物的时用效果：
患者从1岁开始出现轻度呼吸道哮喘，1岁半开始出现皮肤哮喘的特应性皮炎，发生于肘窝、腘窝和小腿伸侧，近10岁时延伸至手腕及双手手背，手腕以下皮炎覆盖面达～60％，皮疹外围处干燥肥厚，有明显苔藓样变，中间严重渗出。
数年间患者做过数次过敏原测试，家长一直采取保湿和隔离过敏原等防护措施，期间辗转多家医疗机构，治疗特应性皮炎的西药几乎用遍，每次治疗时都多少有一定效果，但几周内，最长不超过3个月，皮炎又复发。患者近10岁时，皮炎延伸至手腕及双手手背，手腕以下皮炎覆盖面达～60％，皮疹外围处干燥肥厚，有明显苔藓样变，中间严重渗出，采用原先的西药治疗，几乎没有效果。患者不敢出门，也不能参加学校的游泳和工艺课等多项活动。
采用本发明新配方外敷治疗，共5个疗程，每个疗程7天。第一个疗程后，皮炎覆盖面的扩大得到遏制，渗出减轻，苔藓样变缓和；第二个疗程后，基本没有渗出，苔藓样变进一步缓和，干燥肥厚的外围皮肤开始脱落；第三个疗程后，渗出完全停止，为新皮肤覆盖，苔藓样变基本消失，肥厚的外围皮肤进一步脱落；第四个疗程 后，新皮肤生长完全，苔藓样变消失，肥厚的外围皮肤的脱落基本完成，特应性皮炎的症状消失；第五个疗程后为巩固和维护过程，该疗程后，患者特应性皮炎的症状完全消失，原先的皮炎处全部恢复正常皮肤状。本发明新配方外敷治疗后至今8个月，患者原先的皮炎处一直保持正常皮肤状，没有任何复发迹象。
工业实用性
本发明的特应性皮炎中药制剂、制备方法及其用途可以在工业中制造，并且具有特应性皮炎的效果。
以上描述是对本发明的解释，不是对发明的限定，本发明所限定的范围参见权利要求，在不违背本发明的精神的情况下，本发明可以作任何形式的修改。

Claims (8)

  1. 一种特应性皮炎中药制剂，其特征在于：它包括：按照体积计算的诺丽果汁发酵原汁10份、臭草叶汁1份和百里香叶汁0.5份，诺丽果汁发酵原汁是将新鲜成熟的诺丽果清洗晾干，在250C～350C温度下的密闭容器内放置3个月，使其自然发酵，过滤制得诺丽果发酵原汁。
  2. 根据权利要求1所述的特应性皮炎中药制剂，其特征在于：所述渃丽果包括：来自生长于南太平洋群岛，菲律宾，夏威夷，海南岛、台湾、热带或亚热带的诺丽果。
  3. 根据权利要求1或2所述的特应性皮炎中药制剂，其特征在于：所述臭草叶是产自中国或世界各地的臭草叶；所述百里香叶是产自中国或世界各地的百里香叶。
  4. 一种制造如权利要求1所述特应性皮炎中药制剂的制备方法，它包括以下步骤：将新鲜成熟的诺丽果清洗晾干，在250C～350C温度下的密闭容器内放置3个月，使其自然发酵，过滤制得诺丽果发酵原汁；将选好的新鲜臭草叶和百里香叶分别用清水洗净、消毒、榨汁和过滤得到臭草叶汁和百里香叶汁；按配方的体积比,分别将诺丽果汁发酵原汁10份、臭草叶汁1份和百里香叶汁0.5份均匀混合后，得到特应性皮炎中药制剂。
  5. 如权利要求1所述的一种特应性皮炎中药制剂的用途，其特征在于：所述特应性皮炎中药制剂是用于治疗特应性皮炎的药物。
  6. 如权利要求5所述的一种特应性皮炎中药制剂的用途，其特征在于：所述特应性皮炎中药制剂在治疗特应性皮炎的药物中占10-90％，其余为辅料。
  7. 如权利要求6所述的一种特应性皮炎中药制剂的用途，其特征在于：所述的辅料为淀粉、山梨醇、麦芽糖、葡萄糖、蔗糖、乳糖、硅衍生物、纤维素及其衍生物、明胶、甘油、滑石粉、碳酸钙、碳酸氢钙、蒸馏水、环糊精中的一种或几种的混合物。
  8. 如权利要求7所述的一种特应性皮炎中药制剂的用途，其特征在于：所述治疗特应性皮炎的药物为栓剂、软硬膏剂、霜剂、喷雾剂、滴剂、贴剂、片剂、糖衣片剂、 肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、丹剂、粉剂或注射剂。
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CN112870330A (zh) * 2021-01-27 2021-06-01 贝壳派创新科技（深圳）有限公司 一种治疗急性渗出期皮炎湿疹的湿敷贴及其制备方法
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