CN105213557A - A kind of traditional Chinese medicine composition for treating eczema - Google Patents
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Abstract
Description
技术领域technical field
本发明属于中药领域,特别是涉及一种治疗湿疹的中药组合物。The invention belongs to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating eczema.
背景技术Background technique
湿疹是一种常见的过敏性炎症性皮肤病,其特点为多形性皮疹,渗出倾向,对称分布,易于复发和慢性化。湿疹病因较复杂,目前多认为是过敏性疾病,属第Ⅳ型变态反应。过敏原可来自外界,亦可来自机体内部。外界过敏原如化学药品、化妆品、染料、某些动物的毒素,蛋、鱼、虾、牛奶等异性蛋白以及某些花粉、尘埃等。内部过敏原如体内病灶,肠寄生虫病,某些代谢、内分泌或消化道功能失调以及人体本身某些组织在某些因子的影响下,其成份发生改变而形成自身抗体等。Eczema is a common allergic inflammatory skin disease, characterized by polymorphic rash, exudative tendency, symmetrical distribution, easy to relapse and chronic. The etiology of eczema is more complicated, and it is mostly considered to be an allergic disease at present, belonging to the fourth type of allergy. Allergens can come from the outside world or from inside the body. External allergens such as chemicals, cosmetics, dyes, toxins from certain animals, heterosexual proteins such as eggs, fish, shrimp, and milk, as well as certain pollen and dust. Internal allergens such as internal lesions, intestinal parasitic diseases, some metabolic, endocrine or digestive tract dysfunction, and some tissues of the human body under the influence of certain factors, the composition of which changes to form autoantibodies, etc.
中医认为该病主要由于病初脾胃失健,湿邪内生,郁久化热,湿热内蕴,外越肌肤则疹色鲜红,浸淫流液,病久反复发作,阴血被耗;气血失和,化燥生风,肌肤失养,粗糙肥厚,缠绵难愈。总之,该病属湿热,血热,湿阻,血燥所引起。临床应根据患者的体质、脉证,选方用药,不可拘泥成方。Traditional Chinese medicine believes that the disease is mainly due to spleen and stomach failure at the beginning of the disease, internal dampness, stagnant heat for a long time, damp heat accumulated in the body, and the skin becomes bright red when it is outside, soaked in liquid, and the disease recurs for a long time, and the blood is consumed; Qi and blood Disharmony, dryness and wind, skin loss of nourishment, rough and thick, lingering and difficult to heal. In short, the disease is caused by damp heat, blood heat, damp resistance, and blood dryness. Clinically, prescriptions and medications should be selected according to the patient's constitution and pulse syndrome, and prescriptions should not be rigidly formulated.
西医治疗以内服抗组胺药物为主,外用药主要根据不同病期表现选用溶液、洗剂、糊剂或软膏等湿敷或外涂,存在继发性感染时,会考虑使用抗生素治疗,但是一些西药对皮肤存在较大的毒副作用,同时抗生素、激素等治疗不仅会直接影响病人的健康,而且较长时间或短期大剂量使用,会成瘾并导致药物依赖性皮炎。Western medicine mainly uses antihistamines for oral administration. For external use, solutions, lotions, pastes, or ointments are mainly used for wet compresses or external application according to the symptoms of different stages of the disease. When there is a secondary infection, antibiotics will be considered for treatment, but Some western medicines have relatively large toxic and side effects on the skin. At the same time, treatments such as antibiotics and hormones will not only directly affect the health of patients, but also lead to addiction and drug-dependent dermatitis if used in large doses for a long time or in a short period of time.
艾叶为菊科植物艾的干燥叶,又名灸草,蕲艾,艾蒿和艾蓬等,其味苦,辛,性温;归肝、脾、肾经;具有理气血,温经止血,散寒止痛等功效,是一种妇科良药,用于吐血,衄血,崩漏,月经过多,胎漏下血,少腹冷痛,经寒不调,宫冷不孕等。药理研究表示,艾叶在体外对金黄色葡萄球菌、大肠杆菌、枯草杆菌等多种细菌均有抗菌作用,同时艾叶油对卵白蛋白引起的豚鼠过敏性休克有对抗作用,可降低死亡率。中国专利申请201210287998.9公开了一种治疗湿疹的外敷药,该药物由由土茯苓、连翘、荆芥、艾叶、朴硝、透骨草、甘草、花椒中药材分别浸泡在经煮开冷却的米醋中,再接种醋酸杆菌,经不同发酵时间发酵后,再将其发酵液勾兑制成。该药物在治疗湿疹方面具有一定疗效,但是该药物制备方法复杂,治疗疗程长。Artemisia argyi is the dried leaf of the plant Artemisia argyi, also known as moxibustion grass, Artemisia argyi, Artemisia argyi and Artemisia argyi, etc. It is bitter, pungent, and warm in nature; it returns to the liver, spleen, and kidney channels; it has the functions of regulating qi and blood, warming the meridian and stopping bleeding. , dispelling cold and relieving pain and other effects, is a good gynecological medicine, used for vomiting blood, epistaxis, metrorrhagia, menorrhagia, fetal leakage, bleeding in the lower abdomen, cold pain in the lower abdomen, irregular menstruation, cold uterine infertility, etc. Pharmacological studies have shown that Artemisia argyi has antibacterial effects on various bacteria such as Staphylococcus aureus, Escherichia coli, and Bacillus subtilis in vitro. At the same time, Artemisia argyi oil has an antagonistic effect on anaphylactic shock in guinea pigs caused by ovalbumin, which can reduce mortality. Chinese patent application 201210287998.9 discloses a medicine for external application for treating eczema. , and then inoculated with Acetobacter, fermented for different fermentation times, and then blended with the fermented liquid. The medicament has a certain curative effect in treating eczema, but the preparation method of the medicament is complicated and the treatment course is long.
发明内容Contents of the invention
本发明要解决的技术问题是提供一种治疗湿疹的中药组合物,该中药组合物能够快速止痒,具有针对性强、疗效好、复发率低的优点,具有良好的远期效果。The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating eczema, which can quickly relieve itching, has the advantages of strong pertinence, good curative effect, low recurrence rate, and good long-term effect.
此外,本发明还提供该中药组合物的制备工艺,在保证疗效的基础上,将传统中药制成普适性强、易于携带使用的成品制剂。In addition, the present invention also provides the preparation process of the traditional Chinese medicine composition, on the basis of ensuring the curative effect, the traditional Chinese medicine is made into a finished preparation with strong universal applicability and easy to carry and use.
本发明所述的治疗湿疹的中药组合物主要由以下重量份数的制备原料组成:艾叶26-35份、马齿苋24-33份、荆芥19-24份、白鲜皮20-27份、蝉蜕18-26份、黄连17-25份、紫草19-26份、黄芪14-20份、桂皮13-20份、合欢花16-21份、夜交藤15-22份、辣木叶12-18份、银杏叶13-19份和甘草10-20份。The traditional Chinese medicine composition for treating eczema of the present invention is mainly composed of the following preparation raw materials in parts by weight: 26-35 parts of Artemisia argyi, 24-33 parts of purslane, 19-24 parts of Schizonepeta, 20-27 parts of white fresh skin , 18-26 parts of cicada slough, 17-25 parts of coptis, 19-26 parts of comfrey, 14-20 parts of astragalus, 13-20 parts of cassia bark, 16-21 parts of albizia julibrissin, 15-22 parts of night vine, Moringa leaf 12-18 parts, 13-19 parts of ginkgo biloba and 10-20 parts of licorice.
优选地,本发明所述的治疗湿疹的中药组合物主要由以下重量份数的制备原料组成:艾叶26份、马齿苋24份、荆芥19份、白鲜皮20份、蝉蜕18份、黄连17份、紫草19份、黄芪14份、桂皮13份、合欢花16份、夜交藤15份、辣木叶12份、银杏叶13份和甘草10份。Preferably, the traditional Chinese medicine composition for treating eczema according to the present invention mainly consists of the following preparation raw materials in parts by weight: 26 parts of Artemisia argyi leaves, 24 parts of purslane, 19 parts of Nepeta chinensis, 20 parts of white fresh skin, 18 parts of cicada slough, 17 parts of coptis, 19 parts of comfrey, 14 parts of astragalus, 13 parts of cinnamon, 16 parts of albizia flower, 15 parts of night vine, 12 parts of Moringa leaf, 13 parts of ginkgo leaf and 10 parts of licorice.
优选地,本发明所述的治疗湿疹的中药组合物主要由以下重量份数的制备原料组成:艾叶35份、马齿苋33份、荆芥24份、白鲜皮27份、蝉蜕26份、黄连25份、紫草26份、黄芪20份、桂皮20份、合欢花21份、夜交藤22份、辣木叶18份、银杏叶19份和甘草20份。Preferably, the traditional Chinese medicine composition for treating eczema according to the present invention mainly consists of the following preparation raw materials in parts by weight: 35 parts of Artemisia argyi leaves, 33 parts of purslane, 24 parts of Nepeta chinensis, 27 parts of white fresh skin, 26 parts of cicada slough, 25 parts of coptis, 26 parts of comfrey, 20 parts of astragalus, 20 parts of cinnamon, 21 parts of albizia flower, 22 parts of night vine, 18 parts of Moringa leaf, 19 parts of ginkgo leaf and 20 parts of licorice.
优选地,本发明所述的治疗湿疹的中药组合物主要由以下重量份数的制备原料组成:艾叶30份、马齿苋30份、荆芥22份、白鲜皮25份、蝉蜕24份、黄连23份、紫草23份、黄芪18份、桂皮17份、合欢花18份、夜交藤20份、辣木叶16份、银杏叶15份和甘草15份。Preferably, the traditional Chinese medicine composition for treating eczema according to the present invention mainly consists of the following preparation raw materials in parts by weight: 30 parts of Artemisia argyi leaves, 30 parts of purslane, 22 parts of Nepeta chinensis, 25 parts of white fresh skin, 24 parts of cicada slough, 23 parts of coptis, 23 parts of comfrey, 18 parts of astragalus, 17 parts of cinnamon, 18 parts of albizia flower, 20 parts of night vine, 16 parts of moringa leaf, 15 parts of ginkgo leaf and 15 parts of licorice.
本发明中药组合物的制备方法包含以下步骤:The preparation method of Chinese medicine composition of the present invention comprises the following steps:
S1:取马齿苋,洗去杂质,干燥后粉碎,过60-80目筛,加入药材总重量8-10倍量体积分数为60-80%的乙醇,微波提取8-15分钟,微波功率为240-300W,提取温度为40-60℃,过滤并保留马齿苋药渣,滤液减压浓缩至60℃下测相对密度为1.20-1.25的浸膏,制得马齿苋提取物;S1: Take purslane, wash away impurities, dry and pulverize, pass through a 60-80 mesh sieve, add 8-10 times the total weight of medicinal materials in ethanol with a volume fraction of 60-80%, microwave extraction for 8-15 minutes, microwave power 240-300W, the extraction temperature is 40-60°C, filter and retain the purslane medicinal residue, and concentrate the filtrate under reduced pressure to 60°C to measure the extract with a relative density of 1.20-1.25 to obtain the extract of purslane;
S2:取艾叶、荆芥、白鲜皮、蝉蜕、黄连、紫草、黄芪、桂皮、合欢花、夜交藤、辣木叶、银杏叶和甘草,洗去杂质,干燥后粉碎,合并所述马齿苋药渣,加入粗粉总量15-20倍量的水,浸泡20-30分钟,回流提取2-3次,每次1-3小时,过滤,合并滤液,滤液减压浓缩至60℃下测相对密度为1.10-1.20的浸膏,冷却,边搅拌边缓慢加入乙醇至含醇量为达40-60%,4℃静置12-24小时,过滤并保留滤渣,得滤液A;S2: Take Artemisia argyi leaves, Nepeta, Ginkgo biloba, Cicada slough, Coptis chinensis, Comfrey, Astragalus, Cinnamon bark, Albizia julibrissin, Nocturnal vine, Moringa leaves, Ginkgo leaves and licorice, wash away impurities, dry and pulverize, and combine the Purslane medicine dregs, add 15-20 times the amount of coarse powder in water, soak for 20-30 minutes, reflux extraction 2-3 times, 1-3 hours each time, filter, combine the filtrate, and concentrate the filtrate under reduced pressure to 60 Measure the extract with a relative density of 1.10-1.20 at ℃, cool, slowly add ethanol while stirring until the alcohol content reaches 40-60%, let stand at 4 ℃ for 12-24 hours, filter and retain the filter residue to obtain filtrate A;
S3:将S2中得到的滤渣边搅拌边缓慢加入其重量4-6倍量体积分数为40-60%的乙醇,4℃静置3-5小时,过滤,得滤液B和滤渣;滤渣再用40-60%的乙醇洗涤2-3遍,收集并合并洗涤液;S3: Slowly add 4-6 times the weight of ethanol with a volume fraction of 40-60% to the filter residue obtained in S2 while stirring, let stand at 4°C for 3-5 hours, and filter to obtain filtrate B and filter residue; filter residue is reused Wash with 40-60% ethanol for 2-3 times, collect and combine the washing liquid;
S4:合并所述滤液A,滤液B和洗涤液,混匀后减压浓缩至60℃条件下测相对密度为1.20-1.25的浸膏;S4: Combine the filtrate A, filtrate B and the washing liquid, mix well, concentrate under reduced pressure to 60°C, and measure the extract with a relative density of 1.20-1.25;
S5:将所述马齿苋提取物和S4中制得的浸膏合并混匀,在60℃温度下进行真空带式干燥,干燥压力为-0.08MPa,进料速度为12L/h,料带传送速度为28cm/min,干燥后将干浸膏粉碎,过100-200目筛,即得。S5: Combine and mix the purslane extract and the extract prepared in S4, and carry out vacuum belt drying at a temperature of 60°C, the drying pressure is -0.08MPa, and the feeding speed is 12L/h. The transmission speed is 28cm/min. After drying, the dry extract is crushed and passed through a 100-200 mesh sieve.
利用现代通用的中药制剂技术,本发明中药组合物可制成临床需要的成品制剂,如糊剂、凝胶剂、乳膏剂、软膏剂或搽剂等剂型。Utilizing modern general Chinese medicine preparation technology, the Chinese medicine composition of the present invention can be made into clinically required finished preparations, such as dosage forms such as paste, gel, cream, ointment or liniment.
本发明中药组合物所用中药材的来源、性味、归经及功效:The source, nature and flavor, meridian distribution and efficacy of the Chinese medicinal materials used in the Chinese medicine composition of the present invention:
艾叶:本品为菊科植物艾的干燥叶;味辛、苦,性温;归脾、肝、肾经;理气血,逐寒湿,散寒止痛,温经止血。Artemisia argyi: This product is the dried leaf of Artemisia argyi of Compositae; taste is pungent, bitter, warm in nature; returns to spleen, liver, kidney meridians; regulates qi and blood, expels cold-dampness, dispels cold and relieves pain, warms meridians to stop bleeding.
马齿苋:本品为马齿苋科一年生草本植物的干燥全草;酸,寒;清热解毒,散血消肿。Purslane: This product is the dried whole plant of the annual herb of the family Portulaca oleracea; sour, cold; heat-clearing and detoxifying, dispersing blood and detumescence.
荆芥:本品为唇形科植物荆芥的干燥地上部分;味辛,性微温;归肺、肝经;解表散风,透疹。Schizonepeta: This product is the dried aboveground part of Nepeta chinensis of Lamiaceae; pungent in taste, slightly warm in nature; returns to lung and liver meridian; relieves exterior and dispels wind, and penetrates rash.
白鲜皮:本品为芸香科植物白鲜的干燥根皮;味苦,性寒;归脾、胃、膀胱经;清热燥湿,祛风止痒,解毒。Radix Radix Cortex: This product is the dry root bark of Radix Radix Radix Rutaceae plant; Bitter in the mouth, cold in nature; returns spleen, stomach, bladder meridian; clears away heat and dampness, expelling wind and relieving itching, detoxification.
蝉蜕:本品为蝉科昆虫黑蚱的幼虫羽化时脱落的皮壳;味甘,性寒;归肺、肝经;散风除热,利咽,透疹,退翳,解痉。Cicada slough: This product is the shell shed by the larvae of Cicadae insects, black grasshoppers when they emerge; sweet in taste, cold in nature; returns to the lung and liver meridian; dispels wind and heat, relieves throat, clears rash, relieves nebula, and relieves spasm.
黄连:本品为毛茛科植物黄连、三角叶黄连或云连的干燥根茎;味苦,性寒;归心、脾、胃、肝、胆、大肠经;清热燥湿,泻火解毒。Coptis: This product is the dried rhizome of Coptis chinensis, Coptidis triangularis or Yunlian of Ranunculaceae; bitter in taste, cold in nature; Guixin, spleen, stomach, liver, gallbladder, large intestine meridian; heat-clearing and damp-drying, purging fire and detoxifying.
紫草:本品为紫草科植物新疆紫草、紫草或内蒙紫草的干燥根;味甘、咸,性寒;归心、肝经;凉血,活血,解毒透疹。Comfrey: This product is the dry root of Xinjiang Comfrey, Comfrey or Inner Mongolia Comfrey; sweet, salty, cold in nature; heart-guiding, liver meridian; cooling blood, promoting blood circulation, detoxifying and penetrating rash.
黄芪:本品为豆科植物红花岩黄芪的根;味甘,性温;归心、肺、脾、肾经;补气固表,利尿,托毒排脓,生肌敛疮。Astragalus: This product is the root of the leguminous plant Astragalus safflower; sweet in taste, warm in nature; Guixin, lung, spleen, and kidney meridian; invigorating qi and strengthening the exterior, diuretic, supporting toxin and expulsion of pus, promoting muscle regeneration and astringing sores.
桂皮:本品为樟科植物天竺桂、阴香、细叶香桂或川桂等的树皮;味辛、甘,性温;归脾、胃、肝、肾经;温脾胃,暖肝肾,祛寒止痛,散瘀消肿。Cinnamon bark: This product is the bark of Lauraceae plants such as Tianzhugui, Yinxiang, Xiyexianggui or Chuangui; it is pungent, sweet, and warm in nature; it returns to the spleen, stomach, liver, and kidney channels; Cold for relieving pain, dissipating blood stasis and detumescence.
合欢花:本品为豆科植物合欢的干燥花序;味甘,性平;归心、肝经;舒郁,理气,安神,活络。Albizia Julibrissin: This product is the dried inflorescence of Albizia juliensis of leguminous plant; sweet in taste, flat in nature; heart-guiding and liver meridian; relieving depression, regulating qi, calming the nerves and activating collaterals.
夜交藤:为蓼科植物何首乌的藤茎或带叶藤茎;味甘、微苦,性平;归心、肝经;养心安神,祛风,通络。Yejiaoteng: It is the cane or leafy cane of Polygonum Polygoni Multiflori Polygonum in the family Polygonaceae; sweet, slightly bitter, flat in nature; heart-guiding and liver meridian; nourishing the heart and calming the nerves, expelling wind, and dredging collaterals.
辣木叶:本品为多年生热带落叶乔木辣木树(又称为鼓槌树)的干燥树叶,有降血糖、降脂、降压、抗肿瘤、抗氧化、通便、利尿、驱虫、改善睡眠等功效。Moringa leaf: This product is the dry leaves of the perennial tropical deciduous tree Moringa tree (also known as the drumstick tree). Improve sleep and other effects.
银杏叶:本品为银杏科植物银杏的干燥叶;甘、苦、涩,平;归心、肺经;活血化瘀,通络止痛,敛肺平喘,化浊降脂。Ginkgo biloba: This product is the dried leaves of Ginkgo biloba plant; sweet, bitter, astringent, flat; heart-guiding, lung meridian; promoting blood circulation and removing blood stasis, dredging collaterals to relieve pain, astringing lungs to relieve asthma, reducing turbidity and reducing fat.
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,调和诸药。Licorice: This product is the dried root of leguminous licorice, licorice inflating or licorice glabra. Sweet in taste, calm in nature; Guixin, lung, spleen, and stomach meridian; invigorating the spleen and replenishing qi, clearing away heat and detoxification, and harmonizing various medicines.
本发明中药组方的组方分析:The prescription analysis of Chinese medicine prescription of the present invention:
本发明中药组合物是以艾叶、荆芥、马齿苋为君药,温中止痛,解毒止痒;以白鲜皮、蝉蜕、黄连、紫草为臣药,解毒透疹,清热燥湿,泻火解毒;以夜交藤、黄芪、桂皮、合欢花、辣木叶、银杏叶为佐药,养心安神,托毒排脓;以甘草为使药,补脾益气,清热解毒,调和诸药性,使诸药搭配,共同达到杀菌止痒,解毒透疹,托毒排脓,生肌敛疮的功效,对湿疹具有显著的治疗效果。The traditional Chinese medicine composition of the present invention is to take Artemisia argyi, Schizonepeta, and purslane as monarch drugs, warming middle-JIAO pain relief, detoxifying and relieving itching; taking D. chinensis, cicada slough, Coptis chinensis, and comfrey as ministerial drugs, detoxifying and penetrating rash, clearing heat and drying dampness, Purging fire and detoxifying; using Nocturna vine, astragalus, cinnamon bark, acacia, Moringa leaf, and ginkgo biloba as adjuvant medicines, nourishing the heart and tranquilizing the nerves, supporting toxins and expulsion of pus; using licorice as an envoy, nourishing the spleen and Qi, clearing away heat and detoxification, and harmonizing The properties of various medicines make the combination of various medicines jointly achieve the effects of sterilizing and relieving itching, detoxifying and penetrating rashes, removing toxins and discharging pus, promoting muscle growth and suppressing sores, and has a significant therapeutic effect on eczema.
经过临床试验验证,本发明中药组合物与现有药物相比具有如下优势:Through clinical test verification, the traditional Chinese medicine composition of the present invention has the following advantages compared with existing medicines:
1)本发明能够显著改善湿疹的症状,起效快,治疗疗程短,并可抑制继发性感染。1) The present invention can significantly improve the symptoms of eczema, has quick onset, short treatment course, and can inhibit secondary infection.
2)本发明中药组合物为天然纯中药制剂,毒副作用小,对皮肤无刺激性。2) The Chinese medicine composition of the present invention is a natural pure Chinese medicine preparation, has little toxic and side effects, and is non-irritating to the skin.
3)本发明中药组合物协同作用强,使用剂量小,同时不会产生药物依赖性。3) The traditional Chinese medicine composition of the present invention has a strong synergistic effect, a small dosage and no drug dependence.
具体实施方式detailed description
以下通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,且包含在本发明的范围之内。The present invention is further described by specific examples below, and the present invention is not limited only to the following examples. Within the scope of the present invention or without departing from the content, spirit and scope of the present invention, changes, combinations or substitutions to the present invention are obvious to those skilled in the art and are included in the scope of the present invention Inside.
实施例lExample 1
本发明实施例1中药组合物主要由以下重量份数的制备原料组成:The Chinese medicine composition of Example 1 of the present invention mainly consists of the following preparation raw materials in parts by weight:
艾叶26份、马齿苋24份、荆芥19份、白鲜皮20份、蝉蜕18份、黄连17份、紫草19份、黄芪14份、桂皮13份、合欢花16份、夜交藤15份、辣木叶12份、银杏叶13份和甘草10份。26 parts of mugwort leaves, 24 parts of purslane, 19 parts of nepeta, 20 parts of white fresh skin, 18 parts of cicada slough, 17 parts of berberine, 19 parts of comfrey, 14 parts of astragalus, 13 parts of cinnamon, 16 parts of Albizia juliensis, night vine 15 parts, Moringa leaf 12 parts, Ginkgo biloba 13 parts and licorice 10 parts.
制备方法:Preparation:
S1:取马齿苋,洗去杂质,干燥后粉碎,过60目筛,加入药材总重量10倍量体积分数为60%的乙醇,微波提取8分钟,微波功率为240W,提取温度为40℃,过滤并保留马齿苋药渣,滤液减压浓缩至60℃下测相对密度为1.20的浸膏,制得马齿苋提取物;S1: Take purslane, wash away impurities, dry and crush, pass through a 60-mesh sieve, add 10 times the total weight of medicinal materials in ethanol with a volume fraction of 60%, and extract by microwave for 8 minutes with a microwave power of 240W and an extraction temperature of 40°C , filter and retain the purslane medicine dregs, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.20 measured at 60° C., and obtain a purslane extract;
S2:取艾叶、荆芥、白鲜皮、蝉蜕、黄连、紫草、黄芪、桂皮、合欢花、夜交藤、辣木叶、银杏叶和甘草,洗去杂质,干燥后粉碎,合并所述马齿苋药渣,加入粗粉总量15倍量的水,浸泡30分钟,回流提取2次,每次3小时,过滤,合并滤液,滤液减压浓缩至60℃下测相对密度为1.10的浸膏,冷却,边搅拌边缓慢加入乙醇至含醇量为达40%,4℃静置24小时,过滤并保留滤渣,得滤液A;S2: Take Artemisia argyi leaves, Nepeta, Ginkgo biloba, Cicada slough, Coptis chinensis, Comfrey, Astragalus, Cinnamon bark, Albizia julibrissin, Nocturnal vine, Moringa leaves, Ginkgo leaves and licorice, wash away impurities, dry and pulverize, and combine the Purslane medicinal dregs, add 15 times of the total amount of coarse powder in water, soak for 30 minutes, reflux extraction twice, each time for 3 hours, filter, combine the filtrate, and concentrate the filtrate under reduced pressure to 60°C to measure the relative density of 1.10 extract, cool, slowly add ethanol while stirring until the alcohol content reaches 40%, let it stand at 4°C for 24 hours, filter and retain the filter residue to obtain filtrate A;
S3:将S2中得到的滤渣边搅拌边缓慢加入其重量4倍量体积分数为60%的乙醇,4℃静置5小时,过滤,得滤液B和滤渣;滤渣再用60%的乙醇洗涤3遍,收集并合并洗涤液;S3: Slowly add 4 times the weight of ethanol with a volume fraction of 60% to the filter residue obtained in S2 while stirring, let it stand at 4°C for 5 hours, and filter to obtain filtrate B and filter residue; the filter residue is washed with 60% ethanol for 3 Collect and combine the washing solution;
S4:合并所述滤液A,滤液B和洗涤液,混匀后减压浓缩至60℃条件下测相对密度为1.20的浸膏;S4: Combine the filtrate A, filtrate B and the washing liquid, mix well, concentrate under reduced pressure to 60°C, and measure the extract with a relative density of 1.20;
S5:将所述马齿苋提取物和S4中制得的浸膏合并混匀,在60℃温度下进行真空带式干燥,干燥压力为-0.08MPa,进料速度为12L/h,料带传送速度为28cm/min,干燥后将干浸膏粉碎,过100目筛,即得本发明中药组合物细粉;S5: Combine and mix the purslane extract and the extract prepared in S4, and carry out vacuum belt drying at a temperature of 60°C, the drying pressure is -0.08MPa, and the feeding speed is 12L/h. The conveying speed is 28cm/min, after drying, the dry extract is pulverized, and passed through a 100-mesh sieve to obtain the fine powder of the Chinese medicine composition of the present invention;
S6:将卡波姆和乳化剂聚山梨酯加入足量的水浸泡30小时,使卡波姆完全润涨,再加入枸缘酸钠和冰醋酸调节其PH值为7.5,混合均匀,制得凝胶基质;S6: Add carbomer and emulsifier polysorbate into enough water to soak for 30 hours to make carbomer fully moisten, then add sodium citrate and glacial acetic acid to adjust its pH value to 7.5, and mix well to obtain gel matrix;
S7:将S5制得的本发明中药组合物细粉溶于水中,依次将丙三醇和丁二醇、本发明中药组合物细粉溶液加入到凝胶基质中,搅拌均匀,即得本发明中药组合物凝胶剂。S7: Dissolve the fine powder of the Chinese medicine composition of the present invention prepared in S5 in water, sequentially add glycerin, butylene glycol, and the fine powder solution of the Chinese medicine composition of the present invention into the gel matrix, and stir evenly to obtain the Chinese medicine of the present invention Composition gel.
实施例2Example 2
本发明实施例2中药组合物主要由以下重量份数的制备原料组成:The traditional Chinese medicine composition of embodiment 2 of the present invention is mainly made up of the preparation raw material of following parts by weight:
艾叶35份、马齿苋33份、荆芥24份、白鲜皮27份、蝉蜕26份、黄连25份、紫草26份、黄芪20份、桂皮20份、合欢花21份、夜交藤22份、辣木叶18份、银杏叶19份和甘草20份。35 parts of mugwort leaves, 33 parts of purslane, 24 parts of nepeta, 27 parts of white fresh skin, 26 parts of cicada slough, 25 parts of berberine, 26 parts of comfrey, 20 parts of astragalus, 20 parts of cinnamon, 21 parts of albizia flower, vine 22 parts, Moringa leaf 18 parts, Ginkgo biloba 19 parts and licorice 20 parts.
制备方法:Preparation:
S1:取马齿苋,洗去杂质,干燥后粉碎,过80目筛,加入药材总重量8倍量体积分数为80%的乙醇,微波提取15分钟,微波功率为300W,提取温度为60℃,过滤并保留马齿苋药渣,滤液减压浓缩至60℃下测相对密度为1.25的浸膏,制得马齿苋提取物;S1: Take purslane, wash away impurities, dry it, crush it, pass through an 80-mesh sieve, add ethanol with a volume fraction of 80% in an amount 8 times the total weight of medicinal materials, and extract with microwave for 15 minutes at a microwave power of 300W and an extraction temperature of 60°C , filter and retain the purslane medicine dregs, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.25 measured at 60° C., and obtain a purslane extract;
S2:取艾叶、荆芥、白鲜皮、蝉蜕、黄连、紫草、黄芪、桂皮、合欢花、夜交藤、辣木叶、银杏叶和甘草,洗去杂质,干燥后粉碎,合并所述马齿苋药渣,加入粗粉总量20倍量的水,浸泡20分钟,回流提取3次,每次1小时,过滤,合并滤液,滤液减压浓缩至60℃下测相对密度为1.20的浸膏,冷却,边搅拌边缓慢加入乙醇至含醇量为达60%,4℃静置12小时,过滤并保留滤渣,得滤液A;S2: Take Artemisia argyi leaves, Nepeta, Ginkgo biloba, Cicada slough, Coptis chinensis, Comfrey, Astragalus, Cinnamon bark, Albizia julibrissin, Nocturnal vine, Moringa leaves, Ginkgo leaves and licorice, wash away impurities, dry and pulverize, and combine the Purslane medicinal dregs, add 20 times the amount of coarse powder in water, soak for 20 minutes, reflux extraction 3 times, each time for 1 hour, filter, combine the filtrate, and concentrate the filtrate under reduced pressure to 60 ° C to measure the relative density of 1.20 extract, cool, slowly add ethanol while stirring until the alcohol content reaches 60%, let stand at 4°C for 12 hours, filter and retain the filter residue to obtain filtrate A;
S3:将S2中得到的滤渣边搅拌边缓慢加入其重量6倍量体积分数为40%的乙醇,4℃静置3小时,过滤,得滤液B和滤渣;滤渣再用60%的乙醇洗涤2遍,收集并合并洗涤液;S3: Slowly add 6 times the weight of ethanol with a volume fraction of 40% to the filter residue obtained in S2 while stirring, let it stand at 4°C for 3 hours, and filter to obtain filtrate B and filter residue; the filter residue is washed with 60% ethanol for 2 Collect and combine the washing solution;
S4:合并所述滤液A,滤液B和洗涤液,混匀后减压浓缩至60℃条件下测相对密度为1.25的浸膏;S4: Combine the filtrate A, filtrate B and the washing solution, mix well, concentrate under reduced pressure to 60°C, and measure the extract with a relative density of 1.25;
S5:将所述马齿苋提取物和S4中制得的浸膏合并混匀,在60℃温度下进行真空带式干燥,干燥压力为-0.08MPa,进料速度为12L/h,料带传送速度为28cm/min,干燥后将干浸膏粉碎,过200目筛,即得本发明中药组合物细粉;S5: Combine and mix the purslane extract and the extract prepared in S4, and carry out vacuum belt drying at a temperature of 60°C, the drying pressure is -0.08MPa, and the feeding speed is 12L/h. The conveying speed is 28cm/min, after drying, the dry extract is pulverized, and passed through a 200-mesh sieve to obtain the fine powder of the Chinese medicine composition of the present invention;
S6:取羧甲基纤维素钠置于研钵中,加入甘油研匀,然后边研边加入羟苯乙酯的乙醇溶液,待溶胀后研匀,将S5制得的中药组合物细粉分次加入,研匀,即得本发明中药组合物的软膏剂。S6: Put sodium carboxymethyl cellulose in a mortar, add glycerin and grind it evenly, then add the ethanol solution of ethylparaben while grinding, grind it evenly after swelling, and divide the fine powder of the traditional Chinese medicine composition prepared in S5 Add once, grind evenly, obtain the ointment of Chinese medicine composition of the present invention.
实施例3Example 3
本发明实施例3中药组合物包括以下重量份数的制备原料:Embodiment 3 of the present invention Chinese medicine composition comprises the preparation raw material of following parts by weight:
艾叶30份、马齿苋30份、荆芥22份、白鲜皮25份、蝉蜕24份、黄连23份、紫草23份、黄芪18份、桂皮17份、合欢花18份、夜交藤20份、辣木叶16份、银杏叶15份和甘草15份。30 parts of mugwort leaf, 30 parts of purslane, 22 parts of nepeta, 25 parts of white fresh skin, 24 parts of cicada slough, 23 parts of berberine, 23 parts of comfrey, 18 parts of astragalus, 17 parts of cinnamon, 18 parts of Albizia juniper, and vine 20 parts, Moringa leaf 16 parts, Ginkgo biloba 15 parts and licorice 15 parts.
制备方法:Preparation:
S1:取马齿苋,洗去杂质,干燥后粉碎,过80目筛,加入药材总重量9倍量体积分数为70%的乙醇,微波提取10分钟,微波功率为280W,提取温度为50℃,过滤并保留马齿苋药渣,滤液减压浓缩至60℃下测相对密度为1.20的浸膏,制得马齿苋提取物;S1: Take purslane, wash away impurities, dry and pulverize, pass through an 80-mesh sieve, add 9 times the total weight of medicinal materials, and add ethanol with a volume fraction of 70%, microwave extraction for 10 minutes, the microwave power is 280W, and the extraction temperature is 50°C , filter and retain the purslane medicine dregs, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.20 measured at 60° C., and obtain a purslane extract;
S2:取艾叶、荆芥、白鲜皮、蝉蜕、黄连、紫草、黄芪、桂皮、合欢花、夜交藤、辣木叶、银杏叶和甘草,洗去杂质,干燥后粉碎,合并所述马齿苋药渣,加入粗粉总量18倍量的水,浸泡25分钟,回流提取3次,每次1小时,过滤,合并滤液,滤液减压浓缩至60℃下测相对密度为1.20的浸膏,冷却,边搅拌边缓慢加入乙醇至含醇量为达50%,4℃静置24小时,过滤并保留滤渣,得滤液A;S2: Take Artemisia argyi leaves, Nepeta, Ginkgo biloba, Cicada slough, Coptis chinensis, Comfrey, Astragalus, Cinnamon bark, Albizia julibrissin, Nocturnal vine, Moringa leaves, Ginkgo leaves and licorice, wash away impurities, dry and pulverize, and combine the Purslane medicine dregs, add 18 times the amount of water of the total amount of coarse powder, soak for 25 minutes, reflux extraction 3 times, each time for 1 hour, filter, combine the filtrate, and concentrate the filtrate under reduced pressure to 60 ° C to measure the relative density of 1.20 extract, cool, slowly add ethanol while stirring until the alcohol content reaches 50%, let stand at 4°C for 24 hours, filter and retain the filter residue to obtain filtrate A;
S3:将S2中得到的滤渣边搅拌边缓慢加入其重量5倍量体积分数为50%的乙醇,4℃静置4小时,过滤,得滤液B和滤渣;滤渣再用50%的乙醇洗涤3遍,收集并合并洗涤液;S3: Slowly add 5 times the weight of ethanol with a volume fraction of 50% to the filter residue obtained in S2 while stirring, let it stand at 4°C for 4 hours, and filter to obtain filtrate B and filter residue; the filter residue is washed with 50% ethanol for 3 Collect and combine the washing solution;
S4:合并所述滤液A,滤液B和洗涤液,混匀后减压浓缩至60℃条件下测相对密度为1.20的浸膏;S4: Combine the filtrate A, filtrate B and the washing liquid, mix well, concentrate under reduced pressure to 60°C, and measure the extract with a relative density of 1.20;
S5:将所述马齿苋提取物和S4中制得的浸膏合并混匀,在60℃温度下进行真空带式干燥,干燥压力为-0.08MPa,进料速度为12L/h,料带传送速度为28cm/min,干燥后将干浸膏粉碎,过200目筛,即得本发明中药组合物细粉;S5: Combine and mix the purslane extract and the extract prepared in S4, and carry out vacuum belt drying at a temperature of 60°C, the drying pressure is -0.08MPa, and the feeding speed is 12L/h. The conveying speed is 28cm/min, after drying, the dry extract is pulverized, and passed through a 200-mesh sieve to obtain the fine powder of the Chinese medicine composition of the present invention;
S6:取羧甲基纤维素钠置于研钵中,加入甘油研匀,然后边研边加入羟苯乙酯的乙醇溶液,待溶胀后研匀,将S5制得的中药组合物细粉分次加入,研匀,即得本发明中药组合物的软膏剂。S6: Put sodium carboxymethyl cellulose in a mortar, add glycerin and grind it evenly, then add the ethanol solution of ethylparaben while grinding, grind it evenly after swelling, and divide the fine powder of the traditional Chinese medicine composition prepared in S5 Add once, grind evenly, obtain the ointment of Chinese medicine composition of the present invention.
本发明中药组合物药效学研究:Pharmacodynamic study of Chinese medicine composition of the present invention:
试验一:本发明中药组合物对耳部湿疹小鼠的研究试验。Test 1: the research test of the traditional Chinese medicine composition of the present invention on mice with ear eczema.
试验动物:由某生物技术有限公司提供清洁级昆明小鼠50只,体重22g±4g,雌雄各半。将50只小鼠随机分为5组,每组10只。Experimental animals: 50 clean-grade Kunming mice provided by a biotechnology company, weighing 22g±4g, half male and half male. 50 mice were randomly divided into 5 groups, 10 in each group.
耳部湿疹小鼠模型建立:第一天在小鼠双耳的双面涂抹40μL5%的二硝基氯苯(DNCB)溶液致敏,第四天涂抹40μL1%的DNCB溶液,之后每隔四日一次涂抹一次,共5次,建立耳部湿疹小鼠模型。Ear eczema mouse model establishment: on the first day, smear 40 μL of 5% dinitrochlorobenzene (DNCB) solution on both sides of the mouse’s ears for sensitization, on the fourth day, apply 40 μL of 1% DNCB solution, and then every four days Apply once a time, 5 times in total, to establish ear eczema mouse model.
给药方案:Dosing regimen:
A组:取本发明实施例1制得的本发明中药组合物凝胶剂;每次涂抹DNCB激发后24h,48h,72h外涂试验药物于小鼠双耳内侧,1g/每次,2次/天。Group A: Get the Chinese medicine composition gel of the present invention prepared in Example 1 of the present invention; 24h, 48h, and 72h after each smearing of DNCB excitation, externally apply test medicine on the inside of both ears of mice, 1g/each time, 2 times /sky.
B组:取本发明实施例2制得的本发明中药组合物软膏剂;给药方案同A组。Group B: take the traditional Chinese medicine composition ointment of the present invention prepared in Example 2 of the present invention; the administration regimen is the same as that of Group A.
C组:取本发明实施例3制得的本发明中药组合物软膏剂;给药方案同A组。Group C: take the traditional Chinese medicine composition ointment of the present invention prepared in Example 3 of the present invention; the administration regimen is the same as that of Group A.
阳性对照组:取复方地塞米松乳膏(广州白云山制药股份有限公司白云山何济公制药厂,国药准字H44024298),给药方案同A组。Positive control group: take compound dexamethasone cream (Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Baiyunshan Hejigong Pharmaceutical Factory, National Pharmaceutical Approval H44024298), and the administration regimen is the same as that of group A.
模型对照组:取本发明实施例1中不含药物的凝胶剂,给药方案同A组。Model control group: the drug-free gel in Example 1 of the present invention was taken, and the administration regimen was the same as that of group A.
按以下标准进行皮损程度计分:双耳明显红肿增厚及渗出,或明显角化结痂者记3分;轻度红肿,渗出不明显,或者中度角化者记为2分;红肿和渗出均不明显者,或轻度角化者记为1分;正常皮肤为0分。Score the degree of skin lesions according to the following criteria: 3 points for obvious redness, swelling, thickening and oozing of both ears, or obvious keratosis and scab; 2 points for mild redness, no obvious oozing, or moderate keratosis ; Redness and exudation are not obvious, or mild keratosis recorded as 1 point; normal skin is 0 points.
同时使用螺旋测微仪分别测量耳朵肿胀厚度。At the same time, the ear swelling thickness was measured separately using a screw micrometer.
表1各组耳部皮损情况比较Table 1 Comparison of ear skin lesions in each group
注:与模型对照组比较,*P0.05;**P0.01.Note: Compared with the model control group, * P0.05; ** P0.01.
药物试验组与模型对照组相比,小鼠耳部皮损积分与耳朵肿胀厚度均有显著性差异。试验数据表明,药物试验组小鼠与模型对照组小鼠相比,耳部皮损明显好转,耳朵肿胀程度明显降低,同时本发明药物试验组C组,即本发明实施例3制备的本发明中药组合物与阳性对照组的疗效相当。试验结果表明,本发明的中药组合物治疗与预防湿疹效果明显,可用于临床推广。Compared with the model control group, the drug test group had significant differences in ear skin lesion score and ear swelling thickness. The test data shows that compared with the mice in the model control group, the skin lesions in the ears of the mice in the drug test group are significantly better, and the degree of ear swelling is significantly reduced. The curative effect of the traditional Chinese medicine composition is equivalent to that of the positive control group. The test results show that the traditional Chinese medicine composition of the invention has obvious effects in treating and preventing eczema, and can be used for clinical promotion.
试验二:本发明中药组合物的临床试验。Test two: the clinical test of the traditional Chinese medicine composition of the present invention.
一、诊断标准1. Diagnostic criteria
参照《中医病证诊断疗效标准》中“湿疹的诊断依据”的内容拟定。诊断标准为:It is formulated with reference to the content of "Diagnostic Basis of Eczema" in "Diagnostic and Curative Criteria for Diseases and Syndromes of Traditional Chinese Medicine". The diagnostic criteria are:
1、急性湿疹1. Acute eczema
1)皮损呈多形性,如潮红、丘疹、水疱、糜烂、渗出、痂皮、脱屑,常数种形态同时存在。1) The skin lesions are pleomorphic, such as flushing, papules, blisters, erosions, exudations, crusts, and desquamation, and multiple forms exist at the same time.
2)起病急,自觉灼热,剧烈瘙痒。2) Acute onset, conscious burning, severe itching.
3)皮损常对称分布,以头、面、四肢远端、阴囊等处多见。可泛发全身。3) Skin lesions are often distributed symmetrically, and are more common on the head, face, distal extremities, and scrotum. Can be distributed all over the body.
4)可发展成亚急性或慢性湿疹,时轻时重,反复不愈。4) It can develop into subacute or chronic eczema, which is sometimes mild and sometimes severe, and does not heal repeatedly.
2、亚急性湿疹:皮损渗出较少,以丘疹、丘疱疹、结痂、鳞屑为主。有轻度糜烂面,颜色较暗红。亦可见轻度浸润,剧烈瘙痒。2. Subacute eczema: less exudation of skin lesions, mainly papules, papules, scabs, and scales. There is a mildly erosive surface, and the color is darker red. Mild infiltration and severe itching can also be seen.
3、慢性湿疹:多限局于某一部位,境界清楚,有明显的肥厚浸润,表面粗糙,或呈苔癣样变,颜色褐红或褐色,常伴有丘疱疹、痂皮、抓痕。倾向湿润变化,常反复发作,时轻时重,有阵发性瘙痒。3. Chronic eczema: mostly limited to a certain part, with clear boundary, obvious hypertrophy and infiltration, rough surface, or lichen-like changes, brownish red or brown in color, often accompanied by papules, scabs, and scratches. It tends to be moist and changes, often recurrent, sometimes mild and sometimes severe, with paroxysmal itching.
二、临床试验方案2. Clinical trial plan
1.试验对象基本资料1. Basic information of test subjects
本发明收集临床湿疹志愿者100例,男52例,女48例,年龄16-45岁,将所有受试者随机分成2个组,每组50名,2个组病例在性别、年龄、病程等方面经统计学分析,具有可比性。The present invention collects 100 clinical eczema volunteers, 52 males, 48 females, aged 16-45 years old, all subjects are randomly divided into 2 groups, 50 in each group, 2 groups of cases in terms of gender, age, course of disease And so on by statistical analysis, comparable.
2.试验药物及试验方法2. Test drugs and test methods
治疗组:本发明实施例3制备的软膏剂,每支软膏剂含有药物12.5g,涂抹在湿疹处,每天二次,连续涂抹10天。Treatment group: the ointment prepared by Example 3 of the present invention, each ointment contains 12.5g of medicine, applied on the eczema, twice a day, continuously for 10 days.
阳性对照组:涂抹复方地塞米松乳膏(广州白云山制药股份有限公司白云山何济公制药厂,国药准字H44024298),每天两次,连续涂抹10天。Positive control group: apply compound dexamethasone cream (Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Baiyunshan Hejigong Pharmaceutical Factory, National Pharmaceutical Approval H44024298), twice a day, for 10 consecutive days.
3.疗效标准3. Curative effect standard
有效:湿疹红斑明显减少,发作次数减少。Effective: Eczema erythema is significantly reduced, and the number of attacks is reduced.
无效:和治疗前相比较,症状没有消失或者反而加重。Ineffective: Compared with before treatment, the symptoms did not disappear or aggravated instead.
复发:治好后3个月遇到湿热气候仍然发作。Recurrence: 3 months after being cured, it still occurs in hot and humid climate.
4.治疗结果,如表2所示4. Treatment results, as shown in Table 2
表2治疗效果Table 2 Treatment effect
试验结果表明,治疗组本发明中药组合物治疗湿疹的效果优于阳性对照药复方地塞米松乳膏。治疗组与阳性对照组相比较,治疗组的总有效率为94.0%高于阳性对照组组的总有效率90.0%,且治疗组的复发例数显著低于阳性对照组的复发例数,临床观察,治疗组患者在治疗过程未见任何不良反应。本发明中药组合物治疗湿疹起效快,安全性高,复发率低,临床推广价值高。The test results show that the effect of the traditional Chinese medicine composition of the present invention in treating eczema in the treatment group is better than that of the positive control drug compound dexamethasone cream. Compared with the positive control group in the treatment group, the total effective rate of the treatment group was 94.0% higher than the total effective rate of 90.0% in the positive control group, and the number of recurrences in the treatment group was significantly lower than that of the positive control group. According to observation, the patients in the treatment group did not see any adverse reactions during the course of treatment. The traditional Chinese medicine composition of the invention has quick onset of effect for treating eczema, high safety, low recurrence rate and high clinical popularization value.
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CN105796807A (en) * | 2016-04-29 | 2016-07-27 | 欧卉 | Externally-applied medicine capable of treating acute eczema |
CN105920093A (en) * | 2016-06-24 | 2016-09-07 | 桂林淮安天然保健品开发有限公司 | Medicinal composition for treating eczema |
CN105998846A (en) * | 2016-07-21 | 2016-10-12 | 何颖 | Method for preparing product |
CN116059300A (en) * | 2022-11-29 | 2023-05-05 | 伊犁弥玥泉生物科技有限公司 | A kind of skin antibacterial ointment and its preparation process |
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CN105796807A (en) * | 2016-04-29 | 2016-07-27 | 欧卉 | Externally-applied medicine capable of treating acute eczema |
CN105920093A (en) * | 2016-06-24 | 2016-09-07 | 桂林淮安天然保健品开发有限公司 | Medicinal composition for treating eczema |
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