WO2022011881A1 - 一种用于预防和治疗痔疮的药物及其应用 - Google Patents

一种用于预防和治疗痔疮的药物及其应用 Download PDF

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WO2022011881A1
WO2022011881A1 PCT/CN2020/125117 CN2020125117W WO2022011881A1 WO 2022011881 A1 WO2022011881 A1 WO 2022011881A1 CN 2020125117 W CN2020125117 W CN 2020125117W WO 2022011881 A1 WO2022011881 A1 WO 2022011881A1
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extract
hemorrhoids
chinese medicine
preventing
agrimony
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PCT/CN2020/125117
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English (en)
French (fr)
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李明
梅丽萍
凌发祥
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杭州科倍安生物制药有限公司
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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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Definitions

  • the invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a medicine for preventing and treating hemorrhoids and its application.
  • Hemorrhoids are a common disease located in the anus, which are soft venous masses formed by the expansion and flexion of the submucosal venous plexus at the end of the rectum and the subcutaneous venous plexus of the anal canal.
  • the etiology and pathogenesis of hemorrhoids are multi-faceted, and the main cause is standing or sitting for a long time, or walking with weight for a long time, or long-term constipation, which affects the venous return of the pelvic cavity and makes the blood flow in the pelvic cavity slow and corresponding.
  • Congestion of the organs causes overfilling of the hemorrhoidal veins, the tension of the vein wall decreases, and further blood stasis expands.
  • Anatomical and physiological defects, improper diet, constipation, chronic diarrhea, increased abdominal pressure during pregnancy, excessive sexual intercourse and inability to ejaculate can also induce a series of pathological changes in hemorrhoids.
  • Hemorrhoids can be easily divided into three types according to the location of occurrence.
  • Internal hemorrhoids the common symptoms are bleeding, prolapse, swelling and pain.
  • External hemorrhoids usually without special symptoms, swelling and pain when thrombosis and inflammation occur.
  • Mixed hemorrhoids mainly manifested as the coexistence of symptoms of internal hemorrhoids and external hemorrhoids.
  • the general treatment methods of Western medicine for hemorrhoids are surgical treatment, or ultra-low temperature, ultra-high temperature therapy, knot sleeve, band ligation and injection therapy.
  • Western medicine surgery and other above-mentioned treatments can quickly eliminate lesions and symptoms, but complications often occur, and postoperative recurrence is easy.
  • the efficacy of ultra-low temperature and ultra-high temperature therapy is similar to that of surgery, and the recurrence rate after treatment is high.
  • Conditioning and banding often lead to blockage of blood circulation in the anus, which is prone to complications such as congestion, edema, pain, and difficulty in defecation.
  • the clinical operation of injection therapy is simple, but the precise selection of the injection site and the control of the dose of the drug are difficult.
  • the purpose of the present invention is to design and provide a medicament for preventing and treating hemorrhoids and a technical solution for its application.
  • a medicament for preventing and treating hemorrhoids is characterized in that it comprises one or more of the extracts of Lambracea chinensis, the extract of celery, and the extract of Agrimony.
  • the described medicine for preventing and treating hemorrhoids is characterized in that the blue cloth zheng extract, the celery extract and the Agrimony grass extract are the alcohol extracts of the corresponding raw materials.
  • the described medicine for preventing and treating hemorrhoids is characterized in that the medicine contains 0.01% to 99.99% by weight of the extract.
  • the described medicine for preventing and treating hemorrhoids is characterized in that it further comprises a pharmaceutically acceptable carrier and/or auxiliary agent.
  • the application is characterized in that the blue cloth orthodox extract, the celery extract and the Agrimony grass extract are the alcohol extracts of the corresponding raw materials.
  • hemorrhoids include: internal hemorrhoids, mixed hemorrhoids, external hemorrhoids, anal cryptitis, anal fissure, anal carbuncle, anal leakage, prolapse or hemorrhoid complication.
  • the blue cloth orthodox extract, the celery extract and the Agrimony grass extract are obtained by ethanol extract; more preferably, the blue cloth orthodox extract, the celiac wilt extract and the Agrimony grass extract are obtained by the following steps: Select the blue cloth is, the celery and/or the Agrimony, wash and remove the impurities, respectively dry and pulverize, and pass through a 80-100 mesh sieve to obtain the blue cloth, the wilted cabbage and/or the Agrimony coarse meal. , 60% ethanol was added to each coarse powder and 60% ethanol in a mass volume ratio of 1:8-10.
  • a kind of medicine for preventing and treating hemorrhoids is ointment, spray or oral preparation, and the scheme of ointment or spray is respectively: firstly, alcohol/water extraction is carried out respectively on Chinese medicine blue cloth, celery, and Agrimony. , spray-dried into powder, then the extracted traditional Chinese medicine powder is adjusted into a paste with accessories in proportion, and then the traditional Chinese medicine paste is pushed into the anus through the ejector, so that the medicine can directly act on the hemorrhoids. Or the extracted traditional Chinese medicine powder is dissolved in 5% ethanol water to make a spray, and the spray is directly sprayed on the affected area, so that the medicine can directly act on the hemorrhoids.
  • the concentration and percentage ratio of the medicinal powder are: 7% of blue cloth extract, 1% of celery extract, 1% of Agrimony grass extract, 70% of auxiliary material Vaseline, and 21% of lanolin. Or: 9% celery extract, 70% vaseline, and 21% lanolin. Or Agrimony Extract 9%, Vaseline 70%, and Lanolin 21%.
  • the concentration percentage ratio of the raw materials of the traditional Chinese medicine ointment or spray is: 5% of blue cloth extract, 2% of celiac extract, 2% of Agrimony grass extract, 70% of auxiliary materials Vaseline, 21% of lanolin.
  • the core is matched with the traditional Chinese medicine ointment, the small diameter head of the bolus injection tube is inserted into the anus 5-7 cm, pushed to the end of the core, and the bolus injection tube is pulled out to complete the application of the medicine, which is used once every morning and before going to bed;
  • the traditional Chinese medicine preparation is:
  • spray on the affected part of the hemorrhoid when the traditional Chinese medicine preparation is an oral traditional Chinese medicine, the use method is: 0.1-10 g/kg body weight orally every day.
  • the medicine of the present invention alleviates the inflammation at the hemorrhoid wound and the damage and destruction of the corresponding tissue caused by secondary bacterial infection, relieves clinical symptoms, and can also inhibit bacteria or sterilize, converge the wound at the damaged part, and promote the microvascular regeneration of the tissue around the wound. , Promote wound healing and tissue repair and regeneration, which greatly improves the damage caused by hemorrhoid disease and its complications to the body, and helps restore the function of damaged tissue.
  • the medicine complies with the quality standard of the composition of the active parts of traditional Chinese medicine, the quality control of the repeatable production procedure, the safety and reliability of the product, the remarkable therapeutic effect and the convenient use.
  • Blue Buzheng Extract Blue Buzheng (Geumjaponicum Thunb.var.chinenseBolle) traditional Chinese medicine, as the monarch medicine of this group, it is mainly used for hypertension, dizziness, headache, irregular menstruation, lower abdominal pain, leucorrhea, infantile convulsions , Rheumatic waist and leg pain, external treatment of carbuncle furuncle swollen poison, bruises.
  • Blue cloth is containing active polyphenolic compounds, which can help clear the necrotic soft tissue of the wound, astringe the injured wound, promote the regeneration of microvascular in the process of tissue repair, stop bleeding and regenerate muscle, clear heat and detoxify, reduce swelling and disperse knots, and has strong properties. antibacterial and anti-inflammatory effect.
  • the pentacyclic triterpenoids contained in it can promote the regeneration and repair of soft tissue in wounds.
  • Phyllanthus sinensis extract Potentillachinensis Ser.
  • traditional Chinese medicine as the minister medicine of this prescription, it is mainly used for clearing away heat and detoxifying, cooling blood to stop dysentery, dysentery abdominal pain, chronic dysentery, hemorrhoid hemorrhage, carbuncle swollen sore.
  • the total flavonoids contained in celery can reduce insulin resistance and repair islet cells, so it can be used to treat type II diabetes. It contains active polyphenolic compounds, including fumaric acid, gallic acid, protocatechuic acid, quercetin, naringenin, etc., which have antibacterial, antibacterial and anti-inflammatory effects on bacteria, especially Shigella, and can be used for the treatment of dysentery. , scabies, and also help to astringe the wound surface of the injured wound and promote the regeneration of microvessels in the process of tissue repair.
  • the triterpenoids it contains can promote soft tissue regeneration and repair in wounds.
  • Agrimonia pilosa extract the traditional Chinese medicine of the dry aerial part of Agrimoniapilosa Ldb., as an adjuvant of this formula, which is mainly used as a tonic astringent hemostatic agent. It mainly contains Agrimonytin, Agrimony Lactone, tannins (such as pyrocatechol tannins, gallic tannins, etc.), sterols, organic acids, phenolic components, saponins and the like. Its extract can be used to help astringe the wounds of hemorrhoids, and has strong astringent hemorrhoid wounds and hemorrhoids hemostasis.
  • the Agrimony Root, Agrimony Lactone, Polyphenols, Saponins, Polysaccharides, etc. contained in it have cardiotonic effect and can be used for hemoptysis in pulmonary diseases, intestinal bleeding, gastric ulcer bleeding, uterine bleeding, dental bleeding, hemorrhoids and other diseases hemostatic effect, etc.
  • Lanbuzheng extract also plays the role of making medicine, anti-inflammatory and analgesic, clearing heat and detoxifying, reconciling the effects of various medicines, so that various medicines work synergistically to achieve antibacterial and anti-inflammatory, heat-clearing and detoxifying, elimination of edema, debridement of necrotic tissue, hemostasis and dissipating blood stasis.
  • blood circulation, muscle regeneration, tissue regeneration and repair effect has a very significant therapeutic effect on internal hemorrhoids, mixed hemorrhoids and external hemorrhoids.
  • Vaseline acts as a drug-carrying adhesive matrix and lubrication.
  • Lanolin acts as an adhesive and lubricating agent.
  • Embodiment 2 the preparation and use of hemorrhoid Chinese medicine preparation-Chinese medicine plaster
  • Embodiment 3 the preparation of hemorrhoid Chinese medicine preparation-Chinese medicine plaster
  • Embodiment 4 the preparation of hemorrhoid Chinese medicine preparation-Chinese medicine plaster
  • Embodiment 5 the preparation of hemorrhoid Chinese medicine preparation-Chinese medicine plaster

Abstract

一种用于预防和治疗痔疮的药物及其应用，属于中药技术领域。该药物包括蓝布正提取物、萎凌菜提取物和仙鹤草提取物中的一种或几种。蓝布正提取物、萎凌菜提取物和/或仙鹤草提取物在制备用于预防和治疗痔疮的药物中的应用。本发明药物减轻了痔疮创口处的炎症和继发细菌感染引起的相应组织的损坏和破坏，减轻临床症状，还可以抑菌或灭菌、收敛受损处的创口、促进创口周围组织的微血管再生、促进创口的愈合和组织修复再生，改善了痔疮疾病及其并发症对机体造成的损害，帮助恢复受损组织的功能。该药物符合中药活性部位组合物的质量标准，可重复的生产程序质量控制，产品安全可靠，治疗效果显著，使用方便。

Description

一种用于预防和治疗痔疮的药物及其应用 技术领域
本发明属于中药技术领域，具体涉及一种用于预防和治疗痔疮的药物及其应用。
背景技术
痔疮是一种位于肛门部位的常见疾病，是由于直肠末端粘膜下和肛管皮肤下静脉丛发生扩张和屈曲所形成的柔软静脉团。痔疮的病因病机是多方面的，其中发生的最主要原因主要是久站或久坐，或者长时间负重行走，抑或长期便秘，影响了盆腔内静脉回流，使盆腔内血流缓慢和相应的脏器充血，引起痔静脉过度充盈，静脉壁张力下降，进一步瘀血扩张。解剖生理上的缺陷及饮食不节、便秘、久泻久痢、妊娠腹压增高、房事过度及忍精不射等诱因作用下也可以诱导产生痔疮的一系列病理变化。
痔疮依据发生的部位，简易地分成三种类型，(1)内痔，常见症状为出血、脱垂、肿胀、疼痛。(2)外痔，平时无特殊症状，发生血栓及炎症时有肿胀、疼痛。(3)混合痔，主要表现为内痔和外痔的症状同时存在。痔疮患者常见症状有便血，大便疼痛，内痔严重时肛门内部会出现肿物脱出，肛门流分泌物，使肛门周边皮肤终日潮湿，导致肛门湿疹和瘙痒，严重影响患者生活质量和身心健康。
西医对于痔疮的一般治疗方法为手术治疗，抑或超低温、超高温疗法，结套、套扎疗法和注射疗法等。西医的手术等上述疗法能快速消除病灶和症状，但常有并发症发生，术后易复发。超低温、超高温疗法的疗效与手术疗法相似，治疗后复发率高。结套、套扎疗法经常会导致肛门局部血液循环受阻，易产生 淤血水肿、疼痛、排便困难等并发症。注射疗法临床操作简便，但注射部位的精准选择和用药剂量的控制比较难，药量控制过多会引起手注射部位的组织坏死和大出血、严重感染等。中医虽有较多的治疗方法包括用口服汤剂、针灸、外敷膏等，但是见效慢并且难以根治。
根据以上的中西医不同疗法的特点和不足之处，寻求一种起效快，效果显著，药效稳定，标本兼治及治疗方法方便的治疗痔疮的有效药物，是目前临床上的迫切需求。
发明内容
针对上述现有技术中存在的问题，本发明的目的在于设计提供一种用于预防和治疗痔疮的药物及其应用的技术方案。
为了实现上述目的，采用以下技术方案：
一种用于预防和治疗痔疮的药物，其特征在于包括蓝布正提取物、萎凌菜提取物和仙鹤草提取物中的一种或几种。
所述的一种用于预防和治疗痔疮的药物，其特征在于所述蓝布正提取物、萎凌菜提取物和仙鹤草提取物为对应原料的醇提物。
所述的一种用于预防和治疗痔疮的药物，其特征在于该药物含有0.01％到99.99％重量的所述提取物。
所述的一种用于预防和治疗痔疮的药物，其特征在于还包括药学可接受载体和/或助剂。
蓝布正提取物、萎凌菜提取物和/或仙鹤草提取物在制备用于预防和治疗痔疮的药物中的应用。
所述的应用，其特征在于所述蓝布正提取物、萎凌菜提取物和仙鹤草提取物为对应原料的醇提物。
所述的应用，其特征在于所述痔疮包括：内痔、混合痔、外痔、肛隐窝炎、 肛裂、肛痈、肛漏、脱肛或痔疮并发症。
作为优选，蓝布正提取物、萎凌菜提取物和仙鹤草提取物为通过乙醇提取物；更优选，蓝布正提取物、萎凌菜提取物和仙鹤草提取物通过以下步骤得到：精选蓝布正、萎凌菜和/或仙鹤草，洗净去杂质，分别干燥后粉碎，过80-100目筛，得到蓝布正粗粉、萎凌菜粗粉和/或仙鹤草粗粉，以各粗粉与60％乙醇1：8-10质量体积比分别加入60％乙醇，40℃浸提3-8h后，60℃回流提取2h，降至室温，过滤，得到滤液减压浓缩，喷雾干燥，得到蓝布正提取物、萎凌菜提取物和仙鹤草提取物。
作为优选，一种用于预防和治疗痔疮的药物为膏剂、喷剂或者口服剂，膏剂或者喷剂的方案分别是：首先对中药蓝布正，萎凌菜，仙鹤草分别进行醇/水提取，喷雾干燥成粉，然后将提取的中药粉按比例用辅料调成膏状，然后将中药膏经推射器推入肛门，使药物直接作用在痔疮部位。或者将提取的中药粉溶解于5％乙醇水中，制成喷剂，将喷剂直接喷在患处，使药物直接作用在痔疮部位。药粉的浓度百分比配比为：蓝布正提取物7％、萎凌菜提取物1％、仙鹤草提取物1％、辅料凡士林70％、羊毛脂21％。或者：萎凌菜提取物9％、辅料凡士林70％、羊毛脂21％。再或者仙鹤草提取物9％、辅料凡士林70％、羊毛脂21％。作为优选，中药膏或喷剂原料其浓度百分比配比为，蓝布正提取物5％、萎凌菜提取物2％、仙鹤草提取物2％、辅料凡士林70％、羊毛脂21％。
一种用于预防和治疗痔疮的药物的使用方法，所述中药制剂为中药膏剂时使用方法为：直接涂抹患处，或者取3g中药制剂注入推注管小径头部后，装进推芯，推芯与中药膏吻合，将推注管小径头塞入肛门5-7公分，推至推芯到底，拔出推注管完成上药，每天早上和临睡前各用一次；所述中药制剂为中药喷剂时使用方法为：喷施于患处痔疮部位；所述中药制剂为中药口服剂时使用方法为：每日口服0.1-10克/公斤体重。
本发明具有以下有益效果：
本发明药物减轻了痔疮创口处的炎症和继发细菌感染引起的相应组织的损坏和破坏，减轻临床症状，还可以抑菌或灭菌、收敛受损处的创口、促进创口周围组织的微血管再生、促进创口的愈合和组织修复再生，这就极大地实质性地改善了痔疮疾病及其并发症对机体造成的损害，帮助恢复受损组织的功能。该药物符合中药活性部位组合物的质量标准，可重复的生产程序质量控制，产品安全可靠，治疗效果显著，使用方便。
具体实施方式
以下将通过具体实施例来进一步说明本发明。
实施例1：药物和辅料的组方分析
蓝布正提取物：蓝布正(GeumjaponicumThunb.var.chinenseBolle)传统中药，作为该组方的君药，其主要用于高血压病，头晕头痛，月经不调，小腹痛，白带，小儿惊风，风湿腰腿痛，外用治痈疖肿毒，跌打损伤。蓝布正含有活性多酚类化合物，可以帮助清除创面的已经坏死的软组织，收敛损伤伤口创面，促进组织修复过程中的微血管再生，止血生肌，清热解毒，消肿散结，并且具有很强的抗菌消炎作用。其中含有的五环三萜类化合物可以促进伤口的软组织再生和修复。
萎凌菜提取物：萎凌菜(Potentillachinensis Ser.)传统中药，作为作为该组方的臣药，其主要用于清热解毒，凉血止痢，赤痢腹痛，久痢不止，痔疮出血，痈肿疮毒。萎凌菜含有的总黄酮可以降低胰岛素抵抗，以及修复胰岛细胞，所以可以用于治疗II型糖尿病。其含有活性多酚类化合物，其中含有的富马酸、没食子酸、原儿茶酸、槲皮素、柚皮素等对细菌尤其是痢疾杆菌具有抑菌和抗菌消炎作用，可以用于治疗痢疾，疮疥，也帮助收敛损伤伤口创面，促进组织修复过程中的微血管再生。含有的三萜类化合物可以促进伤口的软组 织再生和修复。
仙鹤草提取物：仙鹤草(AgrimoniapilosaLdb.)的干燥地上部分传统中药，作为该组方的佐药，其主要用于强壮性收敛止血剂。其主要含有仙鹤草素、仙鹤草内酯、鞣质(为焦性儿茶酚鞣质、没食子鞣质等)、甾醇、有机酸、酚性成分、皂甙等。其提取物可用于帮助收敛痔疮的伤口创面，有强力的收敛痔疮创口和痔疮的止血作用。其中所含的仙鹤草素、仙鹤草内酯、多酚成分、皂甙、多糖等，有强心作用，可用于肺病咯血，肠出血，胃溃疡出血，子宫出血，齿科出血，痔血等疾病的止血作用等。
蓝布正提取物也起到使药的作用，消炎止痛，清热解毒，调和诸药作用，使诸药搭配协同作用，共同达到抗菌消炎、清热解毒、消除水肿、清创坏死组织、止血散瘀、活血、生肌、组织再生修复的功效，对内痔、混合痔、外痔都有十分显著的治疗效果。
凡士林：起到承载药物粘合基质和润滑作用。
羊毛脂：起到粘合润滑作用。
实施例2：痔疮中药制剂-中药膏剂的制备及使用
精选中药原料去杂质，分别取蓝布正(贵州)、萎凌菜(河南)、和仙鹤草(山东)，洗净去杂质，干燥后粉碎，过80-100目筛，得到蓝布正粗粉、萎凌菜粗粉和仙鹤草粗粉。以各粗粉与60％乙醇的质量体积比1：9分别加入60％乙醇，40℃浸提7h后，60℃回流提取2h，降至室温，过滤，得到滤液减压浓缩，喷雾干燥，得到蓝布正提取物、萎凌菜提取物和仙鹤草提取物。取蓝布正提取物5％、萎凌菜提取物2％和仙鹤草提取物2％混合，加入凡士林70％和羊毛脂21％调制均匀，得到中药膏剂。
使用方法：使用方法直接涂抹患处，或者取3g中药制剂注入推注管小径头部后，装进推芯，推芯与中药膏吻合，将推注管小径头塞入肛门5-7公分，推 至推芯到底，拔出推注管完成上药，每天早上和临睡前各用一次。
实施例3：痔疮中药制剂-中药膏剂的制备
精选中药原料去杂质，分别取蓝布正(贵州)、萎凌菜(河南)、和仙鹤草(山东)，洗净去杂质，干燥后粉碎，过80-100目筛，得到蓝布正粗粉、萎凌菜粗粉和仙鹤草粗粉。以各粗粉与60％乙醇的质量体积比1：8分别加入60％乙醇，40℃浸提3h后，60℃回流提取2h，降至室温，过滤，得到滤液减压浓缩，喷雾干燥，得到蓝布正提取物、萎凌菜提取物和仙鹤草提取物。取蓝布正提取物7％、萎凌菜提取物1％和仙鹤草提取物1％混合，加入凡士林70％和羊毛脂21％调制均匀，得到中药膏剂。
实施例4：痔疮中药制剂-中药膏剂的制备
精选中药原料去杂质，取萎凌菜(河南)洗净去杂质，干燥后粉碎，过80-100目筛，得到萎凌菜粗粉。以粗粉与60％乙醇的质量体积比1：10加入60％乙醇，40℃浸提8h后，60℃回流提取2h，降至室温，过滤，得到滤液减压浓缩，喷雾干燥，得到萎凌菜提取物。取萎凌菜提取物9％，加入凡士林70％和羊毛脂21％调制均匀，得到中药膏剂。
实施例5：痔疮中药制剂-中药膏剂的制备
精选中药原料去杂质，取仙鹤草(山东)，洗净去杂质，干燥后粉碎，过80-100目筛，得到仙鹤草粗粉。以粗粉与60％乙醇的质量体积比1：8分别加入60％乙醇，40℃浸提3h后，60℃回流提取2h，降至室温，过滤，得到滤液减压浓缩，喷雾干燥，得到仙鹤草提取物。取仙鹤草提取物9％，加入凡士林70％和羊毛脂21％调制均匀，得到中药膏剂。
实施例6：
对9例内痔患者观察，使用实施例2得到的痔疮中药制剂(膏剂)，推膏剂进入肛门，使药膏直接作用在内痔部位，每天两次。三天内该9例患者的痔疮 临床症状显著改善，其中9例患者治疗前均有肛门口有炎性渗出和肛门周围皮肤瘙痒症，三天后基本上渗出和瘙痒全部消失。其中7例有便血，应用本膏剂治疗5天后，便血症状也显著改善。1-2周用本药膏治疗后，肛门口炎性渗出、肛门周围瘙痒症、出血、疼痛、肿胀、等症状基本完全消失。再使用本中药膏1-2周基本完全治痊。其中有五例肛门内部出现肿物脱出病人在治疗两周后痔脱垂消失。
实施例7：
吴某，男60岁患混合痔20年以上，2018年初病情变得严重。肛门口有明显的炎性渗出，肛门周围皮肤起湿疹样外观并且瘙痒，出血，排便时常有肛门内出现肿物脱出。该患者首先口服蓝布正活性提取物痔疮中药口服剂，一周后基本上渗出、瘙痒和出血基本都消失，肛门内出现肿物脱出症状也完全消失。而后又使用本实施例2得到的痔疮中药制剂(膏剂)、每日两次，2周后发现肛门突出部位(外痔凸起)完全收起消失，便血、疼痛、肿胀等症状也完全消失，至今(2年后)未复发。
实施例8：
邢某，男56岁患痔疮10年多，每次发作时出血、肿胀、肛门周围渗出、瘙痒、疼痛难忍，2020年4月又复发，肛门有肿物痔核脱出，不能自行回缩。采用多种治疗方案未见明显效果。用本实施例2得到的痔疮中药制剂(膏剂)治疗三天后，出血、疼痛、肿胀、肛门周围渗出等症状都显著减轻一周后，肛门内肿物脱出也完全消失。治疗四周左右后，患者感觉完全治愈，至今末复发。
实施例9：
某女士，36岁，怀孕时患混合痔，到用该膏剂治疗时已经6年左右。期间，经常有排便时肛门出血、肿胀、肛门周围渗出和瘙痒、疼痛。肛门外可见或触摸到表面覆盖皮肤的痔核，不能送入肛门内、有异物感，肛门坠涨感。2020年 3月又复发，有肛门出血、肿胀、肛门周围渗出和瘙痒等症状。用力排便时肛门有肿物痔核脱出，不能自行回缩，肛缘皮肤皱壁突起如水泡样，经多种药物治疗后未见明显效果。先口服蓝布正活性部位一周，发现痔疮的临床症状如：疼痛、出血、肿胀、肛门坠涨感、肛门周围渗出瘙痒等都显著减轻。在加用本实施例2得到的痔疮中药制剂(膏剂)治疗一周后，排便时肛门内肿物脱出现象也完全消失，其它出血、疼痛、肿胀、肛门周围渗出等症状都基本完全消失。治疗六周左右后，患者感觉完全治愈，甚至肛门旁的覆盖皮肤的外痔核都回缩进入到肛门内，至今末复发。

Claims (7)

  1. 一种用于预防和治疗痔疮的药物，其特征在于包括蓝布正提取物、萎凌菜提取物和仙鹤草提取物中的一种或几种。
  2. 如权利要求1所述的一种用于预防和治疗痔疮的药物，其特征在于所述蓝布正提取物、萎凌菜提取物和仙鹤草提取物为对应原料的醇提物。
  3. 如权利要求1所述的一种用于预防和治疗痔疮的药物，其特征在于该药物含有0.01％到99.99％重量的所述提取物。
  4. 如权利要求1-3任一所述的一种用于预防和治疗痔疮的药物，其特征在于还包括药学可接受载体和/或助剂。
  5. 蓝布正提取物、萎凌菜提取物和/或仙鹤草提取物在制备用于预防和治疗痔疮的药物中的应用。
  6. 如权利要求5所述的应用，其特征在于所述蓝布正提取物、萎凌菜提取物和仙鹤草提取物为对应原料的醇提物。
  7. 如权利要求5所述的应用，其特征在于所述痔疮包括：内痔、混合痔、外痔、肛隐窝炎、肛裂、肛痈、肛漏、脱肛或痔疮并发症。
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