CN107875352A - 一种治疗聚合性痤疮的药物组合物及其制备方法和用途 - Google Patents
一种治疗聚合性痤疮的药物组合物及其制备方法和用途 Download PDFInfo
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- CN107875352A CN107875352A CN201711349730.2A CN201711349730A CN107875352A CN 107875352 A CN107875352 A CN 107875352A CN 201711349730 A CN201711349730 A CN 201711349730A CN 107875352 A CN107875352 A CN 107875352A
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Abstract
本发明公开了一种治疗聚合性痤疮的药物组合物,它是由下列重量配比的原料药制备而成:夏枯草25‑30份、白花舌蛇草25‑30份、白附子15‑20份、白蔹15‑20份、皂角刺25‑30份、浙贝母25‑30份、丹参25‑30份、土茯苓15‑20份、僵蚕5‑10份、桃仁15‑20份、红花5‑10份、川芎15‑20份、生地黄25‑30份、赤芍15‑20份、银花藤25‑30份、连翘15‑20份、蒲公英15‑20份、野菊花10‑15份、海藻10‑15份、昆布10‑15份、三棱10‑15份、莪术5‑10份、没药10‑15份、乳香5‑10份、白芷5‑10份、黄芩10‑15份。本发明还提供了所述药物组合物的制备方法和用途。本发明药物组合物,可明显缓解聚合性痤疮患者面部皮损之红肿、破溃症状及并能加速皮损愈合,有效减少复发次数,改善预后瘢痕、痘印情况,具有独特的优势和较好的临床应用前景。
Description
技术领域
本发明涉及一种治疗聚合性痤疮的药物组合物及其制备方法和用途。
背景技术
聚合性痤疮是痤疮类疾病中最严重也最难治的一型。多见于青中年男性。常位于面、胸、肩、背及后颈部,同时也可在臂部、前臂、大腿及面部发生。皮损成多形性,有粉刺、丘疹、囊肿、脓疱。数个脓肿聚合,破溃后有的形成流脓的窦道,愈后留下明显瘢痕或瘢痕疙瘩。本病病程缠绵,病情时轻时重,治疗颇为棘手。并且愈后仍可能留下明显瘢痕或疙瘩,影响面容,给患者的身心都带来伤害。其发病机制比较复杂,一般认为该病的发生与毛囊上皮过度角化、皮脂分泌增多、相关细菌感染及遗传因素等有关。近年来,随着饮食结构的变化和生活、工作压力的增大,其发病明显呈增高趋势,人们对于损美性皮肤病也逐渐重视。在中医古籍中对本病多有描述,如《素问·生气通天论》说:“劳汗当风,寒薄为皶,郁乃痤”。《诸病源候论》说:“面疱者,谓面上有风热气生疮。”张介宾注:“痤,谓色赤,脂愤内蕴血脓,形小而大,如酸刺枣,或如按(疑“豌”)豆,此皆阳气内郁所为,待耎而攻之,大甚出之。”西医口服抗生素、维甲酸类药,或试用内分泌疗法,皮损内注射糖皮质激素,是治疗本病的主要措施。本病初期多表现气虚,可进一步发展为阳虚,病久则气虚血瘀,故本病的基本病机为本虚标实,心气虚、脾、肾阳虚为本,血瘀为标,久之则虚实夹杂。
西医治疗多主要以抗组胺药的应用为主,但临床疗效不一。赛庚啶过去一直被认为是治疗聚合性痤疮的首选,但最近通过实践证明二苯环庚啶(赛庚啶)、酮体芬、口服色甘酸钠、H2受体阻滞剂对聚合性痤疮患者效果并不好,均只能达到暂时控制的目的,停止服药后极易复发甚至症状较前加重。
中医药治疗历史悠久,患者接受性好。因此,亟需一种有效治疗的方剂来治疗本病,缓解瘙痒和皮损,减少复发次数,延长缓解期,改善生活患者质量。
发明内容
本发明的目的在于提供一种治疗聚合性痤疮的药物组合物及其制备方法和用途。
本发明提供了一种治疗聚合性痤疮的药物组合物,它是由下列重量配比的原料药制备而成:
夏枯草25-30份、白花舌蛇草25-30份、白附子15-20份、白蔹15-20份、皂角刺25-30份、浙贝母25-30份、丹参25-30份、土茯苓15-20份、僵蚕5-10份、桃仁15-20份、红花5-10份、川芎15-20份、生地黄25-30份、赤芍15-20份、银花藤25-30份、连翘15-20份、蒲公英15-20份、野菊花10-15份、海藻10-15份、昆布10-15份、三棱10-15份、莪术5-10份、没药10-15份、乳香5-10份、白芷5-10份、黄芩10-15份。
优选地,它是由下列重量配比的原料药制备而成:
夏枯草30份、白花舌蛇草30份、白附子20份、白蔹20份、皂角刺30份、浙贝母30份、丹参30份、土茯苓20份、僵蚕10份、桃仁20份、红花10份、川芎20份、生地黄30份、赤芍20份、银花藤30份、连翘20份、蒲公英20份、野菊花15份、海藻15份、昆布15份、三棱15份、莪术10份、没药15份、乳香10份、白芷10份、黄芩15份。
上述药物组合物,是由所述原料药的原生药粉,或者水或有机溶剂提取物为活性成分,加上药学上可接受的辅料或者辅助性成分制备而成制剂。
进一步地,所述制剂为外用制剂。
优选地,所述外用制剂为糊剂、散剂、搽剂或涂膜剂。
更优选地,所述外用制剂为糊剂。
本发明提供了一种制备上述药物组合物的方法,它包括如下步骤:
a)称取各重量配比的原料药;
b)干燥药物,粉碎,用时加清水调至糊状,即得。
本发明还提供了上述药物组合物在制备治疗聚合性痤疮的药物中的用途。
进一步地,所述聚合性痤疮为中医的粉刺。
更进一步地,所述聚合性痤疮针对所有聚合性痤疮患者的皮损及痘印、瘢痕。
更进一步地,所述聚合性痤疮包括中医的热毒炽盛;痰湿瘀结;湿热蕴结型;肺经风热型。
本发明药物组合物是由夏枯草、白花舌蛇草、白附子、白蔹、皂角刺、浙贝母、丹参、土茯苓、僵蚕、桃仁、红花、川芎、生地黄、赤芍、银花藤、连翘、蒲公英、野菊花、海藻、昆布、三棱、莪术、没药、乳香、白芷、黄芩二十六味药物组成。
聚合性痤疮外在表象为红肿、结节、甚则破溃,辨病治疗当以清热凉血解毒、活血散结。白花蛇舌草、白蔹、黄芩能清热除湿,凉血解毒,并以银花藤、连翘、蒲公英、野菊花、土茯苓苦寒之品清解热毒,而本方为外用药方,故可忽略苦寒伤胃的弊端。夏枯草能清肝火兼有消散郁结之功。聚合性痤疮乃寻常痤疮,发展迁延而来,病机为痰瘀互结,与痰气交阻之瘿瘤有一定相似之处,治法上可资借鉴。昆布、海藻仍治痰气交阻瘿瘤之要药,本方以以专攻男性患者下颌部好发之痤疮结节、瘢痕、窦道;而白附子祛风痰,解毒散结止痛,外治瘰疬痰核,配以浙贝母更能散结消痈。僵蚕为虫药,入络搜剔陈痰旧瘀。方中桃仁、红花、川芎、丹参行血散瘀,配以三棱、莪术旨在以其峻猛之性散瘀结,乳香、没药行气以助行血;皂刺能消肿排脓,化痰散结;生地、赤芍凉血养血,合白芷排脓生肌、活血以助破溃处新生。全方以清热解毒、活血化痰散结,以辅助养血之品,以外敷的给药方式不仅能直达并处消散结节,还有助以破溃的新生。
本发明药物组合物,配伍精当,各药味相辅相成,可明显缓解聚合性痤疮患者面部皮损之红肿、破溃症状及并能加速皮损愈合,有效减少复发次数,改善预后瘢痕、痘印情况,具有独特的优势和较好的临床应用前景。另外,由于聚合性痤疮为皮肤表面疾病,内服药物药力难以直达病所,故本发明所用的外治法在聚合性痤疮的治疗中疗效显著,明显优于内服药物。
根据本发明的上述内容,按照本发明相关领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1本发明药物组合物的制备
1.原料:夏枯草30g、白花舌蛇草30g、白附子20g、白蔹20g、皂角刺30g、浙贝母30g、丹参30g、土茯苓20g、僵蚕10g、桃仁20g、红花10g、川芎20g、生地黄30g、赤芍20g、银花藤30g、连翘20g、蒲公英20g、野菊花15g、海藻15g、昆布15g、三棱15g、莪术10g、没药15g、乳香10g、白芷10g、黄芩15g。
2.制备方法:将上述中药置100℃烤箱中,烘烤12h,上药共研细末,过120目筛,装瓶备用。
实施例2本发明药物组合物的制备
1.原料:夏枯草25g、白花舌蛇草25g、白附子20g、白蔹20g、皂角刺25g、浙贝母25g、丹参30g、土茯苓20g、僵蚕5g、桃仁15g、红花10g、川芎20g、生地黄25g、赤芍15g、银花藤30g、连翘20g、蒲公英15g、野菊花10g、海藻15g、昆布15g、三棱10g、莪术5g、没药15g、乳香10g、白芷5g、黄芩10g。
2.制备方法:将上述中药置100℃烤箱中,烘烤12h,上药共研细末,过120目筛,装瓶备用。
实施例3本发明药物组合物的制备
1.原料:夏枯草30g、白花舌蛇草30g、白附子15g、白蔹15g、皂角刺30g、浙贝母30g、丹参25g、土茯苓15g、僵蚕10g、桃仁20g、红花5g、川芎15g、生地黄30g、赤芍20g、银花藤25g、连翘15g、蒲公英20g、野菊花15g、海藻10g、昆布10g、三棱15g、莪术10g、没药10g、乳香5g、白芷10g、黄芩15g。
2.制备方法:将上述中药置100℃烤箱中,烘烤12h,上药共研细末,过120目筛,装瓶备用。
以下通过具体临床试验证明本发明的有益效果:
试验例1本发明组合物的临床疗效
1、临床资料
全部病例来自2012年9月至2017年4月间成都中医药大学皮肤科门诊。选择临床确诊为聚合性痤疮并符合中医热毒炽盛、痰湿瘀结、湿热蕴结型、肺经风热型的患者142例。
142例中,男89例,女53例;平均年龄(24.97±7.40)岁。
随机分为治疗组和对照组。对照1组(克林霉素+阿达帕林凝胶组)71例中,男43例,女23例。治疗组(实用本外用药物组合)71例中,男46例,女30例。
2、病例选择标准
(1)纳入标准
选择临床确诊为聚合性痤疮并符合中医热毒炽盛、痰湿瘀结、湿热蕴结型、肺经风热型的患者。
(2)排除标准
年龄在14岁以下或40岁以上;妊娠或哺乳期妇女;过敏体质或对本药或药物成分过敏者;治疗期间可能接受强烈日晒或紫外线者;不合作者,包括不能坚持治疗或私自加用其他治疗,从而影响资料收集及疗效评定者;治疗前30d内服用过与本病相关的内服药,7d内用过与本病相关的外用药;合并有心血管、脑血管、肝、肾和造血系统等严重原发性疾病、精神病患者;不符合纳入标准的其他病例。
3、治疗方法
①治疗组:使用本发明药物组合物,使用前先以温水清洁面部。取本发明药物组合物的面膜粉约30g,放于调膜碗中,加入10ml蒸馏水用调膜棒调成糊状,调膜时间1min以内。将糊状物均匀涂于患者面部,形成面膜,厚度约2mm,避开眼睛、眼睑、鼻孔及唇红区;保持面膜30min后去除。睡前外敷,连续使用一周为一个疗程。连续使用4个疗程。
②对照1组(克林霉素组):口服克林霉素(药剂名:盐酸克林霉素胶囊,广州白云山光华制药股份有限公司),200mg po tid。同时外涂阿达帕林凝胶;一周为一个疗程。
4个疗程后评定疗效,停药后观察3个月。治疗期间注意饮食调整,少吃油腻、辛辣食物,适当多食蔬菜水果,饮食清淡,多饮水。保持心情轻松平静,情绪平稳;保持大便通畅,保持充足的睡眠,禁止自行用手或其他器械挤压皮损,并停用一切影响本临床研究的药物或治疗方法。
4、疗效观察
4.1疗效标准:
皮损程度按4级评分,见表1:
表1皮损程度的4级评分标准
各项评分相加,即为疾病积分。
疗效指数(%)=(治疗前总积分-治疗后总分值)/治疗前总积分×100%。
痊愈:疗效指数为80%~100%;显效:疗效指数为60%~79%;显效:疗效指数为30%~59%;无效:疗效指数为0~29%。
4.2治疗结果
治疗时间:4周。
疗效判定:结果如下,见表2、表3。
表2治疗组例患者经过4周治疗后的疗效
治疗结果 | 病例数(例) | 有效率(%) |
痊愈 | 16 | 22.5 |
显效 | 28 | 39.4 |
有效 | 25 | 35.2 |
无效 | 2 | 2.9 |
总计 | 71 | 97.1 |
表3对照组组例患者经过4周治疗后的疗效
治疗结果 | 病例数(例) | 有效率(%) |
痊愈 | 8 | 11.3 |
显效 | 17 | 23.9 |
有效 | 26 | 36.6 |
无效 | 28 | 28.2 |
总计 | 71 | 71.8 |
结果显示治疗组总有效率为97.1%,对照组有效率为71.8%,P<0.05,差异具有统计学意义。
不良反应:用药期间未见不良反应,偶见部分患者治疗后皮肤微红,嘱患者注意水温后情况改善。部分患者查血象、肝肾功能无异常。
4.3典型病例
患者张某,男性,27岁。患者5年前于外院诊断为聚合性痤疮每年冬季加重,外出时极易发作,以至严重影响其正常工作。长期口服枸地氯雷他定片8.8mg一日一次,服药期间可一定程度上降低发作几率,但仍难以回归正常生活。患者自述发作时瘙痒剧烈,周身无规律出现苍白色风团。自述平时怕冷,食冷食后易腹泻结合舌淡,苔白,齿痕伴裂纹,脉沉缓。经诊断为脾阳不振型。治宜补中益气,温脾驱寒。使用本发明的具体实施方法,并建议患者保持饮食清淡,忌肥甘厚味,忌甜食、海鲜食物及热性水果。按上述治疗1疗程,皮损减少,瘙痒减轻;再用药1疗程后,皮损、瘙痒消失。
上述实验表明,本发明要物组合物,对缓解聚合性痤疮患者病情疗效显著。
本发明药物组合物,配伍精当,各药味相辅相成,可明显缓解聚合性痤疮患者面部皮损之红肿、破溃症状及并能加速皮损愈合,有效减少复发次数,改善预后瘢痕、痘印情况,具有独特的优势和较好的临床应用前景。另外,由于聚合性痤疮为皮肤表面疾病,内服药物药力难以直达病所,故本发明所用的外治法在聚合性痤疮的治疗中疗效显著,明显优于内服药物。
Claims (8)
1.一种治疗聚合性痤疮的药物组合物,其特征在于:它是由下列重量配比的原料药制备而成:
夏枯草25-30份、白花舌蛇草25-30份、白附子15-20份、白蔹15-20份、皂角刺25-30份、浙贝母25-30份、丹参25-30份、土茯苓15-20份、僵蚕5-10份、桃仁15-20份、红花5-10份、川芎15-20份、生地黄25-30份、赤芍15-20份、银花藤25-30份、连翘15-20份、蒲公英15-20份、野菊花10-15份、海藻10-15份、昆布10-15份、三棱10-15份、莪术5-10份、没药10-15份、乳香5-10份、白芷5-10份、黄芩10-15份。
2.根据权利要求1所述的药物组合物,其特征在于:它是由下列重量配比的原料药制备而成:
夏枯草30份、白花舌蛇草30份、白附子20份、白蔹20份、皂角刺30份、浙贝母30份、丹参30份、土茯苓20份、僵蚕10份、桃仁20份、红花10份、川芎20份、生地黄30份、赤芍20份、银花藤30份、连翘20份、蒲公英20份、野菊花15份、海藻15份、昆布15份、三棱15份、莪术10份、没药15份、乳香10份、白芷10份、黄芩15份。
3.根据权利要求1或2所述的药物组合物,其特征在于:它是由所述原料药的原生药粉,或者水或有机溶剂提取物为活性成分,加上药学上可接受的辅料或者辅助性成分制备而成制剂。
4.根据权利要求3所述的药物组合物,其特征在于:所述制剂为外用制剂。
5.根据权利要求4所述的药物组合物,其特征在于:所述外用制剂为糊剂、散剂、搽剂或涂膜剂。
6.根据权利要求5所述的药物组合物,其特征在于:所述外用制剂为糊剂。
7.一种制备权利要求1-6任意一项所述的药物组合物的方法,其特征在于:它包括如下步骤:
a)称取各重量配比的原料药;
b)干燥药物,粉碎,用时加清水调至糊状,即得。
8.权利要求1-6任意一项所述的药物组合物在制备治疗聚合性痤疮的药物中的用途。
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