CN104274736B - 一种祛痤疮的中药组合物及其制备方法与应用 - Google Patents
一种祛痤疮的中药组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明涉及一种祛痤疮的中药组合物，所述组合物由包括以下重量份的原料制备而成：金银花1～10份，蒲公英3～15份，芦根3～15份，薏苡2～13份，桃仁1～10份，丹皮1～10份，车前子1～10份，苦丁茶1～8份，薄荷1～8份，辅料0～20份。本发明所提供的中药组合物，具有清热利湿、解毒消痤的作用，对于消除痤疮效果明显。
Description
技术领域
本发明涉及中医药领域，具体涉及一种祛除痤疮的中药组合物，还涉及了该组合物的制备方法与其在制备祛除痤疮药物中的应用。
背景技术
痤疮俗称青春痘、粉刺、暗疮，是皮肤科常见病多发病，是一种发生于毛囊皮脂腺的慢性皮肤病，多发于头面部，颈部前胸后背等皮脂腺丰富的部位。痤疮是一种多因素的疾病，其发病主要与性激素水平、皮脂腺大量分泌、痤疮丙酸杆菌增殖，毛囊皮脂腺导管的角化异常及炎症等因素相关。西医常采用抗生素、性激素、维甲酸类等来治疗痤疮，虽有一定效果，但治标不治里，诱发痤疮的内在因素仍然存在，并且用这些化学药物治疗存在一定的副作用。
中医认为，痤疮多数是饮食不节，损伤脾胃，脾胃郁热，上蒸颜面而致，其证多属实证。且与患者心情有关，如果长期精神不舒，热毒之邪乘虚而入，客于肌腠之间，或流窜于经络，以致气血脉络受阻，瘀久化腐成脓而致。
现有技术公开了可以用于去除痤疮的中药组合物。专利文献CN103860958A公开了一种用于治疗痤疮的中药组合物，其由以下原料制成：金银花、野菊花、蒲公英、白花蛇舌草、丹参、黄芪、紫花地丁、鱼腥草、板蓝根、生薏苡仁。然而，现有技术提供的组方对于痤疮的综合治疗效果欠佳，对以清热利湿、解毒消痤为治则的辨证配伍组方尚无报道。
发明内容
本发明的目的在于提供一种中药组合物，针对痤疮的发病机理进行组方的辩证配伍，起到清热、利湿、解毒作用，对于消除痤疮效果明显。
本发明提供了一种祛痤疮的中药组合物，所述组合物由包括以下重量份的原料制备而成：金银花1～10份，蒲公英3～15份，芦根3～15份，薏苡2～13份，桃仁1～10份，丹皮1～10份，车前子1～10份，苦丁茶1～8份，薄荷1～8份，辅料0～20份。
优选地，所述组合物由包括以下重量份的原料制备而成：金银花3份，蒲公英5份，芦根5份，薏苡4份，桃仁3份，丹皮3份，车前子3份，苦丁茶2份，薄荷2份，辅料9份。
本发明所述重量份可以是μm、mg、g、kg等医药领域公知的重量单位，也可以是其倍数，如1/10、1/100、10倍、100倍等。
本发明所述组合物为医药领域的常规剂型，可以为汤剂、粉末剂、片剂、胶囊剂、糖浆剂等。
本发明所述辅料可以根据剂型的需要选择添加；具体而言，所述辅料包括麦芽糊精、乳糖、葡萄糖、微晶纤维素、甲基纤维素、羧甲基纤维素钠、硬脂酸镁、二氧化硅、滑石粉、聚乙二醇或淀粉中的一种或几种。
本发明所述组合物优选为粉末剂，该剂型加工方法简单且易于患者服用，所述辅料优选为麦芽糊精。
本发明进一步提供了所述组合物的制备方法。
组合物为汤剂时，可直接称取药材按照常规方法煎煮而成。其它剂型的组合物可通过添加辅料按照常规方法加工制备而成，所述方法具体包括以下步骤：
1)取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入8～12倍体积的水，浸泡20～40min，煎煮100～150min，减压过滤，滤液备用，保留药渣；
优选加入的水量为10倍体积，浸泡时间为30min，煎煮时间为120min；
2)在步骤1)所得药渣中再加入6～10倍体积的水，煎煮40～80min，减压过滤，滤液备用；
优选加入的水量为8倍体积，煎煮时间为60min；
3)将步骤1)与步骤2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度0.9～1.3，优选为1.1；添加辅料，制备成常规剂型。
当组合物为粉末剂时，步骤(3)所述辅料为麦芽糊精，经过常规喷雾干燥后，即得粉末剂。
作为最优选方案，本发明所述组合物的制备方法包括以下步骤：
(1)取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入10倍体积的水，浸泡30min，煎煮120min，减压过滤，滤液备用，保留药渣；
(2)在步骤(1)所得药渣中再加入8倍体积的水，煎煮60min，减压过滤，滤液备用；
(3)将步骤(1)与步骤(2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度1.1，添加麦芽糊精，喷雾干燥得粉末，即得组合物。
本发明进一步保护所述组合物在制备祛除痤疮药物中的应用。
本发明提供的中药组合物中，所有药材按照君臣佐使的原则共同发挥药效。
具体的，在本发明的中药组合物是在传统中医理论和临床经验指导下，精选的药物组方中：金银花、蒲公英性偏寒，清热解毒，化痰消痈；芦根甘寒轻浮，善清肺热，而肺主皮毛，使肺热清而皮肤之疮痈消散；薏苡仁甘淡，渗湿利水而健脾，与芦根一清一利，从根源上消除病因，共奏清热利湿之功，合用为君药；桃仁活血逐瘀，可助消痈；丹皮清热凉血、活血化瘀；车前子甘淡性寒，渗湿利水，使湿热从下焦而去；苦丁茶苦寒清热，解毒消痈，可缓解湿热体质引起的痤疮、口干口苦等；薄荷宣利上焦肺气，疏散风热，清利头目，疏肝行气，气行则湿化。
本发明中药组合物的组分均采用天然的中药原料，其配制简便、药源广，祛痤疮效果显著，且无毒副作用。
具体实施方式
以下实施例用于说明本发明，但不用来限制本发明的范围。
实施例1
1、原料组成：金银花3g，蒲公英5g，芦根5g，薏苡4g，桃仁3g，丹皮3g，车前子3g，苦丁茶2g，薄荷2g，麦芽糊精9g。
2、按照以下步骤制备组合物：
(1)按用量取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入300ml水，浸泡30min，煎煮120min，减压过滤，滤液备用，保留药渣；
(2)在步骤(1)所得药渣中再加入240ml水，煎煮60min，减压过滤，滤液备用；
(3)将步骤(1)与步骤(2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度1.1，添加麦芽糊精，喷雾干燥得粉末，即得组合物。
实施例2
1、原料组成：金银花1g，蒲公英3g，芦根3g，薏苡2g，桃仁1g，丹皮1g，车前子1g，苦丁茶1g，薄荷1g，麦芽糊精4g。
2、按照以下步骤制备组合物：
与实施例1相比，区别仅在于，步骤(1)加入水量为168ml，步骤(2)加入水量为140ml。
实施例3
1、原料组成：金银花10g，蒲公英15g，芦根15g，薏苡13g，桃仁10g，丹皮10g，车前子10g，苦丁茶8g，薄荷8g，麦芽糊精20g。
2、按照以下步骤制备组合物：
与实施例1相比，区别仅在于，步骤(1)加入水量为1188ml，步骤(2)加入水量为990ml。
实施例4
1、原料组成：同实施例1。
2、按照以下步骤制备组合物：
(1)按用量取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入360ml水，浸泡40min，煎煮100min，减压过滤，滤液备用，保留药渣；
(2)在步骤(1)所得药渣中再加入300ml水，煎煮60min，减压过滤，滤液备用；
(3)将步骤(1)与步骤(2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度0.9，添加麦芽糊精，喷雾干燥得粉末，即得组合物。
实施例5
1、原料组成：同实施例1。
2、按照以下步骤制备组合物：
(1)按用量取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入330ml水，浸泡20min，煎煮150min，减压过滤，滤液备用，保留药渣；
(2)在步骤(1)所得药渣中再加入240ml水，煎煮40min，减压过滤，滤液备用；
(3)将步骤(1)与步骤(2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度1.3，添加麦芽糊精，喷雾干燥得粉末，即得组合物。
实验例1
1、实验组别：共10组；其中，实验组为实施例1～5提供的组合物；对照组的分别为治疗痤疮的常用药金银花、蒲公英、马齿苋、薏苡仁以及专利文献CN103860958A提供的配方(对比例)，经实施例1提供的方法制备得到。
2、实验方法：
(1)病例选择：参加实验人员均为志愿者，由3名皮肤科门诊医师同时诊断为座疮者，要符合《临床皮肤病学》中有关寻常性痤疮的诊断标准，采用Pilllbury分类法，将I～IV度患者纳入观察，且所有患者应于实验开始2周前停用治疗痤疮的任何药物或保健品。共筛选病例300例，其中男性213例，女性87例，年龄19-49岁，平均年龄(26.5±6.0)岁。
入选标准:
I度：黑头粉刺，散发至多发，炎性丘疹散发；
II度：I度+浅在性脓疱，炎性丘疹数目在增加，局限在颜面；
III度：II度+深在性炎性丘疹、结节，发生颜面、颈部、胸背部；
IV度：III度+囊肿，易形成疤痕，发生于上半身；
(2)实验方法：全部受试志愿者随机分成10组，每组30人，第一组服用金银花、第二组服用蒲公英、第三组服用马齿苋、第四组服用薏苡仁、第五组服用对比例，第六组至第十组分别服用实施例1、实施例2、实施例3、实施例4、实施例5，每天两次，每次6g，热水冲调后服用，45天为一个疗程，每周随访一次，分别计录丘疹、脓疤和囊肿数量，了解志愿者自觉满意度。
(3)评价标准：皮疹消退率＞90％为痊愈；消退率在60％～90％为显效；消退率在20～60％为好转；消退率＜20％为无效。总有效率＝痊愈+显效+好转。
实验结果参见表1。
表1：祛痤疮效果
| 组别 | n | 痊愈 | 显效 | 好转 | 无效 | 总有效率％ |
| 金银花 | 30 | 1 | 2 | 7 | 20 | 33 |
| 蒲公英 | 30 | 0 | 1 | 5 | 24 | 20 |
| 马齿苋 | 30 | 0 | 0 | 4 | 26 | 13 |
| 薏苡仁 | 30 | 0 | 0 | 2 | 28 | 7 |
| 对比例 | 30 | 4 | 6 | 11 | 9 | 70 |
| 实施例1 | 30 | 8 | 15 | 3 | 4 | 87 |
| 实施例2 | 30 | 7 | 13 | 2 | 8 | 73 |
| 实施例3 | 30 | 6 | 13 | 4 | 7 | 77 |
| 实施例4 | 30 | 7 | 13 | 4 | 6 | 80 |
| 实施例5 | 30 | 7 | 14 | 4 | 5 | 83 |
由以上实验结果可知，本发明提供的中药组合物祛痤疮效果明显，且显著优于现有技术。
实验例2
将本发明实施例1提供的中药组合物应用于临床观察病例。60例患者来自门诊病历，经过体质辨识属于湿热体质。患者的临床症状为：面部痤疮，脾气急躁，心烦易怒，舌红苔黄腻，脉滑数。
1、用法用量：每天两次，每次6g，热水冲调后服用，45天为一疗程。
2、疗效标准：
(1)皮疹消退率＞90％为痊愈；
(2)消退率在60％～90％为显效；
(3)消退率在20～60％为好转；
(4)消退率＜20％为无效；
3、治疗效果：经临床干预服药2～7个疗程后，显效16例，有效35例，无效9例，总有效率85％。治疗期间未发生毒副作用。
4、典型病例：
秦某，男，28岁。2012年10月18日初诊。
现病史：患者诉10年前无明显诱因出现面部痤疮伴瘙痒疼痛，自觉无明显规律和外界刺激。现面部痤疮满布，色红，有白头，部分已形成结节，高于皮肤表面，呈淡红色或暗红色，质地较硬。面部出油多，经常有口臭，脾气急躁，阴囊潮湿瘙痒，心烦易怒，舌红苔黄腻，脉滑数。
诊断：结节性痤疮。
治法：一日两次，每次6g，热水冲调后服用，45天为一疗程。
2012年12月复诊：服药后原油痤疮消退，未有新生痤疮，面部结节基本消退，皮肤较治疗前光滑。
由以上结果可知，本发明提供的中药组合物可以安全、有效地祛除痤疮。
虽然，上文中已经用一般性说明、具体实施方式及试验，对本发明作了详尽的描述，但在本发明基础上，可以对之作一些修改或改进，这对本领域技术人员而言是显而易见的。因此，在不偏离本发明精神的基础上所做的这些修改或改进，均属于本发明要求保护的范围。
Claims (10)
1.一种祛痤疮的中药组合物，其特征在于，所述组合物由以下重量份的原料制备而成：金银花1～10份，蒲公英3～15份，芦根3～15份，薏苡2～13份，桃仁1～10份，丹皮1～10份，车前子1～10份，苦丁茶1～8份，薄荷1～8份，辅料0～20份。
2.根据权利要求1所述的组合物，其特征在于，所述组合物由以下重量份的原料制备而成：金银花3份，蒲公英5份，芦根5份，薏苡4份，桃仁3份，丹皮3份，车前子3份，苦丁茶2份，薄荷2份，辅料9份。
3.根据权利要求1或2所述的组合物，其特征在于，所述辅料选自麦芽糊精、乳糖、葡萄糖、微晶纤维素、甲基纤维素、羧甲基纤维素钠、硬脂酸镁、二氧化硅、滑石粉、聚乙二醇或淀粉中的一种或几种。
4.根据权利要求3所述的组合物，其特征在于，所述辅料为麦芽糊精。
5.根据权利要求1所述的组合物，其特征在于，所述组合物由以下重量份的原料制备而成：金银花1～10份，蒲公英3～15份，芦根3～15份，薏苡2～13份，桃仁1～10份，丹皮1～10份，车前子1～10份，苦丁茶1～8份，薄荷1～8份，麦芽糊精4～20份。
6.根据权利要求1、2或5所述的组合物，其特征在于，所述组合物由以下重量份的原料制备而成：金银花3份，蒲公英5份，芦根5份，薏苡4份，桃仁3份，丹皮3份，车前子3份，苦丁茶2份，薄荷2份，麦芽糊精9份。
7.权利要求1～6任意一项所述组合物的制备方法，其特征在于，包括以下步骤：
(1)取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入8～12倍体积的水，浸泡20～40min，煎煮100～150min，减压过滤，滤液备用，保留药渣；
(2)在步骤(1)所得药渣中再加入6～10倍体积的水，煎煮40～80min，减压过滤，滤液备用；
(3)将步骤(1)与步骤(2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度0.9～1.3，添加辅料，制备成常规剂型。
8.根据权利要求7所述的制备方法，其特征在于，包括以下步骤：
(1)取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入8～12倍体积的水，浸泡20～40min，煎煮100～150min，减压过滤，滤液备用，保留药渣；
(2)在步骤(1)所得药渣中再加入6～10倍体积的水，煎煮40～80min，减压过滤，滤液备用；
(3)将步骤(1)与步骤(2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度0.9～1.3，添加麦芽糊精，喷雾干燥成粉末，即得组合物。
9.根据权利要求7或8所述的制备方法，其特征在于，包括以下步骤：
(1)取金银花、蒲公英、芦根、薏苡、桃仁、丹皮、车前子、苦丁茶、薄荷，粉碎后混合，加入10倍体积的水，浸泡30min，煎煮120min，减压过滤，滤液备用，保留药渣；
(2)在步骤(1)所得药渣中再加入8倍体积的水，煎煮60min，减压过滤，滤液备用；
(3)将步骤(1)与步骤(2)所得滤液合并，依次过200目筛和400目筛，浓缩滤液至相对密度1.1，添加麦芽糊精，喷雾干燥得粉末，即得组合物。
10.权利要求1～6任意一项所述组合物或权利要求7～9任意一项所述方法制备得到的组合物在制备祛除痤疮药物中的应用。
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