CN108159145B - 一种治疗痤疮的中药组合物及其制备方法和用途 - Google Patents
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Abstract
本发明涉及一种治疗痤疮的中药组合物及其制备方法和用途,组合物的主要原料药为枇杷叶、黄芩、蒲公英、连翘、天花粉、皂角刺、丹参、墨旱莲、女贞子和甘草。将上述原料药材经洗净干燥后用超微粉碎设备制备成细粉加入常用基质中制备成各种外用制剂或者用常规提取方法进行提取后制备成内服制剂使用。本发明的组合物配方合理,疗效明确。对各种原因引起的痤疮有较好的治疗作用,见效快、费用低、治愈率高、复发率低。
Description
技术领域
本发明属于中药组合物技术领域,特别是涉及一种治疗痤疮的中药组合物及其制备方法和用途。
背景技术
随着人民生活水平提高和生活节奏加快,学习和工作压力加大,越来越多的年轻人受到痤疮的困扰。
痤疮又叫“青春痘”或“粉刺”,实质上是一种毛囊、皮脂腺的慢性炎症,通常发生在面部及胸背等身体的多脂部位。痤疮主要好发于青少年,青春期后有的能够自然减轻或痊愈。但是,痤疮引发的丘疹、脓疱、结节等皮损发作时不仅给患者带来痛苦,严重时还会留下疤痕和影响面貌,给青少年的心理和社交带来很大的负面影响,因此,药物干预治疗痤疮是广大患者的迫切需求。临床上有的使用米诺环素等抗生素类药物,但是抗生素类药物的耐药性和安全性问题严重影响患者的顺应性。
中医认为痤疮的病因病机主要是肺经风热、胃腑湿热、脾虚痰凝、血瘀阻络等。也有一些现有文献涉及使用不同的中药方剂治疗痤疮,大多涉及清泻内热、凉血解毒、除湿化瘀等机理。例如,中国专利申请号CN2007100141387公开了治疗痤疮的药物,原料包括枇杷叶、知母、栀子、菊花、蒲公英、玄参、黄柏、皂角刺、紫草、丹参和甘草等11味。CN2008101596990公开了一种治疗粉刺、痤疮的中成药,原料包括女贞子、旱莲草、丹参、当归、柴胡、郁金、生地、蒲公英、白芍、麦冬、熟地、黄连、连翘、枸杞、甘草等15味。CN2015100098127公开了一种痤疮药,原料包括蒲公英、丹参、黄芩、黄连、旱莲草、大黄、女贞子、白芷、薏苡、天花粉、甘草、白花蛇舌草、皂角刺、柴胡、白癣皮、桑白皮等16味。
尽管如此,本领域对新的有效治疗痤疮的中药组合物依然存在很大需求,本申请进一步筛选原料药,根据痤疮的病机和治疗原则对配伍原料药材和用量进行了调整,在现有技术的基础上进一步进行处方加减化裁和调整君臣佐使关系,优化了处方,获得了本发明的组方,本发明的组合物配方合理,疗效明确。对各种原因引起的痤疮有较好的治疗作用,见效快、费用低、治愈率高、复发率低。
发明内容
本发明提供一种治疗痤疮的中药组合物,由以下重量份配比的原料药制成:枇杷叶25-42份,黄芩15-30份,蒲公英50-80份,连翘15-30份,天花粉25-42份,皂角刺15-30份,丹参33-55份,墨旱莲25-42份,女贞子25-42份甘草8-18份。
优选地,本发明提供一种治疗痤疮的中药组合物,由以下重量份配比的原料药制成:枇杷叶30-35份,黄芩20-24份,蒲公英65-70份,连翘20-24份,天花粉30-35份,皂角刺20-24份,丹参42-46份,墨旱莲30-35份,女贞子30-35份,甘草10-15份。更优选地,本发明的治疗痤疮的中药组合物由以下重量份配比的原料药制成:枇杷叶33份,黄芩22份,蒲公英67份,连翘22份,天花粉33份,皂角刺22份,丹参44份,墨旱莲33份,女贞子33份,甘草13份。
本发明的中药组合物可以通过将所述原料药用超微粉碎设备制成细粉后与基质混合制成外用制剂,外用制剂的剂型可以为乳剂、膏剂、霜剂、洗剂、擦剂、酊剂、水凝胶剂、喷雾剂或涂膜剂。
本发明的中药组合物也可以通过以下方法制备成各种内服制剂:将原料药材用水煎煮两次,第一次加8倍量水,煎煮1.5h,滤过;第二次加6倍量水,煎煮1.5h,滤过,合并滤液;65℃以下真空减压浓缩后置65℃以下真空干燥,干燥后的提取物粉碎,以常规制备方法制备成各种内服制剂。内服制剂的剂型为颗粒剂、软胶囊剂、硬胶囊剂、片剂、丸剂或糖浆剂。最优选地,内服制剂的剂型为颗粒剂,将干燥粉碎的提取物加入适量微晶纤维素,混匀,以75%乙醇制粒,干燥,整粒、分装即得颗粒剂。本发明还提供所述中药组合物在制备治疗痤疮的药物中的用途。
本发明在现有技术的基础上进一步优化处方,选择疗效确切、来源广泛、价格低廉、无毒副作用的药材进行组方,根据君臣佐使调整药材用量,配伍合理,服用方便,安全可靠,治愈率高。以下对药材功效进行阐述,本发明方剂中的药材都是本领域熟知和经典的药材,本发明所述的药材原料均为符合相关卫生规范的市售生药材或饮片。
枇杷叶:别名:杷叶或巴叶,药性苦,凉。味苦、平。归肺、胃二经。偏理肺脏兼清胃热,清肺和胃,降气化痰。主治:痰热咳嗽,胃热呕吐等症,为清解肺热胃热的常用药。枇杷叶含挥发油、维生素B和C等,有一定的镇咳、镇疼作用,对白色葡萄球菌,金黄色葡萄球菌,肺炎双球菌及福氏痢疾杆菌均有明显抑制作用,并有抑制流感病毒作用。
黄芩:唇形科植物黄芩的干燥根。味苦、性寒,归肺、心、肝、胆、大肠经。清热泻火,燥湿解毒,止血,安胎。主治温热病、上呼吸道感染、肺热咳嗽、湿热黄疸、肺热咳嗽、高热烦渴、血热吐衄、泻痢、热淋、崩漏、胎热不安、痈肿疔疮等症。黄芩煎剂在临床上有较好的抗菌活性,抗菌谱广,黄芩苷能显著减轻金黄色葡萄球菌外毒素诱发的病理损伤。
蒲公英:味苦、甘,性寒。归肝、胃经。清热解毒,消痈散结。主治乳痈,肺痈、痄腮、瘰疬、疔毒疮肿、目赤肿痛、感冒发热、急性扁桃体炎、急性支气管炎、胃炎、肠炎、肝炎、胆囊炎、尿路感染、烧烫伤。
连翘:为木犀科多年生落叶灌木连翘的干燥果实。性味:苦、微寒。归肺、心、胆经。清热解毒,消肿散结。主治风热感冒、温病、热淋尿闭、痈疽、肿毒、瘰疬、瘿瘤、喉痹等症,可疏风清热,消肿排脓。连翘具有广谱而有效的抗微生物作用,对多种细菌有抑制作用。
天花粉:为葫芦科植物栝蒌的根。药性甘、微苦,微寒。归肺、胃经。清热生津、润肺化痰、消肿排脓。主治热病口渴、消渴多饮、黄疸、肺热燥咳、疮疡肿毒。
皂角刺:为豆科植物皂荚的干燥棘刺。味辛,性温。归肝、肺、胃经。消肿透脓,搜风杀虫。主治痈疽初起或脓成不溃、瘰疬、疮疹顽癣等。
丹参:为唇形科植物丹参的干燥根和根茎。味苦,微寒。归心、肝经。具有活血祛瘀,调经止痛,除烦安神,凉血消痈之功效。主治胸痹心痛、脘腹胁痛。热痹肿痛、心烦失眠、月经不调、痛经经闭,痈疮肿毒等症。丹参酮具有抗炎和抗过敏作用。
墨旱莲:为菊科鳢肠属植物鳢肠的全草。味甘、酸,性凉。归肝、肾经。有补益肝肾、凉血止血、消肿强壮之功效。主治肝肾不足、须发早白、吐血咳血、尿血便血、痔疮出血,外伤出血等症。墨旱莲有抑菌作用,能增强免疫功能。
女贞子:为木犀科植物女贞的干燥成熟果实。药性甘、苦,凉。归肝、肾经。补益肝肾,明目,清虚热。主治头昏目眩,须发早白,目暗不明,骨蒸潮热等症。女贞子中的齐墩果酸具有抗炎和抗过敏作用。
甘草:药性甘、平,归心,肺,脾,胃经。补脾益气,和中缓急、润肺解毒、调和诸药。甘草有肾上腺皮质激素样作用,具有抗炎、抗过敏和抗微生物作用。生用治疗咽喉肿痛、痈疮肿毒等症。
青少年痤疮患者多有热证实证,皮脂分泌旺盛,且有时候不能很好地注意个人卫生,容易导致疮痘炎症加重的情况。针对以上特点,本申请的组合物中多选能清肺胃热,凉血消肿、散结祛斑、散瘀排脓、抗炎抑菌和抗过敏的中药材,标本兼治,消痘快,不留疤,不易复发,无毒副作用。本发明的组合物具有疏风散热,凉血解毒,透肿散瘀,排脓除菌的功效,安全有效,未见不良反应,治疗粉刺痤疮效果良好。
本方重用清热解毒、消痈散结且来源广泛价格低廉的蒲公英,专门针对青少年痤疮患者热毒之症,枇杷叶入肺、胃二经,主攻清解肺胃热盛越于肌肤之蕴毒,兼有抗菌消炎之功效。本申请从立足病因,调节脏腑的角度出发,在现有技术中数量庞大的清热凉血、抗菌消炎类药材中精选出本方药味进行组方,在现有技术已知的诸多方剂的基础上进行加减化裁,综合考虑治疗效果和药材成本,选方精当,诸药相伍,配比合理,药效显著。
具体实施方式
实施例1:
治疗痤疮的中药组合物,由以下重量份配比的原料药制成:枇杷叶33份,黄芩22份,蒲公英67份,连翘22份,天花粉33份,皂角刺22份,丹参44份,墨旱莲33份,女贞子33份,甘草13份。将原料药材用水煎煮两次,第一次加8倍量水,煎煮1.5h,滤过;第二次加6倍量水,煎煮1.5h,滤过,合并滤液;65℃以下真空减压浓缩后置65℃以下真空干燥,干燥后的提取物粉碎后加入适量微晶纤维素,混匀,以75%乙醇制粒,干燥,整粒、分装即得。
如果以g为单位,按照枇杷叶330g,黄芩220g,蒲公英670g,连翘220g,天花粉330g,皂角刺220g,丹参440g,墨旱莲330g,女贞子330g,甘草130g,提取物干燥粉碎后加入微晶纤维素后的总重量为1000g,分装成10g/袋的颗粒剂,口服施用,每次1袋,一日3次。
实施例2:
治疗痤疮的中药组合物,由以下重量份配比的原料药制成:枇杷叶35份,黄芩24份,蒲公英70份,连翘24份,天花粉35份,皂角刺24份,丹参45份,墨旱莲35份,女贞子35份,甘草15份。将原料药材用水煎煮两次,第一次加10倍量水,煎煮2h,滤过;第二次加8倍量水,煎煮1.5h,滤过,合并滤液;65℃以下真空减压浓缩后置65℃以下真空干燥,干燥后的提取物粉碎后加入适量微晶纤维素,混匀,以75%乙醇制粒,干燥,整粒、分装即得。
如果以g为单位,按照枇杷叶350g,黄芩240g,蒲公英700g,连翘240g,天花粉350g,皂角刺240g,丹参450g,墨旱莲350g,女贞子350g,甘草150g,提取物干燥粉碎后加入微晶纤维素后的总重量为1000g,分装成10g/袋的颗粒剂,口服施用,每次1袋,一日3次。
实施例3:
治疗痤疮的中药组合物,由以下重量份配比的原料药制成:枇杷叶32份,黄芩20份,蒲公英65份,连翘20份,天花粉32份,皂角刺22份,丹参42份,墨旱莲33份,女贞子32份,甘草12份。将原料药材用水煎煮两次,第一次加8倍量水,煎煮1.5h,滤过;第二次加6倍量水,煎煮1.5h,滤过,合并滤液;65℃以下真空减压浓缩后置65℃以下真空干燥,干燥后的提取物粉碎后加入适量微晶纤维素,混匀,以75%乙醇制粒,干燥,整粒、分装即得。
如果以g为单位,按照枇杷叶320g,黄芩200g,蒲公英650g,连翘200g,天花粉320g,皂角刺220g,丹参420g,墨旱莲330g,女贞子320g,甘草120g,提取物干燥粉碎后加入微晶纤维素后的总重量为1000g,分装成10g/袋的颗粒剂,口服施用,每次1袋,一日3次。
对比例1:在实施例1的基础上减去丹参和墨旱莲,其余同实施例1。
对比例2:在实施例1的基础上减去蒲公英,其余同实施例1。
对比例3:在实施例1的基础上减去枇杷叶,其余同实施例1。
对比例4:在实施例1的基础上减去枇杷叶和连翘,其余同实施例1。
对比例5:按照中国专利申请CN2007100141387的实施例1选择药材,即枇杷叶10g、知母6g、栀子5g、菊花13g、蒲公英10g、玄参12g、黄柏4g、皂角刺3g、紫草4g、丹参15g和甘草15g。按照本申请实施例1的类似方法和生药材/辅料比制备成颗粒剂。
对比例6:按照中国专利申请CN2008101596990的实施例1选择药材,即女贞子11g、旱莲草11g、丹参11g、当归11g、柴胡11g、郁金11g、生地11g、蒲公英16g、白芍11g、麦冬11g、熟地11g、黄连11g、连翘11g、枸杞12g、甘草4g。按照本申请实施例1的类似方法和生药材/辅料比制备成颗粒剂。
对比例7:按照中国专利申请CN2015100098127的实施例1选择药材,即蒲公英160g、丹参240g、黄芩240g、黄连48g、旱莲草150g、大黄48g、女贞子160g、白芷160g、薏苡240g、天花粉160g、甘草48g、白花蛇舌草320g、皂角刺240g、柴胡48g、白癣皮120g、桑白皮120g。按照本申请实施例1的类似方法和生药材/辅料比制备成颗粒剂。
临床试验
为验证本发明药物的疗效,申请人于2012年4月-2017年12月与重庆市人民医院皮肤科、重庆市中医院皮肤科等医院合作进行了临床试验:
1、病例选择:入选的痤疮患者共120例,其中女48例,男72例,年龄14-25岁之间,全部病例均符合“痤疮”诊断标准(有粉刺、毛囊炎性丘疹、脓疱和结节等多形损害,但无明显皮肤破溃者)。
2、治疗方法:将上述患者随机分为4组,每组30例,男女分布基本均衡:第1组用本申请实施例1的药物治疗,第2组用本申请实施例2的药物治疗,第3组用本申请实施例3的药物治疗,口服施用,每次1袋,一日3次;第4组为对照组,口服市售维甲酸联合外用盐酸克林霉素凝胶。全部4组均以四周为一疗程。
3、疗效评价标准:皮肤损害完全消失,自觉症状消失为治愈;自觉症状明显减轻,皮肤红肿痘疮消退大于50%为显效,30-50%为有效;自觉症状无明显变化或痘疮粉刺消退不足30%为无效。
4、疗效结果:
5、结论:
从以上对比试验可见:本发明药物对于治疗痤疮有明显的疗效,且治愈率、总有效率高于一般临床上使用的抗生素类药物,更重要的是,本申请药物用药好转后粉刺痤疮不易复发,皮肤恢复状态好。
6、典型病例:
病例1:李某,男,16岁,重庆市涪陵区人,2015年10月因患痤疮并逐渐加重,使用市售抗生素和外用药膏和化妆品祛痘无效或无显效。该患者符合寻常痤疮临床诊断标准,诊断为3级(中度)痤疮,除粉刺外,还有较多的炎性丘疹和脓疱。随于2015年10月中旬开始服用本申请实施例1的颗粒剂,每次1袋,一日3次。5周后,患者已基本痊愈,3个月后随访无复发。
病例2:宋某,女,22岁,重庆市万州区人,患者患痤疮病史已有5年以上,尝试过多种治疗痤疮的药品和化妆品,也服用过一些中药汤剂,效果均不理想。患者诊断为2级(中度)痤疮,除粉刺外,还有较多炎性丘疹。随于2016年1月开始服用本申请实施例2的颗粒剂,每次1袋,一日3次。4周后,患者症状明显改善,5周后痊愈,5个月后随访无复发。
病例3:何某,男,18岁,重庆市渝中区人,患者自述从青春期开始就患痤疮,在多家医疗美容机构联合使用物理疗法和内服外用药物,有时有效果,但是停药不久之后就复发甚至反弹,痤疮加剧。患者诊断为4级(重度)痤疮,除有粉刺、炎性丘疹及脓疱外,还有囊肿和瘢痕。随于2017年4月开始服用本申请实施例1的颗粒剂,每次1袋,一日3次。5周后,患者症状明显改善,6周后痊愈,6个月后随访无复发。
7、对比试验:发明人对本申请的处方进行了多种调适、对药材进行加减化裁和含量调整,对比了多种处方的效果之后选择了最终的处方,其间付出了大量的劳动并进行了众多次对比试验。以上述对比例1-7为例,进行类似如上所述的临床试验,病例选择:入选的痤疮患者共140例,其中女58例,男82例,年龄14-25岁之间,全部病例均符合“痤疮”诊断标准(有粉刺、毛囊炎性丘疹、脓疱和结节等多形损害,但无明显皮肤破溃者)。治疗方法:将上述患者随机分为7组,每组20例,男女分布基本均衡。第1-7组依次用对比例1-7的药物治疗,口服施用,每次1袋,一日3次,全部7组均以四周为一疗程。疗效评价标准如前。结果如下:
从以上结果可以看出,本申请的组方在综合考量各种因素优化后的效果最好,相比现有技术的组方更合理,疗效更好,药材成本更低,对青少年痤疮粉刺具有很好的治疗效果。
以上实施例仅为本申请的非限制性示例,凡是在不脱离本申请组方的配伍原则的基础上进行的变型均在本申请的保护范围之内。
Claims (5)
1.一种治疗痤疮的中药组合物,由以下重量份配比的原料药制成:枇杷叶33份,黄芩22份,蒲公英67份,连翘22份,天花粉33份,皂角刺22份,丹参44份,墨旱莲33份,女贞子33份,甘草13份;其制备方法为:将原料药材用水煎煮两次,第一次加6-10倍量水,煎煮1-2h,滤过;第二次加4-8倍量水,煎煮1-2h,滤过,合并滤液;65℃以下真空减压浓缩后置65℃以下真空干燥,干燥后的提取物粉碎,以常规制备方法制备成各种内服制剂。
2.根据权利要求1所述的中药组合物:其中制备方法为:将原料药材用水煎煮两次,第一次加8倍量水,煎煮1.5h,滤过;第二次加6倍量水,煎煮1.5h,滤过,合并滤液;65℃以下真空减压浓缩后置65℃以下真空干燥,干燥后的提取物粉碎,以常规制备方法制备成各种内服制剂。
3.根据权利要求1所述的中药组合物,其中内服制剂的剂型为颗粒剂、软胶囊剂、硬胶囊剂、片剂、丸剂或糖浆剂。
4.根据权利要求3所述的中药组合物,其中内服制剂的剂型为颗粒剂,所述颗粒剂制备方法为:将干燥粉碎的提取物加入适量微晶纤维素,混匀,以75%乙醇制粒,干燥,整粒、分装即得。
5.权利要求1-4任一项所述的中药组合物在制备治疗痤疮的药物中的用途。
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