CN110787264A - 一种治疗痤疮的中药组合物及其制备方法和应用 - Google Patents
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Abstract
本发明涉及中药制剂技术领域,具体涉及一种治疗痤疮的中药组合物及其制备方法和应用,由以下重量份数的原料制成:生薏苡仁20~30份、牛蒡子12~18份、大青叶12~20份、板蓝根10~15份、茯苓8~14份、猪苓10~20份、乳香8~12份、赤芍12~20份、白芷6~10份、败酱草7~14份、黄连6~10份、甘草4~8份。本发明原料丰富,组方科学、合理,易于生产制造,成本相对较低,服用方便,效果好,针对不同病因引起的痤疮都可进行调理治疗,纯中药制剂,无副作用产生,有实际的临床意义。
Description
技术领域
本发明涉及中药制剂技术领域,具体涉及一种治疗痤疮的中药组合物及其制备方法和应用。
背景技术
很多人都有过这样的经历,亮丽的脸上突然出现了很多痘痘、痤疮,抹了不少的药膏也无济于事,其实这不只是单单的皮肤问题,这些痤疮也是内分泌不稳定时再受到外界因素不良刺激引起的。痤疮的发生主要与皮脂分泌过多、皮囊皮脂腺导管堵塞、细菌感染和炎症反应等因素密切相关,进入青春期后人体内雄激素特别是睾酮的水平迅速升高,促进皮脂腺发育并产生大量皮脂;同时毛囊皮脂腺导管的角化异常造成导管堵塞,皮脂排出障碍,形成角质栓即微粉刺。毛囊中多种微生物尤其是痤疮丙酸杆菌大量繁殖,痤疮丙酸杆菌产生的脂酶分解皮脂生成游离脂肪酸,同时趋化炎症细胞和介质,最终诱导并加重炎症反应。
对于痤疮的治疗问题,西医的指导原则是调节内分泌,使之重新达至平衡。通常对激素分泌过多造成的功能亢进,以抑制、消减为原则,可以采取手术切除内分泌肿瘤,或用药物抑制激素的分泌和合成;对激素分泌过少造成的失调,原则上是补充其不足,包括补充生理剂量激素,器官移植等。这种激素类药物的长期使用有诱发乳腺疾病和妇科肿瘤的危险,使用不当则会加剧女性内分泌紊乱的状态,另外,外源性激素的副作用和依赖症也较为明显,这些因素使激素替代疗法治疗女性内分泌紊乱往往得不偿失,甚至会带来新的健康问题,且治疗效果也不理想、治疗费用高治疗周期长。
近代中医认为,痤疮患者因青春期生机旺盛,血气充沛,阳热偏旺,热盛伤肺,肺热熏蒸,蕴阻肌肤可致肺经风热证;饮食不洁,偏嗜辛辣肥甘、油腻腥发之品,湿热困阻中焦,循经上蒸,致胃经实火证;心经伏热,恋而不去,心火允盛,积热上冲颜面而发心火充盛证;性情急躁,或情志不畅,致肝失疏泄,肝郁则病,郁久化火,或过食膏粱厚味,则生湿助热,肝郁与湿热共存,外泛肌肤而成肝经湿热证;肾阴不足致肾之阴阳平衡失调,相火偏旺,循经上蒸而发肾阴不足证;脾虚不运,忧思伤脾,水湿内停,湿聚成痰,日久化热,湿热夹痰,凝结肌肤致痰湿凝结证;病久不愈,邪聚不散,气滞血癖,经脉失畅,或风湿热邪蕴于肌肤,气血受遏,凝聚而成气血疲滞证。因此在治疗上以清热解毒,祛湿活血法为主。
发明内容
为解决上述问题,本发明的目的在于提供一种治疗痤疮的中药组合物。
本发明的第一个目的是提供一种治疗痤疮的中药组合物,由以下重量份数的原料制成:生薏苡仁20~30份、牛蒡子12~18份、大青叶12~20份、板蓝根10~15份、茯苓8~14份、猪苓10~20份、乳香8~12份、赤芍12~20份、白芷6~10份、败酱草7~14份、黄连6~10份、甘草4~8份。
优选地,所述中药组合物由以下重量份数的原料制成:生薏苡仁30份、牛蒡子18份、大青叶20份、板蓝根15份、茯苓14份、猪苓20份、乳香12份、赤芍20份、白芷10份、败酱草14份、黄连10份、甘草8份。
本发明的第二个目的是提供一种治疗痤疮的中药组合物的制备方法,包括以下步骤:
S1:分别称取以下重量份数的原料:生薏苡仁20~30份、牛蒡子12~18份、大青叶12~20份、板蓝根10~15份、茯苓8~14份、猪苓10~20份、乳香8~12份、赤芍12~20份、白芷6~10份、败酱草7~14份、黄连6~10份、甘草4~8份;
S2:将水生薏苡仁、茯苓、猪苓、赤芍、白芷、黄连粉碎,过150目筛得到混合粉末;
S3:将S2的混合粉末与牛蒡子、大青叶、板蓝根、乳香、败酱草、甘草加相当于原料2~4倍重量的水煎煮2次,每次煎煮2~3小时后过滤掉滤液,再次加入相当于原料5~6倍重量的水煎煮,煮沸后煎煮2~3小时,过滤后得到滤液,将滤液浓缩至50℃时相对密度为1.3~1.4的浓缩药液。
优选的,将所述浓缩药液与药学上可接受的辅料制成口服药液、颗粒剂、片剂、丸剂或分散片剂。
本发明的第三个目的是提供一种上述中药在用于制备治疗痤疮的药物制剂中的应用。
本发明采用的原料药的药性、药理及作用如下:
生薏苡仁:入脾、肺、肾经。健脾,补肺,清热,利湿。治泄泻,湿痹,筋脉拘挛,屈伸不利,水肿,脚气,肺痿,肺痈,肠痈,淋浊,白带。
牛蒡子:疏散风热;清热解毒透疹;宣肺利咽散肿。风热感冒、温病初起;风热或肺热咳嗽、咯痰不畅;咽喉肿痛;斑疹不透;麻疹初期,疹出不畅及风疹瘙痒;疮疡肿毒及痄腮等。生用可润肠通便,热毒咽喉红肿疼痛,兼有热结便秘尤宜。
大青叶:苦,寒。清热,解毒,凉血,止血。治温病热盛烦渴,流行性感冒,急性传染性肝炎,菌痢,急性胃肠炎,急性肺炎,丹毒,吐血,衄血,黄疸,痢疾,喉痹,口疮,痈疽肿毒。
板蓝根:性寒,味先微甜后苦涩,具有清热解毒、预防感冒、利咽之功效。主要用于治疗温毒发斑、舌绛紫暗、烂喉丹痧等疾病。
茯苓:宁心安神,败毒抗癌。药性平和,利湿而不伤正气。适量服食可作为春夏潮湿季节的调养佳品,可治小便不利、水肿胀满、痰饮咳逆、呕逆、恶阻、泄泻、遗精、淋浊、惊悸、健忘等症。所含茯苓酸具有增强免疫力、抗肿瘤以及镇静、降血糖等的作用。可松弛消化道平滑肌,抑制胃酸分泌,防止肝细胞坏死,抗菌等功效。
猪苓:味甘、淡,平。治脉浮发热,渴欲饮水,小便不利;妊娠从脚上至腹肿,小便不利,微渴引饮;肠胃寒湿,濡泻无度,嗜卧不食;年壮气盛,梦遗白浊;通身肿满,小便不利。
乳香:性辛苦,温。调气活血,定痛,追毒。治气血凝滞、心腹疼痛,痈疮肿毒,跌打损伤,痛经,产后瘀血刺痛。
赤芍:性酸敛阴柔,具有养阴、行瘀、止痛、凉血、消肿。主治:治瘀滞经闭、疝瘕积聚、腹痛、胁痛、衄血、血痢、肠风下血、目赤、痈肿、跌扑损伤
白芷:性温,味辛,气芳香,微苦。祛风湿,活血排脓,生肌止痛。用于头痛、牙痛、鼻渊、肠风痔漏、赤白带下、痈疽疮疡、皮肤瘙痒。
败酱草:味辛、苦,微寒。用于肠痈,肺痈高热,咳吐脓血,热毒疮疔,疮疖痛肿,胸腹疼痛,阑尾炎,肠炎、痢疾,产后腹痛,痛经。
黄连:清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。酒黄连善清上焦火热。用于目赤,口疮。姜黄连清胃和胃止呕。用于寒热互结,湿热中阻,痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不和,呕吐吞酸。
甘草:味甘,性平。补脾益气,清热解毒,祛痰止咳,缓解止痛,调和诸药。用于脾胃虚弱,倦怠乏力、心悸气短,咳嗽痰多、四肢孪急疼痛,缓解药物毒性、烈性。
本发明中药配伍机理:
本发明以牛蒡子、大青叶、板蓝根、黄连为君药,诸药共凑清热解毒之功效,热去则毒自消;生薏苡仁、败酱草、猪苓、茯苓等健脾祛湿,清利湿热,共为臣药,同时诸药可消肿散结,消散肿块;白芷、乳香、赤芍等活血化瘀,消散痘印,共为佐药,甘草为使,调和诸药。上述中草药协同作用,可清热利湿、活血散结、消肿排脓等,从痤疮的各个方面进行治疗,符合符合中医药“君、臣、佐、使”的配伍原则。
本发明的有益效果是:
本发明原料丰富,组方科学、合理,易于生产制造,成本相对较低,服用方便,效果好,针对不同病因引起的痤疮都可进行调理治疗,纯中药制剂,无副作用产生,有实际的临床意义。
具体实施方式
下面结合具体实施方式对本发明进行详细说明,但应当理解本发明的保护范围并不受具体实施方式的限制。下列实施例中未注明具体条件的试验方法,通常按照常规条件操作,未注明的实验材料来源均为市售,由于不涉及发明点,故不对其步骤进行详细描述。
实施例1
一种治疗痤疮的中药组合物,由以下原料制成:生薏苡仁30g、牛蒡子18g、大青叶20g、板蓝根15g、茯苓14g、猪苓20g、乳香12g、赤芍20g、白芷10g、败酱草14g、黄连10g、甘草8g。
上述治疗痤疮的中药组合物是具体由以下步骤制得:
S1:分别称取以下重量的原料:生薏苡仁30g、牛蒡子18g、大青叶20g、板蓝根15g、茯苓14g、猪苓20g、乳香12g、赤芍20g、白芷10g、败酱草14g、黄连10g、甘草8g;
S2:将水生薏苡仁、茯苓、猪苓、赤芍、白芷、黄连粉碎,过150目筛得到混合粉末;
S3:将S2的混合粉末与牛蒡子、大青叶、板蓝根、乳香、败酱草、甘草加相当于原料2~4倍重量的水煎煮2次,每次煎煮2~3小时后过滤掉滤液,再次加入相当于原料5~6倍重量的水煎煮,煮沸后煎煮2~3小时,过滤后得到滤液,将滤液浓缩至50℃时相对密度为1.3~1.4的浓缩药液。
实施例2
一种治疗痤疮的中药组合物,由以下原料制成:生薏苡仁20g、牛蒡子12g、大青叶12g、板蓝根10g、茯苓8g、猪苓10g、乳香8g、赤芍12g、白芷6g、败酱草7g、黄连6g、甘草4g。
上述治疗痤疮的中药组合物是具体由以下步骤制得:
S1:分别称取以下重量份数的原料:生薏苡仁20g、牛蒡子12g、大青叶12g、板蓝根10g、茯苓8g、猪苓10g、乳香8g、赤芍12g、白芷6g、败酱草7g、黄连6g、甘草4g;
S2:将水生薏苡仁、茯苓、猪苓、赤芍、白芷、黄连粉碎,过150目筛得到混合粉末;
S3:将S2的混合粉末与牛蒡子、大青叶、板蓝根、乳香、败酱草、甘草加相当于原料2~4倍重量的水煎煮2次,每次煎煮2~3小时后过滤掉滤液,再次加入相当于原料5~6倍重量的水煎煮,煮沸后煎煮2~3小时,过滤后得到滤液,将滤液浓缩至50℃时相对密度为1.3~1.4的浓缩药液。
实施例3
一种治疗痤疮的中药组合物,由以下原料制成:生薏苡仁25g、牛蒡子16g份、大青叶18g、板蓝根12g、茯苓10g、猪苓15g、乳香10g、赤芍16g、白芷8g、败酱草10g、黄连8g、甘草6g。
上述治疗痤疮的中药组合物是具体由以下步骤制得:
S1:分别称取以下重量份数的原料:生薏苡仁25g、牛蒡子16g份、大青叶18g、板蓝根12g、茯苓10g、猪苓15g、乳香10g、赤芍16g、白芷8g、败酱草10g、黄连8g、甘草6g;
S2:将水生薏苡仁、茯苓、猪苓、赤芍、白芷、黄连粉碎,过150目筛得到混合粉末;
S3:将S2的混合粉末与牛蒡子、大青叶、板蓝根、乳香、败酱草、甘草加相当于原料2~4倍重量的水煎煮2次,每次煎煮2~3小时后过滤掉滤液,再次加入相当于原料5~6倍重量的水煎煮,煮沸后煎煮2~3小时,过滤后得到滤液,将滤液浓缩至50℃时相对密度为1.3~1.4的浓缩药液。
上述实施例1~3所制备的中药药效相似,下面以实施例1制备的中药为例,通过采用下述试验来进一步对本发明的效果进行说明。
1、药理学毒性试验
1.1、药物蓄积毒性试验方法
取BALB/c裸鼠40只,雌、雄各半,体重20~23g,由中国医学科学院实验动物研究所提供。实验前置动物于室内适应环境3天,室温25~27℃,相对湿度50~60%。每天灌胃本发明上述实施例1的中药组合物一次,开始灌胃剂量2.5g/kg·bw,以后按定期递增剂量法,逐步增加每天灌胃的剂量,使之达到25g/kg·bw,连续30天。每5天称体重一次。
检测结果:上述所有动物均正常存活,无死亡现象发生,且未见明显的毒性反应;检测心、肝肺、肾、肾上腺等器官,结果表明上述器官均没有发生明显病变。
1.2、急性毒性试验方法
取BALB/c裸鼠40只,雌、雄各半,体重22~25g,由中国医学科学院实验动物研究所提供。实验前置动物于室内适应环境3天,室温25~27℃,相对湿度50~60%。以成人临床日用量的500倍给裸鼠灌胃上述实施例1的中药组合物(灌胃前,用水调匀)一次,即刻观察动物反应情况、中毒症状及死亡情况,连续观察7日。
观察结果:所有动物活动自如,摄食饮水、毛发、排泄物均未发现异常,未见毒性反应。
综上所述,通过上述药物蓄积毒性试验和急性毒性试验结果可以证明,本发明制备的中药安全性好,毒性低。
2、临床资料
2.1、一般资料
自2015年起收治多种痤疮患者共192例,年龄15-30岁,平均年龄21.5岁;病程3-5年,病程小于3年的108例,3-5年的84例。
2.2、临床表现
额部、两颊部、眉间等生有红斑、丘疹、脓疱,胸背部亦有类似皮疹发生,且皮疹逐渐增多,同时伴有大便干结、口干欲饮、舌苔黄腻等症,分皮疹退后留有色素沉着,以及萎缩性疤痕。
2.3、中医辨证标准
依据国家中医药管理局制定的《中医病证诊断疗效标准》和《中药新药临床研究指导原则》。
3、治疗过程
患者服用本发明中药,每日一剂,饭后服用,两周一个疗程。
4、疗效
对疗效进行判定时,规定显效为粉刺、丘莎、脓疱、结节及囊肿全部消失;有效为粉刺、丘莎、脓疱,结节及囊肿40%以上消失;无效为粉刺、丘莎、脓疱、结节及囊肿无明显改善,或仅有部分减轻。
根据诊断标准和治疗过程,经对随机抽取的192例痤疮患者观察,有显著效果者178例,有明显改善者11例,无效者3例,总有效率98%,而且有较好的远期效果。
5、安全性
临床观察结果表明,治疗的192例患者服用本发明中药组合物后,血常规、尿常规均无异常,对肾功能没有产生不良影响,无明显毒副作用,服用安全。
6、典型案例
李某,女,19岁,寻常型痤疮。病史:皮疹、粉刺2年余,起初面部皮疹为红色,随着时间的改变呈现红色粉刺样丘疹,伴有小脓疱、小结节。口干,心烦,失眠多梦,小便短赤,大便干,舌红少苔,阴虚内热证。临床诊断为寻常型痤疮,证属肝阳上亢,风火上扰引起的内分泌失调所致,服用本发明中药10剂,患者粉刺消退,丘疹消失,仍按原方案治疗并嘱保持心态平和,继续服用月余,患者所有症状消失。
曲某,女,23岁,前额、下颌、面颊等多处均有多发性白头粉刺,面部爆痘,失眠多梦、精神焦虑,舌暗红,苔薄。证属血凝瘀滞,治宜祛瘀生新。诊断后持续服用本发明中药5剂,精力渐充,面部痘痘基本消失,舌偏红,苔薄,,仍按原方案治疗服用10剂,患者面部痤疮全部消失,皮肤红润。
安某,男,29岁,面部色斑沉着、不光滑、来诊时面色咣白、色斑明显,面部痤疮,自述起初为分散小丘疹,周围赤红,面部瘙痒且市场伴有刺痛感,用手挤压有白色分泌物、时有脓疮,反反复复,久久不能痊愈,检查舌质暗淡,舌苔薄白,脉沉细,临床诊断脾虚、色斑沉着,证属气虚血淤,脾胃失和,内分泌功能紊乱。诊断后持续服用本发明中药10剂,10天后复诊,面部色斑开始减退,面部痤疮显著减少,继续服药20剂,患者面色红润,面部色斑和痤疮基本消失,半年后回访已无复发。
尽管已描述了本发明的优选实施例,但本领域内的技术人员一旦得知了基本创造性概念,则可对这些实施例作出另外的变更和修改。所以,所附权利要求意欲解释为包括优选实施例以及落入本发明范围的所有变更和修改。
显然,本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。
Claims (5)
1.一种治疗痤疮的中药组合物,其特征在于,由以下重量份数的原料制成:生薏苡仁20~30份、牛蒡子12~18份、大青叶12~20份、板蓝根10~15份、茯苓8~14份、猪苓10~20份、乳香8~12份、赤芍12~20份、白芷6~10份、败酱草7~14份、黄连6~10份、甘草4~8份。
2.根据权利要求1所述的治疗痤疮的中药组合物,其特征在于,由以下重量份数的原料制成:生薏苡仁30份、牛蒡子18份、大青叶20份、板蓝根15份、茯苓14份、猪苓20份、乳香12份、赤芍20份、白芷10份、败酱草14份、黄连10份、甘草8份。
3.根据权利要求1所述的治疗痤疮的中药组合物的制备方法,其特征在于,包括以下步骤:
S1:分别称取以下重量份数的原料:生薏苡仁20~30份、牛蒡子12~18份、大青叶12~20份、板蓝根10~15份、茯苓8~14份、猪苓10~20份、乳香8~12份、赤芍12~20份、白芷6~10份、败酱草7~14份、黄连6~10份、甘草4~8份;
S2:将水生薏苡仁、茯苓、猪苓、赤芍、白芷、黄连粉碎,过150目筛得到混合粉末;
S3:将S2的混合粉末与牛蒡子、大青叶、板蓝根、乳香、败酱草、甘草加相当于原料2~4倍重量的水煎煮2次,每次煎煮2~3小时后过滤掉滤液,再次加入相当于原料5~6倍重量的水煎煮,煮沸后煎煮2~3小时,过滤后得到滤液,将滤液浓缩至50℃时相对密度为1.3~1.4的浓缩药液。
4.根据权利要求3所述的治疗痤疮的中药组合物的制备方法,其特征在于,将所述浓缩药液与药学上可接受的辅料制成口服药液、颗粒剂、片剂、丸剂或分散片剂。
5.根据权利要求1所述的中药在用于制备治疗痤疮的药物制剂中的应用。
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