CN116370537A - 荆防制剂在制备治疗乳腺疾病药物中的用途 - Google Patents
荆防制剂在制备治疗乳腺疾病药物中的用途 Download PDFInfo
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Abstract
本发明属于中药技术领域,具体涉及一种含羌活、独活、茯苓、防风、荆芥、川芎、桔梗、柴胡、前胡、枳壳、甘草的荆防制剂在制备治疗乳腺疾病药物中的用途。本发明荆防制剂,配伍合理,协同效果好,临床上能有效治疗乳腺炎、乳腺增生等乳腺疾病。本发明为纯中药制剂,总有效率高且不易复发,治疗过程简单易行,不良反应小。
Description
技术领域
本发明属于中药技术领域,涉及荆防制剂新的医药用途,具体涉及荆防制剂在制备治疗乳腺疾病药物中的用途。
背景技术
乳腺疾病是影响女性健康的最主要因素,中医关于乳腺疾病的认知早已记载,汉代《中藏经》即载有“乳癖”病名。临床上的乳腺疾病以乳腺炎、乳腺增生、乳腺良性病变、乳腺恶性肿瘤等为主。
慢性乳腺炎病为非细菌性炎症,好发于非哺乳期、非妊娠期的女性,其发病率为乳腺良性疾病的4%-5%,常以肿块或乳头溢液为首发症状,加之肝郁气滞,聚结成块,久之则易气血瘀滞,痰瘀互结,继而生热,蒸酿肉腐,终致脓肿。此外,还与冲任失调、外感邪实有关,禀赋不足是其本虚,情志不舒,肝气犯脾,再加邪毒侵犯乳络,致气血运行失调,凝聚成块,郁久化热,肉腐成脓。
急性乳腺炎是乳腺的急性化脓性感染,表现为一侧或双侧乳房局部红斑、疼痛、肿胀,有时伴有发热和疲乏等全身不适症状,多发于哺乳期妇女。研究表明,急性化脓性乳腺炎主要致病菌是革兰氏阳性葡萄球菌,尤以金黄色葡萄球菌为主。临床上常用静脉注射抗生素的方法治疗,但存在着加快细菌耐药,影响母乳喂养等问题。
临床常见的乳腺肿物包括乳腺增生、乳腺囊肿等。乳腺增生症是乳腺正常发育和退化过程失常导致的一种既非炎症又非肿瘤的一种慢性良性增生性疾病,主要表现为乳房有形状、大小不一的肿块、疼痛,其发病率占乳腺疾病的首位。古代文献将其归属于“乳癖”“乳痞”范畴,如《医宗金鉴·外科心法要诀》言:“乳中结核梅李形,按之不移,色不红,时时隐痛劳岩渐,证由肝脾郁结成”,表明乳腺增生的发生多为肝脾郁结所致。
历代医家多认为肝郁气滞为乳癖病机之本。古代医家多以养血活血、理气化痰、疏肝行气为原则,还认识到肝木乘脾,故也多见组方中健脾益气的药物以扶土。《神农本草经》云:“丹参,主心腹邪气……破癥除瘕,止烦满。”佐以赤芍、莪术、牡丹皮破气行血、散瘀止痛;薏苡仁、广郁金、柴胡健脾补肺、清热利湿、和解表里、清心凉血;皂角刺、路路通等在通络散结的同时引经下行;白芍、当归柔肝疏肝缓急止痛,并以甘草调和诸药。
发明内容
本发明是在现有产品“荆防颗粒/合剂”的基础上所做的对其用途的进一步开发,研究发现荆防颗粒/合剂具有疏肝解郁,调和气血,通络散结等功效,基于这一作用,发明人对荆防颗粒/合剂及其组方进行了治疗乳腺疾病的进一步研究与开发。
本发明目的之一在于提供一种制备治疗乳腺疾病药物的中药组合物,所述的中药组合物主要由羌活、独活、茯苓、防风、荆芥、川芎、桔梗、柴胡、前胡、枳壳、甘草制备而成。
根据一些实施例,本发明所述的乳腺疾病包括但不限于乳腺炎、乳腺增生、乳腺囊肿、乳腺良性肿瘤等。
本发明目的之二在于提供上述中药组合物的具体组成,即所述中药组合物主要由以下原料制备而成:
根据一些实施例,所述中药组合物可以是由以下原料制备而成:
本发明的目的之三在于提供由上述中药组合物制备而成的荆防制剂在制备治疗乳腺疾病药物中的用途。
根据一些实施例,上述荆防制剂可以为临床上可接受的口服制剂;
根据一些实施例,所述临床上可接受的口服制剂为丸剂、胶囊剂、片剂、颗粒剂或液体口服制剂中的一种或多种;
根据一些实施例,所述口服制剂为荆防颗粒和/或荆防合剂。
本发明上述荆防颗粒是按照以下方法制备而得:
荆芥、防风、羌活、独活、前胡、川芎和枳壳分别提取挥发油,川芎、枳壳蒸馏后的水溶液另器收集;川芎、枳壳的药渣与茯苓用上述水溶液配成25%乙醇溶液作溶剂,进行渗漉;荆芥、防风、羌活、独活和前胡的药渣与其余柴胡、桔梗、甘草等三味加水煎煮二次,每次1.5小时,合并煎液,滤过,滤液浓缩成稠膏;合并漉液和稠膏,混匀,静置,滤过,滤液浓缩成相对密度为1.30(80~85℃)的清膏,取清膏1份,加蔗糖6份,混匀制成颗粒,干燥,加入上述荆芥等挥发油,混匀,即得。
本发明上述荆防合剂是按照以下方法制备而得:
荆芥、防风、羌活、独活、枳壳、川芎和前胡分别蒸馏提取挥发油,蒸馏后的水溶液另器收集;川芎、枳壳药渣与茯苓用蒸馏后的水溶液配成25%乙醇作溶剂,进行渗漉,收集渗漉,减压回收乙醇。其余五味药渣与柴胡、桔梗、甘草加水煎煮三次,滤过,合并滤液,浓缩至约1300ml,与漉液合并,静置,滤过,浓缩至约1000ml,加入苯甲酸钠3g和上述挥发油,搅匀,加水使成1000ml,即得。
与现有技术相比,本发明取得了显著的技术效果:
1本发明所述的荆防制剂在治疗乳腺疾病中的用途来源于使用反馈,个别患有乳腺炎或乳腺增生的患者在服用荆防颗粒或荆防合剂,发现有乳腺炎、乳腺增生临床症状得到明显改善。
2临床研究结果显示,采用本中药组合物可以疏肝解郁,调和气血,通络散结,利用荆防颗粒或合剂可以治疗乳腺炎、乳腺增生等乳腺疾病,配伍合理,协同效果好,同时在病理学实验上得到一定的验证。
附图说明
图1:小鼠乳房组织中炎症因子TNF-α含量的变化(与空白对照组相比,▲<0.05,▲▲P<0.01;与模型组相比,*P<0.05,**P<0.01;与环丙沙星组相比,&P<0.05,&&P<0.01;与荆防颗粒组相比,#P<0.05,##P<0.01;)与空白组相比,模型组小鼠的乳腺组织中TNF-α出现极显著的升高(P<0.01);与模型组相比,阳性对照组、具体实施例4组和荆防颗粒组小鼠乳腺组织中TNF-α呈显著下降趋势。
图2:小鼠乳房组织中炎症因子IL-6含量的变化(与空白对照组相比,▲<0.05,▲▲P<0.01;与模型组相比,*P<0.05,**P<0.01;与环丙沙星组相比,&P<0.05,&&P<0.01;与荆防颗粒组相比,#P<0.05,##P<0.01;)与空白组相比,模型组小鼠的乳腺组织中IL-6出现极显著的升高(P<0.01);与模型组相比,阳性对照组、具体实施例4组和荆防颗粒组小鼠乳腺组织中IL-6成显著下降趋势,在后期阳性对照组和具体实施例4组、荆防颗粒组含量差异不显著(P>0.05)。
具体实施方式
实施例1市售荆防颗粒(国药准字Z37020357)
【成份】荆芥、防风、羌活、独活、柴胡、前胡、川芎、枳壳、茯苓、桔梗、甘草。辅料为蔗糖。
【性状】本品为棕色的颗粒;气香,味甜、微苦。
【功能主治】发汗解表,散风祛湿。用于风寒感冒,头痛身痛,恶寒无汗,鼻塞清涕,咳嗽白痰。
【规格】每袋装15克。
【用法用量】开水冲服,一次1袋,一日3次。
实施例2市售荆防合剂(国药准字Z20053800)
【成份】荆芥、防风、羌活、独活、柴胡、前胡、川芎、枳壳、茯苓、桔梗、甘草。辅料:苯甲酸钠、纯化水。
【性状】本品为棕黑色的澄清液体;气芳香,味微苦。
【功能主治】发汗解表,散风祛湿。用于风寒感冒,头痛身痛,恶寒无汗,鼻塞清涕,咳嗽白痰。
【规格】每支装10毫升
【用法用量】口服,一次10~20毫升,一日3次,用时摇匀。
实施例3颗粒剂制备
荆芥15g、防风15g、羌活15g、独活15g、柴胡15g、前胡15g、川芎15g、枳壳15g、茯苓15g、桔梗15g、甘草5g。
制备方法:荆芥、防风、羌活、独活、前胡、川芎和枳壳分别提取挥发油,川芎、枳壳蒸馏后的水溶液另器收集;川芎、枳壳的药渣与茯苓用上述水溶液配成25%乙醇溶液作溶剂,进行渗漉;荆芥、防风、羌活、独活和前胡的药渣与其余柴胡、桔梗、甘草等三味加水煎煮二次,每次1.5小时,合并煎液,滤过,滤液浓缩成稠膏;合并漉液和稠膏,混匀,静置,滤过,滤液浓缩成相对密度为1.30(80~85℃)的清膏,取清膏1份,加蔗糖6份,混匀制成颗粒,干燥,加入上述荆芥等挥发油,混匀,即得。
实施例4合剂制备
荆芥10g、防风30g、羌活10g、独活20g、柴胡5g、前胡20g、川芎5g、枳壳25g、茯苓5g、桔梗25g、甘草1g。
制备方法:荆芥、防风、羌活、独活、枳壳、川芎和前胡分别蒸馏提取挥发油,蒸馏后的水溶液另器收集;川芎、枳壳药渣与茯苓用蒸馏后的水溶液配成25%乙醇作溶剂,进行渗漉,收集渗漉,减压回收乙醇。其余五味药渣与柴胡、桔梗、甘草加水煎煮三次,滤过,合并滤液,浓缩至约1300ml,与漉液合并,静置,滤过,浓缩至约1000ml,加入苯甲酸钠3g和上述挥发油,搅匀,加水使成1000ml,即得。
实施例5片剂制剂
荆芥30g、防风10g、羌活30g、独活5g、柴胡20g、前胡5g、川芎25g、枳壳5g、茯苓25g、桔梗5g、甘草15g。
制备方法:荆芥、防风、羌活、独活、前胡、川芎和枳壳分别提取挥发油,川芎、枳壳蒸馏后的水溶液另器收集;川芎、枳壳的药渣与茯苓用上述水溶液配成25%乙醇溶液作溶剂,进行渗漉;荆芥、防风、羌活、独活和前胡的药渣与其余柴胡、桔梗、甘草等三味加水煎煮二次,每次1.5小时,合并煎液,滤过,滤液浓缩成稠膏;合并漉液和稠膏,混匀,静置,滤过,滤液浓缩成相对密度为1.30(80~85℃)的清膏,取清膏1份,加蔗糖6份,混匀制成颗粒,干燥,加入上述荆芥等挥发油,混匀,压片,即得。
实施例6胶囊剂制备
荆芥20g、防风15g、羌活20g、独活15g、柴胡20g、前胡15g、川芎20g、枳壳15g、茯苓25g、桔梗15g、甘草10g。
荆芥、防风、羌活、独活、前胡、川芎和枳壳分别提取挥发油,川芎、枳壳蒸馏后的水溶液另器收集;川芎、枳壳的药渣与茯苓用上述水溶液配成25%乙醇溶液作溶剂,进行渗漉;荆芥、防风、羌活、独活和前胡的药渣与其余柴胡、桔梗、甘草等三味加水煎煮二次,每次1.5小时,合并煎液,滤过,滤液浓缩成稠膏;合并漉液和稠膏,混匀,静置,滤过,滤液浓缩成相对密度为1.30(80~85℃)的清膏,取清膏1份,加蔗糖6份,混匀制成颗粒,干燥,加入上述荆芥等挥发油,混匀,制成颗粒,干燥,粉碎,装入胶囊,即得。
二、治疗效果验证
实验例1本发明对小鼠急性乳腺炎的影响
1材料
1.1实验动物与菌株
金黄色葡萄球菌(ATCC25923)。制备菌液,将纯化保存的金黄色葡萄球菌接种于BHI培养基中,37℃摇床培养18-24h至对数期。采用平板计数法将细菌悬液调至1×104CFU/mL,4℃保存备用。
SPF级健康小鼠(雌性75只,怀孕2-2.5周,55-65g),许可证号:SCXK(鲁)20190003,济南朋悦实验动物繁育有限公司提供,动物饲养温度控制在18-25℃,相对湿度控制在50%-60%,通风良好,小鼠自由饮水进食,实验前在实验环境中适应两周。
1.2实验药品与试剂
1.2.1实验药品
荆防颗粒(国药准字Z37020357),由山东新时代药业有限公司生产。环丙沙星,实施例4合剂,所用药材、制剂均为普通市售,产品质量均符合国家规定。
1.2.2实验试剂
小鼠肿瘤坏死因子(TNF-α)酶联免疫试剂盒、小鼠白介素(IL-6)酶联免疫试剂盒。
2方法
2.1金黄色葡萄球菌性小鼠乳腺炎建立
将分娩3-10d的小鼠腹腔注射麻药0.05mL/只,麻醉后将小鼠四肢伸展仰卧绑定,用75%的酒精对第4乳腺周围进行消毒,左手持小镊子将乳头固定,右手持微量注射器,从小鼠第4乳腺基部进行注射细菌悬液,50μL/乳腺。小鼠乳腺炎成模的判断标准:注射细菌24h后,观察各试验组小鼠饮食量变化、乳腺是否肿胀变硬、对外界刺激的反应、被毛颜色及光泽度变化等,如果小鼠出现饮水和进食量减少、乳腺开始肿胀甚至溃烂、被毛泛黄粗糙杂乱、对外界的刺激反应迟钝,则判为模型构建成功。
2.2分组及给药
取造模成功的小鼠60只,分为模型组、阳性对照组、荆防颗粒组,实施例4合剂组,每组15只,荆防颗粒组每日给药5.85g/kg,实施例4合剂组每日给药3.9ml/kg,阳性对照环丙沙星组每日给药0.195g/kg,模型组每日给予等量生理盐水灌胃;另取正常分娩3-10d的小鼠15只,为空白对照组,每日给予等量生理盐水灌胃。
在给药3、5、10d,观察各组小鼠的精神状态、饮食和饮水情况。
2.3样品处理
在给药3、5、10d,分别从每个组中随机抓取5只小鼠进行脱颈处死,消毒后将小鼠腹部的皮肤剖开,对第4对乳腺组织的病理变化进行观察。然后迅速摘出其中的一侧乳腺组织,称质量后,将其放入提前预冷好的研磨器中,加入10倍PBS缓冲液研磨,取研磨好的匀浆液进行倍比稀释,从中取50μL涂布于甘露醇高盐琼脂培养基,置于恒温培养箱培养48h,测定乳腺组织中的细菌数量。将剩余的匀浆液4℃离心10min,移取上清液进行TNF-α、IL-6蛋白含量的检测,检测步骤见说明书。
2.4数据处理
3结果与分析
3.1小鼠临床症状观察
在给药过程中,空白对照组小鼠采食、饮水正常,精神良好;模型组小鼠出现体重下降,寒颤、怕冷、聚堆、竖毛、嗜睡、行为迟缓等行为,进食,饮水量明显减少,乳腺肿胀溃烂;荆防颗粒组、实施例4组和阳性对照组小鼠精神状态、饮食和采食逐渐恢复,乳腺肿胀程度较模型组变化小,溃烂程度较轻。
3.2乳房组织内金黄色葡萄球菌数量的变化
表1小鼠乳房组织中金黄色葡萄球菌数量的变化
与模型组相比,*P<0.05,**P<0.01;
与环丙沙星组相比,&P<0.05,&&P<0.01;
实验结果表明,荆防颗粒可以改善金黄色葡萄球菌诱发乳腺炎小鼠的乳腺组织损伤,与模型组相比,荆防颗粒组与阳性对照的环丙沙星同样对金黄色葡萄球菌引起的乳腺炎有一定的治疗作用。
3.3小鼠乳腺组织中炎症因子TNF-α和IL-6的含量的变化,见图1和2。
TNF-α和IL-6是一种调节炎症及相关疾病的主要促炎因子。实验结果表明,荆防制剂可以下调乳腺组织炎症因子TNF-α和IL-6的水平,降低细胞致炎因子表达,改善免疫功能,改善小鼠乳腺组织炎症情况,对小鼠的乳腺组织具有保护作用。
临床典型病例举例
患者李X,女,38岁。主诉:发现乳腺囊肿半年有余,期间无疼痛感,发半年后,左侧乳房触摸呈疙瘩状,胸部胀痛,月经量少,经期缩短。采用中医贴与荆防颗粒,内调外敷治疗数月,手触摸无感觉,经期恢复正常,乳腺囊肿症状明显改善。
患者刘XX,女,27岁。主诉:乳腺反复周期性疼痛3年,平日无乳腺疼痛,每次月经前5天开始乳房胀痛,月经前1天及月经第1天疼痛明显,伴触痛,月经来潮后3天疼痛缓解。经过检查示乳腺增生。予以中药疏肝理气通络方剂治疗并服用荆防颗粒7天。当次月经期间无明显乳痛,仅治疗一周期,随访3月患者未再出现乳腺疼痛。
Claims (10)
1.一种含有羌活、独活、茯苓、防风、荆芥、川芎、桔梗、柴胡、前胡、枳壳、甘草中药组合物在制备治疗乳腺疾病药物中的用途。
2.如权利要求1所述的用途,其特征在于,所述中药组合物主要由以下原料制备而成:
荆芥10-30重量份 防风10-30重量份 羌活10-30重量份
独活5-20重量份 柴胡5-20重量份 前胡5-20重量份
川芎5-25重量份 枳壳5-25重量份 茯苓5-25重量份
桔梗5-25重量份 甘草1-15重量份。
3.如权利要求2所述的用途,其特征在于,所述中药组合物主要由以下原料制备而成:
荆芥10-20重量份 防风10-20重量份 羌活10-20重量份
独活10-20重量份 柴胡10-20重量份 前胡10-20重量份
川芎5-15重量份 枳壳5-15重量份 茯苓5-15重量份
桔梗5-15重量份 甘草1-10重量份。
4.如权利要求3所述的用途,其特征在于,所述中药组合物主要由以下原料制备而成:
荆芥15重量份 防风15重量份 羌活15重量份
独活15重量份 柴胡15重量份 前胡15重量份
川芎15重量份 枳壳15重量份 茯苓15重量份
桔梗15重量份 甘草5重量份。
5.如权利要求1-4任一项所述的用途,其特征在于,所述的乳腺疾病包括但不限于乳腺炎、乳腺增生、乳腺囊肿、乳腺良性肿瘤。
6.荆防制剂在制备治疗乳腺疾病药物中的用途,所述的荆防制剂由权利要求1-5任一项所述的中药组合物制备而成。
7.如权利要求6所述的用途,其特征在于,所述的荆防制剂为口服制剂。
8.如权利要求7所述的用途,其特征在于,所述的荆防制剂包括但不限于荆防颗粒、荆防合剂。
9.如权利要求1-4任一项所述的用途,其特征在于,所述制备方法包含以下步骤:
步骤A:将荆芥、防风、羌活、独活、前胡、川芎、枳壳,蒸馏提取挥发油备用,蒸馏后的药渣、蒸馏后的川芎、枳壳水溶液备用;
步骤B:将步骤A所得蒸馏后的川芎、枳壳水溶液配制成10-40%的乙醇溶液,备用;
步骤C:将茯苓、步骤A所得蒸馏后的川芎、枳壳药渣混合,以步骤B所得乙醇溶液渗漉提取,渗漉液备用;
步骤D:将柴胡、桔梗、甘草、步骤A所得蒸馏后的荆芥、防风、羌活、独活、前胡药渣,加水煎煮,煎煮液浓缩后备用;
步骤E:将步骤D所得煎煮液浓缩成稠膏,与将步骤C所得渗漉液混合,浓缩成清膏,加入步骤A所得挥发油,按常规工艺制备成口服固体制剂;或将步骤D所得煎煮液与步骤C所得渗漉液合并,加入步骤A所得挥发油,按常规工艺制备成口服液体制剂。
10.如权利要求9所述的用途,其特征在于,所述中药组合物的制备方法主要包括以下步骤:
步骤A:将荆芥、防风、羌活、独活、前胡、川芎、枳壳,蒸馏提取挥发油备用,蒸馏后的药渣、蒸馏后的川芎、枳壳水溶液备用;
步骤B:将步骤A所得蒸馏后的川芎、枳壳水溶液配制成25%的乙醇溶液,备用;
步骤C:将茯苓、步骤A所得蒸馏后的川芎、枳壳药渣混合,以步骤B所得乙醇溶液渗漉提取,渗漉液备用;
步骤D:将柴胡、桔梗、甘草、步骤A所得蒸馏后的荆芥、防风、羌活、独活、前胡药渣,加水煎煮,煎煮液备用;
步骤E:将步骤D所得煎煮液浓缩成稠膏,与将步骤C所得渗漉液混合,浓缩成清膏,加入步骤A所得挥发油,按常规工艺制备成口服固体制剂;或将步骤D所得煎煮液与步骤C所得渗漉液合并,加入步骤A所得挥发油,按常规工艺制备成口服液体制剂。
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