CN104491156A - 一种治疗出血性痔疮的中药组合物及其制备方法 - Google Patents

一种治疗出血性痔疮的中药组合物及其制备方法 Download PDF

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CN104491156A
CN104491156A CN201510009918.7A CN201510009918A CN104491156A CN 104491156 A CN104491156 A CN 104491156A CN 201510009918 A CN201510009918 A CN 201510009918A CN 104491156 A CN104491156 A CN 104491156A
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李建美
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Lu Yan
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Abstract

本发明属于中药领域,具体涉及一种治疗出血性痔疮的中药组合物及其制备方法与应用。本发明的提供一种治疗出血性痔疮的中药组合物,其包括如下组分:薄荷10份、黄连15份,细辛6份,白芷10份、大黄10份,牛蒡子6份,玄参20份,红花17份、连翘10份、蒲公英13份,金银花15份,白术30份、丁香6份、蛇床子10份。该中药组合物在治疗出血性痔疮方面具有很好的治疗效果,具有显著的临床推广价值。

Description

一种治疗出血性痔疮的中药组合物及其制备方法
技术领域
本发明属于医药领域,具体涉及一种治疗出血性痔疮的中药组合物及其制备方法与应用。
背景技术
痔疮便血是临床上的常见病,多发病。中医理论认为,痔疮据痔的部位而分为外痔、内痔、混合痔等。病因为热迫血下行,郁结不散所至。年老体弱,饮酒吸烟,饮食过辛辣等都是其诱发因素。痔疮的临床表现为肛门瘙痒、肿痛、出血。据有关普查资料表明,肛门直肠疾病的发病率为59.1%,痔疮占所有肛肠疾病中的87.25%,而其中又以内痔最为常见,占所有肛肠疾病的52.19%。男女均可得病,女性的发病率为67%,男性的发病率为53.9%,以女性的发病率为高;任何年龄都可发病,其中20-40岁的人较为多见,并可随着年龄的增加而逐渐加重,故有“十人九痔”之说。痔疮给患者带来难以忍受的痛苦,严重者坐立不安,影响正常的工作和生活。
当前治疗这些疾病的方法有手术、套扎、注射、激光及药物内服外用等疗法,其不足是患者痛苦大,术后感染等。西药治疗镇痛效果好,但成本高,副作用大,不易根除。保守治疗的药物外用疗法中有马应龙麝香痔疮膏(栓)、九华痔疮栓、化痔栓、荣昌肛泰,然而配方不同,功效各异,尚不能满足临床需要。
出血、搔痒、疼痛和脱出是痔疮的四种常见临床表现,同时痔疮也很容易引发肛肠疾病、贫血、妇科炎症、肛周湿疹、植物神经紊乱等其它系统性疾病,因此对痔疮进行及时的治疗,显得尤为重要。目前对痔疮的治疗方法主要包括手术疗法、药物内服疗法和药物外用疗法等,但是,手术疗法在病后容易产生并发症,药物内服疗法疗效较慢,而目前市场上常见的痔疮外用药物疗效不够理想,因此,发明一种治疗出血性痔疮的有效外用药物,是目前临床上的迫切需求。
目前西医在治疗出血性痔疮方面治疗效果欠佳,这是因为化学药物使用不当会引起谷丙转氨酶升高,反而会损害肝功能,甚至还会促进血液内的脂质沉积在肝脏,加重痔疮的病情,而中医药为我国的传统瑰宝,其在治疗痔疮方面积累了丰富的临床经验和治疗理论。
发明内容
针对目前痔疮临床治疗药物的不足,本发明的第一个目的在于提供一种治疗出血性痔疮的中药组合物,该中药组合物在治疗出血性痔疮方面具有很好的治疗效果。本发明所述的中药组合物,主要由以下重量份的原料制得:薄荷10份、黄连15份,细辛6份,白芷10份、大黄10份,牛蒡子6份,玄参20份,红花17份、连翘10份、蒲公英13份,金银花15份,白术30份、丁香6份、蛇床子10份。
本发明中药组合物中的中药组分均取其常用入药部位入药,其中本发明组合物具有显著的消肿散结、活血化淤、化痰祛湿之功效。优选地,所述的中药组合物由以下重量份的原料制得:薄荷10g、黄连15g,细辛6g,白芷10g、大黄10g,牛蒡子6g,玄参20g,红花17g、连翘10g、蒲公英13g,金银花15g,白术30g、丁香6g、蛇床子10g。
制备本发明中药组合物的方法如下:取上述重量组分的各药材,加药材总重量的5-15倍的水,浸泡10-60分钟,煎煮1-4次,每次1-3小时,滤过,合并滤液,滤液减压浓缩至相对密度1.05-1.25的浸膏,该相对密度是在60摄氏度下的检测结果,加入乙醇至含醇量为60-90%(v/v),静置24小时,取上清液,回收乙醇至浓缩,即得。本发明上述中药组合物可以进一步制备成临床上常用的药物制剂,优选为水剂、酊剂、软膏剂、搽剂或凝胶剂。
本发明还公开上述中药组合物的一种用途,即上述中药组合物在制备治疗出血性痔疮药物中的用途。本发明中药组合物用于痔疮时具有显著的抗炎效果以及降脂效果,对于痔疮具有标本兼治的治疗效果。本发明实施例6表明,本发明中药组合物能很好的降低巴豆油痔疮模型小鼠的直肠血管通透性,组合物中各种中药组分在治疗大鼠巴豆油痔疮模型方面取得了很好的协同作用,从实验数据中可见,一定比例的组合物疗效优于马应龙对照治疗组。本发明实施例7表明,本发明中药组合物组合物有明显抗炎作用,中药组合物高组的抗炎效果强于马应龙组。本发明实施例8表明,本发明中药组合物具有显著的镇痛活性,中药组合物高组的镇痛效果强于马应龙组。
总之,本发明与现有技术相比,具有很好治疗出血性痔疮的活性,并且本发明为纯中药制剂,对人体特别是对肝脏无毒性。本发明作为痔疮治疗药物使用时,药物作用全面,在疏肝解郁、健脾消导的同时,还能够取得活血化淤、化痰祛湿的功效,能够迅速使痔疮患者病情好转;并且本发明中药组合物制备简单,基本无毒,原料易得,适于大众化使用,具有很好的临床应用前景。
具体实施方式
以下通过具体实施方式进一步描述本发明,但本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明所述的中药组合物进行适当改进、替换功效相同的组分,对于本领域技术人员来说是显而易见的,它们都被视为包括在本发明的范围之内。
第一部分,本发明中药组合物的制备
实施例1中药组合物水剂
处方:薄荷10份、黄连15份,细辛6份,白芷10份、大黄10份,牛蒡子6份,玄参20份,红花17份、连翘10份、蒲公英13份,金银花15份,白术30份、丁香6份、蛇床子10份。
制备方法:取处方中各药材,按照常规中药煎煮工艺操作,滤除药渣即得。该水剂(或称汤剂)用于治疗痔疮时,外用清洗皮肤面,每日2-3次。
实施例2中药组合物酊剂
处方:薄荷10份、黄连15份,细辛6份,白芷10份、大黄10份,牛蒡子6份,玄参20份,红花17份、连翘10份、蒲公英13份,金银花15份,白术30份、丁香6份、蛇床子10份。
制备方法:取组合物中各药材,按照常规工艺研磨成粉状,置密闭的瓷坛中,加入4倍重量的80%乙醇溶液,密闭浸渍2天(即48h),取出浸液,压榨药渣,榨出液与浸液合并,密闭,静置24h,滤过,加入适量蒸馏水,乙醇浓度控制在70%~75%,充分搅拌均匀,灌装,即得。该酊剂用于治疗皮肤过敏或瘙痒症时,外用清洗创面,每日2-3次。
实施例3中药组合物软膏剂
处方:薄荷10份、黄连15份,细辛6份,白芷10份、大黄10份,牛蒡子6份,玄参20份,红花17份、连翘10份、蒲公英13份,金银花15份,白术30份、丁香6份、蛇床子10份。
制备工艺:首先,取处方量的各中药材粉碎成粗粉,按照粗粉总重量的5倍加入体积浓度为80%的乙醇溶液,回流提取三次,回流时间每次3h,滤过,滤液回收乙醇,冷却过滤,用水洗涤,干燥后即得中药浸膏;其次,将鸡蛋壳小火焙黄研成粉末;最后,将中药浸膏、鸡蛋壳粉混合均匀,加入鸡蛋黄、100g白凡士林、20g单硬脂酸甘油脂、120g硬脂酸和适量的蒸馏水制成软膏剂。
实施例4中药组合物搽剂
处方
制备工艺:中药组合物处方同实施例1。取各药材,加药材总重量的5-15倍的水,浸泡10-60分钟,煎煮1-4次,每次1-3小时,滤过,合并滤液,滤液减压浓缩至相对密度1.05-1.25的浸膏,该相对密度是在60摄氏度下的检测结果,加入乙醇至含醇量为60-90%(v/v),静置24小时,取上清液,回收乙醇至浓缩,即得。将浸膏烘干后粉碎即可制得中药组合物细粉。
称取处方量取硫酸锌细粉和尿素颗粒,混匀后于研钵中磨至细粉,再加入甘油快速研磨均匀,加入少量纯化水多次,至研钵中混合物全部转移到合适容器中,加水适量,加入处方量的中药组合物细粉,混匀,加入新洁尔灭,搅拌均匀,最后加水至1000ml。再用1%NaOH溶液调PH至6.5,搅拌均匀,备用。
实施例5中药组合物凝胶剂
处方
制备工艺:中药组合物处方同实施例5,中药组合物细粉的制备方法同实施例9。取卡波姆洒入适量纯化水中,搅拌,静置过夜,使充分溶胀,加入亚硫酸钠与丙二醇搅拌溶解,搅拌下滴加三乙醇胺,制成凝胶基质;另取硼酸与硫酸锌溶解于少量水中,然后加入中药组合物细粉和乙醇,混匀,搅拌下加入凝胶基质中,搅匀,密封,放置备用。
第二部分,本发明中药组合物的药效学考察
实施例6中药组合物对大鼠巴豆油痔疮模型的实验
50只SD大鼠(200克左右)按体重随机分成五组,即模型对照组、中药组合物低组(给药剂量为100mg/kg)、中药组合物中组(给药剂量为1000mg/kg)、中药组合物高组(给药剂量为10g/kg)、马应龙组,每组10只。给药:大鼠提前两天直肠内给药,每天二次,用10mg棉球沾满药物,将棉球塞入直肠内,下次给药时,应先检查直肠内是否有棉球(如有棉球应取出)。最后一次给药应在造模后2小时。
造模:巴豆油是一种常用的致炎剂,常用的巴豆油混合液用1份蒸馏水、4份吡啶、5份乙醚和10份15%巴豆油乙醚溶液配制。用10mg棉球沾满巴豆油混合液,将浸泡后的棉球放入大鼠肛门内,停留15秒后取出。
指标测定:造模7小时后,每只大鼠静脉注射1%伊文氏兰生理盐水溶液(2ml/kg),40分钟后放血处死动物,取直肠及肛门周围组织,称重后用丙酮生理盐水7:3溶液浸泡48小时,3000rpm离心10分钟,取上清液于590nm测吸光度,作为评价血管通透性指标,结果见表1。
表1各治疗组和模型对照组吸光度值的比较
组别 n 吸光度值
模型对照组 10 0.141±0.038
中药组合物低组 10 0.139±0.037*
中药组合物中组 10 0.109±0.021
中药组合物高组 10 0.073±0.025**
马应龙组 10 0.116±0.022*
*与模型对照组比较,*P<0.05,**P<0.01
结果显示,本发明中药组合物能很好的降低巴豆油痔疮模型小鼠的直肠血管通透性,组合物中各种中药组分在治疗大鼠巴豆油痔疮模型方面取得了很好的协同作用,从实验数据中可见,一定比例的组合物疗效优于马应龙对照治疗组。
实施例7中药组合物的小鼠二甲苯抗炎实验
60只KM小鼠,雌雄各半,体重25-30克,按体重随机分成五组,即模型对照组、中药组合物低组(给药剂量为100mg/kg)、中药组合物中组(给药剂量为1000mg/kg)、中药组合物高组(给药剂量为10g/kg)、马应龙组,每组12只。
实验方法:
取二甲苯20μl,涂于各小鼠右耳。30min后取各受试药分别均匀涂于小鼠右耳,右耳给二甲苯3.5h后处死,并测定耳重差,测定方法为:沿耳廓基线处剪下两耳,用8mm打孔器在左右耳同一部位打下耳片,称重,耳重差=右耳片重-左耳片重,结果见表2。
表2各实验组耳重差比较
组别 n 耳重差(mg)
模型对照组 12 7.17±2.88
中药组合物低组 12 6.88±2.89
中药组合物中组 12 5.33±2.30*
中药组合物高组 12 2.89±2.10**
马应龙组 12 5.09±3.73*
与对照组比较,*P<0.05,**P<0.01。
结论:本发明中药组合物组合物有明显抗炎作用,中药组合物高组的抗炎效果强于马应龙组。
实施例8本发明中药组合物对小鼠镇痛作用实验
KM小鼠60只,雌雄各半,体重25-30克,按体重随机分成四组,即模型对照组、中药组合物低组(给药剂量为100mg/kg)、中药组合物中组(给药剂量为1000mg/kg)、中药组合物高组(给药剂量为10g/kg)、马应龙组,每组12只。小鼠肛门给药,用10mg棉球沾满药物,将棉球塞入直肠内,每日一次,连续三日,于最后一次给药完毕后30分钟,距肛门3.5cm处直肠壁注射5%福尔马林0.2ml。记录小鼠20分钟内扭体次数。具体结果见表3。
表3各实验组扭体次数比较
组别 n 扭体次数
模型对照组 12 45.3±20.1
中药组合物低组 12 35.0±18.9
中药组合物中组 12 33.4±10.3*
中药组合物高组 12 23.4±12.7**
马应龙组 12 34.4±20.6*
与对照组比较,*P<0.05,**P<0.01。
结论:在本次实验中,中药组合物具有显著的镇痛活性,中药组合物高组的镇痛效果强于马应龙组。

Claims (5)

1.一种治疗出血性痔疮的中药组合物,其特征在于它主要由以下重量份的原料制得:薄荷10份、黄连15份,细辛6份,白芷10份、大黄10份,牛蒡子6份,玄参20份,红花17份、连翘10份、蒲公英13份,金银花15份,白术30份、丁香6份、蛇床子10份。
2.如权利要求1所述的药物组合物,其特征在于,它主要由以下重量份的原料制得:薄荷10g、黄连15g,细辛6g,白芷10g、大黄10g,牛蒡子6g,玄参20g,红花17g、连翘10g、蒲公英13g,金银花15g,白术30g、丁香6g、蛇床子10g。
3.如权利要求1所述的药物组合物,其特征在于所述药物组合物为水剂、酊剂、软膏剂、搽剂或凝胶剂。
4.一种制备如权利要求1或2所述的中药组合物的方法,其特征在于它包括以下步骤:取各药材,加药材总重量的5-15倍的水,浸泡10-60分钟,煎煮1-4次,每次1-3小时,滤过,合并滤液,滤液减压浓缩至相对密度1.05-1.25的浸膏,该相对密度是在60摄氏度下的检测结果,加入乙醇至含醇量为60-90%(v/v),静置24小时,取上清液,回收乙醇至浓缩,即得。
5.权利要求1或2所述的中药组合物在制备治疗出血性痔疮药物中的用途。
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