CN109172752A - 一种治疗痔疮的植物提取物及其制备方法 - Google Patents
一种治疗痔疮的植物提取物及其制备方法 Download PDFInfo
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- CN109172752A CN109172752A CN201811045260.5A CN201811045260A CN109172752A CN 109172752 A CN109172752 A CN 109172752A CN 201811045260 A CN201811045260 A CN 201811045260A CN 109172752 A CN109172752 A CN 109172752A
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Abstract
本发明提供了一种治疗痔疮的植物提取物及其制备方法,其中植物提取物包括以下重量份的植物组合物提取制成:白茅5‑12份、天花粉5‑12份、地龙7‑14份、归尾7‑14份、丹参10‑15份、生地黄5‑10份、熟地黄10‑15份、大蓟8‑16份、小蓟5‑10份、锁阳7‑12份、桃仁5‑12份、火麻仁5‑10份、旱莲草10‑15份、女贞子10‑15份、仙鹤草10‑20份、生大黄5‑8份、马齿苋10‑20份、升麻5‑10份、牧丹皮5‑10份、麦冬8‑15份、党参8‑15份、紫草10‑14份、茄子根15‑20份、空心泡8‑15份、鬼针草5‑10份和马兰头8‑13份。本治疗痔疮的植物提取物能够有效治疗痔疮,无需进行手术,复发率低。
Description
技术领域
本发明涉及植物提取物技术领域,尤其涉及一种治疗痔疮的植物提取物及其制备方法。
背景技术
痔疮是人体直肠末端粘膜下和肛管皮肤下静脉丛发生扩张和屈曲所形成的柔软静脉团。多见于经常站立者和久坐者。痔疮包括内痔、外痔、混合痔,是***直肠底部及***粘膜的静脉丛发生曲张而形成的一个或多个柔软的静脉团的一种慢性疾病。
痔疮是肛垫综合症结果。正常情况下,肛垫内动静脉吻合的开放和闭合是交替进行的,约每分钟可开放8~12次。由于吻合管能自由开放,对肛垫区的温度与血量调节有重大作用,是良好的血量调节器。动静脉吻合管平滑肌的收缩与舒张主要由局部产生的血管舒缩素。
痔疮是人类特有的常见病、多发病。据有关普查资料表明,***直肠疾病的发病率为59.1%,痔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%;任何年龄都可发病,其中20-40岁的人较为多见,并随着年龄的增长而逐渐加重,故有“十人九痔”之说。
医学所指痔疮包括内痔、外痔、混合痔,是***直肠底部及***粘膜的静脉丛发生曲张而形成的一个或多个柔软的静脉团的一种慢性疾病。通常当排便时持续用力,造成此处静脉内压力反复升高,静脉就会肿大。妇女在妊娠期,由于盆腔静脉受压迫,妨碍血液循环常会发生痔疮,许多肥胖的人也会罹患痔疮。如果患有痔疮,***内肿大扭曲的静脉壁就会变得很薄,因此排便时极易破裂。内痔是长在***管起始处的痔,如果膨胀的静脉位于更下方,几乎是在肛管口上,这种曲张的静脉就叫外痔。外痔有时会脱出或突现于肛管口外。但这种情形只有在排便时才会发生,排便后它又会缩回原来的位置。无论内痔还是外痔,都可能发生血栓。在发生血栓时,痔中的血液凝结成块,从而引起疼痛。
痔疮最主要的症状是便血和脱出,大便时反复多次地出血,会使体内丢失大量的铁,引起缺铁性贫血。
痔疮的治疗方法有饮食疗法、口服用药、外敷用药、注射疗法、枯痔疗法、手术疗法等。手术疗法是采用外剥内扎术切除痔核,是近年来最常用的重度痔的治疗方法,但是传统手术疗法所带来的术后疼痛以及较长的住院与愈合时间等问题,常常使病人闻之色变,而且传统手术疗法存在一定的复发可能性。
发明内容
有鉴于此,本发明要解决的技术问题是提供一种治疗痔疮的植物提取物及其制备方法,其中治疗痔疮的植物提取物能够有效治疗痔疮,无需进行手术,复发率低。
本发明的技术方案是这样实现的:
一种治疗痔疮的植物提取物,包括以下重量份的植物组合物提取制成:
白茅5-12份、天花粉5-12份、地龙7-14份、归尾7-14份、丹参10-15份、生地黄5-10份、熟地黄10-15份、大蓟8-16份、小蓟5-10份、锁阳7-12份、桃仁5-12份、火麻仁5-10份、旱莲草10-15份、女贞子10-15份、仙鹤草10-20份、生大黄5-8份、马齿苋10-20份、升麻5-10份、牧丹皮5-10份、麦冬8-15份、党参8-15份、紫草10-14份、茄子根15-20份、空心泡8-15份、鬼针草5-10份和马兰头8-13份。
优选的,包括以下重量份的植物组合物提取制成:
白茅8份、天花粉9份、地龙10份、归尾11份、丹参12份、生地黄8份、熟地黄22份、大蓟12份、小蓟7份、锁阳9份、桃仁9份、火麻仁7份、旱莲草12份、女贞子12份、仙鹤草15份、生大黄7份、马齿苋15份、升麻8份、牧丹皮8份、麦冬12份、党参12份、紫草12份、茄子根18份、空心泡12份、鬼针草7份和马兰头11份。
本发明还提出了一种上述治疗痔疮的植物提取物的制备方法,包括以下步骤:
S1:将天花粉、地龙、归尾、丹参、生地黄、熟地黄、锁阳、桃仁、火麻仁、女贞子、马齿苋、升麻、牧丹皮、麦冬、党参、空心泡和鬼针草混合打碎,放入蒸锅蒸10-15分钟;
S2:将大蓟、小蓟、仙鹤草、紫草、马兰头、旱莲草、生大黄混合打碎后放入蒸锅,将蒸锅内的组合物蒸熟并冷却;
S3:在冷却的组合物中加入发酵剂发酵,发酵完成后干燥;
S4:将干燥的组合物用酒精浸泡4-8小时后,过滤去药渣得到滤液,将所述滤液减压蒸干,得到膏状植物提取物。
S5:将白茅根和茄子根炒炭并打粉后加入所述膏状植物提取物中。
优选的,所述发酵剂为红曲,红曲添加量为所述冷却的组合物的重量的1/4到1/3,发酵温度为36-39度。
5、如权利要求3所述的治疗痔疮的植物提取物的制备方法,其特征在于,所述减压蒸干条件为负压0.08pa、温度55-60度。
优选的,还包括:
S6:将S5中的膏状植物提取物制成膏体、精油、口服剂中的一种或几种。
所述S4中的酒精,包括没有发酵的浓度大于等于95%的酒精和发酵的浓度大于等于75%的酒精,浸泡时酒精没过组合物浸泡,浸泡为4-8小时。
现有的提取中,加水加热,热提效率高,但杂质亦多,不适合做外用,而且因为有水分,容易发霉,不易保存。
所述S4减压蒸干条件为负压0.08pa、温度55-60度,55-60度是酶解最理想温度。本实施例中所述提取方法得率高,同样100公斤植物组合物,现有的超临界萃取等,大概能提取3.7kg提取物左右,而本实施例的方法,可以提取20公斤左右的提取物,大概提高了5倍。
本发明中,精油可以按重量百分比配制所述植物提取物5%-10%、桧木油50-65%和荷荷巴油25-40%组成制成。
所述植物提取物中可加入巴布剂可作为凝胶剂型,所述巴布剂可以是卡波姆、丙烯酸或甲丙烯酸三者中的一种或其组合,凝胶剂型中的巴布剂含量和具体凝胶的制备方法为现有技术。
所述植物提取物中加入丙烯酸压敏胶做膏药剂型,然后以无纺布为衬布涂上所述膏药,再盖上硅油纸,膏药剂型中的丙烯酸压敏胶的含量和具体膏药的制备方法为现有技术。
同理,口服剂的制备方法为现有技术。
上述植物组合物中,白茅具有凉血,止血的功效;
天花粉具有清热泻火,消肿排脓的功效;
地龙具有清热,镇痉的功效;
归尾具有活血补血破瘀的功效;
丹参具有活血祛瘀,通经止痛,清心除烦,凉血消痈的功效;
生地具有清热生津,养血的功效;
熟地黄具有滋阴,补血的功效;
大蓟具有凉血止血,祛瘀消肿的功效;
小蓟具有凉血止血,祛瘀消肿的功效;
锁***有润燥、治疗肠燥便秘的功效;
桃仁具有活血祛瘀,润肠通便的功效;
火麻仁具有润肠通便的功效;
旱莲草具有凉血止血的功效;
女贞子具有凉血、益血的功效;
仙鹤草具有收敛止血,截疟,止痢,解毒,补虚的功效;
生大黄具有攻积滞、清湿热、泻火、凉血、祛瘀和解毒的功效;
马齿苋具有清热解毒的功效;
升麻具有发表透疹,清热解毒,升阳举陷的功效;
牧丹皮具有清热凉血,活血化瘀的功效;
麦冬具有养阴生津的功效;
党参具有治疗便溏,便血,崩漏,脱肛的功效;
紫草具有凉血,活血,清热,解毒的功效;
茄子根具有清热利湿,收敛止血的功效;
空心泡具有清热解毒,活血止痛的功效;
鬼针草具有清热,解毒,散瘀,消肿;
马兰头具有清热解毒,消食积,利小便,散瘀止血的功效。
本发明以白茅、天花粉、地龙、归尾、丹参、生地黄、熟地黄、大蓟、小蓟、锁阳、桃仁、火麻仁、旱莲草、女贞子、仙鹤草、生大黄、马齿苋、升麻、牧丹皮、麦冬、党参、紫草、茄子根、空心泡、鬼针草和马兰头为原料,以益气固脱,收敛止血为主,具有良好的治疗痔疮的作用,无需进行手术,复发率低。
具体实施方式
下面将结合本发明实施例的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种治疗痔疮的植物提取物,包括以下重量份的植物组合物提取制成:
白茅5份、天花粉5份、地龙7份、归尾7份、丹参10份、生地黄5份、熟地黄10份、大蓟8份、小蓟5份、锁阳7份、桃仁5份、火麻仁5份、旱莲草10份、女贞子10份、仙鹤草10份、生大黄5份、马齿苋10份、升麻5份、牧丹皮5份、麦冬8份、党参8份、紫草10份、茄子根15份、空心泡8份、鬼针草5份和马兰头8份。
上述治疗痔疮的植物提取物的制备方法,包括以下步骤:
S1:将天花粉、地龙、归尾、丹参、生地黄、熟地黄、锁阳、桃仁、火麻仁、女贞子、马齿苋、升麻、牧丹皮、麦冬、党参、空心泡和鬼针草混合打碎,放入蒸锅蒸10分钟;
S2:将大蓟、小蓟、仙鹤草、紫草、马兰头、旱莲草、生大黄混合打碎后放入蒸锅,将蒸锅内的组合物蒸熟并冷却;
S3:在冷却的组合物中加入红曲发酵剂发酵,红曲添加量为所述冷却的组合物的重量的1/4到1/3,发酵温度为36度,发酵完成后晒干;
S4:将干燥的组合物用酒精浸泡4小时后,过滤去药渣得到滤液,将所述滤液减压蒸干,减压蒸干条件为负压0.08pa、温度55度,得到膏状植物提取物;
S5:将白茅根和茄子根炒炭并打粉后加入所述膏状植物提取物中;
S6:将S5中的膏状植物提取物制成膏体、精油、口服剂中的一种或几种。
实施例2
一种治疗痔疮的植物提取物,包括以下重量份的植物组合物提取制成:
白茅8份、天花粉9份、地龙10份、归尾11份、丹参12份、生地黄8份、熟地黄22份、大蓟12份、小蓟7份、锁阳9份、桃仁9份、火麻仁7份、旱莲草12份、女贞子12份、仙鹤草15份、生大黄7份、马齿苋15份、升麻8份、牧丹皮8份、麦冬12份、党参12份、紫草12份、茄子根18份、空心泡12份、鬼针草7份和马兰头11份。
上述治疗痔疮的植物提取物的制备方法,包括以下步骤:
S1:将天花粉、地龙、归尾、丹参、生地黄、熟地黄、锁阳、桃仁、火麻仁、女贞子、马齿苋、升麻、牧丹皮、麦冬、党参、空心泡和鬼针草混合打碎,放入蒸锅蒸13分钟;
S2:将大蓟、小蓟、仙鹤草、紫草、马兰头、旱莲草、生大黄混合打碎后放入蒸锅,将蒸锅内的组合物蒸熟并冷却;
S3:在冷却的组合物中加入红曲发酵剂发酵,红曲添加量为所述冷却的组合物的重量的1/4到1/3,发酵温度为37度,发酵完成后晒干;
S4:将干燥的组合物用酒精浸泡6小时后,过滤去药渣得到滤液,将所述滤液减压蒸干,减压蒸干条件为负压0.08pa、温度58度,得到膏状植物提取物;
S5:将白茅根和茄子根炒炭并打粉后加入所述膏状植物提取物中;
S6:将S5中的膏状植物提取物制成膏体、精油、口服剂中的一种或几种。
实施例3
一种治疗痔疮的植物提取物,包括以下重量份的植物组合物提取制成:
白茅12份、天花粉12份、地龙14份、归尾14份、丹参15份、生地黄10份、熟地黄15份、大蓟16份、小蓟10份、锁阳12份、桃仁12份、火麻仁10份、旱莲草15份、女贞子15份、仙鹤草20份、生大黄8份、马齿苋20份、升麻10份、牧丹皮10份、麦冬15份、党参15份、紫草14份、茄子根20份、空心泡15份、鬼针草10份和马兰头13份。
上述治疗痔疮的植物提取物的制备方法,包括以下步骤:
S1:将天花粉、地龙、归尾、丹参、生地黄、熟地黄、锁阳、桃仁、火麻仁、女贞子、马齿苋、升麻、牧丹皮、麦冬、党参、空心泡和鬼针草混合打碎,放入蒸锅蒸15分钟;
S2:将大蓟、小蓟、仙鹤草、紫草、马兰头、旱莲草、生大黄混合打碎后放入蒸锅,将蒸锅内的组合物蒸熟并冷却;
S3:在冷却的组合物中加入红曲发酵剂发酵,红曲添加量为所述冷却的组合物的重量的1/4到1/3,发酵温度为39度,发酵完成后晒干;
S4:将干燥的组合物用酒精浸泡8小时后,过滤去药渣得到滤液,将所述滤液减压蒸干,减压蒸干条件为负压0.08pa、温度60度,得到膏状植物提取物;
S5:将白茅根和茄子根炒炭并打粉后加入所述膏状植物提取物中;
S6:将S5中的膏状植物提取物制成膏体、精油、口服剂中的一种或几种。
采用实施例2的提取物进行对皮肤的安全性考察:包括动物皮肤急性毒性试验、皮肤刺激性试验和皮肤过敏试验。
实验材料:实验动物新西兰兔,普通级,体重(2.0±0.2)kg,雌雄兼用。豚鼠,体重250~300g雌雄兼用,由实验动物中心提供。
实验方法与结果:
皮肤急性毒性试验取体重(2.0±0.2)kg的新西兰兔20只,雌雄各半,于给药前24h,将背部脊柱两侧去毛,每只去毛面积约150cm2(约为体表面积的10%)。分为5组,每组4只,对照组每只涂生理盐水1.0ml;高低剂量组各两组(分别为完整皮肤组和破损皮肤组)。其中破损皮肤将去毛皮肤消毒并用针划破。以渗血为度。实验组去毛皮肤上涂以实施例2的提取物,低剂量组每只涂实施例2的提取物2.0ml,高剂量组每只涂实施例2的提取物4.0ml,均匀涂于脱毛区,并用无刺激性纱布、胶布固定,分笼饲养,给药24h后,用温水将残留药物洗除,去除药物后1、24、48、72h至第7天,观察家兔体重、皮肤、毛发、眼、黏膜及呼吸、活动等情况,均未见异常,无死亡,与对照组比较未有明显差异。即实施例3的提取物对新西兰兔皮肤急性毒性很小,提示实际使用安全。
皮肤刺激性试验取体重(2.0±0.2)kg新西兰兔20只,雌雄各半,于给药前24h,将背部脊柱两侧去毛,每只去毛面积约3cm×3cm。采用同体左右侧自身对照法,分为两组,每组4只,皮肤完整组和皮肤破损组,家兔右侧涂生理盐水1ml,左侧涂实施例2的提取物2.0ml。皮肤破损组将去毛皮肤消毒并用针划破,以渗血为度。涂药后,用两层纱布2.5cm×2.5cm和一层玻璃纸覆盖,再用无刺激性胶布和绷带加以固定,分笼饲养。给药24h后,用温水将残留药物洗除,去除药物后0.5、1、24、48、72h观察并记录涂抹部位有无红斑和水肿,按皮肤刺激性反应一般常用评分标准评判,记录各组在不同时间的评分值及恢复情况。结果实施例2的提取物对皮肤完整组和皮肤破损组均未见其它刺激性反应。
皮肤过敏试验取健康白色豚鼠30只,雌雄各半,体重250-300g,于给药前24h将每只豚鼠背部两侧去毛(3cm×3cm)。实验室将已去毛的豚鼠分为三组,受试药物组、空白对照组(给予生理盐水)和阳性对照组(1%2,4一硝基氯代苯),每组10只(雌雄各5只)。致敏接触:实施例2的提取物1.0ml涂于动物左侧去毛区并用一层玻璃纸及两层纱布覆盖,再用无刺激性胶布固定,持续6h。第7天和第14天以同样方法各重复致敏一次。空白对照组和阳性对照组同法分别给予相应药物进行致敏接触。激发接触:于末次给药后14d将相应药物1.0ml涂于豚鼠背部右侧去毛区,6h后去掉药物即可观察,然后于24、48、72h再次观察皮肤过敏反应情况。结果受试药物组和空白对照组均未出现红斑、水肿、哮喘、站立不稳或休克等严重的全身性过敏反应,无致敏性。阳性对照组均出现明显的中毒红斑水肿,反映平均值为4,致敏率100%,呈极度敏感性。实验结果表明膏状植物提取物对豚鼠无皮肤过敏反应,对机体免疫***影响很小。
经皮肤急性毒性、皮肤刺激性试验和皮肤过敏试验,结果表明实施例2的提取物对家兔无明显急性毒性反应,对家兔完整皮肤组和破损皮肤组均无刺激性,对豚鼠无皮肤过敏反应。说明本制剂毒性甚小,安全性较好。实施例1和3的提取物的实验结果与实施例2基本一致。
临床实验:
1、观察对象
痔疮患者;观察160例,其中成年男性120例,成年女性40例;将观察对象随机分为4组,其中三组分别使用实施例1-3中的产品,对照组使用市售痔疮膏。
2、治疗方法
实施例组,口服剂配合膏体或精油。膏体或精油涂抹于患处,每日一至两次;口服剂每日三次,每次服用20克。连续涂抹半个月为一疗程,观察四个疗程,期间少活动,戒酒,忌辛辣。
3、疗效判定:
治愈:溃疡面消失,止血、排便正常,四月内无复发。
有效:用后不适症状明显改善。
无效:使用后不适症状无变化。
结果见表1。
表1:各试验组治疗痔疮的效果比较
由上表的结果可知,本发明的治疗痔疮的提取物在治疗痔疮的效果明显优于市售的痔疮膏,本发明的治疗痔疮的提取物治疗的治愈率高,复发率极低,在治疗痔疮的效果突出。
最后需要说明的是:以上所述仅为本发明的较佳实施例,仅用于说明本发明的技术方案,并非用于限定本发明的保护范围。凡在本发明的精神和原则之内所做的任何修改、等同替换、改进等,均包含在本发明的保护范围内。
Claims (6)
1.一种治疗痔疮的植物提取物,其特征在于,包括以下重量份的植物组合物提取制成:
白茅5-12份、天花粉5-12份、地龙7-14份、归尾7-14份、丹参10-15份、生地黄5-10份、熟地黄10-15份、大蓟8-16份、小蓟5-10份、锁阳7-12份、桃仁5-12份、火麻仁5-10份、旱莲草10-15份、女贞子10-15份、仙鹤草10-20份、生大黄5-8份、马齿苋10-20份、升麻5-10份、牧丹皮5-10份、麦冬8-15份、党参8-15份、紫草10-14份、茄子根15-20份、空心泡8-15份、鬼针草5-10份和马兰头8-13份。
2.如权利要求1所述的治疗痔疮的植物提取物,其特征在于,包括以下重量份的植物组合物提取制成:
白茅8份、天花粉9份、地龙10份、归尾11份、丹参12份、生地黄8份、熟地黄22份、大蓟12份、小蓟7份、锁阳9份、桃仁9份、火麻仁7份、旱莲草12份、女贞子12份、仙鹤草15份、生大黄7份、马齿苋15份、升麻8份、牧丹皮8份、麦冬12份、党参12份、紫草12份、茄子根18份、空心泡12份、鬼针草7份和马兰头11份。
3.一种如权利要求1或2所述的治疗痔疮的植物提取物的制备方法,其特征在于,包括以下步骤:
S1:将天花粉、地龙、归尾、丹参、生地黄、熟地黄、锁阳、桃仁、火麻仁、女贞子、马齿苋、升麻、牧丹皮、麦冬、党参、空心泡和鬼针草混合打碎,放入蒸锅蒸10-15分钟;
S2:将大蓟、小蓟、仙鹤草、紫草、马兰头、旱莲草、生大黄混合打碎后放入蒸锅,将蒸锅内的组合物蒸熟并冷却;
S3:在冷却的组合物中加入发酵剂发酵,发酵完成后干燥;
S4:将干燥的组合物用酒精浸泡4-8小时后,过滤去药渣得到滤液,将所述滤液减压蒸干,得到膏状植物提取物。
S5:将白茅根和茄子根炒炭并打粉后加入所述膏状植物提取物中。
4.如权利要求3所述的治疗痔疮的植物提取物的制备方法,其特征在于,所述发酵剂为红曲,红曲添加量为所述冷却的组合物的重量的1/4到1/3,发酵温度为36-39度。
5.如权利要求3所述的治疗痔疮的植物提取物的制备方法,其特征在于,所述减压蒸干条件为负压0.08pa、温度55-60度。
6.如权利要求3-5任一项所述的治疗痔疮的植物提取物的制备方法,其特征在于,还包括:
S6:将S5中的膏状植物提取物制成膏体、精油、口服剂中的一种或几种。
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