CN104547266A - 一种中药组合物在制备治疗痔疮药物中的用途 - Google Patents

一种中药组合物在制备治疗痔疮药物中的用途 Download PDF

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CN104547266A
CN104547266A CN201410842069.9A CN201410842069A CN104547266A CN 104547266 A CN104547266 A CN 104547266A CN 201410842069 A CN201410842069 A CN 201410842069A CN 104547266 A CN104547266 A CN 104547266A
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黎细乐
黄健仪
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Abstract

本发明属于医药领域，涉及一种中药组合物在制备治疗痔疮药物中的用途。所述的中药组合物由黄芩10-22份、白芷6-16份、荆芥6-10份、枸杞2-7份、补骨脂10-17份、穿心莲10-18份、熟地5-11份、连翘2-10份、党参5-15份、大蓟4-12份、仙鹤草6-15份、鸡血藤8-25份、细辛10-20份、黄连3-13份、黄柏10-30份、桂枝2-10份、厚朴3-19份、甘草10-20份组成，各组分相辅相成，协同作用，达到凉血润肠、清利湿热、清热消肿、消炎、抗菌、镇痛、止血生肌、消肿止痛的功效，从根本上解决痔疮问题，减轻痔疮患者的痛苦。该中药组合物疗效显著、安全可靠，具有广阔的临床应用前景。

Description

一种中药组合物在制备治疗痔疮药物中的用途
技术领域
本发明属于医药领域，涉及一种中药组合物在制备治疗痔疮药物中的用途。
背景技术
痔疮是一种位于肛门部位的常见疾病，痔疮临床分为内痔、外痔和混合痔，任何年龄都可发病，而且随着年龄增长，发病率逐渐增高。在我国，痔疮是最常见的肛肠疾病，素有“十男九痔”、“十女十痔”的说法。因为人们工作繁忙，久坐、久站、久蹲，血液循环障碍使人体直肠末端粘膜和肛管皮肤下静脉丛发生扩张屈曲；饮食不规律，长期吸烟、喝酒、吃辣；生活没节凑，经常熬夜加班，夜生活丰富；造成人们长期便秘，习惯忍便，所以容易引发痔疮的发生。痔疮轻者失血脱肛，面色苍白、乏力、头晕、记忆力下降、甚至出现眼花、耳鸣的现象，重者肛门坏死，无法控制排便，诱发肛门瘙痒或肛门湿疹，食欲下降，强忍不便，恶性循环，最终导致肝、肾病、肛裂和大肠肿瘤的发生。痔疮给人们的生活带来不便，给人们的生理和心理都造成了极大的影响。
目前，治疗痔疮主要是依靠手术和医药治疗，但是，手术仅能去除痔核，无法根治，手术后容易感染，并造成一系列并发症的发生，现有的痔疮的药物主要是口服液、丸剂和片剂，该药物存在治疗周期长，易复发，难以消除病灶，长期用药花费高，对身体存在副作用，无法从根本上解决痔疮给人们带来的痛苦。因此，研究和开发出有效治疗痔疮的药物，是目前临床上的迫切需求。
发明内容
为了解决现有技术治疗痔疮存在周期长，易复发，难以消除病灶的缺陷，本发明的目的提供一种中药组合物在制备治疗痔疮药物中的用途，公开一种治疗痔疮的中药组合物，该中药组合物疗效显著、安全可靠，具有广阔的临床应用前景。
本发明的技术方案为：
一种中药组合物在制备治疗痔疮药物中的用途，所述的中药组合物由下列重量份的原料制成：黄芩10-22份、白芷6-16份、荆芥6-10份、枸杞2-7份、补骨脂10-17份、穿心莲10-18份、熟地5-11份、连翘2-10份、党参5-15份、大蓟4-12份、仙鹤草6-15份、鸡血藤8-25份、细辛10-20份、黄连3-13份、黄柏10-30份、桂枝2-10份、厚朴3-19份、甘草10-20份。
上述所述的中药组合物中，优选的中药组合物由下列重量份的原料制成：黄芩16份、白芷10份、荆芥7份、枸杞4份、补骨脂12份、穿心莲14份、熟地6份、连翘5份、党参8份、大蓟8份、仙鹤草9份、鸡血藤12份、细辛14份、黄连7份、黄柏13份、桂枝6份、厚朴11份、甘草15份。
    依据传统验方和中药配伍原理，科学搭配药材，本发明中药组合物各组分相辅相成，协同作用，达到凉血润肠、清利湿热、清热消肿、消炎、抗菌、镇痛、止血生肌、消肿止痛、止血收敛的功效，可以从根本上治疗痔疮问题，减轻痔疮患者的痛苦。
为了更好地表达本发明的中药组合物，本发明的中药组合物可以制备成临床上常用的剂型。比如，粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、口服液、糖浆、片剂或胶囊剂等制剂，所述药物制剂均可按照本领域技术人员所熟知的中药制剂制备方法制备得到。优选地，本发明中药组合物按照常规制备工艺制备成散剂、水剂、片剂或胶囊剂。
本发明还提供了一种上述所述中药组合物的制备方法，其主要包含下述步骤：取处方量中药材碎成粗粉，按照粗粉总重量的6倍加入体积浓度为70%的乙醇溶液，回流提取三次，回流时间为3h，过滤，滤液减压回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；加入辅料制成制剂。本发明中药组合物在治疗痔疮方面，与现有技术相比具有如下优势：
1)   与当前治疗的化学治疗药物相比，本发明中药组合物为天然纯中药制剂，不良反应和副作用小，且本发明中药组合物作用全面，药物治疗效果更佳，并提高了患者的生活质量；
2)   本发明中药组合物中含有多种药物组分，作用靶点众多，可以从根本上解决治疗痔疮问题，大大的减轻痔疮患者的痛苦。
具体实施方式
以下通过具体实施例进一步描述本发明，但本领域技术人员应该知晓，所述实施例并不以任何方式限制本发明。
一)制剂实施例部分
实施例1、本发明中药组合物胶囊剂制备
处方：
    黄芩10份、白芷6份、荆芥6份、枸杞2份、补骨脂10份、穿心莲10份、熟地5份、连翘2份、党参5份、大蓟4份、仙鹤草15份、鸡血藤25份、细辛20份、黄连13份、黄柏30份、桂枝10份、厚朴19份、甘草20份。
制备方法：按照上述处方量称取 黄芩、白芷、荆芥、枸杞、补骨脂、穿心莲、熟地、连翘、党参、大蓟、仙鹤草、鸡血藤、细辛、黄连、黄柏、桂枝、厚朴、甘草等药物组合物原料研磨成粗粉，按照粗粉总重量的6倍加入体积浓度为70%的乙醇溶液，回流提取三次，回流时间为3h，过滤，滤液减压回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏，加入可压性淀粉、乳糖和低取代羟丙基纤维素混合均匀后，加入乙醇溶液制软材，过筛制颗粒，干燥，过筛整粒，装填胶囊，制成胶囊剂。
实施例2、本发明中药组合物胶囊剂制备
处方：
    黄芩16份、白芷10份、荆芥7份、枸杞4份、补骨脂12份、穿心莲14份、熟地6份、连翘5份、党参8份、大蓟8份、仙鹤草9份、鸡血藤12份、细辛14份、黄连7份、黄柏13份、桂枝6份、厚朴11份、甘草15份。
制备方法：按照上述处方量称取 黄芩、白芷、荆芥、枸杞、补骨脂、穿心莲、熟地、连翘、党参、大蓟、仙鹤草、鸡血藤、细辛、黄连、黄柏、桂枝、厚朴、甘草等药物组合物原料研磨成粗粉，按照粗粉总重量的6倍加入体积浓度为70%的乙醇溶液，回流提取三次，回流时间为3h，过滤，滤液减压回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏，加入可压性淀粉、乳糖和低取代羟丙基纤维素混合均匀后，加入乙醇溶液制软材，过筛制颗粒，干燥，过筛整粒，装填胶囊，制成胶囊剂。
实施例3、本发明中药组合物片剂制备
处方：
    黄芩22份、白芷16份、荆芥10份、枸杞7份、补骨脂17份、穿心莲18份、熟地11份、连翘10份、党参15份、大蓟12份、仙鹤草6份、鸡血藤8份、细辛10份、黄连3份、黄柏10份、桂枝2份、厚朴3份、甘草10份。
    制备方法：按照上述处方量称取 黄芩、白芷、荆芥、枸杞、补骨脂、穿心莲、熟地、连翘、党参、大蓟、仙鹤草、鸡血藤、细辛、黄连、黄柏、桂枝、厚朴、甘草等药物组合物原料研磨成粗粉，按照粗粉总重量的6倍加入体积浓度为70%的乙醇溶液，回流提取三次，回流时间为3h，过滤，滤液减压回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏，加入淀粉、糊精和低取代羟丙基纤维素混合均匀，另取适宜量的乙醇溶液混合均匀后制软材，干燥后完成后整粒，筛出干粒中的细粉，与过筛的硬脂酸镁混匀，压片，制备成片剂。
实施例4 、本发明中药组合物散剂制备
处方：
    黄芩22份、白芷10份、荆芥8份、枸杞6份、补骨脂13份、穿心莲12份、熟地8份、连翘6份、党参15份、大蓟12份、仙鹤草10份、鸡血藤20份、细辛15份、黄连5份、黄柏15份、桂枝2份、厚朴3份、甘草20份。
    制备方法：按照上述处方量称取 黄芩、白芷、荆芥、枸杞、补骨脂、穿心莲、熟地、连翘、党参、大蓟、仙鹤草、鸡血藤、细辛、黄连、黄柏、桂枝、厚朴、甘草等药物组合物原料研磨成粗粉，按照粗粉总重量的6倍加入体积浓度为70%的乙醇溶液，回流提取三次，回流时间为3h，过滤，滤液减压回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏，筛出干粒中的细粉，制备成散剂。
实施例5、本发明中药组合物对痔疮的临床试验
1、一般资料
选择2012年1月-2013年12月，某市肛肠科门诊和病区收治的内痔、外痔、混合痔患者共300例，其中男188例，女112例，年龄 22-65岁。平均年龄40.5岁。
2、临床症状
痔疮临床分为内痔、外痔和混合痔。
（1）内痔的常见症状为出血、脱垂、肿胀、疼痛，分为 4 度。
I度：便时带血、滴血，便后出血可自行停止；无痔脱出。
Ⅱ度：常有便血；排便时有痔脱出，便后可自行还纳。
Ⅲ度：可有便血；排便或久站及咳嗽、劳累、负重时有痔脱出，需用手还纳。
Ⅳ度：可有便血；痔持续脱出或还纳后易脱出。
（2）外痔：:出现血栓或炎症，肿胀、疼痛。
（3）混合痔：:内痔和外痔症状同时存在。
3、试验方法
口服本发明实施例2制备的胶囊剂,5g/次，每天3次，10天为一个疗程，连续治疗3个疗程。
4、疗效评定标准
（1）治愈：痔疮临床症状消失，体质恢复正常，检查痔已经消失；
（2）有效：痔疮临床症状明显改善，体质逐步恢复，检查痔有明显缩小；
（3）无效：痔疮临床症状无改变。
5、试验结果
参见表1
表1本发明中药组合物临床疗效数据
表1治疗结果显示：用本发明中药组合物治疗内痔患者120例，治愈98例，总有效率为95.9%；外痔患者70例，治愈58例，总有效率为95.7%；混合痔患者 110例， 治愈88例，总有效率为 95.5%。可见，本发明中药组合物适合内痔、外痔和混合痔等各种类型痔疮的治疗。

Claims (4)

1.一种中药组合物在制备治疗痔疮药物中的用途，其特征在于，所述的中药组合物由下列重量份的原料制成：
黄芩10-22份、白芷6-16份、荆芥6-10份、枸杞2-7份、补骨脂10-17份、穿心莲10-18份、熟地5-11份、连翘2-10份、党参5-15份、大蓟4-12份、仙鹤草6-15份、鸡血藤8-25份、细辛10-20份、黄连3-13份、黄柏10-30份、桂枝2-10份、厚朴3-19份、甘草10-20份。
2.如权利要求1所述的用途，其特征在于，所述的中药组合物由下列重量份的原料制成：
黄芩16份、白芷10份、荆芥7份、枸杞4份、补骨脂12份、穿心莲14份、熟地6份、连翘5份、党参8份、大蓟8份、仙鹤草9份、鸡血藤12份、细辛14份、黄连7份、黄柏13份、桂枝6份、厚朴11份、甘草15份。
3.如权利要求1或2所述的用途，其特征在于，所述的中药组合物为散剂、水剂、片剂或胶囊剂。
4.如权利要求1-3任一所述的用途，其特征在于，所述的中药组合物的制备方法包含下述步骤：取处方量中药材碎成粗粉，按照粗粉总重量的6倍加入体积浓度为70%的乙醇溶液，回流提取三次，回流时间为3h，过滤，滤液减压回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；加入辅料制成制剂。
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CN105726733A (zh) * 2016-03-29 2016-07-06 圣原健康产业有限公司 防治痔疮的中药组合物及其制备方法和应用以及痔疮膏
CN111643556A (zh) * 2020-07-16 2020-09-11 杭州科倍安生物制药有限公司 一种用于预防和治疗痔疮的药物及其应用

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CN105726733A (zh) * 2016-03-29 2016-07-06 圣原健康产业有限公司 防治痔疮的中药组合物及其制备方法和应用以及痔疮膏
CN111643556A (zh) * 2020-07-16 2020-09-11 杭州科倍安生物制药有限公司 一种用于预防和治疗痔疮的药物及其应用

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