CN104383154A - 治疗便秘的中药制剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种治疗便秘的中药制剂及其制备方法,属于中药技术领域。本发明所述的治疗便秘的中药制剂,包括以下重量份数的原料:当归10-30份、牛膝5-10份、肉苁蓉5-15份、泽泻1-5份、升麻1-5份、枳壳5-10份、姜厚朴5-15份、白术5-10份、首乌10-15份、桃仁8-10份、车前子10-20份。本发明所述的治疗便秘的中药制剂,其配制简便、口感和疗效好,无依赖性、无毒副作用,具有温肾益精、润肠通便、行气消积的功效;同时本发明提供了一种简单便捷的治疗便秘的中药制剂的制备方法。
Description
技术领域
本发明涉及一种治疗便秘的中药制剂及其制备方法,属于中药技术领域。
背景技术
便秘是临床上常见疾病,同时也是多种疾病常见症状之一。其主要临床表现为排便困难、次数减少、粪便硬结。国外资料显示,便秘的发病率在年轻人中为3%,中老年人8%,老年人达到20%。近几年来,随着人们工作和社会生活压力增大、精神心理、社会因素的影响以及饮食结构的调整,尤其是蛋白类食物摄入过多,蔬菜摄入相对不足等,便秘的发病率呈现上升并且年轻化的趋势。它给患者带来很大的痛苦,并且严重影响人们的生活和工作,尤其是对老年患者的危害更加严重,常因为排便费力诱发冠心病、心绞痛甚至心肌梗死等。
目前我国慢性便秘的患病率逐渐上升,严重影响人民的生活质量。流行病学调查还发现,便秘患者的就诊率只有10.6%,但有45.7%的患者自行服用非处方药。常用的治疗便秘的泻药有如下几种:容积性泻药、润滑性泻药、高渗性泻药、刺激性泻药,以上泻药都具有很好的通便作用,但是也有一定的副作用。西沙必利等胃肠动力药和红霉素都具有促进肠蠕动的作用,因此也被一些人用于治疗便秘。人们在长期使用泻药后,肠道的正常蠕动功能会逐渐减弱,直肠排便反射的敏感性会逐渐降低,肠肌间的神经丛也会受到损伤。此时,患者一旦停止服用泻药,就会出现更加严重的便秘。滥用泻剂造成泻剂依赖、泻剂结肠等不良反应,增加医疗费用,造成医疗资源浪费。
根据流行病学调査发现,便秘常见于小儿以及老年人。小儿稚阴稚阳;女子七七,任脉虚,太冲脉衰少,天癸竭;男子七八,肝气衰,天癸竭,精少,肾藏衰,形体皆极,加之“年四十而阴气自半”,部分患者阳气亦衰。张景岳《景岳全书》云:“凡病涉虚损而大便秘结不通,则硝、黄攻击等剂必不可用。若势有不得不通者,宜补之,此用通于补也。”肾司二便,肾气亏虚,下元不温,五液不化,肠道失润而大便不通,法当温肾润肠。因此,中老年人与小儿的便秘都需要重视虚的病机,不可犯虚虚实实之戒。
发明内容
本发明的目的是提供一种治疗便秘的中药制剂,其配制简便、口感和疗效好,无依赖性、无毒副作用,具有温肾益精、润肠通便、行气消积的功效;同时本发明提供了一种简单便捷的治疗便秘的中药制剂的制备方法。
所述治疗便秘的中药制剂,包括以下重量份数的原料:当归10-30份、牛膝5-10份、肉苁蓉5-15份、泽泻1-5份、升麻1-5份、枳壳5-10份、姜厚朴5-15份、白术5-10份、首乌10-15份、桃仁8-10份、车前子10-20份。
优选地,包括以下重量份数的原料:当归15份、牛膝6份、肉苁蓉9份、泽泻4.5份、升麻3份、枳壳5份、姜厚朴9份、白术10份、首乌15份、桃仁10份、车前子10份。
所述治疗便秘的中药制剂的制备方法,可以采用以下两种方法中的任意一种:
(1)包括以下步骤:向当归、牛膝、肉苁蓉、泽泻、升麻、枳壳、姜厚朴、白术、首乌、桃仁和车前子的混合原料中加入6-12倍重量的溶剂,浸泡0-2小时,然后采用煎煮法、回流提取法或连续回流提取法提取2-3次,每次1-2小时,合并提取液,分次过滤,合并滤液,将滤液浓缩至60℃时相对密度为1.08~1.30g/cm3,制得浸膏,最后按照常规的方法制得所需剂型。
(2)包括以下步骤:姜厚朴用溶剂提取两次,每次1-2小时、过滤,滤液备用;枳壳加水蒸馏,收集蒸馏液,蒸馏后的水溶液过滤备用;将枳壳药渣与其余九种原料混合后,加入6-12倍重量的溶剂,然后采用煎煮法、回流提取法或连续回流提取法提取2-3次,每次1-2小时,合并提取液,分次过滤,合并滤液,将滤液浓缩至60℃时相对密度为1.08-1.15g/cm3,再加入1-5倍重量的乙醇使提取物沉淀、过滤,将滤液与姜厚朴滤液合并,然后加入枳壳蒸馏液,混匀,按照常规的方法制得所需剂型。
所述溶剂为水、甲醇、乙醇、5-95wt%含水甲醇、5-95wt%含水乙醇或乙酸乙酯。
所述的辅料根据制备剂型的不同而不同。
所述治疗便秘的中药制剂的剂型为口服液、片剂、胶囊剂或颗粒剂。
本发明所述治疗便秘的中药制剂中相关组分的性质和功效如下:
肉苁蓉性温,味甘、咸,入肾、大肠经,具有温肾益精,暖腰润肠的功效。当归性温,味甘、辛,入肝、心、脾经,具有养血润肠的功效;牛膝性平,味苦、酸,益肝肾,能引诸药下行;枳壳宽肠下气而助便;姜厚朴行气消积,燥湿除满;升麻引阳明清气上升,清阳得升,浊阴自降,与枳壳相配,使清升浊降,便秘自通;复用泽泻甘淡润降,分泄肾浊,使浊降腑通而便秘得解,再取白术除湿益燥和中益气,温中,去脾胃中湿,除胃热,强脾胃;首乌养血滋阴,佐以桃仁、车前子润肠通便。
本发明所述的治疗便秘的中药制剂,以肉苁蓉、当归、牛膝、首乌温肾益精,养血润肠为主,在温润治本的前提下考虑到肾虚气化失职,水液代谢失常,以致浊阴不降,故以泽泻入肾泄浊,枳壳降气宽肠,姜厚朴行气消积,使浊降腑通而大便得下,以增其润下之功;又因浊阴不降原于清阳不升,故少佐升麻升清以降浊,白术去脾胃中湿,除胃热,强脾胃,桃仁、车前子润肠通便,尤善治年老体虚便秘。
本发明所述的治疗便秘的中药制剂的主要药效学试验如下:
(一)对小鼠排便的影响
1、材料
动物:选用SPF级小鼠,雌雄各半,体重18-24g。
药材:本发明所述的治疗便秘的中药制剂。
阳性对照:济川煎汤剂。
2、便秘模型
将小鼠随机分成3组,每组20只,分别为燥结便秘组、地芬诺酯便秘组、空白组。
造模方法:(1)燥结便秘组:实验前72h开始禁水不禁食,实验前16h后禁食,造成燥结便秘模型。(2)地芬诺酯便秘组:实验前16h开始禁食不禁水,按10mg/kg的剂量给予复方地芬诺酯混悬液(0.02ml/g),30min后造成地芬诺酯便秘模型。
3、小鼠排便测定
所用药液、蒸馏水及阳性对照药液均于给药前溶入曙红(用量为药液的1%),造模后,各组按0.6ml/只灌胃给药,记录给药时间和小鼠排出第一粒红色粪便的时间,计算小鼠通便时间,连续观察6h,记录6h内小鼠总排红色粪便点数,结果见表1。
表1本发明所述中药制剂对便秘型小鼠排便的影响
结果显示,与空白组相比,模型组首次排红便时间显著延长,6h红便点数显著减少,表明小鼠便秘模型建立成功(P<0.01);与模型组相比,给药组与阳性对照组的首次排红便时间均缩短(P<0.01),红便点数均增多(P<0.05),有统计学差异;给药组与阳性对照组相比,本发明所述的中药制剂能显著缩短首次排红便时间、增加排便量。
(二)对便秘型小鼠小肠推进的影响
选用SPF级小鼠60只,雌雄各半,体重18-24g,按体重均匀分3组,分别为空白组,给药组,阳性组,阳性对照为济川煎汤剂。所用药液、蒸馏水及阳性对照液均于给药前混入炭末(用量为药液的5%)。小鼠禁食不禁水16h后按0.6ml/只灌胃给药,20min后处死。剖腹取出小肠测量。以幽门至炭末行进最远处为推进长度,幽门至回肓瓣为全长,前者除以后者为推进度,结果见表2。
表2本发明所述中药制剂对便秘型小鼠小肠推进的影响
组别 | 小肠全长(cm) | 黑肠长(cm) | 推进率(%) |
空白组 | 21.44±3.46 | 7.57±2.03 | 36.25±11.56 |
给药组 | 23.40±3.90 | 15.49±4.83 | 65.41±14.81 |
阳性组 | 24.73±3.55 | 15.03±5.92 | 59.51±16.38 |
结果显示,与空白组相比,给药组和阳性组均能显著加强小鼠肠蠕动作用;给药组和阳性组相比表明,本发明所述中药制剂对小鼠肠蠕动作用更好。
临床试验以及疗效如下:
采用随机双盲平行对照多中心临床试验评价本药治疗老年便秘的有效性和安全性。
本发明选取201例老年便秘病例,其中男性101例,女性100例,年龄处于64-89岁。随机A组101人,男性51人,女性50人;B组100人,男性50人,女性50人。上面两组资料均符合筛选标准。经统计学分析两组患者的性别、年龄大致相同,差异无统计学意义,P>0.05,具有可比性。A组给予本发明所述的中药制剂服用15日,B组服用济川煎汤剂至症状缓解或至15日,临床疗效根据《中医病证诊断疗效标准》判断患者治疗结果。
临床中A组患者有73例治愈,23例缓解,5例症状无效,治愈率为73%,缓解率为95%,无效率为5%;B组患者有50例治愈,27例缓解,23例无效,治愈率为50%,缓解率为77%,无效率为23%。A、B两组患者在两个月后随访无特殊情况发生。
与现有技术相比,本发明具有以下有益效果:
(1)本发明所述治疗便秘的中药制剂,配制简便、口感和疗效好,无依赖性、无毒副作用,具有温肾益精、润肠通便、行气消积的功效,有效治疗便秘,尤其适合老年人和儿童;
(2)本发明所述治疗便秘的中药制剂,还避免了泻剂依赖、泻剂结肠等不良反应,降低了医疗费用,避免了医疗资源的浪费;
(3)本发明所述治疗便秘的中药制剂的制备方法简单便捷,产品质量便于控制。
具体实施方式
下面结合实施例对本发明作进一步的说明,但其并不限制本发明的实施。
实施例1
称取当归15份、牛膝6份、肉苁蓉9份、泽泻4.5份、升麻3份、枳壳5份、姜厚朴9份、白术10份、首乌15份、桃仁10份、车前子10份,混合均匀,加入10倍重量的水,煎煮2小时,过滤,药渣继续用8倍水煎煮1小时,过滤,合并滤液,将滤液浓缩至60℃时相对密度为1.08g/cm3,制得浸膏。称取15份辅料糊精,加入40份的水,在80℃下加热使糊精溶解,再加入所得的浸膏,混合均匀,然后在100±10℃下干燥,制粒,即得治疗便秘的中药制剂。
实施例2
称取当归15份、牛膝10份、肉苁蓉5份、泽泻5份、升麻1份、枳壳10份、姜厚朴5份、白术5份、首乌10份、桃仁8份、车前子20份,其中姜厚朴用8倍重量的60wt%含水乙醇提取两次,每次1小时,过滤,滤液备用;枳壳加水蒸馏,收集蒸馏液,蒸馏后的水溶液过滤,备用;枳壳药渣与其余九味原料混合,加入8倍重量的水,煎煮2小时,过滤,药渣继续用6倍水煎煮1小时,过滤,合并滤液,将滤液浓缩至60℃时相对密度为1.15g/cm3,加入2倍重量的乙醇使提取物沉淀、过滤,将滤液与姜厚朴滤液合并,回收乙醇,然后加入枳壳蒸馏液,混匀,加水至1000ml,静置,过滤,灌装,即得治疗便秘的中药制剂。
实施例3
称取当归10份、牛膝5份、肉苁蓉15份、泽泻1份、升麻5份、枳壳6份、姜厚朴15份、白术6份、首乌11份、桃仁9份、车前子10份,混合均匀,加6倍重量的水,浸泡2小时,然后煎煮1小时,过滤,药渣继续用10倍重量的水煎煮1小时,过滤,合并滤液,滤液浓缩至60℃时相对密度为1.30g/cm3,加入淀粉、硬脂酸镁适量,混匀,制粒,干燥,压制成1000片,包薄膜衣,即得治疗便秘的中药制剂。
实施例4
称取当归30份、牛膝6份、肉苁蓉9份、泽泻4.5份、升麻3份、枳壳8份、姜厚朴6份、白术7份、首乌10份、桃仁8份、车前子15份,混合均匀,加12倍重量的水,浸泡1小时,然后煎煮1小时,过滤,药渣继续用10倍重量的水煎煮1小时,过滤,合并滤液,滤液浓缩至60℃时相对密度为1.10g/cm3,加入淀粉、硬脂酸镁适量,混匀,制粒,干燥,压制成1000片,包薄膜衣,即得治疗便秘的中药制剂。
Claims (4)
1.一种治疗便秘的中药制剂,其特征在于包括以下重量份数的原料:当归10-30份、牛膝5-10份、肉苁蓉5-15份、泽泻1-5份、升麻1-5份、枳壳5-10份、姜厚朴5-15份、白术5-10份、首乌10-15份、桃仁8-10份、车前子10-20份。
2.根据权利要求1所述的治疗便秘的中药制剂,其特征在于包括以下重量份数的原料:当归15份、牛膝6份、肉苁蓉9份、泽泻4.5份、升麻3份、枳壳5份、姜厚朴9份、白术10份、首乌15份、桃仁10份、车前子10份。
3.一种权利要求1或2所述治疗便秘的中药制剂的制备方法,其特征在于采用以下两种方法中的任意一种:
(1)包括以下步骤:向当归、牛膝、肉苁蓉、泽泻、升麻、枳壳、姜厚朴、白术、首乌、桃仁和车前子的混合原料中加入6-12倍重量的溶剂,浸泡0-2小时,然后采用煎煮法、回流提取法或连续回流提取法提取,合并提取液、过滤,将滤液浓缩至60℃时相对密度为1.08-1.30g/cm3,制得浸膏,最后制得所需剂型;
(2)包括以下步骤:姜厚朴用溶剂提取、过滤,滤液备用;枳壳加水蒸馏,蒸馏后的水溶液过滤备用;将枳壳药渣与其余九种原料混合后,加入6-12倍重量的溶剂,然后采用煎煮法、回流提取法或连续回流提取法提取,合并提取液、过滤,将滤液浓缩至60℃时相对密度为1.08-1.15g/cm3,再加入1-5倍重量的乙醇使提取物沉淀、过滤,将滤液与姜厚朴滤液合并,然后加入枳壳蒸馏液,混匀制得所需剂型。
4.根据权利要求3所述治疗便秘的中药制剂的制备方法,其特征在于:溶剂为水、甲醇、乙醇、5-95wt%含水甲醇、5-95wt%含水乙醇或乙酸乙酯。
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