CN116889594A - 一种治疗慢性传输型便秘的中药栓剂 - Google Patents
一种治疗慢性传输型便秘的中药栓剂 Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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Abstract
本发明涉及一种治疗慢性传输型便秘的中药栓剂,属于中药领域。该中药由枳实1~40份、白术1~40份、莱菔子1~50份、蜂蜜1~500份组成,采用现代科技手段及制剂工艺提取制备的治疗慢性传输型便秘的中药制剂。本发明全部采用中草药组方,无西药长期应用产生的毒副作用;制得的新药具有组方新颖精练,疗效确切,工艺简单易行,服用携带方便、生物利用度高的优点,因此极具市场竞争力。
Description
技术领域
本发明属于中药制药技术领域,尤其涉及一种治疗慢性传输型便秘的中药新药。
背景技术
便秘是指粪便在肠内滞留过久,排便时间延长或周期不长但粪质干结、排出艰难或粪质不硬,虽有便意但便而不畅的症状。分为慢性传输型便秘、排便障碍型便秘及混合型便秘三种类型。其中慢性传输型便秘在临床十分常见,是指由于结肠动力障碍,使肠内容物滞留在结肠及结肠运输缓慢所致的便秘,主要表现为排便次数减少,无便意或不自主排便等,多数伴有腹胀、纳呆等症状。但流行病学研究显示,多数人对此认识不足,就诊率较发病率低,常自服泻药,导致贻误或加重病情。
根据《中国慢性便秘诊治指南》及文献检索结果,无论中医西医,在治疗慢性传输型便秘方面,均主要以口服药物为主,也有配合穴位贴敷、中药灌肠。西医如口服促胃肠动力剂,如西沙比利、替加色罗等,其可促进肌间神经丛血管活性肠肽和乙酰胆碱的生理学的释放,可以明显加强结肠的运动,促进小肠和大肠的运转,但其副作用较大,长期应用疗效有待进一步证实。中医常经辨证论治服用复方汤剂,或应用针刺或穴位贴敷治疗本病。治疗大便秘结严重,应急使用中药灌肠或西药灌肠及栓剂,主要是甘油栓剂和肥皂水,直接刺激肠壁而反射性促进肠蠕动,使大便排出,起效快,但反复多次应用可损害直、结肠粘膜。
也有患者采用容积性、刺激性、滑润性等泻药治疗。其中容积性泻药通过吸收水份、气体改变结肠内菌群,以增加粪便量及容积,如糠数、琼指、葡甘聚糖、硫酸镁、硫酸钠等,该类药起效时间1-3天,应注意摄入水份,否则起不到通便的作用,反而加重便秘的症状,且肠扩张及出口梗阻型便秘者不宜使用此类药物;刺激性泻药,如番泻叶、大黄、多库酷钠、比沙可睫等,可刺激结肠增加肠蠕动,软化粪便,通过降低粪便表面张力使水份容易渗入以软化粪便,但如长期大剂量使用可致结肠黑素沉着病,损害肠功能;滑润性泻药,如液状石蜡可通过润滑肠壁,使大便易于排出,但口感差,作用弱,长期大量应用可干扰指溶性维生素的吸收和引起肉芽肿性肝炎,并有吸入肺部引起脂质性肺炎的危险;渗透性泻药,如乳果糖、山梨醇、甘露醇等,不被人体吸收,通过细菌分解后释放有机酸在结肠起作用,但是在细菌作用下发酵产生气体,引起腹胀等不适感。以上药物均不宜长期服用,副作用大,且远期效果不佳。
发明内容
作者在《伤寒论》蜜煎导方的基础上,加入莱菔子、白术、枳实而成。原蜜煎导方仅用蜂蜜一味药,制成栓剂,通过润滑肛门,起到通便作用。从中医理论角度,认为其具有滋阴通便功效,可治疗大便干结,但对慢性传输型便秘没有促进结肠运动的作用。
根据《素问·举痛论篇》曰:“热气留于小肠,肠中痛,瘅热焦渴,则坚干不得出,故痛而闭不通矣。”《兰室秘藏·大便结燥门》谓:“若饥饱失节,劳役过度,损伤胃气,及食辛热厚味之物,而助火邪,伏于血中,耗散真阴,津液亏少,故大便燥结。”故作者以行气导滞,润肠通便立法,以莱菔子健脾消食,行气导滞为君药,以蜂蜜补气温中、润燥通便为臣药。佐以枳实健脾行气,佐以白术健脾益气。诸药配伍,共奏行气润肠之功效,以通腑中郁滞。
进一步药效学动物实验及初步的药理研究,结果证实本药物可改善便秘症状并明显促进肠道蠕动。
本发明药物组分的用量也是经过发明人进行大量摸索总结得出的,各组分用量为在下述重量范围内均具有较好疗效:
枳实1~40份、白术1~40份、莱菔子1~50份、蜂蜜1~500份。
优选为:
枳实1份、白术1份、莱菔子1份、蜂蜜10份。
优选为:
枳实1份、白术1份、莱菔子1份。
本发明药物可以采用中药制剂的常规方法制备成肛门外用制剂或任何常规内服制剂。优选地,本发明药物活性组分的制备方法如下:
莱菔子油提取:精密称取莱菔子粗粉50g,于圆底烧瓶中,以500mL乙醇为溶剂进行回流提取,提取至经检验无油迹为止。用旋转蒸发仪减压挥尽溶剂,用无水Na2SO4脱水干燥,得稍混浊金黄色莱菔子脂肪油,在真空干燥箱中干燥至恒重。得率为20%。
枳实活性组分的提取:精密称取枳实粗粉50g,取加入到圆底烧瓶中,加入6倍量的70%乙醇溶液,加热回流提取3次,每次1.5h,趁热倾出回流液,合并回流液,静置,滤过、旋转蒸发仪减压回收乙醇,转移至蒸发皿中,水浴浓缩蒸干。干膏得率50%。
白术活性组分的提取:精密称取白术粗粉50g,加500m L蒸馏水,浸泡过夜,取加入到圆底烧瓶中,回流2次,每次30min,趁热倾出回流液,合并回流液,静置,滤过,旋转蒸发仪减压浓缩后,转移至蒸发皿中,水浴浓缩蒸干。干膏得率10%。
取500ml蜂蜜,加入莱菔子50克、枳实50克、白术50克的提取物,相融加热160℃,搅拌10分钟,形成浓稠液体,冷却至30℃,塑形成长5cm,直径0.5cm的栓剂,或同体积的丸剂,再次冷却4℃保存待用。
本发明药物的活性组分可以加入制备不同剂型时所需的各种常规辅料,如崩解剂、润滑剂、粘合剂等以常规的中药制剂方法制备成任何一种常用口服剂型或肛门外用剂型,如颗粒剂、丸剂、散剂、片剂、胶囊剂、口服液、栓剂、凝胶剂等。
本发明的优点是:利用中医药辨症优势的特色和长期研究积累的丰富经验,针对中西医在治疗慢性传输型便秘方面存在的缺陷,研制出的一种疗效确切、工艺简单易行、服用携带方便、生物利用度高的治疗慢性传输型便秘的药物。药效学试验结果表明:本与西药具有相同的促排便作用;药理学研究表明:该药物对结肠粘膜紊乱具有更好的保护作用。
具体实施方式
下面通过有关具体的实施例和试验对本发明作进一步的阐述,但不受限于此。
实施例1本发明栓剂的制备。
组方:枳实50g、白术50g、莱菔子50g、蜂蜜500g。
精密称取枳实药材粗粉50g,加入到圆底烧瓶中,加入6倍量的70%乙醇溶液,加热回流提取3次,每次1.5h,趁热倾出回流液,合并回流液,静置,滤过、旋转蒸发仪减压回收乙醇,转移至蒸发皿中,水浴浓缩蒸干,得干膏23.64g。
精密称取白术粗粉50g,加500m L蒸馏水,浸泡过夜,加入到圆底烧瓶中,回流2次,每次30min,趁热倾出回流液,合并回流液,静置,滤过,旋转蒸发仪减压浓缩后,转移至蒸发皿中,水浴浓缩蒸干,得干膏5.06g。
精密称取莱菔子粗粉50g,于圆底烧瓶中,以500mL乙醇为溶剂进行回流提取,提取至经检验无油迹为止。用旋转蒸发仪减压挥尽溶剂,用无水Na2SO4脱水干燥,得稍混浊金黄色莱菔子脂肪油,在真空干燥箱中干燥至恒重,得到莱菔子10.69ml。
取蜂蜜500g,融化后与制备好的莱菔子、枳实、白术提取物充分融合,160℃,20分钟,形成浓稠液体,冷却至20℃,塑形成长5cm,直径1cm的栓剂,再次冷却,4℃保存备用。
实施例2本发明凝胶剂的制备。
组方:枳实50g、白术50g、莱菔子50g。
精密称取莱菔子粗粉50g,加入水过夜,加热回流提取2次,第一次1.5h,第二次1h,过滤,合并滤液,旋转蒸发仪减压浓缩转移至蒸发皿中,水浴浓缩蒸干,得干膏7.26g。
精密称取枳实药材粗粉50g,加入到圆底烧瓶中,加入6倍量的70%乙醇溶液,加热回流提取3次,每次1.5h,趁热倾出回流液,合并回流液,静置,滤过、旋转蒸发仪减压回收乙醇,转移至蒸发皿中,水浴浓缩蒸干,得干膏23.64g。
精密称取白术粗粉50g,加500mL蒸馏水,浸泡过夜,加入到圆底烧瓶中,回流2次,每次30min,趁热倾出回流液,合并回流液,静置,滤过,旋转蒸发仪减压浓缩后,转移至蒸发皿中,水浴浓缩蒸干,得干膏5.06g。
取SA 0.25g分散于适量蒸馏水中,待其完全溶胀后加入0.6g PEG4000,再加入5%氢氧化钠水溶液3.00g及莱菔子、白术、枳实提取物各3.85g,搅拌使形成橘黄色溶液,立即加入4℃预制的30%P407水溶液18.00g,补足蒸馏水至50.0g,500r/min磁力搅拌至形成均匀凝胶溶液,置于4℃使气泡完全溢出,制成温感凝胶。
实施例3本发明颗粒剂的制备。
组方:枳实50g、白术50g、莱菔子50g。
精密称取枳实药材粗粉50g,取加入到圆底烧瓶中,加入6倍量的70%乙醇溶液,加热回流提取3次,每次1.5h,趁热倾出回流液,合并回流液,静置,滤过、旋转蒸发仪减压回收乙醇,转移至蒸发皿中,水浴浓缩蒸干,得干膏23.64g。
精密称取白术粗粉50g,加500m L去离子水,浸泡过夜,取加入到圆底烧瓶中,回流2次,每次30min,趁热倾出回流液,合并回流液,静置,滤过,旋转蒸发仪减压浓缩后,转移至蒸发皿中,水浴浓缩蒸干,得干膏5.06g。
精密称取莱菔子粗粉50g,每份加入水过夜,加热回流提取2次,第一次1.5h,第二次1h,过滤,合并滤液,旋转蒸发仪减压浓缩转移至蒸发皿中,水浴浓缩蒸干,得干膏7.26g。
将枳实、白术、莱菔子提取的干膏粉碎、过筛、加入糊精与甜蜜素,混匀,制软材,制粒,干燥,整粒,即得。
实施例4本发明片剂的制备
组方:枳实50g、白术50g、莱菔子50g
精密称取枳实药材粗粉50g,加入到圆底烧瓶中,加入6倍量的70%乙醇溶液,加热回流提取3次,每次1.5h,趁热倾出回流液,合并回流液,静置,滤过、旋转蒸发仪减压回收乙醇,转移至蒸发皿中,水浴浓缩蒸干,得干膏23.64g。
精密称取白术粗粉50g白术,加500m L去蒸馏水,浸泡过夜,加入到圆底烧瓶中,回流2次,每次30min,趁热倾出回流液,合并回流液,静置,滤过,旋转蒸发仪减压浓缩后,转移至蒸发皿中,水浴浓缩蒸干,得干膏5.06g。
精密称取莱菔子粗粉50g,每份加入水过夜,加热回流提取2次,第一次1.5h,第二次1h,过滤,合并滤液,旋转蒸发仪减压浓缩转移至蒸发皿中,水浴浓缩蒸干,得干膏7.26g。
将枳实、白术、莱菔子提取的干膏粉碎,加入淀粉适量混合,加入润湿剂、粘合剂,制软材,制颗粒,干燥,整粒,加入润滑剂并压片,即得。
试验例1本药物栓剂急性毒性试验研究
为了解本药物对实验动物安全性的影响,根据毒理学试验观察的要求,进行相关的试验观察,该栓剂为肛门直肠给药的中药复方栓剂,根据预试验情况,分组给药后高剂量组动物未见死亡,故无法进行动物半数致死量(LD50)测定。改为动物肛门直肠给药的最大给药量测定。
因受给药方式(肛门直肠给药)、药物浓度及给药体积所限,给予最大浓度,给药剂量已无法再增加,故采用每天2次的给药方式,每次0.125g/10g累积用药量为25g/kg,以上剂量为人临床应用剂量10g/70kg的175倍。给药后连续观察七天,所有受试动物均未见有异常表现,无一死亡。由此可以证明该肛门直肠给药毒性较低。
[实验目的]
观察受试药物最大剂量给予动物后,所产生的毒性反应情况和死亡情况。
[材料]
动物:昆明小鼠40只。体重19-21g。由吉林大学实验动物中心提供。无病未孕,雌雄分笼喂养,自由饮食。小白鼠饲养和实验均在清洁级动物实验室内进行。小白鼠标准饲料为消毒饲料,小白鼠垫料为消毒垫料,均由吉林大学实验动物中心供给。笼具用过氧乙酸溶液消毒。饮用水为蒸馏水。
药品:枳莱栓:由长春中医药大学提供。
[实验方法]
取昆明小鼠40只,雌雄各20只,分笼饲养,实验前自由进食及饮水,实验时两次肛门直肠给药0.125g/10g,2次给药间隔12小时,累积用药量为25g/kg,按表2观察相关指标。
[实验结果]
受试动物给药后自主活动程度减少,给药后4小时恢复正常,未见其他异常变化,后经连续观察7天均未见毒性反应及死亡,其每日最大给药量为25g/kg,为人用量10g/70kg的175倍。
急性毒性试验报告表-1
急性毒性试验报告表-2
[讨论与说明]
枳莱栓为使用多年的经验方剂,由莱菔子、白术、枳实、蜂蜜经科学方法精制而成的复方栓剂,具有健脾理气,润肠通便等功效,临床上主要用于治疗多种因素导致的慢性传输型便秘。
为判定其使用的安全性故进行急毒实验,根据预试验情况,分组给药后动物未见死亡,故无法进行动物半数致死量测定。改为动物肛门直肠给药的最大给药量测定。
因受给药方式(肛门直肠给药)、药物浓度及给药体积所限,给予最大浓度枳莱栓,给药剂量已无法再增加,采用每天2次的给药方式,每次0.125g/10g累积用药量为25g/kg,以上剂量为人临床应用剂量10g/70kg的175倍。给药后连续观察七天,所有受试动物均未见有异常表现,无一死亡。由此可以证明该肛门直肠给药毒性较低。
Claims (4)
1.一种治疗便秘的中药药物,其特征在于它是由下列重量份的原料药制成:中药由枳实1~40份、白术1~40份、莱菔子1~50份、蜂蜜1~500份。
2.如权利要求1所述的治疗便秘的中药药物,其特征在于它是由下列重量份的原料药制成:枳实1份、白术1份、莱菔子1份、蜂蜜10份。
3.如权利要求1所述的治疗便秘的中药药物,其特征在于它是由下列重量份的原料药制成:枳实1份、白术1份、莱菔子1份。
4.如权利要求1或3所述药物的制备方法,包括下列步骤:取枳实、白术、莱菔子生药或提取物与蜂蜜融合,加热浓缩制成栓剂、凝胶剂、膏剂、丸剂、冲剂。
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