CN110338406A - 一种适用于术后胃肠功能障碍恢复的肠内营养制剂 - Google Patents
一种适用于术后胃肠功能障碍恢复的肠内营养制剂 Download PDFInfo
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- CN110338406A CN110338406A CN201910484079.2A CN201910484079A CN110338406A CN 110338406 A CN110338406 A CN 110338406A CN 201910484079 A CN201910484079 A CN 201910484079A CN 110338406 A CN110338406 A CN 110338406A
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Abstract
本发明提供了一种适用于术后胃肠功能障碍恢复的肠内营养制剂及其制备方法,所述肠内营养制剂的功效成分由番泻叶提取物、乳双歧杆菌、嗜酸乳杆菌、德氏乳杆菌、低聚果糖、低聚半乳糖、低聚木糖、复合维生素、复合电解质等组成,通过混合方式获得。所述肠内营养制剂能有效改善术后患者胃肠功能紊乱、对预防术后肠梗阻、腹腔粘连、病人长时间不排气、及加速术后病人康复和缩短住院时间具有重要临床意义;其制备方法简单,适合规模化工业生产的需要。
Description
技术领域
本发明涉及功能性食品领域和临床营养治疗领域,尤其是一种适用于术后胃肠功能障碍(PGID)恢复的肠内营养制剂及其制备方法。
背景技术
术后胃肠功能障碍(Postoperative Gastrointestinal Dysfunction,PGID)又称为术后胃肠功能紊乱,是指由于手术麻醉、创伤,术后禁食、长时间卧床、电解质紊乱、腹腔内炎症、残留积血或引流管的机械刺激、以及患者原发病恶化、高龄等综合因素的作用,导致术后出现:腹胀,腹痛,排气排便困难,恶心呕吐或腹泻等胃肠运动功能障碍的一系列症状。PGID是普通外科手术后常见的并发症,是腹腔手术后“难以避免的生理性或病理性胃肠道反应”。据调查,一般腹部手术术后肠梗阻发生率20%,腹腔粘连发生率高达90%,其中40%以上引起粘连性肠梗阻。
在不同术后胃肠道功能障碍中,术后肠梗阻、腹腔粘连、延迟性肠麻痹最为常见,是外科手术尤其是腹部手术后胃肠运动障碍“最常见”的类型。延迟性肠麻痹表现为腹胀、肠鸣音未恢复或极弱,尚未经肛门排气排便,胃管抽吸引流量仍高,甚至呕吐,已给不少患者术后胃肠功能恢复、营养状况恢复、甚至病灶的恢复、临床治疗计划的推进,造成了极大的阻碍。
手术病人一般需在术后常规禁食,如临床观察中医生确认患者肠蠕动已自动恢复(肛门排气),方允许患者开始进食。所以“肛门排气时间的早晚又直接关系到术后身体的恢复情况”。若手术后出现腹胀现象,不采用任何方法促进排气,肛门排气时间常延长至72小时,则发展为病理性肠梗阻;这不仅使患者感到不适及恐慌、影响切口组织的修复及机体的恢复,还严重影响病人的营养摄入,不利于病人的康复,甚至可引起机体内环境紊乱,诱发各种并发症。
目前临床上常规治疗和护理有:胃肠减压、鼓励患者下床活动、药物及其他治疗等:胃肠减压不但增加了患者插鼻胃管的痛苦,且可能出现“拔管”现象。再如公开号CN105148349A公布了一种肠道灌洗治疗仪:有利于术后肠道功能恢复,减少术后腹胀、排便痛苦;早期下床则由于术后疼痛,患者不愿意活动;通过胃镜注气扩张胃腔和空肠输出拌,能机械刺激胃肠道平滑肌;药物治疗包括利用促进胃肠蠕动药物多巴胺受体阻滞剂胃复安、吗丁啉;5-羟色胺(5-HT)受体拮抗剂等。其他中药制剂如公开号108837018A公开了一种促进胃肠道功能恢复及提高机体免疫力的中药复方。目前很多专有技术都具有重要的市场基础和应用价值,但药物因为胃肠功能尚未恢复不能取得良好的效果,药物的不良反应是“针对术后”药物治疗中难以回避的问题。
常规情况下,术后6h给病人流质饮食,排气后开始给予软食。术后早进流食时胃肠道内容物对平滑肌的牵拉、温度可引起内容物排空,促进胃舒张,小肠分泌活动在进食后逐渐加强,结肠运动也随之增多,促进患者早排气、排便。“但是不适宜形态、营养成分、预消化程度的食物反而会为胃肠消化吸收带来负担”。
所以,在针对术后病人胃肠功能障碍(PGID)的干预方案探讨中,开发一些食用方式得当、食用时间适宜、营养组分合理的肠内“营养制剂”越来越受到普通外科手术医疗工作者和特殊医学用途配方食品开发者们的关注和重视,对于改善术后患者胃肠功能紊乱状况,尤其针对肠梗阻、腹腔粘连、术后延迟性肠麻痹等具有重要影响和研究价值。
同时,开发一种适用于手术后肠梗阻、腹腔粘连及术后延迟性肠麻痹等胃肠功能障碍的专用、安全性肠内营养制剂是极其必要的,是医疗工作者判断手术顺利与否、患者是否恢复胃肠功能并依赖肠内营养干预方式顺利进食的关键所在。
发明内容
本发明所要解决的技术问题在于提供一种适用于术后胃肠功能障碍(PGID)恢复的肠内营养制剂。
本发明所要解决的另一技术问题在于提供上述适用于术后胃肠功能障碍恢复肠内营养制剂的制备方法。
为解决上述技术问题,本发明的技术方案是:
一种适用于术后胃肠功能障碍恢复的肠内营养制剂,功效成分由番泻叶提取物、益生菌(乳双歧杆菌、嗜酸乳杆菌、德氏乳杆菌)、益生元(低聚果糖、低聚半乳糖、低聚木糖)、复合维生素、复合电解质组成,按其重量份数计益生菌1-5份、番泻叶提取物3-10份,益生元60-80份、复合维生素0.05-5份、复合电解质0.05-5份;
其中,所述复合维生素由维生素B1、维生素B3、维生素B6组成,各组分按重量份数计维生素B1 0.01-0.05份、维生素B3 0.1-0.5份、维生素B6 0.01-0.05份(各维生素所占份数关系为复合维生素中各组分的份数关系);所述复合电解质由氯化钠、氯化钾组成,各组分按重量份数计氯化钠0.1-5份、氯化钾0.1-0.5份(各电解质所占份数关系为复合电解质中各组分的份数关系)。
优选的,上述适用于术后胃肠功能障碍恢复的肠内营养制剂,所述番泻叶提取物为水提物,其中番泻叶甙A+B的含量为20%-30%。
优选的,上述适用于术后胃肠功能障碍恢复的肠内营养制剂,所述益生菌可以是乳双歧杆菌、嗜酸乳杆菌、植物乳杆菌、德氏乳杆菌、青春双歧杆菌、嗜热链球菌中的一种或任意几种,菌活数5-15亿cfu/g。
优选的,上述适用于术后胃肠功能障碍恢复的肠内营养制剂,所述益生元可以是低聚果糖、低聚半乳糖、低聚木糖、菊粉、L-阿拉伯糖中的一种或任意几种组合。
优选的,上述适用于术后胃肠功能障碍恢复的肠内营养制剂,还可以加入食品辅料,为增稠剂、甜味剂的任意组合,所述食品辅料中增稠剂为黄原胶、阿拉伯胶中的一种或两种组合。
优选的,上述适用于术后胃肠功能障碍恢复的肠内营养制剂,所述食品辅料在终成品中按重量份数计为:黄原胶0.5-1份、阿拉伯胶0.5-1份、甜菊糖苷0.05-0.5份。
上述适用于力量速度型运动的机能强化剂的制备方法,具体步骤如下:
(1)按组方量称取各组分备用;
(2)将各组分在三维混料罐中利用等量递增法进行预混、总混、铝箔袋背封罐装及成品封装组合。
本发明的有益效果是:
上述适用于术后胃肠功能障碍(PGID)恢复的肠内营养制剂,解决了术后肠道功能障碍中的肠道不排气、及延迟性肠麻痹等问题。本发明中的制剂通过复合益生菌、益生元及纯天然植物活性成分等协同效果,促进患者术后24小时内或24小时左右产生排气、并促进肠运动功能恢复,效果明显。
所述肠内营养制剂相对于现阶段各类制剂,其配方优势在于:
一、纯天然、植物提取,食品级、具有安全性;
二、使患者在24小时内、或24小时左右产生明显的肛门排气现象,有效促进肠蠕动,消除肠胀气,促进早排气,无腹痛腹泻,促进排气且有明显的效果;
三、使肠道菌群平衡化、正常化,不利于有害菌群的生长;防止便秘,促进肠道蠕动,从而改善延迟性肠麻痹,恢复肠道吸收功能,重建优质的肠道微生态环境。
正因为“肛门排气时间是胃肠道恢复正常蠕动的标志”,是肠道功能恢复的重要节点,所以,本发明就此为突破重点,为长期以来市面无安全高效渐变的肠内营养制剂提供科学的解决方案。
本发明中的肠内营养制剂作用效果快、明显,简便、患者无痛苦,能更准确、直接地通过优化排气时间和排气次数,辅助临床医生判断术后肠功能的恢复情况,并有效恢复肠道有益菌群优势、这无论是对医生判断病人身体状况、制定治疗恢复方案,还是患者增加营养、加快恢复,都具有重要意义,同时帮助患者更早的恢复出院。
具体实施方式
实施例1
一种适用于术后肠道功能障碍恢复的肠内营养制剂,由番泻叶提取物(番泻叶甙A+B 25%)、乳双歧杆菌、嗜酸乳杆菌、低聚果糖、低聚半乳糖、维生素B1、维生素B3、维生素B6、氯化钠、氯化钾组成,其中,番泻叶提取物25%0.1g、乳双歧杆菌0.05g、嗜酸乳杆菌0.05g、低聚果糖4g、低聚半乳糖1g、维生素B1 0.005g、维生素B3 0.05g、维生素B6 0.005g、氯化钠0.1g、氯化钾0.01g组成。
上述适用于术后肠道功能障碍恢复的肠内营养制剂的制备方法,具体步骤如下:(1)按组方量称取各组分备用;(2)将各组分在三维混料罐中利用等量递增法进行微量成分预混、总混、背封铝箔封装及成品封装。
实施例2
一种适用于术后肠道功能障碍恢复的肠内营养制剂,由番泻叶提取物(番泻叶甙A+B 30%)、德氏乳杆菌、嗜酸乳杆菌、低聚木糖、低聚半乳糖、维生素B1、维生素B3、维生素B6、氯化钠、氯化钾组成,其中,番泻叶提取物30%0.1g、德氏乳杆菌0.05g、嗜酸乳杆菌0.05g、低聚木糖3g、低聚半乳糖2g、维生素B1 0.005g、维生素B3 0.03g、维生素B60.005g、氯化钠0.1g、氯化钾0.01g。
制备方法同实施例1。
实施例3
一种适用于术后肠道功能障碍恢复的肠内营养制剂,由番泻叶提取物(番泻叶甙A+B 30%)、德氏乳杆菌、嗜酸乳杆菌、低聚木糖、低聚半乳糖、维生素B1、维生素B3、维生素B6、氯化钠、氯化钾组成,其中,番泻叶提取物30%0.1g、德氏乳杆菌0.05g、嗜酸乳杆菌0.05g、低聚木糖3g、低聚果糖2g、菊粉0.5g、维生素B1 0.005g、维生素B3 0.01g、维生素B6 0.005g、氯化钠0.1g、氯化钾0.05g。
制备方法同实施例1。
实施例4
一种适用于术后肠道功能障碍恢复的肠内营养制剂,由番泻叶提取物(番泻叶甙A+B 30%)、德氏乳杆菌、嗜酸乳杆菌、低聚木糖、低聚半乳糖、维生素B1、维生素B3、维生素B6、氯化钠、氯化钾组成,其中,番泻叶提取物20%0.1g、植物乳杆菌0.05、德氏乳杆菌0.05g、嗜酸乳杆菌0.05g、低聚木糖3g、低聚果糖2g、菊粉0.5g、维生素B1 0.005g、维生素B3 0.05g、维生素B6 0.003g、氯化钠0.01g、氯化钾0.05g。
制备方法同实施例1。
上述适用于肠道功能恢复的营养制剂中各组分均为市售食品级原材料,其中,所述食品级植物提取物为市售水提物。
综上,本发明提供的肠内营养制剂各组分配伍科学,纯天然、食品级、安全性高,使术后患者在24小时内、或24小时左右产生明显的肛门排气活动,有效促进肠蠕动,消除肠胀气,促进早排气,无腹痛腹泻且效果明显,同时帮助肠道菌群平衡化、正常化,防止便秘,从而改善延迟性肠麻痹,预防病变性肠梗阻及肠黏连等,恢复肠道应有功能。
试服试验
探讨营养制剂对术后肠道功能恢复中首次自主排气或排便时间的影响:
一、试验设计:
1、选取2018年3月-7月某市中医院普外科行择期腹腔镜患者作为研究对象。纳入病种及人群:阑尾炎、胆囊结石伴慢性胆囊炎、腹股沟疝及结直肠癌。共108例,其中男性56例,女性52例。年龄最小为20岁,最大为85岁,平均年龄约为53岁。
2、纳入标准及分组方法:A/年满18周岁行全麻下择期腹腔镜手术者;B/患者意识清晰,理解能力可,可清晰完整表达者;C/其他常规;排除标准及试验终止标准:略。采用SpSS22.0软件完成随机分组。将所纳入的108例患者:1-36为阴性对照组;37-72为实验组,73-108为合生元组。根据手术执行顺序分配入组,每组各36例。
3、制剂干预方案:实验组麻醉结束后患者清醒后6小时为其服用本配方制剂(实施例3中配方制剂,溶于50毫升40摄氏度,温开水冲服);益生元组(实施例3配方中除去番泻叶提取物及维生素、矿物质成分的配方制剂,同样溶于50毫升40摄氏度,温开水冲服)
4、阳性
二、测量方案:记录术后首次自主排气或排便时间。
时间标准:麻醉结束至患者首次排气或排便时间,以出现较早者为准。
操作方法:由患者自行记录,嘱患者术后回病房起,如有排气或排便第一时间嘱其家属记录下时间并告知护士。麻醉时间根据麻醉记录获取。计算出首次排气或排便时间,精确到分钟。
三、试验结果:术后首次自主排气或排便时间比较.
其中实验组和对照组相比,两组患者术后首次排气或排便时间比较,差异有统计学意义(F=18.927,P<0.01)。实验组、对照组、益生元组比较,实验组患者术后首次自主排气或排便时间较对照组明显缩短,差异均有统计学意义(P<0.01),见表1。
表1.术后首次自主排气或排便时间比较(h,±s)
组别 | 例数 | 术后首次自主排气或排便时间 |
实验组 | 36 | 24.84±8.05 |
对照组 | 35 | 35.08±6.51 |
益生元组 | 35 | 35.42±4.74 |
F | 18.927 | |
P | 0.004 |
在该试服试验中,使用本发明所述肠内营养制剂,可以明显降低术后首次自主排气、排便时间。若术后不能及时排气,不仅影响患者术后进食时间、营养支持、生活质量,若不及时处理或将导致肠粘连、肠梗阻等严重并发症,加重患者病情,延长住院时间,増加医疗负担与患者经济负担。
其次,科学界普遍认知益生菌与益生元(即能被益生菌利用的养分)在制剂配方中相互协同,对于提升益生菌群优势及对人体康复是有积极意义。但对于如本试验中的术后病人胃肠功能虚弱的特殊人群,“合生元组”(即未使用本发明中植物提取物成分制剂进行干预的患者),与对照组相比在排气、排便情况的差异不大。所以本发明中制剂组分的协同配合效果,是可观的。
可见,排气(肛门排气)时间是胃肠道恢复正常蠕动的标志,是肠道功能恢复的重要节点,是医生判断术后身体状况的重要指标,也是患者开始恢复饮食的必要前提。其方便观察,能够直观准确的反应术后患者身体状况,所以,及时排气无论是对医生判断病人身体状况、制定治疗恢复方案,还是患者增加营养、加快恢复,都具有重要意义。
实际上,因为早期小量口服饮食能使大部分患者能耐受,并且能明显缩短术后肠麻痹恢复时间,所以,对于大多数肠蠕动不能自动恢复(肛门排气)的患者来说,首选安全、高效的肠内营养制剂是极其重要的。《加速康复外科中国专家共识及路径管理指南(2018版)》也指出:择期腹部手术术后尽早恢复经口进食、饮水及早期口服辅助营养可促进肠道运动能恢复,有助于维护肠黏膜功能,防止菌群失调和异位,还可以降低术后感染发生率及缩短术后住院时间。
本申请针对术后患者临床上普遍易出现的肠道功能紊乱、肠道运动功能障碍现状,开发的一种有效的营养干预制剂及其制备技术,方便有效且无副作用。制备出的肠内营养制剂能有效地改善术后患者胃肠功能紊乱、对预防术后肠梗阻、腹腔粘连、病人长时间不排气、加速术后病人营养状况恢复和疾病康复、以及缩短住院时间具有重要临床意义。
上述参照具体实施方式对该种术后胃肠功能障碍(PGID)恢复的肠内营养制剂及其制备方法进行的详细描述,是说明性的而不是限定性的,可按照所限定范围列举出若干个实施例,因此在不脱离本发明总体构思下的变化和修改,应属本发明的保护范围之内。
Claims (6)
1.一种适用于术后胃肠功能障碍恢复的肠内营养制剂,其特征在于:功效成分由番泻叶提取物、乳双歧杆菌、嗜酸乳杆菌、德氏乳杆菌、低聚果糖、低聚半乳糖、低聚木糖、复合维生素和复合电解质组成,按其重量份数计番泻叶提取物3-10份,益生菌1-5份、益生元60-80份、复合维生素0.05-5份、复合电解质0.05-5份;
其中,所述复合维生素由维生素B1、维生素B3、维生素B6组成,各组分按重量份数计维生素B1 0.01-0.05份、维生素B3 0.1-0.5份、维生素B6 0.01-0.05份;所述复合电解质由氯化钠和氯化钾组成,各组分按重量份数计氯化钠0.1-5份、氯化钾0.1-0.5份。
2.根据权利要求1所述的术后胃肠功能障碍恢复的肠内营养制剂,其特征在于:所述番泻叶提取物为水提物,其中番泻叶甙A+B的含量为20%-30%。
3.根据权利要求1所述的术后胃肠功能障碍恢复的肠内营养制剂,其特征在于:所述益生菌为乳双歧杆菌、嗜酸乳杆菌、植物乳杆菌、德氏乳杆菌、青春双歧杆菌、嗜热链球菌中一种或任意几种,菌活数5-15亿cfu/g。
4.根据权利要求1所述的术后胃肠功能障碍恢复的肠内营养制剂,其特征在于:益生元是低聚果糖、低聚半乳糖、低聚木糖、菊粉、L-阿拉伯糖中的一种或任意几种组合。
5.根据权利要求1所述的术后胃肠功能障碍恢复的肠内营养制剂,其特征在于:还包括食品辅料,所述食品辅料为增稠剂、甜味剂的任意组合,所述食品辅料中增稠剂为黄原胶、阿拉伯胶中的一种或两种组合。
6.权利要求1所述的肠内营养制剂的制备方法,具体步骤如下:
(1)按组方量称取各组分备用;
(2)将各组分在三维混料罐中利用等量递增法进行预混、总混、铝箔袋背封罐装及成品封装组合。
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