CN116407585A - 一种缓解老年习惯性便秘的药食同源中药组合物及其应用 - Google Patents
一种缓解老年习惯性便秘的药食同源中药组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种缓解老年习惯性便秘的药食同源中药组合物及其应用，该药食同源中药组合物按质量份数计包含由以下中药原料制备得到：火麻仁5‑15重量份、枳子1‑5重量份、杏仁1‑5重量份，特别是由火麻仁10重量份、枳子3重量份、杏仁3重量份组成的药食同源中药组合物辅以肠道益生元得到一种缓解由肠胃燥热、脾津不足引起的老年习惯性便秘症状的药食同源饮品，在改善原药材口感的同时，能够增效减毒，更好更快吸收；调理肠道，保持肠道微生态平衡；缓解大便干结难解的症状，改善体质，简便易食，适应现代人的养生需求。
Description
技术领域
本发明属于中药技术领域，具体涉及一种缓解老年习惯性便秘的药食同源中药组合物及其应用。
背景技术
便秘一词在中医很多古籍均有相关记载及论述，便秘之症首见于《黄帝内经》，其称便秘为“后不利”、“大便难”；汉代张仲景所著《伤寒杂病论》称便秘为“脾约”，同时也提出便秘的4种不同发病机制：虚、实、寒、热等，并相应设立麻子仁丸、承气汤、大黄附子汤、厚朴三物汤及蜜煎导等治疗方法，为便秘开创辨证论治的先河；《景岳全书·秘结篇》将便秘分为阳结、阴结，而“便秘”一名首见于清代沈金鏊所著《杂病源流犀烛》，并沿用至今。
老年习惯性便秘指的是60岁以上的老年人患有的长期或慢性功能性便秘，由于多种原因导致的非器质性排便减少，患者出现排便困难、干燥和黏滞等症状，症状达到12周以上。习惯性便秘会引发腹胀、痔疮、肛裂、脱肛及直肠癌和肛裂等，严重者甚至会出现脑血管意外。老年习惯性便秘的临床治疗中，常采取比沙可啶、酚酞片(果导片)、开塞露等药物进行对症治疗，但是会增加患者对药物的依赖性，且治疗安全性较有限。便秘属于临床中较为常见的疾病，尤其是在近年来饮食和生活习惯不断变化的背景下，我国便秘患者人数明显增加，相关调查表明，我国的老年人便秘患者数量达到18％–28％，由于年龄的增长，肠胃功能逐渐减退，便秘发生率更高。
便秘不仅可作为一个独立的疾病，也可作为其他疾病的主症或伴随症状。尽管慢性便秘不会对生命健康产生直接威胁，但会增加心脑血管疾病及肠癌等疾病发生的风险，长期便秘会带来巨大的危害，采取及时有效的防控和诊治手段，控制慢性便秘的发生和发展对患者身心健康至关重要。国内对于便秘进行深入研究的资料相对较少，加之患者长期擅自使用非处方药物治疗，导致慢性便秘临床治疗中的难度较大，很多患者转诊多家医院仍旧无法得到有效治疗。从目前慢性便秘治疗较为严峻的现状可以看出，对慢性便秘进行有效治疗，需要首先明确疾病的流行病学特征，了解引发便秘的原因及慢性便秘发生的生理病理基础，西医治疗老年习惯性便秘，主要是使用泻药、胃肠动力药及盐水灌肠等方式，治疗无效患者实施外科手术治疗，而传统中医药在治疗便秘方面有着悠久的历史，中医重视整体观念，注重辨证论治，积累丰富的经验，以其不良反应小、有效率高的优势在便秘治疗方面日趋受到重视。
中医理论认为便秘的发生是由于大肠正常传导功能减退或是丧失，导致粪便停留在大肠，水分被吸收，进而使得粪便干结，并且其发生和脾肺、肝脏等器官功能失调具有密切关系。根据患者的病情病症，从其证型出发实施针对性的辩证治疗，能够促进治疗效果的提升。《伤寒论·辨阳明病脉证并治》：“趺阳脉浮而涩，浮则胃气强，涩由小便数，浮涩相搏，大便则硬，其脾为约，麻子仁丸主之。”，本证多由胃有燥热，脾津不足所致，治疗以润肠泻热，行气通便为主。在老年习惯性便秘的临床治疗中，合理使用麻子仁丸进行治疗能够使患者的临床症状得到显著改善，患者的排便情况能够显著优化，并且能够促进患者抑郁情绪的缓解，提升患者的生活质量。
综上，尽管中医药治疗便秘具有较多的治疗方法及较好疗效，包括中药内服、针刺、艾灸、中药敷贴疗、耳针等疗法，但以上疗法不够便捷，如汤剂药味多辛、苦难饮，煎煮方法耗时费力，且不方便取食，外治疗法大多属于有创操作对实施者技术要求较高，引起患者长期诊治的依从性下降，绝大部分老年人及儿童因为中药特有的苦味口感、涩味嗅觉对于中药产品的饮用、食用存在一定的心理排斥，故该类中医药治疗产品一直无法大量普及推广。
发明内容
针对现有技术的上述不足，本发明的主要目的是提供一种缓解老年习惯性便秘的药食同源中药组合物，以火麻仁、枳子、杏仁多种道地药食同源药材为主要原料，同时辅以肠道益生菌对药食同源药材进行长时间转化，用于开发一种缓解由肠胃燥热、脾津不足引起的老年习惯性便秘症状的药食同源饮品。
本发明的另一目的是提供一种缓解老年习惯性便秘的药食同源饮品，其包含所述缓解老年习惯性便秘的药食同源中药组合物，缓解大便干结难解的症状。
为实现上述目的，本发明采用如下技术方案：
本发明提供一种缓解老年习惯性便秘的药食同源中药组合物，按质量份数计包含由以下中药原料制备得到：火麻仁5-15重量份、枳子1-5重量份、杏仁1-5重量份，所有中药药材均在原国家卫生部规定的药食同源目录大全中药食两用名单(2020版)内，其中麻子仁性味甘平，质润多脂，功能润肠通便，是为君药；杏仁上肃肺气，下润大肠为臣；枳子以轻下热结，除胃肠燥热为佐，全方共奏润肠泻热，行气通便。
作为优选，所述药食同源中药组合物由以下原料制备得到：火麻仁10重量份、枳子3重量份、杏仁3重量份。
本发明还提供所述缓解老年习惯性便秘的药食同源中药组合物在制备缓解老年习惯性便秘的药食同源产品中的应用。
本发明还提供一种缓解老年习惯性便秘的药食同源饮品，其包含所述缓解老年习惯性便秘的药食同源中药组合物，还包括常规剂量的代糖、柠檬酸钠、果粉、低GI值物料和益生元。
作为优选，所述低GI值物料选自赤藓糖醇和/或异麦芽酮糖；所述益生元选自低聚木糖、低聚异麦芽糖、低聚果糖中的至少一种。
作为优选，所述药食同源饮品通过所述药食同源中药组合物的有效成分经提取后的混合物与天然果汁、低GI值物料和益生元混配得到。
本发明的药食同源饮品通过所述药食同源中药组合物辅以调节肠道的益生元共同起到润肠泻热、行气通便的作用，药食价值高，口感丰富、方便饮用，更能适应现代人的需求。
作为优选，所述药食同源饮品的制备方法，包括：
步骤一、中药提取工艺流程包括：中药饮片称重配药→10倍常温水浸泡→萃取→过滤→浓缩→中药浓缩汁；
分别采取低温研磨、浸提浓缩二种工艺方式进行原料药材处理：
(1)低温研磨：四倍水量加入药材中冷浸，整体加入胶体磨中进行低温研磨；
(2)浸提浓缩：十倍水量常温浸泡，熬煮，过滤，真空浓缩，得到中药浓缩汁；其中真空浓缩条件：真空度为65-75kPa、浓缩温度55-60℃、浓缩时间5-8h；
步骤二、饮品制作工艺流程包括：配料→溶胶→熬胶→调配→调节pH→调香→灌装→后杀→风冷→检验→成品；
其中所述溶胶的制备过程为：将复配胶体、中药浓缩汁、代糖、柠檬酸钠、果粉、低GI值物料和益生元混合并过50目筛，加入到40-50℃的热水中，搅拌15min，使其混合均匀并充分溶胀，加热温度为80-90℃，时间为45-50min，完全溶解的胶溶液过100目滤布；
所述调配、灌装、杀菌的过程为：调配罐降温至70℃保温，搅拌状态下进行调酸调香，搅拌均匀后趁热灌装、封口，杀菌温度为85℃，时间为20min，冷水冷却，风淋干燥，即得。
作为优选，所述药食同源饮品由火麻仁10重量份、枳子3重量份、杏仁3重量份和常规剂量的西梅浓缩汁、益生元浓缩液、聚葡萄糖、DL-苹果酸、柠檬酸、山梨酸钾组成。
与现有技术相比，本发明的有益效果在于：
1、本发明中药食同源中药组合物临床证明具有润肠泻热、行气通便之效作用，通过饮品制备工艺与具有良好临床疗效的中药复方的中药提取工艺相结合，开发一种口感适宜且具有润肠通便功效的功能性保健饮品，缓解大便干结难解的症状，改善体质，简便易食，更能适应现代人的养生需求。
2、本发明的药食同源饮品在改善原药材口感的同时，能够增效减毒，更好更快吸收；采用天然果汁进行调味，不额外添加蔗糖等引起血糖升高的糖类物质，采用赤藓糖醇、异麦芽酮糖等低GI值物料调配口感；添加低聚木糖、低聚异麦芽糖、低聚果糖等益生元能很好的调理肠道，保持肠道微生态平衡；不含有防腐剂、甜味剂、人工色素，开发出一种润肠通便的饮品，适用于缓解肠胃燥热、脾津不足引起的习惯性便秘症状。
附图说明
图1为实施例中缓解老年习惯性便秘的药食同源饮品的制备工艺流程图。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面结合实施例对本发明的技术方案进行清楚、完整地描述。显然，所描述的实施例是本发明的一部分实施例，而不是全部的实施例。基于所描述的本发明的实施例，本领域普通技术人员在无需创造性劳动的前提下所获得的所有其它实施例，都属于本发明保护的范围。
实施例1
1 材料与方法
1.1 材料
(1)中药材：火麻仁10g、枳子3g、杏仁3g、西梅浓缩汁(10％)、益生元浓缩液、聚葡萄糖、DL-苹果酸、柠檬酸、山梨酸钾，添加西梅浓缩汁等营养果蔬及多种益生菌调节肠道，具有润肠通便的功效，符合《中华人民共和国药典》，同时全部为卫计委发布的“药食同源原料目录+新资源食品原料”。
1.2实验方法
1.2.1中药提取工艺确认
分别采取传统煎煮、低温研磨、浸提浓缩三种工艺方式进行原料药材的处理。
(1)传统煎煮：三倍水量煎煮，蒸发至一倍水，过滤。
(2)低温研磨：四倍水量加入药材中冷浸，整体加入胶体磨中进行低温研磨。(3)浸提浓缩：十倍水量常温浸泡，熬煮，过滤，真空浓缩。
1.2.2生产工艺流程确认
1.2.2.1工艺流程
中药提取工艺流程：药食同源中药饮片验收→称重配药→10倍常温水浸泡→熬煮→过滤→浓缩→中药浓缩汁。
饮品制作工艺流程：辅料验收→配料→调配→调节pH→调香→灌装→后杀→风冷→检验→成品。
1.2.2.2中药饮片选购
在验收中药饮片时要根据原始的凭证，对中药饮片的名称、生产批号及日期、厂家、规格、外观形态、包装、数量等进行审核。
1.2.2.3浸提浓缩
真空浓缩条件：真空度为65～75kPa、浓缩温度55～60℃、浓缩时间5～8h。
1.2.2.4熬煮
将复配中药浓缩汁、果粉、柠檬酸钠等混合并过50目筛,加入到40～50℃的热水中,搅拌15min,使其混合均匀并充分溶胀,加热温度选择80～90℃,时间45～50min,完全溶解的溶液过100目滤布。
1.2.2.5调配、灌装、杀菌
调配罐降温至70℃保温，搅拌状态下进行调酸调香(用适量水溶解成溶液),搅拌均匀后趁热灌装、封口。杀菌温度为85℃,时间为20min，冷水冷却，风淋干燥，即得成品。
1.2.3中药浓缩汁参数确认
根据多次浓缩实验确认最适合后续工艺操作的中药浓缩汁参数，以可溶固形物含量和pH作为指标，评定浓缩终点。
1.2.4饮品配方调整
指标采用综合评分＝中药用量(20分)+滋味(20分)+口感(20分)+外观(20分)+气味(20分)，采用L9(34)正交表，通过感官综合评分，获得最佳配方组合。
2 质量评价指标
2.1 中药浓缩汁指标
(1)感官要求：中药汁应有的棕黑色，色泽均匀透亮；中药的酸、苦，味道纯正；无正常视力可见外来异物。
(2)理化指标要求：可溶固形物含量(20℃)≤30％；pH＝4.3±0.2。
微生物指标要求如表1：
表1：微生物限量
3饮品质量指标
感官要求：饮品应色泽均匀透亮；滋味酸甜，略带中药材的清苦，有果香；无正常视力可见外来异物。
理化指标要求：可溶固形物含量(20℃)＝22％±1％；pH＝4.0±0.2。
微生物指标要求如表2：
表2
4食品安全质量检测
4.1自测实验室货架期加速试验
设置37℃下0、15、30、45、90d，54℃下6、9、12、15d，以及室温下90、180、270d9组条件，观察并记录产品是否胀包、颜色、气味、口味、析水情况、微生物情况。
4.2委托第三方检测机构浓缩中药汁有效成分及中药饮品有效成品。
采用现代自动化发酵系统，模拟人体肠道环境，系统化、流程化、标准化发酵工艺，严格按照30多道工序，200多项控制节点，严苛流程控制，生产安全、有效、稳定、均一的现代医学产品。同时项目组突破性的改变传统中药熬煮的工艺，采用食品级别高度萃取方式将药食同源的中药方剂榨取出汤汁，经少批量测试，证实中药有效成分产出率大幅上升，经对比测试，使用熬煮工艺实现预定产量需消耗18kg的测试原材料，经过先进的食品工艺提升，预定产量消耗原材料降为6kg，此项突破性改变减少使用2/3原材料，实现预期产量及功效目标。
一、通过以下临床试验来观察和评价本发明的药食同源中药组合物在缓解老年习惯性便秘的临床疗效。
前期针对老年习惯性便秘在病房开展研究，共纳入28人，其中男12例，女16例，年龄60～86岁，平均年龄(74.75±3.76)岁，病程2个月至10年，平均病程(4.75±1.84)年。使用中药食同源饮品口服，7d为1个疗程，连续治疗2个疗程，之后停药观察2w。排便次数、通畅度及大便形态无任何改善为无效；排便次数3d内至少1次，大便质地软润、形态、颜色、排便畅通程度有所改善为有效；排便次数2d内至少1次，大便颜色形态正常，排便较为通畅，短期内便秘不易复发为显效；排便次数1d内1次，
大便通畅，大便形态正常为痊愈。总有效＝痊愈+显效+有效。治疗前后依据《中药新药临床研究指导原则》评估通便效果评分，主要从排便间隔、粪便性质和排便困难三个方面评估，分级为0～3分，分数越高，表示患者排便效果越差；研究组的治疗总有效率(92.86％；治愈15例、有效11例、未愈2例)治疗前后的排便间隔、粪便性质和排便困难评分均有明显差异(P＜0.05)。
表3：治疗前后通便效果评分(x±s，n＝28)
| 排便间隔 | 粪便性质 | 排便困难 | |
| 治疗前 | 2.25±0.74 | 2.25±0.65 | 2.52±0.48 |
| 治疗后 | 1.51±0.51 | 1.12±0.35 | 1.07±0.14 |
| P | 0.022 | 0.023 | 0.025 |
结论：上述临床研究结果表明，本实施例中药食同源饮品可以有效改善便秘的症状及实验室指标，经过多方调研及尝试和目前的测试反馈，拟进一步开发改良产品形态，将最终产品形态定位为饮品形态，开发形成成熟产品，实现市场销售。
二、临床效果
下面结合典型病例更具体地说明本发明的内容，并对本发明作进一步阐述，但这些典型病例绝非对本发明有任何限制。
表1
以实施例1制备的药食同源饮品临床应用如表1所示，在改善原药材口感的同时，能够增效减毒，更好更快吸收，保持肠道微生态平衡，在缓解肠胃燥热、脾津不足引起的习惯性便秘症状方面效果显著。
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应所述以权利要求的保护范围为准。
Claims (8)
1.一种缓解老年习惯性便秘的药食同源中药组合物，其特征在于，按质量份数计包含由以下中药原料制备得到：火麻仁5-15重量份、枳子1-5重量份、杏仁1-5重量份。
2.根据权利要求1所述缓解老年习惯性便秘的药食同源中药组合物，其特征在于，所述药食同源中药组合物由以下原料制备得到：火麻仁10重量份、枳子3重量份、杏仁3重量份。
3.权利要求1或2所述缓解老年习惯性便秘的药食同源中药组合物在制备缓解老年习惯性便秘的药食同源产品中的应用。
4.一种缓解老年习惯性便秘的药食同源饮品，其特征在于，其包含权利要求1或2所述缓解老年习惯性便秘的药食同源中药组合物，还包括常规剂量的代糖、柠檬酸钠、果粉、低GI值物料和益生元。
5.根据权利要求4所述缓解老年习惯性便秘的药食同源饮品，其特征在于，所述低GI值物料选自赤藓糖醇和/或异麦芽酮糖；所述益生元选自低聚木糖、低聚异麦芽糖、低聚果糖中的至少一种。
6.根据权利要求4所述缓解老年习惯性便秘的药食同源饮品，其特征在于，所述药食同源饮品通过所述药食同源中药组合物的有效成分经提取后的混合物与所述常规剂量的代糖、柠檬酸钠、果粉、低GI值物料和益生元混配得到。
7.根据权利要求6所述缓解老年习惯性便秘的药食同源饮品，其特征在于，所述药食同源饮品的制备方法，包括：
步骤一、中药提取工艺流程包括：中药饮片称重配药→10倍常温水浸泡→萃取→过滤→浓缩→中药浓缩汁；
分别采取低温研磨、浸提浓缩二种工艺方式进行原料药材处理：
(1)低温研磨：四倍水量加入药材中冷浸，整体加入胶体磨中进行低温研磨；
(2)浸提浓缩：十倍水量常温浸泡，熬煮，过滤，真空浓缩，得到中药浓缩汁；其中真空浓缩条件：真空度为65-75kPa、浓缩温度55-60℃、浓缩时间5-8h；
步骤二、饮品制作工艺流程包括：配料→溶胶→熬胶→调配→调节pH→调香→灌装→后杀→风冷→检验→成品；
其中所述溶胶的制备过程为：将复配胶体、中药浓缩汁、代糖、柠檬酸钠、果粉、低GI值物料和益生元混合并过50目筛，加入到40-50℃的热水中，搅拌15min，使其混合均匀并充分溶胀，加热温度为80-90℃，时间为45-50min，完全溶解的胶溶液过100目滤布；
所述调配、灌装、杀菌的过程为：调配罐降温至70℃保温，搅拌状态下进行调酸调香，搅拌均匀后趁热灌装、封口，杀菌温度为85℃，时间为20min，冷水冷却，风淋干燥，即得。
8.根据权利要求4所述缓解老年习惯性便秘的药食同源饮品，其特征在于，由火麻仁10重量份、枳子3重量份、杏仁3重量份和常规剂量的西梅浓缩汁、益生元浓缩液、聚葡萄糖、DL-苹果酸、柠檬酸、山梨酸钾组成。
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