CN113768983A - 含有苦杏仁的组合物及其制备方法和用途 - Google Patents
含有苦杏仁的组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明提供了一种含有苦杏仁的组合物及其制备方法和用途。所述组合物可用于制备促进润肠通便功效的休闲食品、保健品或药物。本发明组合物由苦杏仁、陈皮原料或者原料的提取物组成,配比为陈皮7‑35重量份,苦杏仁2‑10重量份。组合物可与稀释剂0‑77.42份重量份,和/或酸味剂0‑0.1份重量份,和/或香精0‑0.5重量份进一步制备成固体饮料、液体饮料、合剂、煎膏剂、散剂、片剂、胶囊剂、颗粒剂、丸剂、口服液等药学/食品上可接受的口服形式。本发明的组合物,因与陈皮配伍口感更佳、质量可控,且润肠通便效果显著,对排便次数减少、粪便干硬、排便不畅等情况有明显的改善作用。
Description
发明领域
本发明属于医药和保健食品领域,具体地,本发明提供了一种含有苦杏仁的组合物及其制备方法和用途。
背景技术
由于现代人们生活节奏快,精神压力大、长期久坐、饮食失衡及环境变化等因素,导致排便困难,对健康的危害较为严重,若不及时缓解可能会加重肠胃功能紊乱。排便困难主要表现为排便次数减少、粪便干硬、排便不畅等,在全球范围内发生广泛,故研制一款可缓解排便困难的健康产品具有广阔的市场前景。
常见具有润肠通便功能的中药材有番泻叶、大黄、决明子、荷叶、瓜萎仁、苦杏仁等,其中苦杏仁作为宁夏特色中药材,于2002年被国家卫生健康委员会收录于《按照传统既是食品又是中药材物质目录》。
苦杏仁始载与《神农本草经》,为蔷薇科植物山杏、西伯利亚杏、东北杏的干燥成熟种子,主治润肠通便、降气止咳平喘,用于肠燥便秘、咳嗽气喘、血虚津枯。苦杏仁中富含有多种人体必需氨基酸、矿物质元素及维生素,主要化学成分有苦杏仁苷、脂肪油、苦杏仁酶、苦杏仁苷酶、樱叶酶、多种维生素及矿物质元素等,国外一些研究表明苦杏仁中含有黄酮等多酚类成分。现代药理研究表明,苦杏仁具有镇咳平喘、润肠通便、抗炎、镇痛、抗肿瘤等药理作用。
陈皮首载于《神农本草经》,为芸香科柑橘属小乔木植物橘及其栽培变种的成熟果皮,其所含的化学成分较多,其中以黄酮类成分为主,此外还含有柠檬苦素类、生物碱类及挥发油类等。研究表明,陈皮中黄酮类成分有调节胃肠平滑肌运动、保肝、强心等药理作用。
但目前使用苦杏仁实际制备的保健品/药品,特别是只与陈皮配伍具有润肠通便作用的保健品/药品尚无先例,而本发明将苦杏仁与陈皮配伍所得的产品口感佳、质量可控,润肠通便效果更为显著。
发明内容
为了解决上述问题,本发明提供了一种含有苦杏仁的组合物及其制备方法和用途。
一方面,本发明提供了一种含有苦杏仁成分的组合物,其特征在于,包括以下重量份员原料或者原料的提取物:苦杏仁2-10重量份,陈皮7-35重量份,。更优选为:苦杏仁3-6重量份,陈皮10-20重量份。
进一步地,组合物还包含稀释剂0-77.42份重量份,和/或酸味剂0-0.1份重量份,和/或香精0-0.5重量份。
进一步地,所述组合物包含以下质量份数的原料:原料的提取物25.9份、稀释剂68.9份、酸味剂0.02份、香精0.03份。
进一步地,所述稀释剂选自甘露醇、木糖醇、果糖醇、山梨糖醇、麦芽糖醇、异麦芽酮糖醇、聚葡萄糖、糊精、乳糖、麦芽糊精、食用玉米淀粉、微晶纤维素或小麦粉中的一种或以上。
进一步地,所述酸味剂为选自柠檬酸、乳酸、磷酸、酒石酸、苹果酸、偏酒石酸、乙酸、盐酸、己二酸、富马酸、氢氧化钠、碳酸钾、碳酸钠、柠檬酸钠、柠檬酸三钾、碳酸氢三钠、柠檬酸一钠的一种或一种以上。
进一步地,所述香精为选品葡萄香精、哈密瓜香精、水蜜桃香精、橘子香精、苹果香精、柠檬香精、山楂香精、可乐香精、话梅香精中的一种或一种以上。
进一步地,所述稀释剂为乳糖和糊精的组合。
进一步地,所述酸味剂为柠檬酸。
进一步地,所述香精为柠檬香精。
进一步地,所述提取物为水提物。
进一步地,本发明同时提供了组合物的制备方法。其中,所述原料的提取物在提取方法中,提取溶剂用量为5-20倍,优选10-15倍,更优选15倍。
进一步地,提取次数为1-3次,优选2次。
进一步地,每次提取时间0.5-2h,优选1.5h。
进一步地,提取过程为将苦杏仁、陈皮以15倍水为溶剂提取2次,每次1.5h,合并提取液后浓缩干燥得到苦杏仁陈皮浸膏。
进一步地,组合物为固体饮料、液体饮料、合剂、煎膏剂、散剂、片剂、胶囊剂、颗粒剂、丸剂、口服液等药学/食品上可接受的口服形式,优选为固体饮料形式。
另一方面,本发明提供了上述组合物在制备有助于润肠通便的食品、保健品或药物中的用途。
进一步地,所述润肠通便包括促进小肠运动、增加粪便粒数及重量、缩短首粒排黑便时间。
本申请中的原料苦杏仁、陈皮可采用符合国家食品/药品要求的各种产地、品种的产品,不局限于宁夏、山西等地。
本申请的饮料、制剂中还可以根据形式/剂型的需要包含各种食品/药学可接受的辅料,包括但不限于包衣材料、溶剂、增溶剂、粘合剂、稳定剂、抗氧化剂、pH调节剂、矫味剂,这些辅料成分本领域技术人员可以根据食品/药剂学常识选用。
本申请的饮料、制剂中还可以根据需要加入各种已知或未知的有助于肠通便的药物/提取物/食物原材料成分或与这些成分联通,这些成分包括但不限于柏子仁、郁李仁、桃仁、甜杏仁、当归、魔芋、肉苁蓉、何首乌、决明子等。
发明人将充分利用苦杏仁的保健功效,结合陈皮开发了一款含有药食同源中药材的具有润肠通便功能的健康食品。本发明使用的苦杏仁、陈皮为药食同源中药材,安全可靠。实验证明将这些原料经科学合理配伍后组合在一起,对排便次数减少、粪便干硬、排便不畅等情况有明显的改善作用。
附图说明
图1为受试物对小肠蠕动抑制模型小鼠肠推进率的影响(x±SE,n=8),与空白组比较:***P<0.001;与模型组比较:##P<0.01,###P<0.001。
图2为受试物对小鼠便秘模型首粒排黑便时间的影响(x±SE,n=8),与空白组比较:***P<0.001;与模型组比较:##P<0.01,###p<0.001。
图3为受试物对小鼠便秘模型5h内粪便粒数的影响(x±SE,n=8),与空白组比较:***P<0.001;与模型组比较:##P<0.01,###P<0.001。
图4为受试物对小鼠便秘模型5h内粪便重量的影响(x±SE,n=8),与空白组比较:***P<0.001;与模型组比较:##P<0.01,###P<0.001。
具体实施方式
下面结合具体实施例详述本发明,但本发明的保护范围不局限于以下实施例。
实施例1
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取2次,每次1.5h,溶剂量为5倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.2g柠檬酸,0.3g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例2
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取1次,每次1h,溶剂量为15倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.2g柠檬酸,0.3g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例3
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取2次,每次1.5h,溶剂量为10倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.2g柠檬酸,0.3g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例4
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取3次,每次1.5h,溶剂量为5倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.2g柠檬酸,0.3g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例5
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取2次,每次1.5h,溶剂量为15倍,合并提取液,浓缩后制成相对密度约1.40的膏剂,包装即得。
实施例6
将苦杏仁6g、陈皮共20g,以纯水为溶剂,提取1次,每次1.5h,溶剂量为5倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.4g柠檬酸,0.6g柠檬香精,以纯水制软材,过14目筛制粒,干燥后加入硬脂酸镁,压片,制成片剂,包装即可。
实施例7
将苦杏仁6g、陈皮共20g,以纯水为溶剂,提取3次,每次1.5h,溶剂量为10倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.2g柠檬酸,0.3g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例8
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取2次,每次1.5h,溶剂量为15倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.2g柠檬酸,0.3g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例9
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取3次,每次1h,溶剂量为10倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏25.85g,加入46.10g乳糖,22.83g糊精,0.2g柠檬酸,0.3g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例10
将苦杏仁6g、陈皮20g,以纯水为溶剂,提取2次,每次1.5h,溶剂量为10倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏12.93g,加入23.05g乳糖,11.42g糊精,0.1g柠檬酸,0.15g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例11
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取2次,每次1.5h,溶剂量为5倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏12.93g,加入23.05g乳糖,11.42g糊精,0.1g柠檬酸,0.15g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例12
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取2次,每次1.5h,溶剂量为10倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏12.93g,加入23.05g乳糖,11.42g糊精,0.1g柠檬酸,0.15g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例13
将苦杏仁3g、陈皮10g,以纯水为溶剂,提取3次,每次1.5h,溶剂量为5倍,合并提取液,浓缩后进行干燥,得到提取物浸膏;取提取物浸膏12.93g,加入23.05g乳糖,11.42g糊精,0.1g柠檬酸,0.15g柠檬香精,以纯水制软材,过14目筛制成颗粒,干燥后制成固体饮料。
实施例14
本实施方式所述的一种含有苦杏仁的组合物及制备方法制备的含苦杏仁的健康食品,对实施例8所制备的产品进行小鼠安全性和通便功能实验,经实验初步证明,实施例8所制备的产品颗粒颜色大小均匀,性状稳定,服用和携带方便,口感较其他实施例好;
(1)动物最大耐受量安全性检测实验
筛选雌雄小鼠各20只,体重范围为18-22g雌雄分笼饲养。根据一次性最大灌胃法,将小鼠放置于实验环境下适应2-3d。实验前,将小鼠禁食不禁水12h,以含有苦杏仁的固体饮料以最大溶解度所配置的溶液对小鼠进行最大灌胃体积(0.4mL/10g)灌胃一次,连续观察一周,记录小鼠体重、毛发、是否中毒及死亡情况。
实验结果:以最适宜溶解度(1.50g/mL)及灌胃量(0.4mL/10g)给予小鼠含有苦杏仁的固体饮料,一周后:小鼠体重变化在正常范围内,毛发、摄食量均正常,未见中毒、死亡现象,各大主要脏器检查后均无明显异常变化,说明本发明对ICR雌雄小鼠最大耐受量大于60.0g/kg·bw,属于无毒级。
(2)产品润肠通便的功效实验
实验动物:清洁级ICR健康雄性小鼠,体重范围18-22g。本实验将动物分为2个实验组(1组进行小肠运动实验、2组进行首粒排黑便时间、5h内粪便数量、5h内粪便重量实验),每个实验组均将50只小鼠随机分成5个小组,每组10只动物。
剂量选择及给药途径:除去空白对照组及模型对照组外,设定三个剂量组,分别为:低剂量组(6.0g/kg·BW),中剂量组(12.0g/kg·BW)、高剂量组(18.0g/kg·BW)。受试物用纯化水配置,每日称重,并按体重经口灌胃(0.2mL/10g),连续7d,均喂养基础饲料,正常给水。
a)小肠运动实验
实验方法:给予受试物7天后,各组禁食不禁水16h,除空白对照组除外,其余各组给予复方地芬诺酯溶液(5mg/kg·BW),0.5h后,空白对照组和模型对照组给予墨汁,低、中、高剂量组分别给予含相应受试物的墨汁,25min后拖颈处死取肠管,分离自幽门至回盲肠部肠管,计算墨汁推进率。
实验结果:如图1所示,与空白对照组相比,模型对照组肠推进率明显缩短,表明模型对照组造模成功;与模型对照组相比,低、中、高剂量组肠推进率明显增加,表明供试物可以增加由复方地芬诺酯造成的小肠蠕动抑制模型小鼠肠推进率。
b)首粒排黑便时间、5h内粪便数量、5h内粪便质量实验
实验方法:给予受试物7天后,各组禁食不禁水16h,除空白对照组除外,其余各组给予复方地芬诺酯溶液(10mg/kg·BW),0.5h后,空白对照组和模型对照组给予墨汁,低、中、高剂量组分别给予含相应受试物的墨汁,自灌墨汁开始,记录每只小鼠首粒排黑便时间、5h内粪便重量及粪便粒数。
实验结果1:如图2所示,与空白对照组相比,模型对照组首粒排黑便时间明显延长,表明模型对照组造模成功;与模型对照组相比,低、中、高剂量组首粒排黑便时间显著缩短,表明供试物可以缩短由复方地芬诺酯造成的小肠便秘模型小鼠首粒排黑便时间。
实验结果2:如图3所示与空白对照组相比,模型对照组5h内粪便粒数明显减少,表明模型对照组造模成功;与模型对照组相比,低、中、高剂量组5h内粪便粒数显著增加,表明供试物可以增加由复方地芬诺酯造成的小肠便秘模型小鼠5h内粪便粒数。
实验结果3:如图4所示。与空白对照组相比,模型对照组5h内粪便重量明显减少,表明模型对照组造模成功;与模型对照组相比,低、中、高剂量组5h内粪便重量显著增加,表明供试物可以增加由复方地芬诺酯造成的小肠便秘模型小鼠5h内粪便重量。
Claims (17)
1.一种含有苦杏仁的组合物,其特征在于,包括以下重量份原料或者原料的提取物:苦杏仁2-10重量份,陈皮7-35重量份。
2.根据权利要求1所述的组合物,其特征在于,包括以下重量份原料或者原料的提取物:苦杏仁3-6重量份,陈皮10-20重量份。
3.根据权利要求1或2所述的组合物,其中所述组合物还包含稀释剂0-77.42份重量份,和/或酸味剂0-0.1份重量份,和/或香精0-0.5重量份。
4.根据权利要求3所述的组合物,其中所述稀释剂选自甘露醇、木糖醇、果糖醇、山梨糖醇、麦芽糖醇、异麦芽酮糖醇、聚葡萄糖、糊精、乳糖、麦芽糊精、食用玉米淀粉、微晶纤维素或小麦粉中的一种或以上;所述酸味剂为选自柠檬酸、乳酸、磷酸、酒石酸、苹果酸、偏酒石酸、乙酸、盐酸、己二酸、富马酸、氢氧化钠、碳酸钾、碳酸钠、柠檬酸钠、柠檬酸三钾、碳酸氢三钠、柠檬酸一钠的一种或一种以上;所述香精为选品葡萄香精、哈密瓜香精、水蜜桃香精、橘子香精、苹果香精、柠檬香精、山楂香精、可乐香精、话梅香精中的一种或一种以上。
5.根据权利要求4所述的组合物,其中所述组合物包含:原料的提取物25.9份、稀释剂68.9份、酸味剂0.02份、香精0.03份。
6.根据权利要求5所述的组合物,其中所述稀释剂为乳糖和糊精的组合;所述酸味剂为柠檬酸;所述香精为柠檬香精。
7.根据权利要求6所述的组合物,其中按照总质量百分数计,包含的乳糖为46.1%、糊精为22.8%,柠檬酸为0.2%,柠檬香精为0.3%。
8.根据权利要求1或2所述的组合物,还包含各种食品/药学可接受的辅料,包括但不限于包衣材料、溶剂、增溶剂、粘合剂、稳定剂、抗氧化剂、pH调节剂、矫味剂。
9.根据权利要求1-8中任一项所述的组合物,还可以根据需要加入有助于肠通便的其它原材料成分或其提取物。
10.根据权利要求9所述的组合物,所述原材料包括但不限于柏子仁、郁李仁、桃仁、甜杏仁、当归、魔芋、肉苁蓉、何首乌、决明子。
11.根据上述任一权利要求所述的组合物,其特征在于,其中所述原料的提取物为水提物。
12.根据上述任一权利要求所述的组合物的制备方法,其特征在于,其中所述提取物的制备过程中,提取溶剂用量为5-20倍;提取次数为1-3次,;每次提取时间为0.5-2h。
13.根据权利要求12所述的组合物的制备方法,其特征在于,所述提取溶剂为水,提取溶剂用量为10-15倍。
14.根据权利要求12所述的组合物的制备方法,其中提取过程为将苦杏仁、陈皮以15倍水为溶剂提取2次,每次1.5h,合并提取液后浓缩干燥得到提取物在60℃、25MPa条件下进行均质处理后,将提取液浓缩或浓缩干燥,得到提取物浸膏。
15.根据权利要求1-11任一项所述的组合物或权利要求12-14所述制备方法制备得到的组合物,所述组合物为药学/食品上可接受的口服形式,包括固体饮料、液体饮料、合剂、煎膏剂、散剂、片剂、胶囊剂、颗粒剂、丸剂、口服液。
16.根据上述任一项权利要求所述的组合物在制备有助于润肠通便的保健品、食品或药物中的用途。
17.根据权利要求16所述的用途,其中所述润肠通便包括促进小肠运动、增加粪便粒数及重量、缩短首粒排黑便时间。
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