CN114128882A - 具有润肠通便的苁蓉益生咀嚼片及其制备方法和应用 - Google Patents
具有润肠通便的苁蓉益生咀嚼片及其制备方法和应用 Download PDFInfo
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- CN114128882A CN114128882A CN202010925660.6A CN202010925660A CN114128882A CN 114128882 A CN114128882 A CN 114128882A CN 202010925660 A CN202010925660 A CN 202010925660A CN 114128882 A CN114128882 A CN 114128882A
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- Medicinal Preparation (AREA)
Abstract
本发明公开了一种具有润肠通便的苁蓉益生咀嚼片，包括以下按重量份计各组分：肉苁蓉干粉0.5‑10份、鼠李糖杆菌0.5‑5份、唾液乳杆菌0.5‑5份、山梨醇1‑5份、奶粉0.5‑1份、甘氨酸0.02‑0.05份、硬脂酸镁0.05‑0.1份及95％乙醇。本发明以肉苁蓉干粉为原料，添加鼠李糖杆菌，唾液乳杆菌，及其山梨醇，全脂奶粉，甘氨酸，硬脂酸镁等进行混合，压片制作成具有润肠通便的苁蓉益生咀嚼片，各原料之间相互配合作用具有良好的润肠通便作用，对便秘具有很好的预防和治疗作用。本发明将肉苁蓉与益生菌合用，加强肉苁蓉润肠通便功效，加入奶粉、山梨醇和甘氨酸代替糖调味，集味道、营养和功效于一体。
Description
技术领域
本发明涉及食品加工技术领域，更特别地，涉及一种具有润肠通便的苁蓉益生咀嚼片及其制备方法和应用。
背景技术
功能性便秘(functional constipation，FC)多由非器质性原因引起，临床上分为排空迟缓型、功能性出口梗阻型和混合型。功能性便秘是临床常见病与多发病。近年来由于膳食结构改变，精神和社会压力的增大，人们体力活动量减少以及社会老龄化程度的加快，便秘的全球发生率逐年增加。便秘可发生在任何年龄的人，但老年人便秘的比例较高，是青壮年的2～3倍。由于老年人肠功能减退等因素，且缺乏膳食纤维，水分吸收过少，造成体内缺水，排便动力不足，致使肠内食物残渣运行滞缓，引起功能性便秘。近年来研究表明，目前的西药对便秘的治疗具有快速、疗效好的特点，但对肠道蠕动缓慢以及以肠道功能紊乱为主的肠道整体功能调节，不能令人满意，且长期应用会产生有明显的不良反应，药物循环性的长期刺激肠道，易诱发肠道功能紊乱，反而会进一步加重便秘。临床显示，大约有20％～40％的功能性便秘会发结肠癌，危及患者生命。刺激性泻药包括蒽醌类、蓖麻油等，能直接刺激结肠黏膜而促进蠕动，减少肠腔水分吸收。对功能性便秘患者而言，可迅速缓解症状，但容易出现腹痛、电解质紊乱等不良反应，长期使用也有致癌风险。
因此，开发一种有干预缓解便秘作用，调节肠道整体功能，毒副作用低，且具有较高营养价值功能性食品是目前急需解决的问题。
目前，市场上常用于预防和治疗便秘的药物主要成分有硫酸镁、液体石蜡、甘油、大黄、番泻叶、巴豆等，虽然能达到迅速通便的作用，但对肠道内壁有较强的刺激作用，而且长期服用药物，破坏人体的自主排便功能，容易产生药物依赖性，还会损伤肠道的末梢神经，干扰肠道的正常功能，影响人体健康。
近年研究发现在缓解功能性便秘方面，除了要改变饮食习惯的改变，建议在日常膳食中摄入足够的膳食纤维和水分、适当补充润肠通便功能食品如富含益生菌和益生元、维生素和植物性化学物质的食品或补充剂。
益生菌是一类对宿主有益的活性微生物，具有多种生物活性，广泛应用于食品、药品、保健品和动物饲料中。益生菌可以有效定植于人体肠道，可以抑制有害菌在肠内的繁殖，改善肠道菌群，减少毒素，保护肠道黏膜，促进肠道蠕动，从而提高肠道机能，改善排便状况，应用于预防和治疗功能性便秘。
中药肉苁蓉为列当科植物肉苁蓉Cisanche deserticola Y.C.Ma或管花肉苁蓉Cistanche tubulosa(Schenk)R.Wight干燥带鳞叶的肉质茎。其性温，味苦、咸，归肾、大肠经。具有补肾阳、益精血、润肠通便等功效。多用于肾阳不足、精血亏虚、阳痿***、腰膝酸软、筋骨无力、肠燥便秘。肉苁蓉属于润肠通便类中药，具有作用缓和、便而不泻的特点，尤其适合于老年人、产妇和身体虚弱等人群的便秘治疗。
发明内容
为解决以上技术问题，本发明以肉苁蓉干粉为原料，添加鼠李糖杆菌，唾液乳杆菌，及其山梨醇，全脂奶粉，甘氨酸，硬脂酸镁等进行混合，压片制作成具有润肠通便的苁蓉益生咀嚼片，属于功能性食品。且各原料之间相互配合作用具有良好的润肠通便作用，对便秘具有很好的预防和治疗作用。
为实现上述目的，本发明提供一种具有润肠通便的苁蓉益生咀嚼片，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉0.5-5份、鼠李糖杆菌0.5-5份、唾液乳杆菌0.5-5份、山梨醇1-5份、奶粉0.5-1份、甘氨酸 0.02-0.05份、硬脂酸镁0.05-0.1份及95％乙醇。
在本发明提供的具有润肠通便的苁蓉益生咀嚼片中，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉0.5-1份、鼠李糖杆菌0.5-1份、唾液乳杆菌0.5-1份、山梨醇1-2份、奶粉0.5-1份、甘氨酸0.02-0.05份、硬脂酸镁0.05-0.1份及95％乙醇。
在本发明提供的具有润肠通便的苁蓉益生咀嚼片中，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉4-5份、鼠李糖杆菌2-3份、唾液乳杆菌2-3份、山梨醇2-3份、奶粉0.5-1份、甘氨酸0.02-0.05份、硬脂酸镁 0.05-0.1份及95％乙醇。
在本发明提供的具有润肠通便的苁蓉益生咀嚼片中，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉10份、鼠李糖杆菌4-5份、唾液乳杆菌4-5份、山梨醇4-5份、奶粉0.5-1份、甘氨酸0.02-0.05份、硬脂酸镁 0.05-0.1份及95％乙醇。
本发明还提供用于制备如上所述的苁蓉益生咀嚼片的制备方法，包括以下步骤：
以鲜肉苁蓉为原料制备肉苁蓉冻干粉；
按比例称取鼠李糖杆菌、唾液乳杆菌、山梨醇、全脂奶粉、甘氨酸、硬脂酸镁，并混合加入所述肉苁蓉冻干粉，缓慢倒入95％的乙醇，制成湿混料；
将拌好的所述湿混料过筛进行制粒；
将制好的粒子放入45℃的恒温干燥箱中进行烘干、整粒；
加入硬脂酸镁充分摇匀后，放入单冲式压片机中压片，得到所述苁蓉益生咀嚼片。
在本发明提供的制备方法中，以鲜肉苁蓉为原料制备肉苁蓉冻干粉的所述步骤包括：
将鲜肉苁蓉作为肉苁蓉干粉的原料，切片，置于-80℃冰箱将肉苁蓉预冷24h后，置于真空冷冻干燥机中，干燥72h后取出，粉碎机粉碎，过100目的筛制的肉苁蓉冻干粉。
本发明还提供一种如上所述的苁蓉益生咀嚼片的在预防和治疗功能性便秘中的应用。
本发明的具有润肠通便的苁蓉益生咀嚼片及其制备方法和应用，具有以下有益效果：
(1)本发明精选道地产区肉苁蓉，采用冻干粉为原料成分温和，添加鼠李糖杆菌，唾液乳杆菌，及其山梨醇，奶粉，甘氨酸，硬脂酸镁等辅料，经混合、制粒、烘干、整粒、压片等一系列工艺制成，可直接食用；
(2)制粒过程中采用低温烘干的方法，不会破坏原料的营养成分；
(3)本发明选用纯天然的食材，用科学的配方，制造出能方便携带的咀嚼片，含有丰富的营养成分，肉苁蓉和益生菌之间相互配合作用，通过干预复方地芬诺酯诱导的便秘性小鼠模型，结果表明本发明的苁蓉益生咀嚼片增加便秘小鼠小肠推进，缩短首粒黑便排出时间，增加6h内的排便粒数，软化便秘小鼠的粪便，表现出典型的润肠通便功效。
具体实施方式
本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容更加透彻全面。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
应当理解本发明实施例以及实施例中的具体特征是对本申请技术方案的详细的说明，而不是对本申请技术方案的限定，在不冲突的情况下，本发明实施例以及实施例中的技术特征可以相互组合。
实施例1苁蓉益生咀嚼片1的制备
1.材料
所述实施例中所需要的菌株为鼠李糖杆菌(Lactobacillus rhamnosus)，保藏编号为CTCC6133；唾液乳杆菌(Lactobacillus salivarius)，保藏编号为 JCM1213，由广东省微生物菌种保藏中心提供，所需药材肉苁蓉采自内蒙古阿拉善，经北京大学屠鹏飞教授鉴定为荒漠肉苁蓉Cisanche deserticola Y.C.Ma 肉质茎。
2.实验方法
2.1.原料配比的确定
苁蓉益生咀嚼片1原料配比，按重量份计，取肉苁蓉干粉0.5-1份，添加鼠李糖杆菌0.5-1份，唾液乳杆菌0.5-1份，山梨醇1-2份，奶粉0.5-1份，甘氨酸 0.02-0.05份，硬脂酸镁0.05-0.1份，及其95％乙醇适量。
2.2.苁蓉益生咀嚼片的制备工艺
将鲜肉苁蓉作为肉苁蓉干粉的原料，切片，置于-80℃冰箱将肉苁蓉预冷 24h后，置于真空冷冻干燥机中(真空度600Pa、冷冻温度-56℃)，干燥72h 后取出，粉碎机粉碎，过100目的筛制的肉苁蓉冻干粉；按比例称取鼠李糖杆菌，唾液乳杆菌，山梨醇，全脂奶粉，甘氨酸，硬脂酸镁混合20min，缓慢倒入95％的乙醇，制成湿混料，将拌好的混合料过20目的筛子进行制粒；将制好的粒放入45℃的恒温干燥箱中进行烘干，整粒；先后过20目、80目筛子；向混料中加入0.05份的硬脂酸镁充分摇匀后，放入单冲式压片机中压片，即得产品苁蓉益生咀嚼片。将咀嚼片在紫外照射20min后进行装瓶，该实施例中试过程在潮州市和利坤食品有限公司车间完成，符合SC标准。
实施例2苁蓉益生咀嚼片2的制备
1.材料
所需材料与实施例1中所述相同。
2.实验方法
2.1.原料配比的确定
本实施例与实施例一不同仅在于，苁蓉益生咀嚼片2原料配比，按重量份计，包括肉苁蓉干粉4-5份，添加鼠李糖杆菌2-3份，唾液乳杆菌2-3份，山梨醇2-3份，奶粉0.5-1份，甘氨酸0.02-0.05份，硬脂酸镁0.05-0.1份，及其95％乙醇适量。
2.2.苁蓉益生咀嚼片的制备工艺
苁蓉益生咀嚼片2的制备方法如实施例1的制备方法所述。
实施例3苁蓉益生咀嚼片3的制备
1.材料
所需材料与实施例1中所述相同。
2.实验方法
2.1.原料配比的确定
本实施例与实施例一不同仅在于，苁蓉益生咀嚼片3原料配比，按重量份计，包括肉苁蓉干粉10份，添加鼠李糖杆菌4-5份，唾液乳杆菌4-5份，山梨醇4-5份，奶粉0.5-1份，甘氨酸0.02-0.05份，硬脂酸镁0.05-0.1份，及其95％乙醇适量。
2.2.苁蓉益生咀嚼片的制备工艺
苁蓉益生咀嚼片3的制备方法如实施例1的制备方法所述。
实施例4苁蓉益生咀嚼片营养成分测定
1.材料
苁蓉益生咀嚼片1，实施例一生产，批号S2020011701，苁蓉益生咀嚼片 2，实施例二生产，批号S2020011702，苁蓉益生咀嚼片3，实施例三生产，批号S2020011703。
2.实验方法
根据GB 28050-2011食品安全国家标准预包装食品营养标签通则，委托上海标检产品检测有限公司对三个实施例的苁蓉益生咀嚼片进行营养成分检测。蛋白质含量测定采用GB/T 5009.5-2016第一法；脂肪含量测定GB/T 5009.6-2016第一法；能量的定义采用GB/Z 21922-2008计算；钠含量测定采用GB/T 5009.91-2007第一法；水分含量测定采用GB/T5009.3-2016第一法；灰分含量测定采用GB/T 5009.3-2016第一法。
3.实验结果
3.1.苁蓉益生咀嚼片营养成分分析
苁蓉益生咀嚼片营养成分分析见表1.
表1苁蓉益生咀嚼片营养成分
实施例5苁蓉益生咀嚼片对便秘性小鼠的干预作用
1.材料
1.1.药品
上述实施例3种苁蓉益生咀嚼片，批号分别同实施例1，2，3；复方地芬诺酯，购自常州康普药业有限公司，批号国药准字H22022037；吗丁啉，购自西安杨森制药有限公司，批号20013876；浓度稀释为65％的蓝墨汁(标记物)。
1.2.动物的饲养
选昆明种雄性小鼠，8周龄，体重为25±5g，购自康美华大基因技术有限公司，许可证号SYXK(粤)2020-0205自由饮水，温度22～26℃，湿度45％～55％。
2.实验方法
2.1小肠推进实验
将实验小鼠随机分为6组，每组10只。实验设正常对照组、便秘模型组和 3种苁蓉益生咀嚼片组，阳性药组。其中正常组为蒸馏水，3种苁蓉益生咀嚼片组剂量都为1g/kg BW，均用蒸馏水配成0.2mL的灌胃溶液，阳性组为0.5 mg/L的吗叮啉水溶液。各组灌胃14天后，各组小鼠禁食不禁水16h，除正常组以外，分别灌胃10mg/kg的复方地芬诺酯，对照组灌胃相应体积的蒸馏水。灌胃复方地芬诺酯30min后，各剂量组给予每只0.2mL的蓝墨汁，墨汁灌胃25 min后，颈椎脱臼法处死小鼠，取其肠系膜和部分小肠(幽门至回盲部)，并将取得的小肠置于托盘上，轻轻拉成直线，测量得其长度，为“小肠总长度”，从幽门至活性炭前沿的长度为“墨汁推进长度”，按下式计算墨汁推进率：
墨汁推进率(％)＝墨汁推进长度(cm)/小肠总长度(cm)×100％
2.2排便时间和粪便粒数的测定
小鼠造模方法同实施例5中“2.1”部分，记录每只小鼠灌胃墨汁后6h内首粒黑便的排便时间、排便总粒数以及性状(软便或稀便)。与模型组相比，粪便含水量小于55％为软便，粪便含水量大于等于55％为稀便。
2.3小鼠肠道含水量的测定
小鼠造模方法同实施例5中“2.1”部分。于复方地芬诺酯灌胃后3h和5h，分别随机将每组的一半动物采用颈椎脱臼法处死，自幽门处剪下肠管，分离至直肠末端，并分离大小肠，分别称其湿重，于105℃烘干至恒重，称量大小肠的干重，并按下式计算含水量：
肠含水量(％)＝(肠湿重(g)-肠干重(g))/肠湿重(g)×100％
2.4.小鼠体重及一般状况观察
记录各实验组小鼠实验前和实验末的体重，并观察小鼠的进食情况、反应灵敏度和皮毛光泽情况。
2.5.数据统计分析
采用SPSS 20.0统计软件进行数据分析，数据均以平均值±标准差
表示，采用单样本K-S检验进行正态性检验，正态分布数据采用单因素方差分析，不满足正态分布的数据采用非参数检验，P<0.05时为差异显著，具有统计学意义。
3.实验结果
3.1.苁蓉益生咀嚼片对小鼠小肠推进的影响
苁蓉益生咀嚼片对便秘小鼠小肠推进的影响结果见表2。由表2可知，便秘模型组小鼠的小肠活性炭推进率显著低于对照组(P<0.05)，表明便秘模型建立成功。与模型组相比，咀嚼片各组及其阳性药组均能增强小肠推进性蠕动，增加墨汁推进长度，提高墨汁推进率。其中，咀嚼片2、3，阳性组与模型组相比，具有显著性差异(P<0.05)，表明苁蓉益生咀嚼片具有促进便秘小鼠小肠运动的作用。
表2苁蓉益生咀嚼片对便秘小鼠小肠推进的影响(n＝10)
注：与正常对照组相比，#表示P<0.05；与模型组相比，*表示P<0.05
3.2.苁蓉益生咀嚼片对小鼠排便的影响
墨汁灌胃小鼠6h后，观察每只小鼠是否排黑便，并记录首粒黑便排出的时间。苁蓉益生咀嚼片对便秘小鼠排便情况的影响如表3所示。小鼠首粒黑便的排出时间和6h排便粒数的结果表明，与对照组相比，模型组小鼠首粒黑便出现的时间明显滞后，6h内的排便粒数明显减少，并且两项指标在对照组和模型组之间均具有显著性差异(P<0.05)，表明小鼠便秘模型建立成功。与模型组相比，咀嚼片各组及其阳性药组小鼠的首粒黑便排出时间均有所缩短， 6h排便粒数均有所增加。其中，咀嚼片3、阳性组小鼠的首粒黑便排出时间和 6h排便粒数与模型组相比具有显著性差异(P<0.05)。在小鼠的6h排便时间内，与模型组相比，咀嚼片各组与阳性药组小鼠的大便含水量逐渐增大，且为软便。以上结果表明，苁蓉益生咀嚼片能明显缩短便秘小鼠的首粒黑便排出时间，增加6h内的排便粒数，软化便秘小鼠的粪便，表现出典型的通便功效。
表3苁蓉益生咀嚼片对便秘小鼠排便的影响(n＝10)
注：与正常对照组相比，#表示P<0.05；与模型组相比，*表示P<0.05
3.3.苁蓉益生咀嚼片对小鼠肠道含水量的影响
于各组造模灌胃后3h和5h，分别随机将每组的一半动物采用颈椎臼法处死，测定其肠道含水量，结果见表4。由表中数据可知，咀嚼片各组及其阳性药组对小鼠大肠和小肠含水量的影响不显著，与表3中粪便含水量的结果一致，这可能与实验过程中小鼠自由饮水有关。
表4苁蓉益生咀嚼片对便秘小鼠肠道含水量的影响(n＝10)
3.4小鼠体重及一般状况观察
本研究中，咀嚼片各组与阳性组小鼠的体重增长情况与对照组及模型组相比，均无显著性差异(表5)。实验期间，无小鼠死亡现象，健康状况良好，食欲旺盛、反应灵敏且皮毛有光泽。
表5苁蓉益生咀嚼片对便秘小鼠体重的影响(n＝10)
Claims (7)
1.一种具有润肠通便的苁蓉益生咀嚼片，其特征在于，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉0.5-10份、鼠李糖杆菌0.5-5份、唾液乳杆菌0.5-5份、山梨醇1-5份、奶粉0.5-1份、甘氨酸0.02-0.05份、硬脂酸镁0.05-0.1份及95％乙醇。
2.如权利要求1所述的具有润肠通便的苁蓉益生咀嚼片，其特征在于，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉0.5-1份、鼠李糖杆菌0.5-1份、唾液乳杆菌0.5-1份、山梨醇1-2份、奶粉0.5-1份、甘氨酸0.02-0.05份、硬脂酸镁0.05-0.1份及95％乙醇。
3.如权利要求1所述的具有润肠通便的苁蓉益生咀嚼片，其特征在于，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉4-5份、鼠李糖杆菌2-3份、唾液乳杆菌2-3份、山梨醇2-3份、奶粉0.5-1份、甘氨酸0.02-0.05份、硬脂酸镁0.05-0.1份及95％乙醇。
4.如权利要求1所述的具有润肠通便的苁蓉益生咀嚼片，其特征在于，所述苁蓉益生咀嚼片包括以下按重量份计各组分：肉苁蓉干粉10份、鼠李糖杆菌4-5份、唾液乳杆菌4-5份、山梨醇4-5份、奶粉0.5-1份、甘氨酸0.02-0.05份、硬脂酸镁0.05-0.1份及95％乙醇。
5.一种用于制备如权利要求1-4所述的苁蓉益生咀嚼片的制备方法，其特征在于，包括以下步骤：
以鲜肉苁蓉为原料制备肉苁蓉冻干粉；
按比例称取鼠李糖杆菌、唾液乳杆菌、山梨醇、全脂奶粉、甘氨酸、硬脂酸镁，并混合加入所述肉苁蓉冻干粉，缓慢倒入95％的乙醇，制成湿混料；
将拌好的所述湿混料过筛进行制粒；
将制好的粒子放入45℃的恒温干燥箱中进行烘干、整粒；
加入0.05份的硬脂酸镁充分摇匀后，放入单冲式压片机中压片，得到所述苁蓉益生咀嚼片。
6.如权利要求5所述的制备方法，其特征在于，以鲜肉苁蓉为原料制备肉苁蓉冻干粉的所述步骤包括：
将鲜肉苁蓉作为肉苁蓉干粉的原料，切片，置于-80℃冰箱将肉苁蓉预冷24h后，置于真空冷冻干燥机中，干燥72h后取出，粉碎机粉碎，过100目的筛制的肉苁蓉冻干粉。
7.一种如权利要求1-4所述的苁蓉益生咀嚼片的在预防和治疗功能性便秘中的应用。
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