CN107050147B - 一种双向改善胃肠道功能、减肥美容组合物及其制剂 - Google Patents
一种双向改善胃肠道功能、减肥美容组合物及其制剂 Download PDFInfo
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Abstract
本发明提供一种双向改善胃肠道功能、减肥美容的组合物及其制剂，尤其涉及圆苞车前子壳、山楂、乳酸菌素复配组合物及其制剂。其中，圆苞车前子壳经低温气流粉碎得超微破壁粉，膳食纤维含量≥85％、多糖含量≥9％；山楂经50％乙醇回流提取得提取物，有机酸含量以枸橼酸计≥15％；乳酸菌素系脱脂牛乳经嗜酸性乳杆菌发酵制得，总酸含量(以乳酸计)10％～20％、蛋白质含量≥30％。组合物还可添加1:0.1～0.6的矫味剂，并可添加或不添加药学可接受辅料制成各种口服固体制剂。实验证明：本发明组合物双向改善胃肠道功能、减肥效果明显优于组合前各组成物质，对于开发利用圆苞车前子壳、山楂、乳酸菌素等新资源或传统药食两用物质具有重要意义。
Description
技术领域
本发明涉及一种双向改善胃肠道功能、减肥美容组合物及其制剂。属于生物医药、大健康领域。
技术背景
综合社会发展、生活节奏加快、工作压力增加、膳食结构改变、食品安全及环境恶化等因素影响，胃肠功能紊乱、便秘、腹泻、肥胖已成为亚健康及器质性病变人群重点关注问题，严重影响着人们的健康和生活质量。目前，临床上治疗肥胖、便秘、腹泻主要以改变饮食结构、增加运动并辅以渗透性、单向调节、刺激性和抗生素药物。通过双向调节胃肠功能而达到显著改善便秘、腹泻、减肥美容、且对人体无任何不良损害的健康产品极其少见。
圆苞车前子壳是车前科车前属圆苞车前的干燥成熟种子外壳， 2014年被国家卫计委(2014年第10号公告)批为新食品原料，公告规定的生产工艺为圆苞车前子壳经碾磨后制得，膳食纤维含量≥80％。现代研究认为，圆苞车前子壳还含有多糖、微量元素、蛋白质、维生素B1、胆碱等多种人体所需的营养成分，因其超大膨胀系数和高含量不溶性膳食纤维而备受关注。山楂是蔷薇科植物山里红或山楂的干燥成熟果实。作为传统药食两用药材，其在《中华人民共和国药典》中功能主治表述为：健胃消食，行气散瘀，化浊降脂。现代研究表明，山楂含有黄酮、三萜、脂肪酸、氨基酸、维生素、多糖等多种营养及功能成分。乳酸菌素系脱脂牛乳经嗜酸性乳杆菌发酵而成，原***部颁标准规定乳酸含量≥10％、蛋白质含量≥28％，是一种广泛应用于药品、食品、发酵、畜牧、饲料、化妆品等领域，完全无毒，不会引起细菌抗药性的天然抗菌肽。
《液态乳制品及其制备方法》(专利申请公布号： CN201610045234.7)公开了一种液态乳制品由重量份200～750的生牛乳或复原乳、重量份10～20的圆苞车前子壳、重量份1～100的果蔬汁(选自香蕉汁、山楂汁、菠萝汁、芹菜汁、西瓜汁、胡萝卜汁中的至少一种)、重量份1～20的稳定剂、重量份10～80的白砂糖、重量份0～10的甜菊糖苷和罗汉果甜苷中的至少一种、重量份5～80的乳清蛋白粉组成。《一种减肥酸奶及其制备方法》(专利申请公布号： CN201210361849.2)公开了一种减肥酸奶采用草决明粉、乌梅粉、车前子粉、荷叶粉、山楂粉以及脱脂生牛乳进行混合并发酵制得减肥酸奶。
本发明旨在采用新食品原料圆苞车前子壳与传统药食同源山楂、乳酸菌素组方，通过本发明特定比例、特有工艺及质量控制技术方案，制备显著提高胃肠道双向调节、减肥美容的组合物及其制剂。实验证明取得了预想不到的技术效果。
发明内容
本发明的目的之一是提供一种显著提高双向调节胃肠道功能、减肥美容的组合物及其制备方法；目的之二是提供该组合物制剂及其应用。
本发明目的之一是通过下述技术方案来实现的。
首先，本发明提供一种显著提高双向调节胃肠道功能、减肥美容的组合物，所述组合物由重量份数为13.7％～60.2％的圆苞车前子壳，重量份数为30.8％～72.3％的山楂，重量份数为12.3％～43.4％乳酸菌素组成。
作为优选，所述组合物，其特征在于：所述组合物由重量份数为 18.9％～46.4％的圆苞车前子壳，重量份数为37.9％～56.7％的山楂，重量份数为16.7％～33.0％的乳酸菌素组成。
进一步优选，所述组合物，其特征在于，所述组合物由重量份数为24.6％～37.4％的圆苞车前子壳，重量份数为42.2％～50.0％的山楂，重量份数为20.9％～26.6％的乳酸菌素组成。
其次，所述圆苞车前子壳采用低温气流粉碎技术，于-20℃、液氮条件下粉碎成800-1200目超微破壁粉。其中，膳食纤维含量≥85％、多糖含量≥9％。
所述山楂粉碎至20～40目粗粉，添加10倍量50％乙醇浸泡0.5～ 1小时，于65～70℃热回流提取1.5～2小时，连续提取2次，收集提取液浓缩干燥得山楂提取物。其中，有机酸含量以枸橼酸计≥15％。
所述乳酸菌素系脱脂牛乳经嗜酸性乳杆菌发酵制得。其中，蛋白质含量≥30％，总酸含量(以乳酸计)10％～20％、优选为12％～18％、更优选为14％～16％。
最后，山楂提取物、乳酸菌素粉碎过80目筛，与圆苞车前子壳超微破壁粉充分混合均匀，制得显著提高双向调节胃肠道功能、减肥美容的组合物。
优选地，所述组合物还可添加蔗糖、葡萄糖、木糖醇、三氯蔗糖、甜菊糖、阿斯巴坦中的一种或几种，添加比例为1：0.1～0.6、优选为1：0.2～0.5、更优选为1:0.3～0.4。
本发明的目的之二是通过下述技术方案实现的。
首先，所述组合物在制备具有双向改善胃肠道功能、减肥美容功能的药品、保健食品、功能性普通食品、特殊医学食品、特殊膳食食品中的应用。
其次，本发明所述组合物添加药品、保健食品、功能性普通食品、特殊医学食品、特殊膳食食品可接受的辅料，制成散剂、颗粒剂、片剂、胶囊剂。
具体实施内容
下面对本发明作进一步的说明，但不以任何方式对本发明加以限制，基于本发明教导所作的任何变换或替换，均属于本发明的保护范围。
本发明的圆苞车前子壳、山楂、乳酸菌素的组合物及其制备方法，提供了一种适应于现代高节奏生活，便于携带、方便易用，双向调节胃肠道功能效果显著，并具有减肥美容效果的组合物。对改善人体健康状况有显著有益效果。
实施例1：圆苞车前子壳超微破壁粉制备
采用低温气流粉碎技术对圆苞车前子壳进行破壁粉碎制得圆苞车前子壳超微破壁粉，具体方法如下：
粉碎设备：液氮低温气流粉碎机(高桥/M-250型)，由上海浦东高桥试验机厂有限公司制造。
制备工艺：将液氮气流低温粉碎机开机预冷至-20℃，加入水分含量≤10％的圆苞车前子壳，通过气流粉碎，得1000目的破壁粉。
质量控制：取制备工艺项下圆苞车前子壳粉，经检测：膳食纤维含量为88.4％；多糖含量为9.47％。
实施例2：山楂提取物制备
1.工艺条件筛选
⑴提取方法的选择
水提取法：称取山楂30g,加水200ml浸泡30min后，煎煮60min，过滤，药渣再加水150ml，煎煮1h,过滤，合并两次滤液，水浴蒸干，测定有机酸含量(以枸橼酸计)为9.4％。
乙醇提取法：称取山楂30g,加乙醇200ml浸泡30min后，水浴回流1h，过滤，药渣再加乙醇150ml，水浴回流1h,过滤，合并两次滤液，回收乙醇，水浴蒸干。测定有机酸含量(以枸橼酸计)为15.8％。
实验证明，山楂采用乙醇提取法有机酸含量远远高于水提法。故乙醇提取法优于水提取法。
⑵提取工艺优化
1)提取方法一
取干燥的山楂粉碎过20目筛，从中称取100g山楂粉置于圆底烧瓶中，按料液比1:10加入30％的乙醇溶液，将温度升至60℃静置1h 后，开启回流装置，将温度升至65℃回流2h，抽滤出滤液；然后按料液比1:4加入30％乙醇溶液，将温度升至65℃再回流1h，抽滤出滤液。合并两次滤液，浓缩干燥成干浸膏，粉碎过80目筛，备用。
2)提取方法二
取干燥的山楂粉碎，过20目筛，从中称取100g山楂粉置于圆底烧瓶中，按料液比1:10加入50％的乙醇溶液，将温度升至60℃静置 1h后，开启回流装置，将温度升至70℃回流1.5h。抽滤出滤液，然后按料液比1:8加入50％乙醇溶液，将温度升至70℃再回流1h，抽滤出滤液。合并两次滤液，浓缩干燥成干浸膏，粉碎过80目筛，备用。
3)提取方法三
取干燥的山楂粉碎，过20目筛，从中称取100g山楂粉置于圆底烧瓶中，按料液比1:10加入75％的乙醇溶液，将温度升至60℃静置 0.5h后，开启回流装置，将温度升至65℃回流1.5h。抽滤出滤液，然后按料液比1:7加入75％乙醇溶液，将温度升至65℃再回流1h，抽滤出滤液。合并两次滤液，浓缩干燥成干浸膏，粉碎过80目筛，备用。
4)提取方法四
取干燥的山楂粉碎过20目筛，从中称取100g山楂粉置于圆底烧瓶中，按料液比1:10加入95％的乙醇溶液，将温度升至60℃静置0.5h 后，开启回流装置，将温度升至70℃回流1.5h。抽滤出滤液，然后按料液比1:10加入95％乙醇溶液，将温度升至70℃再回流1h，抽滤出滤液。合并两次滤液，浓缩干燥成干浸膏，粉碎过80目筛，备用。
⑶工艺评价
现代研究认为：山楂主要含总黄酮，有机酸和山楂多糖。本实验依据本发明需要，选取浸膏率、提取物有机酸含量作为评价指标，对提取方法一～四进行评价。
有机酸含量测定方法：参考《中国药典》2015版中山楂有机酸含量的测定方法。具体为：取提取物粉约1g，精密称定，精密加水 100ml，振摇溶解，滤过。精密量取续滤液25ml，加水50ml，加入酚酞指示液2滴，用氢氧化钠滴定液(0.1mol/L)滴定，记录样品所消耗的滴定液的体积，再根据每1ml氢氧化钠滴定液(0.1mol/L)相当于6.404mg的枸橼酸(C6H8O7)，计算出每个样品中有机酸的含量。
浸膏率测定方法：称量每种提取方法得到的干浸膏质量，再与山楂投料量相比，计算山楂经不同的提取方法得到的浸膏率。
提取方法一～四所得干浸膏有机酸含量、浸膏率结果见表1。
表1不同提取方法干浸膏有机酸含量和浸膏率
表1看出：提取方法二～四提取效果较好。综合考虑山楂提取物得率、有机酸含量及产业化提取的方便、安全、成本，选取提取方法二作为本发明优选提取方法。
实施例3：乳酸菌素的准备
本发明所述组合物，直接购买嗜酸乳杆菌接种到含有脱脂牛乳的发酵液中发酵、干燥得到的食品级或药品级乳酸菌素。经检测：蛋白质含量为35.07％、总酸含量(以乳酸计)为15.03％。
实施例4：组合物制备1
称取圆苞车前子壳95g，按实施例1制备超微破壁粉；称取山楂 115g，按实施例2制备山楂提取物；称取实施例3准备的乳酸菌素粉 68g。三者置洁净的不锈钢混合容器中，充分搅拌混合均匀，即得。
实施例5：组合物制备2
称取圆苞车前子壳85g，按实施例1制备超微破壁粉；称取山楂 110g，按实施例2制备山楂提取物；称取实施例3准备的乳酸菌素粉 60g。三者置洁净的不锈钢混合容器中，充分搅拌混合均匀，即得。
实施例6：组合物制备3
称取圆苞车前子壳350g，按实施例1制备超微破壁粉；称取山楂525g，按实施例2制备山楂提取物；称取实施例3准备的乳酸菌素粉270g。三者置洁净的不锈钢混合容器中，充分搅拌混合均匀，即得。
实施例7：组合物制备4
称取实施例6制备的组合物300g,加入木糖醇与三氯蔗糖混合粉105g，充分搅拌混合均匀，即得。
实施例8：制剂制备1
称取实施例6制备的组合物100g,加入少许预胶化淀粉、微晶纤维素、硬脂酸镁，经制粒、压片制成片剂。
实施例9：制剂制备2
称取按实施例7制备的组合物100g，采用湿法/干法制备成粉剂或颗粒剂。
为了更进一步对本发明组合物技术效果进行说明，本发明选取实施例6、实施例7所制备的组合物作为试验样品，编号为④、⑤。选取按实施例1～3制备的圆苞车前子壳超微粉、山楂提取物、乳酸菌素及三者按重量比3:5.3:8制备的组合物(备注：所述组合物各组成物质组成比例在本发明组合物组成比例之外)作为对照样品，编号依次为①、②、③、⑥。同时设阴性对照组、模型对照组以排除造模干扰与误差，开展便秘、泄泻、减肥改善比较试验，结果如下：
㈠改善便秘功能实验
实验动物：健康雄性昆明种小鼠(体重：18～22g)
致便秘剂：复方地芬诺脂片(2.5mg/片)
实验方法与结果：
1、给样剂量：本发明所述组合物(试验样品④、⑤)60kg成年人日给样剂量确定为10g，据此折算体重为20g小鼠给样剂量为 26.0mg/只。依据等剂量给样可比原则确定对照样品⑥给样剂量为26.0mg/只。依据等剂量给样可比原则，结合国家规定的圆苞车前子壳粉、山楂、乳酸菌素日最高推荐剂量确定对照样品①给样量为 26.0mg/只；对照样品②给样量为10.6mg/只；对照样品③给样量为 18.7mg/只。
2、试验方案及数据：选取健康昆明种雄性小鼠80只，按体重均衡分为空白对照组、模型对照组、样品对照组(①、②、③、⑥)及试验组(④、⑤)，每组10只。正常喂养10d，实验前禁食16h。模型对照组和①～⑥个实验组小鼠均以灌胃的方式给予10mg/kg复方地芬诺脂造便秘模型，空白对照组给予等量的水代替造模药物，造模 30min。按2ml/100g灌胃量给予空白对照组和模型对照组空白墨汁、给予①～⑥个实验组含对应样品的墨汁混悬液。试验中，小鼠正常单笼饲养，正常饮水进食，记录每只小鼠首粒排黑便时间及5h内排便粒数及重量，结果见表2。
表2小鼠便秘造模及排黑便统计学数据
表2看出：模型对照组与空白对照组首粒排便时间、5h内排便粒数、5h内排便重量均满足P<0.01，具有高度统计学差异，说明经口服给予10mg/kg复方地芬诺脂造小鼠便秘模型成立。试验组(④、⑤)相较于模型对照组、样品对照组(①、②、③、⑥)首粒排便时间、5h内排便粒数、5h排便重量均满足P<0.05，具有统计学差异；而试验组④、试验组⑤比较的首粒排便时间、5h内排便粒数、5h排便重量均满足P＞0.05，无统计学差异。
3、试验结论：试验组(④、⑤)相较于样品对照组(①、②、③、⑥)首粒排便时间缩短1.5～5.7倍；5h内排便粒数增加1.4～ 3.2倍；5h内排便重量增加1.2～1.6倍。说明本发明所述组合物对小鼠便秘改善显著提高。
㈡缓解泄泻的实验
实验动物：健康昆明种大鼠(180～220g)
致泻剂:番泻叶水煎液
实验方法与结果：
1、给样剂量：本发明所述组合物(试验样品④、⑤)60kg成年人日给样剂量确定为10g，据此折算体重为200g大鼠日给样剂量为180.0mg/只。依据等剂量给样可比原则确定对照样品⑥给样剂量为 180.0mg/只。依据等剂量给样可比原则，结合国家规定的圆苞车前子壳粉、山楂、乳酸菌素日最高推荐剂量确定对照样品①给样量为 180.0mg/只；对照样品②给样量为74.0mg/只；对照样品③给样量为 129.6mg/只。
2、致泻剂制备：番泻叶冷水浸泡30min，煮沸后煎煮5min，去渣，药液浓缩为1g/ml浓度，即得。
3、试验方案及数据：选取健康昆明种大鼠80只，雌雄各半，按体重均衡分为空白对照组、模型对照组、样品对照组(①、②、③、⑥)及试验组(④、⑤)，每组10只。正常喂养10d，实验前禁食16h。模型对照组和①～⑥个实验组大鼠均以灌胃的方式给予番泻叶水煎液1ml/100g，1次/日，造腹泻模型，空白对照组给予等量的水代替造模药物。按2ml/100g灌胃量给予空白对照组和模型对照组蒸馏水、给予①～⑥个实验组含对应样品的蒸馏水混悬液。灌胃番泻叶水煎液与灌胃样品物质时间间隔3h,连续3d。试验中，大鼠正常单笼饲养，正常饮水进食，记录0～72h每只大鼠排便情况，并按如下公式计算稀便率，结果见表3。
表3大鼠腹泻造模及稀便率统计数据
表3看出：模型对照组与空白对照组稀便率满足P＜0.01，具有高度统计学差异，说明经灌胃给予1ml/100g番泻叶水煎液造大鼠腹泻模型成立。试验组(④、⑤)相较于模型对照组、样品对照组(①、②、③、⑥)稀便率均满足P<0.05，具有统计学差异；而试验组④、试验组⑤比较稀便率满足P＞0.05，无统计学差异。
4、试验结论：试验组(④、⑤)相较于样品对照组(①、②、③、⑥)稀便率在3d内减小1.8～3.7倍。说明本发明所述组合物显著缓解大鼠泄泻。
㈢减肥实验
实验动物：肥胖大鼠(体重240～270g)
实验方法与结果：
1、给样剂量：本发明所述组合物(试验样品④、⑤)60kg成年人日给样剂量确定为10g，据此折算体重为255g大鼠日给样剂量为 180.0mg。依据等剂量给样可比原则确定对照样品⑥给样剂量为 180.0mg/只。依据等剂量给样可比原则，结合国家规定的圆苞车前子壳粉、山楂、乳酸菌素日最高推荐剂量确定对照样品①给样量为180.0mg/只；对照样品②给样量为74.0mg/只；对照样品③给样量为 129.6mg/只。
2、试验方案及数据：选取肥胖大鼠各60只(雌雄各半)，按体重均衡和性别均衡分为样品对照组(①、②、③、⑥)及试验组(④、⑤)，每组10只。按编号每天上午和下午分别给予含对应①～⑥样品的饲料168g/d，自由饮水，连续饲养两周，并记录实验前大鼠体重和两周后大鼠体重，结果见表4。
表4肥胖大鼠体重变化试验数据
表4看出：试验组(④、⑤)相较于样品对照组(①、②、③、⑥)体重差均满足P<0.05，具有统计学差异；而试验组④、试验组⑤比较的体重差均满足P＞0.05，无统计学差异。
3、试验结论：试验组(④、⑤)相较于样品对照组(①、②、③、⑥)显著减轻肥胖大鼠体重，减肥效果差异具有显著性。
Claims (5)
1.一种双向调节胃肠道功能、减肥美容的组合物，所述组合物由重量份为24.6%～37.4%的圆苞车前子壳采用低温气流粉碎技术，于液氮、-20℃粉碎至800-1200目得圆苞车前子壳超微破壁粉，其膳食纤维含量≥85%、多糖含量≥9%；重量份为42.2%～50.0%的山楂采用50%乙醇回流提取,料液比为1:10、温控65～70℃、提取时间1.5～2小时、连续提取2次、收集提取液浓缩干燥得山楂提取物,其有机酸含量以枸橼酸计≥15%；重量份为20.9%～26.6%、蛋白质含量≥30%、乳酸含量10%～20%的乳酸菌素组成；各组分含量之和为100%，不添加或添加1：0.1～0.6的甜味剂制得。
2.如权利要求1所述组合物，其特征在于：所述乳酸菌素中乳酸含量为14%～16%。
3.如权利要求1所述组合物，其特征在于：所述组合物不添加或添加1:0.3～0.4的甜味剂制得。
4.如权利要求1所述组合物，其特征在于：所述甜味剂为蔗糖、葡萄糖、木糖醇、三氯蔗糖、甜菊糖、阿斯巴甜中的一种或几种。
5.如权利要求1所述组合物，其特征在于：所述组合物在制备具有双向改善胃肠道功能、减肥美容功能的药品、保健食品、功能性普通食品、特殊医学食品、特殊膳食食品中的应用，添加药品、保健食品、功能性普通食品、特殊医学食品、特殊膳食食品可接受辅料，进一步制成散剂、颗粒剂、片剂、胶囊剂。
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