CN105535756A - 一种助婴幼儿消化和睡眠的中药组合物及其制备方法和制剂 - Google Patents
一种助婴幼儿消化和睡眠的中药组合物及其制备方法和制剂 Download PDFInfo
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- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
本发明公开了一种助婴幼儿消化和睡眠的中药组合物,包含如下成分,以质量份数计:益智仁5-50份、桑叶2-20份、橘红2-20份、薏苡仁30-90份、山楂5-50份、淡竹叶10-70份、甘草3-15份、赤小豆20-80份、麦芽20-80份、鸡内金5-30份、低聚果糖0.5-5份。本发明的中药组合物,所用的活性成分药食同源,易于为幼儿吸收;各组分之间的药效作用相互协同,显著改善良小儿睡眠和消化功能,促进身体健康。
Description
技术领域
本发明涉及一种助婴幼儿消化和睡眠的中药组合物以及由该中药组合物制成的中药制剂,属于中医药和保健品领域。
背景技术
婴幼儿由于处于生理器官的发育早期阶段,各相关饮食、消化等器官功能尚不健全,常因脾气虚弱、胃阴不足或因长期摄入奶制品导致纳呆厌食、消化不良、口干燥渴、大便久泻、面黄体弱、记忆力差、精神不振、盗汗、便秘等症状,影响婴幼儿的生长发育。
针对上述问题,除了就医诊疗外,在中国的广东、香港等地区根据传统习俗普通使用七星茶以改善小儿脾胃功能,减低小儿因长期摄入奶类制品而产成的热气,从而达到改善小儿饮食及消化功能的效果。已有的七星茶,其配方以苡仁、淡竹叶、赤小豆、麦芽等为主,剂型主要有颗粒剂、即冲茶包、传统中药材包装等类型。这些制品大都饮用方便,但其多含有大量的蔗糖、淀粉等辅料,其中所用的蔗糖大量食用会导致蛀牙、肥胖等,淀粉等会影响口感及饮用。
因此,如何有效保证此类制品的保健效果,又能显著降低各类辅料的用量,同时还便于为婴幼儿食用,依旧是本领域亟待解决的问题。
发明内容
针对现有技术的不足,本发明公开了一种助婴幼儿消化和睡眠的中药组合物,相对于传统的七星茶,本发明的中药组合物各成分之间的复配更加科学,原料之间的协同作用能最大限度的保证活性成分的药理活性,显著降低了蔗糖等辅料的用量,对于小儿健康,尤其是改善饮食消化和改善睡眠具有良好促进作用。
具体地说,本发明是通过如下技术方案实现的:
一种助婴幼儿消化和睡眠的中药组合物,包含如下成分,以质量份数计:益智仁5-50份、桑叶2-20份、橘红2-20份、薏苡仁30-90份、山楂5-50份、淡竹叶10-70份、甘草3-15份、赤小豆20-80份、麦芽20-80份、鸡内金5-30份、低聚果糖0.5-5份。
作为优选,各成分质量份数为益智仁10-40份、桑叶5-15份、橘红5-15份、薏苡仁40-80份、山楂10-40份、淡竹叶20-50份、甘草5-10份、赤小豆30-60份、麦芽30-60份、鸡内金10-25份、低聚果糖1-4份。
更优选的,各成分质量份数为益智仁20-30份、桑叶10-15份、橘红10-15份、薏苡仁50-70份、山楂20-30份、淡竹叶30-40份、甘草6-8份、赤小豆40-50份、麦芽40-50份、鸡内金15-20份、低聚果糖3份
在上述限定范围内,可提供本发明的若干具体实现:如益智仁30份、桑叶15份、橘红15份、薏苡仁60份、山楂25份、淡竹叶35份、甘草8份、赤小豆50份、麦芽40份、鸡内金18份、低聚果糖4份;又如益智仁25份、桑叶12份、橘红14份、薏苡仁55份、山楂30份、淡竹叶30份、甘草6份、赤小豆45份、麦芽45份、鸡内金15份、低聚果糖5份;或益智仁20份、桑叶10份、橘红10份、薏苡仁40份、山楂40份、淡竹叶40份、甘草6份、赤小豆50份、麦芽50份、鸡内金20份、低聚果糖2份;又或益智仁10份、桑叶10份、橘红10份、薏苡仁40份、山楂10份、淡竹叶20份、甘草10份、赤小豆60份、麦芽60份、鸡内金10份、低聚果糖1份。
在本发明中,所用的益智仁具有温和的补肾壮阳、固精缩尿、温脾止泄、提高记忆力的效果;桑叶有利于清肝明目、清肺润燥、疏散风热;橘红则能燥湿、利气、消痰;薏苡仁能够健脾渗湿、除痹止泻;山楂则能开胃消食、化滞消积;赤小豆具有清热利尿、润肠通便的功效;麦芽能够行气消食、健脾开胃;鸡内金有助于消食健胃消化;甘草则能益气补中、泻火解毒、调和诸药。
上述各成分间相互协同,改善良小儿脾胃功能,开胃消滞,清热定惊,减低小儿因长期摄入奶类制品而产成的积热,从而达到改善小儿睡眠和消化功能、增加记忆力的效果;且对因小儿长期摄入奶类制品而致小儿积滞化热,消化不良,不思饮食,烦躁易惊,夜寝不安,大便不畅,小便短赤、记忆力差、精神不振等症状有明显改善效果。
上述各原料均可从中药材市场上购买原药材或其加工品,也可根据相关中药典籍的记载自行从相关植物获得。
与传统的七星茶制品相比,本发明的中药组合物各成分之间的协同更科学,用量匹配更合理,制备提取时各成分之间的融合更好,辅之以使用合理量的低聚果糖,显著降低了将其制备为成品制剂时的高糖分、难溶解等带来的副作用大、难于引用的弊端。
相应的,本发明公开了上述中药组合物的制备方法,具体包括下述步骤:
1.将益智仁、桑叶、橘红、薏苡仁、山楂、淡竹叶、甘草、赤小豆、麦芽、鸡内金,加入到水中进行一次或多次煎煮后过滤的滤液浓缩至相对密度1.06-1.16的清膏;
2.所得清膏加入乙醇至乙醇质量含量为40-75%,静置后滤液回收乙醇并浓缩成稠膏,稠膏与低聚果糖混合均匀。
在上述煎煮制备过程中,可根据原料量合理调整煎煮的水用量和煎煮效果,一般在煎煮过程中采用3-10倍重量的水煎煮至少2次,每次1-2小时,过滤后合并滤液。
在上述基础上,本发明还公开了一种助婴幼儿消化和睡眠的中药制剂,包括本发明上述的中药组合物,和与制剂剂型对应的、药学上可接受的药用辅料,药用辅料的重量份数为30-60份。
本领域技术人员容易理解,上述所称的对应的、药学上可接受的药用辅料指的是本领域在婴幼儿药物制品中已经普遍应用、被认为是安全的用于制备各种制剂的药用辅料,考虑到婴幼儿这一特定应用群体,上述药用辅料选自葡萄糖、蔗糖、糊精、可溶性淀粉中的一种或多种。
作为优选,所述药用辅料用量为40-50份。
根据不同的制剂类型需要,本领域技术人员在将中药组合物制备为相应剂型时可合理选择上述辅料中的一种或几种的混合物。作为优选,当葡萄糖、蔗糖中的一种或两种与糊精、可溶性淀粉中的一种或两种共同使用时,葡萄糖或/和蔗糖的总重量占辅料总量的30-60%;更优选的,葡萄糖或/和蔗糖的总重量占辅料总量的40-50%。
根据制剂类型的需要,并结合婴幼儿的饮食特点,在上述中药制剂中还可以包含口味调节剂、防腐剂、pH调节剂中的一种或多种。
上述辅料的用量是微量的,以质量百分比计,通常在最终的药物制剂中,包含口味调节剂0.05-0.30%或/和防腐剂0.005-0.20%或/和pH调节剂0.005-0.50%;作为优选,包含口味调节剂0.1-0.25%或/和防腐剂0.01-0.18%或/和pH调节剂0.01-0.4%。
在上述中,所用的口味调节剂采用各种香味剂,如香蕉香味剂、橘子香味剂、菠萝香味剂、柠檬香味剂、草莓香味剂、甜橙香味剂、苹果香味剂、蓝梅香味剂等;防腐剂选自对羟苯甲酸乙酯、羟苯甲酸丙酯、山梨酸钾、苯甲酸、苯甲酸钠等常见食品和药用防腐剂;pH调节剂选自稀盐酸、枸橼酸、柠檬酸-柠檬酸铵缓冲溶液、磷酸盐缓冲液等。上述辅料的使用不仅安全可靠,保证产品的质量稳定,还可改善口味、甜度和口感,适合不同小儿的喜好,有利于服用,促进营养吸收。
相应的,本发明公开了上述中药剂型的制备方法,如本领域技术人员所熟知的,小儿用药物制剂通常制备为口服剂型,以便饮用或食用。因此,本发明的剂型也是制备为口服剂型,在上述中药组合物制备的基础上,取相应用量的药用辅料以及额外根据需要添加的口味调节剂、防腐剂、pH调节剂等,根据常见口服剂型的制备工艺制备即可。
例如,所述剂型为口服颗粒剂(冲剂):中药组合物加入药用辅料,混匀,制成颗粒,干燥,再加入可选的口味调节剂,混匀,即得。所得口服颗粒剂具有溶解性好,澄清透明,口味佳的特点。
例如,所述剂型为口服片剂(包括咀嚼片):将中药组合物加入药用辅料,混匀,制成颗粒,干燥,再根据需要添加口味调节剂,混匀,压制成片,即得。所得制剂便于携带、服用更方便;且还可起到“磨牙棒”的效果,促进小儿牙齿的健康生长。
例如,所述剂型为硬胶囊剂:将中药组合物加入药用辅料,混匀,制成颗粒,干燥,再添加可选的口味调节剂,混匀,填充胶囊,即得。所得剂型不仅能降低辅料的用量,而且携带、服用更方便,适合于年龄较大的儿童的服用。
例如,所述剂型为口服液体制剂(包括糖浆剂、合剂(含口服液)):将中药组合物加入药用辅料,混匀,制成颗粒,干燥,再添加可选的口味调节剂,混匀,加纯化水制成糖浆剂或合剂(含口服液),即得。所得剂型不仅携带、服用方便,而且具有广泛的适用性,可适合于各年龄段的小儿服用。
上述所列举的剂型仅为婴幼儿用药领域的若干常见剂型,所公开的制备方法也为本领域常见的制备工艺。根据制剂发展以及生产条件、设备的需要,可选择其它剂型或更科学的制备方法。
与传统的七星茶制品相比,本发明的中药制剂组成更加科学,且在中药组合物的制备过程中提取物稠膏经过水提醇沉、滤过、回收的纯化过程,有效去除杂质,最大程度地保留了主要物料的有效成分活性,增加最终成型制剂的溶解度和/或澄清度,保证了产品的质量、口感和有效性。同时,所得中药制剂便于口服给药,具有口感良好、服用方便、生物利用度高、药食同源、安全无毒,制备工艺术简单,适合工业化大生产等特点。
具体实施方式
为了更好地说明本发明的发明精神,在下述中申请人提供了若干具体实施以说明本发明的技术方案是如何实现的。如下所提供的实施例仅为示意性的,本领域技术人员在理解和掌握本发明发明实质的基础上所进行的改进、调整依旧属于本发明的保护范围。
实施例1:颗粒(冲剂)
称取主要物料:益智仁30份、桑叶15份、橘红15份、薏苡仁60份、山楂25份、淡竹叶35份、甘草8份、赤小豆50份、麦芽40份、鸡内金18份、低聚果糖4份,备用。称取辅料(葡萄糖20份、糊精30份)和口味调节剂(草莓香味剂0.15%),备用。
制备方法:按上述配方的主要物料(不含低聚果糖),加10倍量的水煎煮2次,每次2小时,过滤,合并滤液;滤液浓缩至相对密度1.10的清膏;加入乙醇适量,使醇含量为60%,静置12小时,滤过,滤液回收乙醇并浓缩成稠膏,备用;
将低聚果糖与主要物料提取物稠膏合并,拌匀,再加入辅料(葡萄糖、糊精),混匀,制成颗粒,干燥,再加所述的口味调节剂(草莓香味剂),混匀,分装,即得。
实施例2:咀嚼片
称取主要物料:益智仁25份、桑叶12份、橘红14份、薏苡仁55份、山楂30份、淡竹叶30份、甘草6份、赤小豆45份、麦芽45份、鸡内金15份、低聚果糖5份,备用。取辅料(蔗糖15份、淀粉15份、糊精15份)和口味调节剂(甜橙香味剂0.10%),备用。
制备方法:按上述配方的主要物料(不含低聚果糖),加8倍量的水煎煮2次,每次1.5小时,过滤,合并滤液;滤液浓缩至相对密度1.15的清膏;加入乙醇适量,使醇含量为55%,静置12小时,滤过,滤液回收乙醇并浓缩成稠膏,备用;
将低聚果糖与主要物料提取物稠膏合并,拌匀,再加入辅料(蔗糖、淀粉、糊精),混匀,制成颗粒,干燥,再加所述的口味调节剂(甜橙香味剂),混匀,压片,即得。
实施例3:胶囊
称取主要物料:益智仁20份、桑叶10份、橘红10份、薏苡仁40份、山楂40份、淡竹叶40份、甘草6份、赤小豆50份、麦芽50份、鸡内金20份、低聚果糖2份,备用。取辅料(淀粉15份、糊精15份),备用。
制备方法:按上述配方的主要物料(不含低聚果糖),加8倍量的水煎煮2次,每次1.5小时,过滤,合并滤液;滤液浓缩至相对密度1.15的清膏;加入乙醇适量,使醇含量为55%,静置12小时,滤过,滤液回收乙醇并浓缩成稠膏,备用;
将低聚果糖与主要物料提取物稠膏合并,拌匀,再加入辅料(淀粉、糊精),混匀,制成颗粒,干燥,混匀,分装胶囊,即得。
实施例4:口服液
称取主要物料:益智仁10份、桑叶10份、橘红10份、薏苡仁40份、山楂10份、淡竹叶20份、甘草10份、赤小豆60份、麦芽60份、鸡内金10份、低聚果糖1份,备用。取葡萄糖35份备用。
制备方法:按上述配方的主要物料(不含低聚果糖),加8倍量的水煎煮2次,每次1.5小时,过滤,合并滤液;滤液浓缩至相对密度1.15的清膏;加入乙醇适量,使醇含量为55%,静置12小时,滤过,滤液回收乙醇至浸膏,备用;
将主要物料提取物浸膏和低聚果糖投入配料罐,搅拌均匀,再加入辅料葡萄糖等,加水至规定量,过滤,分装,即得。
取上述颗粒进行了临床效果初步观察,研究应用其治疗小儿因长期服用奶粉引起厌食症的疗效,初步观察报告如下:
1.试用小儿资料:凡夜啼、夜睡不宁、烦躁易惊,伴不思饮食,小便短赤,大便不畅的小儿均为湿热引起的夜啼症。统计64例患儿,年龄6个月到6岁之间,其中6个月~3岁30例,3~6岁34例。
2.产品服用方法:6个月至1岁半小儿,半包/次,3次/天;一岁半以上小儿,1包/次,3次/天,6天为1疗程,轻者2个疗程,重者3个疗程。
3.疗效判定标准:夜睡安宁,食欲正常,大小便正常,为治愈;夜睡好转,哭闹次数明显减少,大小便好转,食欲好转,为好转;食欲未见改善,夜睡易哭易醒,为无效。
4.初步统计结果:64例小儿经治疗后,治愈32例,有效26例,无效6例,总有效率为90.63%。
Claims (7)
1.一种助婴幼儿消化和睡眠的中药组合物,其特征在于包含如下成分,以质量份数计:益智仁5-50份、桑叶2-20份、橘红2-20份、薏苡仁30-90份、山楂5-50份、淡竹叶10-70份、甘草3-15份、赤小豆20-80份、麦芽20-80份、鸡内金5-30份、低聚果糖0.5-5份。
2.根据权利要求1的中药组合物,其特征在于益智仁10-40份、桑叶5-15份、橘红5-15份、薏苡仁40-80份、山楂10-40份、淡竹叶20-50份、甘草5-10份、赤小豆30-60份、麦芽30-60份、鸡内金10-25份、低聚果糖1-4份。
3.权利要求1的中药组合物的制备方法,其特征在于将益智仁、桑叶、橘红、薏苡仁、山楂、淡竹叶、甘草、赤小豆、麦芽、鸡内金,加入到水中进行一次或多次煎煮后过滤的滤液浓缩至相对密度1.06-1.16的清膏;所得清膏加入乙醇至乙醇含量为40-75%,静置后滤液回收乙醇并浓缩成稠膏,稠膏与低聚果糖混合均匀。
4.根据权利要求3的制备方法,其特征在于在煎煮过程中,采用3-10倍重量的水煎煮至少2次,每次1-2小时,过滤后合并滤液。
5.一种助婴幼儿消化和睡眠的中药制剂,其特征在于包括权利要求1的中药组合物,和与制剂剂型对应的、药学上可接受的药用辅料,药用辅料的重量份数为30-60份。
6.根据权利要求5的中药制剂,其特征在于药用辅料选自葡萄糖、蔗糖、糊精、可溶性淀粉中的一种或多种。
7.根据权利要求5的中药制剂,其特征在于还包含口味调节剂、防腐剂、pH调节剂中的一种或多种。
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