CN107669837A - 一种具有减肥作用的药物组合物 - Google Patents
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Abstract
本发明属于医药技术或保健食品等技术领域,具体涉及一种具有减肥作用的药物组合物,其中药物组合物包括魔芋、低聚木糖、决明子提取物、绿茶提取物、山楂提取物、葡萄籽提取物。本发明药物组合物采用现代药理试验筛选获得,药理试验和临床试验表明,本发明药物组合物具有很好的减肥降脂的功效。
Description
技术领域
本发明属于医药技术或保健食品等技术领域,具体涉及一种具有减肥作用的药物组合物。
背景技术
肥胖症是一种由多种因素引起的慢性代谢性疾病,以体内脂肪细胞的体积和细胞数增加致体脂占体重的百分比异常增高并在某些局部过多沉积脂肪为特点。单纯性肥胖患者全身脂肪分布比较均匀,没有内分泌紊乱现象,也无代谢障碍性疾病,其家族往往有肥胖病史。随着社会的发展、生活水平的提高,肥胖已经成为当前一个世界性的公共卫生问题,这是因为肥胖与多种疾病的发生相关,是糖尿病、心血管病、高血压的危险因素。近年来,超重和肥胖的患病率在全世界呈上升趋势,目前全球有高达1亿多肥胖患者。国内外研究证实,肥胖症不但体型异常,而且存在糖脂代谢异常。中医认为肥胖是在内外因素作用下,脏腑功能失调导湿、痰饮、膏脂等壅盛于体内而致。现代医学认为饮食,营养过剩,摄入量高于人体消耗而以脂肪形式存于体内形成肥胖。
目前已在临床应用和正在研究的各种减肥药主要有中枢性食欲抑制剂、消化吸收阻滞剂、代谢促进剂、肥胖基因产物和其他治疗肥胖的药物,这些减肥药物都或多或少存在些副作用的,中药治疗肥胖是从整体出发,严格按照辨证论治的原则进行的,具有疗效确切,副作用少,有着西药不可替代的综合优势。
发明内容
基于上述原因,申请人经过多次创造性筛选试验,得到一种新的药物组合物,该药物组合物含有魔芋、低聚木糖、决明子提取物、绿茶提取物、山楂提取物、葡萄籽提取物,本发明药物组合物采用现代药理试验筛选获得,药理试验和临床试验表明,本发明药物组合物具有很好的减肥降脂的功效。
本发明通过下述技术方案实现的。
一种药物组合物,药物组合物包括:魔芋、低聚木糖、决明子提取物、绿茶提取物、山楂提取物、葡萄籽提取物。
所述的一种药物组合物,其中魔芋70-90重量份、低聚木糖50-70重量份、决明子提取物45-55重量份、绿茶提取物45-55重量份、山楂提取物45-55重量份、葡萄籽提取物15-25重量份。
所述的一种药物组合物,其中魔芋80重量份、低聚木糖60重量份、决明子提取物50重量份、绿茶提取物50重量份、山楂提取物48重量份、葡萄籽提取物20重量份。
所述的药物组合物在减肥药物中的应用。
所述的药物组合物在减肥食品或减肥功能的保健食品中的应用。
所述的药物组合物为原料制备成的药物制剂。
所述的药物组合物为原料制备成的口服制剂。
所述的口服制剂包括片剂、胶囊剂和颗粒剂。
所述的口服制剂辅料包括赤藓糖醇、绿茶香精和甜菊糖苷。本发明采用上述辅料,可以用于糖尿病病人的应用。
本发明所述魔芋为魔芋精粉,又称魔芋粉或魔芋甘露聚糖;
本发明药物组合物中,魔芋具有活血化瘀、解毒消肿、宽肠通便、化痰软坚的作用,低聚木糖,具有防止便秘、降低胆固醇等的作用,二者为方中君药;辅以臣药决明子、绿茶、山楂、葡萄籽的提取物,共奏降脂、减肥之功效。
本发明药物组合物,是通过现代医学试验筛选获得的。
本发明试验原料来源,见表1。
表1本发明试验原料来源
具体实施例
以下以具体实施例来说明本发明的技术方案,但本发明的保护范围不限于此。
本说明书实施例所述的内容仅仅是对发明构思的实现形式的列举,本发明的保护范围不应当被视为仅限于实施例所陈述的具体形式,本发明的保护范围也及于本领域技术人员根据本发明构思所能够想到的等同技术手段。尽管以下本发明的实施方案进行了描述,但本发明并不局限于上述的具体实施方案和应用领域,下述的具体实施方案仅仅是示意性的、指导性的,而不是限制性的。本领域的普通技术人员在本说明书的启示下和在不脱离本发明权利要求所保护的范围的情况下,还可以做出很多种的形式,这些均属于本发明保护之列。
本发明下述试验,是在多次创造性试验的基础上,以本发明所要保护的技术方案为基础,总结的研发人员的结论性试验。
试验1
对营养性肥胖小鼠减肥作用
试验1组:魔芋80mg、低聚木糖60mg;
试验2组:魔芋80mg、低聚木糖60mg、决明子提取物50mg;
试验3组:魔芋80mg、低聚木糖60mg、绿茶提取物50mg;
试验4组:魔芋80mg、低聚木糖60mg、山楂提取物48mg;
试验5组:魔芋80mg、低聚木糖60mg、葡萄籽提取物20mg;
试验6组:魔芋80mg、低聚木糖60mg、决明子提取物50mg、绿茶提取物50mg、山楂提取物48mg、葡萄籽提取物20mg;
试验7组:魔芋80mg、低聚木糖60mg、连翘提取物50mg、绿茶提取物50mg、山楂提取物48mg、山荆子提取物20mg。
试验方法:ICR小鼠,雌雄各半,体重20±2g;将ICR小鼠按体重随机分为正常对照组和高脂饲料组,正常对照组动物从试验开始至结束用普通饲料喂养,其余动物均喂高脂饲料(高脂饲料配方:胆固醇1%、蛋黄粉10%、猪油10%、基础饲料79%),3周后测量体重,高脂饲料组动物体重高于正常对照组,经t检验,数据差异具有显著意义(P<0.01),确定已形成肥胖模型,再将高脂饲料组动物按体重随机分为模型对照组,试验药物组,各试验组给药量为10mg/kg,模型对照组给予等容量的去离子水,17d后,各组小鼠称重,眼眶取血,分离血清备用。记录给药前体重(始重),解剖前体重(终重)。
试验结果:见表2、表3。
表2对营养性肥胖小鼠体重的影响
注:与模型对照组比较**P<0.01,*P<0.05;与试验1组比较#P<0.05。
试验结论:(1)以魔芋和低聚木糖为基本方,分别加入决明子提取物、绿茶提取物、山楂提取物、葡萄籽提取物,在给药量相同的情况下,与试验1组比较(基本方)并没有明显降低大鼠体重(与试验1组比较没有差异);(2)以魔芋和低聚木糖为基本方,加入决明子提取物、绿茶提取物、山楂提取物、葡萄籽提取物,在给药量相同的情况下,能够显著的降低大鼠体重(与试验1组比较具有显著性差异);(3)以魔芋和低聚木糖为基本方,加入连翘提取物、绿茶提取物、山楂提取物、山荆子提取物,并没有显著降低大鼠体重(与试验1组比较没有显著性差异),进一步说明,在以魔芋和低聚木糖为基本方时,选择配伍的成分,不能简单的、随意的选择成分与其组合,充分说明,本发明药物组合物配伍具有科学性。
表3对营养性肥胖小鼠小鼠血清总胆固醇和甘油三酯的影响
注:与模型对照组比较**P<0.01,*P<0.05;与试验1组比较#P<0.05。
试验结论:从血脂试验数据分析,本发明组合物具有很好的降低血脂的作用。
试验2
减肥功能人体试食试验
试验样品:魔芋8kg、低聚木糖6kg、决明子提取物5kg、绿茶提取物5kg、山楂提取物4.8kg、葡萄籽提取物2kg。辅料赤藓糖醇68kg,绿茶香精1.3kg,甜菊糖苷0.4kg。
制备方法:将决明子提取物、绿茶提取物、魔芋、低聚木糖、山楂提取物、葡萄籽提取物分别粉碎,过80目筛后,混合均匀,得到混合粉1;将甜菊糖苷、绿茶香精分别粉碎,过80目筛,混合均匀,得到混合粉2;将混合粉1和混合粉2混合均匀,加入粉碎过80目筛的赤藓糖醇粉,混合均匀,用水制粒,干燥,得到颗粒剂。
受试者入选标准:单纯性肥胖人群,成人BMI大于等于30,或总脂肪百分率达到男大于25%,女大于30%的自愿受试者,签署知情同意书。
排除标准:(1)合并有心、肝、肾和造血***等严重疾病,精神病患者;(2)短期内服用与受试功能有关的药品或食品,影响结果判断者;(3)未按规定食用受试样品,无法判断功效或资料不全影响功效或安全性判断者。
试验方法:纳入受试者106例,试验过程中试食组脱落1人,有效受试者105人,试食组52例,对照组53例,受试者试验前血常规、尿常规、大便常规、肝肾功能、胸透、心电图等检查,均在正常范围内,实施前两组患者年龄、性别、体胖时间、体重指数和百分率指数均无明显差异(P>0.05);试食组给予本发明样品,每次3g,每天2次,餐前服用,热水冲服,搅拌均匀服用,时间60天,对照组给予空白对照。按照盲法进行试食试验。
试验结果:见表4.
表4试食前后体重变化
注:与自身比较***P<0.001;与对照组比较##P<0.01。
试验结论:临床试验表明,本发明药物组合物制备成的制剂具有很好的降低体重的作用,能够在临床中应用于肥胖患者。
制备实施例
实施例1
魔芋70kg、低聚木糖60kg、决明子提取物45kg、绿茶提取物45kg、山楂提取物45kg、葡萄籽提取物15kg。辅料赤藓糖醇651kg,绿茶香精11kg,甜菊糖苷4kg。
制备方法:将决明子提取物、绿茶提取物、魔芋、低聚木糖、山楂提取物、葡萄籽提取物分别粉碎,过80目筛后,混合均匀,得到混合粉1;将甜菊糖苷、绿茶香精分别粉碎,过80目筛,混合均匀,得到混合粉2;将混合粉1和混合粉2混合均匀,加入粉碎过80目筛的赤藓糖醇粉,混合均匀,用水制粒,干燥,得到颗粒剂。
实施例2
魔芋90kg、低聚木糖70kg、决明子提取物55kg、绿茶提取物55kg、山楂提取物55kg、葡萄籽提取物25kg。辅料赤藓糖醇711kg,绿茶香精15.6kg,甜菊糖苷5.1kg。
制备方法:将决明子提取物、绿茶提取物、魔芋、低聚木糖、山楂提取物、葡萄籽提取物分别粉碎,过80目筛后,混合均匀,得到混合粉1;将甜菊糖苷、绿茶香精分别粉碎,过80目筛,混合均匀,得到混合粉2;将混合粉1和混合粉2混合均匀,加入粉碎过80目筛的赤藓糖醇粉,混合均匀,用水制粒,干燥,得到颗粒剂。
实施例3
魔芋80kg、低聚木糖60kg、决明子提取物50kg、绿茶提取物50kg、山楂提取物48kg、葡萄籽提取物20kg。辅料赤藓糖醇680kg,绿茶香精13kg,甜菊糖苷4.4kg。
制备方法:将决明子提取物、绿茶提取物、魔芋、低聚木糖、山楂提取物、葡萄籽提取物分别粉碎,过80目筛后,混合均匀,得到混合粉1;将甜菊糖苷、绿茶香精分别粉碎,过80目筛,混合均匀,得到混合粉2;将混合粉1和混合粉2混合均匀,加入粉碎过80目筛的赤藓糖醇粉,混合均匀,用水制粒,干燥,得到颗粒剂。
实施例4
魔芋78kg、低聚木糖58kg、决明子提取物48kg、绿茶提取物48kg、山楂提取物46kg、葡萄籽提取物16kg。辅料赤藓糖醇672kg,绿茶香精12kg,甜菊糖苷3.9kg。
制备方法:将决明子提取物、绿茶提取物、魔芋、低聚木糖、山楂提取物、葡萄籽提取物分别粉碎,过80目筛后,混合均匀,得到混合粉1;将甜菊糖苷、绿茶香精分别粉碎,过80目筛,混合均匀,得到混合粉2;将混合粉1和混合粉2混合均匀,加入粉碎过80目筛的赤藓糖醇粉,混合均匀,用水制粒,干燥,装胶囊,得到胶囊剂,或者压片,得到片剂。
实施例5
魔芋82kg、低聚木糖65kg、决明子提取物52kg、绿茶提取物52kg、山楂提取物50kg、葡萄籽提取物22kg。辅料赤藓糖醇693kg,绿茶香精14.5kg,甜菊糖苷4.8kg。
制备方法:将决明子提取物、绿茶提取物、魔芋、低聚木糖、山楂提取物、葡萄籽提取物分别粉碎,过80目筛后,混合均匀,得到混合粉1;将甜菊糖苷、绿茶香精分别粉碎,过80目筛,混合均匀,得到混合粉2;将混合粉1和混合粉2混合均匀,加入粉碎过80目筛的赤藓糖醇粉,混合均匀,用水制粒,干燥,装胶囊,得到胶囊剂,或者压片,得到片剂。
Claims (9)
1.一种药物组合物,其特征药物组合物包括:魔芋、低聚木糖、决明子提取物、绿茶提取物、山楂提取物、葡萄籽提取物。
2.根据权利要求1所述的一种药物组合物,其中魔芋70-90重量份、低聚木糖50-70重量份、决明子提取物45-55重量份、绿茶提取物45-55重量份、山楂提取物45-55重量份、葡萄籽提取物15-25重量份。
3.根据权利要求1所述的一种药物组合物,其中魔芋80重量份、低聚木糖60重量份、决明子提取物50重量份、绿茶提取物50重量份、山楂提取物48重量份、葡萄籽提取物20重量份。
4.根据权利要求1-3任一项所述的一种药物组合物,其特征在于药物组合物在减肥药物中的应用。
5.根据权利要求1-3任一项所述的一种药物组合物,其特征在于药物组合物在减肥食品或减肥功能的保健食品中的应用。
6.根据权利要求1-3任一项所述的一种药物组合物,其特征在于药物组合物为原料制备成的药物制剂。
7.根据权利要求1-3任一项所述的一种药物组合物,其特征在于药物组合物为原料制备成的口服制剂。
8.根据权利要求7任一项所述的一种药物组合物,其中口服制剂包括片剂、胶囊剂和颗粒剂。
9.根据权利要求7所述的一种药物组合物,其中口服制剂辅料包括赤藓糖醇、绿茶香精和甜菊糖苷。
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