CN117064964A - 用于减肥的中药组合物 - Google Patents
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Abstract
本申请公开了用于减肥的中药组合物,其由包含以下重量份的原料制备而成:40‑60份的茯苓、20‑40份的荷叶、10‑30份的山楂、20‑40份的葛根、40‑60份的泽泻、20‑40份的决明子、10‑30份的诺丽、10‑30份的榧子;任选地,所述原料还包含5‑15份的朝鲜蓟、5‑15份的金花茶和5‑15份的杜仲雄花。本申请的中药组合物用于预防和/或治疗肥胖症。
Description
技术领域
本申请属于中药领域,更具体地涉及用于减肥的中药组合物。
技术背景
肥胖是由于机体热量摄入超过消耗,多余的热量转化为脂肪过度蓄积体内,使体重增加超过正常20%以上的一种异常体态,严重损害机体健康,也是引起糖尿病、高血压、心脑血管疾病、中风等多种慢性疾病的重要危险因素。肥胖常引起机体激素水平紊乱、慢性炎症反应等,能增加乳腺癌、子宫内膜癌、卵巢癌、前列腺癌、结肠癌、食道癌等癌症的发病率。另外,肥胖人群易产生自卑、敏感、社交恐惧等心理问题,对个人健康及社会造成严重影响,应值得广泛关注和早日防治。
目前,西医对肥胖的治疗主要通过抑制食欲减少机体的热量摄入,或者通过将抑制肠道对营养物种的吸收,或者减少机体脂肪的合成为主,短时间内会达到减肥或减重的目的,但长期服用会对机体造成严重不良反应。
中医对肥胖的认识始于《黄帝内经》,后经过历代医家的不断完善,对肥胖的病因病机认识更为全面,认为肥胖是本虚标实,虚实夹杂之证本,病位在脾,与肝、肾、肺、胃、大肠有关,本虚以脾虚为主,标实以痰湿、湿热、气滞、血瘀为主,各种病机互相夹杂,形成脾虚湿阻证、胃热湿阻证、肝郁气滞证、脾肾阳虚证、阴虚内热证多种肥胖的中医证型,其中脾虚湿阻证人群最多,也是引起其他肥胖的中医证型的基础证型。
脾为后天之本,气血生化之源,主运化,胃为水谷之海,主受纳。脾胃一阴一阳,一升一降,为气机升降之枢纽,若饮食不节、思虑伤脾、久坐伤气,则脾气虚弱升清运化功能减退,水谷肥甘之物无以化生精微气血,反成膏脂痰瘀积聚体内,形成肥胖。脾不升清,清气不升上注于肺,水湿精微不能正常通过肺部百脉进行输布化生,水液内停称为痰湿。脾不能为胃行其津液,胃不能正常腐熟水谷,反而与内停聚的水湿酿成痰瘀,化为肥胖。另外,痰浊内聚,阻碍气血运行,反困于脾,影响运化,形成恶性循环,使肥胖不愈,严重者会影响其他脏腑功能,导致其他疾病发生。
中医对疾病的防治体现以人为本、因人制宜、标本兼治的特点,中药复方配伍具有辨证论治、协同增效的优点,中药副作用小、作用全面,能为广大肥胖人群接受。
本发明需要解决的技术问题在于如何根据肥胖病因病机,筛选验证有效药物,研制针对脾虚湿盛型肥胖的疗效确定、剂型简便且副作用小的中药组合物。
发明内容
针对肥胖特别是脾虚湿阻证肥胖防治的不足,根据中医辨证减肥理论结合现代药理学研究,本申请提供用于治疗肥胖症,特别是中医脾虚湿阻证肥胖的中药组合物,具有标本兼治的作用。
在一个或多个实施方式中,本申请的中药组合物的原料包含茯苓、荷叶、山楂、葛根、泽泻、决明子、诺丽、榧子、朝鲜蓟、金花茶、杜仲雄花,均为药食同源,可应用在肥胖及相关疾病防治的药品、保健食品及功能食品中。
本申请的中药组合物体现“辨证论治”的中医理论,巧妙组方,针对脾虚湿阻型肥胖人群,发挥健脾祛湿、降脂减重的作用,体现出中医“辨证减肥”的独特优势。
本申请的一个或多个实施方式提供用于减肥的中药组合物,其由包含以下重量份的原料制备而成:40-60份(例如45、50、55份)的茯苓、20-40份(例如25、30、35份)的荷叶、10-30份(例如15、20、25份)的山楂、20-40份 (例如25、30、35份)的葛根、40-60份(例如45、50、55份)的泽泻、20-40 份(例如25、30、35份)的决明子、10-30份(例如15、20、25份)的诺丽、 10-30份(例如15、20、25份)的榧子。在一个或多个实施方式中,所述原料还包含5-15份(例如7、10、13份)的朝鲜蓟、5-15份(例如7、10、13份) 的金花茶和5-15份(例如7、10、13份)的杜仲雄花。
在一个或多个实施方式中,所述中药组合物由包含以下重量份的原料制备而成:茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子 30份、诺丽20份、榧子20份。在一个或多个实施方式中,任选地,所述原料还包含朝鲜蓟10份、金花茶10份、和杜仲雄花10份。
在一个或多个实施方式中,所述中药组合物由包含以下重量份的原料提取而成:40-60份的茯苓、20-40份的荷叶、10-30份的山楂、20-40份的葛根、40-60 份的泽泻、20-40份的决明子、10-30份的诺丽、10-30份的榧子。在一个或多个实施方式中,所述原料还包含5-15份的朝鲜蓟、5-15份的金花茶、和5-15 份的杜仲雄花。
在一个或多个实施方式中,所述中药组合物由包含以下重量份的原料提取而成:茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子 30份、诺丽20份、榧子20份;任选地,所述原料还包含朝鲜蓟10份、金花茶10份和杜仲雄花10份。
在一个或多个实施方式中,所述中药组合物由包含以下重量份的原料用水提取而成:40-60份的茯苓、20-40份的荷叶、10-30份的山楂、20-40份的葛根、 40-60份的泽泻、20-40份的决明子、10-30份的诺丽、10-30份的榧子。在一个或多个实施方式中,所述原料还包含5-15份的朝鲜蓟、5-15份的金花茶和5-15 份的杜仲雄花。
在一个或多个实施方式中,所述中药组合物由包含以下重量份的原料用水提取而成:茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份。在一个或多个实施方式中,所述原料还包含朝鲜蓟10份、金花茶10份和杜仲雄花10份。
在一个或多个实施方式中,所述中药组合物还包含辅料,并被制成片剂、散剂、颗粒剂、胶囊剂、茶剂、或口服液。
一个或多个实施方式提供本申请的用于减肥的中药组合物的制备方法,包括以下步骤:
(1)称取以下重量份的原料:40-60份(例如45、50、55份)的茯苓、 20-40份(例如25、30、35份)的荷叶、10-30份(例如15、20、25份)的山楂、20-40份(例如25、30、35份)的葛根、40-60份(例如45、50、55 份)的泽泻、20-40份(例如25、30、35份)的决明子、10-30份(例如15、 20、25份)的诺丽、10-30份(例如15、20、25份)的榧子,以及任选的 5-15份(例如7、10、13份)的朝鲜蓟、5-15份(例如7、10、13份)的金花茶和5-15份(例如7、10、13份)的杜仲雄花;或者,茯苓50份、荷叶 30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份,以及任选的朝鲜蓟10份、金花茶10份和杜仲雄花10份;
(2)将称量后的药材用水提取1-2次,将提取液过滤,得到滤液,将所述滤液浓缩,得到中药组合物浸膏;
(3)任选地,将所述中药组合物浸膏干燥,得到干浸膏,将所述干浸膏粉碎,得到中药组合物干燥粉末。
在一个或多个实施方式中,在步骤(2)之前,将称量后的药材用水浸泡0.5-1小时。
在一个或多个实施方式中,在所述步骤(2)中,将称量后的药材用重量为所述药材重量12倍和10倍重量的水分别提取1-2小时,或1.5小时,过滤得滤液,合并两次滤液;将所述滤液在55℃-60℃下浓缩,得到中药组合物浸膏。
在一个或多个实施方式中,在所述步骤(3)中,将所述中药组合物浸膏在55℃-60℃下进行减压干燥,得到干浸膏,将所述干浸膏粉碎,粉碎后过80目筛,得到中药组合物干燥粉末。
一个或多个实施方式提供本申请用于减肥的中药组合物在制备用于预防和/或治疗肥胖症的药物、保健食品、功能食品或保健品中的用途。
在一个或多个实施方式中,所述肥胖症为脾虚湿阻型肥胖症。
一个或多个实施方式提供本申请用于减肥的中药组合物在制备用于健脾除湿和/或降脂的药物中的用途。
在一个或多个实施方式中,用于减肥的中药组合物,其由包含以下重量份的原料或原料的粉末混合而成:40-60份的茯苓、20-40份的荷叶、10-30 份的山楂、20-40份的葛根、40-60份的泽泻、20-40份的决明子、10-30份的诺丽、10-30份的榧子;任选地,所述原料或原料的粉末还包含5-15份的朝鲜蓟、5-15份的金花茶和5-15份的杜仲雄花的粉末。
在一个或多个实施方式中,用于减肥的中药组合物,其由包含以下重量份的原料或原料的粉末混合而成:茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份;任选地,所述原料或原料的粉末还包含朝鲜蓟10份、金花茶10份和杜仲雄花10份的粉末。
在一个或多个实施方式中,称量各个药材后,将各个药材用水分别提取 1-2次。
在一个或多个实施方式中,称量各个药材后,将各个药材混合后用水提取1-2次。
在一个或多个实施方式中,称量各个药材后,将各个药材粉碎并混合后用水提取1-2次。
在一个或多个实施方式中,采用以下方法制备本申请的中药组合物:
(1)称取:按照上述组分重量配比称取各原料药材并混合;
(2)提取:向混合后的药材加12倍量的纯净水浸泡0.5小时,煎煮1.5 小时,过滤后得到滤液,第二次加10倍量的水,煎煮1.5小时,过滤得到滤液,合并两次滤液;
(3)浓缩:将所述滤液在55℃-60℃下浓缩为稠膏;
(4)干燥:将得到的稠膏在55℃-60℃减压干燥,得到干浸膏,粉碎后过80目筛,得中药组合物的干膏粉。
茯苓为多孔菌科真菌茯苓Poriacocos(Schw.)Wolf的干燥菌。味甘、淡,性平,归心、肺、脾、肾经,能利水渗湿,健脾宁心。
荷叶为睡莲科植物莲Nelumbo nucifera Gaertn.的干燥叶。味苦性平,归肝、脾、胃经,能清暑化湿,升发清阳。
山楂为蔷薇科植物山里红Crataegus pinnatifida Bge.var.major N.E.Br. 或山楂Crataegus pinnatifida Bge.的干燥成熟果实。味酸、甘,性微温。归脾、胃、肝经,能消食健胃,行气散瘀,化浊降脂。
葛根为豆科植物野葛Pueraria lobata(Willd.)Ohwi或甘葛藤PuerariathomsoniiBenth.的干燥根。味甘、辛,性凉,归脾、胃、肺经,能解肌退热,生津止渴,升阳止泻,通经活络。
泽泻为泽泻科植物泽泻Alisma orientalis(Sam.)Juzep.的干燥块茎。味甘、淡,性寒,归肾、膀胱经,能泄热利水渗湿,化浊降脂。
决明子为豆科植物决明Cassia obtusifoliaL.或小决明Cassia toraL.的干燥成熟种子。味甘、苦、咸,性微寒,归肝、大肠经,能清热明目,润肠通便。
诺丽为茜草科植物海巴戟天(又称海巴戟)Morindacitrifolia L.的干燥果实。味酸、甘,性平,归肾、肝、脾经,能益气养阴,滋补肝肾。
榧子为红豆杉科植物榧Torreya grandis Fort.的干燥成熟种子。味甘,性平。归肺、胃、大肠经,能杀虫消积,润燥通便。
朝鲜蓟为菊科植物菜蓟Cynara scolymus L.的干燥叶。味苦,性微寒,归脾、胃、肝、胆经,能消积导滞,理气和胃,清利湿热,化浊降脂。
金花茶为山茶科植物金花茶Camellia chrysantha(Hu)Tuyama的干燥叶或花。味微苦、涩,性平,能清热解毒,利尿消肿。
杜仲雄花为杜仲科植物杜仲Eucommia ulmoidesOliv.的雄性树的干燥花。能镇静安神、保肝护肝、滋阴补肾、通肠润便。
在一个或多个实施方式中,本申请的中药组合物适用于肥胖特别是脾虚湿阻证肥胖,以肥胖,尤其腹部肥胖胀满明显,肌肉松软,脾胃功能减退为主症,兼具有出汗多且黏,胸闷痞满,食欲差,痰多,口中发黏或甜,便溏,小便量少或微浑浊,舌苔腻,脉滑。肥胖的根本病机是脾虚为本,痰湿瘀阻为标,脾胃是人体消化吸收实物的首要器官,当饮食不规律、饥饱失常、过量食用寒凉生冷食物时,容易使脾胃损伤,运化功能减退,脾胃功能减退,食物中的营养成分无法被机体消化吸收,过量堆积在体内,直接形成膏脂痰瘀积聚体内,形成肥胖。另外脾主升清,脾虚不能助水液上注于肺部百脉进行输布化生,内停为痰湿痰浊,重浊黏腻,阻碍气血运行,反困于脾,使运化失司,进而形成恶性循环,使肥胖不愈,严重者会影响其他脏腑功能。本申请从肥胖的病因病机入手,健脾为本,除湿为标,标本兼顾,达到脂消身轻的目的。
在一个或多个实施方式中,本申请的用于减肥的中药组合物,紧扣脾虚湿盛的肥胖关键病机,以补脾健脾醒脾运脾为本,脾胃功能正常,后天之本得养,则饮食中的营养物质得以消化吸收,机体中水液得以正常运化输布和代谢,除湿化浊为标;不仅祛除体内已聚的痰浊膏脂,还能阻滞新的痰浊的形成,即促进机体脂肪的代谢,减少脂肪的形成,配伍科学,协同增效,标本兼治,达到脂消身轻的效果。原料均属于药食同源,成分稳定易吸收,安全性有保证,无毒副作用,可长期使用。
附图说明
图1表示各组大鼠肝组织油红染色结果(×200),其中:
A:空白组;B:模型组;C:奥利司他组;D:实施例1组合物高剂量组; E:实施例1组合物中剂量组;F:实施例1组合物低剂量组。
具体实施方式
为了使本发明的目的、技术方案和优点更加清晰,通过以下具体实施例对本发明的技术进行进一步详细说明。应理解,本发明所包含的实施例不局限于以下实施例,基于本发明中的实施例,基于本发明主旨做出的所有其他实施例,都属于本发明保护的范围。
制备实施例1
取茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份和榧子20份,加入纯净水浸泡0.5h,第一次加重量为全部药材重量12倍重量的水,煎煮1.5h,第二次加重量为全部药材重量10 倍重量的水,分别煎煮1.5h,合并两次滤液,将滤液在55℃-60℃下浓缩减压干燥,得中药组合物的干膏粉,加入辅料麦芽糊精、二氧化硅、山梨糖醇、三氯蔗糖,混合均匀,制成规格为8g/袋的粉剂。
制备实施例2
取茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份、朝鲜蓟10份、金花茶10份和杜仲雄花 10份,加入纯净水浸泡0.5h,第一次加重量为全部药材重量12倍重量的水,煎煮1.5h,第二次加重量为全部药材重量10倍重量的水,分别煎煮1.5h,合并两次滤液,将滤液在55℃-60℃下浓缩减压干燥,得中药组合物的干膏粉,加入辅料羧甲基淀粉钠、硬脂酸镁、微晶纤维素混合均匀,采用湿法制粒法,制成规格为0.8g/片的片剂。
制备实施例3
取茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份、朝鲜蓟10份、金花茶10份和杜仲雄花10份,加入纯净水浸泡0.5h,第一次加重量为全部药材重量12倍重量的水,煎煮1.5h,第二次加重量为全部药材重量10倍重量的水,分别煎煮1.5h,合并两次滤液,将滤液在55℃-60℃下浓缩减压干燥,得中药组合物的干膏粉,加入辅料甜菊糖甙、三氯蔗糖、二氧化硅,以湿法制粒制成规格为8g/ 袋的颗粒剂。
活性实施例4对肥胖大鼠的减肥作用
实验方法:取SPF级雄性健康SD大鼠70只,体质量180g-200g,随机抽取10只为空白组,给予普通饲料,其余60只给予高脂饲料(普通饲料中另加如15.0%蔗糖、15.0%猪油)喂养,连续喂养2周。剔除肥胖不敏感大鼠后,将剩余大鼠随机分为模型组、阳性药奥利司他组(0.048g/kg)、实施例1组合物低剂量组(1.2g/kg)、实施例1组合物中剂量组(2.4g/kg)和实施例1组合物高剂量组(3.6g/kg),每组10只,灌胃量为1mL/100g,每日灌胃1次,空白组灌胃生理盐水,连续给药8周,每周记录各组体质量。最后一次给药1h后用 1%戊巴比妥钠麻醉,解剖取肾周围脂肪、睾丸周围脂肪,并称重,计算脂/体比,固定部分肝脏,制备肝脏组织切片。
实验结果:由表1、表2可以得知,与空白组相比,模型组大鼠的体质量、附睾及肾周脂肪含量有显著差异(P<0.01),提示肥胖大鼠模型造模成功;与模型组相比,阳性药奥利司他能明显降低肥胖大鼠的体质量、附睾及肾周围脂肪含量(P<0.01);与模型组相比,实施例1中药组合物的各剂量组,在第四周、第八周均能明显降低肥胖大鼠的体质量(P<0.05,P<0.01),中剂量和高剂量能明显降低附睾及肾周围脂肪含量(P<0.05,P<0.01);表明本申请的中药组合物能促进脂肪代谢且抑制脂肪形成,具有减肥作用。
表1各组大鼠体质量统计结果
注:模型组与空白组相比,#P<0.05,##P<0.01,各给药组与模型组相比,*P <0.05,**P<0.01
表2各组大鼠体脂肪含量及脂/体比统计结果
注:模型组与空白组相比,#P<0.05,##P<0.01;各给药组与模型组相比,*P <0.05,**P<0.01
通过红油染色观察肝细胞内及细胞外结缔组织脂肪分布情况,如图1所示,空白组大鼠肝脏脂肪面积百分比均值为52.12%±14.82,模型组大鼠肝脏脂肪面积占比均值为68.65%±15.92,显著高于空白组大鼠肝脏的脂肪占比;奥利司他组脂肪面积占比53.11%±15.42;实施例1中药组合物的高、中、低剂量组大鼠肝脏脂肪面积占比均值分别为52.75%±8.36、40.02%±13.14和57.25%±12.46,显著低于模型组。表明本申请的中药组合物具能促进脂肪代谢和抑制脂肪形成的作用。
活性实施例5对脾虚湿阻证肥胖大鼠的健脾除湿作用
实验方法:取SPF级雄性健康SD大鼠70只,体质量180g-200g,随机抽取10只为空白组,给予普通饲料,其余60只给予高脂饲料(普通饲料中另加如15.0%蔗糖、15.0%猪油)喂养,连续喂养2周。剔除肥胖不敏感大鼠后,将剩余大鼠随机分为模型组、阳性药参苓白术散组(1.8g/kg)、实施例1组合物低剂量组(1.2g/kg)、实施例1组合物中剂量组(2.4g/kg)和实施例1组合物高剂量组(3.6g/kg),每组10只,灌胃量为1mL/100g,每日灌胃1次。空白组灌胃生理盐水,连续给药8周,期间观察并记录各组大鼠的一般状态,最后一次给药1h后用1%戊巴比妥钠麻醉,腹主动脉取血,保存血清和血浆,取脾脏、胃和小肠组织放于液氮中冻存,用全自动生化分析仪检测血脂四项水平含量,酶联免疫法检测血清胃泌素、血浆胃动素和及胃促生长素水平;采用放射免疫分析法检测血浆白蛋白和血清醛固酮含水平。
实验结果:与空白组相比,模型组大鼠出现进食减少,倦怠懒动,大便黏稠,形状不规则,毛色发黄无光泽的中医脾虚湿阻证的状态;与模型组相比,阳性参苓白术散和实施例1中药组合物的各剂量组的大鼠的精神状态、进食量、大便状态、毛色均有好转。表明本申请的中药组合物能改善脾虚湿阻症状,具有健脾除湿的作用。
水湿内停,聚而为痰浊,瘀于血脉,与现代肥胖导致的血脂异常一致。由表3可以得知,与空白组相比,模型组大鼠的总胆固醇(TC)、甘油三脂(TG) 和低密度脂蛋白(LDL-C)均升高,高密度脂蛋白(HDL-C)降低,差异具有统计学意义(P<0.05,P<0.01),符合现代痰湿内盛中医肥胖血脂的特点;与模型组相比,阳性药参苓白术散能显著降低TC、TG,升高HDL-C(P<0.01, P<0.05);实施例1中药组合物的各剂量组能显著降低TC、TG水平(P<0.01, P<0.05),高剂量组能升高HDL-C(P<0.05),降低LDL-C(P<0.05),其作用效果优于参苓白术散,表明本申请中药组合物能改善湿浊内停导致的血脂升高,具有除湿排浊的作用。
表3对化浊作用(血脂四项)的影响
注:模型组与空白组相比,#P<0.05,##P<0.01;各给药组与模型组相比,*P <0.05,**P<0.01
水湿内停,聚为痰浊,溢于组织,则表现为水肿,与现代肥胖导致的水液代谢异常一致。由表4可以得知,与空白组相比,模型组大鼠血浆白蛋白含量明显下降,血清醛固酮含量升高(P<0.01,P<0.01),水液代谢慢,符合中医痰湿内盛的表现。与模型组相比,阳性药参苓白术散能升高血浆白蛋白含量 (P<0.05),降低血清醛固酮含量(P<0.01);实施例1中药组合物的高剂量和中剂量组能显著升高血浆白蛋白含量(P<0.05),降低血清醛固酮含量(P <0.01,P<0.05),且高剂量组作用效果优于参苓白术散。表明本申请的中药组合物能改善饮湿浊内停导致的水液代谢异常,具有化湿利浊的作用。
表4对利湿作用(水液代谢)的影响
注:模型组与空白组相比,#P<0.05,##P<0.01,各给药组与模型组相比,*P <0.05,**P<0.01
脾主运化,脾虚则对营养物质的消化、吸收以及运输失常,与现代肥胖导致的消化系统的功能异常一致。由表5可以得知,与空白组相比,模型组大鼠血清胃泌素、血浆胃动素和及胃促生长素水平显著降低(P<0.01);脾胃消化能力降低,符合中医脾虚的特征。与模型组相比,阳性药参苓白术散能提高胃动素和胃促生长素的水平(P<0.05)。实施例1中药组合物的各剂量组能显著升高血清胃泌素、血浆胃动素和及胃促生长素水平(P<0.05,P<0.01),且中剂量和高剂量组作用效果优于参苓白术散。表明本申请的中药组合物能改善脾虚导致的胃肠激素水平紊乱,增强消化功能,具有健脾运脾的作用。
表5对脾脏运化作用(胃肠激素)的影响
注:模型组与空白组相比,#P<0.05,##P<0.01,各给药组与模型组相比,*P <0.05,**P<0.01
临床实施例6
病例1:陈某,女,32岁,河南郑州人。身高160cm,体重75kg,BMI 为29.3,腰围110cm,自述自生育后体重一直不降,腹部肥胖明显,并伴有高血脂,平素胃口差,易疲劳,口中发黏,痰多,大便不规律且成形,活动多时易气喘,尝试多种减肥方法均无果,经诊断为典型的脾虚湿阻型肥胖。于2021 年2月开始服用本申请实施例2所制备的片剂,口服,每天早中晚各一次,一次2片。服用1个月后,体重为70kg,胃口转好,疲劳感减轻,大便成形;连续服用3个月后,体重为54kg,腰围82cm,BMI为21.1,血脂正常,脂肪肝消失,饮食、大便等恢复正常,停止服用后体重无反弹,各种不适症状没有出现,生活正常。
临床实施例7
病例2:张某,男,45岁,江苏无锡人。身高180cm,体重93kg,BMI 为28.7,腰围128cm,并伴有高血压、高血脂、脂肪肝等,自述因肥胖导致行动不便,曾服用多种减肥药,停药后体重反弹。于2021年9月开始服用本申请实施例3所制备的颗粒剂,热水冲服,每天早中晚各一次,一次一袋。服用1 个月后,体重为85kg;连续服用3个月后,体重为73kg,腰围96cm,BMI为 22.5,血压稳定,甘油三酯、胆固醇和低密度脂蛋白均降低,停止服用后体重无反弹,血脂指标稳定,生活恢复正常。
安全性实施例8本申请中药组合物的安全性研究
取20只6周龄的昆明种小鼠,雌雄性各半,体重18-22g,适应喂养一周后,根据实施例1中制备急毒实验用药200g/kg(相当于人临床用药量的100 倍),灌胃量为0.2ml/10g,4h内分两次灌胃,观察7天,并记录各小鼠整体状况及死亡情况。
结果显示各组小鼠整体状态正常,未出现死亡现象,表明本发明专利的中药组合物安全,没有毒副作用。
综上所述,本发明中的中药组合物具有原料安全,适合长期服用,制备工艺简单,适合工业化生产,对于肥胖症具有治疗效果,尤其针对脾虚湿阻证肥胖具有显著的健脾除湿、消脂轻身的功效。
Claims (10)
1.用于减肥的中药组合物,其由包含以下重量份的原料制备而成:40-60份的茯苓、20-40份的荷叶、10-30份的山楂、20-40份的葛根、40-60份的泽泻、20-40份的决明子、10-30份的诺丽、10-30份的榧子;任选地,所述原料还包含5-15份的朝鲜蓟、5-15份的金花茶和5-15份的杜仲雄花。
2.如权利要求1所述的中药组合物,所述中药组合物由包含以下重量份的原料制备而成:茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份;任选地,所述原料还包含10份朝鲜蓟、金花茶10份和杜仲雄花10份。
3.如权利要求1所述的中药组合物,所述中药组合物由包含以下重量份的原料提取而成:40-60份的茯苓、20-40份的荷叶、10-30份的山楂、20-40份的葛根、40-60份的泽泻、20-40份的决明子、10-30份的诺丽、10-30份的榧子;任选地,所述原料还包含5-15份的朝鲜蓟、5-15份的金花茶和5-15份的杜仲雄花;
优选地,所述中药组合物由包含以下重量份的原料提取而成:茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份;任选地,所述原料还包含10份的朝鲜蓟、金花茶10份和杜仲雄花10份。
4.如权利要求1所述的中药组合物,所述中药组合物由包含以下重量份的原料用水提取而成:40-60份的茯苓、20-40份的荷叶、10-30份的山楂、20-40份的葛根、40-60份的泽泻、20-40份的决明子、10-30份的诺丽、10-30份的榧子;任选地,所述原料还包含5-15份的朝鲜蓟、5-15份的金花茶和5-15份的杜仲雄花;
优选地,所述中药组合物由包含以下重量份的原料用水提取而成:茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份;任选地,所述原料还包含朝鲜蓟10份、金花茶10份和杜仲雄花10份。
5.如权利要求书1-4中任一项所述的中药组合物,所述中药组合物还包含辅料,并被制成片剂、散剂、颗粒剂、胶囊剂、茶剂、或口服液。
6.权利要求书1-5中任一项所述的用于减肥的中药组合物的制备方法,包括以下步骤:
(1)称取以下重量份的原料:40-60份的茯苓、20-40份的荷叶、10-30份的山楂、20-40份的葛根、40-60份的泽泻、20-40份的决明子、10-30份的诺丽、10-30份的榧子,以及任选的5-15份的朝鲜蓟、5-15份的金花茶和5-15份的杜仲雄花;优选地,茯苓50份、荷叶30份、山楂20份、葛根30份、泽泻50份、决明子30份、诺丽20份、榧子20份,以及任选的朝鲜蓟10份、金花茶10份和杜仲雄花10份;
(2)将称量后的药材用水提取1-2次,将提取液过滤,得到滤液,将所述滤液浓缩,得到中药组合物浸膏;
(3)任选地,将所述中药组合物浸膏干燥,得到干浸膏,将所述干浸膏粉碎,得到中药组合物干燥粉末。
7.如权利要求6所述的制备方法,其中
任选地,在步骤(2)之前,将称量后的药材用水浸泡0.5-1小时;
在所述步骤(2)中,将称量后的药材用重量为所述药材重量12倍和10倍重量的水分别提取1-2小时,优选1.5小时,过滤得滤液,合并两次滤液;将所述滤液在55℃-60℃下减压浓缩,得到中药组合物浸膏;
在所述步骤(3)中,将所述中药组合物浸膏在55℃-60℃下进行减压干燥,得到干浸膏,将所述干浸膏粉碎,粉碎后过80目筛,得到中药组合物干燥粉末。
8.权利要求书1-5中任一项所述的用于减肥的中药组合物在制备用于预防和/或治疗肥胖症的药物、保健食品、功能食品或保健品中的用途。
9.如权利要求8所述的用途,其中所述肥胖症为脾虚湿阻型肥胖症。
10.权利要求书1-5中任一项所述的用于减肥的中药组合物在制备用于健脾除湿和/或降脂的药物中的用途。
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