CN112915131A - 一种具有燃烧脂肪功能的中药组合物 - Google Patents
一种具有燃烧脂肪功能的中药组合物 Download PDFInfo
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Abstract
本发明公开了一种具有燃烧脂肪功能的中药组合物,按照重量份数包括:柑橘果粉6‑25份、葛花提取物5‑15份、L‑阿拉伯糖10‑22份、岩藻黄素2‑13份、金针菇粉6‑18份和红参粉4‑15份。本发明的中药组合物成分明确,服用量小,疗效稳定,安全性高,通过药效试验可知,可以显著的促进斑马鱼脂肪的分解、抑制脂肪的吸收,不仅符合传统中医药燃烧脂肪的组方原则,而且符合中药现代化的发展要求,对推动医药产业从仿制向自主创新转变以及对推动我国中药国际化具有重要意义。
Description
技术领域
本发明属于中医药领域,具体涉及一种具有燃烧脂肪功能的中药组合物。
背景技术
世界卫生组织WHO对于超重和肥胖的定义是:可损害健康的异常或过量脂肪累积。
数据显示,2019年中国肥胖人口规模超2.5亿人,肥胖人群规模的发展,以及由肥胖引起的健康问题已逐渐成为社会关注的焦点。七成受访网民认为形体管控与健康相关,国民对于个人体重健康相关意识较强。
市场调研分析,现时代肥胖群体增加的原因复杂,其实与人类生活环境及人文文化有一定关系,尤其,年轻人导致肥胖现象较普遍,肥胖人群中80和90后的体质指数高于60与70后,跟他们生活的环境是离不开的。随着生活水平的提高及购物的便利性,因为他们生活添加对比之前出生人群更优越,饮食多样化更丰富,鱼肉类食品不在缺乏,目前交通便利,随着人们收入提高,汽车行业发展使人均都可拥有一辆汽车,减少走路运动量。对于互联网信息现代的兴起人们对购买食物更加便利,不需要逛街或走很远的路购物,同时这些导致了年轻人运动量的减少。超重和肥胖,一方面会带来生理外观的不美和生活的不便,影响生活质量;另一方面,它会引起身心障碍,尤其对年轻人而言,使他们产生自卑,焦虑和抑郁等问题;最重要的是,它与诸多危及健康的疾病密切相关。
世界卫生组织预计到2030年,全球超重人口将突破21.6亿,肥胖人口将达到11.2亿。2008年我国的超重人数为25.4%,肥胖人数为5.7%,到2020年,我国的肥胖人数可能超过美国的肥胖人数。大量研究证实,肥胖不仅与糖尿病、多囊卵巢综合征等代谢性疾病密切相关,也是引发高血压、高血脂、动脉粥样硬化等代谢性疾病的独立危险因素,给健康造成极大危害。肥胖已经成为21世纪威胁人类健康和生命安全的头号杀手。生活水平的提高和生活方式的改变是我国肥胖症发病率迅速升高的主要原因。
肥胖的病机归于脾失健运,水谷精微传输失职,聚生痰湿;或胃强脾弱,胃火灼津,成痰成饮,痰饮流溢肌肤;或肝失疏泄,气机失调,脾胃运化失职;或脾肾不足,水湿不化。《素问通评虚实论篇》谓:“肥贵人,则膏梁之疾也。”指出肥胖可因摄入膏粱厚味过多引起,即现代人所说的“富贵病”。《脾胃论》曰:“油腻厚味,滋生痰涎。”肥人多痰湿,痰池虽为脾不运化所致,但痰浊属阴,归属水类,亦为肾所主。肾为先天之本,水火之根,内藏元阴元阳,维持和调节人体的水液代谢。
目前临床上治疗肥胖的方法主要有改变生活方式(饮食、运动疗法)、西药治疗、手术治疗、中医药治疗等。药物干预因其有效性、安全性问题,不容易被广大肥胖患者接受。胃肠外科手术治疗费用较高,术后并发症风险较高,且有严格的手术指征。很多患者往往不能坚持控制饮食、调整饮食结构、增加运动量等方法,最终达不到减肥的效果。中医药疗法具有不良反应小,疗效显著的特点,近年深受广大肥胖患者的喜爱,越来越多的单纯性肥胖患者选择中医药疗法来减肥。
发明内容
本发明针对上述现有技术存在的不足,提供一种具有燃烧脂肪功能的中药组合物。
具体技术方案如下:
一种具有燃烧脂肪功能的中药组合物,按照重量份数包括:柑橘果粉6-25份、葛花提取物5-15份、L-阿拉伯糖10-22份、岩藻黄素2-13份、金针菇粉6-18份和红参粉4-15份。
进一步,所述的中药组合物按照重量份数包括:柑橘果粉8-18份、葛花提取物7-15份、L-阿拉伯糖10-20份、岩藻黄素5-10份、金针菇粉6-12份和红参粉5-10份。
进一步,所述的柑橘果粉为柑橘果实的聚乙二醇提取物;所述的柑橘果实为柳橙、葡萄柚、瓜拉纳、红柳橙和皇帝柑。
再进一步,柳橙、葡萄柚、瓜拉纳、红柳橙和皇帝柑的质量比为1:(2-5):(1-3):(2-4):(1-3),优选为1:3:2.5:2:1。
再进一步,所述的聚乙二醇为PEG2000。
优选地,所述的柑橘果粉的制备工艺包括如下步骤:
将柑橘果实打浆后滤掉汁液,保留残渣;将残渣加入PEG2000/硫酸铵双水相体系中,进行超声提取,收集PEG2000相,干燥后得柑橘果粉。
具体地,在打浆前对柑橘果实进行清洗。
具体地,打浆后使用60-80目双层纱布滤掉汁液。
具体地,料液比(残渣与提取剂的用量比)为1g:(10-30)mL。
具体地,超声提取的工作条件优选为超声频率60-80Hz,超声温度为50-60℃,超声20-30min。
具体地,收集PEG2000相后,在干燥前进行浓缩,浓缩优选使用加压浓缩机,真空度为-0.08Mpa,料液浓缩温度为55-75℃,将滤液浓缩至相对密度为1.05-1.25之间。
具体地,所述的干燥优选为喷雾干燥。
进一步,所述的葛花提取物为葛花的水提取物。具体为葛花的水提取物的喷雾干燥粉。
进一步,所述的金针菇粉为新鲜金针菇破碎后过滤所得的滤液的干燥粉,优选为冷冻干燥粉。
进一步,所述的红参粉为红参的水提取物。
再进一步,于50-60℃对红参进行微波提取30min,微波提取功率设定为300W,频率为50Hz。
本发明还提供了上述中药组合物在具有燃烧脂肪功能的保健食品中的应用。
进一步,以所述的中药组合物为有效成分,制备成片剂、颗粒剂、硬胶囊剂、丸剂、滴丸、软胶囊、软糖、凝胶糖果或口服液。
组方的药理分析如下:
葛花是豆科植物野葛或甘葛藤的干燥花,是我国的传统药材之一。研究结果显示葛花提取物可以透过抑制肝脏中的脂肪生成,促进白色脂肪组织进行脂肪分解,用棕色脂肪促进脂肪燃烧的作用,达到抗肥胖和抗脂肪肝的效果。
柑橘果粉:柑橘果粉可以抑制磷酸二酯酶(PDE-4)对环磷酸腺苷(cAMP)的水解作用,使身体产生更多的cAMP,较高浓度的cAMP可以激活脂肪细胞中的脂肪酶,增加三油甘酯链的切断比率,从而释放更多游离脂肪酸为机体提供能量,减脂脂肪细胞体积。
金针菇粉:是它具有的多种成分的协同作用,包括抑制脂肪吸收的植物壳聚糖和能够分解脂肪的脂肪酸混合物等。脂肪酸混合物能够直接作用于人体脂肪组织的脂肪细胞中的堆积的中性脂肪(甘油三酯),所以可以减去体内脂肪并降低肥胖发展趋势。从生物学角度来说,体重的减少可直接反应体内脂肪的减少。加速体内脂肪的燃烧。脂类化合物激活脂肪细胞,加速脂肪燃烧。
红参粉:红参是人参经蒸熟、干燥制作的熟制品,不仅保留了人参的多种有效成分,更在熟制过程中新产生多种红参特有皂苷,同时非皂苷含量也有所上升,使其具有更好的补气培元、益血生津、强心健胃等作用。研究显示,服用一定量红参具有提高运动能力、缓解疲劳的功效,且发挥这一作用的主要成分或是人参皂苷。
L-阿拉伯糖:L-阿拉伯糖是一种五碳单糖,最初从阿拉伯树胶中分离得到。在自然界中,L-阿拉伯糖很少以游离的状态存在,多以杂多糖的形式存在于水果和粗粮的皮壳(半纤维素、果胶)中。
岩藻黄质(fucoxanthin)也被称为褐藻黄素、岩藻黄素,是类胡萝卜素中叶黄素类的一种天然色素,占大约700种天然出现的类胡萝卜素总量的10%以上,颜色呈淡黄至褐色,为褐藻、硅藻、金藻及黄绿藻所含有的色素。广泛存在于各种藻类、海洋浮游植物、水生贝壳类等动植物中。具有抗肿瘤、抗炎、抗氧化、减肥、神经细胞保护,增加小鼠体内的ARA(花生四烯酸)和DHA(二十二碳六烯酸)的含量等药理作用。岩藻黄素具有燃烧脂肪细胞,消除脂肪堆积的作用,并通过两种方式消除脂肪堆积,(1)岩藻黄素能够减少腹部白色脂肪组织(WAT)重量;(2)可以调解线粒体解耦连蛋白1(UCPl)表达,促进脂肪分解,从而起到显著的减肥效果,使岩藻黄素在减肥市场中占据重要地位。
本发明的有益效果如下:
本发明的中药组合物成分明确,服用量小,疗效稳定,安全性高,通过药效试验可知,可以显著的促进斑马鱼脂肪的分解、抑制脂肪的吸收,不仅符合传统中医药燃烧脂肪的组方原则,而且符合中药现代化的发展要求,对推动医药产业从仿制向自主创新转变以及对推动我国中药国际化具有重要意义。
具体实施方式
以下结合实例对本发明的原理和特征进行描述,所举实例只用于解释本发明,并非用于限定本发明的范围。
实施例1
一种具有燃脂功能的中药组合物,其成分为:柑橘果粉54g,葛花提取物30g,L-阿拉伯糖60g,岩藻黄素30g,金针菇粉20g,红参粉15g。
以上述中药组合物为有效成分,制备颗粒剂,包括以下步骤:
1、制备中药组合物中的柑橘果粉、葛花提取物、金针菇粉和红参粉:
(1)制备柑橘果粉:
取质量比为1:3:2.5:2:1的柳橙、葡萄柚、瓜拉纳、红柳橙、皇帝柑五种水果进行清洗处理,打浆之后,用80目双层纱布滤掉汁液,残渣加入PEG2000/硫酸铵双水相体系中,料液比1g:20mL,超声30min,超声温度为60℃,超声频率60Hz,收集PEG2000相,用加压浓缩机进行浓缩,真空度为-0.08Mpa,料液浓缩温度为70℃,将滤液浓缩至相对密度为1.05-1.25之间,对浓缩液进行喷雾干燥,所得物料过60目筛,即得柑橘果粉。
(2)制备葛花提取物:
取干燥的葛花,与8倍重量的水混合,煎煮1.5h,过滤,向所得滤渣中加入滤渣6倍重量的水,煎煮1h,过滤,合并2次滤液,滤液浓缩至相对密度1.15-1.20,搅拌均匀后喷雾干燥,过筛混合后即得葛花提取物。
(3)制备金针菇粉:
以新鲜金针菇为原料,经挑选、去杂、清洗后,打浆,过滤浆液,对滤液进行浓缩,灭菌后进行冷冻干燥,即得金针菇粉。
(4)制备红参粉:
取红参,经粉碎处理后,与其8倍重量的水混合,于50℃进行微波提取30min,微波提取功率设定为300W,频率为50Hz;用管式离心机离心分离残渣,离心机转速为12000转/min,得提取液;用0.2μm的陶瓷膜过滤,得滤液;滤液浓缩至相对密度1.15-1.25,进行履带式干燥,粉碎过筛混合后即得红参粉。
2、制备颗粒剂:
颗粒剂除了中药组合物各组分外,还包括罗汉果甜苷1g,麦芽糊精200g。
将各组分分别过60目筛,混合均匀,使用50%乙醇作为黏合剂,制成软材。将软材经16目筛选的摇摆制粒机制成颗粒,将颗粒置入多功能沸腾干燥机中,设置进风温度70℃,干燥20min,控制颗粒水分在5%以下,整理,装袋,制成6g/袋,样品共400g。
实施例2
一种具有燃脂功能的中药组合物,其成分为:柑橘果粉40g,葛花提取物25g,L-阿拉伯糖50g,岩藻黄素15g,金针菇粉30g,红参粉30g。
使用实施例1制备的柑橘果粉、葛花提取物、金针菇粉和红参粉。
以上述中药组合物为有效成分,制备颗粒剂;颗粒剂除了中药组合物各组分外,还包括罗汉果甜苷1g,微晶纤维素10g,D-甘露糖醇30g,麦芽糊精30g。
颗粒剂的制备方法同实施例1。
实施例3
一种具有燃脂功能的中药组合物,其成分为:柑橘果粉30g,葛花提取物40g,L-阿拉伯糖45g,岩藻黄素30g,金针菇粉18g,红参粉20g。
使用实施例1制备的柑橘果粉、葛花提取物、金针菇粉和红参粉。
以上述中药组合物为有效成分,制备片剂;片剂中除了中药组合物各组分外,还包括微晶纤维素20g,低聚异麦芽糖60g,硬脂酸镁5g。
上述片剂的制备方法为:将各物料分别过60目筛,将除硬脂酸镁、低聚异麦芽糖以外的物料混合均匀,使用质量浓度70%的低聚异麦芽糖水溶液作为黏合剂,制成软材。将软材经16目筛网的摇摆制粒机制成颗粒,将颗粒置入多功能沸腾干燥机中,设置进风温度为70℃,干燥20min,控制颗粒水分在2.5-3.5%,整粒,在颗粒中加入硬脂酸镁,总混,压片,制成片剂0.35g/片的素片,素片总重250g。
对比例1
制备颗粒剂,其原料组分为:葛花提取物30g,L-阿拉伯糖60g,岩藻黄素30g,金针菇粉20g,红参粉15g,罗汉果甜苷1g,麦芽糊精200g。
制备方法同实施例1。
与实施例1的区别在于,中药组合物中不包括柑橘果粉。
对比例2
制备颗粒剂,其原料组分为:柑橘果粉54g,L-阿拉伯糖60g,岩藻黄素30g,金针菇粉20g,红参粉15g,罗汉果甜苷1g,麦芽糊精200g。
制备方法同实施例1。
与实施例1的区别在于,中药组合物中不包括葛花提取物。
对比例3
制备颗粒剂,其原料组分为:柑橘果粉54g,葛花提取物30g,岩藻黄素30g,金针菇粉20g,红参粉15g,罗汉果甜苷1g,麦芽糊精200g。
制备方法同实施例1。
与实施例1的区别在于,中药组合物中不包括L-阿拉伯糖。
对比例4
制备颗粒剂,其原料组分为:柑橘果粉54g,葛花提取物30g,L-阿拉伯糖60g,金针菇粉20g,红参粉15g,罗汉果甜苷1g,麦芽糊精200g。
制备方法同实施例1。
与实施例1的区别在于,中药组合物中不包括岩藻黄素。
对比例5
制备颗粒剂,其原料组分为:柑橘果粉54g,葛花提取物30g,L-阿拉伯糖60g,岩藻黄素30g,红参粉15g,罗汉果甜苷1g,麦芽糊精200g。
制备方法同实施例1。
与实施例1的区别在于,中药组合物中不包括金针菇粉。
对比例6
制备颗粒剂,其原料组分为:柑橘果粉54g,葛花提取物30g,L-阿拉伯糖60g,岩藻黄素30g,金针菇粉20g,罗汉果甜苷1g,麦芽糊精200g。
制备方法同实施例1。
与实施例1的区别在于,中药组合物中不包括红参粉。
对比例7
制备颗粒剂,其原料组分为:L-阿拉伯糖60g,岩藻黄素30g,金针菇粉20g,红参粉15g,罗汉果甜苷1g,麦芽糊精200g。
制备方法同实施例1。
与实施例1的区别在于,中药组合物中不包括柑橘果粉和葛花提取物。
实验
通过动物实验验证本发明组合物的效果。
一、抑制脂肪吸收的动物实验
1.检测材料
1.1.样品配制信息
将实施例1-3和对比例1-7获得的颗粒剂或片剂,用标准稀释水配制成20.0mg/mL母液,现配现用。
阳性对照:左旋肉碱茶多酚荷叶片,棕色片剂,批号20180404A,汤臣倍健股份有限公司,阴凉储存。用10%DMSO配制成30.0mg/mL母液,-20℃储存。
1.2.实验动物
斑马鱼均饲养于28℃的养鱼用水中(水质:每1L反渗透水中加入200mg速溶海盐,电导率为450-550μS/cm;pH为6.5-8.5;硬度为50-100mg/L CaCO3),由本公司养鱼中心繁殖提供,实验动物使用许可证号为:SYXK(浙)2012-0171,饲养管理符合国际AAALAC认证(认证编号:001458)的要求。黑色素等位基因突变斑马鱼(Albino),以自然成对交配繁殖方式进行。
1.3.仪器、耗材与试剂
解剖显微镜(SZX7,OLYMPUS,Japan);CCD相机(VertA1,上海土森视觉科技有限公司,China);精密电子天平(CP214,OHAUS,USA)。
蛋黄粉(批号20200809,浙江艾格生物科技股份有限公司,China);二甲基亚砜(DMSO,批号BCBZ1685,Sigma,USA);PBS缓冲液(批号70125000,Biosharp,China);1,2-丙二醇(批号20191125,国药集团化学试剂有限公司,China);4%组织细胞固定液(批号20201216,Solarbio,China);油红O(批号MKCJ3586,Sigma,China);甲基纤维素(批号079K0054V,Sigma,USA)。
2.检测方法
2.1抑制脂肪吸收功效评价
随机选取5dpf黑色素等位基因突变斑马鱼于50mL烧杯中,每杯(实验组)处理10尾斑马鱼。分别水溶给予实施例1-3和对比例1-7以中药组合物(有效成分)计浓度为249μg/mL,阳性对照左旋肉碱茶多酚荷叶片407μg/mL浓度,设置模型对照组每杯容量为20mL。28℃处理1h后,各浓度组均水溶给予高脂饲料饲喂斑马鱼建立食物脂肪吸收模型。28℃继续处理30h后,对斑马鱼进行固定,用油红O进行染色,染色结束后,每个实验组选取10尾斑马鱼置于解剖显微镜下拍照,使用NIS-Elements D 3.20高级图像处理软件采集数据,分析肠道至尾部血管脂肪染色强度,以该指标的统计学分析结果评价实施例1-3和对比例1-7抑制脂肪吸收功效。统计学处理结果采用mean±SE表示。用SPSS26.0软件进行统计学分析,p<0.05表明差异具有统计学意义。
3.检测结果
3.1抑制脂肪吸收功效
在本实验条件下,实施例1-3具有明显的抑制脂肪吸收功效,对比例1-7没有明显的抑制脂肪吸收的功效。实验结果详见表1。
表1.实施例1-3和对比例1-7抑制脂肪吸收功效评价实验结果(n=10)
与模型对照组比较,**p<0.01,***p<0.001。
可见,本发明的中药组合物各组分之间产生了显著的协同作用,可有效抑制脂肪吸收,效果与左旋肉碱茶多酚荷叶片相仿。
二、促进脂肪分解功效
1.检测材料
1.1样品配制信息
实施例1-3和对比例1-7,用标准稀释水配制成20.0mg/mL母液,现配现用。
阳性对照:左旋肉碱茶多酚荷叶片,棕色片剂,批号20180404A,汤臣倍健股份有限公司,阴凉储存。用10%DMSO配制成30.0mg/mL母液,-20℃储存。
1.2实验动物
斑马鱼均饲养于28℃的养鱼用水中(水质:每1L反渗透水中加入200mg速溶海盐,电导率为450-550μS/cm;pH为6.5-8.5;硬度为50-100mg/L CaCO3),由本公司养鱼中心繁殖提供,实验动物使用许可证号为:SYXK(浙)2012-0171,饲养管理符合国际AAALAC认证(认证编号:001458)的要求。黑色素等位基因突变斑马鱼(Albino),以自然成对交配繁殖方式进行。
解剖显微镜(SZX7,OLYMPUS,Japan);CCD相机(VertA1,上海土森视觉科技有限公司,China);电动聚焦连续变倍荧光显微镜(AZ100,Nikon,Japan);精密电子天平(CP214,OHAUS,USA);6孔板(Nest Biotech,China)。二甲基亚砜(DMSO,批号BCBZ1685,Sigma,USA);Nile Red(批号MKBP6198V,Sigma,USA);甲基纤维素(批号079K0054V,Sigma,USA)。
2.检测方法
2.1促进脂肪分解功效评价
随机选取2dpf黑色素等位基因突变斑马鱼于6孔板中,每孔(实验组)10尾。分别水溶给予实施例1-3和对比例1-7以中药组合物(有效成分)计浓度为249μg/mL,阳性对照左旋肉碱茶多酚荷叶片45.0μg/mL浓度,同时设置正常对照组,每孔容量为3mL。28℃处理24h,水溶给予尼罗红进行脂肪染色过夜,染色结束后,每个实验组选取10尾斑马鱼置于荧光显微镜下拍照,用NIS-Elements D 3.20高级图像处理软件分析并采集数据,分析卵黄囊荧光强度,以该指标的统计学分析结果评价实施例1-3和对比例1-7促进脂肪分解功效。统计学处理结果采用mean±SE表示。用SPSS26.0软件进行统计学分析,p<0.05表明差异具有统计学意义。
3.检测结果
3.1促进脂肪分解功效
在本实验条件下,实施例1-3具有明显的促进脂肪分解功效,对比例1-7没有明显的促进脂肪分解功效。实验结果见表2。
表2.实施例1-3和对比例1-7促进脂肪分解功效评价实验结果(n=10)
与正常对照组比较,*p<0.05,**p<0.01,***p<0.001。
可见,本发明的中药组合物各组分之间产生了显著的协同作用,可有效促进脂肪分解,效果与左旋肉碱茶多酚荷叶片相仿。
以上所述仅为本发明的较佳实施例,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种具有燃烧脂肪功能的中药组合物,其特征在于,按照重量份数包括:柑橘果粉6-25份、葛花提取物5-15份、L-阿拉伯糖10-22份、岩藻黄素2-13份、金针菇粉6-18份和红参粉4-15份。
2.根据权利要求1所述的中药组合物,其特征在于,所述的中药组合物按照重量份数包括:柑橘果粉8-18份、葛花提取物7-15份、L-阿拉伯糖10-20份、岩藻黄素5-10份、金针菇粉6-12份和红参粉5-10份。
3.根据权利要求1或2所述的中药组合物,其特征在于,所述的柑橘果粉为柑橘果实的聚乙二醇提取物;所述的柑橘果实为柳橙、葡萄柚、瓜拉纳、红柳橙和皇帝柑。
4.根据权利要求3所述的中药组合物,其特征在于,柳橙、葡萄柚、瓜拉纳、红柳橙和皇帝柑的质量比为1:(2-5):(1-3):(2-4):(1-3)。
5.根据权利要求4所述的中药组合物,其特征在于,柳橙、葡萄柚、瓜拉纳、红柳橙和皇帝柑的质量比为1:3:2.5:2:1。
6.根据权利要求3所述的中药组合物,其特征在于,所述的聚乙二醇为PEG2000。
7.根据权利要求6所述的中药组合物,其特征在于,所述的柑橘果粉的制备工艺包括如下步骤:
将柑橘果实打浆后滤掉汁液,保留残渣;将残渣加入PEG2000/硫酸铵双水相体系中,进行超声提取,收集PEG2000相,干燥后得柑橘果粉。
8.根据权利要求1或2所述的中药组合物,其特征在于,
所述的葛花提取物为葛花的水提取物;
所述的金针菇粉为新鲜金针菇破碎后过滤所得的滤液的干燥粉;
所述的红参粉为红参的水提取物。
9.一种如权利要求1-8任一项所述的中药组合物在具有燃烧脂肪功能的保健食品中的应用。
10.根据权利要求9所述的应用,其特征在于,以所述的中药组合物为有效成分,制备成片剂、颗粒剂、硬胶囊剂、丸剂、滴丸、软胶囊、软糖、凝胶糖果或口服液。
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