CN106421173A - 一种供顽固性头痛患者食用的保健食品及其制备方法 - Google Patents
一种供顽固性头痛患者食用的保健食品及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种供顽固性头痛患者食用的保健食品,属于功能性食品技术领域。其由燕麦、黑米、绿豆、黑豆、中药提取物制得;其中中药提取物是由羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草等中药材提取而来的。该保健食品对顽固性头痛具有良好的保健和辅助治疗的效果。与现有技术相比,该保健食品可以药食双补,既避免了长期用药的毒副作用,又解决了有益食材的不便常食的难题;既可以帮助患者改善体质、增强免疫力,去除疾病赖以生存的土壤,又可以缓解疼痛、调理患病器官,辅助治疗疾病以增强常规治疗的效果。
Description
技术领域
本发明属于功能性食品技术领域,涉及一种供顽固性头痛患者食用的保健食品及其制备方法。
背景技术
药膳发源于我国传统的饮食和中医食疗文化,药膳是在中医学、烹饪学和营养学理论指导下,严格按药膳配方,将中药与某些具有药用价值的食物相配伍,采用我国独特的饮食烹调技术和现代科学方法制作而成的具有一定色、香、味、形的美味食品。(简言之,药膳即药材与食材相配伍而做成的美食。)它是中国传统的医学知识与烹调经验相结合的产物。它“寓医于食”,既将药物作为食物,又将食物赋以药用,药借食力,食助药威,二者相辅相成,相得益彰;既具有较高的营养价值,又可防病治病、保健强身、延年益寿。药膳是中医学的一个重要组成部分,是中华民族历经数千年不断探索、积累而逐渐形成的独具特色的一门临床实用学科,是中华民族祖先遗留下来宝贵的文化遗产。
头痛(headache)是临床常见的症状,通常将局限于头颅上半部,包括眉弓、耳轮上缘和枕外隆突连线以上部位的疼痛统称头痛。头痛病因繁多,神经痛、颅内感染、颅内占位病变、脑血管疾病、颅外头面部疾病、以及全身疾病如急性感染、中毒等均可导致头痛。发病年龄常见于青年、中年和老年。
中医认为,头痛的病因可分为外感和内伤两大类。外感头痛多因感受风、寒、湿、热等外邪,而以风邪为主;内伤头痛与肝、脾、肾三脏有关。此外,外伤跌仆,久病人络,气滞血瘀,脉络瘀阻,亦可导致头痛。
病理变化为六淫之邪外袭,上犯巅顶,邪气稽留,阻遏清阳,气血不畅,阻遏络道而致头痛。因于肝者,一因情志所伤,肝失疏泄,郁而化火,上扰清空,而为头痛;一因火盛伤阴,肝失濡养,或肾水不足,水不涵木,导致肝肾阴亏,肝阳上亢,上扰清空而致头痛。因于肾者,多由禀赋不足,肾精久亏,脑髓空虚而致头痛;亦可阴损及阳,肾阳衰微,清阳不展,而为头痛。因于牌者,多系饥饱劳倦,或病后产后体虚,脾胃虚弱,生化不足,或失血之后,营血亏虚,不能上荣于脑髓脉络,而致头痛;或饮食不节,嗜食肥甘,牌失健运,痰湿内生,上蒙清空,阻遏清阳而致头痛。至于外伤跌仆,久病人络,气滞血瘀,脉络瘀阻,不通则痛,每易致头痛。 中医将头痛分成如下辨证分型:
1、风寒头痛症状:头痛时作,痛连项背,遇风尤剧,恶风畏寒,口不渴。舌苔薄白,脉浮。
证候分析:头为诸阳之会,风寒外袭,循太阳经上犯巅顶,清阳之气被遏,故头痛乃作;太阳经主一身之表,其经脉上性巅顶,循项背,故其痛连及项背;风寒束于肌表,卫阳被遏,不得宣达,故恶风畏寒;无热则口不渴;苔薄白,脉浮均为风寒在表之征。
治则:疏散风寒。
2、风热头痛症状:头痛而胀,甚则头痛如裂,发热或恶风,面红目赤,口渴欲饮,便秘渡黄。舌红苔黄,脉浮数。
证候分析:热为阳邪,其性炎上,风热中于阳络,上扰清窍,故头痛而胀,甚则头痛如裂;面红目赤,亦为热邪上炎之征;风热之邪犯卫,故发热恶风;热盛耗津,则口渴欲饮,便秘溲赤;舌红苔黄,脉浮数均为风热邪盛之象。
治则:疏风清热。
3、风湿头痛症状:头痛如裹,肢体困重,纳呆胸闷,小便不利,大便或塘。苔白腻,脉儒。
证候分析:风湿外邪,上犯巅顶,清空为邪阻遏,故头痛如裹;脾司运化而主四肢,湿浊中阻,脾阳为湿所困,故见肢体困重,纳呆胸闷;湿邪内蕴,不能分清泌浊,故小便不利,大便或溏;苔白腻,脉濡均为湿浊中阻之象。
治则:祛风胜湿。
4、肝阳头痛症状:头痛而眩,心烦易怒,夜眠不宁,或兼胁痛,面红口苦。舌苔薄黄,脉弦有力。
证候分析:诸风掉眩,皆属于肝,肝失条达,肝阳偏亢,循经上扰清窍,故头痛而眩;肝火偏亢,扰乱心神,则心烦易怒,夜眠不宁;肝胆气郁化火,肝阳上亢,故胁痛,口苦面红;苔薄黄,脉弦有力均为肝阳亢盛之象。
治则:平肝潜阳。
5、肾虚头痛症状:头痛且空,每兼眩晕,腰痛酸软,神疲乏力,遗精带下,耳鸣少寐。舌红少苔,脉细。
证候分析:脑为髓海,其主在肾,肾虚髓不上荣,脑海空虚,故头脑空痛,眩晕耳鸣;腰为肾之府,肾虚精关不固而遗精,女子则带脉不束而带下;少寐,舌红少苔,脉细是肾阴不足,心肾不交之象。
治则:养阴补肝。
6、血虚头痛症状:头痛而晕,心悸不宁,神疲乏力,面色苍白。舌质淡,苔薄白,脉细弱。
证候分析:血分不足,虚火上逆,故头痛而晕;血不足则心神失养,故心悸易慌:血虚易导致气虚,气虚则神疲乏力;面统,舌淡,脉细弱均为血虚之象。
治则:养血调血。
7、痰浊头痛症状;头痛昏蒙,胸脘满闷,呕恶痰涎。苔白腻,脉滑或弦滑。
证候分析:牌失健运,痰浊中阻,上蒙清窍,清阳不展,故头痛昏蒙;痰阻胸膈,故胸脘满闷;痰浊上这,则呕恶痰涎;苔白腻,脉滑或弦滑均为痰湿内停之征。
治则:化痰降浊。
8、瘀血头痛症状:头痛经久不愈,痛处固定不移,痛如锥刺,或有头部外伤史。舌质紫,苔薄白,脉细或细涩。
证候分析:久病人络,或头部外伤,瘀血内停,脉络不畅,故头痛经久不愈,痛有定处,且如锥刺;舌紫,脉细涩乃瘀血内阻之征。
治则:活血化瘀。
发明内容
本发明要解决的技术问题是,为顽固性头痛患者开发一种保健食品,使该食品对顽固性头痛患者的治疗有较好的保健和辅助作用。
为了解决上述技术问题,发明人的技术方案是,从中国传统的药膳理论出发,结合自身多年积累的中医临床经验和中医养生知识,精心研究食品营养学和食品加工技术,通过反复研究摸索和临床试验的检验调整,最终发明了一种保健食品和一套与之相配的制备方法,由此获得的保健食品对顽固性头痛患者有着十分显著的保健效果和辅助治疗作用。该保健食品的配方以重量份表示为:
燕麦12-50份、黑米10-40份、绿豆5-30份、黑豆1-15份、中药提取物5-15份;
所述中药提取物的原料组成为:羌活6-19份、白芍8-27份、蔓荆子8-30份、川芎7-24份、白芷7-20份、蝉衣2-10份、黄芩6-17份、葛根7-22份、山楂8-28份、丹参7-24份、乳香6-19份、蒺藜8-20份、防风4-15份、桃仁4-18份、甘草5-16份。
在实践中优选出来的具有上佳效果的配方以重量份可以表示为:
燕麦28份、黑米20份、绿豆13份、黑豆5份、中药提取物9份;
所述中药提取物的原料组成为:羌活12份、白芍16份、蔓荆子18份、川芎17份、白芷13份、蝉衣5份、黄芩11份、葛根14份、山楂18份、丹参15份、乳香12份、蒺藜14份、防风8份、桃仁8份、甘草9份。
本发明保健食品的制备工艺为以下步骤:
(1)、按本发明配方准确称取各种原材料,备用;
(2)、将羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草,分别粉碎,混合,加入初始药材5-17倍重量的纯化水,浸泡4-24小时,回流煎煮1-6小时,过滤,再加入初始重量4-12倍重量的纯化水,回流煎煮1-4小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(3)、将步骤(2)的滤渣加5-13倍重量的浓度60-85%的乙醇,回流提取2次,每次1-5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.20-1.25的中药浓缩液,即为中药提取物,备用;
(5)、将黑豆和绿豆分别加6-19倍的水,浸泡4-24小时,带水粉碎,混合;将燕麦粉碎与黑米一起加入,混匀,熬制30-180分钟;将按配方称好的中药提取物加入,继续熬制10-60分钟,冷却即为原料保健品;
(6)、利用现代通用的食品后加工技术,添加适当的辅料,如色素、香精、甜味剂、蔬菜、增稠剂等等,制成液态或干燥粉状,再配合相应的易拉罐、塑料(塑料袋、塑料杯和塑料碗)等简易包装形式,即可制成成品。
本发明保健食品的原材料的营养价值和功用功效:
燕麦:据中国医学科学院卫生研究所综合分析,中国裸燕麦含粗蛋白质达15.6%,脂肪8.5%,还有淀粉释放热量以及磷、铁、钙等元素,与其它8种粮食相比,均名列前茅。燕麦中水溶性膳食纤维分别是小麦和玉米的4.7倍和7.7倍。燕麦中的B族维生素、尼克酸、叶酸、泛酸都比较丰富,特别是维生素E,每100克燕麦粉中高达15毫克。此外燕麦粉中还含有谷类食粮中均缺少的皂甙(人参的主要成分)。蛋白质的氨基酸组成比较全面,人体必需的8种氨基酸含量的均居首位,尤其是含赖氨酸高达0.68克。
燕麦的医疗价值和保健作用,已被古今中外医学界所公认。降低血压、降低胆固醇、防治大肠癌、防治心脏疾病。据1981-1985年中国农科院与北京市心脑血管研究中心、北京市海淀医院等18家医疗单位5轮动物试验和3轮997例临床观察研究证明,裸燕麦能预防和治疗由高血脂引发的心脑血管疾病。即服用裸燕麦片3个月(日服100克),可明显降低心血管和肝脏中的胆固醇、甘油三脂、β-脂蛋白,总有效率达87.2%,其疗效与冠心病无显著差异,且无副作用。对于因肝、肾病变,糖尿病,脂肪肝等引起的继发性高脂血症也有同样明显的疗效。长期食用燕麦片,有利于糖尿病和肥胖病的控制。
黑米:黑米含蛋白质、碳水化合物、B族维生素、维生素E、钙、磷、钾、镁、铁、锌等营养元素,营养丰富;黑米具有清除自由基、改善缺铁性贫血、抗应激反应以及免疫调节等多种生理功能;黑米中的黄铜类化合物能维持血管正常渗透压,减轻血管脆性,防止血管破裂和止血;黑米有抗菌,降低血压、抑制癌细胞生长的功效;黑米还具有改善心肌营养,降低心肌耗氧量等功效。黑米有开胃益中、健脾活血、明目的功效。可抗衰老;补充人体需要的蛋白质、锰、锌等多种矿物资。
绿豆:绿豆中所含蛋白质,磷脂均有兴奋神经、增进食欲的功能,为机体许多重要脏器增加营养所必需;绿豆中的多糖成分能增强血清脂蛋白酶的活性,使脂蛋白中甘油三酯水解达到降血脂的疗效,从而可以防治冠心病、心绞痛;绿豆中含有一种球蛋白和多糖,能促进动物体内胆固醇在肝脏中分解成胆酸,加速胆汁中胆盐分泌并降低小肠对胆固醇的吸收;据临床实验报道,绿豆的有效成分具有抗过敏作用,可治疗荨麻疹等疾病;绿豆对葡萄球菌以及某些病毒有抑制作用,能清热解毒;绿豆含丰富胰蛋白酶抑制剂,可以保护肝脏,减少蛋白分解,从而保护肾脏。经典中医认为:可消肿通气,清热解毒。将生绿豆研碎绞成汁水吞服,可医治丹毒,烦热风疹,药石发动,热气奔腾。补肠胃。可作枕头,使眼睛清亮。可治伤风头痛,消除呕吐。经常吃,补益元气,和调五脏,安神,通行十二经脉,除去皮屑,滋润皮肤,煮汁汤可解渴,解一切药草、牛马、金石之毒。但不可与鲤鱼同吃,否则使人肝黄形成渴病。
黑豆:黑豆中所含的不饱和脂肪酸,可促进胆固醇的代谢、降低血脂,预防心血管疾病,且黑豆的纤维质含量高,可促进肠胃蠕动,预防便秘,所以是不错的减肥佳品。而且黑豆浆不像黄豆性冷,喝多了也不会拉肚子,而且还有治疗风湿、抗衰老等效果。 黑豆浆,全麦面包,可以称之为营养减肥早餐的黄金搭档了。黑豆一直被人们视为药食两用的佳品,因为它具有高蛋白、低热量的特性。有机黑豆中蛋白质含量高达36%-40%,相当于肉类的2倍、鸡蛋的3倍、牛奶的12倍,还能提供食物中粗纤维,促进消化,防止便秘发生。黑豆性平、味甘;归脾、肾经;具有消肿下气、润肺燥热、活血利水、祛风除痹、补血安神、明目健脾、补肾益阴、解毒的作用;用于水肿胀满、风毒脚气、黄疸浮肿、风痹痉挛、产后风疼、口噤、痈肿疮毒,可解药毒,制风热而止盗汗,乌发黑发以及延年益寿的功能。
羌活:本品为伞形科植物羌活(背翅芹)或宽叶羌活的干燥根茎及根。味辛、苦,性温;归膀胱、肾经;散寒,祛风,除湿,止痛。
白芍:本品为毛茛科植物芍药的干燥根。味苦、酸,性微寒;归肝、脾经;平肝止痛,养血调经,敛阴止汗。
蔓荆子:本品为马鞭草科植物单叶蔓荆或蔓荆的干燥成熟果实。味辛、苦,性微寒;归膀胱、肝、胃经;疏散风热,清利头目。
川芎:本品为伞形科植物川芎的干燥根茎。味辛,性温;归肝、胆、心包经;活血行气,祛风止痛。
白芷:本品为伞型科植物白芷或杭白芷的干燥根。味辛,性温;归胃、大肠、肺经;散风除湿,通窍止痛,消肿排脓。
蝉衣:本品为蝉科昆虫黑蚱的幼虫羽化时脱落的皮壳。味甘,性寒;归肺、肝经;散风除热,利咽,透疹,退翳,解痉。
黄芩:本品为唇形科植物黄芩的干燥根。味苦,性寒;归肺、胆、脾、大肠、小肠经;清热燥湿,泻火解毒,止血,安胎。
葛根:本品为豆科植物野葛或甘葛藤的干燥根。味甘、辛,性凉;归脾、胃经;解肌退热,生津,透疹,升阳止泻。
山楂:本品为蔷薇科植物山里红或山楂的干燥成熟果实。味酸、甘、性微温;归脾、胃、肝经;消食健胃,行气散瘀。
丹参:本品为唇形科植物丹参的干燥根及根茎。味苦,性微寒;归心、肝经;祛瘀止痛,活血通经,清心除烦。
乳香:橄榄科乳香树属植物乳香树、药胶香树及野乳香树等,以其树干皮部伤口渗出的油胶树脂入药。味辛苦,性温;入心、肝、脾经;调气活血,定痛,追毒。
蒺藜:本品为蒺藜科植物蒺藜的干燥成熟果实。味辛、苦,性微温; 归肝经;平肝解郁,活血祛风,明目,止痒。
防风:本品为伞形科植物防风的干燥根。味辛、甘,性温;归膀胱、肝、脾经;解表祛风,胜湿,止痉。
桃仁:本品为蔷薇科植物桃或山桃的干燥成熟种子。味苦、甘,性平;归心、肝、大肠经;活血祛瘀,润肠通便。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明保健食品的配方解析:
中医认为顽固性头痛的病因为:六淫之邪外袭,上犯巅顶,邪气稽留,阻遏清阳,气血不畅,阻遏络道而致头痛。因于肝者,一因情志所伤,肝失疏泄,郁而化火,上扰清空,而为头痛;一因火盛伤阴,肝失濡养,或肾水不足,水不涵木,导致肝肾阴亏,肝阳上亢,上扰清空而致头痛。因于肾者,多由禀赋不足,肾精久亏,脑髓空虚而致头痛;亦可阴损及阳,肾阳衰微,清阳不展,而为头痛。因于脾者,多系饥饱劳倦,或病后产后体虚,脾胃虚弱,生化不足,或失血之后,营血亏虚,不能上荣于脑髓脉络,而致头痛;或饮食不节,嗜食肥甘,牌失健运,痰湿内生,上蒙清空,阻遏清阳而致头痛。至于外伤跌扑,久病人络,气滞血瘀,脉络瘀阻,不通则痛,每易致头痛。治宜:疏风散寒、清热祛湿、平肝潜阳、养阴补肝、养血调血、化痰降浊、活血化瘀。
本发明配方中有多种食材和中药材,其中蔓荆子、山楂、川芎、白芍、丹参具有疏散风热、行气散瘀、祛风止痛、养血调经、祛瘀止痛等功效;蒺藜、葛根、羌活、白芷具有平肝解郁、生津透疹、祛风除湿、通窍止痛等功效;黄芩、桃仁、防风具有泻火解毒、活血祛瘀、胜湿止痉等功效;蝉衣、乳香具有散风除热、定痛追毒等功效;甘草可以调和诸药性质。而对于配方中的食材除了可以提供患者所必需的丰富的营养物质以外,还具有开胃益中、健脾活血、消肿通气、清热解毒、活血利水、祛风除痹、补血安神、明目健脾、补肾益阴等功效。这些食材与药材按科学比例搭配,使其功效相得益彰、相互促进,从而使整个配方具备了良好的保健和辅助治疗的效果。
与现有技术相比,本发明保健食品,可以药食双补,既避免了长期用药的毒副作用,又解决了有益食材的不便常食的难题;既可以帮助患者改善体质、增强免疫力,去除疾病赖以生存的土壤,又可以缓解疼痛、调理患病器官,辅助治疗疾病以增强常规治疗的效果。此外,本发明保健食品效果好、成本低、易推广等也是其显著的技术优势。
具体实施方式
实施例1
以配方原材料范围的最小值和制备方法的优化工艺参数生产杯装营养粉:
(1)、按本发明配方准确称取燕麦12kg、黑米10kg、绿豆5kg、黑豆1kg、羌活600g、白芍800g、蔓荆子800g、川芎700g、白芷700g、蝉衣200g、黄芩600g、葛根700g、山楂800g、丹参700g、乳香600g、蒺藜800g、防风400g、桃仁400g、甘草500g,备用;
(2)、将羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草,分别粉碎,混合,加入初始药材13倍重量的纯化水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(3)、将步骤(2)的滤渣加9倍重量的浓度75%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.20-1.25的中药浓缩液,即为中药提取物,备用;
(5)、将黑豆和绿豆分别加14倍的水,浸泡14小时,带水粉碎,混合;将燕麦粉碎与黑米一起加入,混匀,熬制120分钟;将按配方称好的中药提取物5kg加入,继续熬制30分钟,冷却即为原料保健品;
(6)、利用现代通用的食品后加工技术,添加适当的辅料,将原料保健品制成杯装营养粉,规格为60g/杯,中药含量为4.39g生药/杯。
实施例2
以配方原材料范围的最大值和制备方法的优化工艺参数生产杯装营养粉:
(1)、按本发明配方准确称取燕麦50kg、黑米40kg、绿豆30kg、黑豆15kg、羌活1900g、白芍2700g、蔓荆子3000g、川芎2400g、白芷2000g、蝉衣1000g、黄芩1700g、葛根2200g、山楂2800g、丹参2400g、乳香1900g、蒺藜2000g、防风1500g、桃仁1800g、甘草1600g,备用;
(2)、将羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草,分别粉碎,混合,加入初始药材13倍重量的纯化水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(3)、将步骤(2)的滤渣加9倍重量的浓度75%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.20-1.25的中药浓缩液,即为中药提取物,备用;
(5)、将黑豆和绿豆分别加14倍的水,浸泡14小时,带水粉碎,混合;将燕麦粉碎与黑米一起加入,混匀,熬制120分钟;将按配方称好的中药提取物15kg加入,继续熬制30分钟,冷却即为原料保健品;
(6)、利用现代通用的食品后加工技术,添加适当的辅料,将原料保健品制成杯装营养粉,规格为60g/杯,中药含量为4.39g生药/杯。
实施例3
以配方原材料范围内的任意值和制备方法的优化工艺参数生产杯装营养粉:
(1)、按本发明配方准确称取燕麦12kg、黑米39kg、绿豆6kg、黑豆14kg、羌活700g、白芍2600g、蔓荆子900g、川芎2000g、白芷800g、蝉衣400g、黄芩1600g、葛根900g、山楂2800g、丹参2400g、乳香600g、蒺藜2000g、防风1500g、桃仁400g、甘草500g,备用;
(2)、将羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草,分别粉碎,混合,加入初始药材13倍重量的纯化水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(3)、将步骤(2)的滤渣加9倍重量的浓度75%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.20-1.25的中药浓缩液,即为中药提取物,备用;
(5)、将黑豆和绿豆分别加14倍的水,浸泡14小时,带水粉碎,混合;将燕麦粉碎与黑米一起加入,混匀,熬制120分钟;将按配方称好的中药提取物14kg加入,继续熬制30分钟,冷却即为原料保健品;
(6)、利用现代通用的食品后加工技术,添加适当的辅料,将原料保健品制成杯装营养粉,规格为60g/杯,中药含量为4.39g生药/杯。
实施例4
以优选配方原材料配比值和制备方法的优化工艺参数生产杯装营养粉:
(1)、按本发明配方准确称取燕麦28kg、黑米20kg、绿豆13kg、黑豆5kg、羌活1200g、白芍1600g、蔓荆子1800g、川芎1700g、白芷1300g、蝉衣500g、黄芩1100g、葛根1400g、山楂1800g、丹参1500g、乳香1200g、蒺藜1400g、防风800g、桃仁800g、甘草900g,备用;
(2)、将羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草,分别粉碎,混合,加入初始药材13倍重量的纯化水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(3)、将步骤(2)的滤渣加9倍重量的浓度75%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.20-1.25的中药浓缩液,即为中药提取物,备用;
(5)、将黑豆和绿豆分别加14倍的水,浸泡14小时,带水粉碎,混合;将燕麦粉碎与黑米一起加入,混匀,熬制120分钟;将按配方称好的中药提取物9kg加入,继续熬制30分钟,冷却即为原料保健品;
(6)、利用现代通用的食品后加工技术,添加适当的辅料,将原料保健品制成杯装营养粉,规格为60g/杯,中药含量为4.39g生药/杯。
实施例5
以优选配方原材料配比值但去掉中药材和制备方法的优化工艺参数生产杯装营养粉:
(1)、按本发明配方准确称取燕麦28kg、黑米20kg、绿豆13kg、黑豆5kg,备用;
(2)、将黑豆和绿豆分别加14倍的水,浸泡14小时,带水粉碎,混合;将燕麦粉碎与黑米一起加入,混匀,熬制120分钟,将按配方称好的纯淀粉糊(55℃相对密度为1.20-1.25)9kg加入,继续熬制30分钟,冷却即为原料保健品;
(3)、利用现代通用的食品后加工技术,添加适当的辅料,将原料保健品制成杯装营养粉,规格为60g/杯,外观与实施例4所生产的样品相同。
实施例6
以优选配方原材料配比值但去掉食材成分和制备方法的优化工艺参数生产杯装营养粉:
(1)、按本发明配方准确称取羌活1200g、白芍1600g、蔓荆子1800g、川芎1700g、白芷1300g、蝉衣500g、黄芩1100g、葛根1400g、山楂1800g、丹参1500g、乳香1200g、蒺藜1400g、防风800g、桃仁800g、甘草900g,备用;
(2)、将羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草,分别粉碎,混合,加入初始药材13倍重量的纯化水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(3)、将步骤(2)的滤渣加9倍重量的浓度75%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.20-1.25的中药浓缩液,即为中药提取物,备用;
(5)、将纯淀粉加水,熬制成糊,使重量比与所替代的食材相同;将按配方称好的中药提取物9kg加入,继续熬制30分钟,冷却即为原料保健品;
(6)、利用现代通用的食品后加工技术,添加适当的辅料,将原料保健品制成杯装营养粉,规格为60g/杯,中药含量为4.39g生药/杯,外观与实施例4所生产的样品相同。
实施例7
以纯淀粉代替所有原材料生产特制的空白杯装营养粉:
(1)、将淀粉加水熬制,调制成与实施例4原料保健品相同浓度,备用;
(2)、利用现代通用的食品后加工技术,添加与实施例4相同的辅料,制成杯装营养粉,规格为60g/杯,外观与实施例4的产品相同。
实施例8
本发明保健食品的安全性试验
1、急性毒性试验
(1)、受试样品:本发明实施例1-6所制造的营养粉,加热水,调制成稀糊,冷却备用;
(2)、试验动物:昆明种小鼠,体重22g±4g,雌雄各半,雌性小鼠均无孕;
(3)、小鼠灌胃本发明营养粉配制的稀糊,当灌胃148g/kg剂量时,小鼠出现最大喂食量,给食后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常;
(4)、试验结果表明:小鼠灌胃实施例1-6所制造的营养粉的最大给食量为148g/kg。本发明的保健食品每日最大使用量以9杯计,小鼠灌胃实施例1-6所制造的营养粉的耐受量为人最大食用量的31.4倍。提示该营养粉急性毒性极低,临床食用安全;
2、动物长期毒性试验
(1)、受试样品:本发明实施例1-6所制造的营养粉,加热水,调制成稀糊,冷却备用。
(2)、试验动物:普通级SD大鼠,体重236g±15g,雌雄各半,雌性大鼠均无孕。
(3)、方法与结果:
6种营养粉均以大鼠所能灌胃的最大量来喂食,单位体重给食量为成人食用量(以每日为9杯计)约40倍;将实验鼠随机分成7组,其中6组分别灌胃6种营养粉调制的稀糊,剩余一组灌胃等量生理盐水;所有7组均连续灌胃180天,观察动物全身毒性反应及严重程度,处死后按操作规程检查各部位,并进行血液学,ALT、BUN及心、肝、脾、肺、肾、胃等主要脏器的病理学检查;
经过长期喂食,7组大鼠均未出现毒性反应。发育良好。肉眼外观及主要脏器未见异常。外周血象及血清ALT、BUN与对照组比较无病理性改变。病理报告心、肝、脾、肺、肾、胃等均未有意义的改变,因此,认为经病理证实,6种营养粉对动物无慢性毒性表现。
通过以上两个毒性实验,证明本发明按实施例1-6制作的营养粉是安全的,无毒副作用的,可以被患者食用。
实施例9
本发明保健食品的临床试验
为了验证本发明保健食品的保健功效,同时证明本发明的创造性,发明人选取顽固性头痛的患者进行临床试验。
1、试验设计
试验从2014年7月开始,试验设置4个组,为随机双盲试验,4个组分别编号为空白组、对比1组、对比2组、试验组,每组计划入组100例,50男,50女,年龄18-65岁,在入组时,需均已被确诊患有顽固性头痛,并且自愿参与本次临床试验;平均分配患者,使各组患者在年龄性别、病情病史、用药治疗周期等具备统计学意义上的可比性。
2、试验样品
空白样品:本发明实施例7生产的空白杯装营养粉,规格为60g/杯,外观与实施例4的产品相同;
对比样品1:本发明实施例5所生产的杯装营养粉,规格为60g/杯,外观与实施例4所生产的样品相同;
对比样品2:本发明实施例6所生产的杯装营养粉,规格为60g/杯,中药含量为4.39g生药/杯,外观与实施例4所生产的样品相同;
试验样品:本发明实施例4所生产的杯装营养粉,规格为60g/杯,中药含量为4.39g生药/杯。
2、试验方法
所有患者均接受医院的常规治疗,并且坚持完成医院所制定的疗程和用药等技术手段。治疗的同时,进行本临床试验,所有患者均食用本发明保健食品,每日3次,每次一杯,用开水冲泡后随餐食用,连续食用100天;空白组给予空白样品,对比1组给予对比样品1,对比2组给予对比样品2,试验组给予试验样品。试验过程中记录患者体征、体感的变化,治疗结束后,对治疗的效果记录,并对治愈的患者在停止给药6个月后,进行跟踪回访,记录复发的病例。
3、试验效果评判
(1)、患者体征、体感变化:主要以头疼的严重程度、发作时间、发作间隔、患者饮食状况四个方面进行性价。
(2)、对试验的结果进行统计分析,比较各组疗效的差异。
4、试验结果
(1)、患者体征、体感变化:与空白组相比较,试验组患者头痛的严重程度明显偏低,发作时间变短,发作间隔增长,饮食状况也明显好于空白组,表现为胃口好、饭量大、气色好。
(2)、试验结果统计分析:
各组全部完成入组的计划后,并多出10%的病例,以便弥补中途出组、脱落的病例,保证入组统计结果的可比性。试验全部结束以后,每组只统计有效病例,对试验结果统计分析如表1所示。
表1 试验结果统计分析表
5、试验结论
试验结果显示:
(1)、从患者体征、体感变化的结果可以看出,与空白组相比,试验组具有很好的保健效果,有效的减轻了患者的痛苦,增强了患者的体质;
(2)、表1试验结果统计分析显示,与空白组相比,试验组的治愈率提高了28.6个百分点,总有效率提高了20.6个百分点,而复发率降低了24.6个百分点;与对比1组和对比2组相比,试验组的各项指标均显现出明显优势,说明本发明保健食品具有十分显著的保健效果和辅助治疗作用,同时说明,本发明保健食品的功效不是从原料简单的推测和臆断,不是食材和药材的偶然叠加,而是发明人多年的经验积累和反复科学实验的结果,其创造性值得肯定。
Claims (5)
1.一种供顽固性头痛患者食用的保健食品,其特征在于,所述保健食品由以下重量份的原料组成:
燕麦12-50份、黑米10-40份、绿豆5-30份、黑豆1-15份、中药提取物5-15份;
所述中药提取物的原料组成为:羌活6-19份、白芍8-27份、蔓荆子8-30份、川芎7-24份、白芷7-20份、蝉衣2-10份、黄芩6-17份、葛根7-22份、山楂8-28份、丹参7-24份、乳香6-19份、蒺藜8-20份、防风4-15份、桃仁4-18份、甘草5-16份。
2.根据权利要求1所述的供顽固性头痛患者食用的保健食品,所述保健食品由以下重量份的原料组成:
燕麦28份、黑米20份、绿豆13份、黑豆5份、中药提取物9份;
所述中药提取物的原料组成为:羌活12份、白芍16份、蔓荆子18份、川芎17份、白芷13份、蝉衣5份、黄芩11份、葛根14份、山楂18份、丹参15份、乳香12份、蒺藜14份、防风8份、桃仁8份、甘草9份。
3.根据权利要求1或2所述的供顽固性头痛患者食用的保健食品,其特征在于,所述保健食品的制备方法为以下步骤:
步骤(1)按本发明配方准确称取各种原材料,备用;
步骤(2)将羌活、白芍、蔓荆子、川芎、白芷、桔梗、蝉衣、黄芩、葛根、山楂、丹参、乳香、蒺藜、防风、桃仁、甘草,分别粉碎,混合,加入初始药材5-17倍重量的纯化水,浸泡4-24小时,回流煎煮1-6小时,过滤,再加入初始重量4-12倍重量的纯化水,回流煎煮1-4小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
步骤(3)将步骤(2)的滤渣加5-13倍重量的浓度60-85%的乙醇,回流提取2次,每次1-5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.12-1.16的浓缩液备用;
步骤(4)将步骤(2)和(3)所得的浓缩液合并,继续浓缩至55℃相对密度为1.20-1.25的中药浓缩液,即为中药提取物,备用;
步骤(5)将黑豆和绿豆分别加6-19倍的水,浸泡4-24小时,带水粉碎,混合;将燕麦粉碎与黑米一起加入,混匀,熬制30-180分钟;将按配方称好的中药提取物加入,继续熬制10-60分钟,冷却即为原料保健品;
步骤(6)利用现代通用的食品后加工技术,制成成品。
4.根据权利要求3所述的供顽固性头痛患者食用的保健食品,其特征在于,所述保健食品添加辅料,制成液态或干燥粉状;所述辅料为色素、香精、甜味剂、蔬菜、增稠剂中的一种或几种。
5.根据权利要求4所述的供顽固性头痛患者食用的保健食品,其特征在于:所述保健食品的包装形式有易拉罐、塑料袋、塑料杯和塑料碗。
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