CN109223973A - 一种防辐射的组合物及其制备方法和用途 - Google Patents
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Abstract
本发明提供了一种食品、保健食品或药物组合物,它是由下述重量配比的原料制备而成:松茸2‑6份、枸杞子6‑15份、百合3‑8份、乌梅1‑4份、黄精1‑5份、山药3‑8份、人参1‑4份。本发明还提供了所述组合物的制备方法和用途,根据益气养阴,补气固表的治疗法则防辐射。本发明提供了一种药效确切,疗效可靠,制备工艺简单,口感良好的防辐射保健食品、药物组合物。
Description
技术领域
本发明涉及一种防辐射的食品、保健食品或药物组合物及其制备方法和用途。
背景技术
近年来,随着核能及其放射技术在各个领域的广泛应用,辐射造成的损伤已成为人们日益关注的重要问题。传统中医学理论发现现代日常辐射对人体的伤害和毒邪致病内涵相类似,按中医理论认为辐射损伤人体的病机是热毒邪气,内侵脏腑;毒热入络,耗气伤精,导致痰淤阻滞,气阴两伤。《内经》谓:“正气存内、邪不可干”,正气能够抵御外邪,防止疾病的发生,并且有利于病后恢复,故研究利用中药的生物学活性,提高机体抗辐射能力、减轻辐射对人体的损伤具有重要而实用的价值。
人体的防辐射功能与卫气的充足有直接关系,所以根据辐射对人体损伤的病因病机,可知益气养阴,补气固表是中医药防辐射的治疗法则。
传统经典的补血养血方四物汤和补气健脾的补中益气丸有较好的抗辐射作用。在现代组方中,无论是养阴抗毒散,还是芩丹扶正胶囊、康艾注射液、安多林、安迪等,也都有抗辐射作用。
中医认为,射线辐射属于火热毒邪致病范畴,火热邪气易化火上炎,易伤津耗气。辐射可干扰肝、脾、心、肺、肾等脏器的功能,还会使气血失调,从而导致人正气不足、抗病能力低下,故益气养阴,补益肺脾,补肾固精,提高自身免疫力对抗辐射是极为重要的。人体一身阴之根本在于肝肾,而气血不足致血行无力容易出现血瘀,应适当使用滋补肝肾和活血化瘀的方法,使用如当归、熟地、山萸肉、丹参等,使肝肾之阴得补和血行健旺,则有助于损伤症状的恢复。尽管部分组方在抗辐射损伤方面取得了一定的效果,但仍未达到比较满意的疗效。
因此,研究中医经方名方,筛选出药效确切,疗效可靠的中医复方,制备工艺简单,口感良好的防辐射药物组合物、保健食品非常重要。
发明内容
本发明的目的在于提供一种防辐射的食品、保健食品或药物组合物。本发明的另一目的在于提供所述组合物的制备方法和用途。
本发明提供了一种防辐射的组合物,它是由下述重量配比的原料制备而成:松茸2-6份、枸杞子6-15份、百合3-8份、乌梅1-4份、黄精1-5份、山药3-8份、人参1-4份。
优选地,它是由下述重量配比的原料制备而成:松茸4份、枸杞子9份、百合5份、乌梅2份、黄精3份、山药5份、人参2份。
其中,所述组合物是由所述原料的原生粉末,或者水或有机溶剂提取物为活性成分,加上可接受的辅料或者辅助性成分制备成常用的制剂。
优选地,所述制剂为固体饮料、颗粒剂、片剂、丸剂、散剂、胶囊剂或口服液。
优选地,所述辅料或者辅助性成分为:麦芽糊精。
本发明提供了一种所述组合物的制备方法,包括如下步骤:
a、称取重量配比的原料;
b、浸泡,水提,收膏;
c、冷冻干燥,加入辅料混匀,制粒,干燥,即得。
进一步的,所述水提取方法为:第一次水煎20min,第二次水煎15min;十层纱布过滤,收集滤液。
进一步的,步骤c中,冷冻干燥法包括如下步骤;
a、稠膏放-80度冰箱冷冻过夜,次日,置于真空冷冻干燥机进行冷冻干燥,冷冻干燥48-72小时;优选地,冷冻干燥60小时;
b、冷冻干燥物再放入烘箱60-65度烘烤8-16小时,烘干致干燥物不黏手,加入辅料,制粒,干燥,即得;优选地,烘烤12小时。
本发明提供了所述组合物在制备防辐射的药物或者固体饮料中的用途。
本发明还提供了所述组合物在制备具有益气养阴,补益脾肺,补肾固精功效的药物或者固体饮料中的用途。
本发明药物组合物由松茸、枸杞子、百合、乌梅、黄精、山药、人参七味原料药组成。人参大补元气,复脉固脱,补脾益肺,生津;山药补脾养胃,生津益肺,补肾涩精,共为君药。枸杞滋补肝肾,益精明目,黄精补气养阴,健脾润肺益肾,百合养阴润肺,乌梅敛肺生津;松茸含有β-萄萄糖酸,核酸衍生物,肽类物质,多糖LPB等稀有营养元素,具有提高SOD活性,加速自由基的清除,延缓组织器官衰退,改善心血管功能,促进新陈代谢,提高人体抗病毒、抗细胞突变和增加免疫功能的能力。常食松茸能强精补肾,恢复精力,另具有益胃补气,强心补血等作用。共为臣药,与君药配伍增强益气养阴,补益脾肺,补肾固精之功效。
本发明提供了一种药效确切,疗效可靠,制备工艺简单,口感良好的防辐射保健食品、药物组合物。
根据本发明的上述内容,按照本发明相关领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
附图说明
图1两种固体饮料的描述型感官评价结果
具体实施方式
实施例1本发明药物组合物的制备
1.原料:松茸4g、枸杞子9g、百合5g、乌梅2g、黄精3g、山药5g、人参2g。
2.制备方式:a、称取配方量的松茸、枸杞子、百合、乌梅、黄精、山药、人参混合,10倍水浸泡20min;
b、煎煮两次,第一次20min,第二次15分钟,十层纱布过滤,收集滤液;将滤液经滤纸过滤完成除杂,将滤液加热进行浓缩致稠膏状;
c、利用冷冻干燥法干燥:稠膏放-80度冰箱冷冻过夜,次日,置于真空冷冻干燥机进行冷冻干燥60小时;冷冻干燥物再放入烘箱60-65度进行烘干12h,致干燥物不黏手,与辅料混匀,制粒,干燥,即得。
实施例2本发明药物组合物的制备
1.原料:松茸2g、枸杞子6g、百合3g、乌梅1g、黄精1g、山药3g、人参1g。
2.制备方式:a、称取配方量的松茸、枸杞子、百合、乌梅、黄精、山药、人参混合,10倍水浸泡20min;
b、煎煮两次,第一次20min,第二次15分钟,十层纱布过滤,收集滤液;将滤液经滤纸过滤完成除杂,将滤液加热进行浓缩致稠膏状;
c、利用冷冻干燥法干燥:稠膏放-80度冰箱冷冻过夜,次日,置于真空冷冻干燥机进行冷冻干燥60小时;冷冻干燥物再放入烘箱60-65度进行烘干12h,致干燥物不黏手,与辅料混匀,制粒,干燥,即得。
实施例3本发明药物组合物的制备
1.原料:松茸6g、枸杞子15g、百合8g、乌梅4g、黄精5g、山药8g、人参4g。
2.制备方式:a、称取配方量的松茸、枸杞子、百合、乌梅、黄精、山药、人参混合,10倍水浸泡20min;
b、煎煮两次,第一次20min,第二次15分钟,十层纱布过滤,收集滤液;将滤液经滤纸过滤完成除杂,将滤液加热进行浓缩致稠膏状;
c、利用冷冻干燥法干燥:稠膏放-80度冰箱冷冻过夜,次日,置于真空冷冻干燥机进行冷冻干燥60小时;冷冻干燥物再放入烘箱60-65度进行烘干12h,致干燥物不黏手,与辅料混匀,制粒,干燥,即得。
以下通过具体实验证明本发明的有益效果。
实验例1本发明组合物防辐射的动物实验研究
1、实验方法
将150只清洁级昆明种雌性小鼠(体重18-22g)随机分为3批,每批50只,再随机分为空白对照组、辐射模型对照组、低剂量组(人体推荐量的10倍)、中剂量组(人体推荐量的20倍)、高剂量组(人体推荐量的40倍),每组10只。各剂量组于照射前后经口连续给予本发明组合物14天,空白对照组和辐射模型对照组均给予2mL/kg的蒸馏水。除空白对照组外,剂量组与辐射模型对照组均以同一γ射线全身照射一次,然后分别于照射前、照射后第3天、照射后第14天对第1批小鼠采末梢血,测定小鼠外周血白细胞数;于辐射后第7天,取第2批小鼠测定超氧化物歧化酶(SOD)活性;于辐射后第18天,取第3批小鼠眼球采血,测定血清溶血素值。根据《现代保健食品研发与生产新技术新工艺及注册申报实用手册》第八篇第三章第十四节“对辐射危害有辅助保护功能检验方法”,分别对小鼠进行外周血白细胞计数、SOD活性和血清溶血素值的测定。
2、实验结果
(1)本发明组合物对辐照小鼠外周血白细胞数的影响
由表1可知,照射前各剂量组小鼠外周血白细胞数与各对照组比较,差异无显著性(P>0.05);照射后3天,辐射模型对照组小鼠的白细胞数与照射前相比,差异极显著(P<0.01),可判定辐射损伤模型成立。高剂量组与辐射模型对照组比较,白细胞总数增多,差异有显著性(P<0.05)。照射后14天,低、中、高剂量组的白细胞总数均明显高于辐射模型对照组,且差异极显著(P<0.01),可判定该实验阳性。
表1本发明组合物对辐照小鼠外周血白细胞数的影响(n=10,)
注:**表示与照射前辐射模型对照组相比差异极显著(P<0.01);#表示与辐射模型对照组相比差异显著(P<0.05);##表示与辐射模型对照组相比差异极显著(P<0.01)。
(2)本发明组合物对辐照小鼠SOD活性的影响
由表2可知,照射后7天,与辐射模型对照组比较,中、高剂量组的超氧化物歧化酶(SOD)活性显著增强(P<0.01),说明本发明组合物能有效增强小鼠的SOD活性,且差异极显著,可判定该实验阳性。
表2本发明组合物对辐照小鼠SOD活力的影响(n=10,)
注:#表示与辐射模型对照组相比差异显著(P<0.05);##表示与辐射模型对照组相比差异极显著(P<0.01)。
(3)本发明组合物对辐照小鼠血清溶血素的影响
由表3可知,照射后18天,与辐射模型对照组比较,低剂量组的小鼠血清溶血素值显著增多(P<0.05),中、高剂量组的的小鼠血清溶血素值极显著增多(P<0.01),可判定该实验阳性。
表3本发明组合物对辐照小鼠血清溶血素值的影响(n=10,)
注:#表示与辐射模型对照组相比差异显著(P<0.05);##表示与辐射模型对照组相比差异极显著(P<0.01)。
3、结论
根据《现代保健食品研发与生产新技术新工艺及注册申报实用手册》,在外周血白细胞计数实验、骨髓细胞DNA含量或骨髓有核细胞数实验、小鼠骨髓细胞微核实验、血/组织中超氧化物歧化酶活性实验、血清溶血素含量实验中,任何两项实验结果为阳性,可判定该受试样品对辐射危害具有辅助保护功能的作用。本研究结果表明,本发明组合物对外周血白细胞数、超氧化物歧化酶(SOD)活性和血清溶血素值(HC50)均有所提高,三个实验均为阳性,由此可判定本发明组合物对辐射危害具有辅助保护功能的作用。
实验例2基于感官评价对本发明组合物干燥方式的研究
1、实验方法
按配方量称取本发明组合物原料,浸泡,水提,将滤液加热浓缩致稠膏状。分别采用冷冻干燥法和减压干燥法将稠膏干燥,干燥后与辅料混匀,制粒,干燥,制成固体饮料。各取5.0g(按实施例1配比)两种干燥方式制成的固体饮料样品,加入150mL 85℃热水冲泡,搅拌均匀。对产品色泽、口感、香气、外形进行评分,每项指标总分5分,各项的特征描述见表4,分值越高表明该特征指标越好。通过12名专业评价员对两种干燥方式固体饮料样品的感官特征进行描述型打分,用FIZZ软件对结果进行分析。冷冻干燥法:稠膏放-80度冰箱冷冻过夜,次日,置于真空冷冻干燥机进行冷冻干燥60小时;冷冻干燥物再放入烘箱60-65度进行烘干12h,致干燥物不黏手。
所述的的减压干燥法为:稠膏放入烘箱60-65度进行烘干16h,干燥致不能流动;再置于减压干燥器(55度,-0.1MPa)中进行减压干燥8小时,彻底干燥。
表4本发明组合物固体饮料评价标准
2、实验结果
由图1可以看出,两种干燥方式对固体饮料的色泽和外形的影响无显著差异(P>0.05),两种干燥方式制成的固体饮料均是色泽明亮,颗粒饱满,清爽。冷冻干燥的固体饮料口味香醇,回味无穷;减压干燥的口感太重,回味差,两种固体饮料口感存在极显著差异(P<0.01)。冷冻干燥的固体饮料具有松茸香气,无异味,减压干燥的异味明显,无香味,两种固体饮料的香气存在极显著差异(P<0.01)。
3、结论
通过对两种干燥方式制成的固体饮料样品的感官特征进行描述型打分,用软件对结果进行分析,最终确定冷冻干燥方式制成的固体饮料口感更好。
综上,本发明提供了一种药效确切,疗效可靠,制备工艺简单,口感良好的防辐射保健食品、药物组合物。
Claims (9)
1.一种食品、保健食品或药物组合物,其特征在于:它是由下述重量配比的原料制备而成:松茸2-6份、枸杞子6-15份、百合3-8份、乌梅1-4份、黄精1-5份、山药3-8份、人参1-4份。
2.根据权利要求1所述的组合物,其特征在于:它是由下述重量配比的原料制备而成:松茸4份、枸杞子9份、百合5份、乌梅2份、黄精3份、山药5份、人参2份。
3.根据权利要求1或2所述的组合物,其特征在于:所述组合物是由所述原料的原生粉末,或者水或有机溶剂提取物为活性成分,加上可接受的辅料或者辅助性成分制备成常用的制剂。
4.根据权利要求3所述的组合物,其特征在于:所述制剂为固体饮料、颗粒剂、片剂、丸剂、散剂、胶囊剂或口服液。
5.根据权利要求3所述的组合物,其特征在于:所述辅料或者辅助性成分为:麦芽糊精。
6.一种制备权利要求1-5任意一项所述的组合物的方法,其特征在于:包括如下步骤:
a、称取重量配比的原料;
b、浸泡,水提,收膏;
c、冷冻干燥,加入辅料混匀,制粒,干燥,即得。
7.根据权利要求6所述的制备方法,其特征在于:步骤c中,冷冻干燥方法包括以下步骤:
a、稠膏放-80度冰箱冷冻过夜,次日,置于真空冷冻干燥机进行冷冻干燥,冷冻48-72小时;优选地,冷冻60小时;
b、冷冻干燥物再放入烘箱60-65度烘烤8-16小时,烘干致干燥物不黏手,加入辅料,制粒,干燥,即得;优选地,烘烤12小时。
8.权利要求1-5任意一项所述的组合物在制备防辐射的药物或者保健食品中的用途。
9.权利要求1-5任意一项所述的组合物在制备具有益气养阴,补益脾肺,补肾固精功效的药物或保健食品中的用途。
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