CN104382038B - 一种用于提高免疫力的软胶囊 - Google Patents
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Abstract
一种用于提高免疫力的软胶囊,具体制备步骤如下:(1)将各原料:蚕蛹复合氨基酸:2~5份;太子参:9~30份;牛膝:5~12份;炙甘草:2~10份;仙茅:3~10份;山楂叶:3~10份;肉苁蓉:6~10份;竹节参:6~9份;自然铜:3~9份;龟甲:9~24份;鹿茸:1~2份混合均匀得到预混料;(2)将纯化水、甘油、明胶、二氧化钛、柠檬黄制得胶液;(3)将玉米油、蜂蜡制得混合油料;(4)将预混料投入混合油料中制得内容物物料;(5)将胶液和内容物物料压丸、定型、洗丸、干燥、拣丸。本发明的优点是中国传统中草药与人体基本组成物质氨基酸进行黄金搭配,能够有效的增强人体免疫力。
Description
技术领域
本发明涉及中药保健技术领域,尤其是涉及一种可以增强人体免疫力的中草药组合物制备得到的软胶囊。
背景技术
目前市场上的免疫功能性食品主要有小球藻、螺旋藻等藻类;乳酸菌、双歧杆菌等细菌类;蘑菇多糖、担子菌等食用真菌类;黄绿色蔬菜和水果、大豆肽、芦荟等植物成分;甲壳素、蜂王浆、蜂蜡、牡蛎肉等动物成分;人参、灵芝、刺五加、虫草等传统中草药类;还有褪黑素、核酸等合成物质等等。以上这些成分按其作用机制大体可分为两大类,第一类是以p—蘑菇多糖为代表,有刺激白细胞表面膜的作用,使细胞活素生成能力增强;另一类以蔬菜中含硫化合物为代表,对白细胞内代谢有调节作用。长期以来,增强免疫功能食品一直受广大消费者欢迎,其销量在国外一直呈稳定增长势头。
随着社会和经济的进步,人们生活水平的提高,科学技术的发展,疾病模式的改变以及对健康长寿的追求,增强免疫力的功能性食品已逐渐深人人心,人们已开始从重治疗转向重预防,这将极大地促进增强免疫力的功能性食品的发展。21世纪将是功能性食品大显身手的世纪。我国拥有中草药这一功能性食品巨大的宝库和其它特色资源,我们应结合增强免疫力的功能性食品发展趋势和我国发展的着力点,努力挖掘这些宝贵资源,开发出具有中国特色的增强免疫力的功能性食品,以在激烈的国际竞争中取得应有的地位。
发明内容
针对现有技术存在的上述问题,本申请人提供了一种用于提高免疫力的软胶囊。本发明的优点是中国传统中草药与人体基本组成物质氨基酸进行黄金搭配,能够有效的增强人体免疫力。
本发明的技术方案如下:
一种用于提高免疫力的软胶囊,具体制备步骤如下:
(1)将以下重量份数的原料粉碎、过120目筛:蚕蛹复合氨基酸:2~5份;太子参:9~30份;牛膝:5~12份;炙甘草:2~10份;仙茅:3~10份;山楂叶:3~10份;肉苁蓉:6~10份;竹节参:6~9份;自然铜:3~9份;龟甲:9~24份;鹿茸:1~2份;
(2)将步骤(1)得到的各原料混合均匀,得到预混料;
(3)将纯化水106~120份、甘油15~20份置于化胶罐中,加热至60℃后,将明胶10~12份、二氧化钛5~8份、柠檬黄3~5份投入化胶罐中,继续加热升温至80℃,边加热边搅拌,使明胶溶解完全,保温1~2小时,静置待泡沫上浮后,抽真空脱泡,过100目筛,得胶液,保温备用;
(4)取玉米油10~12份、蜂蜡4~5份置于调配罐中,加热升温至70~80℃,溶解搅拌混匀,冷却,得混合油料;
(5)将步骤(2)得到的预混料投入混合油料中,混合搅拌均匀,搅拌时间20~30分钟,再过胶体磨研磨2~3次后,抽真空脱泡,过80目筛,得内容物物料,备用;
(6)在室温18~22℃、相对湿度≤45%的环境下,将内容物物料与胶液分别投入到软胶囊机中压丸,然后定型、洗丸、干燥、拣丸,即得本用于提高免疫力的软胶囊。
步骤(6)所述的定型、洗丸、干燥、拣丸过程为:压丸后得到的胶丸定型干燥2~4小时,定型后用95wt%的食用乙醇洗丸,再转至温度25~28℃、相对湿度为≤40%的环境下干燥18~24小时;干燥后拣丸,剔除异形丸、有气泡或漏油丸等不合格品,得合格胶丸。
步骤(6)得到的用于提高免疫力的软胶囊的规格为0.5g/粒。步骤(1)~(6)的生产过程均在十万级生产洁净区条件下操作。
本发明有益的技术效果在于:
蛋白质的合理营养供给是维持机体细胞免疫和体液免疫能力的物质基础,氨基酸是构成蛋白质的基本单位。选择用复合氨基酸作为提高免疫力的功效成分符合营养学、营养免疫学基本理论和应用实践。在生产复合氨基酸的原料筛选中,选择蚕蛹蛋白,具有原料资源丰富,其氨基酸构成比例为必需氨基酸占氨基酸总量的46%以上,非常符合FAO/WHO提出的氨基酸模式。而且蚕蛹干品含蛋白质量高达45~50%,含蛋白质量高,蚕蛹又属于普通食品,食用安全。
我国所产的蚕蛹在用于食品药品方面应属于起步阶段。蚕蛹及其蛋白质利用的再水解生产的氨基酸、肽类具有很高的营养价值、药用价值。并作为良好的保健食品功效成分,这些都已经反复实验研究所证明。水解蚕蛹蛋白制备氨基酸,有酸水解、酶水解、碱水解和微生物酵解法,由于水解条件的不同,有些水解生成的氨基酸产品,还含有一定量未完全水解成氨基酸的肽。蚕蛹复合氨基酸和肽都是增强免疫力的功效物质。
本发明配方中太子参与炙甘草搭配有补脾益气之效,牛膝、仙茅、肉苁蓉、龟甲、鹿茸之间搭配,补肾益精血的功效,山楂叶、竹节参与自然铜搭配,有活血通络,强筋健体之效,以上药品搭配可以做到益气补血,强健脾肾,舒经通络,活血化瘀。本配方通过气血双补、脾肾双益这一传统的保健方法再搭配人体必需的氨基酸,达到对人体机体的免疫力增强。
具体实施方式
实施例1:
本用于提高免疫力的软胶囊,具体制备步骤如下:
(1)将以下重量份数的原料粉碎、过120目筛:蚕蛹复合氨基酸:3份;太子参:18份;牛膝:8份;炙甘草:5份;仙茅:7份;山楂叶:7份;肉苁蓉:8份;竹节参:7份;自然铜:5份;龟甲:15份;鹿茸:2份;
(2)将步骤(1)得到的各原料混合均匀,得到预混料;
(3)将纯化水110份、甘油18份置于化胶罐中,加热至60℃后,将明胶11份、二氧化钛6份、柠檬黄4份投入化胶罐中,继续加热升温至80℃,边加热边搅拌,使明胶溶解完全,保温1小时,静置待泡沫上浮后,抽真空脱泡,过100目筛,得胶液,保温备用;
(4)取玉米油11份、蜂蜡4份置于调配罐中,加热升温至70℃,溶解搅拌混匀,冷却,得混合油料;
(5)将步骤(2)得到的预混料投入混合油料中,混合搅拌均匀,搅拌时间25分钟,再过胶体磨研磨3次后,抽真空脱泡,过80目筛,得内容物物料,备用;
(6)在室温20℃、相对湿度≤45%的环境下,将内容物物料与胶液分别投入到软胶囊机中压丸,然后定型、洗丸、干燥、拣丸,即得本用于提高免疫力的软胶囊。
步骤(6)所述的定型、洗丸、干燥、拣丸过程为:压丸后得到的胶丸定型干燥3小时,定型后用95wt%的食用乙醇洗丸,再转至温度26℃、相对湿度为≤40%的环境下干燥20小时;干燥后拣丸,剔除异形丸、有气泡或漏油丸等不合格品,得合格胶丸。步骤(6)得到的用于提高免疫力的软胶囊的规格为0.5g/粒。步骤(1)~(6)的生产过程均在十万级生产洁净区条件下操作。
实施例2:
本用于提高免疫力的软胶囊,具体制备步骤如下:
(1)将以下重量份数的原料粉碎、过120目筛:蚕蛹复合氨基酸:5份;太子参:30份;牛膝:12份;炙甘草:10份;仙茅:10份;山楂叶:10份;肉苁蓉:10份;竹节参:9份;自然铜:9份;龟甲:24份;鹿茸:2份;
(2)将步骤(1)得到的各原料混合均匀,得到预混料;
(3)将纯化水120份、甘油20份置于化胶罐中,加热至60℃后,将明胶12份、二氧化钛8份、柠檬黄5份投入化胶罐中,继续加热升温至80℃,边加热边搅拌,使明胶溶解完全,保温2小时,静置待泡沫上浮后,抽真空脱泡,过100目筛,得胶液,保温备用;
(4)取玉米油12份、蜂蜡5份置于调配罐中,加热升温至80℃,溶解搅拌混匀,冷却,得混合油料;
(5)将步骤(2)得到的预混料投入混合油料中,混合搅拌均匀,搅拌时间30分钟,再过胶体磨研磨3次后,抽真空脱泡,过80目筛,得内容物物料,备用;
(6)在室温22℃、相对湿度≤45%的环境下,将内容物物料与胶液分别投入到软胶囊机中压丸,然后定型、洗丸、干燥、拣丸,即得本用于提高免疫力的软胶囊。
步骤(6)所述的定型、洗丸、干燥、拣丸过程为:压丸后得到的胶丸定型干燥4小时,定型后用95wt%的食用乙醇洗丸,再转至温度28℃、相对湿度为≤40%的环境下干燥24小时;干燥后拣丸,剔除异形丸、有气泡或漏油丸等不合格品,得合格胶丸。步骤(6)得到的用于提高免疫力的软胶囊的规格为0.5g/粒。步骤(1)~(6)的生产过程均在十万级生产洁净区条件下操作。
实施例3:
本用于提高免疫力的软胶囊,具体制备步骤如下:
(1)将以下重量份数的原料粉碎、过120目筛:蚕蛹复合氨基酸:2份;太子参:9份;牛膝:5份;炙甘草:2份;仙茅:3份;山楂叶:3份;肉苁蓉:6份;竹节参:6份;自然铜:3份;龟甲:9份;鹿茸:1份;
(2)将步骤(1)得到的各原料混合均匀,得到预混料;
(3)将纯化水106份、甘油15份置于化胶罐中,加热至60℃后,将明胶10份、二氧化钛5份、柠檬黄3份投入化胶罐中,继续加热升温至80℃,边加热边搅拌,使明胶溶解完全,保温1小时,静置待泡沫上浮后,抽真空脱泡,过100目筛,得胶液,保温备用;
(4)取玉米油10份、蜂蜡4份置于调配罐中,加热升温至70℃,溶解搅拌混匀,冷却,得混合油料;
(5)将步骤(2)得到的预混料投入混合油料中,混合搅拌均匀,搅拌时间20分钟,再过胶体磨研磨2次后,抽真空脱泡,过80目筛,得内容物物料,备用;
(6)在室温18℃、相对湿度≤45%的环境下,将内容物物料与胶液分别投入到软胶囊机中压丸,然后定型、洗丸、干燥、拣丸,即得本用于提高免疫力的软胶囊。
步骤(6)所述的定型、洗丸、干燥、拣丸过程为:压丸后得到的胶丸定型干燥2小时,定型后用95wt%的食用乙醇洗丸,再转至温度25℃、相对湿度为≤40%的环境下干燥18小时;干燥后拣丸,剔除异形丸、有气泡或漏油丸等不合格品,得合格胶丸。步骤(6)得到的用于提高免疫力的软胶囊的规格为0.5g/粒。步骤(1)~(6)的生产过程均在十万级生产洁净区条件下操作。
检测例:
1、样品及剂量:实施例1~3制备得到的软胶囊,每个成年人每次服用2粒,每日需服用2次。按照成年人体重60kg换算,检测例使用的小鼠平均体重为20g,每次需服用实施例1~3制备得到的软胶囊内容物的0.06wt%的量,每天摄入2次。实验动物与分组:SPF级昆明种雌性小鼠,体重18g~22g,由长沙市开福区东创试验动物科技服务部提供,生产许可证号为SCXK(湘)2009-0012,饲料由同一单位提供。
2、实验分组:每个测试均取40只小鼠,分为4组。第一组为对照组,摄入由杭州皓宇生物科技有限公司生产的皓宇牌黄芪枸杞茯苓氨基酸片,摄入剂量通过该产品的说明书上的成人剂量进行换算:一次摄入每片的0.03wt%的量,每天摄入两次。第二组为低剂量组,每次摄入实施例1制备得到的软胶囊内容物的0.03wt%的量,每天摄入两次。第三组为正常剂量组,每次摄入实施例1制备得到的软胶囊内容物的0.06wt%的量,每天摄入两次。第四组为高剂量组,每次摄入实施例1制备得到的软胶囊内容物的0.12wt%的量,每天摄入两次。
3、ConA诱导的小鼠淋巴细胞转化实验(MTT法)
无菌取脾,置于盛有适量无菌Hank’s液的小平皿中,制成细胞悬液,经200目筛网过滤。用Hank’s液洗2次,每次离心10分钟(l000r/min)。然后将细胞悬浮于lmL完全培养液中,计数活细胞数,用RPMI1640培养液调整细胞浓度为3×106个/mL。再将细胞悬液分两孔加入24孔培养板中,每孔lmL,在其中一孔加75μLConA液(相当于7.5μg/mL),另一孔作为对照,置5%二氧化碳,37℃培养72h。培养结束前4h,每孔轻轻吸去上清液0.7mL,加入0.7mL不含小牛血清的RPMI1640培养液,同时加入MTT(5mg/mL)50uL/孔,继续培养4h。培养结束后,每孔加入lmL酸性异丙醇,吹打混匀,使紫色结晶完全溶解。然后分装到96孔培养板中,每个孔作3个平行孔,用酶标仪,以570nm波长测定光密度值。淋巴细胞的增殖能力用加ConA孔的光密度值减去不加ConA孔的光密度值表示。四组药物对小鼠淋巴细胞转化能力的影响如表1所示。
表1
由表1可见,经口给予小鼠不同剂量的产品30天,高剂量能增加小鼠淋巴细胞转化能力,与对照组比较差异有显著性(P<0.05)。
4、抗体生成细胞检测(Jerne改良玻片法)
取羊血用生理盐水洗涤3次,每次离心(2000r/min)10min,将压积SRBC用生理盐水配成2%(v/v)的细胞悬液,每鼠腹腔注射0.2ml。5天后将小鼠处死,取脾,轻轻磨碎,用Hanks液制成细胞悬液,200目筛网过滤,洗涤、离心2次,最后将细胞悬浮在8mlHanks液中。计数细胞,并将细胞浓度调整为5×l06个/mL。将表层培养基加热溶解后与等量的pH7.4、2倍浓度的Hanks液混合,分装小试管,每管0.5ml,再向管内加入用SA液配制的10%SRBC50ul(v/v)、20ul脾细胞悬液(5×l06个/mL),迅速混匀后倾倒于已刷薄层琼脂糖的玻片上,待琼脂糖凝固后将玻片平扣放在玻片架上,放入二氧化碳培养箱中温育1.5h,将用SA液稀释的补体(1:8)加入到玻片凹槽内继续温育1.5h后计数溶血空斑数。四组药物对小鼠抗体生成细胞数的影响如表2所示。
表2
由表2可知,经口给予小鼠不同剂量的皓宇牌黄芪枸杞氨基酸片30天,高剂量能增加小鼠抗体生成细胞数,与对照组比较差异有显著性(P<0.05)。
5、NK细胞活性的测定(乳酸脱氢酶测定法)
受试小鼠颈椎脱臼处死,无菌取脾,制成脾细胞悬液,用Hank’s液洗2次,每次离心10min(1000r/min),弃上清将细胞浆弹起,加入0.5ml灭菌水20秒,裂解红细胞后再加入0.5ml2倍Hank’s液及8mlHank’s液,l000rpm离心l0min,用lmL含10%小牛血清的RPMI1640完全培养液重悬,用台酚兰染色计数(活细胞数应在95%以上),调整细胞浓度为2×107个/mL此为效应细胞,取传代后24h生长良好的YAC—1细胞用RPMI1640完全培养液调整细胞浓度为4×105个/ml此为靶细胞;取靶细胞和效应细胞各l00ul(效靶比50:1),加入U型96孔培养板中;靶细胞自然释放孔加靶细胞和培养液各l00ul,靶细胞最大释放孔加靶细胞和2.5%Triton各l00ul上述各项均设三个平行孔,于37℃,5%二氧化碳培养箱中培养4h,然后将96孔培养板以1500r/min离心5min,每孔吸取上清100ul置平底96孔培养板中,同时加入LDH基质液100ul,根据室温反应3-10min,每孔加入lmol/L的HC130ul,在酶标仪490nm处测定光密度(OD)。
NK细胞活性=[(反应孔OD-自然释放孔OD)/(最大释放孔OD-自然释放孔OD)]×100%。四组药物对小鼠NK细胞活性的影响如表3所示。
表3
由表3可见,经口给予小鼠不同剂量的产品30天,中、高剂量能增加NK细胞活性,与对照组比较差异有显著性(P<0.05)。
Claims (4)
1.一种用于提高免疫力的软胶囊,其特征在于具体制备步骤如下:
(1)将以下重量份数的原料粉碎、过120目筛:蚕蛹复合氨基酸:2~5份;太子参:9~30份;牛膝:5~12份;炙甘草:2~10份;仙茅:3~10份;山楂叶:3~10份;肉苁蓉:6~10份;竹节参:6~9份;自然铜:3~9份;龟甲:9~24份;鹿茸:1~2份;
(2)将步骤(1)得到的各原料混合均匀,得到预混料;
(3)将纯化水106~120份、甘油15~20份置于化胶罐中,加热至60℃后,将明胶10~12份、二氧化钛5~8份、柠檬黄3~5份投入化胶罐中,继续加热升温至80℃,边加热边搅拌,使明胶溶解完全,保温1~2小时,静置待泡沫上浮后,抽真空脱泡,过100目筛,得胶液,保温备用;
(4)取玉米油10~12份、蜂蜡4~5份置于调配罐中,加热升温至70~80℃,溶解搅拌混匀,冷却,得混合油料;
(5)将步骤(2)得到的预混料投入混合油料中,混合搅拌均匀,搅拌时间20~30分钟,再过胶体磨研磨2~3次后,抽真空脱泡,过80目筛,得内容物物料,备用;
(6)在室温18~22℃、相对湿度≤45%的环境下,将内容物物料与胶液分别投入到软胶囊机中压丸,然后定型、洗丸、干燥、拣丸,即得本用于提高免疫力的软胶囊。
2.根据权利要求1所述的用于提高免疫力的软胶囊,其特征在于步骤(6)所述的定型、洗丸、干燥、拣丸过程为:压丸后得到的胶丸定型干燥2~4小时,定型后用95wt%的食用乙醇洗丸,再转至温度25~28℃、相对湿度为≤40%的环境下干燥18~24小时;干燥后拣丸,剔除异形丸、有气泡或漏油丸的不合格品,得合格胶丸。
3.根据权利要求1所述的用于提高免疫力的软胶囊,其特征在于步骤(6)得到的用于提高免疫力的软胶囊的规格为0.5g/粒。
4.根据权利要求1所述的用于提高免疫力的软胶囊,其特征在于步骤(1)~(6)的生产过程均在十万级生产洁净区条件下操作。
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CN101095717A (zh) * | 2006-06-27 | 2008-01-02 | 陈国栋 | 一种机体免疫功能改善剂 |
CN101444590A (zh) * | 2008-09-25 | 2009-06-03 | 成钢 | 一种香身壮阳的微量元素蛇鞭制剂配方工艺 |
CN101856430A (zh) * | 2009-04-08 | 2010-10-13 | 周艳 | 预防亚健康的绿色膏滋补品灵芝(三仙)膏及其制备方法 |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN1085785A (zh) * | 1993-05-04 | 1994-04-27 | 宝鸡民族医药保健品厂 | 参鹿益元膏及其制备方法 |
CN1194843A (zh) * | 1997-04-01 | 1998-10-07 | 李恩洪 | 绿色保健药的制造方法 |
CN101095717A (zh) * | 2006-06-27 | 2008-01-02 | 陈国栋 | 一种机体免疫功能改善剂 |
CN101444590A (zh) * | 2008-09-25 | 2009-06-03 | 成钢 | 一种香身壮阳的微量元素蛇鞭制剂配方工艺 |
CN101856430A (zh) * | 2009-04-08 | 2010-10-13 | 周艳 | 预防亚健康的绿色膏滋补品灵芝(三仙)膏及其制备方法 |
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