CN104397703B - 一种增强免疫力的中药片剂 - Google Patents
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Abstract
本发明公开了一种增强免疫力的中药片剂，该中药片剂包括蚕蛹复合氨基酸粉5～15份、太子参2～18份、当归10～20份、炙甘草8～15份、仙茅6～12份、枸杞3～10份、竹节参2～10份、鹿胎2～5份、龟甲5～15份、阿胶2～5份，将各组分经过粉碎、过筛、造粒、压片、包覆等步骤制得所述片剂。本发明片剂将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药片剂。
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。
总之，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增强免疫力的中药片剂。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：
一种增强免疫力的中药片剂，具体制备方法如下：
(1)将蚕蛹复合氨基酸粉5～15份、太子参2～18份、当归10～20份、炙甘草8～15份、仙茅6～12份、枸杞3～10份、竹节参2～10份、鹿胎2～5份、龟甲5～15份、阿胶2～5份，分别粉碎成粉，过80目筛；
(2)将过筛后的太子参、当归、炙甘草、仙茅、枸杞、竹节参混合均匀，再与蚕蛹复合氨基酸粉、鹿胎、龟甲、阿胶的混合粉进行倍增套研混合，制得预混粉；
(3)将羟丙基纤维素用纯化水配制成4％的羟丙基纤维溶液，并将其加入到步骤(2)制得的预混粉中，1000～1500rpm转速下，混合润湿2～8h后，制成颗粒软材，过18目筛摇摆制粒，干燥后过20目筛粒，制得片芯颗粒；
(4)将步骤(3)制得的片芯颗粒与3～10份硬质酸镁混合、压片制得片剂素片；
(5)按照常规方法在片剂素片外围喷涂一层糖衣，经干燥脱水，制得包覆糖衣的片剂；
上述各原料的份数均为重量份数。
所述步骤(1)中粉碎过程在球磨罐中进行，乙醇为研磨剂，氧化锆球为研磨介质。
所述步骤(2)中预混粉的含水量≤10％。
所述步骤(4)中片剂素片的规格为0.343g/片。
所述步骤(1)～(5)的生产过程均在三十万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、鹿胎与炙甘草搭配有补脾益气之效，当归、枸杞、仙茅、龟甲、阿胶之间搭配，补肾益精血的功效，竹节参，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
下面结合实施例，对本发明进行具体描述。
实施例1
一种增强免疫力的中药片剂，具体制备方法如下：
(1)将蚕蛹复合氨基酸粉15份、太子参2份、当归15份、炙甘草10份、仙茅12份、枸杞3份、竹节参10份、鹿胎5份、龟甲10份、阿胶5份，分别粉碎成粉，过80目筛；所述粉碎过程在球磨罐中进行，乙醇为研磨剂，氧化锆球为研磨介质；
(2)将过筛后的太子参、当归、炙甘草、仙茅、枸杞、竹节参混合均匀，再与蚕蛹复合氨基酸粉、鹿胎、龟甲、阿胶的混合粉进行倍增套研混合，制得预混粉；所述预混粉的含水量为5％；
(3)将羟丙基纤维素用纯化水配制成4％的羟丙基纤维溶液，并将其加入到步骤(2)制得的预混粉中，1000rpm转速下，混合润湿8h后，制成颗粒软材，过18目筛摇摆制粒，干燥后过20目筛粒，制得片芯颗粒；
(4)将步骤(3)制得的片芯颗粒与3份硬质酸镁混合、压片制得片剂素片；片剂素片的规格为0.343g/片；
(5)按照常规方法在片剂素片外围喷涂一层糖衣，经干燥脱水，制得包覆糖衣的片剂；
上述各原料的份数均为重量份数。
所述步骤(1)～(5)的生产过程均在三十万级生产洁净区条件下操作。
实施例2
一种增强免疫力的中药片剂，具体制备方法如下：
(1)将蚕蛹复合氨基酸粉5份、太子参18份、当归10份、炙甘草8份、仙茅10份、枸杞8份、竹节参6份、鹿胎4份、龟甲15份、阿胶2份，分别粉碎成粉，过80目筛；所述粉碎过程在球磨罐中进行，乙醇为研磨剂，氧化锆球为研磨介质；
(2)将过筛后的太子参、当归、炙甘草、仙茅、枸杞、竹节参混合均匀，再与蚕蛹复合氨基酸粉、鹿胎、龟甲、阿胶的混合粉进行倍增套研混合，制得预混粉；所述预混粉的含水量为6％；
(3)将羟丙基纤维素用纯化水配制成4％的羟丙基纤维溶液，并将其加入到步骤(2)制得的预混粉中，1500rpm转速下，混合润湿2h后，制成颗粒软材，过18目筛摇摆制粒，干燥后过20目筛粒，制得片芯颗粒；
(4)将步骤(3)制得的片芯颗粒与6份硬质酸镁混合、压片制得片剂素片；片剂素片的规格为0.343g/片；
(5)按照常规方法在片剂素片外围喷涂一层糖衣，经干燥脱水，制得包覆糖衣的片剂；
上述各原料的份数均为重量份数。
所述步骤(1)～(5)的生产过程均在三十万级生产洁净区条件下操作。
实施例3
一种增强免疫力的中药片剂，具体制备方法如下：
(1)将蚕蛹复合氨基酸粉10份、太子参12份、当归20份、炙甘草15份、仙茅6份、枸杞10份、竹节参2份、鹿胎2份、龟甲5份、阿胶4份，分别粉碎成粉，过80目筛；所述粉碎过程在球磨罐中进行，乙醇为研磨剂，氧化锆球为研磨介质；
(2)将过筛后的太子参、当归、炙甘草、仙茅、枸杞、竹节参混合均匀，再与蚕蛹复合氨基酸粉、鹿胎、龟甲、阿胶的混合粉进行倍增套研混合，制得预混粉；所述预混粉的含水量为5％；
(3)将羟丙基纤维素用纯化水配制成4％的羟丙基纤维溶液，并将其加入到步骤(2)制得的预混粉中，1200rpm转速下，混合润湿6h后，制成颗粒软材，过18目筛摇摆制粒，干燥后过20目筛粒，制得片芯颗粒；
(4)将步骤(3)制得的片芯颗粒与10份硬质酸镁混合、压片制得片剂素片；片剂素片的规格为0.343g/片；
(5)按照常规方法在片剂素片外围喷涂一层糖衣，经干燥脱水，制得包覆糖衣的片剂；
上述各原料的份数均为重量份数。
所述步骤(1)～(5)的生产过程均在三十万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制备得到的增强免疫力的中药片剂，每个成年人每日需服用2次，每次一片。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制备得到的中药片剂的0.03wt％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：一次摄入成人剂量的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3制备得到的中药片剂的0.015wt％的量，每天摄入两次。第三组为正常剂量组，每次摄入实施例3制备得到的中药片剂的0.03wt％的量，每天摄入两次。第四组为高剂量组，每次摄入实施例3制备得到的中药片剂的0.06wt％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液的小平皿中，制成细胞悬液，经200目筛网过滤。用Hank液洗2次，每次离心10分钟(1000r/min)。然后将细胞悬浮于l mL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l mL，在其中一孔加ConA液75μL(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l mL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，测570nm波长处的光密度值。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。片剂对四组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本发明片剂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，将压积绵羊红细胞SRBC用生理盐水配成2％(v/v)的细胞悬液，每鼠腹腔注射0.2mL，免疫后5天，将小鼠处死，取脾，轻轻磨碎，用Hank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8mLHank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pH值7.4、2倍浓度的Hank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％SRBC 50uL(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。片剂对四组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本发明片剂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)，表明本发明片剂具有增强小鼠体液免疫的功能。
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0.5mL 2倍Hank液及8mL Hank液，1000rpm转速下，离心10min，用l mL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做为效应细胞，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做为靶细胞；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100uL；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的转速离心5min，每孔吸取上清液100uL置平底96孔培养板中，同时加入LDH基质液100uL/孔，根据室温反应3-10min，每孔加入30uL 1mol/L的HCl，在酶标仪490nm波长处测定光密度(OD)。
NK细胞活性＝[(反应孔OD值-自然释放孔OD值)/(最大释放孔OD值-自然释放孔OD值)]×100％。
片剂对四组小鼠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本发明片剂30天，正常剂量与高剂量能对小鼠NK细胞活性有明显提高作用，与对照组比较差异有显著性(P<0.05)。
Claims (1)
1.一种增强免疫力的中药片剂，其特征在于具体制备方法如下：
(1)将蚕蛹复合氨基酸粉5～15份、太子参2～18份、当归10～20份、炙甘草8～15份、仙茅6～12份、枸杞3～10份、竹节参2～10份、鹿胎2～5份、龟甲5～15份、阿胶2～5份，分别粉碎成粉，过80目筛；
(2)将过筛后的太子参、当归、炙甘草、仙茅、枸杞、竹节参混合均匀，再与蚕蛹复合氨基酸粉、鹿胎、龟甲、阿胶的混合粉进行倍增套研混合，制得预混粉；
(3)将羟丙基纤维素用纯化水配制成4％的羟丙基纤维素溶液，并将其加入到步骤(2)制得的预混粉中，1000～1500rpm转速下，混合润湿2～8h后，制成颗粒软材，过18目筛摇摆制粒，干燥后过20目筛粒，制得片芯颗粒；
(4)将步骤(3)制得的片芯颗粒与3～10份硬脂酸镁混合、压片制得片剂素片；
(5)按照常规方法在片剂素片外围喷涂一层糖衣，经干燥脱水，制得包覆糖衣的片剂；
上述各原料的份数均为重量份数；
所述步骤(1)中粉碎过程在球磨罐中进行，乙醇为研磨剂，氧化锆球为研磨介质；
所述步骤(2)中预混粉的含水量≤10％；
所述步骤(4)中片剂素片的规格为0.343g/片；
所述步骤(1)～(5)的生产过程均在三十万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 |
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