CN103519172B - 大枣西洋参沙棘籽油软胶囊 - Google Patents
大枣西洋参沙棘籽油软胶囊 Download PDFInfo
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Abstract
本发明提出一种大枣西洋参沙棘籽油软胶囊,其包括下述重量份的组份:大枣提取物30-50份、沙棘籽油300-500份、西洋参提取物50-60份,辅料10-20份;及包覆上述组分的囊皮。本发明的配方原料为沙棘籽油、西洋参提取物、大枣提取物。沙棘甘酸化阴,有益气生津之功,西洋参性凉而补,能补心气、益肺气、充脾气、培元气,并能养阴生津止渴。与沙棘同用,能协同增强补气养阴生津作用。大枣补中益气,养血安神。三者合用,补益肺、脾、心、肾之气,振奋脏腑机能,同时,养阴生津,补血扶正,共同发挥补气生血,养阴生津的作用,可有效增强免疫力。且没有配伍禁忌,合理而安全。
Description
技术领域
本发明涉及一种来自植物的组合物,具体涉及一种提取自大枣的组合物及其制备方法。
背景技术
在日常生活经受生活或工作压力、环境污染、摄入的水和食物的变化会导致人体对微生物或其他原因引起的疾病的免疫力降低。现代人在不断寻找可以增强免疫力的方法。然而,一般情况下,因为西医的医学方案通常被认为有副作用,因此针对免疫力低下问题更倾向用中药或其他天然原料制成的组合物来解决。
大枣具有营养丰富的特点,为中医所推荐的补血营养品。新疆南疆阿克苏地区位于北纬40°,海拔在800米上下,是全球最适宜出产优质红枣的地区。当地所产“天枣”与其他地区种植的通种类枣相比,具有个大、皮薄、肉厚、味甘的特质。李时珍《本草纲目》载,枣之精华取决于其阳光。新疆南疆地区光照时间长,每年4-10月累计日照时数达2027.1小时,平均每天的日照时数可达10小时以上,且光照度强,十分有利于枣的果实生长。
沙棘树是我国西北沙漠地区特产植物,耐干旱,抗风沙,可以在盐碱化土地上生存,被广泛用于水土保持。所结果实叫沙棘果,沙棘果汁可做饮料,沙棘果肉可以离心出果油,而沙棘果的精华沙棘籽,可以制取沙棘籽油,含有维生素类、黄酮类、脂肪酸、氨基酸及其它微量元素等200多种生物活性物质,因此国内外专家赋予它维生素宝库的美称。西洋参具有补气养血、滋阴补肾、键脾养胃、延缓衰老及养颜等功效。西洋参提取物主要含有西洋参总皂苷,通常为颗粒物。
现有技术中还没有大枣西洋参沙棘籽油的合理组合以实现对免疫力低下的有效治疗。
发明内容
针对本领域的不足之处,本发明的目的是提供一种大枣西洋参沙棘籽油软胶囊。
本发明的另一目的是提供所述软胶囊的制备方法。
实现本发明上述目的的具体技术方案为:
一种大枣西洋参沙棘籽油软胶囊,包括下述重量份的组份:
及包覆上述组分的囊皮。
优选地,所述软胶囊包括下述重量份的组份:
及包覆上述组分的囊皮。
其中,所述辅料为药学可接受的辅料,选自蜂蜡、羧甲基纤维素、淀粉、硬脂酸镁中的一种或多种。
其中,所述软胶囊的囊皮的制备原料为重量份的明胶250-450份、甘油150-250份、纯化水300-500份、柠檬黄0.1-0.2份、胭脂红0.1-0.3份、二氧化钛0.1-0.5份。囊皮的制备方法采用常规的制备方法,例如先将甘油、纯化水、柠檬黄、胭脂红、二氧化钛混合,然后加入明胶,熔融为胶液,使用胶囊机成型。
其中,所述大枣提取物为水提醇沉方法提取得到,所述水提醇沉方法包括步骤:
1)取大枣破碎去核,加水提取后过滤,取滤液;
2)减压浓缩至相对密度1.17-1.20(60℃测),然后加入乙醇使含乙醇量为70-80wt%,静置20-30小时;
3)减压干燥,得干膏,干膏粉碎过筛,即得大枣提取物。
其中,所述步骤1)中,加水提取两次,第一次加固体质量7-9倍的水,第二次加固体质量5-7倍的水。每次水提的时间为1-3小时。
步骤2)中减压浓缩采用常规减压浓缩的压力,温度控制在常温至60℃。
其中,所述步骤3)中,在真空度-0.02至-0.07kPa、温度50-80℃条件下减压干燥。粉碎后过筛时,采用本领域常规的过筛参数,例如过80目筛、或140目筛、或200目筛。
所述大枣提取物为新疆南疆地区产大枣的提取物,大枣种植地区位于北纬40°,海拔为800±50米,例如新疆阿克苏地区。大枣的品种为灰枣、骏枣或沾化冬枣(商品名均为天枣)。种植大枣的地区8-10月平均日温差在17.0—18.5℃,有利于枣果可溶固形物和糖分积累;秋季降雨量少,也使得培植出来的天枣更具营养。
其中,所述软胶囊通过以下方法制得:
1)甘油、纯化水、柠檬黄、胭脂红、二氧化钛按比例混合,然后加入明胶;
2)步骤1)所得混合物在65-75℃下搅拌1-2小时,再静置2-3小时,浇铸成型,得到胶皮;
3)大枣提取物、沙棘籽油、西洋参提取物混合,搅拌均匀,压入步骤2)所得胶皮,然后压丸。
本发明的有益效果在于:
选取大枣提取物、沙棘籽油、西洋参提取物,以合适配比进行组合,能够有效改善免疫力低下等症状;以沙棘油作为组分同时作为另外两种组分的分散剂,不需要在制备过程中加入有机溶剂,简化了制备过程。
本发明的配方原料为沙棘籽油、西洋参提取物、大枣提取物。沙棘甘酸化阴,有益气生津之功,西洋参性凉而补,能补心气、益肺气、充脾气、培元气,并能养阴生津止渴。与沙棘同用,能协同增强补气养阴生津作用。大枣补中益气,养血安神。三者合用,补益肺、脾、心、肾之气,振奋脏腑机能,同时,养阴生津,补血扶正,共同发挥补气生血,养阴生津的作用,可有效增强免疫力。且没有配伍禁忌,合理而安全。对本品进行急性毒性(根据《食品安全性毒理学评价程序和方法》)、三十天喂养、精子畸变、微核、Ames等试验,结果表明,本品安全无毒。
本配方所用西洋参的用量符合《中国药典》规定,且为下限,有效而安全。
附图说明
图1为大枣提取物的制备流程图。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例中,所用红枣为天枣。产于新疆阿克苏地区的国家级绿色食品基地。
其中沙棘籽油购买于内蒙古宇航人高技术产业有限责任公司,西洋参提取物购买于吉林省宏久生物科技股份有限公司,粒度为80目。
实施例1:大枣提取物的制备
制备的工艺流程图如图1。
1)取大枣,破碎去核,加水提取2次,每次1小时,第一次加8倍量水,第二次加6倍量水,过滤去滤液。
2)在温度60℃下减压(真空度0.05kPa)浓缩至相对密度1.18(60℃测),加乙醇使含醇量为75%,静置24小时,取沉淀物。
3)沉淀物减压干燥(真空度为-0.07kPa,温度为70℃)至水分≤4.0%,得干膏。干膏粉碎,过80目筛,即得大枣提取物。出膏率为10%。
大枣提取物的微生物检测结果见表1。
表1微生物检验结果
实施例2:软胶囊的制备
原料:沙棘籽油395g、西洋参提取物52.5g、大枣提取物37.5g
辅料:蜂蜡15g
共500g,制成1000粒软胶囊
囊皮原料:明胶400g、甘油200g、纯化水400g、柠檬黄0.17g、胭脂红0.18g、二氧化钛0.3g。
制备:甘油、纯化水、柠檬黄、胭脂红、二氧化钛混合均匀,然后加入明胶,保持温度70℃、转速为300rpm搅拌1.5h,然后静置2hr,获得胶液。使用软胶囊机(YWJ250-IIIA型全自动高速软胶囊机,北京鑫航成科技发展有限公司)加入原料和辅料制成1000粒软胶囊。产品为棕红色软胶囊,内容物为棕褐色油状,具有本品特有的气味及滋味,无异味,无肉眼可见杂质。
实施例3
原料:沙棘籽油400g、西洋参提取物55g、大枣提取物38g
辅料:蜂蜡16g
共509g,制成1000粒软胶囊
囊皮原料:明胶400g、甘油200g、纯化水400g、柠檬黄0.16g、胭脂红0.16g、二氧化钛0.3g。
制备方法同实施例2。
实施例4
原料:沙棘籽油390g、西洋参提取物52g、大枣提取物38g
辅料:蜂蜡20g
共483g,制成1000粒软胶囊
囊皮原料:明胶400g、甘油200g、纯化水400g、柠檬黄0.16g、胭脂红0.16g、二氧化钛0.3g。
制备方法同实施例2。
实验例1:常规检验
对实施例2-4所制组合物,常温放置24个月。按《保健食品检验与评价技术规范(2003版)》中“保健食品中α-亚麻酸、γ-亚麻酸的测定”规定的方法测定亚麻酸。按《保健食品检验与评价技术规范(2003版)》中“保健食品中总皂甙的测定”规定的方法测定总皂苷。营养成分检测结果见表2。按照标准(GB/T22474)进行微生物检测,结果见表3。
表2营养成分指标
项目 | 实施例2 | 实施例3 | 实施例4 |
亚麻酸,mg/g | 130 | 120 | 125 |
总皂苷(以人参皂苷Re计),mg/g≥ | 15 | 13 | 14 |
表3:微生物检测结果
按《中华人民共和国药典》2010版一部的测定方法测定崩解速度。实施例2-4产品均能在60min内崩解。
实验例2.安全性试验
采用霍恩氏法选择雌、雄性小白鼠,分别对实施例2-4产品作一次性经口急性毒性试验,结果雌鼠LD50=5.84(4.30~7.94)g/kg;雄鼠LD50=5.01(3.44~7.3)g/kg。根据《食品安全性毒理学评价程序和方法》中,经口急性毒性分级标准,表明为无毒级。以2.5g/kg、1.25g/kg、0.625g/kg三个剂量,用雌、雄性小白鼠分别对实施例2-4作股骨骨髓细胞微核试验。另设阴性对照组蒸馏水和阳性对照组(环磷酰胺50mg/kg),实验结果表明:微核试验属阴性结果。设2g/kg、1g/kg、0.5g/kg三个剂量组,选用健康成年雄性小白鼠对实施例2-4产品作小鼠精子畸形试验。另设阴性对照组蒸馏水和阳性对照组(丝裂霉素2.5g/kg)。经统计处理,各剂量组精子畸变率与阴性精子畸变率间差异无显著性(P>0.05),阴性对照与阳性对照精子畸变率间差异有非常显著性(P<0.01)。表明精子畸形试验属阴性结果。
根据实验确定动物最大给药量,约合人4.0g/日。即,成人的内容物日用配方量:沙棘籽油3.16g、西洋参提取物0.42g、大枣提取物0.3g蜂蜡0.12g,共4.0g8粒软胶囊,每粒0.5g。
《中华人民共和国药典·一部》(2010版)第122页记载,西洋参每日常用量为3~6g。本发明配方中西洋参提取物0.42g,出膏率为14%,相当于西洋参药材量为3g,为《中华人民共和国药典》所载的每日常用剂量的下限。既能保证有效性,又能保证安全性。
实验例3.
NR8383大鼠肺泡巨噬细胞,购自中国科学院细胞库。使用培养基为F12K培养基(SIGMA,货号N3520,添加NaHCO32.5g/L),80%;胎牛血清,20%。37摄氏度下扩大培养。
实施例2-4软胶囊各一粒放入250毫升蒸馏水,并在室温下保持2小时。将其在80℃煮沸1小时,并使体积为10毫升。通过0.22μm过滤器过滤上清液。
以105细胞/盖玻片的密度在盖玻片上涂覆NR8383大鼠肺泡巨噬细胞,并使其粘附。用实施例2-4制得软胶囊溶解得上清液培养。培育后,用106乳胶珠/105细胞(细胞∶珠=1∶10)培育细胞2小时。风干盖玻片上的细胞,并用甲醇固定细胞。细胞经Giemsa染色10分钟,并用显微镜计数。巨噬细胞吞噬试验的结果表示为吞噬作用指数,即,每100个细胞的细胞内的珠总数。使用统计方法分析的数据表明t检验中置信度大于95%。
表4巨噬细胞吞噬试验的结果
药物 | 培养基中浓度 | 吞噬作用指数 |
实施例2 | 0.01±0.001 | 1.35 |
实施例3 | 0.01±0.001 | 1.32 |
实施例4 | 0.01±0.001 | 1.29 |
因此,本发明提供的大枣西洋参沙棘籽油软胶囊,各组分相互协同作用,体现了增强免疫力的效果。
以上仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (2)
1.一种大枣西洋参沙棘籽油软胶囊,其特征在于,由下述重量份的组份组成:
及包覆上述组分的囊皮;
其中,所述大枣提取物为水提醇沉方法提取得到,所述水提醇沉方法包括步骤:
1)取大枣破碎去核,加水提取后过滤,取滤液;其中,加水提取两次,第一次加固体质量7-9倍的水,第二次加固体质量5-7倍的水;
2)减压浓缩至相对密度1.17-1.20,然后加入乙醇使含乙醇量为70-80%,静置20-30小时;
3)在真空度-0.02kPa至-0.07kPa、温度50-80℃条件下减压干燥,得干膏,干膏粉碎过筛,即得大枣提取物;
其中,所述辅料为蜂蜡;
其中,所述囊皮的制备原料为重量份的明胶250-450份、甘油150-250份、纯化水300-500份、柠檬黄0.1-0.2份、胭脂红0.1-0.3份、二氧化钛0.1-0.5份。
2.根据权利要求1所述的软胶囊,其特征在于,所述软胶囊通过以下方法制得:
1)甘油、纯化水、柠檬黄、胭脂红、二氧化钛按比例混合,然后加入明胶;
2)步骤1)所得混合物在65-75℃下搅拌1-2小时,再静置2-3小时,浇铸成型,得到胶皮;
3)大枣提取物、沙棘籽油、西洋参提取物和辅料混合,搅拌均匀,压入步骤2)所得胶皮,然后压丸。
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