CN109419001A - 免疫灵胶囊及其制备方法 - Google Patents
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Abstract
本发明公开了一种免疫灵胶囊及其制备方法,其特征在于由雪莲培养物、红景天提取物和灵芝提取物按照比例混合而成,各组分比例为:雪莲培养物10~40份;红景天提取物60~90份;灵芝提取物80~120份。本品选用雪莲培养物、红景天提取物和灵芝提取物为主要原料,具有清热解毒、补气安神、健脾养肝,提高人体免疫力的功效。针对目前广泛的亚健康人群,具有积极的意义,因此本发明具有广阔的市场前景。
Description
技术领域
本发明属于食品医药技术领域,具体涉及一种含有雪莲培养物、灵芝提取物和红景天提取物的组合物,以及所述组合物在制备免疫调节用药物或保健食品中的应用。
背景技术
雪莲是天山上特有的名贵中草药。中医认为,雪莲温肾助阳,祛风除湿,通经活血。雪莲的独特功效越来越受到重视,临床主要用于素体阳虚、血瘀阻络之风寒湿痹痛、小腹疼痛、月经不调等病证的预防和治疗,在抗早孕方面亦有一定的疗效。现代研究表明,天山雪莲具有以下功能:抗风湿、消炎、镇痛作用;免疫调节;对心血管系统的作用;抗辐射等作用;清除自由基、抗氧化作用;抗疲劳作用;吸收紫外线。但是,野生雪莲是国家重点保护野生植物,严禁采摘,而且人工种植雪莲培植难道大,成活率低,生长缓慢,物种退化严重,成本高。
雪莲培养物,是在无菌条件下,将雪莲离体的植物器官、组织、细胞、胚胎或原生质体培养在人工配制的培养基上,在人工控制的条件下进行培养,使其组织或细胞增值进而按照需要进行培养的技术;或使其脱分化产生愈伤组织,并再逐步分化出器官并长成完整的植株而生产的培养物。该方法技术成熟、安全可靠,经系统研究表明,雪莲培养物不仅含有与天然雪莲相近的活性成分,且亦具有与之相当的多方面的药理活性,是野生雪莲完美的替代物。
灵芝为多孔菌科(Polyporaceae)真菌赤芝(Leyss.ex Fr.)Karst.或紫芝G.sinense Zhao,Xu et Zhang的干燥子实体。灵芝是祖国中医药宝库中的珍品,素有“仙草”之誉。灵芝的子实体具有强烈的药理学活性,有止痛、镇静、解毒的作用,可以抗肿瘤、调节免疫力、降低血糖,具有滋补强身、延年益寿的功效。灵芝的药理成分非常丰富,其中有效成分包括灵芝多糖、三萜类化合物、氨基酸、蛋白质、生物碱以及微量元素等,各有效成分之间具有协同作用。
红景天是景天科红景天属的多年生草本植物。红景天全草都可入药,民间常用于清肺止咳、止血、跌打损伤、烧烫伤、阳痿及糖尿病等症的治疗。现代研究表明,红景天有着与人参、刺五加相似的滋补强壮、扶正固本的功能,而且不会出现人参的过度兴奋作用和刺五加的致便秘作用。
中国专利CN103750339B公开了一种雪莲培养物和红景天提取物为主要原料的保健食品,具有缓解体力疲劳和对辐射危害有辅助保护功能。经过研究,本发明将在此基础上加入灵芝提取物,制备一种具有提高人体免疫功能的保健食品。
发明内容
本发明公开了一种含有雪莲培养物、灵芝提取物和红景天提取物的保健食品及其制备方法,本品具有增强免疫力的保健功效。
本发明目的之一是提供一种保健食品,主要包括如下重量份比的:
雪莲培养物 10~40份;
红景天提取物 60~90份;
灵芝提取物 80~120份。
所述的雪莲培养物为雪莲培养细胞经干燥处理得到的干粉。
所述的雪莲培养细胞为天山雪莲经细胞组织培养所得,市售可购。
优选地,所述的雪莲培养物保健食品,包括如下重量份比的:
雪莲培养物 25份;
红景天提取物 75份;
灵芝提取物 100份。
进一步地,所述的灵芝提取物由以下步骤制备:
①粉碎:将灵芝子实体粉碎,得粗粉;
②提取:灵芝粗粉用15~50倍量乙醇回流提取2次,每次1~3h,过滤,得乙醇提取液及滤渣;滤渣再用15~50倍量水回流提取2次,每次1~3h,过滤,得到水提取液及滤渣,合并乙醇提取液和水提取液,备用。
③浓缩:合并后的提取液在双效节能浓缩器中,温度60-80℃,真空度0.07-0.08Mpa下浓缩至相对密度1.04±0.1,得浓缩液;浓缩液经200目筛网过滤得到的滤液置于球形浓缩罐中,浓缩温度控制在60-80℃,减压浓缩至相对密度1.15±0.1的清膏。
④喷雾干燥:将浓缩液在进风温度180±5℃,出风温度70±5℃下喷雾干燥,得喷干粉;
⑤过筛:将喷干粉粉碎后过80目筛,得灵芝提取物。
所述的红景天提取物由以下步骤制备:
①粉碎:将红景天粉碎,得粗粉;
②提取:红景天粗粉用水回流提取2次,第一次10倍水量,提取时间2h,第二次8倍水量,时间1.5h,提取液100目筛过滤,合并滤液;
③浓缩:合并后的提取液在双效节能浓缩器中,温度70-80℃,真空度0.07-0.08Mpa下浓缩至相对密度1.04±0.1,得浓缩液;
④喷雾干燥:将浓缩液在进风温度180±5℃,出风温度70±5℃下喷雾干燥,得喷干粉;
⑤过筛:将喷干粉粉碎后过80目筛,得红景天提取物。
本发明再一目的是提供一种雪莲培养物保健食品制剂,将以上所述的雪莲培养物保健食品,任选地按本领域技术人员公知的技术加入辅料加工成制剂。
即根据临床需要与实验研究的实践,将本发明雪莲培养物保健食品与辅料和任选的包衣材料一起被制备成本领域中常用的剂型,如片剂、颗粒剂、胶囊剂、丸剂、糖浆剂、粉剂等。
本发明所述的保健食品制剂,按照如下步骤制备:
①雪莲培养物、红景天提取物、灵芝提取物、微晶纤维素分别过80目筛,备用;
②按配方比例取所需物料,将称好的雪莲培养物、红景天提取物、灵芝提取物、微晶纤维素混合30分钟,加入95%乙醇制软材。所得软材用24目筛制粒;
③湿颗粒50-60℃干燥,得干颗粒,颗粒水分控制在5%以下,干颗粒24目筛整粒;
④将制得的颗粒填充胶囊,填充过程中控制重量差异±5%。将上述填充后的胶囊进行抛光处理,去除不合格胶囊;
⑤采用口服固体药用高密度聚乙烯瓶为内包装材料,包装瓶符合YBB00122002《口服固体药用高密度聚乙烯瓶》的要求,每瓶60粒。
附图说明
图1为灵芝提取物工艺流程图
图2为红景天提取物工艺流程图
具体实施方式
下面结合实施例对本发明作进一步的详细说明,但应注意本发明的范围并不受这些实例的任何限制。
实施例1:
处方:
1、前处理:
雪莲培养物、红景天提取物、灵芝提取物、微晶纤维素分别过80目筛,备用。
2、称量、混合、制粒
按配方比例取所需物料,将称好的雪莲培养物、红景天提取物、灵芝提取物、微晶纤维素混合30分钟,加入95%乙醇制软材。所得软材用24目筛制粒。
3、干燥、整粒
湿颗粒50-60℃干燥,得干颗粒,颗粒水分控制在5%以下,干颗粒24目筛整粒。
4、填充、抛光
将制得的颗粒填充胶囊,填充过程中控制重量差异±5%。将上述填充后的胶囊进行抛光处理,去除不合格胶囊。
5、包装
采用口服固体药用高密度聚乙烯瓶为内包装材料,包装瓶符合YBB00122002《口服固体药用高密度聚乙烯瓶》的要求,每瓶60粒。
Claims (8)
1.免疫灵胶囊及其制备方法,其特征在于:由雪莲培养物、红景天提取物和灵芝提取物按照比例混合而成。
2.根据权利要求1所述的免疫灵胶囊及其制备方法,其特征在于:它是以下述重量配比的原料制成,
雪莲培养物 10-40份、
红景天提取物 60-90份、
灵芝提取物 80-120份。
3.根据权利要求2所述的免疫灵胶囊及其制备方法,其特征在于:它是以下述重量配比的原料制成,
雪莲培养物 25份、
红景天提取物 75份、
灵芝提取物 100份。
4.根据权利要求1-3所述的免疫灵胶囊及其制备方法,其特征在于:按下述步骤制备;
a、雪莲培养物、红景天提取物、灵芝提取物和适当的辅料分别过80目筛,备用;
b、按配方比例取所需物料,称好后混合30分钟,加入95%乙醇制软材。所得软材用24目筛制粒;
c、湿颗粒50-60℃干燥,得干颗粒,颗粒水分控制在5%以下,干颗粒24目筛整粒;
d、将制得的颗粒填充胶囊,填充过程中控制重量差异±5%。将上述填充后的胶囊进行抛光处理,去除不合格胶囊;
e、采用口服固体药用高密度聚乙烯瓶为内包装材料。
5.根据权利要求1-4所述的免疫灵胶囊及其制备方法,其特征在于:灵芝提取物按以下步骤制备
a、粉碎:将灵芝子实体粉碎,得粗粉;
b、提取:灵芝粗粉用15~50倍量乙醇回流提取2次,每次1~3h,过滤,得乙醇提取液及滤渣;滤渣再用15~50倍量水回流提取2次,每次1~3h,过滤,得到水提取液及滤渣,合并乙醇提取液和水提取液,备用。
c、浓缩:合并后的提取液在双效节能浓缩器中,温度60-80℃,真空度0.07-0.08Mpa下浓缩至相对密度1.04±0.1,得浓缩液;浓缩液经100目筛网过滤得到的滤液置于球形浓缩罐中,浓缩温度控制在60-80℃,减压浓缩至相对密度1.15±0.1的清膏。
d、喷雾干燥:将浓缩液在进风温度180±5℃,出风温度70±5℃下喷雾干燥,得喷干粉;
e、过筛:将喷干粉粉碎后过80目筛,得灵芝提取物。
6.根据权利要求1-4所述的免疫灵胶囊及其制备方法,其特征在于:红景天提取物按以下步骤制备
a、粉碎:将红景天粉碎,得粗粉;
b、提取:红景天粗粉用水回流提取2次,第一次10倍水量,提取时间2h,第二次8倍水量,时间1.5h,提取液100目筛过滤,合并滤液;
c、浓缩:合并后的提取液在双效节能浓缩器中,温度70-80℃,真空度0.07-0.08Mpa下浓缩至相对密度1.07±0.1,得浓缩液;
d、喷雾干燥:将浓缩液在进风温度180±5℃,出风温度70±5℃下喷雾干燥,得喷干粉;
e、过筛:将喷干粉粉碎后过80目筛,得红景天提取物。
7.根据权利要求1所述的免疫灵胶囊及其制备方法,其特征在于,还包括药用辅料:溶剂、增溶剂、助溶剂、乳化剂、着色剂、黏合剂、崩解剂、填充剂、润滑剂、润湿剂、稳定剂、矫味剂、防腐剂、包衣材料、芳香剂。
8.根据权利要求7所述的药用辅料,其优选为微晶纤维素。
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