CN104352736A - 一种预防与治疗血管性痴呆的药食两用组合物及制备方法 - Google Patents
一种预防与治疗血管性痴呆的药食两用组合物及制备方法 Download PDFInfo
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Abstract
本发明公开了一种预防与治疗血管性痴呆的药食两用组合物及制备方法,属于食疗、保健品及中药制备领域。该组合物产品优选剂型为软胶囊剂型,药食两用品种组合物重量份数为:沙棘籽原花青素提取物10~18,沙棘黄酮提取物4~11,薤白提取物8~18,沙棘籽油63~72。该软胶囊的制备方法是先将其内包物制成油粉混悬剂,再制成软胶囊剂型。本发明组成全为药食两用品种,安全、可长期服用。本发明能有效降低血小板聚集率及血液粘度,增加脑血流量,具有极强的清除自由基抗氧化作用,减少MDA生成,修复保护脑神经损伤,抑制海马神经元凋亡,起到有效预防血管性痴呆与治疗血管性痴呆的作用。
Description
技术领域:
本发明涉及食疗和保健品及中药制备领域,具体涉及一种预防与治疗血管性痴呆的药食两用组合物及制备方法。
背景技术:
我国60岁以上的老年人数已超过2亿。随着人口老龄化的日趋凸现,血管性痴呆(VD)的患者也逐渐增多,我国血管性痴呆发病率占到痴呆总数的60%以上。据2014年10月14日的报道,我国痴呆患者已超过1000万人。问题还在于血管性痴呆已不是老年人的“专利”,四五十岁就出现血管性痴呆的人,数量也在逐年增加。目前临床公认治疗血管性痴呆的阿尼西坦和银杏叶制剂,其治疗效果并不明显,不仅西药有明显的毒副作用,银杏叶制剂也有多种副作用。至今,国内外对血管性痴呆的治疗尚无有效方法和药物,为此,国家已将治疗血管性痴呆纳入国家攻关项目。
目前,采用沙棘和薤白药食两用品种组合物预防与治疗血管性痴呆的功能食品和保健品及准字药品尚属空白。
发明内容:
本发明的目的在于根据现有技术中的上述不足,提供一种预防血管性痴呆与治疗血管性痴呆的药食两用品种组合物。
本发明的另一目的是提供上述预防与治疗血管性痴呆的药食两用品种组合物制备方法。
本发明通过以下技术方案实现上述目的:
本发明药食两用品种组合物是由:沙棘籽原花青素提取物、沙棘黄酮提取物、薤白提取物、沙棘籽油组成。
本发明预防与治疗血管性痴呆的药食两用品种组合物,由以下重量份数的药食两用品种提取物组成:沙棘籽原花青素提取物10~18,沙棘黄酮提取物4~11,薤白提取物8~18,沙棘籽油63~72。
作为一种优选方案,上述药食两用品种提取物由以下重量份数组成:沙棘籽原花青素提取物12~15,沙棘黄酮提取物5~8,薤白提取物10~14,沙棘籽油65~68。
本发明处方中的沙棘籽原花青素提取物、沙棘黄酮提取物、沙棘籽油是药食两用品种沙棘的主要组成部分。实验研究表明,沙棘籽原花青素提取物抗氧化作用优于葡萄籽原花青素提取物,因为沙棘籽原花青素提取物中含有更多的二聚体、三聚体。沙棘籽原花青素具有极强的清除自由基抗氧化作用,提高脑组织SOD活性、GSH含量和总抗氧化能力,减少MDA生成;修复保护神经损伤,减轻脑组织被自由基损害,抑制海马神经元凋亡。沙棘籽原花青素还可以通过调节脑内神经递质含量,保护胆碱能神经起到脑保护作用。研究表明,沙棘黄酮具有抗心肌缺血、改善心肌细胞功能、抗心率失常、降血压、降血糖、提高免疫、抗氧化、神经保护和抗衰老等广泛的药理活性。近年的研究发现,沙棘总黄酮可以影响单胺氧化酶(MAO)和酪氨酸羟化酶(TH)活性,使脑内***受体(ER)的数目增加,使脑内单胺类递质的含量上升,起到预防与治疗血管性痴呆。沙棘总黄酮还能够改善异常的血液流变学,降低血液粘稠度,增加脑血流量,促进缺血缺氧神经细胞功能的恢复,而起到预防与治疗血管性痴呆。实验结果表明:沙棘籽油可明显改善脑梗塞大鼠血液流变学性质,对全血还原粘度的改善方面比尼莫地平和络欣通要好,对全血粘度的降低方面比络欣通要好。可显著减少脑梗塞大鼠脑组织MDA含量,减轻脑组织的脂质过氧化反应。为此,沙棘籽油能够明显预防与治疗血管性痴呆。实验研究表明,薤白提取物能通过增加脑部缺血区域的供血量,改善脑组织病理状态,降低其血小板聚集率及血液粘稠度,改善脑组织微循环,促进其神经元功能的恢复。为此,薤白提取物能起到预防与治疗血管性痴呆的作用。本方四类活性成份群共同作用,将起到有效预防血管性痴呆与治疗血管性痴呆的作用。
本发明所述产品优选剂型为软胶囊剂型,也可制成硬胶囊、颗粒剂或丸剂。
本发明还提供一种预防与治疗血管性痴呆的药食两用组合物的软胶囊制备方法,该方法在10万级洁净车间,包括如下步骤:
1、胶囊皮胶液制备
胶液原料准备:食用明胶(41%)、食用甘油(16.5%)、纯化水(41%)、焦糖色素(1.5%)
胶液制备:将处方量的纯化水和食用甘油加入水浴式化胶罐,加热至70-80℃,加入明胶、焦糖色素,搅拌、溶融,保温1小时,抽真空无明显气泡,经80目滤网过滤放入胶桶保温(60-65℃),静置2~6小时,待用。
2、内包物制备
内包物原辅料准备:沙棘籽原花青素提取物10~18,沙棘黄酮提取物4~11,薤白提取物8~18,沙棘籽油63~72,蜂蜡(内包物的4.5%)内包物配制过程:将上述物料中沙棘籽油的1/5~1/3加入真空均质乳化机中加温至65℃溶化蜂蜡,降温至30℃加入剩余沙棘籽油及以上三种粉剂提取物,搅拌均质0.5小时,过胶体磨2遍,并抽真空无气泡,降温至22℃过60目滤网出料至保温料桶待用。
3、压制胶丸:制胶丸、洗丸、干燥、选丸、擦丸、包装。
本发明的有益效果:
(1)本发明配方全为药食两用品种,确保了产品的安全性,可以长期服用,无毒副作用。
(2)本发明为预防血管性痴呆与干预血管性痴呆的加重提供了安全、有效的产品。
具体实施方式:
以下实施例为软胶囊剂型,用于说明本发明,但不用来限制本发明的剂型范围:
实施例1:
(1)物料准备
i)按比例称取胶囊皮原料:食用明胶7公斤,食用甘油2.8公斤,纯化水7公斤,焦糖色素0.6公斤。
ii)按比例称取内包物原料:沙棘籽原花青素提取物13.7公斤,沙棘黄酮提取物5.5公斤,薤白提取物10.4公斤,沙棘籽油63.5公斤,蜂蜡4.4公斤。
(2)胶囊皮胶液制备:将纯化水7公斤和食用甘油2.8公斤加入水浴式化胶罐,加热至75℃,加入食用明胶7公斤和焦糖色素0.6公斤,搅拌、溶融,保温1小时,抽真空无明显气泡,经80目滤网过滤放入胶桶保温(65℃),静置4小时以上,待用。
(3)内包物配制:将15公斤沙棘籽油加入真空均质乳化机中加温至65℃溶化蜂蜡,降温至30℃加入剩余沙棘籽油48.5公斤及沙棘籽原花青素提取物13.7公斤,沙棘黄酮提取物5.5公斤,薤白提取物10.4公斤。搅拌均质0.5小时,过胶体磨2遍,并抽真空无气泡,降温至22℃过60目滤网出料至保温料桶,制得97.5公斤油粉混悬剂软胶囊内包物待用。
(4)压制胶丸:制内包物重量为0.65克/粒的胶丸,洗丸、干燥、选丸、擦丸、包装。其理论产量为150000粒,实际产量为144000粒,软胶囊出品率为96%。检验、成品。待用。
(5)服用剂量及方法:
早晚空腹服用,每日2次,每次2粒。
实施例2:
(1)物料准备
i)按比例称取胶囊皮原料:食用明胶14公斤,食用甘油5.8公斤,纯化水14公斤,焦糖色素1.5公斤。
ii)按比例称取内包物原料:沙棘籽原花青素提取物25.5公斤,沙棘黄酮提取物9公斤,薤白提取物18公斤,沙棘籽油114公斤,蜂蜡8.5公斤。
(2)胶囊皮胶液制备:将纯化水14公斤和食用甘油5.8公斤加入水浴式化胶罐,加热至75℃,加入食用明胶14公斤和焦糖色素1.5公斤,搅拌、溶融,保温1小时,抽真空无明显气泡,经80目滤网过滤放入胶桶保温(65℃),静置4小时以上,待用。
(3)内包物配制:将30公斤沙棘籽油加入真空均质乳化机中加温至65℃溶化蜂蜡,降温至30C加入剩余沙棘籽油84公斤及沙棘籽原花青素提取物25.5公斤,沙棘黄酮提取物9公斤,薤白提取物18公斤。搅拌均质0.5小时,过胶体磨2遍,并抽真空无气泡,降温至22℃过60目滤网出料至保温料桶,制得175公斤油粉混悬剂软胶囊内包物待用。
(4)压制胶丸:制内包物重量为0.7克/粒的胶丸,洗丸、干燥、选丸、擦丸、包装。其理论产量为250000粒,实际产量为242500粒,软胶囊出品率为97%。检验、成品。待用。
(5)服用剂量及方法:
早晚空腹服用,每日2次,每次2粒。
Claims (3)
1.一种预防与治疗血管性痴呆的药食两用组合物,其特征由以下药食两用品种组成:沙棘、薤白,其提取物重量份数的药物组成:沙棘籽原花青素提取物10~18,沙棘黄酮提取物4~11,薤白提取物8~18,沙棘籽油63~72。
2.根据权利要求1所述预防与治疗血管性痴呆的药食两用品种组合物,其优选方案特征在于由以下重量份数的药物组成:沙棘籽原花青素提取物12~15,沙棘黄酮提取物5~8,薤白提取物10~14,沙棘籽油65~68。
3.根据权利要求1所述的预防与治疗血管性痴呆的药食两用组合物,其特征在于优选剂型为软胶囊,也可制成硬胶囊、颗粒剂或丸剂。
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