CN113017090A - 一种用于辅助治疗特发性震颤的脂肪酸组合物及其制备方法 - Google Patents
一种用于辅助治疗特发性震颤的脂肪酸组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于保健品领域，具体涉及一种用于辅助治疗特发性震颤的脂肪酸组合物及其制备方法。本发明的脂肪酸组合物由下列成分组成：含有神经酸的食用油、亚麻籽油与其他食用油。经过药效与临床试验验证，本发明的用于辅助治疗特发性震颤的脂肪酸组合物能够有效改善遗传性手抖、手颤抖、肢体麻木、失眠多梦、认知障碍，并且安全无副作用，临床案例证明对特发性震颤有改善作用，适合于开发成治疗特发性震颤的辅助产品，具有市场价值。
Description
技术领域
本发明属于保健品技术领域，具体涉及一种辅助治疗特发性震颤的脂肪酸组合物及其制备方法。
背景技术
特发性震颤又称为家族性震颤，是最常见的运动障碍性疾病，主要为手、头部及身体其他部位的姿位性和运动性震颤。约60％的特发性震颤病人有家族史。在多个特发性震颤家族未发现跨代现象，性别分布平衡，一般认为这是常染色体显性遗传，在65～70岁前完全外显，也有报道不完全外显和散发病例，散发者和有遗传者临床特征完全一致，通常认为是同一疾病，但目前尚未确定相关基因异常。特发性震颤发病年龄的双峰特征提示可能存在两个不同的异常基因。家族性震颤发病年龄比散发病例早，提示早发的特发性震颤更强烈地受遗传易感性的影响，遗传易感性能明显影响临床亚型特征。
特发性震颤的治疗目前主要有三种手段：一种是以酒精对患者进行麻醉，然而酒精的半衰期短暂并具有许多副作用；一种是以肾上，腺β-受体阻滞剂、扑米酮等化药进行治疗，但在化药的服用过程中伴随恶心、呕吐和共济失调等不良反应，长期服用存在耐受等副作用；一种是通过立体定向丘脑手术来进行治疗，丘脑毁损术使80％的病人术后获得中等以上疗效，1年内有4％～20％复发，术后可能发生短暂的智能缺损、构音障碍、吞咽困难和轻瘫。现有的治疗手段都伴有严重的副反应，且治愈率不能满足病患需求。
发明内容
针对上述情况，本发明的目的在于提供一种用于辅助治疗特发性震颤的脂肪酸组合物及其制备方法。
为了实现上述目的，本发明采用如下技术方案：
一种用于辅助治疗特发性震颤的脂肪酸组合物，本发明的脂肪酸组合物由下列成分组成：含有神经酸的食用油、亚麻籽油、其他食用油。
含有神经酸的食用油包括元宝枫籽油或添加神经酸的其他食用油。
其他食用油包括菜籽油、花生油、火麻油、玉米油、橄榄油、山茶油、棕榈油、葵花子油、大豆油、芝麻油、葡萄籽油、核桃油、牡丹籽油中的一种或几种。优选所述脂肪酸组合物重量百分比组成：40～80％含有神经酸的食用油、20～40％亚麻籽油、0～20％其他食用油。
优选所述脂肪酸组合物重量百分比组成：60％含有神经酸的食用油、40％亚麻籽油。
含有神经酸的食用元宝枫籽油中神经酸的重量百分比大于56％。
亚麻籽油中α亚麻酸的重量百分比大于55％。
一种制备上述用于辅助治疗特发性震颤的脂肪酸组合物的方法，包括以下步骤：将配方量的含有神经酸的食用油、亚麻籽油、其他食用油混合，于室温下1000r搅拌30min，得到用于辅助治疗特发性震颤的脂肪酸组合物。
本发明的同现有技术相比具有的有点在于：
1、具有更好的治疗效果。
2、不会产生恶心、呕吐和共济失调等不良反应，副反应更小。
本发明的有益效果是：本发明提供的用于辅助治疗特发性震颤的脂肪酸组合物能补充人所需的脂肪酸，主要包括饱和脂肪酸、单不饱和脂肪酸和多不饱和脂肪酸。元宝枫籽油含神经酸，神经酸是一种修复疏通大脑神经纤维并促进神经细胞再生的双效神奇物质。神经酸的缺乏容易导致神经系统疾病，而补充神经酸可修复损伤的神经细胞和促进神经细胞再生。研究表明，长期食用油酸和维生素E能减少疾病，改善健康，延长寿命。α亚麻酸是合成EPA和DHA的前体，EPA+DHA能促进细胞再生，显著改善神经系统疾病。本发明脂肪酸组合物能通过血脑屏障，促进受损、濒死的神经细胞的恢复，修复神经网络。并且本发明所用原料的品种少，均是人体所需脂肪酸，因此副作用小，并能够实现各有效成分的相辅相成、协同发挥疗效的目的；通过舌下含服使舌下毛细血管将有效成分快速吸收，直接通过血脑屏障进入大脑，吸收快，减少损耗。
具体实施方式：
实施例1：
配方：
60％元宝枫籽油
40％亚麻籽油
将配方量的元宝枫籽油、亚麻籽油混合，于室温下搅拌均匀，得到用于辅助治疗特发性震颤的脂肪酸组合物。
实施例2：配方：
4％神经酸
56％玉米油
40％亚麻籽油
将配方量的神经酸、玉米油、亚麻籽油混合，于室温下搅拌均匀，得到用于辅助治疗特发性震颤的脂肪酸组合物。
实施例3：
配方：
60％元宝枫籽油
10％大豆油
30％亚麻籽油
将配方量的元宝枫籽油、大豆油、亚麻籽油混合，于室温下搅拌均匀，得到用于辅助治疗特发性震颤的脂肪酸组合物。
实施例4：
小鼠急性经口毒性试验
清洁级昆明小鼠20只，雌雄各半，以0.2ml/10g BW的体积给小鼠灌胃实施例1脂肪酸组合物3次(每次间隔5h)，总剂量为54000mg/kg BW。观察、记录动物的中毒表现和死亡情况，结果判定参照GB 15193.3—2003。
结果：试验期间未见小鼠出现中毒症状，无动物死亡。观察期结束处死动物，大体解剖未见异常。试验结果显示样品LD50大于54000mg/kg BW，据此判断该样品的急性经口毒性属无毒级。
实施例:5：
选取30例特发性震颤患者进行临床观察治疗，其中男性20例，女性10例，年龄50-80岁。症状：震颤不愈，肢体麻木，动作笨拙，呆傻健忘，筋脉拘谨，失眠多梦。每天服用实施例1三次，早中晚各一次，每次3ml，1个月为1疗程，连续服用3-5个疗程。
震颤体征及症状观察指标：对纳入本次研究的患者均在治疗前后进行震颤评分，包括：①患者主诉；②上肢震颤程度；③头、下颌、舌、下肢震颤程度；④画圈及画直线；⑤穿衣、进食、扣纽扣、用筷子状况；⑥满水试验。每项指标分值为：正常0分、轻度1分、中度2分、重度3分。总分值越高代表震颤情况越重。
疗效评定标准：
治愈：治疗前后分差7分以上，体征及症状完全改善，心情舒畅，精神焕发。
显效：治疗前后分差4～6分，体征及症状显著改善，心情舒畅，精神很好。
有效：治疗前后分差2～3分，体征及症状有改变，偶感稍有不适，但能接受。
无效：治疗前后分差小于1分，体征无改变，症状如前。
结果：治愈12例，占40％；显效15例，占50％；有效3例，占10％；无效0例；总有效率达100％。说明本发明脂肪酸组合物对特发性震颤治疗效果显著，值得进一步推广。
典型病例
胡某，男，69岁，患者3年前发现左手颤抖，不能自我控制，不能做精细动作，后发展为四肢震颤，步态不稳，失眠，烦躁不安，记忆衰退，临床诊断为特异性震颤。口服本发明的脂肪酸组合物3个月，平举双手基本不抖，手脚稳定性增加，睡眠变好，一觉到天亮，情绪稳定，记忆改善。疗效评定为治愈。
Claims (9)
1.一种用于辅助治疗特发性震颤的脂肪酸组合物，本发明的脂肪酸组合物由下列成分组成：含有神经酸的食用油、亚麻籽油与其他食用油。
2.根据权利要求1所述的用于辅助治疗特发性震颤的脂肪酸组合物，其特征在于：所述含有神经酸的食用油包括元宝枫籽油或添加神经酸的其他食用油。
3.根据权利要求1、2所述的其他食用油，包括菜籽油、花生油、火麻油、玉米油、橄榄油、山茶油、棕榈油、葵花子油、大豆油、芝麻油、葡萄籽油、核桃油、牡丹籽油中的一种或几种。
4.根据权利要求1所述的用于辅助治疗特发性震颤的脂肪酸组合物，其特征在于：所述脂肪酸组合物重量百分比优选为：40～80％含有神经酸的食用油、20～40％亚麻籽油与0～20％其他食用油。
5.根据权利要求1所述的用于辅助治疗特发性震颤的脂肪酸组合物，其特征在于：所述脂肪酸组合物重量百分比优选为：60％含有神经酸的食用油、40％亚麻籽油。
6.根据权利要求1至3任一项所述的用于辅助治疗特发性震颤的脂肪酸组合物，其特征在于：所述含有神经酸的食用油中神经酸的重量百分比大于5％。
7.根据权利要求1至3任一项所述的用于辅助治疗特发性震颤的脂肪酸组合物，其特征在于：所述亚麻籽油中α亚麻酸的重量百分比大于55％。
8.根据权利要求1至3中任一项所述的用于辅助治疗特发性震颤的脂肪酸组合物的制备方法，包括以下步骤：将配方量的含有神经酸的食用油、亚麻籽油、其他食用油于室温下搅拌均匀，得到用于辅助治疗特发性震颤的脂肪酸组合物。
9.根据权利要求1-8所述的组合物，在制备治疗特发性震颤的药物、保健食品及食品中的应用。
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