CN107307418A - 一种用于缓解视疲劳的越橘维生素a软胶囊及其制备方法 - Google Patents
一种用于缓解视疲劳的越橘维生素a软胶囊及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于缓解视疲劳的越橘维生素A软胶囊,由囊心内容物和胶囊皮组成,所述囊心内容物由以下重量份数的原料制成:越橘提取物80‑150、桑葚提取物50‑120、牛磺酸5‑20、虾青素20‑50、维生素A 0.1‑0.25、甘露醇0.1‑2、聚乙二醇50‑100、聚乳酸‑羟基乙酸共聚物30‑80、单硬脂酸甘油酯50‑100、增稠剂10‑25、稀释剂300‑500、乳化剂3‑6。本发明对眼痛、眼胀、畏光、视物模糊、眼干涩等症状具有明显改善,具有缓解视疲劳功能的作用。
Description
技术领域
本发明属于保健食品技术领域,具体涉及一种用于缓解视疲劳的越橘维生素A软胶囊及其制备方法。
背景技术
视疲劳是由于用眼时间过长或用眼过度、且得不到及时有效的休息而造成的以眼部不适为主的一系列症状和体征。其形成原因可能有二:一是眼球长时间地处于搜索注视状态,眼外肌和睫状肌代谢增加,造成代谢废物产生积累增加,从而造成肌细胞结构损伤和功能下降;二是视细胞消耗过度,而所需营养物质供应不及时,造成黄斑及视网膜恢复时间延长。
已有研究发现,花青素能够有效改善人眼黄斑恢复时间,尤其是暗环境中对中高空间数字的辨认更为明显,从而认为花青素能够增加眼底微循环的血流,加速物质代谢交换和增强对毛细血管的保护作用,进而改善黄斑恢复时间和夜间视觉的作用。越橘提取物的主要成分为花青素,国内外临床应用表明,花青素能改善视力、减轻目眩,能保护毛细血管,促进视红细胞再生,增强对黑暗的适应能力,能改善夜间视觉,减轻视觉疲劳,提高低亮度的适应能力。维生素A是人体必需的营养素,也是视色素的主要成分,它对维持正常的视觉有着重要作用。当维生素A缺乏或不足时,可引起暗适应能力降低、夜盲症、角膜角化以及视力障碍。
目前,国内外对花青素缓解视疲劳、改善视力方面做了诸多研究,在一定程度上能够缓解视觉疲劳,但对于改善视力效果不大,尤其是对眼球屈光度的影响无显著性。
发明内容
为弥补现有技术的不足,本发明提供一种用于缓解视疲劳的越橘维生素A软胶囊及其制备方法,对眼痛、眼胀、畏光、视物模糊、眼干涩等症状具有明显改善。
本发明是通过如下技术方案实现的:
一种用于缓解视疲劳的越橘维生素A软胶囊,其特殊之处在于:由囊心内容物和胶囊皮组成,所述囊心内容物由以下重量份数的原料制成:越橘提取物80-150、桑葚提取物50-120、牛磺酸5-20、虾青素20-50、维生素A 0.1-0.25、甘露醇0.1-2、聚乙二醇50-100、聚乳酸-羟基乙酸共聚物30-80、单硬脂酸甘油酯50-100、增稠剂10-25、稀释剂300-500、乳化剂3-6。
本发明的用于缓解视疲劳的越橘维生素A软胶囊,所述胶囊皮由明胶、甘油、水、附加剂、遮光剂制成;所述遮光剂为二氧化钛、苋菜红、亮蓝。
进一步的,胶囊皮中所述明胶、甘油、水、附加剂、遮光剂的质量比为10:4:9:0.01:0.05;
胶囊皮中所述附加剂为海藻酸钠、羟丙甲基纤维素。
作为优选方案,本发明的用于缓解视疲劳的越橘维生素A软胶囊,所述越橘提取物中花色苷质量含量为25%;所述桑葚提取物中花色苷质量含量为15%。。
作为优选方案,本发明的用于缓解视疲劳的越橘维生素A软胶囊,所述增稠剂为蜂蜡或聚乙烯比咯烷酮;所述稀释剂为大豆油、玉米油、葵花籽油中的一种;所述乳化剂为大豆磷脂。
本发明的一种用于缓解视疲劳的越橘维生素A软胶囊的制备方法,包括以下步骤:
A囊心内容物的制备:
A1)、将增稠剂加入到一部分稀释剂中,加热至70-75℃,在搅拌下至增稠剂完全溶解;
A2)、将越橘提取物、桑葚提取物、牛磺酸、虾青素、维生素A、甘露醇、聚乙二醇、聚乳酸-羟基乙酸共聚物、单硬脂酸甘油酯、乳化剂加入到剩余部分稀释剂中,在40-50℃下充分溶解混匀;
A3)、将步骤A1)与步骤A2)所得溶液混匀,采用胶体磨充分研磨,过80-100目筛,搅拌20-30min,得囊心内容物;
B胶囊皮胶液的制备:
B1)、将明胶、甘油加入到水中,加热至65-75℃,加入附加剂,在搅拌下至明胶全部溶解;
B2)、将苋菜红、亮蓝加入水中充分溶解;
B3)、二氧化钛中加入甘油进行研磨;
B4)、将步骤B1)、B2)、B3)所得溶液混匀,抽真空脱气,过80-100目筛,胶液静置,保温50-60℃;
C越橘维生素A软胶囊的制备:
C1)、将步骤A3)得到的囊心内容物和步骤B4)得到的胶液送入制丸机中,压丸,定型,干燥,拣丸,包装即得软胶囊。
作为优选方案,步骤B4)中抽真空的真空度为0.08-0.09MPa。
进一步的,步骤C1)中,压丸:压丸间温度18-26℃,相对湿度30-40%,喷体温度35-50℃,胶皮厚度0.70-0.85mm,模具转速1.5-3.0转/min;定型:定型时间2-3h;干燥:干燥室温度20-25℃,相对湿度20-30%,干燥后胶皮水分7-10%。
本发明的有益效果是:本发明的软胶囊能够清除眼球长时间注视产生的自由基,及时补充视网膜神经和黄斑恢复所需营养物质,增加眼球血流,改善供氧环境,对眼痛、眼胀、畏光、视物模糊、眼干涩等症状具有明显改善,且本发明的软胶囊具有缓释效果,作用时间长,长时间使用对青少年视疲劳和轻度近视具有治愈作用。
具体实施方式
下面结合具体实施方式对本发明作进一步详细的说明,以帮助本领域的技术人员对本发明的发明构思、技术方案有更完整、准确和深入的理解。
实施例1
一种用于缓解视疲劳的越橘维生素A软胶囊,由囊心内容物和胶囊皮组成,囊心内容物由以下原料制成:越橘提取物120g、桑葚提取物60g、牛磺酸10g、虾青素25g、维生素A0.25g、甘露醇0.1、聚乙二醇60g、聚乳酸-羟基乙酸共聚物50g、单硬脂酸甘油酯80g、蜂蜡20g、大豆油355g、大豆磷脂5g;胶囊皮由以下原料制成:明胶100g、甘油40g、纯化水90g、海藻酸钠0.05g、羟丙甲基纤维素0.05g、二氧化钛0.3g、苋菜红0.16g、亮蓝0.04g。
制备工艺
1.原料准备
将检验合格的原料严格按照进入10万级洁净区的程序,在缓冲区脱外包装,对内包装进行表面消毒后,经传递窗进入洁净区备用。
2.称量备料
按计划生产量及配方比例称取各原料,备用。
3.囊心内容物的制备
将蜂蜡加入到适量大豆油中,加热至70℃,在搅拌下至蜂蜡完全溶解;将越橘提取物、桑葚提取物、牛磺酸、虾青素、维生素A、甘露醇、聚乙二醇、聚乳酸-羟基乙酸共聚物、单硬脂酸甘油酯、大豆磷脂加入到剩余部分大豆油中,在40℃下充分溶解混匀;将两部分大豆油溶解物混匀,胶体磨研磨2次,过100目筛,搅拌20min,抽真空,脱气泡,得囊心内容物,备用;
4.胶液的制备
将二氧化钛中加入甘油研磨均匀,得二氧化钛甘油混悬液;将苋菜红、亮蓝加入纯化水中充分溶解,得色素水溶液,备用;将甘油、纯化水投入到化胶罐中,边搅拌边加热,加热至70℃,投入明胶、海藻酸钠和羟丙甲基纤维素,搅拌至明胶全溶;将二氧化钛甘油混悬液、色素水溶液投入到化胶罐中,搅拌均匀,静置10h,保温50-60℃,备用;
5.压丸
将胶囊内容物、胶液在软胶囊机中压成软胶囊,装量为500mg/粒,保持转速2.0转/分钟,喷体温度保持45℃,胶皮厚度为0.70-0.85mm,压好的软胶囊于转笼中定型2.5小时,温度18-26℃,相对湿度30-40%;
6.干燥
经定型出来的胶丸置于干燥盘上,在相对湿度20-30%,温度20-25℃的干燥室中干燥,至胶皮水分7-10%;
7.拣丸
将已干燥好的胶丸放在选丸台上,在灯光下目视拣丸,拣去大小头、异形、漏油、气泡丸、粘连等不合格胶丸;将精选好的胶丸置于具盖洁净桶中,待检验合格后,分装;
8.包装
经拣丸合格的胶丸,按60粒/瓶装入瓶中,贴标签,再装于纸箱中,抽检合格后即为成品。
实施例2
一种用于缓解视疲劳的越橘维生素A软胶囊,由囊心内容物和胶囊皮组成,囊心内容物由以下原料制成:越橘提取物100g、桑葚提取物100g、牛磺酸15g、虾青素30g、维生素A0.2g、甘露醇0.15g、聚乙二醇70g、聚乳酸-羟基乙酸共聚物60g、单硬脂酸甘油酯60g、聚乙烯比咯烷酮25g、玉米油395g、大豆磷脂4g;胶囊皮由以下原料制成:明胶100g、甘油40g、纯化水90g、海藻酸钠0.05g、羟丙甲基纤维素0.05g、二氧化钛0.3g、苋菜红0.16g、亮蓝0.04g。
制备工艺
1.原料准备
将检验合格的原料严格按照进入10万级洁净区的程序,在缓冲区脱外包装,对内包装进行表面消毒后,经传递窗进入洁净区备用。
2.称量备料
按计划生产量及配方比例称取各原料,备用。
3.囊心内容物的制备
将蜂蜡加入到适量大豆油中,加热至75℃,在搅拌下至蜂蜡完全溶解;将越橘提取物、桑葚提取物、牛磺酸、虾青素、维生素A、甘露醇、聚乙二醇、聚乳酸-羟基乙酸共聚物、单硬脂酸甘油酯、大豆磷脂加入到剩余部分大豆油中,在50℃下充分溶解混匀;将两部分大豆油溶解物混匀,胶体磨研磨2次,过80目筛,搅拌30min,抽真空,脱气泡,得囊心内容物,备用;
4.胶液的制备
将二氧化钛中加入甘油研磨均匀,得二氧化钛甘油混悬液;将苋菜红、亮蓝加入纯化水中充分溶解,得色素水溶液,备用;将甘油、纯化水投入到化胶罐中,边搅拌边加热,加热至75℃,投入明胶、海藻酸钠和羟丙甲基纤维素,搅拌至明胶全溶;将二氧化钛甘油混悬液、色素水溶液投入到化胶罐中,搅拌均匀,静置8h,保温50-60℃,备用;
5.压丸
将胶囊内容物、胶液在软胶囊机中压成软胶囊,装量为500mg/粒,保持转速3.0转/分钟,喷体温度保持40℃,胶皮厚度为0.70-0.85mm,压好的软胶囊于转笼中定型3小时,温度18-26℃,相对湿度30-40%;
6.干燥
经定型出来的胶丸置于干燥盘上,在相对湿度20-30%,温度20-25℃的干燥室中干燥,至胶皮水分7-10%;
7.拣丸
将已干燥好的胶丸放在选丸台上,在灯光下目视拣丸,拣去大小头、异形、漏油、气泡丸、粘连等不合格胶丸;将精选好的胶丸置于具盖洁净桶中,待检验合格后,分装;
8.包装
经拣丸合格的胶丸,按60粒/瓶装入瓶中,贴标签,再装于纸箱中,抽检合格后即为成品。
临床观察
1.结果判定标准
症状改善:眼痛、眼胀、畏光、视物模糊、眼干涩任意症状改善1分及1分以上即为改善,5种症状任一改善且其他症状无恶化即判定症状改善;
有效:症状改善且明视持久度前后相差大于等于0.1,并经统计比较差异有显著性;
无效:未达到有效标准;
参考指标:视力改善率。以试食试验后较实验前提高两行为改善,统计两组服用受试物后的视力改善率作为参考指标,参考指标不作为对缓解视疲劳功能是否有效的判定标准。
2试验选择
一般情况:试食组服用本申请实施例1的软胶囊,对照组服食安慰剂。
初始试验人群试验组53例,对照组53例,试食组:男/女为28/25,年龄为13.66±0.52岁;对照组:男/女为28/25,年龄为13.66±0.55岁。试食期间受试者精神、睡眠、饮食、大小便均正常。
3.功效观察
3.1临床症状观察
临床症状积分统计如下表:
*与对照组比较,P<0.05;#与自身比较,P<0.05。
临床症状改善情况如下表:
试验后试食组眼痛、眼胀、畏光、视物模糊、眼干涩等临床症状有改善,其症状积分与试食前比较明显降低,差异有显著性(P<0.05);与对照组比较,差异也显著性(P<0.05)。
3.2疗效观察
临床观察功效比较见下表
*与对照组比较,P<0.05。
服用受试物45天后,试食组临床观察总有效率为82.35%,与对照组比较有显著性(P<0.05)。
3.3对明视持久度的影响
明视持久度变化(±s)见下表
*与对照组比较,P<0.05;#与自身比较,P<0.05。
试验后试食组明视持久度较试验前提高0.12,且明视持久度的提高幅度与对照组比较明显提高,差异有显著性(P<0.05)。说明本发明的软胶囊有提高明视持久度的作用。
3.4对视力的影响
试食前后视力情况(±s)见下表
试验前后视力改善情况见下表
试食组试验后视力水平与试食前及对照组比较有明显提升,试食组视力提高幅度及改善率与对照组比较有明显提高与改善。
综上,服用本发明的软胶囊对眼痛、眼胀、畏光、视物模糊、眼干涩等临床症状有明显改善,症状积分与试食前及对照组比较明显降低,差异有显著性;试食组临床观察总有效率为82.35%,与对照组比较有显著性;试验后试食组明视持久度较试验前提高0.12,且明视持久度的提高幅度与对照组比较明显提高,差异有显著性;试食组试验后视力水平与试食前及对照组比较有明显提升,试食组视力提高幅度及改善率与对照组比较有明显提高与改善。
Claims (9)
1.一种用于缓解视疲劳的越橘维生素A软胶囊,其特征在于:由囊心内容物和胶囊皮组成,所述囊心内容物由以下重量份数的原料制成:越橘提取物80-150、桑葚提取物50-120、牛磺酸5-20、虾青素20-50、维生素A 0.1-0.25、甘露醇0.1-2、聚乙二醇50-100、聚乳酸-羟基乙酸共聚物30-80、单硬脂酸甘油酯50-100、增稠剂10-25、稀释剂300-500、乳化剂3-6。
2.根据权利要求1所述的一种用于缓解视疲劳的越橘维生素A软胶囊,其特征在于:所述胶囊皮由明胶、甘油、水、附加剂、遮光剂制成;所述遮光剂为二氧化钛、苋菜红、亮蓝。
3.根据权利要求1所述的一种用于缓解视疲劳的越橘维生素A软胶囊,其特征在于:所述越橘提取物中花色苷质量含量为25%;所述桑葚提取物中花色苷质量含量为15%。
4.根据权利要求1所述的一种用于缓解视疲劳的越橘维生素A软胶囊,其特征在于:所述增稠剂为蜂蜡或聚乙烯比咯烷酮;所述稀释剂为大豆油、玉米油、葵花籽油中的一种;所述乳化剂为大豆磷脂。
5.根据权利要求2所述的一种用于缓解视疲劳的越橘维生素A软胶囊,其特征在于:所述明胶、甘油、水、附加剂、遮光剂的质量比为10:4:9:0.01:0.05。
6.根据权利要求2所述的一种用于缓解视疲劳的越橘维生素A软胶囊,其特征在于:所述附加剂为海藻酸钠、羟丙甲基纤维素中的一种或两种。
7.根据权利要求2-6中任一项所述的一种用于缓解视疲劳的越橘维生素A软胶囊的制备方法,其特征在于:包括以下步骤:
A囊心内容物的制备:
A1)、将增稠剂加入到一部分稀释剂中,加热至70-75℃,在搅拌下至增稠剂完全溶解;
A2)、将越橘提取物、桑葚提取物、牛磺酸、虾青素、维生素A、甘露醇、聚乙二醇、聚乳酸-羟基乙酸共聚物、单硬脂酸甘油酯、乳化剂加入到剩余部分稀释剂中,在40-50℃下充分溶解混匀;
A3)、将步骤A1)与步骤A2)所得溶液混匀,采用胶体磨充分研磨,过80-100目筛,搅拌20-30min,得囊心内容物;
B胶囊皮胶液的制备:
B1)、将明胶、甘油加入到水中,加热至65-75℃,加入附加剂,在搅拌下至明胶全部溶解;
B2)、将苋菜红、亮蓝加入水中充分溶解;
B3)、二氧化钛中加入甘油进行研磨;
B4)、将步骤B1)、B2)、B3)所得溶液混匀,抽真空脱气,过80-100目筛,胶液静置,保温50-60℃;
C越橘维生素A软胶囊的制备:
C1)、将步骤A3)得到的囊心内容物和步骤B4)得到的胶液送入制丸机中,压丸,定型,干燥,拣丸,包装即得软胶囊。
8.根据权利要求7所述的一种用于缓解视疲劳的越橘维生素A软胶囊的制备方法,其特征在于:步骤B4)中抽真空的真空度为0.08-0.09MPa。
9.根据权利要求7所述的一种用于缓解视疲劳的越橘维生素A软胶囊的制备方法,其特征在于:步骤C1)中,压丸:压丸间温度18-26℃,相对湿度30-40%,喷体温度35-50℃,胶皮厚度0.70-0.85mm,模具转速1.5-3.0转/min;定型:定型时间2-3h;干燥:干燥室温度20-25℃,相对湿度20-30%,干燥后胶皮水分7-10%。
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