CN111820413A - 一种叶黄素蓝莓葡萄籽维生素e软胶囊及其制备方法 - Google Patents
一种叶黄素蓝莓葡萄籽维生素e软胶囊及其制备方法 Download PDFInfo
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- CN111820413A CN111820413A CN201910311866.7A CN201910311866A CN111820413A CN 111820413 A CN111820413 A CN 111820413A CN 201910311866 A CN201910311866 A CN 201910311866A CN 111820413 A CN111820413 A CN 111820413A
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- soft capsule
- lutein
- grape seed
- vitamin
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Abstract
本发明提供一种叶黄素蓝莓葡萄籽维生素E软胶囊,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素10‑50重量份、蓝莓4‑25重量份、葡萄籽10‑45重量份、维生素E 3‑10重量份、大豆油290‑350重量份、蜂蜡4‑25重量份。
Description
技术领域
本发明涉及一种可以缓解视疲劳的叶黄素蓝莓葡萄籽维生素E软胶囊及其制备方法,属于医药保健领域。
背景技术
视疲劳是临床常见病、多发病,是指久视后出现眼胀、头痛、头晕、眼眶胀痛等自觉症状及眼或全身器质性因素与精神(心理)因素相互交织的综合征。引起视疲劳的原因包括环境因素、眼部因素、体质因素和精神因素,并非独立的眼病,属于身心医学范畴。中医学医学文献中没有视疲劳的病名,但本病与祖国医学的“肝劳”、“眉棱骨痛”等病症密切相关。祖国医学认为“肝开窍于目”,《内经》云:“肝受血而能视……五脏六腑之精气皆上注于目而为之精。”孙思邈称本病为“肝劳”,曰:“其读书、博奕过度患目者,名曰肝劳。”亦有人认为此症颇似“目干涩昏花症”。对于其病因,《医学入门》认为:“极目远视,夜书随着细字,镂刻博奕伤神,皆伤目之本。”《审视瑶函》则进一步阐述说:“心藏乎神,运光于目,凡读书作字,与夫妇女描刺,匠作雕蜜,凡此皆以目不转睛而视,又必留心内营。心主火,内营不息,则心火动,心火一动,则眼珠隐隐作痛。”此外,光、声、化学物质刺激,全身性疾病,生活节奏失调,紧张,忧郁等内外环境因素及精神因素亦与发病密切相关。社会竞争的加剧,生活工作节奏增快,从事文字及其它近距离用眼工作人群的增多,尤其是电脑等视频终端的广泛普及,临床上视疲劳的发病率逐年增多。因此,关于视疲劳的病因、病机及防治越来越得到人们的关注。
中医药整体辨证治疗,从全身情况出发,在治疗视疲劳综合征方面有独特的疗效。近年来中医药及针灸等治疗本病有较多报道,临床疗效较好。①辨证论治:确诊视疲劳后,进行辨证分型,依型用药,既是中医传统用药的基本方法亦是现代临床诸多医家习用的主要方法,有较多报道。但因本病病因、病机复杂,各家经验不同而使分型多不一致。②专方专法:一些医家经验证实,对视疲劳一旦确诊,可辨病治疗,一方一法亦可取得良好疗效。如用柴葛解肌汤为基础方治疗视疲劳。③针刺、耳压疗法:庞雅菊针刺治疗51例视疲劳患者,取穴:赞竹、丝竹空、睛明、健明、承泣、球后、风池、风府、百会、内关、合谷等。总体来看,本病为多因素疾病,治疗上除了处理眼局部外,还要对患者的生活习惯、饮食、生活方式、工作量、身体锻练给予合理建议。西医治疗方法偏重眼部对症治疗,并且比较重视视觉低级中枢的生理过程,纠正从眼的屈光系统在视网膜上成像,视觉信息传入枕叶皮层纹状区这一通道的异常。而忽视了高级视觉中枢在视觉信息加工形成有意识的知觉过程中的缺陷。事实上,视觉高级中枢对于像的辨认和识别困难所引起的视疲劳比视觉低级中枢所引起的视疲劳要更常见。所以运用中医整体观念,在治疗上针对整体和眼部的病症加以干预,就能显示出中医的特色和优势,提高机体对环境对工作的适应能力,消除或缓解眼部、身体的不适感,提高工作效率,改善生活质量。
发明内容
针对现有技术的不足,本发明提供一种叶黄素蓝莓葡萄籽维生素E软胶囊及其制备方法。叶黄素、蓝莓、葡萄籽、维生素E对视疲劳均匀很好的调节作用,本发明产品具有剂量准确、服用方便、生物利用度高等特点。
作为本发明的一个方面,本发明提供一种叶黄素蓝莓葡萄籽维生素E软胶囊,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素10-50重量份、蓝莓4-25重量份、葡萄籽10-45重量份、维生素E 3-10重量份、大豆油290-350重量份、蜂蜡4-25重量份。
优选的,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素15-40重量份、蓝莓6-20重量份、葡萄籽15-40重量份、维生素E 4-9重量份、大豆油300-340重量份、蜂蜡6-20重量份。
进一步优选的,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素20-30重量份、蓝莓8-15重量份、葡萄籽20-35重量份、维生素E 3-8重量份、大豆油310-330重量份、蜂蜡10-15重量份。
更进一步优选的,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素25重量份、蓝莓10重量份、葡萄籽25重量份、维生素E 5重量份、大豆油323.5重量份、蜂蜡11.5重量份;
或,叶黄素21重量份、蓝莓9重量份、葡萄籽34重量份、维生素E 8重量份、大豆油312.5重量份、蜂蜡14.5重量份;
或,叶黄素29重量份、蓝莓14重量份、葡萄籽21量份、维生素E 3.5重量份、大豆油328重量份、蜂蜡9重量份。
本发明软胶囊除了以蓝莓和葡萄籽作为原料直接进行投料外,还可以蓝莓提取物和葡萄籽提取物作为原料进行投料,所述蓝莓提取物和葡萄籽提取物可直接采用市售的产品,也可以按照现有技术公开的方法进行制备;优选的,所述蓝莓提取物中原花青素的含量为15%~25%,所述葡萄籽提取物中原花青素的含量为85%~95%。
本发明软胶囊中的叶黄素优选天然叶黄素,维生素E优选天然维生素E。
作为本发明的另一个方面,本发明提供所述叶黄素蓝莓葡萄籽维生素E软胶囊的制备方法,所述方法包括如下步骤:
步骤a,内容物的制备:将蜂蜡加入大豆油中,使蜂蜡熔融后得蜂蜡大豆油溶液;将叶黄素、蓝莓或其提取物、葡萄籽或其提取物、维生素E加入蜂蜡大豆油溶液中,混合均匀,备用;
步骤b,胶囊皮的制备:取明胶、甘油、纯化水及红氧化铁,放入溶胶罐内进行化胶;
步骤c,将步骤a制备的内容物和步骤b制备的胶液经过压丸制成软胶囊。
本发明研究表明,叶黄素、蓝莓、葡萄籽和维生素E配伍使用,可以显著缓解视疲劳,制成软胶囊,具有剂量准确、服用方便、生物利用度高等特点。
具体实施方式
实施例1
配方:
以上制成1000粒,400mg/粒。
制备方法:
1、内容物配制:准确称取天然叶黄素、蓝莓提取物、葡萄籽提取物、天然维生素E、大豆油、蜂蜡,将大豆油加温至60℃左右时加入蜂蜡,使蜂蜡熔融后得蜂蜡大豆油溶液。将天然叶黄素、蓝莓提取物、葡萄籽提取物、天然维生素E加入蜂蜡大豆油溶液中,边放入边搅拌混合得预混料液,将预混料置于胶体磨中研磨2~3次,使料液混悬均匀,混悬料液进行抽真空脱气(真空度为-0.06~-0.08MPa)至无气泡,得到均匀的内容物料液置容器内备用;
2、溶胶:按比例称取合格的明胶、甘油、纯化水及红氧化铁,依次放入溶胶罐内进行化胶,开启蒸汽加热阀门,待温度升高后,开启搅拌机开始搅拌,搅拌1.5~2小时,温度为70℃~80℃,待罐内胶液全部溶解后,打开真空泵进行抽空(真空度为-0.06~-0.08MPa),当罐内胶液无气泡时,用100目滤布过滤后置贮胶罐中60±5℃保温备用;
3、压丸:将内容物、胶液通过软胶囊机制成软胶囊,内容物装量400mg/粒;
4、定型、干燥、包装:将压制好的软胶囊进行定型处理,室内温度控制在18~26℃,湿度控制在30~40%;置于洁净干燥室内,静态干燥,室内温度控制在24~28℃,湿度控制在20~30%;包装,即得。
实施例2
配方:
以上制成1000粒,400mg/粒。
制备方法同实施例1。
实施例3
配方:
以上制成1000粒,400mg/粒。
制备方法同实施例1。
实施例4
配方:
以上制成1000粒,400mg/粒。
制备方法同实施例1。
实施例5
配方:
以上制成1000粒,400mg/粒。
制备方法同实施例1。
实施例6
配方:
以上制成1000粒,400mg/粒。
制备方法同实施例1。
实施例7
配方:
以上制成1000粒,400mg/粒。
制备方法同实施例1。
实施例8效果实验
1材料和方法
1.1样品及安慰剂:叶黄素蓝莓葡萄籽维生素E软胶囊(按实施例1制备),另一个为安慰剂组,人口服每日2次,每次2粒。
1.2受试者选择
1.3试验方法:采用自身和组间两种对照设计,根据随机、双盲的要求,将符合纳入标准并保证配合试验的自愿受试者,根据症状、视力检查情况,同时考虑年龄、性别等因素分为试食组和对照组。试食组与对照组按推荐剂量服用样品或安慰剂,连续45天。试验期间不改变原来的饮食习惯,正常饮食。
2观察指标
2.1安全性指标
2.1.1一般体格检查:试验前详细询问受试者健康情况,了解受试者的精神、睡眠、饮食、大小便等情况,并测量体重、血压、心率变化,对所有受试者进行常规体格检查及必要的实验室检查。
2.1.2血常规:红细胞计数、白细胞计数、血红蛋白含量测定等。
2.1.3尿常规:pH值、白细胞、尿糖等。
2.1.4粪便常规:虫卵检查等。
2.1.5血生化指标检查:血清总蛋白(TP)、白蛋白(ALB)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、胆固醇(CHOL)、甘油三酯(TG)、尿素氮(BUN)、肌酐(Cr)、血尿酸(UA)、血糖(GLU)等的测定。
2.1.6心电图、腹部B超、胸透等检查。
2.1.7不良反应检查。
2.2功效性指标
2.2.1症状观察:详细询问视疲劳情况,观察眼痛、眼胀、畏光、视物模糊、眼干涩等症状,按症状轻重积分(重症3分、中症2分、轻症1分)于试食前后统计积分值,并就其症状改善(任一症状改善1分及以上为改善)情况,观察症状改善率。
2.2.2明视持久度测定。
3实验数据统计
资料结果用均数±标准差表示,自身配对资料采用配对t检验,观察组和对照组之间在方差齐的前提下,均数比较采用成组t检验,否则进行变量转化后满足方差齐后采用t检验,如果方差仍然不齐,采用秩和检验。改善率为计数资料,可以用X2检验,四格表总例数小于40,或总例数等于或大于40但出现理论数等于或小于1时,改用确切概率法。
4结果判定标准
4.1症状改善:眼痛、眼胀、畏光、视物模糊、眼干涩任一症状改善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。
4.2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。
4.3无效:未达到有效标准。
4.4参考指标:视力改善率。以试食试验后较试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。
5结果
5.1一般情况:初始试验人群试食组51例,对照组51例,对照组:男/女为19/32,年龄为46.73±11.36岁;试食组男/女为20/31,年龄为46.57±12.89岁。试食期间受试者精神、睡眠、饮食、大小便均正常。
5.2安全性观察
各指标均在正常范围内,提示本发明软胶囊对机体健康无明显损害。
心电图、腹部B超、胸透检查,均在正常范围内。
试食期间受试者未见明显不良反应。
5.3功效观察
5.3.1症状观察
见表1、2。试食后试食组眼痛、眼胀、畏光、视物模糊、眼干涩等临床症状有明显改善,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,差异也有显著性(P<0.05)。
表1本发明软胶囊试食前后症状积分统计
组别 | 试食前 | 试食后 |
对照组 | 8.14±3.05 | 7.90±2.89 |
试食组 | 8.12±3.01 | 6.61±2.62<sup>*#</sup> |
*与对照组比较,P<0.05,#与自身比较,P<0.05。
表2本发明软胶囊试食前后症状改善情况
5.3.2疗效观察:
结果见表3。由表3可见,服用受试物45天后,试食组临床观察总有效率为80.39%,与对照组(17.65%)比较差异有显著性(P<0.05)。
表3本发明软胶囊试食前后功效观察比较
组别 | 有效 | 无效 | 总有效率(%) |
对照组 | 9 | 42 | 17.65 |
试食组 | 41 | 10 | 80.39* |
*与对照组比较,P<0.05
5.3.3对明视持久度的影响
从表4可见,试验后试食组明视持久度较试验前提高0.13,与自身试食前及对照组试验后比较差异皆有显著性(P<0.05)。
组别 | 试食前 | 试食后 | 提高幅度 |
对照组 | 0.55±0.07 | 0.57±0.05 | 0.02±0.04 |
试食组 | 0.56±0.07 | 0.68±0.06<sup>*#</sup> | 0.13±0.04* |
*与对照组比较,P<0.05#与自身比较,P<0.05。
6小结
试验结果表明:本发明叶黄素蓝莓葡萄籽维生素E软胶囊对眼痛、眼胀、畏光、视物模糊、眼干涩等临床症状有改善,试验后试食组症状积分与试食前及对照组比较差异有显著性(P<0.05);试食组临床观察总有效率为80.39%,与对照组(17.65%)比较差异有显著性(P<0.05);试验后试食组明视持久度较试验前提高0.13,与自身试食前及对照组试验后比较差异皆有显著性(P<0.05)。根据《保健食品检验与评价技术规范》(2003年版)中规定的评判标准,提示本发明叶黄素蓝莓葡萄籽维生素E软胶囊具有缓解视疲劳功能的作用。
实施例9分散介质的筛选
分别以药用大豆油和PEG400为分散介质,以基质吸附率、沉降体积比和流动性为指标,筛选分散介质的种类。
1、将有效成分(天然叶黄素、蓝莓提取物、葡萄籽提取物、天然维生素E)依据实施例1配方混合后,以流动性为指标初步确定有效成份与稀释剂的比例。
两种分散介质与有效成分均能混合均匀,无分层现象,流动性及基质吸附数相当;沉降体积比结果表明,大豆油组沉降比为0.71,PEG400组沉降比为0.23。因此,综合考虑选择大豆油为分散介质。
2、将有效成分(天然叶黄素、蓝莓提取物、葡萄籽提取物、天然维生素E)按实施例1用量混合均匀,所得混粉与大豆油按照1∶3、1∶5、1∶7、1∶9的比例分别充分研磨混合制备成混悬液,观察混悬液的粘度及流动性。结果见表5。
表5大豆油用量筛选实验结果
编号 | 有效成份与大豆油 | 结果 |
1 | 1∶3 | 混悬液流动性较差,黏度较大 |
2 | 1∶5 | 混悬液流动性较好,黏度适宜 |
3 | 1∶7 | 混悬液流动性好,黏度较小 |
4 | 1∶9 | 混悬液流动性很好,过稀 |
结果显示,有效成份与大豆油质量比在1∶3(kg/kg)时混悬液的流动性较差,而质量比在1∶9(kg/kg)以上时混悬液过稀,因此综合考虑各项因素,有效成份与大豆油质量比在1∶5(kg/kg)为宜,这一比例混悬液流动性好,黏度适宜。
实施例10助悬剂的筛选
以叶黄素的体外溶出速度与累计溶出率来对助悬剂进行筛选。
1助悬剂种类的筛选
精密称取叶黄素标准品适量,无水乙醇溶解并用人工肠液(pH7.2的磷酸二氢钾溶液加入胰蛋白酶1g/dL)稀释适当倍数后,紫外分光光度计进行扫描,叶黄素在450nm处有最大吸收;同时蜂蜡、单硬脂酸甘油酯载体溶液在450nm波长处无吸收,选择450nm处为测定波长。
制备叶黄素标准品浓度为5、7、9、11、13、15μg/mL系列溶液,以人工肠液为空白,于450nm处测定吸光度A,建立叶黄素测定标准线。
分别以相同处方量的蜂蜡、单硬脂酸甘油酯为载体材料,与处方量的大豆油混合,水浴加热至60℃熔融。于熔融混合液中加入处方量的叶黄素,搅拌均匀,备用。精密称取叶黄素分散体适量,置50mL量瓶中,以900mL人工肠液为溶出介质,在(37±0.5)℃、75r/min条件下,分别于5、10、20、30、45、60min取样5m L(同时补充同温等量介质),经0.45μm滤膜过滤,弃去初滤液,续滤液于450nm处测定吸光度并计算累积溶出率。
表6两种助悬剂的累计溶出率检测结果
时间(h) | 单硬脂酸甘油酯(%) | 蜂蜡(%) |
0 | 0 | 0 |
5 | 21 | 25 |
10 | 30.5 | 38 |
15 | 35 | 43 |
20 | 37 | 48.5 |
30 | 37.5 | 52.5 |
40 | 38 | 53 |
60 | 38.5 | 53.5 |
由上表可得蜂蜡作为载体材料制备的胶囊内容物在释放过程中叶黄素溶出更快且1小时内累计溶出率远高于单硬脂酸甘油酯,因此选择蜂蜡作为载体材料。
2、助悬剂用量的筛选
将不同比例的蜂蜡加入到1.5kg大豆油中加热至融化,放至室温后,再加入0.3kg有效成份,充分搅拌混合均匀,形成软胶囊内容物,使用上述方法测定吸光度并计算叶黄素的累积溶出率。结果见表7。
表7不同蜂蜡用量累计溶出率的检测结果
时间(h) | 蜂蜡2% | 蜂蜡3% | 蜂蜡4% | 蜂蜡5% |
0 | 0 | 0 | 0 | 0 |
5 | 24 | 28 | 29 | 22 |
10 | 38 | 42 | 43 | 33 |
15 | 46 | 53 | 54 | 42 |
20 | 51.5 | 58.5 | 60 | 48 |
30 | 53.5 | 65.5 | 66 | 56 |
40 | 55.5 | 68 | 68 | 62 |
60 | 56 | 68.5 | 70 | 66 |
由上表可得蜂蜡添加量在3-4%时内容物中叶黄素的溶出速度与累计溶出率最大,添加5%的蜂蜡溶出速度明显变慢可能是蜂蜡过多较为粘稠导致的。考虑到生产成本确定助悬剂选择3%的蜂蜡添加浓度。
Claims (10)
1.一种叶黄素蓝莓葡萄籽维生素E软胶囊,其特征在于,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素10-50重量份、蓝莓4-25重量份、葡萄籽10-45重量份、维生素E3-10重量份、大豆油290-350重量份、蜂蜡4-25重量份。
2.如权利要求1所述的软胶囊,其特征在于,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素15-40重量份、蓝莓6-20重量份、葡萄籽15-40重量份、维生素E4-9重量份、大豆油300-340重量份、蜂蜡6-20重量份。
3.如权利要求2所述的软胶囊,其特征在于,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素20-30重量份、蓝莓8-15重量份、葡萄籽20-35重量份、维生素E3-8重量份、大豆油310-330重量份、蜂蜡10-15重量份。
4.如权利要求3所述的软胶囊,其特征在于,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素25重量份、蓝莓10重量份、葡萄籽25重量份、维生素E5重量份、大豆油323.5重量份、蜂蜡11.5重量份。
5.如权利要求3所述的软胶囊,其特征在于,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素21重量份、蓝莓9重量份、葡萄籽34重量份、维生素E8重量份、大豆油312.5重量份、蜂蜡14.5重量份。
6.如权利要求3所述的软胶囊,其特征在于,所述软胶囊的内容物由如下重量份的原辅料组成:叶黄素29重量份、蓝莓14重量份、葡萄籽21量份、维生素E3.5重量份、大豆油328重量份、蜂蜡9重量份。
7.如权利要求1-6任一项所述的软胶囊,其特征在于,所述蓝莓和葡萄籽分别为蓝莓提取物和葡萄籽提取物。
8.如权利要求7所述的软胶囊,其特征在于,所述蓝莓提取物中原花青素的含量为15%~25%,所述葡萄籽提取物中原花青素的含量为85%~95%。
9.如权利要求1-6任一项所述的软胶囊,其特征在于,所述叶黄素为天然叶黄素,所述维生素E为天然维生素E。
10.如权利要求1-7任一项所述软胶囊的制备方法,其特征在于,所述方法包括如下步骤:
步骤a,内容物的制备:将蜂蜡加入大豆油中,使蜂蜡熔融后得蜂蜡大豆油溶液;将叶黄素、蓝莓或其提取物、葡萄籽或其提取物、维生素E加入蜂蜡大豆油溶液中,混合均匀,备用;
步骤b,胶囊皮的制备:取明胶、甘油、纯化水及红氧化铁,放入溶胶罐内进行化胶;
步骤c,将步骤a制备的内容物和步骤b制备的胶液经过压丸制成软胶囊。
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