CN111838653A - 一种蓝莓葡萄籽维a软胶囊及其制备方法 - Google Patents
一种蓝莓葡萄籽维a软胶囊及其制备方法 Download PDFInfo
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- CN111838653A CN111838653A CN201910311867.1A CN201910311867A CN111838653A CN 111838653 A CN111838653 A CN 111838653A CN 201910311867 A CN201910311867 A CN 201910311867A CN 111838653 A CN111838653 A CN 111838653A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供一种蓝莓葡萄籽维A软胶囊,所述软胶囊的内容物由如下重量份的原辅料组成:蓝莓70‑150重量份、葡萄籽30‑90重量份、维生素A 0.1‑0.5重量份、大豆油290‑350重量份、蜂蜡10‑20重量份。
Description
技术领域
本发明涉及一种可以缓解视疲劳的蓝莓葡萄籽维A软胶囊及其制备方法,属于医药保健领域。
背景技术
视疲劳是目前眼科常见的一种疾病,是眼或全身器质性因素与精神(心理)因素相互交织的综合征,是一组表现为用眼后出现视觉障碍、眼部不适及全身症状以至不能正常进行视作业的症候群,因此,在临床上又常称为眼疲劳综合征。视疲劳中医名曰肝劳,肝劳一词最早见于唐朝孙思邈之《千金要方》,书载:“读书、搏弈过度而伤目者,谓肝劳”。患者通常表现为眼部的疼痛、酸胀、烧灼感、异物感、流泪、畏光、视物模糊、复视、眼睛干涩等症状,严重者甚至出现头痛、恶心、呕吐等全身症状。这些症状严重干扰了患者的视觉和生活质量。随着社会竞争的加剧,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。
迄今为止,西医治疗视疲劳综合症的相关报道多以对症治疗为主,多采用神经营养剂、镇静剂、或局部滴用B受体阻滞剂,针对性弱,如临床广泛应用的萘敏维眼水,仅能缓解暂时局部症状,并不能增强抵抗疲劳能力。近些年出现的花青素、表面活性剂等药物尚处于研究阶段,有学者认为视疲劳患者眼球经常处于紧张状态,眼外肌和睫状肌代谢增加,造成代谢废物和氧自由基积累增加,进一步导致视疲劳加重,由于花青素具有强大的抗氧化作用,推测花青素可以有效消除和缓解眼部疲劳综合征,但其有效性有待进一步研究,尚未广泛应用于临床。另外,应用手术治疗、视觉训练、棱镜矫正治疗视疲劳疗效较为肯定,但应用面窄,不能满足视疲劳防治的需要。
发明内容
针对现有技术的不足,本发明提供一种蓝莓葡萄籽维A软胶囊及其制备方法。蓝莓、葡萄籽、维生素A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,本发明提供一种蓝莓葡萄籽维A软胶囊,所述软胶囊的内容物由如下重量份的原辅料组成:蓝莓70-150重量份、葡萄籽30-90重量份、维生素A 0.1-0.5重量份、大豆油290-350重量份、蜂蜡10-20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:蓝莓80-140重量份、葡萄籽35-85重量份、维生素A 0.15-0.4重量份、大豆油300-340重量份、蜂蜡12-18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:蓝莓90-130重量份、葡萄籽40-80重量份、维生素A 0.2-0.3重量份、大豆油310-330重量份、蜂蜡13-17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:蓝莓100重量份、葡萄籽65重量份、维生素A 0.27重量份、大豆油319.73重量份、蜂蜡15重量份;
或,蓝莓95重量份、葡萄籽75重量份、维生素A 0.22重量份、大豆油325重量份、蜂蜡14重量份;
或,蓝莓110重量份、葡萄籽45重量份、维生素A 0.29重量份、大豆油315重量份、蜂蜡16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%。
作为本发明的另一个方面,本发明提供所述蓝莓葡萄籽维A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;将蓝莓或其提取物、葡萄籽或其提取物、维生素A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、纯化水及靛蓝,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。
蓝莓的果实中含有丰富的花色苷(花青素),主要有抗生素作用、抗自由基作用、抗视力退化及抗动脉硬化和血栓形成的作用;葡萄籽提取物是从天然葡萄籽中提取的有效活性营养成份,葡萄籽提取物主要活性成分是原花青素的低分子量,它是一种强力的抗氧化剂,一种有效的自由基除剂;维生素A是脂溶性的醇类物质,有多种分子形式。其中VA1主要存在于动物肝脏、血液和眼球的视网膜中,又叫视黄醇。维生素A是构成视觉细胞中感受弱光的视紫红质的组成成分,与暗视觉有关,人体缺乏维生素A,影响暗适应能力,如儿童发育不良、皮肤干燥、干眼病、夜盲症等。
本发明研究表明,蓝莓、葡萄籽和维生素A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,500mg/粒。
制备方法:
1、内容物配制:准确称取蓝莓提取物、葡萄籽提取物、维生素A、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。将蓝莓提取物、葡萄籽提取物、维生素A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:按比例称取明胶、甘油、纯化水及靛蓝,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500mg/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,500mg/粒。
制备方法同实施例1。
实施例3
配方:
以上制成1000粒,500mg/粒。
制备方法同实施例1。
实施例4
配方:
以上制成1000粒,500mg/粒。
制备方法同实施例1。
实施例5
配方:
以上制成1000粒,500mg/粒。
制备方法同实施例1。
实施例6
配方:
以上制成1000粒,500mg/粒。
制备方法同实施例1。
实施例7
配方:
以上制成1000粒,500mg/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:蓝莓葡萄籽维A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53例,对照组53例,对照组:男/女为22/31,年龄为44.60±12.11岁;试食组男/女为22/31,年龄为44.81±12.08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 | 8.21±3.01 | 8.00±2.82 |
试食组 | 8.23±2.89 | 6.77±2.56*# |
*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79.25%,与对照组(16.98%)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 | 44 | 16.98 |
试食组 | 42 | 11 | 79.25* |
*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0.11,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 | 0.54±0.08 | 0.55±0.06 | 0.01±0.06 |
试食组 | 0.55±0.07 | 0.66±0.08*# | 0.11±0.02* |
*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79.25%,与对照组(16.98%)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0.11,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,提示本发明软胶囊具有缓解视疲劳功能的作用。
实施例9大豆油用量考察
选用大豆油作为分散介质,油量的多少直接影响内容物混悬液的粘度和流动相:油量多,触变值低,流动性好,但易泄露;油量少,稳定性好,但流动性差,压丸困难,因此筛选适宜的大豆油用量非常关键。
将有效成分(蓝莓提取物、葡萄籽提取物、维生素A)按实施例1用量混合均匀,所得混粉与大豆油按照1∶1.5、1∶2、1∶2.5、1∶3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
结果显示,有效成份与大豆油质量比在1∶1.5(kg/kg)时混悬液的流动性较差,而质量比在1∶3(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∶2(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
模拟胃液中胶囊内容物VA释放筛选助悬剂。
1、助悬剂种类的筛选
取4.5mL浓盐酸,加水约400mL,用4mol/L盐酸调整pH为1.2,用去离子水定容至500mL,添加胃蛋白酶(10mg·100mol/L),于37℃下保温,待用。
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维生素A,搅拌均匀,备用。
准确称取1.0g维生素A内容物,加入到释放介质中去,恒温37℃水浴,每隔一定时间取1mL反应液,补充加入释放介质1mL,高速离心10min(6000r/min),取上清液,萃取、吹干,HPLC测定释放出来的维生素的含量,计算溶出率,结果见表6。
表6两种助悬剂的累计溶出率检测结果
比较两者可得,以蜂蜡为助悬剂的组方对维生素A的累计溶出率基本与单硬脂酸甘油酯相同,但缓释性能更好。因此,选择蜂蜡作为助悬剂。
2、助悬剂用量的筛选
混悬液中选择适宜的助悬剂使内容物保持长时间的稳定是软胶囊制备的关键,加入的适量助悬剂可以提高药液的均匀性,以防止药液在成囊前混悬液发生沉降分层,从而保证分剂量准确。
本胶囊以有效成分(蓝莓提取物、葡萄籽提取物、维生素A)与大豆油比例1:2为基本处方,以沉降体积比、内容物流动性以及90mim维生素A的释放率为考察指标,筛选助悬剂的最佳用量。
将各种比例的蜂蜡加入到1.5kg大豆油中加热至融化,放至室温后,再加入0.75kg有效成份,充分搅拌混合均匀,形成软胶囊内容物,测定内容物的稳定性、沉降比(λ)以及90mim维生素A的释放率。其中,用量筒取出体积(Va)混合均匀的内容物,静置、沉淀30min,上部澄清液之下的混合内容物体积为(Vb)。
λ=Va/Vb×100%。若λ=100%,即为完全混合状态,说明稳定性最好。
结果见表7。
表7蜂蜡用量筛选实验
结果显示,蜂蜡用量占内容物的3.0%时,内容物流动性好,黏度适宜,且沉降比较高。
随着蜂蜡添加量增加对维生素A的缓释效果增强,添加到5%之后维生素A的释放率呈下降趋势,这与维生素在酸性、有氧、高于常温的条件下不稳定,发生了一定程度的降解。3%与4%蜂蜡添加量效果相差不大,综合考虑确定添加3%。
本发明软胶囊采用疏水性材料蜂蜡作为基质,提高了其维生素A及花青素的生物利用率。同时对包裹的活性物质有味觉掩盖作用,可以阻止胶囊内的活性物质进入溶液中与味蕾接触。包埋在疏水性环境中的有效成分可以停留在生物体内一个特殊的区域或者一个特别的场所,使得被包裹的目标成分保持它们的结构,这样就能够提高那些原本生物利用率较低的活性成分的生物利用率。
Claims (9)
1.一种蓝莓葡萄籽维A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:蓝莓70-150重量份、葡萄籽30-90重量份、维生素A0.1-0.5重量份、大豆油290-350重量份、蜂蜡10-20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:蓝莓80-140重量份、葡萄籽35-85重量份、维生素A0.15-0.4重量份、大豆油300-340重量份、蜂蜡12-18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:蓝莓90-130重量份、葡萄籽40-80重量份、维生素A 0.2-0.3重量份、大豆油310-330重量份、蜂蜡13-17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:蓝莓100重量份、葡萄籽65重量份、维生素A 0.27重量份、大豆油319.73重量份、蜂蜡15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:蓝莓95重量份、葡萄籽75重量份、维生素A 0.22重量份、大豆油325重量份、蜂蜡14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:蓝莓110重量份、葡萄籽45重量份、维生素A 0.29重量份、大豆油315重量份、蜂蜡16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1-7任一项所述蓝莓葡萄籽维A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;将蓝莓或其提取物、葡萄籽或其提取物、维生素A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、纯化水及靛蓝,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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