CN113475714A - 一种越橘叶黄素软胶囊及其制备方法 - Google Patents
一种越橘叶黄素软胶囊及其制备方法 Download PDFInfo
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- CN113475714A CN113475714A CN202110812814.5A CN202110812814A CN113475714A CN 113475714 A CN113475714 A CN 113475714A CN 202110812814 A CN202110812814 A CN 202110812814A CN 113475714 A CN113475714 A CN 113475714A
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- parts
- oil
- soft capsule
- lutein
- vitamin
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
- A23L33/155—Vitamins A or D
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A—HUMAN NECESSITIES
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- Health & Medical Sciences (AREA)
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- Botany (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明提供了一种越橘叶黄素软胶囊及其制备方法，涉及保健食品技术领域。本发明针对内容物中含有越橘提取物、叶黄素和玉米黄质等成分的软胶囊，通过在内容物中添加L‑半胱氨酸，配制成均匀的混悬液，进而制备成软胶囊。为了降低软胶囊胶皮内部分子的交联反应和胶皮老化速度，本发明制得的软胶囊，生产过程顺畅，通过L‑半胱氨酸的作用，胶皮内部分子间的交联反应一定程度上得到降低，胶皮的老化速度有所减缓，在长期储存或加速实验过程中，崩解性良好，从而有效解决了含有越橘提取物、叶黄素和玉米黄质等成分的软胶囊出现崩解困难的行业难题。
Description
技术领域
本发明属于保健食品技术领域，涉及一种越橘叶黄素软胶囊及其制备方法。
背景技术
现代医学认为视疲劳的发生与眼肌的使用不当或过度紧张有关，视疲劳的形成原因主要有两个方面，一是眼球长时间处于搜索注视状态，眼外肌和睫状肌代谢增加，造成代谢废物—氧自由基产生积累增加，从而造成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，导致视疲劳加重。因此，通过清除和抑制自由基、增强黄斑、保护视网膜等均可达到缓解视疲劳的目的。而叶黄素是视网膜黄斑的主要色素和抗氧化成分，许多眼科疾病都与叶黄素的缺乏有很大关系，可见叶黄素对于眼睛起着重要保护作用。许多护眼保健品中都含有叶黄素类成分，如中国专利申请CN107375505A公开了一种预防和治疗眼部疾病的组合物及其制备方法与应用，每100重量份包括以下重量份的原料：决明子10-40份、蓝莓粉/越橘粉5-30份、叶黄素酯/叶黄素/叶黄素酯微囊粉10-30份、紫苏籽油/紫苏子油微囊粉10-30份、磷脂1-15份、瓜拉纳提取物1-15份、牛磺酸0.1-3份、维生素C 0.01-0.5份、维生素A/β胡萝卜素0.001-0.1份；再如中国专利申请CN108968069A公开了一种缓解视力疲劳、改善视力、抗氧化、保护视网膜的复合软胶囊及制备方法，该软胶囊包括内容物和囊皮；按重量份数计，内容物包括：叶黄素提取物38-50份、原花青素提取物155-180份、大豆油255-270份和蜂蜡14-23份；按重量份数计，囊皮包括：明胶230-260份、甘油118-130份、去离子水235-260份和二氧化钛1-2份。
而当前护眼保健品很多采用软胶囊制剂，目前在研制和生产中存在的主要问题为软胶囊崩解迟缓，具体表现为胶囊壳内壁出现一层膜状物质，崩解时间延长，溶出速率下降甚至完全不溶。其原因在于小分子类物质及明胶自氧化过程均可使明胶中氨基酸侧链基团之间产生交联，根据实验证明，软胶囊崩解迟缓现象主要由囊壳成分明胶产生交联反应引起老化，使胶囊壳的溶解性质改变所致。明胶软胶囊使用的明胶原料本身含有大量活性基团(氨基酸残基)，导致胶皮容易与小分子类物质，如醛、多酚、还原糖、多电荷阳离子、电解质、阳离子或阴离子聚合物等，发生交联反应，导致出现软胶囊崩解不合格等问题。
现有技术中软胶囊制剂的制备工艺还存在以下问题：
内容物成分相对复杂的软胶囊制剂，在存储过程中或者加速考察过程中胶皮会由于时间的延长而老化、发生交联，导致崩解时限延长而不符合法规要求，使得众多产品需要花更多的成本去开发其他剂型。
发明内容
本发明针对现有技术存在的问题，提供了一种越橘叶黄素软胶囊及其制备方法。本发明的制备方法在内容物中添加L-半胱氨酸，配制成均匀的混悬液，制备成软胶囊，在产品的长期储存或加速实验中降低了胶皮内部分子间的交联反应，减缓了胶皮的老化，有效解决了含有越橘提取物、叶黄素和玉米黄质等成分的软胶囊出现崩解困难的行业难题。
为实现上述目的，本发明采用的技术方案如下：
一种组合物，包括如下组分：大豆油、叶黄素油、越橘提取物、柠檬酸锌、玉米黄质油、维生素A、维生素E、L-半胱氨酸、白蜂蜡。
进一步地，所述组合物包括以下质量份的组分：大豆油40-65份、叶黄素油10-20份、越橘提取物4-6份、柠檬酸锌7-10份、玉米黄质油7-10份、维生素A 0.1-0.5份、维生素E0.2-0.6份、L-半胱氨酸0.25-5份、白蜂蜡4-8份。
进一步地，所述组合物组分的质量份优选为：大豆油45-62份、叶黄素油10-18份、越橘提取物4-5份、柠檬酸锌8-9份、玉米黄质油8-9份、维生素A 0.2-0.4份、维生素E 0.3-0.5份、L-半胱氨酸4-5份、白蜂蜡5-7份。
进一步地，所述组合物组分的质量份最优选为：所述组合物包括以下质量份的组分：大豆油49.1份、叶黄素油17.1份、越橘提取物4.9份、柠檬酸锌8.6份、玉米黄质油8.6份、维生素A 0.3份、维生素E 0.4份、L-半胱氨酸5份、白蜂蜡6份。
一种越橘叶黄素软胶囊，内容物由所述的组合物制备而成。
进一步地，所述的越橘叶黄素软胶囊的胶皮包括以下质量份的组分：明胶35-45份、甘油10-25份、纯化水35-45份；
进一步地，所述胶皮组分的质量份优选为：明胶38-42份、甘油10-21份、纯化水37-40份；最优选为：明胶41份、甘油21份、纯化水37份。
所述越橘叶黄素软胶囊的制备方法，其特征在于，包括以下步骤：
(1)称量、备料：准确称取配方量的各原料；
(2)胶皮化胶：将步骤(1)称取的明胶、甘油和纯化水投入化胶罐中化胶，备用；
(3)内容物的配制：取部分步骤(1)称取配方量40-60％的大豆油65-70℃加热，添加蜂蜡溶解，再添加余量的大豆油，搅拌，添加步骤(1)称取的其他原料，搅拌均匀、研磨，备用；
(4)压丸：将步骤(2)得到的胶和步骤(3)研磨后的粉末在压丸机上进行压丸，制备软胶囊；其中，使用10#橄榄型模具压丸，规格为320-350mg/粒，胶皮厚度为0.80-0.85mm；
(5)干燥：将步骤(4)压好的软胶囊进行干燥、收丸；其中，收丸硬度为1800-2400g。
相对于现有技术，本发明具有以下有益效果：
在长时间存放或加速实验过程中，明显延缓了内容物中含有较大量的越橘提取物、叶黄素和玉米黄质等提取物类软胶囊胶皮的老化，有效解决了该类胶囊崩解时限不合格的问题，保证了产品的质量。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明白，以下结合具体实施例，对本发明进一步详细说明。但下述实施例仅仅为本发明的优选实施例，并非全部。为了清楚，不描述实际实施例的全部特征。基于实施方式中的实施例，本领域技术人员在没有做出创造性劳动的前提下所获得其它实施例，都属于本发明的保护范围。
本发明对所采用原料的来源不作限定，如无特殊说明，本发明所采用的原料均为本技术领域普通市售品。
实施例
(1)准确称取所需质量份的各原料，如表1所示：
表1
(2)将所需质量份的明胶、甘油和纯化水投入化胶罐中化胶；
(3)将步骤(1)称取的大豆油的50％加热，添加白蜂蜡溶解，再添加另外50％的大豆油，搅拌，添加步骤(1)称取的其他原料，搅拌均匀、研磨，备用；
(4)将步骤(3)所得研磨后的混悬内容物在压丸机上进行压丸制备软胶囊，使用10#橄榄型模具压丸，规格为350mg/粒，胶皮厚度为0.85mm；
(5)将步骤(4)压好的软胶囊进行干燥、收丸，得到所述越橘叶黄素软胶囊，收丸硬度为2000g。
对比例1
与实施例1的区别在于：步骤(1)中不添加L-半胱氨酸，其余皆相同。
对比例2
与实施例1的区别在于：步骤(1)中添加8份L-半胱氨酸，其余皆相同。
对比例3
与实施例1的区别在于：步骤(1)中以等质量份的焦亚硫酸钠代替L-半胱氨酸，其余皆相同。
对比例4
与实施例1的区别在于：步骤(1)中以等质量份的迷迭香提取物代替L-半胱氨酸，其余皆相同。
对比例5
与实施例1的区别在于：步骤(1)中以等质量份的叶黄素酯代替叶黄素油，其余皆相同。
对比例6
与实施例1的区别在于：步骤(1)中将等质量的L-半胱氨酸添加在步骤(2)胶皮的制备中，其余皆相同。
实验例
加速实验考察实施例1-8和对比例1-6制得的软胶囊的崩解时限，结果如表2所示：
表2
结论：在本申请配方下制得的越橘叶黄素软胶囊在3个月加速试验中表现出良好的崩解时限，且生产过程顺畅；当去掉配方中的L-半胱氨酸组分，长时间存放会导致软胶囊的崩解时限延长，而当添加过量的L-半胱氨酸组分，则会导致生产过程中配料时固形物粉体量较大，搅拌分散困难、研磨末端固形物残留较多，研磨时间长，生产效率低下；当对L-半胱氨酸采用其他类似组分对进行替代，长时间存放软胶囊的崩解时限延长；当对叶黄素油采用其他类似组分对进行替代，长时间存放软胶囊的崩解时限延长；当将L-半胱氨酸添加在胶皮中时，生产过程中会出现刺激性气味，长期存放气味加重。因此采用本申请的配方制得的越橘叶黄素软胶囊，不仅生产过程顺畅，而且能够在长期存放时延缓胶皮的老化，有效解决了含有越橘提取物、叶黄素和玉米黄质等提取物类胶囊崩解时限不合格的问题，保证了产品的质量。
最后应当说明的是，以上内容仅用以说明本发明的技术方案，而非对本发明保护范围的限制，本领域的普通技术人员对本发明的技术方案进行的简单修改或者等同替换，均不脱离本发明技术方案的实质和范围。
Claims (10)
1.一种组合物，其特征在于，包括如下组分：大豆油、叶黄素油、越橘提取物、柠檬酸锌、玉米黄质油、维生素A、维生素E、L-半胱氨酸、白蜂蜡。
2.如权利要求1所述的组合物，其特征在于：所述组合物包括以下质量份的组分：大豆油40-65份、叶黄素油10-20份、越橘提取物4-6份、柠檬酸锌7-10份、玉米黄质油7-10份、维生素A 0.1-0.5份、维生素E 0.2-0.6份、L-半胱氨酸0.25-5份、白蜂蜡4-8份。
3.如权利要求2所述的组合物，其特征在于：所述组合物包括以下质量份的组分：大豆油45-62份、叶黄素油10-18份、越橘提取物4-5份、柠檬酸锌8-9份、玉米黄质油8-9份、维生素A 0.2-0.4份、维生素E 0.3-0.5份、L-半胱氨酸4-5份、白蜂蜡5-7份。
4.如权利要求3所述的组合物，其特征在于：所述组合物包括以下质量份的组分：大豆油49.1份、叶黄素油17.1份、越橘提取物4.9份、柠檬酸锌8.6份、玉米黄质油8.6份、维生素A0.3份、维生素E 0.4份、L-半胱氨酸5份、白蜂蜡6份。
5.一种越橘叶黄素软胶囊，其特征在于，所述胶囊的内容物由权利要求1-4任一项所述的组合物制备而成。
6.如权利要求5所述的越橘叶黄素软胶囊，其特征在于，所述胶囊的胶皮包括以下质量份的组分：明胶35-45份、甘油10-25份、纯化水35-45份。
7.权利要求5或6所述越橘叶黄素软胶囊的制备方法，其特征在于，包括以下步骤：
(1)称量、备料：准确称取配方量的各原料；
(2)胶皮化胶：将步骤(1)称取的明胶、甘油和纯化水投入化胶罐中化胶，备用；
(3)内容物的配制：取部分步骤(1)称取的大豆油加热，添加蜂蜡溶解，再添加余量的大豆油，搅拌，添加步骤(1)称取的其他原料，搅拌均匀、研磨，备用；
(4)压丸：将步骤(2)得到的胶和步骤(3)研磨后的粉末在压丸机上进行压丸，制备软胶囊；
(5)干燥：将步骤(4)压好的软胶囊进行干燥、收丸。
8.根据权利要求7所述的制备方法，其特征在于：步骤(3)所述加热温度为65-70℃；步骤(3)中先取配方量40-60％的大豆油进行加热，添加蜂蜡溶解后，再添加余量的大豆油。
9.根据权利要求7所述的制备方法，其特征在于：步骤(4)中使用10#橄榄型模具压丸，规格为320-350mg/粒，胶皮厚度为0.80-0.85mm。
10.根据权利要求7所述的制备方法，其特征在于：步骤(5)中，收丸硬度为1800-2400g。
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