CN104000244B - 一种南极磷虾油软胶囊及其制备方法 - Google Patents
一种南极磷虾油软胶囊及其制备方法 Download PDFInfo
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- CN104000244B CN104000244B CN201410267150.9A CN201410267150A CN104000244B CN 104000244 B CN104000244 B CN 104000244B CN 201410267150 A CN201410267150 A CN 201410267150A CN 104000244 B CN104000244 B CN 104000244B
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- krill
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
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- A—HUMAN NECESSITIES
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- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Mycology (AREA)
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- Medicinal Preparation (AREA)
Abstract
本发明涉及一种南极磷虾油软胶囊，所述胶囊由囊壳和囊壳内以南极磷虾油为主要成分的内容物组成，所述囊壳由以下组分按照重量份数组成：壳聚糖6-10份、褐藻酸丙二醇酯为1-3份、增塑剂3-5份、有机弱酸2-5份、水85-92份；所述内容物由以下组分按照重量份数组成：南极磷虾油50-100份，植物油脂0-50份。本发明的优点在于：以壳聚糖和褐藻酸丙二醇酯为主要囊材制成的胶囊壳与南极磷虾油相辅相成，共同发挥降血脂、降血糖和调节胆固醇等保健作用；采用的滴制法制备软胶囊，使囊材和囊心物能够更好的融合而共同发挥保健作用；采用本发明所述的配方制备的南极磷虾油软胶囊产品中含有比例均衡的营养成分，生物利用度高，外形美观，能掩盖组分的不良嗅味。
Description
技术领域
本发明涉及保健品及其制备方法技术领域，特别涉及一种南极磷虾油软胶囊及其制备方法。
背景技术
南极磷虾油含有Omega-3必需脂肪酸二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)，还含有丰富的维生素E、维生素A、虾青素、磷脂质、类黄酮等。其中Omega-3必需脂肪酸有很多促进健康的益处，包括心血管，神经，骨骼和关节，视力，皮肤保健等。其不饱和脂肪酸是目前自然界中唯一以磷脂型态结合Omega-3(EPA、DHA)和多样性超强抗氧化物(磷脂型虾青素Astaxanthin)的分子结构。
美国临床证实，磷虾油具有超强的降血脂，降血糖，降血压，穿越血脑屏障营养及活化脑部细胞和神经，起到预防和治疗脑血管疾病；同时，预防和治疗冠状动脉粥样硬化，冠心病，预防发生心梗、支架、搭桥及二次复发等心血管疾病；当然，南极磷虾油还可以起到抗菌消炎，预防癌症的发生发展，延缓衰老，调节内分泌等多重功效。
南极磷虾油是新食品原料，以南极磷虾油为主要原料的软胶囊剂在心血管方面的保健功效主要是：1、调节“三高”，预防和改善心脑血管疾病，降低胆固醇、预防脑溢血、脑血栓；2、降低血液黏稠度、促进血液循环，预防高血压；3、健脑益智，活跃思维，预防老年痴呆症。
目前市面上的多数药物都采用明胶与辅助材料制备而成，明胶主要以动物皮骨为材料，安全性远低于来源于海洋生物的外壳为原料的壳聚糖，而且明胶为囊材的胶囊壳的质量也不容易控制，含水量太多，囊壳较软，比较容易受挤压变形；含水量太少，胶囊壳较硬、脆，影响软胶囊的质量稳定性及崩解时间。
壳聚糖(chitosan)是由自然界广泛存在的几丁质(chitin)经过脱乙酰作用得到的，化学名称为聚葡萄糖胺(1-4)-2-氨基-B-D葡萄糖，自1859年，法国人Rouget首先得到壳聚糖后，这种天然高分子的生物官能性和相容性、血液相容性、安全性、微生物降解性等优良性能被各行各业广泛关注。有人曾以壳聚糖为囊材，采用与我们不同的配方，以压制法制备了硬胶囊的囊壳。
褐藻酸丙二醇酯，又名藻酸丙二醇酯(PGA)，由天然海藻中提取的海藻酸深加工制成，外观为白色或淡黄色粉末，水溶液呈粘稠状胶体。和海藻酸盐相比，具有更强的耐酸耐盐能力，是一种性能优良的海洋食品添加剂。
发明内容
本发明的目的在于提供一种以南极磷虾油为主要成分的软胶囊，囊材为壳聚糖和褐藻酸丙二醇酯复配，采用滴制法制备而成。产品含有比例均衡的营养成分，生物利用度高，外形美观，能掩盖组分的不良嗅味，满足该类剂型在外观和理化稳定性方面的各种标准，制作方法简单，适合大规模工业化生产。
本发明采用的技术方案是：
一种南极磷虾油软胶囊，所述胶囊由囊壳和囊壳内以南极磷虾油为主要成分的内容物组成，所述囊壳和内容物的重量比为1:0.5-1.5。
在上述方案的基础上，一种南极磷虾油软胶囊，所述囊壳由以下组分按照重量份数组成：壳聚糖6-10份、褐藻酸丙二醇酯为1-3份、增塑剂3-5份、有机弱酸2-5份、水85-92份。
在上述方案的基础上，所述增塑剂为：聚乙二醇类、甘油、丙二醇、木糖醇、山梨糖醇、甘露醇、麦芽糖醇、肌醇中的一种或几种的组合。
在上述方案的基础上，所述有机弱酸为：一氯乙酸、二氯乙酸、丙烯酸、丙酸、丁酸、异丁酸、新戊酸、戊酸、异戊酸、己酸、乳酸、马来酸、苯甲酸、山梨酸、酒石酸、柠檬酸、苹果酸和琥珀酸中的一种或几种的组合。
在上述方案的基础上，所述内容物由以下组分按照重量份数组成：南极磷虾油50-100份，植物油脂0-50份。
在上述方案的基础上，所述植物油脂为：牡丹籽油、亚麻籽油、红花籽油、大豆卵磷脂、橄榄油和核桃油中的一种或几种的组合。
一种制备如上所述的南极磷虾油软胶囊的方法，具体的步骤如下：
(1)按量称取囊壳和囊壳内容物的各组分；
(2)将增塑剂溶于所称量的水中溶解后，在水溶液中缓慢加入壳聚糖，形成混悬液，然后加入有机弱酸，边加边搅拌，直至形成均匀溶液；再加入褐藻酸丙二醇酯搅拌形成胶液；
(3)将囊壳内容物的各组分按比例混合均匀；
(4)以滴制法制备南极磷虾油软胶囊。
本发明的优点在于：
以壳聚糖和褐藻酸丙二醇酯为主要囊材制成的胶囊壳与南极磷虾油相辅相成，共同发挥降血脂、降血糖和调节胆固醇等保健作用；采用的滴制法制备软胶囊，使囊材和囊心物能够更好的融合而共同发挥保健作用；采用本发明所述的配方制备的南极磷虾油软胶囊产品中含有比例均衡的营养成分，生物利用度高，外形美观，能掩盖组分的不良嗅味，满足该类剂型在外观和理化稳定性方面的各种标准；本发明所述的工艺制备的南极磷虾油软胶囊，制备方法简单，适合大规模工业化生产。
具体实施方式
实施例1
材料秤取：
制备方法：
(1)囊材壳聚糖溶液的制备：将聚乙二醇6000溶于水中溶解后，再将壳聚糖缓慢加入到水溶液中，搅拌1小时，形成均匀混悬液，加热至70℃，然后加入丙烯酸，边加边继续搅拌，直至形成均匀溶液，再加入褐藻酸丙二醇酯，搅拌均匀，保温备用。
(2)制丸：将已制好的壳聚糖溶液至壳聚糖胶液贮槽中控制在60℃，将南极磷虾油放入药液贮槽内，控制温度在60℃，冷却液液体石蜡温度控制在10℃，制丸室温控制在15℃，滴头温度45℃；滴制胶囊。
(3)整丸与干燥：滴出的胶丸置胶丸机的纱网上，在10℃以下低温吹风4小时以上，再置于擦丸机擦去丸表面的液体石蜡，然后再在10℃以下低温吹风20小时以上取出，去表面油层，吹干洗液，40℃下干燥24小时。取出干燥的胶丸，灯检，除去废丸后，用95％乙醇洗涤，再在50℃吹干，质检，包装，即得。
实施例2
材料称取：
制备方法：
(1)囊材壳聚糖溶液的制备：将甘露醇溶于水中溶解后，再将壳聚糖缓慢加入到水溶液中，搅拌2小时，形成均匀混悬液，加热至80℃，然后加入乳酸，边加边继续搅拌，直至形成均匀溶液，再加入褐藻酸丙二醇酯，搅拌均匀，保温备用。
(2)内容物的制备：将南极磷虾油和牡丹籽油混合均匀，备用。
制备方法同实施例1。
实施例3
材料称取：
制备方法：
(1)囊材壳聚糖溶液的制备：将甘油和丙二醇按1:2的比例分别溶于水中溶解后，再将壳聚糖缓慢加入到水溶液中，搅拌1.5小时，形成均匀混悬液，加热至75℃，然后加入一氯乙酸，边加边继续搅拌，直至形成均匀溶液，再加入褐藻酸丙二醇酯，搅拌均匀，保温备用。
(2)内容物的制备：将南极磷虾油和亚麻籽油混合均匀，备用。
制备方法同实施例1。
实施例1-3制备的南极磷虾油软胶囊的稳定性试验结果如下：
表一：影响因素试验
表二：40℃加速试验
表三：室温留样试验
从试验结果可以看出，以壳聚糖和褐藻酸丙二醇酯为囊壳制备的南极磷虾油软胶囊的稳定性良好，满足生产和使用需要。
实施例1-3制备的南极磷虾油软胶囊降脂效果评价如下：
试验动物：(2.24±0.18)kg普通级新西兰白兔50只，随机挑选10只作为对照组喂食基础饲料直到实验结束，剩余40只喂食高脂饲料(基础饲料添加胆固醇、猪油和蛋黄粉)20天后，随机挑选30只分为3组，每组10只作为试验组，剩余10只作为高脂模型组。
试验设计
试验组1：本发明实施例1制备的南极磷虾油软胶囊(0.6g/天，温水送服)；
试验组2：本发明实施例2制备的南极磷虾油软胶囊(0.6g/天,温水送服)；
试验组3：本发明实施例3制备的南极磷虾油软胶囊(0.6g/天，温水送服)；
对照组：等量温水。
高脂模型组：等量温水。
服用周期：试验组1-3新西兰白兔连续服用5周，期间喂食等量基础饲料，自由饮水，最后一次口服4h后割尾采血进行检测，获得以下分析结果。
检测指标：总胆固醇(TC)、血清甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)。
表四新西兰白兔血液中脂质物质含量
注：*P<0.05，**P<0.01vs高脂组；^p<0.05,^^p<0.01vs对照组。
上述实施例是说明性的而不是限定性的，可按照所限定范围列举出若干个实施例，因此在不脱离本发明总体构思下的变化和修改，应属本发明的保护范围之内。
Claims (5)
1.一种南极磷虾油软胶囊，其特征在于所述胶囊由囊壳和囊壳内以南极磷虾油为主要成分的内容物组成，所述囊壳和内容物的重量比为1:0.5-1.5；
所述囊壳由以下组分按照重量份数制成：
壳聚糖6-10份、褐藻酸丙二醇酯为1-3份、增塑剂3-5份、有机弱酸2-5份、水85-92份；
所述内容物由以下组分按照重量份数组成：
南极磷虾油50-100份，植物油脂0-50份。
2.根据权利要求1所述南极磷虾油软胶囊，其特征在于所述增塑剂为：
聚乙二醇类、甘油、丙二醇、木糖醇、山梨糖醇、甘露醇、麦芽糖醇、肌醇中的一种或几种的组合。
3.根据权利要求1所述南极磷虾油软胶囊，其特征在于所述有机弱酸为：
一氯乙酸、二氯乙酸、丙烯酸、丙酸、丁酸、异丁酸、戊酸、异戊酸、己酸、乳酸、马来酸、苯甲酸、山梨酸、酒石酸、柠檬酸、苹果酸和琥珀酸中的一种或几种的组合。
4.根据权利要求3所述的南极磷虾油软胶囊，其特征在于所述植物油脂为：
牡丹籽油、亚麻籽油、红花籽油、大豆卵磷脂、橄榄油和核桃油中的一种或几种的组合。
5.一种制备权利要求1-4任一项所述的南极磷虾油软胶囊的方法，其特征在于具体的步骤如下：
(1)按量称取囊壳和囊壳内容物的各组分；
(2)将增塑剂溶于所称量的水中溶解后，将壳聚糖缓慢加入到水溶液中，搅拌1-2小时，形成均匀混悬液，加热至70-80℃，然后加入有机弱酸，边加边继续搅拌，直至形成均匀溶液，再加入褐藻酸丙二醇酯，搅拌形成胶液，保温备用；
(3)将内容物的各组分按比例混合均匀；
(4)以滴制法制备南极磷虾油软胶囊。
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