CN107969706A - 一种纳米级肠内营养制剂及其制备方法 - Google Patents
一种纳米级肠内营养制剂及其制备方法 Download PDFInfo
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- CN107969706A CN107969706A CN201711379977.9A CN201711379977A CN107969706A CN 107969706 A CN107969706 A CN 107969706A CN 201711379977 A CN201711379977 A CN 201711379977A CN 107969706 A CN107969706 A CN 107969706A
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- Medicinal Preparation (AREA)
Abstract
本发明公开了一种纳米级肠内营养制剂及其制备方法，营养制剂包括有蛋清源小肽、大豆源小肽、麦芽糊精、中链甘油三酯、橄榄油、益生元、复合维生素、总膳食纤维、矿物质和卵磷脂，按质量百分比各种原料的含量为：蛋清源小肽15‑25％、大豆源小肽10％‑15％、麦芽糊精20‑35％、中链甘油三酯5‑10％、橄榄油2‑5％、益生元1‑3％、复合维生素0.2‑1％、总膳食纤维5‑10％、矿物质3‑6％和卵磷脂3‑7％。制备方法为：步骤一、小肽脂质体纳米颗粒的制备；步骤二、复合小肽脂质体纳米颗粒的制备；步骤三、将步骤二中制备得到的水‑油‑水体系的复合小肽脂质体纳米颗粒溶液进行喷雾干燥后制备得到该纳米级肠内营养制剂。有益效果：相关工艺有效除去了工艺过程中所使用的有机溶剂，安全、稳定、高效。
Description
技术领域
本发明涉及一种肠内营养制剂及其制备方法，特别涉及一种纳米级肠内营养制剂及其制备方法。
背景技术
目前，肠内营养是临床营养支持治疗的重要方法，同时也是对日常食物中含量较缺乏的营养物质进行有效补充的重要途径。肠内营养适应人体的消化吸收，代谢方式更加符合生理，有助于维持肠粘膜结构与功能的完整性，在促进机体的康复、促进消化道粘膜的修复、维护肠粘膜屏障、减少微生物感染、促进相关物质的分泌、加强新陈代谢、减少相关疾病的发生方面具有重要作用。
现代蛋白质营养理论认为，蛋白质除了以游离氨基酸的方式被机体摄入之外，还有另一条更重要的营养吸收途径，即蛋白质能够以小肽的形式被吸收，与蛋白质和氨基酸相比，小肽具有独特的生理功能，且具有安全高效、生物利用度高、营养性能好等优点。肽类营养制剂是将优质来源的蛋白质通过一定程度的水解后，与其他营养素进行搭配而得到的一类膳食营养补充剂。其中小肽类肠内营养制剂是目前研究和开发的热点。小肽类营养制剂所含蛋白质为蛋白水解产物，所得到的部分小肽具有独特的生理活性，可以被小肠直接吸收进入血液循环，小肠中也有运输低聚肽的体系，低聚肽经小肠粘膜刷状缘的肽酶水解后进入血液，容易被机体利用。有充分的数据和实验证明，小肽的营养和功能活性要优于氨基酸，且能够以完整形式被机体吸收进入血液循环进而在指定位置发挥相应功效，这对促进蛋白质吸收、调节膳食结构，尤其针对胃肠道功能障碍、营养缺乏及亚健康人群进行营养膳食补充具有重要的现实意义。同时此类营养制剂不含乳糖，也避免了乳糖不耐受引起的腹泻和脂代谢障碍等一系列问题。
虽然小肽具有独特的功效，也能够以一定的完整形式进入血液循环被吸收，但其在胃肠道复杂的物理化学条件以及不同酶和微生物的作用下极易被降解为氨基酸，丧失掉其原有的结构和功能，也就无法以完整形式进入血液循环发挥其独特的功效。目前市场上已有部分肠内营养制剂的产品，包括蛋白来源为乳清蛋白的百普素、小百肽、立适康等，但其他蛋白来源，诸如禽蛋蛋白、植物蛋白等相关产品的种类和市场份额还很少。此外，已有的此类产品和专利只注重了各类营养物质的均衡搭配而缺乏对主要营养物质的有效保护及其在胃肠环境中的缓释情况研究。所以，开发一种营养均衡，且对易被胃肠道降解破坏的营养成分进行有效保护的肠内营养制剂迫在眉睫。
目前，国际上运用纳米包埋技术在对生物活性物质的保护和靶向吸收方面进行了广泛的研究，但都局限在对具体的单个营养物质或分子的保护上，诸如对表没食子儿茶素没食子酸酯(EGCG)、牛血清白蛋白(BSA)、DHA等的纳米包埋。对于混合肽或多组分小肽的包埋保护还少有报道。同时，纳米技术在食品中的应用也多局限于在包装上的应用，而对于营养物质本身却并没有较为广泛而有效的实际应用。
发明内容
本发明的目的是为了保持人体内营养均衡，且对易被胃肠道降解破坏的营养成分进行有效保护而提供的一种纳米级肠内营养制剂及其制备方法。
本发明提供的纳米级肠内营养制剂包括有蛋清源小肽、大豆源小肽、麦芽糊精、中链甘油三酯、橄榄油、益生元、复合维生素、总膳食纤维、矿物质和卵磷脂，按质量百分比各种原料的含量为：蛋清源小肽15-25％、大豆源小肽10％-15％、麦芽糊精20-35％、中链甘油三酯5-10％、橄榄油2-5％、益生元1-3％、复合维生素0.2-1％、总膳食纤维5-10％、矿物质3-6％和卵磷脂3-7％。
益生元是由壳寡糖、大豆低聚糖和低聚木糖组成，按质量百分比各种原料的含量为：壳寡糖40％、大豆低聚糖30％和低聚木糖30％。
复合维生素是由维生素C、维生素D、维生素E和叶酸组成，按质量百分比各种原料的含量为：维生素C 30％、维生素D 20％、维生素E 20％和叶酸30％。
总膳食纤维是由燕麦纤维、抗性淀粉、木质素、大豆纤维和豌豆纤维组成，按质量百分比各种原料的含量为：燕麦纤维30％、抗性淀粉8％、木质素12％、大豆纤维32％和豌豆纤维18％。
矿物质是由钙剂、镁剂、锌剂和铁剂组成，按质量百分比各种原料的含量为：钙剂78％、镁剂7％、锌剂11％和铁剂4％。
卵磷脂是由蛋黄或大豆作为原料进行制备。
本发明提供的纳米级肠内营养制剂的制备方法，其制备方法如下所述：
步骤一、小肽脂质体纳米颗粒的制备：取PBS缓冲溶液，加入80-120％，单位为w/v的卵磷脂后加入5-15％单位为v/v的三氯甲烷、乙醇或乙酸乙酯，搅拌5-10min，在20-60℃条件下旋转蒸发5-10min后，于35-60℃的干燥箱中干燥30-120min，加入PBS缓冲溶液保持原体积，随后加入脂质体总质量300-1000％的蛋清源小肽和200％-800％的大豆源小肽，在超声功率为200-800W、超声时间5-30min条件下制备得到包埋率为85％-96％，粒径小于100nm的小肽脂质体纳米颗粒；
步骤二、复合小肽脂质体纳米颗粒的制备：添加蛋清源小肽质量百分比30-50％的中联甘油三酯和10-25％的橄榄油于步骤一中所制备得到的小肽脂质体纳米颗粒溶液中，采用二次超声波辅助分散法在超声功率200-600W、超声时间为5-30min条件下进行复合包埋，得到水-油-水体系的中链甘油三酯+橄榄油/小肽脂质体纳米颗粒溶液，所制备得到的复合小肽脂质体纳米颗粒粒径小于200nm；
步骤三、将步骤二中制备得到的水-油-水体系的复合小肽脂质体纳米颗粒溶液进行喷雾干燥后按照质量百分比：复合小肽脂质体纳米颗粒40-60％，益生元1-3％，复合维生素0.2-1％，总膳食纤维5-10％，矿物质3-6％进行混合后与20-35％的麦芽糊精二次混合，辐照灭菌后制备得到该纳米级肠内营养制剂。
益生元是由壳寡糖、大豆低聚糖和低聚木糖组成，按质量百分比各种原料的含量为：壳寡糖40％、大豆低聚糖30％和低聚木糖30％。
复合维生素是由维生素C、维生素D、维生素E和叶酸组成，按质量百分比各种原料的含量为：维生素C 30％、维生素D 20％、维生素E 20％和叶酸30％。
总膳食纤维是由燕麦纤维、抗性淀粉、木质素、大豆纤维和豌豆纤维组成，按质量百分比各种原料的含量为：燕麦纤维30％、抗性淀粉8％、木质素12％、大豆纤维32％和豌豆纤维18％。
矿物质是由钙剂、镁剂、锌剂和铁剂组成，按质量百分比各种原料的含量为：钙剂78％、镁剂7％、锌剂11％和铁剂4％。
卵磷脂是由蛋黄或大豆作为原料进行制备。
本发明的有益效果：
本发明为禽蛋和植物蛋白的精深加工提供了新的产品形式和技术支持，促进禽蛋和植物蛋白高附加值成分的综合开发利用，对农产品精深加工和稳定高效的肠内营养制剂市场欠缺的补充具有重要意义。
本发明在工艺过程中运用了纳米技术，使该营养制剂的主要营养成分得到了有效的保护，被包埋的小肽在胃肠道中能够不被快速降解，保护了小肽结构和功能的完整性，使其在小肠中能够靶向浓集释放达到一定的量进入血液循环发挥相应功能，提高主要成分的实际应用价值。同时，对该纳米级肠内营养制剂中的油性物质中链甘油三酯和橄榄油进行复合包埋，使整个肠内营养制剂能够较好的溶于水中，提高其实际应用范围。
本发明提供的纳米级肠内营养制剂，营养配比全面，同时考虑到实际生产过程中的营养素配比，性价比高。最后所得到的产品中，均为食品级有效成分，相关工艺有效除去了工艺过程中所使用的有机溶剂，安全、稳定、高效。
附图说明
图1为本发明所述小肽脂质体纳米颗粒透射电镜示意图。
图2为本发明所述小肽脂质体纳米颗粒粒径分布示意图。
具体实施方式
请参阅图1至图2示：
实施例1：
步骤一、取50mLPBS缓冲溶液，加入60mg的蛋黄卵磷脂，5mL的三氯甲烷，搅拌5min，在30℃条件下旋转蒸发8min后，于40℃的干燥箱中干燥30min，加入40mLPBS缓冲溶液搅拌均匀后，加入420mg蛋清源小肽和240mg的大豆源小肽，搅拌均匀后超声15min，得到包埋率为87％、粒径为85nm的小肽脂质体纳米颗粒溶液；
步骤二、将135mg中链甘油三酯和70mg橄榄油加入步骤一中制备得到的小肽脂质体纳米颗粒溶液，超声10min，得到粒径为162nm的水-油-水体系的中链甘油三酯+橄榄油/小肽脂质体纳米颗粒溶液，喷雾干燥后得到所需样品；
步骤三、取50％步骤二中喷雾干燥得到的样品与0.5％的复合维生素，1.5％的益生元，8％的膳食纤维，3％的矿物质充分混合，再与37％的麦芽糊精进行二次混合，辐照灭菌。
益生元是由壳寡糖、大豆低聚糖和低聚木糖组成，按质量百分比各种原料的含量为：壳寡糖40％、大豆低聚糖30％和低聚木糖30％。
复合维生素是由维生素C、维生素D、维生素E和叶酸组成，按质量百分比各种原料的含量为：维生素C 30％、维生素D 20％、维生素E 20％和叶酸30％。
总膳食纤维是由燕麦纤维、抗性淀粉、木质素、大豆纤维和豌豆纤维组成，按质量百分比各种原料的含量为：燕麦纤维30％、抗性淀粉8％、木质素12％、大豆纤维32％和豌豆纤维18％。
矿物质是由钙剂、镁剂、锌剂和铁剂组成，按质量百分比各种原料的含量为：钙剂78％、镁剂7％、锌剂11％和铁剂4％。
卵磷脂是由蛋黄或大豆作为原料进行制备。
实施例2：
步骤一、取100mLPBS缓冲溶液，加入100mg的大豆卵磷脂，12mL的三氯甲烷，搅拌7min，在35℃条件下旋转蒸发5min后，于40℃的干燥箱中干燥35min，加入65mLPBS缓冲溶液搅拌均匀后，加入560mg蛋清源小肽和440mg的大豆源小肽，搅拌均匀后超声10min，得到包埋率为91％、粒径为90nm的小肽脂质体纳米颗粒溶液；
步骤二、将160mg中链甘油三酯和85mg橄榄油加入步骤一中制备得到的小肽脂质体纳米颗粒溶液，超声13min，得到粒径为175nm的水-油-水体系的中链甘油三酯+橄榄油/小肽脂质体纳米颗粒溶液，喷雾干燥后得到所需样品；
步骤三、取55％步骤二中喷雾干燥得到的样品与0.7％的复合维生素，2.3％的益生元，6％的膳食纤维，1.9％的矿物质充分混合，再与34.1％的麦芽糊精进行二次混合，辐照灭菌。
益生元是由壳寡糖、大豆低聚糖和低聚木糖组成，按质量百分比各种原料的含量为：壳寡糖40％、大豆低聚糖30％和低聚木糖30％。
复合维生素是由维生素C、维生素D、维生素E和叶酸组成，按质量百分比各种原料的含量为：维生素C 30％、维生素D 20％、维生素E 20％和叶酸30％。
总膳食纤维是由燕麦纤维、抗性淀粉、木质素、大豆纤维和豌豆纤维组成，按质量百分比各种原料的含量为：燕麦纤维30％、抗性淀粉8％、木质素12％、大豆纤维32％和豌豆纤维18％。
矿物质是由钙剂、镁剂、锌剂和铁剂组成，按质量百分比各种原料的含量为：钙剂78％、镁剂7％、锌剂11％和铁剂4％。
卵磷脂是由蛋黄或大豆作为原料进行制备。
实施例3：
步骤一、取150mLPBS缓冲溶液，加入130mg的蛋黄卵磷脂，13.5mL的三氯甲烷，搅拌4min，在35℃条件下旋转蒸发10min后，于42℃的干燥箱中干燥35min，加入70mLPBS缓冲溶液搅拌均匀后，加入650mg蛋清源小肽和520mg的大豆源小肽，搅拌均匀后超声18min，得到包埋率为89％、粒径为82nm的小肽脂质体纳米颗粒溶液；
步骤二、将185mg中链甘油三酯和13mg橄榄油加入步骤一中制备得到的小肽脂质体纳米颗粒溶液，超声13min，得到粒径为152nm的水-油-水体系的中链甘油三酯+橄榄油/小肽脂质体纳米颗粒溶液，喷雾干燥后得到所需样品；
步骤三、取48％步骤二中喷雾干燥得到的样品与0.8％的复合维生素，1.8％的益生元，9％的膳食纤维，3.4％的矿物质充分混合，再与37％的麦芽糊精进行二次混合，辐照灭菌。
益生元是由壳寡糖、大豆低聚糖和低聚木糖组成，按质量百分比各种原料的含量为：壳寡糖40％、大豆低聚糖30％和低聚木糖30％。
复合维生素是由维生素C、维生素D、维生素E和叶酸组成，按质量百分比各种原料的含量为：维生素C 30％、维生素D 20％、维生素E 20％和叶酸30％。
总膳食纤维是由燕麦纤维、抗性淀粉、木质素、大豆纤维和豌豆纤维组成，按质量百分比各种原料的含量为：燕麦纤维30％、抗性淀粉8％、木质素12％、大豆纤维32％和豌豆纤维18％。
矿物质是由钙剂、镁剂、锌剂和铁剂组成，按质量百分比各种原料的含量为：钙剂78％、镁剂7％、锌剂11％和铁剂4％。
卵磷脂是由蛋黄或大豆作为原料进行制备。
Claims (10)
1.一种纳米级肠内营养制剂，其特征在于：包括有蛋清源小肽、大豆源小肽、麦芽糊精、中链甘油三酯、橄榄油、益生元、复合维生素、总膳食纤维、矿物质和卵磷脂，按质量百分比各种原料的含量为：蛋清源小肽15-25％、大豆源小肽10％-15％、麦芽糊精20-35％、中链甘油三酯5-10％、橄榄油2-5％、益生元1-3％、复合维生素0.2-1％、总膳食纤维5-10％、矿物质3-6％和卵磷脂3-7％。
2.根据权利要求1所述的一种纳米级肠内营养制剂，其特征在于：所述的益生元是由壳寡糖、大豆低聚糖和低聚木糖组成，按质量百分比各种原料的含量为：壳寡糖40％、大豆低聚糖30％和低聚木糖30％。
3.根据权利要求1所述的一种纳米级肠内营养制剂，其特征在于：所述的复合维生素是由维生素C、维生素D、维生素E和叶酸组成，按质量百分比各种原料的含量为：维生素C30％、维生素D 20％、维生素E 20％和叶酸30％。
4.根据权利要求1所述的一种纳米级肠内营养制剂，其特征在于：所述的总膳食纤维是由燕麦纤维、抗性淀粉、木质素、大豆纤维和豌豆纤维组成，按质量百分比各种原料的含量为：燕麦纤维30％、抗性淀粉8％、木质素12％、大豆纤维32％和豌豆纤维18％。
5.根据权利要求1所述的一种纳米级肠内营养制剂，其特征在于：所述的矿物质是由钙剂、镁剂、锌剂和铁剂组成，按质量百分比各种原料的含量为：钙剂78％、镁剂7％、锌剂11％和铁剂4％。
6.一种纳米级肠内营养制剂的制备方法，其特征在于：其制备方法如下所述：
步骤一、小肽脂质体纳米颗粒的制备：取PBS缓冲溶液，加入80-120％，单位为w/v的卵磷脂后加入5-15％单位为v/v的三氯甲烷、乙醇或乙酸乙酯，搅拌5-10min，在20-60℃条件下旋转蒸发5-10min后，于35-60℃的干燥箱中干燥30-120min，加入PBS缓冲溶液保持原体积，随后加入脂质体总质量300-1000％的蛋清源小肽和200％-800％的大豆源小肽，在超声功率为200-800W、超声时间5-30min条件下制备得到包埋率为85％-96％，粒径小于100nm的小肽脂质体纳米颗粒；
步骤二、复合小肽脂质体纳米颗粒的制备：添加蛋清源小肽质量百分比30-50％的中联甘油三酯和10-25％的橄榄油于步骤一中所制备得到的小肽脂质体纳米颗粒溶液中，采用二次超声波辅助分散法在超声功率200-600W、超声时间为5-30min条件下进行复合包埋，得到水-油-水体系的中链甘油三酯+橄榄油/小肽脂质体纳米颗粒溶液，所制备得到的复合小肽脂质体纳米颗粒粒径小于200nm；
步骤三、将步骤二中制备得到的水-油-水体系的复合小肽脂质体纳米颗粒溶液进行喷雾干燥后按照质量百分比：复合小肽脂质体纳米颗粒40-60％，益生元1-3％，复合维生素0.2-1％，总膳食纤维5-10％，矿物质3-6％进行混合后与20-35％的麦芽糊精二次混合，辐照灭菌后制备得到该纳米级肠内营养制剂。
7.根据权利要求6所述的一种纳米级肠内营养制剂的制备方法，其特征在于：所述的益生元是由壳寡糖、大豆低聚糖和低聚木糖组成，按质量百分比各种原料的含量为：壳寡糖40％、大豆低聚糖30％和低聚木糖30％。
8.根据权利要求6所述的一种纳米级肠内营养制剂的制备方法，其特征在于：所述的复合维生素是由维生素C、维生素D、维生素E和叶酸组成，按质量百分比各种原料的含量为：维生素C 30％、维生素D 20％、维生素E 20％和叶酸30％。
9.根据权利要求6所述的一种纳米级肠内营养制剂的制备方法，其特征在于：所述的总膳食纤维是由燕麦纤维、抗性淀粉、木质素、大豆纤维和豌豆纤维组成，按质量百分比各种原料的含量为：燕麦纤维30％、抗性淀粉8％、木质素12％、大豆纤维32％和豌豆纤维18％。
10.根据权利要求6所述的一种纳米级肠内营养制剂的制备方法，其特征在于：所述的矿物质是由钙剂、镁剂、锌剂和铁剂组成，按质量百分比各种原料的含量为：钙剂78％、镁剂7％、锌剂11％和铁剂4％。
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