CN113230389A - 包括酶解卵白蛋白小分子活性短肽的组合物在制备用于改善低白蛋白血症药品、食品的应用 - Google Patents
包括酶解卵白蛋白小分子活性短肽的组合物在制备用于改善低白蛋白血症药品、食品的应用 Download PDFInfo
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- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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Abstract
本申请涉及生物医药技术领域，提供了包括酶解卵白蛋白小分子活性短肽的组合物在制备用于改善低白蛋白血症药品、食品的应用，该组合物包括酶解卵白蛋白小分子活性短肽和酵母β‑葡聚糖，其以酶解卵白蛋白小分子活性短肽和酵母β‑葡聚糖为主要活性成分，通过两者间的协同作用，可实现内生性提高血清白蛋白水平，从根本上改善机体血清白蛋白不足，并同时有效提升人体免疫力，全面优化人体机能，促进伤口愈合，加快术后康复，改善预后，具有应用于制备用于改善低白蛋白血症的药品、食品的潜力，市场前景巨大。
Description
技术领域
本申请属于生物医药技术领域，尤其涉及包括酶解卵白蛋白小分子活性短肽的组合物在制备用于改善低白蛋白血症药品、食品中的应用。
背景技术
低白蛋白血症是指血浆总蛋白或血浆白蛋白的浓度低于正常范围，它不是一个独立的疾病，而是各种原因所致氮负平衡的结果，主要表现营养不良，又称蛋白营养不良或水肿性营养不良。低白蛋白血症在临床的发生率高，如一项关于低白蛋白血症临床发生率的研究统计结果显示，118例全身炎症反应综合征危重患者的低白蛋白血症发生率41.5％，127例住院患者的低白蛋白血症发生率69.3％，139例合并腹泻的ICU患者的低白蛋白血症发生率63.3％，160 例老年ICU患者的低白蛋白血症发生率80.6％，693例肠瘘患者的低白蛋白血症发生率59.2％。同时，血浆白蛋白含量与其死亡危险呈负相关，白蛋白低于25g/L的危重病人并发症发生率提高4倍，病死率提高6倍。一项大型荟萃分析，包括90个分析低白蛋白血症对预后的预测性试验和9个研究纠正低白蛋白血症治疗的前瞻性对照试验发现，低白蛋白血症患者白蛋白水平每降低10g/L，其病死率增加37％，并发症发生率增加89％。
目前，人们主要采用静脉输注入人血白蛋白的方法来提高血清蛋白水平，属于外源性补充血浆白蛋白，其仅可提高血清蛋白水平，但在减少并发症的发生率及改善临床预后等方面并不理想。同时，Spiess等研究发现，外源性人血白蛋白不仅缺乏人体必需的一些氨基酸、半衰期短，输入人体后经过分解并且重新合成自身蛋白质的再利用率相当低，因而，现有方法对患者血浆白蛋白含量的提升程度有限，无法从根本上持续提升机体血清蛋白水平，纠正低白蛋白血症。此外，人血白蛋白属血液制品、注射液剂型，需冷链储运，价格昂贵，存在一定的被污染与变性可能以及感染血行传播疾病风险，仅适宜在医疗机构内准予急危重症患者短期使用。
发明内容
本申请的目的在于提供包括酶解卵白蛋白小分子活性短肽的组合物在制备用于改善低白蛋白血症的药品、食品中的应用，以解决现有方法对患者血浆白蛋白含量的提升程度有限，无法从根本上持续提升机体血清蛋白水平，纠正低白蛋白血症。
本申请提供的具体技术方案如下：
组合物在制备用于改善低白蛋白血症的药品、食品中的应用，所述组合物包括酶解卵白蛋白小分子活性短肽和酵母β-葡聚糖。
本申请所提供的组合物，以酶解卵白蛋白小分子活性短肽和酵母β-葡聚糖为主要活性成分，酶解卵白蛋白小分子活性短肽为活性寡肽，容易被人体吸收，且含有人体所需的20种必需氨基酸和支链氨基酸，其氨基酸组成和比例非常接近人体血清蛋白，利用率高，可快速提升血浆白蛋白含量；酵母β-葡聚糖为非特异性免疫调节剂，可调节人体免疫系统，提高机体对酶解卵白蛋白小分子活性短肽的生物利用度，促进肝脏细胞利用酶解卵白蛋白小分子活性短肽，修补受损肝细胞，恢复或增强肝脏合成蛋白的能力，并促进酶解卵白蛋白小分子活性短肽直接作用到内质网，加强核糖体形成，使肝脏合成白蛋白功能从根本上得到改善与强化，实现内生性提高血清白蛋白水平，从根本上改善机体血清白蛋白不足。此外，酵母β-葡聚糖协同酶解卵白蛋白小分子活性短肽，还可促进合成急性时相反应蛋白，提升人体免疫力，全面优化人体机能，促进伤口愈合，加快术后康复、改善预后，具有应用于制备用于改善低白蛋白血症的药物、保健食品的潜力，市场前景巨大。
与人血白蛋白制品相比，本申请的组合物可实现内生性提供血浆白蛋白，从根本上改善低白蛋白血症，且有利于肿瘤、肝硬化、肾脏疾病等患者的术后康复，提高肿瘤患者抗放化疗能力，延续相关重症疾病患者生命周期；同时，本申请的组合物可常温保存，低变质风险，价格经济，不存在被污染与变性可能以及感染血行传播疾病风险。
具体实施方式
为了使本申请要解决的技术问题、技术方案及有益效果更加清楚明白，以下结合实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
本申请实施例提供了组合物在制备用于改善低白蛋白血症的药品、食品中的应用，组合物包括酶解卵白蛋白小分子活性短肽和酵母β-葡聚糖。
其中，酶解卵白蛋白小分子活性短肽为一种活性寡肽，寡肽为小分子肽，又称为低聚肽，其在胃肠道内几乎无需消化或稍加消化即可经小肠进入人体循环系统，能够明显减轻机体胃肠道的消化负担，吸收利用速度快，同时，酶解卵白蛋白小分子活性短肽含有人体所需的20种必需氨基酸和支链氨基酸，其氨基酸组成和比例非常接近人体血清蛋白，利用率高，可快速提升血浆蛋白尤其是白蛋白含量，从而促进纠正低白蛋白血症。
一些实施例中，酶解卵白蛋白小分子活性短肽的分子量小于1000Da。优选地，酶解卵白蛋白小分子活性短肽的分子量小于1000Da的达92.8％，其中的 76.5％小于500Da。如此，以进一步提升酶解卵白蛋白小分子活性短肽的吸收利用效率。
一些实施例中，酶解卵白蛋白小分子活性短肽的有效浓度为0.01-0.5g/mL，例如0.01g/mL、0.05g/mL、0.08g/mL、0.1g/mL、0.2g/mL、0.3g/mL、0.4g/mL 或0.5g/mL，以保证组合物在改善机体白蛋白水平的同时，有效提高机体免疫力与抗病能力。
本申请实施例的酶解卵白蛋白小分子活性短肽主要采用生物效价高达94％的卵清为原料并利用复合酶定向生化酶切技术制得，其中，复合酶定向生化酶切技术可参考本领域的生化技术手段，本申请实施例在此不一一赘述。
酵母β-葡聚糖是存在于酵母细胞壁中的一种具有增强免疫力活性的β-葡聚糖，为国际公认的具有抗肿瘤、抗感染、抗辐射等多种生物活性和功能的非特异性免疫调节剂。该酵母β-葡聚糖可调节人体免疫系统，提高机体对酶解卵白蛋白小分子活性短肽的生物利用度，促进肝肾细胞利用酶解卵白蛋白小分子活性短肽，修补受损肝细胞，恢复或增强肝脏合成蛋白的能力，并促进酶解卵白蛋白小分子活性短肽直接作用到内质网，加强核糖体形成，使肝合成白蛋白功能从根本上得到改善与强化，实现内生性提高血清白蛋白水平，从根本上改善低白蛋白血症。此外，酵母β-葡聚糖协同酶解卵白蛋白小分子活性短肽，还可促进合成急性时相反应蛋白(包括各种细胞因子、抗体、补体、激肽、激素、凝血因子等)，提升人体免疫力，全面优化人体机能，促进伤口愈合，加快术后康复、改善预后。
低白蛋白血症由肿瘤、肝脏疾病、肾脏疾病、心脑血管疾病、外科手术、烧伤或高强度运动消耗等引起，而肿瘤、肝脏疾病、心脑血管疾病或肾脏疾病等患者尤其是在外科手术术后，均同时存在低白蛋白血症和不同程度的机体免疫力低下的情况，令疾病康复期延长，或造成病发症增加、预后较差，特别是肿瘤患者大多需要接受放化疗，而放化疗期间的射线与化学毒素对人体的损害是极大的。本申请实施例通过将酶解卵白蛋白小分子活性短肽复配酵母-β-葡聚糖，实现了在快速提高患者血清蛋白水平的同时，强化人体免疫系统，增强机体组织抗肿瘤、抗辐射能力，减轻患者放化疗期造成的损害，改善预后、促进早日康复。因而，本申请实施例提供的组合物具有应用于制备用于改善低白蛋白血症的药品、食品的潜力，市场前景巨大。
可以理解的是，高强度运动包括但不限于球类、跑步、爬山、有氧运动、20公里以上物品的搬运、快速游泳、自行车、有氧运动等等，其定义可参考联合国世卫组织公布的界定，在高强度活动时消耗的卡路里大于或等于6METs (代谢当量，指一个人工作时的代谢率与休息时代谢率之间的比率)。
一些实施例中，酵母β-葡聚糖的有效浓度为0.1-2mg/mL，例如为0.1 mg/mL、0.4mg/mL、0.7mg/mL、0.9mg/mL、1mg/mL、1.2mg/mL、1.5mg/mL、 1.8mg/mL或2mg/mL。如此，实现在保证组合物安全性的同时，有效促进提高血浆白蛋白含量以及改善低白蛋白血症和疾病期营养不良，提升人体免疫力，全面优化人体机能，改善预后。
在上述实施例的基础上，组合物还包括枸杞浓缩汁。在组合物中添加枸杞浓缩液，一方面，有利于改善低白蛋白血症患者的整体营养水平，另一方面，可以调解组合物口感，减少甜蜜素等化学物质的添加，提高产品安全性。
本申请实施例所添加的枸杞浓缩汁为枸杞原浆，由鲜枸杞经鲜榨后真空浓缩而成，密度约为1.2-2g/mL。
进一步的，上述组合物还包括药学上可接受的辅料或载体，辅料或载体包括水、甜味剂、防腐剂和增稠剂中的至少一种。其中，甜味剂包括木糖醇、山梨醇、糖精和三氯蔗糖中的至少一种，防腐剂包括柠檬酸、葡萄糖酸钠中的至少一种，增稠剂包括果胶、卡拉胶和黄原胶中的至少一种。一些实施例中，甜味剂选为木糖醇和三氯蔗糖的混合物，防腐剂选为柠檬酸，增稠剂选为果胶和黄原胶的混合物。通过选择上述辅料或载体，使得口服液口感柔和，依从性好。
本申请实施例提供的组合物可制备为多种剂型，包括但不限于水剂、片剂、丸剂、喷雾剂等，可根据消费者需求灵活调整为特定的剂型。
一些实施例中，组合物为口服液，经口补充，成本经济，无需冲调直接饮用，食用方便，且于医院、药店可直接购买，适用人群广泛。
进一步实施例中，口服液由酶解卵白蛋白小分子活性短肽、酵母β-葡聚糖、枸杞浓缩汁、木糖醇、三氯蔗糖、柠檬酸、果胶、黄原胶和水组成。具体地，该口服液由以下组分组成：
水补足至50mL。
与现有人血白蛋白制品相比，本申请实施例提供的组合物以酶解卵白蛋白小分子活性短肽和酵母β-葡聚糖为核心成分，通过两者的协同作用，可内生性提高血浆白蛋白水平，长期有效、安全可持续，全面优化人体机能；可常温保存，低变质风险，价格经济，不存在被污染与变性可能以及感染血行传播疾病风险；可形成为口服液剂型，无需冲调直接饮用，于医院、药店可直接购买，适用人群广泛。
实际应用过程中，本申请实施例提供的上述组合物可作为一种口服强化营养补充剂应用于长期慢性低白蛋白血症患者的家庭康复中，也可以与人血白蛋白制品联合或序贯应用于手术、创伤、烧伤等住院患者，还可以单独应用于低血白蛋白症住院患者中，以纠正低白蛋白血症，增强机体免疫力与抗病抗感染能力，强化营养效率。
一些应用例子中，患者血清白蛋白(ALB)＜28g/L时，可与人血白蛋白联合使用，具体地，注射人血白蛋白的同时每日饮用100mL上述口服液，停止注射人血白蛋白后每日饮用50-100mL上述口服液，直至出院。
一些应用例子中，患者28g/L＜ALB＜40g/L时，可根据患者的综合情况，推荐每日饮用50-100mL上述口服液，直至出院。
一些应用例子中，在患者的居家康复期或肿瘤放化疗周期，可根据患者的综合情况，推荐每日饮用50-100mL上述口服液，直至血清蛋白水平提高到 40g/L，肠道功能可恢复正常饮食。
以下通过实施例对本发明的实施进行举例说明。
实施例1
本实施例提供了一种口服液，其由以下组分组成：
水补足至50mL。
实施例2
本实施例提供了一种口服液，其由以下组分组成：
水补足至50mL。
实施例3
本实施例提供了一种口服液，其由以下组分组成：
水补足至50mL。
以上所述仅为本申请的较佳实施例而已，并不用以限制本申请，凡在本申请的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本申请的保护范围之内。
Claims (10)
1.组合物在制备用于改善低白蛋白血症的药品、食品中的应用，所述组合物包括酶解卵白蛋白小分子活性短肽和酵母β-葡聚糖。
2.如权利要求1所述的应用，其特征在于，所述低白蛋白血症由肿瘤、肝脏疾病、肾脏疾病、心脑血管疾病、外科手术、烧伤或高强度运动消耗等引起。
3.如权利要求1所述的应用，其特征在于，所述酶解卵白蛋白小分子活性短肽的分子量小于1000Da。
4.如权利要求1所述的应用，其特征在于，所述酶解卵白蛋白小分子活性短肽的有效浓度为0.01-0.5g/mL。
5.如权利要求1所述的应用，其特征在于，所述酵母β-葡聚糖的有效浓度为0.1-2mg/mL。
6.如权利要求1至5任一项所述的应用，其特征在于，所述组合物还包括枸杞浓缩液。
7.如权利要求6所述的应用，其特征在于，所述组合物还包括药学上可接受的辅料或载体，所述辅料或载体包括水、甜味剂、防腐剂和增稠剂中的至少一种。
8.如权利要求7所述的应用，其特征在于，所述甜味剂包括木糖醇、山梨醇、糖精和三氯蔗糖中的至少一种；和/或
所述防腐剂包括柠檬酸、葡萄糖酸钠中的至少一种；和/或
所述增稠剂包括果胶、卡拉胶和黄原胶中的至少一种。
9.如权利要求8所述的应用，其特征在于，所述组合物为口服液。
10.如权利要求9所述的应用，其特征在于，所述口服液由酶解卵白蛋白小分子活性短肽、酵母β-葡聚糖、枸杞浓缩汁、木糖醇、三氯蔗糖、柠檬酸、果胶、黄原胶和水组成。
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