CN111803628A - 一种抗幽门螺杆菌复合制剂 - Google Patents
一种抗幽门螺杆菌复合制剂 Download PDFInfo
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Abstract
本发明公开了一种抗幽门螺杆菌复合制剂，属于医药技术领域。本发明提供了一种抗幽门螺杆菌的食品配方，主要包含抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白、溶菌酶和其他食品配料，利用抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶的协同作用来达到较好的抑制幽门螺杆菌的预防、治疗效果。
Description
技术领域
本发明涉及一种抗幽门螺杆菌复合制剂，属于医药技术领域。
背景技术
幽门螺杆菌是一种定植于胃部的革兰氏阴性菌，据统计全球超50％的人类感染这种菌，10％左右感染者发展为慢性萎缩性胃炎、功能性消化不良和消化道溃疡，进而部分患者恶化为胃癌。慢性胃溃疡、胃癌为幽门螺杆菌感染、环境因素和遗传因素共同作用的结果，根除幽门螺杆菌被认为是胃癌一级预防措施，并且根除幽门螺杆菌可以彻底治愈绝大多数慢性、复发性消化溃疡疾病。目前主要临床治疗方法为抗生素制剂，但是抗生素应用范围有限，并且效果逐渐减弱，因为菌株会产生耐药性，而孕妇、儿童、老年人、抗生素过敏者、肝肾功能障碍患者不宜使用抗生素疗法。因此，一种理想的抗幽门螺杆菌的替代预防治疗方案是国内外研究的热点。
卵黄免疫球蛋白(IgY)是指鸡群经被动免疫产生具有特异性活性的抗体蛋白。IgY具有纯度高、特异性强、安全性高、热稳定性强且不激活补体等特性，在食品、医药及日用化工等领域具有广阔的应用前景。目前已经有大量研究表明抗幽门螺杆菌特异性IgY具有治疗幽门螺杆菌感染的效果，并且抗幽门螺杆菌特异性IgY不易产生耐药性、使用范围广、制备方法简单易行、成本低、与哺乳动物免疫球蛋白之间不会发生交叉免疫学反应，因此，抗幽门螺杆菌特异性IgY是一种理想的替代抗生素的治疗预防幽门螺杆菌手段。目前市场上含IgY的产品形式主要是片制剂或者压片糖果，活性成分单一，产品种类也较少，因此，亟需开发新型IgY食品，丰富IgY产品形式，为消费者提供更多的选择，同时产品具备更佳的抑菌效果。
鸡蛋中的卵转铁蛋白具有广谱抗菌性，对不同的革兰氏阴性菌和阳性菌都具有抗菌活性，特别是对于肠道致病菌和病毒，例如假单胞杆菌、大肠杆菌、链球菌、金黄色葡萄球菌等具有抑菌效果。溶菌酶对细菌、真菌都有一定的抑菌作用，抑菌效果根据菌的种类不同而有高低区别，单独作用时对革兰氏阳性菌抑制效果高于阴性菌，因而将溶菌酶与其他物质混用来提高溶菌酶的抑菌能力是一直以来的研究热点。
发明内容
为了解决上述问题，本发明提供了一种抗幽门螺杆菌的食品配方，主要包含抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白、溶菌酶和其他食品配料，利用抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶的协同作用来达到较好的抑制幽门螺杆菌的预防、治疗效果。
本发明提供了一种抗幽门螺杆菌复合制剂，所述复合制剂包括抗幽门螺杆菌特异性免疫球蛋白和卵转铁蛋白。
在本发明一种实施方式中，所述复合制剂还包括溶菌酶。
在本发明一种实施方式中，所述抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶质量比为(1-6)：(1-6)：(0-5)。
本发明提供了一种抗幽门螺杆菌的药物，所述药物含有上述复合剂，还包括药物载体和/或药用辅料。
在本发明一种实施方式中，所述的药物的剂型为医学上认可的任意一种剂型。
本发明提供了一种抗幽门螺杆菌的食品或保健品，所述食品或保健品包括抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶。
在本发明一种实施方式中，所述抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶质量比为(1-6)：(1-6)：(0-5)。
在本发明一种实施方式中，所述食品或保健品中抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶总的质量百分数为10～500mg/g。
在本发明一种实施方式中，所述的抗幽门螺杆菌食品配方中，所述的抗幽门螺杆菌食品配方中还包括食品配料，所述抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白、溶菌酶和食品配料的质量比为(1-6)：(1-6)：(0-5)：(10-80)。
在本发明一种实施方式中，所述的抗幽门螺杆菌食品配方中，其他食品配料包含起赋形、调味、缓冲、着色和保护作用的一种或多种组合配料，包括全脂奶粉、脱脂奶粉、茯苓粉、大豆蛋白粉、果蔬粉、麦芽糊精和低聚糖中的一种或多种。
在本发明一种实施方式中，所述的抗幽门螺杆菌食品配方实际以固态或液态应用到食品体系中，得到酸奶、饮料、含片、胶囊或糖果。
本发明提供了一种抗幽门螺杆菌奶片，所述奶片的制备方法为：将抗幽门螺杆菌免疫球蛋白2-12重量份、卵转铁蛋白2-12重量份、溶菌酶0-10重量份粉碎得混合粉末，将其与奶粉20～150重量份搅拌均匀后，压制成型即得抗幽门螺杆菌奶片。
本发明的有益效果：
本发明采用卵转铁蛋白和抗幽门螺杆菌特异性免疫球蛋白复配，对幽门螺杆菌的抑制率可达95％以上，其抑制效果比单独使用其中一种的效果之和要优越，具有很好的协同作用。通过本发明公开的食品配方，可以有效的预防、治疗幽门螺杆菌感染，并且不产生抗药性，适用范围广，且不易发生不良反应。
具体实施方式
以下对本发明的优选实施例进行说明，应当理解实施例是为了更好地解释本发明，不用于限制本发明。
1.生物材料
抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白、溶菌酶来源于尤丽康(江苏)生物医药有限公司。
2.评估幽门螺杆菌的抑制效果
将被诊断患有幽门螺杆菌感染的患者随机分成50人一组，1-3组分别口服实施例1-3中一种抗幽门螺杆菌复合制剂或奶片，4-6组分别服用对比例1-4中单独的抗幽门螺杆菌、卵转铁蛋白、卵转铁—乳铁蛋白和抗生素药物，每天两次，一次一粒，持续四周，用药期间通过问诊确认患者是否有不良反应，停药两周后评估治愈情况。
实施例1：一种抗幽门螺杆菌复合制剂
一种抗幽门螺杆菌复合制剂，所述复合制剂包括抗幽门螺杆菌特异性免疫球蛋白100mg和卵转铁蛋白100mg。
实施例2：一种抗幽门螺杆菌复合制剂
一种抗幽门螺杆菌复合制剂，所述复合制剂包括100份抗幽门螺杆菌特异性免疫球蛋白100mg、卵转铁蛋白80mg和溶菌酶20mg。
实施例3：一种抗幽门螺杆菌的奶片
一种抗幽门螺杆菌的奶片，奶片包括全脂奶粉500mg、抗幽门螺杆菌特异性免疫球蛋白100mg、卵转铁蛋白60mg和溶菌酶40mg。
对比例1：抗幽门螺杆菌特异性免疫球蛋白
仅含有抗幽门螺杆菌特异性免疫球蛋白200mg。
对比例2：卵转铁蛋白
仅含有卵转铁蛋白200mg。
对比例3：一种抗幽门螺杆菌复合制剂
参照实施例1，将卵转铁蛋白替换成溶菌酶，其他条件同实施例1。
对比例4：一种抗幽门螺杆菌复合制剂
参照实施例1，将卵转铁蛋白替换成乳铁蛋白，其他条件同实施例1。
对比例5：
现有的抗生素药物奥美拉唑肠溶胶囊，每颗胶囊中含有奥美拉唑20mg。
表1产品配方
表2治疗幽门螺杆菌感染的效果
由表1和表2可知，当保持添加量总量不变的情况下，实施例1中抗幽门螺杆菌IgY和卵转铁蛋白组合后对幽门螺杆菌的抑制效果，较单独抗幽门螺杆菌IgY和单独卵转铁蛋白的效果之和更优越，说明抗幽门螺杆菌IgY和卵转铁蛋白之间在治疗幽门螺杆菌感染方面相互支持，具有协同作用。另一方面，相应地，实施例1、2和对比例3的对照结果也证明了抗幽门螺杆菌IgY与卵转铁蛋白、溶菌酶之间在抑制幽门螺杆菌方面也具有相互作用。
虽然本发明已以较佳实施例公开如上，但其并非用以限定本发明，任何熟悉此技术的人，在不脱离本发明的精神和范围内，都可做各种的改动与修饰，因此本发明的保护范围应该以权利要求书所界定的为准。
Claims (10)
1.一种抗幽门螺杆菌复合制剂，其特征在于，所述复合制剂包括抗幽门螺杆菌特异性免疫球蛋白和卵转铁蛋白。
2.根据权利要求1所述的复合制剂，其特征在于，所述复合制剂还包括溶菌酶。
3.根据权利要求2所述的复合制剂，其特征在于，所述抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶质量比为(1-6)：(1-6)：(0-5)。
4.一种抗幽门螺杆菌的药物，其特征在于，所述药物包含权利要求1-3任一所述的复合制剂，还包括药物载体和/或药用辅料。
5.根据权利要求4所述的药物，其特征在于，所述的药物的剂型为医学上认可的任意一种剂型。
6.一种抗幽门螺杆菌的食品或保健品，其特征在于，所述食品或保健品包括抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶中的两种或三种；所述抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶质量比为(1-6)：(1-6)：(0-5)。
7.根据权利要求6所述的食品或保健品，其特征在于，所述食品或保健品中抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白和溶菌酶总的质量百分数为10～500mg/g。
8.根据权利要求6或7所述的食品或保健品，其特征在于，所述的抗幽门螺杆菌食品配方中还包括食品配料，所述抗幽门螺杆菌特异性免疫球蛋白、卵转铁蛋白、溶菌酶和食品配料的质量比为(1-6)：(1-6)：(0-5)：(10-80)。
9.根据权利要求8所述的食品或保健品，其特征在于，所述的抗幽门螺杆菌食品配方中，食品配料包含起赋形、调味、缓冲、着色和保护作用的一种或多种组合配料，包括全脂奶粉、脱脂奶粉、茯苓粉、大豆蛋白粉、果蔬粉、麦芽糊精和低聚糖中的一种或多种。
10.一种制备抗幽门螺杆菌奶片的方法，其特征在于，所述奶片的制备方法为：将抗幽门螺杆菌免疫球蛋白2-12重量份、卵转铁蛋白2-12重量份、溶菌酶0-10重量份粉碎得混合粉末，将其与奶粉20～150重量份搅拌均匀后，压制成型即得抗幽门螺杆菌奶片。
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