CN110898214A - 用于宠物的止泻组合物及其制备方法 - Google Patents
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- CN110898214A CN110898214A CN201911406115.XA CN201911406115A CN110898214A CN 110898214 A CN110898214 A CN 110898214A CN 201911406115 A CN201911406115 A CN 201911406115A CN 110898214 A CN110898214 A CN 110898214A
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Abstract
本发明涉及一种用于宠物的止泻组合物，包括以下组分：溶菌酶5～20重量份，酵母葡聚糖2～10重量份，杆菌肽锌5～20重量份，蒙脱石5～30重量份，碱式碳酸铋2～15重量份，鞣酸蛋白2～10重量份，大蒜素2～15重量份，益生元2～10重量份，L‑谷氨酰胺2～10重量份。本发明还涉及一种用于宠物的止泻组合物的制备方法。本发明的用于宠物的止泻组合物可以治疗和缓解宠物犬猫因各种原因引起的腹泻，并能维护胃肠道健康。
Description
技术领域
本发明涉及一种用于宠物犬猫的止泻组合物，以及该组合物的制备方法，属于动物保健品领域。
背景技术
随着人们生活水平的日益提高，家庭宠物饲养开始逐步进入大众化。但是很多宠物传染病具有人畜共患性，给宠物业的发展和人类的健康带来了不小的伤害。为此，提高宠物免疫力和保证宠物健康生长势在必行。
胃肠道炎症是宠物犬猫常见的一种疾病，大多是因为营养不良、过度疲劳或感冒等因素，导致其防御疾病的机能降低，从而使胃肠屏障机能减弱，于是引起胃肠道内的细菌( 如大肠杆菌、产气荚膜杆菌、沙门氏杆菌和弧菌等) 毒力增强，最终以致病。其症状一般包括急性或慢性腹泻、软便、便血、呕吐、营养物质消化和吸收不良、体重减轻和食欲不振。
使用抗生素可以杀灭致病菌，对胃肠道炎症有一定疗效，但是长期使用，也可能造成肠道的细菌群失调，从而引起二重感染。
发明内容
本发明要解决的技术问题是提供一种可以治疗犬猫腹泻，维护犬猫胃肠道健康的组合物，以及该组合物的制备方法。
本发明为解决上述技术问题提出的一种技术方案是：一种用于宠物的止泻组合物，包括以下组分：溶菌酶5～20重量份，酵母葡聚糖2～10重量份，杆菌肽锌5～20重量份，蒙脱石5～30重量份，碱式碳酸铋2～15重量份，鞣酸蛋白2～10重量份，大蒜素2～15重量份，益生元2～10重量份，L-谷氨酰胺2～10重量份。
溶菌酶是一种碱性蛋白，能够溶解细菌细胞壁，导致细胞壁破裂进而内容物逸出而使细菌溶解，是一种安全高效的广谱抗菌剂，对大肠杆菌、葡萄球菌、链球菌、沙门氏杆菌、多杀巴斯德氏杆菌、痢沙门氏菌、产气杆菌等都有不同程度的抑菌作用。抗菌活性稳定，特别是对一些耐药性菌株有良好的抑菌作用。溶菌酶作为机体非特异免疫因子之一，参与机体多种免疫反应，能增强免疫力，杀死肠道内的腐败球菌，维持肠道内菌群正常化，促进双歧杆菌增殖，加强白清灭菌蛋白，Y-球蛋的防御因子，增强抗感染力。
酵母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多糖—β-葡聚糖，酵母β-葡聚糖能够与巨噬细胞产生特异性结合，激发和活化免疫因子，从而增强免疫功能：可以有效提高机体免疫力；同时酵母葡聚糖能有效调整体内消化道的微生态，促进体内有益菌的增殖及肠道内有害物的排泄，从而维护肠道菌群的稳定。
杆菌肽锌是一种多肽类抗生素，对革兰阳性菌具有较强的抗菌作用，对少数革兰阴性菌、螺旋体和放线菌以至耐青霉素的葡萄球菌也有抗菌效应。抗菌机制为抑制细菌细胞壁的形成和损害细菌胞浆膜。能促进肠道内有益微生物生长，增加肠黏膜通透性，促进营养物质的吸收。鞥狗用于促进动物生长、防治细菌性腹泻。杆菌肽锌内服几乎不吸收，大部分在2天内随粪便排出，故安全性高。 细菌对杆菌肽锌很少产生耐药性，与其他抗生素也无交叉耐药性。
碱式碳酸铋是一种配位化合物，口服后不吸收，但能迅速中和胃酸，生成的铋盐可在炎症处的溃疡表面形成保护膜，抵御胃酸的侵袭而具有收敛作用。此外还可杀灭幽门螺杆菌而促进炎症愈合。可与肠腔内异常发酵产生的硫化氢结合，抑制肠蠕动，起到止泻作用。
蒙脱石是一种天然的硅铝酸盐黏土矿石，口服后不吸收，但对消化道粘膜有很强的覆盖能力，能保护粘膜，吸附各种病毒、细菌及其毒素。可用于食管炎、胃炎和消化性溃疡，尤其对各种原因所致的腹泻有较好疗效。
鞣酸蛋白服用后在胃内不分解，在小肠处分解出鞣酸，使肠黏膜表层蛋白凝固，形成一层保护膜，可以减少液体渗出，减轻肠道刺激及蠕动，具有收敛、止泻作用。
大蒜素是三硫代烯丙醚类化合物，天然存在于百合科植物大蒜的鳞茎中。大蒜素可抑制痢疾杆菌、伤寒杆菌繁殖，对葡萄球菌、肺炎球菌等有明显的抑制灭杀作用。口服大蒜素可治疗动物肠炎、腹泻、食欲不振等。对大肠杆菌、沙门氏菌、金黄色葡萄球菌、痢疾杆菌、伤寒杆菌、肺炎球菌，链球菌等有害菌有明显抑制和杀灭作用，对有益菌如干酪乳杆菌则无抑制作用。被称为“天然抗生素”。
益生元是一类不被宿主消化吸收却能够选择性地促进体内有益菌的代谢和增殖，从而改善宿主健康的有机物质。常用的益生元是低聚糖类的物质，口服后不能被人体分解、吸收和利用，但能促进肠道有益菌群的生长，抑制有害菌的生长，能改善肠道微生态环境，促进脂质、蛋白质与矿物类的吸收和利用。
L-谷氨酰胺参与消化道黏膜黏蛋白构成成分氨基葡萄糖的生物合成，从而促进黏膜上皮组织的修复，有助于溃疡病灶的消除，因此可用于治疗胃及十二指肠溃疡、胃炎及胃酸过多。
上述溶菌酶是肠溶微丸；所述大蒜素是微囊粉；酵母葡聚糖是β-1，3-D-葡聚糖。
上述益生元是低聚果糖、低聚甘露糖、低聚麦芽糖、低聚异麦芽糖、低聚半乳糖、低聚木糖、大豆低聚糖、低聚乳果糖、低聚壳聚糖、菊粉和聚葡萄糖中的一种或多种。
上述用于宠物的止泻组合物，组分还包括3～20重量份的风味剂；所述风味剂是肉粉、肝脏粉、肉味水解蛋白粉、酵母粉和酵母提取物中的一种或多种。
上述肉粉是猪肉粉、羊肉粉、牛肉粉、鸡肉粉、鸭肉粉和鱼肉粉中的一种或多种；所述肉味水解蛋白粉是猪肉味水解蛋白粉、羊肉味水解蛋白粉、牛肉味水解蛋白粉、鸡肉味水解蛋白粉、鸭肉味水解蛋白粉和鱼肉味水解蛋白粉中的一种或多种。
上述用于宠物的止泻组合物，组分还包括10～60重量份的药用辅料；所述药用辅料是填充剂、粘合剂、助流剂、润滑剂、崩解剂和润湿剂中的一种或多种。
上述填充剂是微晶纤维素、低取代羟丙基纤维素、淀粉、预胶化淀粉、糊精、麦芽糊精、蔗糖、乳糖、葡萄糖、果糖、麦芽糖、山梨醇、甘露醇、赤藓糖醇、异麦芽酮糖醇和磷酸氢钙中的一种或多种；所述粘合剂是聚维酮、羟丙基甲基纤维素、羟丙基纤维素、羧甲基纤维素钠、淀粉糊、明胶、黄原胶和瓜尔胶中的一种或多种；所述助流剂是二氧化硅或气相二氧化硅；所述润滑剂是硬脂酸镁、硬脂酸、山嵛酸甘油酯、聚乙二醇、氢化植物油、硬脂酸富马酸钠和滑石粉中的一种或多种；崩解剂是交联聚维酮、交联羧甲基纤维素钠和羧甲基淀粉钠中的一种或多种；润湿剂是纯水、乙醇和异丙醇中的一种或多种。
上述用于宠物的止泻组合物是固体制剂；所述固体制剂包括包衣片剂和颗粒剂。
本发明为解决上述技术问题提出的一种技术方案是：一种用于宠物的止泻片剂的制备方法，包括以下具体步骤：
A．酵母葡聚糖、杆菌肽锌、碱式碳酸铋、蒙脱石、鞣酸蛋白、益生元、L-谷氨酰胺和填充剂经湿法制粒得到颗粒；
B．所得颗粒与溶菌酶肠溶微丸、大蒜素微囊粉、崩解剂、助流剂混合均匀，混合过程中加入润滑剂，得到总混粉；
C．将总混粉压成素片；
D．将风味剂、粘合剂和润湿剂混合制成包衣液，然后对素片进行包衣，得到包衣片剂。
本发明为解决上述技术问题提出的一种技术方案是：一种用于宠物的止泻颗粒剂的制备方法，包括以下具体步骤：
A．酵母葡聚糖、杆菌肽锌、碱式碳酸铋、蒙脱石、鞣酸蛋白、益生元、L-谷氨酰胺和填充剂加入流化床中，采用顶喷制粒工艺，制粒得到颗粒；
B．所得颗粒再与溶菌酶肠溶微丸、大蒜素微囊粉、风味剂混合均匀；
C．所得混合颗粒按一定重量装入铝箔袋中，即得颗粒剂。
本发明具有积极的效果：本发明的用于宠物的止泻组合物原料中没有抗生素，主原料为溶菌酶，酵母葡聚糖，杆菌肽锌，碱式碳酸铋，蒙脱石，鞣酸蛋白，益生元，L-谷氨酰胺、大蒜素，大部分原料服用后不被机体吸收，副作用小，不会有全身性的不良反应。复配使用具有止泻、杀菌、消炎、修复胃肠道黏膜、促进有益菌生长的能力。本发明的组合物口感好，容易被犬猫接受。犬猫等宠物频繁使用抗生素，容易引起耐药性和肠道菌群失调。本发明的组合物能促进肠道有益菌的生长，抑制致病菌的繁殖，长期服用可以保持肠道微生态平衡。本发明的用于宠物犬猫止泻的组合物，使用方法可以直接喂食犬猫，也可以按剂量添加在宠物粮中一起喂食。
具体实施方式
实施例1
本实施例的用于宠物止泻的包衣片剂的配方成分如表1所示。
表1 包衣片剂配方表
本实施例的用于宠物止泻的包衣片剂的制备方法，包括以下具体步骤：
A．聚维酮K90加入纯水中，配成5%浓度的溶液。
B．碱式碳酸铋、蒙脱石、鞣酸蛋白、杆菌肽锌、酵母葡聚糖、低聚果糖、L-谷氨酰胺、交联聚维酮和微晶纤维素加入湿法制粒机中，混合均匀，以5%聚维酮K90水溶液为粘合剂，采用湿法制粒工艺，进行制粒。完成后出料，烘干，整粒后，得到颗粒。
B．颗粒转移至混合机中，加入溶菌酶肠溶微丸和大蒜素微囊粉，混合均匀，然后加入硬脂酸镁润滑，得到总混粉。
C．步骤B所得总混粉，选用专用模具进行压片，每片片重480mg，片重差异：理论片重±5%，脆碎度：≤1%，崩解时限：≤60min。
D．鸡肉味水解蛋白粉与羟丙基甲基纤维素用纯水配制固含量15%的包衣液，然后对上述步骤C所得素片进行包衣，包衣增重5%，包衣片剂片重约500mg。
E．采用HDPE瓶包装或者铝塑泡罩或者双铝泡罩包装进行包装。
实施例2
本实施例的用于宠物犬猫止泻的颗粒剂的配方成分如表2所示。
表2 颗粒剂配方表
本实施例的用于宠物犬猫止泻的颗粒剂的制备方法，包括以下具体步骤：
A．聚维酮K30加入纯水中，配成5%浓度的水溶液，作为粘合剂。
B．葡萄糖经粉碎后过100目筛，然后与碱式碳酸铋，蒙脱石，鞣酸蛋白，杆菌肽锌，酵母葡聚糖，低聚甘露糖，L-谷氨酰胺，交联聚维酮一起混合均匀，转移到流化床中，采用顶喷制粒工艺，以5%聚维酮K30水溶液作为粘合剂，进行制粒。
C．制粒完成后，烘干，出料，整粒，得到干颗粒。
D．干颗粒与大蒜素微囊粉，溶菌酶肠溶微丸，酵母提取物混合均匀，得总混颗粒。
E．颗粒采用铝箔袋灌装，规格：2g/袋。
本发明中所用原辅料如无特殊说明均为外购品，等级均为药用级或者食品级或者饲料级。
为了进一步验证本发明的组合物的效果，选用实施例1的包衣片剂进行了临床试用。
1、试用动物的选择
选择临床上具有急性腹泻或软便症状的犬猫作为试用动物。试用期间一共收治急性腹泻犬8只，猫5只；软便犬5只，猫10只。
2、试用产品
实施例1的用于宠物止泻的包衣片剂
3、试用方法
急性腹泻的犬猫，按照2片/5kg体重/次，2次/天的剂量喂食，腹泻症状减轻后，按照1片/5kg体重/次，2次/天的剂量继续喂食。
软便的犬猫，按照1片/5kg体重/次，2次/天的剂量喂食。
4、疗效判定标准
痊愈：症状消失，粪便形态正常，精神恢复正常。
显效：粪便形态基本正常，精神有所好转。
有效：症状减轻。
无效：症状没有明显改善。
5、治疗效果
治疗效果如表3所示。
表3 临床试用总结表
以上使用结果表明，本发明的组合物对犬猫腹泻和软便症状有明显的效果。
显然，上述实施例仅仅是为清楚地说明本发明所作的举例，而并非是对本发明的实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而这些属于本发明的精神所引伸出的显而易见的变化或变动仍处于本发明的保护范围之中。
Claims (10)
1.一种用于宠物的止泻组合物，其特征在于，包括以下组分：溶菌酶5～20重量份，酵母葡聚糖2～10重量份，杆菌肽锌5～20重量份，蒙脱石5～30重量份，碱式碳酸铋2～15重量份，鞣酸蛋白2～10重量份，大蒜素2～15重量份，益生元2～10重量份，L-谷氨酰胺2～10重量份。
2.根据权利要求1所述的用于宠物的止泻组合物，其特征在于：所述溶菌酶是肠溶微丸；所述大蒜素是微囊粉；酵母葡聚糖是β-1，3-D-葡聚糖。
3.根据权利要求1所述的一种用于宠物犬猫的止泻组合物，其特征在于：所述益生元是低聚果糖、低聚甘露糖、低聚麦芽糖、低聚异麦芽糖、低聚半乳糖、低聚木糖、大豆低聚糖、低聚乳果糖、低聚壳聚糖、菊粉和聚葡萄糖中的一种或多种。
4.根据权利要求1至3中任一项所述的用于宠物的止泻组合物，其特征在于：组分还包括3～20重量份的风味剂；所述风味剂是肉粉、肝脏粉、肉味水解蛋白粉、酵母粉和酵母提取物中的一种或多种。
5.根据权利要求4所述的用于宠物的止泻组合物，其特征在于：所述肉粉是猪肉粉、羊肉粉、牛肉粉、鸡肉粉、鸭肉粉和鱼肉粉中的一种或多种；所述肉味水解蛋白粉是猪肉味水解蛋白粉、羊肉味水解蛋白粉、牛肉味水解蛋白粉、鸡肉味水解蛋白粉、鸭肉味水解蛋白粉和鱼肉味水解蛋白粉中的一种或多种。
6.根据权利要求4所述的用于宠物的止泻组合物，其特征在于：组分还包括10～60重量份的药用辅料；所述药用辅料是填充剂、粘合剂、助流剂、润滑剂、崩解剂和润湿剂中的一种或多种。
7.根据权利要求6所述的用于宠物的止泻组合物，其特征在于：所述填充剂是微晶纤维素、低取代羟丙基纤维素、淀粉、预胶化淀粉、糊精、麦芽糊精、蔗糖、乳糖、葡萄糖、果糖、麦芽糖、山梨醇、甘露醇、赤藓糖醇、异麦芽酮糖醇和磷酸氢钙中的一种或多种；所述粘合剂是聚维酮、羟丙基甲基纤维素、羟丙基纤维素、羧甲基纤维素钠、淀粉糊、明胶、黄原胶和瓜尔胶中的一种或多种；所述助流剂是二氧化硅或气相二氧化硅；所述润滑剂是硬脂酸镁、硬脂酸、山嵛酸甘油酯、聚乙二醇、氢化植物油、硬脂酸富马酸钠和滑石粉中的一种或多种；崩解剂是交联聚维酮、交联羧甲基纤维素钠和羧甲基淀粉钠中的一种或多种；润湿剂是纯水、乙醇和异丙醇中的一种或多种。
8.根据权利要求1所述的用于宠物的止泻组合物，其特征在于：是固体制剂；所述固体制剂包括包衣片剂和颗粒剂。
9.一种用于宠物的止泻片剂的制备方法，其特征在于，包括以下具体步骤：
酵母葡聚糖、杆菌肽锌、碱式碳酸铋、蒙脱石、鞣酸蛋白、益生元、L-谷氨酰胺和填充剂经湿法制粒得到颗粒；
所得颗粒与溶菌酶肠溶微丸、大蒜素微囊粉、崩解剂、助流剂混合均匀，混合过程中加入润滑剂，得到总混粉；
将总混粉压成素片；
将风味剂、粘合剂和润湿剂混合制成包衣液，然后对素片进行包衣，得到包衣片剂。
10.一种用于宠物的止泻颗粒剂的制备方法，其特征在于，包括以下具体步骤：
酵母葡聚糖、杆菌肽锌、碱式碳酸铋、蒙脱石、鞣酸蛋白、益生元、L-谷氨酰胺和填充剂加入流化床中，采用顶喷制粒工艺，制粒得到颗粒；
所得颗粒再与溶菌酶肠溶微丸、大蒜素微囊粉、风味剂混合均匀；
所得混合颗粒按一定重量装入铝箔袋中，即得颗粒剂。
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