CN106729050A - 一种复方免疫增强口服液及其制备方法 - Google Patents
一种复方免疫增强口服液及其制备方法 Download PDFInfo
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- CN106729050A CN106729050A CN201611176943.5A CN201611176943A CN106729050A CN 106729050 A CN106729050 A CN 106729050A CN 201611176943 A CN201611176943 A CN 201611176943A CN 106729050 A CN106729050 A CN 106729050A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供一种复方免疫增强口服液及其制备方法，所述口服液由如下重量份的组分制成：人参皂甙35‑40份、无患子皂甙35‑38份、七叶皂甙33‑38份、苦瓜皂甙30‑35份、三七皂甙28‑33份、蒺藜皂甙25‑33份、大豆皂甙23‑30份、绞股蓝皂甙23‑25份、桔梗皂甙20‑25份、玉米须皂甙18‑25份、黄芪皂甙18‑20份、党参皂甙15‑20份、癞葡萄皂甙15‑18份、柴胡皂甙13‑15份、酸枣仁皂苷13‑15份、山药皂甙10‑15份。制备方法包括将16种皂甙按比例混合，然后加入1000重量份的水和3‑5重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。本发明口服液能够显著地增强免疫功能。
Description
技术领域
本发明属于免疫增强药物领域，具体涉及一种复方免疫增强口服液及其制备方法。
背景技术
随着社会的发展，人们生活节奏加快，职场竞争也愈发激烈，身体与精神长期处于紧张状态，慢性疲劳综合征也威胁着人们的健康。因此，迫切的需要研究一种能够显著增强机体免疫功能、提高机体抗疲劳效果的补剂。
发明内容
本发明的目的在于提供一种复方免疫增强口服液及其制备方法。依据本发明的配方和工艺生产出来的口服液能够显著地增强免疫功能。
为实现上述目的，本发明采用如下技术方案：
一种复方免疫增强口服液，所述复方免疫增强口服液的主要成分按重量份计包括：人参皂甙35-40份、无患子皂甙35-38份、七叶皂甙33-38份、苦瓜皂甙30-35份、三七皂甙28-33份、蒺藜皂甙25-33份、大豆皂甙23-30份、绞股蓝皂甙23-25份、桔梗皂甙20-25份、玉米须皂甙18-25份、黄芪皂甙18-20份、党参皂甙15-20份、癞葡萄皂甙15-18份、柴胡皂甙13-15份、酸枣仁皂苷13-15份、山药皂甙10-15份。
优选的，所述复方免疫增强口服液的主要成分按重量份计包括：人参皂甙38份、无患子皂甙36份、七叶皂甙35份、苦瓜皂甙33份、三七皂甙30份、蒺藜皂甙28份、大豆皂甙25份、绞股蓝皂甙24份、桔梗皂甙23份、玉米须皂甙19份、黄芪皂甙19份、党参皂甙17份、癞葡萄皂甙16份、柴胡皂甙14份、酸枣仁皂苷14份、山药皂甙13份。
一种制备如所述的复方免疫增强口服液的方法，包括如下具体步骤：按比例称取人参皂甙、无患子皂甙、七叶皂甙、苦瓜皂甙、三七皂甙、蒺藜皂甙、大豆皂甙、绞股蓝皂甙、桔梗皂甙、玉米须皂甙、黄芪皂甙、党参皂甙、癞葡萄皂甙、柴胡皂甙、酸枣仁皂苷、山药皂甙，加入1000重量份的水和3-5重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
本发明的显著优点：
本发明的复方免疫增强口服液，能够显著地增强免疫功能。明显延长小鼠负重游泳时间，显著增加小鼠肝糖原含量，显著降低运动小鼠血清尿素氮含量，其可增加动物自身能量供给，增加肝糖原储备，从而减少蛋白质分解代谢供能，延缓机体出现疲劳感。
具体实施方式
为了使本发明所述的内容更加便于理解，下面结合具体实施方式对本发明所述的技术方案做进一步的说明，但是本发明不仅限于此。
实施例1
一种复方免疫增强口服液，所述复方免疫增强口服液的主要成分按重量份计包括：人参皂甙35份、无患子皂甙35份、七叶皂甙33份、苦瓜皂甙30份、三七皂甙28份、蒺藜皂甙25份、大豆皂甙23份、绞股蓝皂甙23份、桔梗皂甙20份、玉米须皂甙18份、黄芪皂甙18份、党参皂甙15份、癞葡萄皂甙15份、柴胡皂甙13份、酸枣仁皂苷13份、山药皂甙10份。
制备方法，包括如下具体步骤：按比例称取人参皂甙、无患子皂甙、七叶皂甙、苦瓜皂甙、三七皂甙、蒺藜皂甙、大豆皂甙、绞股蓝皂甙、桔梗皂甙、玉米须皂甙、黄芪皂甙、党参皂甙、癞葡萄皂甙、柴胡皂甙、酸枣仁皂苷、山药皂甙，加入1000重量份的水和3重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
实施例2
一种复方免疫增强口服液，所述复方免疫增强口服液的主要成分按重量份计包括：人参皂甙38份、无患子皂甙36份、七叶皂甙35份、苦瓜皂甙33份、三七皂甙30份、蒺藜皂甙28份、大豆皂甙25份、绞股蓝皂甙24份、桔梗皂甙23份、玉米须皂甙19份、黄芪皂甙19份、党参皂甙17份、癞葡萄皂甙16份、柴胡皂甙14份、酸枣仁皂苷14份、山药皂甙13份。
制备方法，包括如下具体步骤：按比例称取人参皂甙、无患子皂甙、七叶皂甙、苦瓜皂甙、三七皂甙、蒺藜皂甙、大豆皂甙、绞股蓝皂甙、桔梗皂甙、玉米须皂甙、黄芪皂甙、党参皂甙、癞葡萄皂甙、柴胡皂甙、酸枣仁皂苷、山药皂甙，加入1000重量份的水和4重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
实施例3
一种复方免疫增强口服液，所述复方免疫增强口服液的主要成分按重量份计包括：人参皂甙40份、无患子皂甙38份、七叶皂甙38份、苦瓜皂甙35份、三七皂甙33份、蒺藜皂甙33份、大豆皂甙30份、绞股蓝皂甙25份、桔梗皂甙25份、玉米须皂甙25份、黄芪皂甙20份、党参皂甙20份、癞葡萄皂甙18份、柴胡皂甙15份、酸枣仁皂苷15份、山药皂甙15份。
制备方法，包括如下具体步骤：按比例称取人参皂甙、无患子皂甙、七叶皂甙、苦瓜皂甙、三七皂甙、蒺藜皂甙、大豆皂甙、绞股蓝皂甙、桔梗皂甙、玉米须皂甙、黄芪皂甙、党参皂甙、癞葡萄皂甙、柴胡皂甙、酸枣仁皂苷、山药皂甙，加入1000重量份的水和5重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
对比例1
口服液1，主要成分按重量份计包括：人参皂甙38份、无患子皂甙36份、七叶皂甙35份、苦瓜皂甙33份、三七皂甙30份。
制备方法，包括如下具体步骤：按比例称取人参皂甙、无患子皂甙、七叶皂甙、苦瓜皂甙、三七皂甙，加入1000重量份的水和4重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
对比例2
口服液2，所述复方免疫增强口服液的主要成分按重量份计包括：蒺藜皂甙28份、大豆皂甙25份、绞股蓝皂甙24份、桔梗皂甙23份、玉米须皂甙19份。
制备方法，包括如下具体步骤：按比例称取蒺藜皂甙、大豆皂甙、绞股蓝皂甙、桔梗皂甙、玉米须皂甙，加入1000重量份的水和4重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
对比例3
口服液3，所述复方免疫增强口服液的主要成分按重量份计包括：黄芪皂甙19份、党参皂甙17份、癞葡萄皂甙16份、柴胡皂甙14份、酸枣仁皂苷14份、山药皂甙13份。
制备方法，包括如下具体步骤：按比例称取黄芪皂甙、党参皂甙、癞葡萄皂甙、柴胡皂甙、酸枣仁皂苷、山药皂甙，加入1000重量份的水和4重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
毒性试验
急性经口毒性试验：该品按卫生部《化妆品卫生规范》 (2002年版 )“急性经口毒性试验中一次限量试验法”，一次经口给予小白鼠（体重18g～22g），30只，将获得的实施例1-3的口服液，按灌胃量20ml/kg，每个实施例经口分别给予10只小白鼠，观察 15 天，试验动物未发现中毒表现、无死亡，处死后解剖未明显异常，判断该品对小鼠急性经口毒性属实际无毒级。
抗疲劳实验
研究考察实施例1、实施例2、实施例3、对比例1、对比例2和对比例3制得的口服液对小鼠免疫增强的作用。
1、实验动物
昆明种小鼠，体重l8-22g，共70只，清洁级，雄性。本实验所有动物饲养条件一致，开始实验前3 天置于实验室观察饲养，自由摄食、饮水。各组饲料与饮用水来源均相同。
2、分组
将小鼠随机分成7组，即本发明组1-3、正常组、对比组1-3，每组10只。各组的药物如下：
本发明组1 ：根据本申请实施例1 的处方制得的口服液。
本发明组2 ：根据本申请实施例2 的处方制得的口服液。
本发明组3 ：根据本申请实施例3 的处方制得的口服液。
正常组：生理盐水。
对比组1 ：根据对比例1 的处方制得的口服液1。
对比组2 ：根据对比例2 的处方制得的口服液2。
对比组3 ：根据对比例3的处方制得的口服液3。
3、实验方法
采用分层随机分组法，即将动物按体重分层，层距为2g，再逐一将每层动物随机分到各组，每组10只，形成7组。各组按每天20mL/kg（体重）经口灌胃，30d后测定小鼠负重游泳时间。末次给予受试物30min后，每只鼠尾根部负荷5.00%体重铅皮，置于水深（30±1）cm、水温（25±1）℃游泳箱中游泳，不时搅动水，使小鼠四肢保持运动。记录小鼠自游泳开始至死亡时间（min），作为小鼠游泳时间，结果如表1所示。
表1 各组口服液对小鼠负重游泳时间的影响
本发明采用16种皂甙活性物质为主要成分制备复方免疫增强口服液，对小鼠具有显著的增强免疫力的作用，尤其是实施例2组的口服液效果最佳。而对比例1-3中则单独采用5或6种皂甙制备口服液，试验结果表明，对比例1-3制得的口服液对小鼠的负重游泳时间均没有明显增加，说明本发明口服液的免疫增强效果是这16种皂甙协同作用的结果。
疲劳是指机体生理功能不能持续在特定水平，或不能维持预期的运动负荷强度，致使体力和运动耐力下降，造成工作能力和效率的降低，属于一种复杂的
生理状态，主要由体内能量消耗过多和尿素氮、乳酸等代谢物质的累积而导致。疲劳主要体现为运动耐力下降，而负重游泳时间则作为反映运动耐力的最重要指标。本实验说明，本发明的复方免疫增强口服液能明显延长小鼠负重游泳时间，从而提高受试动物的运动耐力。体力活动时，葡萄糖为骨骼肌主要能量来源，糖原的储备量直接影响机体的运动能力。当耐力运动中消耗大量能量时，肝糖原首先分解入血，输送到肌肉中提供能量并维持血糖正常水平，避免低血糖引起中枢神经系统疲劳感。糖原的含量能间接说明疲劳发生的快慢或程度；服用本实施例2的复方免疫增强口服液能显著增加小鼠肝糖原含量（肝糖原含量由正常组的2.35g/100g肝重增加到9.74g/100g肝重），提高机体运动能力，延缓产生运动性疲劳。尿素为蛋白质与氨基酸分解代谢的最终产物。当剧烈运动时，机体蛋白质及氨基酸的分解代谢也增强，生成尿素，血液内的尿素氮含量与机体功能、疲劳程度及负荷量大小成正相关。服用本发明的复方免疫增强口服液能显著降低运动小鼠血清尿素氮含量，提示其可增加动物自身能量供给，增加肝糖原储备，从而减少蛋白质分解代谢供能，延缓机体出现疲劳感。
以上所述仅为本发明的较佳实施例，凡依本发明申请专利范围所做的均等变化与修饰，皆应属本发明的涵盖范围。
Claims (3)
1.一种复方免疫增强口服液，其特征在于，所述复方免疫增强口服液的主要成分按重量份计包括：人参皂甙35-40份、无患子皂甙35-38份、七叶皂甙33-38份、苦瓜皂甙30-35份、三七皂甙28-33份、蒺藜皂甙25-33份、大豆皂甙23-30份、绞股蓝皂甙23-25份、桔梗皂甙20-25份、玉米须皂甙18-25份、黄芪皂甙18-20份、党参皂甙15-20份、癞葡萄皂甙15-18份、柴胡皂甙13-15份、酸枣仁皂苷13-15份、山药皂甙10-15份。
2.根据权利要求1所述的复方免疫增强口服液其特征在于，所述复方免疫增强口服液的主要成分按重量份计包括：人参皂甙38份、无患子皂甙36份、七叶皂甙35份、苦瓜皂甙33份、三七皂甙30份、蒺藜皂甙28份、大豆皂甙25份、绞股蓝皂甙24份、桔梗皂甙23份、玉米须皂甙19份、黄芪皂甙19份、党参皂甙17份、癞葡萄皂甙16份、柴胡皂甙14份、酸枣仁皂苷14份、山药皂甙13份。
3.一种如权利要求1或2所述的复方免疫增强口服液的制备方法，其特征在于，制备方法包括如下具体步骤：按比例称取人参皂甙、无患子皂甙、七叶皂甙、苦瓜皂甙、三七皂甙、蒺藜皂甙、大豆皂甙、绞股蓝皂甙、桔梗皂甙、玉米须皂甙、黄芪皂甙、党参皂甙、癞葡萄皂甙、柴胡皂甙、酸枣仁皂苷、山药皂甙，加入1000重量份的水和3-5重量份的矫味剂，混合均匀、紫外线灭菌、灌装即得。
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| CN109498665A (zh) * | 2018-12-11 | 2019-03-22 | 宁德市富发水产有限公司 | 一种皂甙提取物作为鱼类免疫增强剂的使用方法 |
| CN109498665B (zh) * | 2018-12-11 | 2021-07-20 | 宁德市富发水产有限公司 | 一种含有皂甙提取物的鱼用饲料 |
| CN117244054A (zh) * | 2023-10-16 | 2023-12-19 | 国药中生生物技术研究院有限公司 | 具有螺甾烷-O-gal结构的化合物的佐剂用途 |
| CN117244054B (zh) * | 2023-10-16 | 2024-06-07 | 国药中生生物技术研究院有限公司 | 具有螺甾烷-O-gal结构的化合物的佐剂用途 |
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