CN109157651A - 具有免疫调节作用的组合物 - Google Patents
具有免疫调节作用的组合物 Download PDFInfo
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- CN109157651A CN109157651A CN201811038781.8A CN201811038781A CN109157651A CN 109157651 A CN109157651 A CN 109157651A CN 201811038781 A CN201811038781 A CN 201811038781A CN 109157651 A CN109157651 A CN 109157651A
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Classifications
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/20—Interleukins [IL]
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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- A—HUMAN NECESSITIES
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Abstract
本案涉及一种具有免疫调节作用的组合物,由以下重量百分比的组分组成的:重组B亚单位CTB 20~50份、白细胞介素18 1000~50000u、益生元10~30份、天冬氨酸镁5~10份、脂肪酸4~8份、维生素E 1~3份、中药提取液1~30份、硫酸软骨素1~5份、甲壳素衍生物1~5份。本发明免疫调节功能的药物,具有抗炎作用,可降低炎性因子水平,减少白细胞的募集,减轻炎症反应,维持内环境的相对稳定,无副作用。
Description
技术领域
本发明涉及组合物,尤其涉及一种具有免疫调节作用的组合物。
背景技术
免疫力是人体抵御外界致病因子和维持体内环境稳定的能力,也就是人体免疫系统进行自我保护的一种能力。免疫力的主要任务是抵抗细菌或病毒等的感染,维系生命的正常生长发育和健康。使免疫系统不能正常发挥保护作用的原因多种多样。随着人们生活节奏的加快和工作压力的增强,心理失衡、营养不全、生活没有规律、锻炼不得法、乱用药品等等,都会导致免疫力低下。免疫力低下,会直接影响人们的身体健康,导致发生影响日常生活、工作和学习的机体障碍。因此,目前迫切需要一种能够增强人体体内免疫调节功能的药物,改进人们的身体健康状况,增强人体抵抗力,消除一些与免疫功能低下相关的疾病。
免疫调节药物又称作免疫增强药,临床主要用其免疫增强作用,治疗免疫缺陷疾病、慢性感染和作为肿瘤的辅助治疗。常见的药物有左旋咪唑、白细胞介素、干扰素、转移因子、胸腺素等。免疫反应的抗炎和抗免疫损失作用在很多情况下能够代替消炎镇痛药、抗组织胺药和糖皮质激素药,取得药物所具有的疗效。在特殊必要使用糖皮质激素时,联合这种免疫反应也可以减少药物剂量,减短疗程。
但是,由于细胞因子类药物在人体内的半衰期较短,需要给与患者高剂量反复多次的注射方能取得一定的疗效,而这种做法又往往会导致严重的毒副作用。
发明内容
针对现有技术中存在的技术问题,本案提供一种具有免疫调节作用的组合物。
为实现上述目的,本案通过以下技术方案实现:
一种具有免疫调节作用的组合物,其中,由以下重量百分比的组分组成的:
重组B亚单位CTB 20~50份、白细胞介素18 1000~50000u、益生元10~30份、天冬氨酸镁5~10份、脂肪酸4~8份、维生素E 1~3份、中药提取液1~30份、硫酸软骨素1~5份、甲壳素衍生物1~5份。
优选的是,所述的具有免疫调节作用的组合物,其中,所述重组B亚单位CTB为冻干粉。
优选的是,所述的具有免疫调节作用的组合物,其中,所述益生元包括40~80wt%低聚异麦芽糖、20~50wt%菊粉、10~20wt%低聚木糖。
优选的是,所述的具有免疫调节作用的组合物,其中,所述脂肪酸包括10~30wt%二十二碳五烯酸、20~35wt%十八碳四烯酸、35~65wt%α-亚麻酸、10~20wt%花生四烯酸。
优选的是,所述的具有免疫调节作用的组合物,其中,所述二十二碳五烯酸源自鱼油,十八碳四烯酸源自葵花籽油。
优选的是,所述的具有免疫调节作用的组合物,其中,所述中药提取液的配方按重量份为:益母草12~16份、白芷5~10份、干姜3~5份、山药7~10份、牛膝9~12份、龙须藤5~10份、川贝3~5份、鸡蛋参7~10份。
优选的是,所述的具有免疫调节作用的组合物,其中,所述硫酸软骨素中硫酸软骨素二糖含量≥98%,分子量在465-470之间。
优选的是,所述的具有免疫调节作用的组合物,其中,所述甲壳素衍生物为脱乙酰化壳聚糖。
本发明的有益效果是:
(1)由本发明制备的具有免疫调节功能的药物具有抗炎作用,可降低炎性因子水平,减轻炎症反应,维持内环境的相对稳定;抗免疫损失,通过多个环节抑制免疫反应,恢复对自身抗原的免疫耐受;同时,因为有效成分剂量微量,不足以造成对身体的伤害,故不会有任何副作用。
(2)本发明通过加入具有杀菌消炎,清除自由基的冻干粉,清除滑液及其所协同组织的炎症异物,提升软骨及周边组织的免疫力;通过低聚异麦芽糖、菊粉、低聚木糖复配添加,能产生协同效应,促进单核巨噬细胞功能增强;通过加入二十二碳五烯酸、十八碳四烯酸、α-亚麻酸、花生四烯酸减少血液脂质并增强细胞功能;通过中药提取物的合理配伍,促进T细胞数量增加,淋巴细胞转化;通过加入硫酸软骨素促进细胞代谢,清除体内血液中的脂质和脂蛋白;通过加入壳聚糖提高吞噬细胞的系统功能;通过加入天冬氨酸镁促进抗体产生。
具体实施方式
下面结合实施例对本发明做进一步的详细说明,以令本领域技术人员参照说明书文字能够据以实施。
本发明提供一种具有免疫调节作用的组合物,由以下重量百分比的组分组成的:
重组B亚单位CTB 20~50份、白细胞介素18 1000~50000u、益生元10~30份、天冬氨酸镁5~10份、脂肪酸4~8份、维生素E 1~3份、中药提取液1~30份、硫酸软骨素1~5份、甲壳素衍生物1~5份。
所述重组B亚单位CTB为冻干粉。冻干粉,具有杀菌消炎,清除自由基,清除滑液及其所协同组织的炎症异物,提升软骨及周边组织的免疫力,使其自身具有灭菌消炎和自我修复功效,快速缓解关节疼痛,具有消肿止痛,提升关节免疫力作用。
所述益生元包括40~80wt%低聚异麦芽糖、20~50wt%菊粉、10~20wt%低聚木糖。低聚异麦芽糖、菊粉、低聚木糖复配添加,能产生协同效应,大大增殖人体结肠双歧杆菌、乳酸菌等有益菌群,调节肠道微生态平衡的作用,并提高肠内有益于健康的优势菌群的构成和数量,并能促进单核巨噬细胞功能增强,的作用。
所述脂肪酸包括10~30wt%二十二碳五烯酸、20~35wt%十八碳四烯酸、35~65wt%α-亚麻酸、10~20wt%花生四烯酸。二十二碳五烯酸、十八碳四烯酸、α-亚麻酸、花生四烯酸能减少血液脂质并增强细胞功能,并具有舒张血管、抗血小板聚集的作用。所述二十二碳五烯酸源自鱼油,十八碳四烯酸源自葵花籽油。
所述中药提取液的配方按重量份为:益母草12~16份、白芷5~10份、干姜3~5份、山药7~10份、牛膝9~12份、龙须藤5~10份、川贝3~5份、鸡蛋参7~10份。益母草、白芷、干姜、山药、牛膝、龙须藤、川贝和鸡蛋参通过合理配伍,能促进T细胞数量增加,淋巴细胞转化。
所述硫酸软骨素中硫酸软骨素二糖含量≥98%,分子量在465-470之间。硫酸软骨素能增加细胞的信使核糖核酸(mRNA)和脱氧核糖核酸(DNA)的生物合成以及具有促进细胞代谢的作用,可以清除体内血液中的脂质和脂蛋白,清除心脏周围血管的胆固醇,并增加脂肪酸在细胞内的转换率。
所述甲壳素衍生物为脱乙酰化壳聚糖。壳聚糖具有激活机体系统、介导机体系统的系列生物学效应,提高吞噬细胞的系统功能。巨噬细胞表面存在着细菌多糖的受体,而壳聚糖作为细菌多糖的类似物,能刺激巨噬细胞活化,促进其吞噬功能,增强它在其它免疫应答中的协同效应,从而实现机体对T细胞、NK细胞和B细胞的调节,介导机体的细胞免疫应答和体液免疫应答。
天冬氨酸镁作为氨基酸螯合物,吸收好,镁被人体吸收后,其载体L-天门冬氨酸亦被人体吸收,以补充人体所缺的氨基酸,并促进抗体产生。
实施例1:
冻干粉20份、白细胞介素18 10000u、益生元12份、天冬氨酸镁6份、脂肪酸4份、维生素E 1份、中药提取液20份、硫酸软骨素1份、脱乙酰化壳聚糖2份。
其中,益生元包括40wt%低聚异麦芽糖、50wt%菊粉、10wt%低聚木糖。
其中,脂肪酸包括10wt%二十二碳五烯酸、35wt%十八碳四烯酸、45wt%α-亚麻酸、10wt%花生四烯酸,二十二碳五烯酸源自鱼油,十八碳四烯酸源自葵花籽油。
其中,中药提取液的配方按重量份为:益母草12份、白芷5份、干姜3份、山药7份、牛膝10份、龙须藤5份、川贝4份、鸡蛋参8份。
中药提取液的制备:按照前述的重量份称取以上中药组份分别粉碎成粗粉;加药材总重量8倍量的水,煎煮时间为2.5h,煎煮2次;合并煎煮液,滤过;滤液浓缩至95℃时相对密度为1.01~1.06的浸膏,干燥,备用。
使用本实施例配方采用通常颗粒剂的制备方法制备颗粒剂:
冻干粉20g、白细胞介素18 10000u、4.8g低聚异麦芽糖、6g菊粉、1.2g低聚木糖、天冬氨酸镁6g、0.4g二十二碳五烯酸、1.4g十八碳四烯酸、1.8gα-亚麻酸、0.4g花生四烯酸、维生素E 1g、中药提取液20g、硫酸软骨素1g、脱乙酰化壳聚糖2g,加入适量淀粉,混匀,制成颗粒剂。
实施例2:
冻干粉30份、白细胞介素18 15000u、益生元20份、天冬氨酸镁8份、脂肪酸6份、维生素E 2份、中药提取液25份、硫酸软骨素3份、脱乙酰化壳聚糖4份。
其中,益生元包括50wt%低聚异麦芽糖、40wt%菊粉、10wt%低聚木糖。
其中,脂肪酸包括20wt%二十二碳五烯酸、30wt%十八碳四烯酸、35wt%α-亚麻酸、15wt%花生四烯酸。
其中,中药提取液的配方按重量份为:益母草15份、白芷6份、干姜4份、山药8份、牛膝10份、龙须藤7份、川贝5份、鸡蛋参7份。
中药提取液的制备:按照前述的重量份称取以上中药组份分别粉碎成粗粉;加药材总重量8倍量的水,煎煮时间为2.5h,煎煮2次;合并煎煮液,滤过;滤液浓缩至95℃时相对密度为1.01~1.06的浸膏,干燥备用。
使用本实施例配方采用通常胶囊剂的制备方法制备胶囊剂:冻干粉30g、白细胞介素18 15000u、益生元20g、天冬氨酸镁8g、脂肪酸6g、维生素E 2g、中药提取液25g、硫酸软骨素3g、脱乙酰化壳聚糖4g,加入适量乳糖,混匀,制粒,装入1号胶囊,即得。
实施例3:
冻干粉40份、白细胞介素18 30000u、益生元30份、天冬氨酸镁6份、脂肪酸7份、维生素E 3份、中药提取液10份、硫酸软骨素2份、脱乙酰化壳聚糖3份。
其中,益生元包括60wt%低聚异麦芽糖、25wt%菊粉、15wt%低聚木糖。
其中,脂肪酸包括30wt%二十二碳五烯酸、20wt%十八碳四烯酸、35wt%α-亚麻酸、15wt%花生四烯酸。
其中,中药提取液的配方按重量份为:益母草16份、白芷7份、干姜5份、山药10份、牛膝10份、龙须藤8份、川贝5份、鸡蛋参8份。
中药提取液的制备:按照前述的重量份称取以上中药组份分别粉碎成粗粉;加药材总重量8倍量的水,煎煮时间为2.5h,煎煮2次;合并煎煮液,滤过;滤液浓缩至95℃时相对密度为1.01~1.06的浸膏,干燥备用。
使用本实施例配方采用通常片剂的制备方法制备片剂:
冻干粉40g、白细胞介素18 30000u、益生元30g、天冬氨酸镁6g、脂肪酸7g、维生素E3g、中药提取液10g、硫酸软骨素2g、脱乙酰化壳聚糖3g,加入适量壳聚糖,混匀,制成片剂。
对比例1:
冻干粉20份、白细胞介素18 10000u、益生元12份、天冬氨酸镁6份、脂肪酸4份、维生素E 1份、硫酸软骨素1份、脱乙酰化壳聚糖2份。
其中,益生元包括40wt%低聚异麦芽糖、50wt%菊粉、10wt%低聚木糖。
其中,脂肪酸包括10wt%二十二碳五烯酸、35wt%十八碳四烯酸、45wt%α-亚麻酸、10wt%花生四烯酸,二十二碳五烯酸源自鱼油,十八碳四烯酸源自葵花籽油。
使用本实施例配方采用通常颗粒剂的制备方法制备颗粒剂:
冻干粉20g、白细胞介素18 10000u、4.8g低聚异麦芽糖、6g菊粉、1.2g低聚木糖、天冬氨酸镁6g、0.4g二十二碳五烯酸、1.4g十八碳四烯酸、1.8gα-亚麻酸、0.4g花生四烯酸、维生素E 1g、硫酸软骨素1g、脱乙酰化壳聚糖2g,加入适量淀粉,混匀,制成颗粒剂。
对比例2:
冻干粉20份、白细胞介素18 10000u、益生元12份、天冬氨酸镁6份、脂肪酸4份、维生素E 1份、中药提取液20份、硫酸软骨素1份、脱乙酰化壳聚糖2份。
其中,益生元为低聚异麦芽糖。
其中,脂肪酸包括10wt%二十二碳五烯酸、35wt%十八碳四烯酸、45wt%α-亚麻酸、10wt%花生四烯酸,二十二碳五烯酸源自鱼油,十八碳四烯酸源自葵花籽油。
其中,中药提取液的配方按重量份为:益母草12份、白芷5份、干姜3份、山药7份、牛膝10份、龙须藤5份、川贝4份、鸡蛋参8份。
中药提取液的制备:按照前述的重量份称取以上中药组份分别粉碎成粗粉;加药材总重量8倍量的水,煎煮时间为2.5h,煎煮2次;合并煎煮液,滤过;滤液浓缩至95℃时相对密度为1.01~1.06的浸膏,干燥,备用。
使用本实施例配方采用通常颗粒剂的制备方法制备颗粒剂:
冻干粉20g、白细胞介素18 10000u、12g低聚异麦芽糖、天冬氨酸镁6g、0.4g二十二碳五烯酸、1.4g十八碳四烯酸、1.8gα-亚麻酸、0.4g花生四烯酸、维生素E 1g、中药提取液20g、硫酸软骨素1g、脱乙酰化壳聚糖2g,加入适量淀粉,混匀,制成颗粒剂。
对比例3:
冻干粉20份、白细胞介素18 10000u、益生元12份、天冬氨酸镁6份、脂肪酸4份、维生素E 1份、中药提取液20份、硫酸软骨素1份、脱乙酰化壳聚糖2份。
其中,益生元包括40wt%低聚异麦芽糖、50wt%菊粉、10wt%低聚木糖。
其中,脂肪酸为十八碳四烯酸。
其中,中药提取液的配方按重量份为:益母草12份、白芷5份、干姜3份、山药7份、牛膝10份、龙须藤5份、川贝4份、鸡蛋参8份。
中药提取液的制备:按照前述的重量份称取以上中药组份分别粉碎成粗粉;加药材总重量8倍量的水,煎煮时间为2.5h,煎煮2次;合并煎煮液,滤过;滤液浓缩至95℃时相对密度为1.01~1.06的浸膏,干燥,备用。
使用本实施例配方采用通常颗粒剂的制备方法制备颗粒剂:
冻干粉20g、白细胞介素18 10000u、4.8g低聚异麦芽糖、6g菊粉、1.2g低聚木糖、天冬氨酸镁6g、十八碳四烯酸4g、维生素E 1g、中药提取液20g、硫酸软骨素1g、脱乙酰化壳聚糖2g,加入适量淀粉,混匀,制成颗粒剂。
对比例4:
冻干粉20份、白细胞介素18 10000u、益生元12份、天冬氨酸镁6份、脂肪酸4份、维生素E 1份、中药提取液20份、硫酸软骨素1份。
其中,益生元包括40wt%低聚异麦芽糖、50wt%菊粉、10wt%低聚木糖。
其中,脂肪酸包括10wt%二十二碳五烯酸、35wt%十八碳四烯酸、45wt%α-亚麻酸、10wt%花生四烯酸,二十二碳五烯酸源自鱼油,十八碳四烯酸源自葵花籽油。
其中,中药提取液的配方按重量份为:益母草12份、白芷5份、干姜3份、山药7份、牛膝10份、龙须藤5份、川贝4份、鸡蛋参8份。
中药提取液的制备:按照前述的重量份称取以上中药组份分别粉碎成粗粉;加药材总重量8倍量的水,煎煮时间为2.5h,煎煮2次;合并煎煮液,滤过;滤液浓缩至95℃时相对密度为1.01~1.06的浸膏,干燥,备用。
使用本实施例配方采用通常颗粒剂的制备方法制备颗粒剂:
冻干粉20g、白细胞介素18 10000u、4.8g低聚异麦芽糖、6g菊粉、1.2g低聚木糖、天冬氨酸镁6g、0.4g二十二碳五烯酸、1.4g十八碳四烯酸、1.8gα-亚麻酸、0.4g花生四烯酸、维生素E 1g、中药提取液20g、硫酸软骨素1g,加入适量淀粉,混匀,制成颗粒剂。
试验例1:免疫调节功能性实验
实验材料
1、实验动物
清洁级ICR雄性小鼠,体重25~28g,由包头医学院医学动物实验研究中心提供。
2、实验药品
2.1本发明所述具有免疫调节作用的组合物(实施例1制得):
取5g实施例1制备的具有免疫调节功能的组合物粉溶于100mL无菌水,小鼠灌胃500μL/20g体重,即为1.25g/kg;
2.2本发明所述具有免疫调节功能的组合物(实施例2制得):
取5g实施例2制备的具有免疫调节功能的组合物粉溶于100mL无菌水,小鼠灌胃500μL/20g体重,即为1.25g/kg;
2.3本发明所述具有免疫调节功能的组合物(实施例3制得):
取5g实施例3制备的具有免疫调节功能的组合物粉溶于100mL无菌水,小鼠灌胃500μL/20g体重,即为1.25g/kg;
2.4本发明所述具有免疫调节功能的组合物(对比例1制得):
取5g对比例1制备的具有免疫调节功能的组合物粉溶于100mL无菌水,小鼠灌胃500μL/20g体重,即为1.25g/kg;
2.5本发明所述具有免疫调节功能的组合物(对比例2制得):
取5g对比例2制备的具有免疫调节功能的组合物粉溶于100mL无菌水,小鼠灌胃500μL/20g体重,即为1.25g/kg;
2.6本发明所述具有免疫调节功能的组合物(对比例3制得):
取5g对比例3制备的具有免疫调节功能的组合物粉溶于100mL无菌水,小鼠灌胃500μL/20g体重,即为1.25g/kg;
2.7本发明所述具有免疫调节功能的组合物(对比例4制得):
取5g对比例4制备的具有免疫调节功能的组合物粉溶于100mL无菌水,小鼠灌胃500μL/20g体重,即为1.25g/kg;
3、实验方法与结果
3.1、试验方法
将小鼠随机分为8组:本发明所述具有免疫调节功能的组合物组(分为实施例1组、实施例2组、实施例3组、对比例1组、对比例2组、对比例3组、对比例4组)和溶剂对照组(蒸馏水)。各组连续经口灌胃给予相同剂量的上述样品,20d后分为3个亚组,分别参照《保健食品检验与评价技术规范》(2003年版)。检测以下指标:脏器/体质量比值;脾淋巴细胞增殖能力(ConA诱导的小鼠脾淋巴细胞转化实验,MTT法);溶血空斑数(抗体生成细胞检测,Jeme改良载法),半数溶血值(HC50,血清凝血素测定);鸡红细胞吞噬率与吞噬指数(小鼠腹腔巨噬细胞吞噬鸡红细胞试验,滴片法)和NK细胞活性。
3.2、结果
对小鼠脏器/体质量比值的影响见表1、对ConA诱导的小鼠淋巴细胞转化实验的影响见表2、对小鼠抗体生成细胞数的影响表2、对小鼠半数溶血值HC50的影响见表2、对非特异性免疫功能的影响见表3。
表1对脏器/体质量比值和细胞免疫功能的影响
表2对ConA诱导的小鼠淋巴细胞转化实验、抗体生成细胞数、半数溶血值HC50的影响
组别 | N | 脾淋巴细胞增殖能力 | 溶血空斑数 | HC<sub>50</sub> |
实施例1组 | 15 | 0.241±0.065 | 256.2±76.5 | 176±57.2 |
实施例2组 | 15 | 0.244±0.062 | 267.1±73.4 | 181±61.3 |
实施例3组 | 15 | 0.239±0.068 | 263.2±78.3 | 178±69.1 |
对比例1组 | 15 | 0.161±0.054 | 247.5±50.1 | 192±43.4 |
对比例2组 | 15 | 0.177±0.035 | 251.2±53.4 | 197±49.3 |
对比例3组 | 15 | 0.146±0.061 | 259.1±71.4 | 208±53.2 |
对比例4组 | 15 | 0.159±0.063 | 261.2±62.2 | 186±45.3 |
溶剂组 | 15 | 0.157±0.045 | 244.1±73.4 | 189±41.7 |
表3对非特异性免疫功能的影响
组别 | N | 吞噬率(%) | 吞噬指数(%) | NK细胞活性(%) |
实施例1组 | 15 | 37±8<sup>#</sup> | 0.57±0.13<sup>#</sup> | 7.9±1.5<sup>#</sup> |
实施例2组 | 15 | 32±7<sup>#</sup> | 0.64±0.13<sup>#</sup> | 7.2±1.3<sup>#</sup> |
实施例3组 | 15 | 35±5<sup>#</sup> | 0.67±0.15<sup>#</sup> | 7.4±1.4<sup>#</sup> |
对比例1组 | 15 | 41±10 | 0.50±0.10 | 9.0±1.8 |
对比例2组 | 15 | 43±9 | 0.43±0.14 | 8.8±1.6 |
对比例3组 | 15 | 38±11 | 0.45±0.12 | 9.7±1.7 |
对比例4组 | 15 | 42±12 | 0.51±0.10 | 9.1±1.6 |
溶剂组 | 15 | 40±10 | 0.48±0.11 | 8.7±2.6 |
#与溶剂对照组比较P<0.05
由表1-3结果可见,经口连续20d给予雄性小鼠相同剂量的
本发明实施例1、实施例2、实施例3和对比例1、对比例2、对比例3、对比例4制得的具有免疫调节作用的组合物对小鼠的胸腺/体质量比和脾脏/体质量比无明显影响。本发明实施例1、实施例2、实施例3和实施例4制得的具有免疫调节功能的组合物均能提高巨噬细胞吞噬鸡红细胞能力,促进ConA诱导的小鼠脾淋巴细胞转化能力,增强NK细胞活性,表明本发明所述具有免疫调节功能的组合物对小鼠的细胞免疫、体液免疫和NK细胞活性有促进作用,且各项结果均好于对比例组。
尽管本发明的实施方案已公开如上,但其并不仅仅限于说明书和实施方式中所列运用,它完全可以被适用于各种适合本发明的领域,对于熟悉本领域的人员而言,可容易地实现另外的修改,因此在不背离权利要求及等同范围所限定的一般概念下,本发明并不限于特定的细节。
Claims (8)
1.一种具有免疫调节作用的组合物,其特征在于,由以下重量百分比的组分组成的:
重组B亚单位CTB 20~50份、白细胞介素18 1000~50000u、益生元10~30份、天冬氨酸镁5~10份、脂肪酸4~8份、维生素E 1~3份、中药提取液1~30份、硫酸软骨素1~5份、甲壳素衍生物1~5份。
2.如权利要求1所述的具有免疫调节作用的组合物,其特征在于,所述重组B亚单位CTB为冻干粉。
3.如权利要求1所述的具有免疫调节作用的组合物,其特征在于,所述益生元包括40~80wt%低聚异麦芽糖、20~50wt%菊粉、10~20wt%低聚木糖。
4.如权利要求1所述的具有免疫调节作用的组合物,其特征在于,所述脂肪酸包括10~30wt%二十二碳五烯酸、20~35wt%十八碳四烯酸、35~65wt%α-亚麻酸、10~20wt%花生四烯酸。
5.如权利要求4所述的具有免疫调节作用的组合物,其特征在于,所述二十二碳五烯酸源自鱼油,十八碳四烯酸源自葵花籽油。
6.如权利要求1所述的具有免疫调节作用的组合物,其特征在于,所述中药提取液的配方按重量份为:益母草12~16份、白芷5~10份、干姜3~5份、山药7~10份、牛膝9~12份、龙须藤5~10份、川贝3~5份、鸡蛋参7~10份。
7.如权利要求1所述的具有免疫调节作用的组合物,其特征在于,所述硫酸软骨素中硫酸软骨素二糖含量≥98%,分子量在465-470之间。
8.如权利要求1所述的具有免疫调节作用的组合物,其特征在于,所述甲壳素衍生物为脱乙酰化壳聚糖。
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