CN114588193A - 一种含山竹活性物的组合物及其制备方法和用途 - Google Patents
一种含山竹活性物的组合物及其制备方法和用途 Download PDFInfo
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- CN114588193A CN114588193A CN202210213741.2A CN202210213741A CN114588193A CN 114588193 A CN114588193 A CN 114588193A CN 202210213741 A CN202210213741 A CN 202210213741A CN 114588193 A CN114588193 A CN 114588193A
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- mangosteen
- active
- polysaccharide
- active substance
- lactobacillus
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Abstract
本发明属于医药制备技术领域,具体涉及一种含山竹活性物的组合物及其制备方法和用途。其包括由活性多糖、山竹活性物和益生菌组成的有效成分,按质量百分比计算,有效成分中,活性多糖、山竹活性物和益生菌的质量百分比为2‑11:0.001‑0.01:0.04‑0.4。本发明通过简单的、活性评价的方法获得山楂多糖、芦荟多糖、山竹活性物‑1最优降脂减肥活性成分,然后将活性多糖组分、山竹活性物‑1与具有降脂减肥功效的益生菌进行优化组合,并用于降脂减肥有非常显著的活性,且无副作用。
Description
技术领域
本发明属于医药制备技术领域,具体涉及一种含山竹活性物的组合物及其制备方法和用途。
背景技术
肥胖症是脂肪组织发生慢性炎症所引发的相关代谢疾病,随着世界各地经济水平的迅猛发展,人们生活质量及生活方式明显改变,而肥胖症的发病率高、增长态势也越发明显,肥胖是大部分代谢类慢性病的通用促病因素。世界卫生组织(WHO)报道,与体重正常的人相比,肥胖者更易罹患高血脂、高血糖、高血压等病症。目前,减轻体质量的方法包括改变生活方式、控制饮食、运动、药物和手术等。医学界虽尝试使用多种药物用于治疗肥胖(如甲状腺提取物、2-硝基苯酚和苯丙胺),但结果临床疗效与安全性均不理想。
多糖是由10个以上单糖通过糖苷键连接而成的天然大分子物质,是除蛋白质、脂质、核酸外构成生命活动基本物质之一。多糖具有十分广泛的作用,其中,抗氧化、降血糖以及降血脂等活性在预防肥胖个体中的肥胖相关的代谢紊乱中具有重要的地位。
肥胖者不仅能量代谢处于不平衡的状态,且肠道菌群构成方面也与正常体重者存在差异。研究及实践表明,摄入适量的益生菌能够重构肠道菌群,增加有益菌的数量,调节肠道微生物构成比例,有效缓解肥胖症状。如,软杆菌是有助于减肥的重要菌群,软杆菌可控制脂肪细胞生长能力。此外,益生菌也可以改善葡萄糖和脂肪代谢水平,调节由高脂肪进食造成的肝脏功能紊乱。
因此,如何优化分离提取中药植物中的活性成分,调节肠道微生物构成比例,达到降血脂及减肥功效的作用,降低药物副作用,提高疗效的技术研究迫在眉睫。
发明内容
本发明的目的是要提供一种采用中医药、副作用小、疗效独特的含山竹活性物的组合物及其制备方法和用途。
为了解决上述技术问题,本发明采取的技术方案如下:
一种含山竹活性物的组合物,其包括由活性多糖、山竹活性物和益生菌组成的有效成分,按质量百分比计算,有效成分中,活性多糖、山竹活性物和益生菌的质量百分比为2-11:0.001-0.01:0.04-0.4。
上述的一种含山竹活性物的组合物,其所述活性多糖包括山楂多糖、芦荟多糖中的一种或两种。
上述的一种含山竹活性物的组合物,其所述山楂多糖、芦荟多糖的分子量小于等于15kD,优选地,山楂多糖的分子量为1-3kD,芦荟多糖的分子量为3-5kD。
上述的一种含山竹活性物的组合物,其所述益生菌包括双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌中的一种或多种。
一种含山竹活性物的组合物的制备方法,其包括如下步骤:
1)活性多糖的制备
取植物多糖,加入10-20倍重量的纯净水溶解,溶液用一定孔径的透析袋透析,收集透析液,冻干制得活性多糖备用;
2)山竹活性物的制备
取山竹提取物,经200-300目的硅胶柱层析,收集石油醚洗脱组分、乙酸乙酯洗脱组分、乙醇洗脱组分,分别冻干获得三种活性组分;所述的三种活性组分经HPLC分离,获得的山竹活性物-1;
3)益生菌的筛选,选用双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌中的一种或几种;
4)组合物制备
将制得的活性多糖、益生菌和山竹活性物-1按一定比例混匀,去离子水调成浆状液体,冻干制成组合物粉末,即得含山竹活性物的组合物。
上述的一种含山竹活性物的组合物的制备方法,其所述活性多糖包括分子量为1-3kD的山楂多糖和分子量为3-5kD的芦荟多糖,所述益生菌包括双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌,组合物中山楂多糖、芦荟多糖、双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌、山竹活性物-1的质量比为1:1-10:0.01-0.1:0.01-0.1:0.01-0.1:0.01-0.1:0.001-0.01,优选的,所述山楂多糖、芦荟多糖、双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌、山竹活性物-1的质量比为1:1:0.05:0.05:0.05:0.05:0.005。
上述的一种含山竹活性物的组合物的制备方法,其取制得的所述含山竹活性物含的组合物,添加辅料,制成硬胶囊、软胶囊、片剂、冲剂口服溶液、混悬剂、乳化剂肠道制剂。
上述的一种含山竹活性物的组合物的制备方法,其所述肠道制剂的有效剂量在10mg-1000mg。
一种含山竹活性物的组合物的用途,其用于制备降血脂、减肥功能的药物、食品中。
有益效果:
本发明通过简单的、活性评价的方法获得山楂多糖、芦荟多糖、山竹活性物-1最优降脂减肥活性成分,然后将活性多糖组分、山竹活性物-1与具有降脂减肥功效的益生菌进行优化组合,并用于降脂减肥有非常显著的活性,且无副作用。
说明书附图
图1为山竹活性物-1 1H NMR(400MHz,CDCl3)谱
图2为山竹活性物-1 13C NMR和DEPT-135(100MHz,CDCl3)谱
图3为山竹活性物-1 HSQC谱、COSY谱、HMBC谱以及ROESY谱
图4为山竹活性物-1 1D and 2D NMR
图5为山竹活性物-1ROSEY谱
图6为实施例功能对比实验对肥胖模型小鼠中p-MAPK、FAS、SREBP1、HO-1、Nrf2及SOD2等蛋白表达的影响
具体实施方式
下面将结合实施例对本发明技术方案进行清楚、完整地描述。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
本实施例公开了一种含山竹活性物的组合物,其包括由活性多糖、山竹活性物和益生菌组成的有效成分,其中,活性多糖包括山楂多糖、芦荟多糖,山楂多糖的分子量为1-3kD,芦荟多糖的分子量为3-5kD,益生菌包括双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌,山竹活性物的结构式为按质量百分比计算,有效成分中,活性多糖、山竹活性物和益生菌的质量百分比为2:0.005:0.2。
本实施例含山竹活性物的组合物的制备方法如下:
1)芦荟多糖的制备
取芦荟多糖200g,加入3000g纯净水溶解,芦荟多糖溶液用孔径为5kD的透析袋透析,收集分子量为3-5kD的透析液,冻干备用。
2)山楂多糖制备
取山楂多糖100g,加入1500g的纯净水溶解,山楂多糖溶液用孔径为3kD的透析袋透析,收集分子量为1-3kD的透析液,冻干备用。
3)益生菌筛选,选用双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌。
4)山竹活性物-1的分离制备、鉴定
取山竹提取物50g,经200-300目硅胶柱层析,收集石油醚洗脱组分4000mL,乙酸乙酯洗脱组分6000mL,乙醇洗脱组分6000mL,分别冻干。基于构建的高脂高糖饲料喂养小鼠肥胖模型评价不同组分的降脂减肥活性,乙醇洗脱组分降脂减肥活性最佳。进一步取乙醇洗脱组分经HPLC分离,获得山竹活性物-1活性多酚。
山竹活性物-1呈淡黄色油状物,浓硫酸-香草醛反应显蓝紫色,易溶于氯仿、甲醇等有机溶剂。HR-ESI-MS给出准分子离子峰m/z 597.3612[M+Na]+(C33H50O8Na,597.3617),可知其分子式为C33H50O8,分子量为574,不饱和度为9。
参照图1,1H NMR(400MHz,CDCl3)谱中显示该化合物含有7个甲基质子信号[δH1.74(3H,s),1.27(3H,s),1.23(3H,s),1.12(3H,d,J=6.8Hz),1.08(3H,t,J=8.0Hz),0.87(3H,d,J=7.8Hz),0.86(3H,t,J=7.6Hz)],2个烯氢质子信号[δH 7.57(1H,s),5.66(1H,d,J=4.8Hz)]。此外,还有3个连氧碳上的质子信号[δH 5.39(1H,d,J=10.4Hz),4.02(1H,d,J=12.8Hz),3.95(1H,d,J=12.8Hz)]。
参照图2,13C NMR和DEPT-135(100MHz,CDCl3)谱显示该化合物共有33个碳信号,包括有9个季碳,8个次甲基,9个亚甲基和7个甲基。化学位移为δC 209.3,176.7,176.4的3个碳信号是羰基碳信号,化学位移为δC 161.1,140.7,133.1,129.5的4个碳信号是双键烯碳信号,化学位移为δC 78.6,76.5,73.9,68.7,65.6的5个碳信号是连氧碳信号,化学位移为δC24.1,17.3,17.2,14.6,14.3,11.8,10.3的7个碳信号是甲基碳信号。
参照图3,通过HSQC谱、COSY谱、HMBC谱以及ROESY谱对化合物的碳、氢信号进行了归属。在HMBC谱中,H-3'(δH 1.62,1.45)、H-4'(δH 1.08)与C=O(δC 176.4)有远程相关,H-5'(δH 1.12)与C-2'(δC 42.0)有远程相关,表明存在2-甲基丁酰酯基。H-12(δH 5.83)与2-甲基丁酰基上的C=O(δC 176.4)有远程相关,表明2-甲基丁酰基取代位于6元环的C-12位。
由图4可得到下表1
表1 1D and 2D NMR data of山竹活性物-1(δ,400MHz,in CDCl3)
参照图5,在ROSEY谱上,可以观察到H-8(δH 3.23)分别与H-11(δH 2.13)、H-17(δH1.27)有相关,说明H-8、H-11和H-17位于同一侧;H-18(δH 0.87)分别与H-10(δH 3.22)、H-12(δH 5.39)、H-14(δH1.07)有相关,说明H-10、H-12、H-14、H-18位于同一侧。综合上述,可推出山竹活性物-1的C-8、C-10、C-11、C-12、C-14的相对构型。
至此确定了化合物山竹活性物-1的结构式为
5)组合物的制备,具体配方如下:
配方:取分子量为1-3kD的山楂多糖1g,分子量为3-5kD的芦荟多糖1g双歧杆菌0.05g,植物乳杆菌0.05g,嗜酸乳杆菌0.05g,干酪乳杆菌0.05g、山竹活性物-1 0.005g。
将上述步骤制备称取的芦荟多糖、山楂多糖、山竹活性物-1复配益生菌双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌,按照上述配方比进行混合混匀,加去离子水调成固含量为10-15%的浆状液体,经过冻干即制成本发明的含山竹活性物的组合物粉末。
取制得的含山竹活性物的组合物粉末,添加辅料,制成硬胶囊或软胶囊肠道制剂,该肠道制剂的有效剂量在10mg-200mg。用于制备降血脂、减肥功能的药物。
降脂减肥应用效果实验:
选用无特定病原体(Specific Pathogen Free,SPF)级7周龄16-20g雄性C57BL/6雄性小鼠70只。适应性饲养5天后,取60只小鼠喂食TP23300型高脂高糖肥胖模型饲料(TP23300型60%高脂高糖饲料(含蛋白质19.4%、碳水化合物20.6、脂肪60%、热量5.1千卡/g)和对照饲料(含蛋白质19.4%、碳水化合物70.6、脂肪10%、热量3.6千卡/g),由南通特洛菲饲料科技有限公司提供。)诱导肥胖模型,另10只作为空白对照组喂食TP23302型对照饲料。肥胖模型饲料喂养第4周(第24天),60只小鼠按体重增重排序,淘汰体重增重较低的1/3肥胖抵抗小鼠。
将筛选出的40只肥胖敏感小鼠随机分为4组:模型组、活性多糖组、益生菌组、活性多糖、益生菌、山竹活性物-1复合物组,继续喂食肥胖模型饲料,空白对照组继续给予低脂低糖对照饲料。所有小鼠均单笼饲养。肥胖模型饲料喂养第5周(第30天),将活性多糖、益生菌及活性多糖、益生菌、山竹活性物-1复合物混于纯净水中使浓度分别为2.0mg/mL给予动物饮用。肥胖模型饲料喂养第13周(给药干预第54天),以第13周体重减去第1周体重计算各组小鼠增重。所有小鼠禁食12h后,异氟烷麻醉,经眼眶静脉丛采血,4000rpm离心分取血清,按试剂盒说明书方法测定血清中丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、谷氨酰转肽酶(GGT)、甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白固醇(LDL-C)、高密度脂蛋白固醇(HDL-C)、IL-6,IL-1β及TNF-α的含量;脱颈椎处死小鼠,剖开腹部,记录腹部脂肪堆积情况,取肾周围脂肪、睾丸周围脂肪,并称重,计算脂/体比。取肝脏,用冰冷的生理盐水冲尽残血,滤纸拭干。称取剩余部分肝脏0.5g,加入5.0mL生理盐水制成10%肝匀浆,Western blotting检测肝脏组织中FAS、HO-1、Nrf2、SOD2、p-AMPK及SREBP1等蛋白的表达。
结果如下:
表2活性多糖、益生菌、山竹活性物-1组合物对肥胖模型小鼠血清中ALT、AST、GGT的影响
表2所示,肥胖小鼠的AST、ALT、GGT水平均高于正常饮食小鼠(p<0.05)。活性多糖、益生菌、山竹活性物-1组合物能够显著降低小鼠血清中AST、ALT、GGT水平(p<0.05)。
表3活性多糖、益生菌、山竹活性物-1组合物对肥胖模型小鼠血清脂质、葡萄糖水平的影响
表3所示,高脂高糖肥胖模型饲料喂养小鼠与对照饲料喂养的正常小鼠TC、TG、LDL-C等脂质水平显著增加(p<0.05),血清Glu含量显著增高(p<0.01)。活性多糖、益生菌、山竹活性物-1组合物组小鼠比肥胖模型组小鼠血清TC、TG、LDL-C、Glu水平更低(p<0.05),HDL水平更高(p<0.05)。结果表明,活性多糖、益生菌、山竹活性物-1组合物可以有效控制肥胖小鼠血脂TC、LDL、Glu、TG水平,可以升高HDL水平。
表4活性多糖、益生菌、山竹活性物-1组合物对肥胖模型小鼠血清中IL-6,IL-1β及TNF-α的影响
由表4可看出,与空白对照组相比,模型组IL-6,IL-1及TNF-α含量显著升高,说明高脂饮食导致的模型小鼠受到一定的炎性损伤。而通过活性多糖、益生菌、山竹活性物-1组合物的治疗,与模型组相比,活性多糖、益生菌、山竹活性物-1组合物治疗组IL-6,IL-1及TNF-α含量显著降低。且活性多糖、益生菌、山竹活性物-1组合物的活性比单独使用活性多糖或益生菌治疗效果更好。
参照图6,活性多糖、益生菌、山竹活性物-1组合物对肥胖模型小鼠中p-MAPK、FAS、SREBP1、HO-1、Nrf2及SOD2等蛋白表达的影响,如图6所示,与空白对照组相比,模型组的p-MAPK蛋白表达下调,活性多糖、益生菌、山竹活性物-1组合物能上调其表达;相反的,与空白对照组相比,模型组的FAS、SREBP1、HO-1、Nrf2及SOD2蛋白表达增加,而活性多糖、益生菌、山竹活性物-1组合物作用使FAS、SREBP1、HO-1、Nrf2及SOD2蛋白表达减少。说明,活性多糖、益生菌、山竹活性物-1组合物可上调小鼠肝脏AMPK的磷酸化水平,同时降低脂肪合成相关蛋白[如固醇调节元件结合蛋白-1c(SREBP-1c)、脂肪酸合酶(FAS)]的表达,从而增加脂肪酸氧化或抑制其合成。进一步的,活性多糖、益生菌、山竹活性物-1组合物可下调模型小鼠肝细胞内促炎因子(TNF-α,IL-1,IL-6)等的表达,同时,它可逆转模型组中肝细胞氧化应激相关蛋白(HO-1,Nrf2,SOD2)的下调,说明活性多糖、益生菌、山竹活性物-1组合物可通过降低肝脏炎症及抑制氧化应激来实现其保护作用。
本发明含山竹活性物的组合物的慢性毒性试验:
试验动物:1、昆明种小鼠,体重21±2g,由广东省实验动物中心提供
2、药物:本发明的活性多糖、益生菌、山竹活性物-1组合物。
3、试验方法:根据国家药品监督管理局颁布修订的“中药新药研究技术要求”,对本发明的活性多糖、益生菌、山竹活性物-1组合物进行慢性毒性实验。因受药物浓度及体积限制,无法测定LD50,故进行最大给药量实验。取昆明种小鼠20只,雌性各半,灌胃给予活性多糖、益生菌组合物1g/mL,每只0.8mL,即小鼠的最大灌胃体积用药后观察小鼠活动状态、饮食、粪便、呼吸、体重及死亡情况,连续观察14d。
4、试验结果:各组小鼠灌胃给药后生长良好,体重增加,行为正常,均未见死亡及明显反应。将动物处死后,肉眼观察各主要脏器无异常现象。
结果表明,本发明的活性多糖、益生菌、山竹活性物-1组合物最大剂量口服应用,对动物无明显损害,未发现对机体产生的毒性反应,是一种安全可靠的药物(膳食补充剂)。
实施例2
本实施例与实施例1的不同之处在于,本实施例的一种含山竹活性物含的组合物,有效成分中,活性多糖包括山楂多糖,山楂多糖的分子量为10-15kD,益生菌包括双歧杆菌、植物乳杆菌,按质量百分比计算,有效成分中,山楂多糖、山竹活性物、双歧杆菌、植物乳杆菌的质量百分比为2:0.001:0.4。
本实施例含山竹活性物含的组合物的制备方法,与实施例1的不同之处在于,仅制备山楂多糖、山竹活性物,益生菌选用双歧杆菌、植物乳杆菌。取分子量为10-15kD的山楂多糖2g,双歧杆菌0.2g,植物乳杆菌0.2g,山竹活性物-1 0.001g。
将上述步骤制备称取的山楂多糖、山竹活性物-1复配益生菌双歧杆菌、植物乳杆菌,按照上述配方比进行混合混匀,加去离子水调成固含量为12%的浆状液体,经过冻干即制成本发明的含山竹活性物含的组合物粉末。
取制得的含山竹活性物含的组合物粉末,添加辅料,制成片剂肠道制剂,该肠道制剂的有效剂量在10mg-500mg。用于制备降血脂、减肥功能的药物。
实施例3
本实施例与实施例1的不同之处在于,本实施例的一种含山竹活性物含的组合物,有效成分中,活性多糖包括芦荟多糖,芦荟多糖的分子量为5-10kD,益生菌包括嗜酸乳杆菌、干酪乳杆菌,按质量百分比计算,有效成分中,芦荟多糖、山竹活性物-1、嗜酸乳杆菌、干酪乳杆菌的质量百分比为2:0.01:0.04。
本实施例含山竹活性物含的组合物的制备方法,与实施例1的不同之处在于,仅制备芦荟多糖、山竹活性物,益生菌选用嗜酸乳杆菌、干酪乳杆菌。取分子量为5-10kD的芦荟多糖2g,嗜酸乳杆菌0.02g,干酪乳杆菌0.02g,山竹活性物-1 0.01g。
将上述步骤制备称取的芦荟多糖、山竹活性物-1复配益生菌嗜酸乳杆菌、干酪乳杆菌,按照上述配方比进行混合混匀,加去离子水调成固含量为15%的浆状液体,经过冻干即制成本发明的含山竹活性物含的组合物粉末。
取制得的含山竹活性物含的组合物粉末,添加辅料,制成冲剂口服溶液肠道制剂,该肠道制剂的有效剂量在500mg-1000mg。用于制备降血脂、减肥功能的药物。
实施例4
本实施例与实施例3的不同之处在于,本实施例的一种含山竹活性物含的组合物,有效成分中,活性多糖包括芦荟多糖和山楂多糖,芦荟多糖和山楂多糖的分子量均低于1kD,益生菌为嗜酸乳杆菌,按质量百分比计算,有效成分中,芦荟多糖、山楂多糖、山竹活性物-1、嗜酸乳杆菌的质量百分比为5:6:0.01:0.04。
取含山竹活性物含的组合物,添加适量辅料,制得混悬剂制剂。制剂中含山竹活性物含的组合物的有效剂量在600mg-900mg之间。
进一步,含山竹活性物含的组合物,添加适量辅料,还可以制得乳化剂的制剂。制剂中含山竹活性物含的组合物的有效剂量在800mg-1000mg之间。
进一步,芦荟多糖和山楂多糖可以用孔径为15kD,10kD,5kD,3kD、1kD的不同透析袋透析,获得10-15kD、5-10kD、3-5kD、1-3kD、低于1kD的不同分子量的活性多糖。
最后说明的是,以上优选实施例仅用以说明本发明的技术方案而非限制,尽管通过上述优选实施例已经对本发明进行了详细的描述,但本领域技术人员应当理解,可以在形式上和细节上对其作出各种各样的改变,而不偏离本发明权利要求书所限定的范围。
Claims (10)
1.一种含山竹活性物的组合物,其特征在于,包括由活性多糖、山竹活性物和益生菌组成的有效成分,按质量百分比计算,有效成分中,活性多糖、山竹活性物和益生菌的质量百分比为2-11:0.001-0.01:0.04-0.4。
3.根据权利要求1所述的一种含山竹活性物的组合物,其特征在于,所述活性多糖包括山楂多糖、芦荟多糖中的一种或两种。
4.根据权利要求3所述的一种含山竹活性物的组合物,其特征在于,所述山楂多糖、芦荟多糖的分子量小于等于15kD,优选地,山楂多糖的分子量为1-3kD,芦荟多糖的分子量为3-5kD。
5.根据权利要求1所述的一种含山竹活性物的组合物,其特征在于,所述益生菌包括双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌中的一种或多种。
6.根据权利要求1-5任意一项所述的一种含山竹活性物的组合物的制备方法,其特征在于,包括如下步骤:
1)活性多糖的制备
取植物多糖,加入10-20倍重量的纯净水溶解,溶液用一定孔径的透析袋透析,收集透析液,冻干制得活性多糖备用;
2)山竹活性物的制备
取山竹提取物,经200-300目的硅胶柱层析,收集石油醚洗脱组分、乙酸乙酯洗脱组分、乙醇洗脱组分,分别冻干获得三种活性组分;所述的三种活性组分经HPLC分离,获得的山竹活性物-1;
3)益生菌的筛选,选用双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌中的一种或几种;
4)组合物制备
将制得的活性多糖、益生菌和山竹活性物-1按一定比例混匀,去离子水调成浆状液体,冻干制成组合物粉末,即得含山竹活性物的组合物。
7.根据权利要求6所述的一种含山竹活性物的组合物的制备方法,其特征在于,所述活性多糖包括分子量为1-3kD的山楂多糖和分子量为3-5kD的芦荟多糖,所述益生菌包括双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌,组合物中山楂多糖、芦荟多糖、双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌、山竹活性物-1的质量比为1:1-10:0.01-0.1:0.01-0.1:0.01-0.1:0.01-0.1:0.001-0.01,优选的,所述山楂多糖、芦荟多糖、双歧杆菌、植物乳杆菌、嗜酸乳杆菌、干酪乳杆菌、山竹活性物-1的质量比为1:1:0.05:0.05:0.05:0.05:0.005。
8.根据权利要求6所述的一种含山竹活性物的组合物的制备方法,其特征在于,取制得的所述含山竹活性物的组合物,添加辅料,制成硬胶囊、软胶囊、片剂、冲剂口服溶液、混悬剂、乳化剂肠道制剂。
9.根据权利要求8所述的一种含山竹活性物的组合物的制备方法,其特征在于,所述肠道制剂的有效剂量在10mg-1000mg。
10.根据权利要求1-5任意一项所述的一种含山竹活性物的组合物的用途,其特征在于,用于制备降血脂、减肥功能的药物、食品中。
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