CN113476525A - 具有降脂减肥作用的中药糖苷类组合物及其制备方法与应用 - Google Patents
具有降脂减肥作用的中药糖苷类组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种具有降脂减肥作用的中药糖苷类组合物及其制备方法。所述组合物由鲜地黄多糖和鲜地黄寡糖组成;所述鲜地黄多糖和鲜地黄寡糖的重量比是1~99﹕1~99。本发明通过大量实验筛选结果表明,鲜地黄多糖和鲜地黄寡糖按特定配比组合后能有针对性地改善血脂,减轻体重;鲜地黄多糖和鲜地黄寡糖组合应用,能更好地发挥降脂减肥作用,可用于多种原因导致的血脂异常和体重升高,且安全性好,无毒副作用。
Description
技术领域
本发明涉及一种中药糖苷类组合物,具体涉及一种具有降脂减肥作用的中药糖苷类组合物及其制备方法。
背景技术
随着人类生活水平的提高,高血脂症在各年龄阶段均越来越常见。高血脂是造成动脉粥样硬化的罪魁祸首,最终可能导致冠心病,心绞痛、心律失常、心肌梗塞,脑血栓、脑溢血等心脑血管疾病。而肥胖是引起、加重高血脂的第一危险因素。近年来人们的健康意识日益增强,市场上也陆续涌现出各式各样的降脂减肥产品,但适应症单一并且副作用较大。因此,对安全有效的降脂减肥保健品或药物的研究开发具有重要的意义。
糖苷类成分是中药中一类重要的活性物质,具有广泛的药理活性,包括抗氧化、抗炎、抑菌、保护心血管等,对于维持人体健康具有重要的作用。大量研究表明,某些中药糖苷类成分对肥胖、高血脂、糖尿病等慢性疾病有一定的预防、缓解和治疗作用。
发明内容
发明目的:本发明的目的在于提供一种具有降脂减肥,尤其是能够调节多种疾病状态下血脂异常和体重升高的,且安全性高、无不良反应的中药糖苷类组合物。本发明的另一目的是提供上述组合物的制备方法和应用。
技术方案:为了实现以上目的,本发明采取的技术方案为:
一种具有降脂减肥作用的中药糖苷类组合物,它由鲜地黄多糖与鲜地黄寡糖制成。
作为优选方案,以上所述的具有降脂减肥作用的中药糖苷类组合物,鲜地黄多糖与鲜地黄寡糖的重量比是1~99﹕1~99。
作为优选方案,以上具有降脂减肥作用的中药糖苷类组合物,其特征在于,鲜地黄多糖与鲜地黄寡糖的重量份数比为10:1、7:4或5:2。
本发明所述的具有降脂减肥作用的中药糖苷类组合物的制备方法,包括以下步骤:
鲜地黄多糖的制备步骤为:
将鲜地黄打碎,过滤汁液得滤渣,滤渣冷冻干燥,加入60~80%乙醇,回流提取1-3次,每次1.0~2.0h,过滤;滤渣挥干乙醇,加蒸馏水,煎煮提取1~3次,每次1.0~2.0h,过滤,合并滤液,减压浓缩,浓缩液中加入乙醇使乙醇的浓度达到65%~85%,静置,沉淀后离心,得沉淀,沉淀挥去乙醇,干燥,得到鲜地黄多糖;
鲜地黄寡糖的制备步骤为:
将鲜地黄打碎,过滤得汁液,减压浓缩后冷冻干燥,冻干粉加蒸馏水溶解,过滤,滤液中加入乙醇使乙醇的浓度达到80%~90%,静置,沉淀后离心,分离沉淀和上清液;上清液中再加入乙醇使溶液中乙醇的浓度达到80%~90%,静置,沉淀后离心,收集上清液,减压浓缩,上大孔树脂柱,收集流出液和蒸馏水洗脱液,超滤处理,超滤膜截留分子量为3kDa,超滤液减压浓缩,浓缩液冷冻干燥,得鲜地黄寡糖。
作为优选方案,以上所述的具有降脂减肥作用的中药糖苷类组合物,鲜地黄多糖分子量范围为5kD至1200kD,其由D-甘露糖、L-鼠李糖、D-葡萄糖醛酸、D-半乳糖醛酸、D-葡萄糖、D-半乳糖和L-阿拉伯糖构成;D-甘露糖、L-鼠李糖、D-葡萄糖醛酸、D-半乳糖醛酸、D-葡萄糖、D-半乳糖和L-阿拉伯糖的摩尔比为0.01~0.05﹕0.05~0.10﹕0.01~0.07﹕0.5~1.5﹕0.10~0.25﹕0.22~0.75﹕0.21~0.68。
作为优选方案,以上所述的具有降脂减肥作用的中药糖苷类组合物,鲜地黄寡糖分子量范围为1kD至2kD,有二糖和三糖两种寡糖,其由果糖、D-葡萄糖、D-半乳糖和D-甘露糖构成。
发明通过大量实验筛选组合,实验结果表明,鲜地黄多糖与鲜地黄寡糖按一定配比组合之后,对多种原因导致的血脂和体重升高具有很好的调节作用。
本发明所述的具有降脂减肥作用的中药糖苷类组合物在制备具有降脂减肥作用的药物或特殊医学用途配方食品或保健品中的应用。
作为优选方案,将组合物和食品载体或药学上可接受的载体,制成口服液、颗粒剂、胶囊剂、煎膏剂等剂型的保健食品或药物。
本发明提供的具有降脂减肥作用的中药糖苷类组合物制成口服液时,把组合物加水溶解后,加入食用防腐剂,充分溶解后,离心除去杂质,灌封,即得。
本发明提供的具有降脂减肥作用的中药糖苷类组合物制成颗粒剂时,把组合物和蔗糖、糊精混合均匀,整粒,干燥,制成颗粒剂。
本发明提供的具有降脂减肥作用的中药糖苷类组合物制成硬胶囊剂时,把组合物和玉米淀粉或乳糖混合均匀,经整粒,然后装胶囊制成硬胶囊剂。
本发明提供的组合物制成其它剂型时,可按药学常规方法制备得到。
有益效果:本发明提供的具有降脂减肥作用的中药糖苷类组合物,通过大量实验筛选,以鲜地黄多糖与鲜地黄寡糖按一定配比组合后,能对多种原因导致的血脂异常和体重升高均显示出了很好的调节作用,取得了非常好的技术效果。
并且对比实验结果表明,本发明提供的按特定重量份数比组成的鲜地黄多糖与鲜地黄寡糖组合物比单一的鲜地黄多糖或鲜地黄寡糖具有更优越的降脂减肥作用,表明鲜地黄多糖与鲜地黄寡糖组合物按特定重量比组合后,具有较好的协同增效作用。
具体实施方式
下面结合具体实施例进一步阐明本发明,应理解这些实施例仅用于说明本发明而不用于限制本发明的范围,在阅读了本发明之后,本领域技术人员对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。
实施例1
鲜地黄多糖的制备:
将鲜地黄打碎,过滤汁液得滤渣,滤渣冷冻干燥,加入80%乙醇,回流提取3次,每次1h,过滤;滤渣挥干乙醇,加蒸馏水,煎煮3次,每次2h,过滤,合并滤液,减压浓缩,浓缩液中加入乙醇使乙醇的浓度达到85%,静置,沉淀后离心,得沉淀,沉淀挥去乙醇,干燥,得到鲜地黄多糖。鲜地黄多糖经2M三氟乙酸水解、PMP衍生化后用于HPLC-UV检测,色谱柱为C18柱,检测波长为245nm,流动相为0.05M的乙酸铵水溶液和乙腈(84:16)等度洗脱,结果表明,鲜地黄多糖由D-甘露糖、L-鼠李糖、D-葡萄糖醛酸、D-半乳糖醛酸、D-葡萄糖、D-半乳糖和L-阿拉伯糖构成;D-甘露糖、L-鼠李糖、D-葡萄糖醛酸、D-半乳糖醛酸、D-葡萄糖、D-半乳糖和L-阿拉伯糖以摩尔比为0.01~0.05﹕0.05~0.10﹕0.01~0.07﹕0.5~1.5﹕0.10~0.25﹕0.22~0.75﹕0.21~0.68组成。经高效凝胶色谱-ELSD检测,以TSK-gel柱为色谱柱,纯水为流动相,结果表明,鲜地黄多糖分子量范围为5kD至1200kD。
鲜地黄寡糖的制备:
将鲜地黄打碎,过滤得汁液,减压浓缩后冷冻干燥,冻干粉加蒸馏水溶解,过滤,滤液中加入乙醇使乙醇的浓度达到80%,静置,沉淀后离心,分离沉淀和上清液;上清液中再加入乙醇使溶液中乙醇的浓度达到80%,静置,沉淀后离心,收集上清液,减压浓缩,上大孔树脂柱,收集流出液和蒸馏水洗脱液,超滤处理,超滤膜截留分子量为3kDa,超滤液减压浓缩,浓缩液冷冻干燥,得鲜地黄寡糖。经HPLC-ELSD检测,以氨基柱为色谱柱,乙腈和水(75:25)等度洗脱,结果表明,鲜地黄寡糖有二糖和三糖两种寡糖,其由果糖、D-葡萄糖、D-半乳糖和D-甘露糖构成。经高效凝胶色谱-ELSD检测,以TSK-gel柱为色谱柱,纯水为流动相,结果表明,鲜地黄寡糖分子量范围为1kD至2kD。
实施例2
鲜地黄多糖与鲜地黄寡糖的组合物对肥胖小鼠血脂和体重的影响
取雄性C57BL/6J小鼠50只,体重20±2g,由上海斯莱克实验动物有限责任公司提供。随机取10只作为空白对照组,给予普通饲料;其余40只给予高脂饲料,分为模型对照组、实验例1制备得到的鲜地黄多糖组、鲜地黄寡糖组及鲜地黄多糖与鲜地黄寡糖按一定的配比(200+80、210+120和300+30)制成的组合物组,每组10只。鲜地黄多糖组、鲜地黄寡糖组及组合物组的动物分别连续给予鲜地黄多糖组、鲜地黄寡糖组及鲜地黄多糖与鲜地黄寡糖的组合物灌胃8周,空白对照组和模型对照组给予等容积的生理盐水,测量给药前、给药结束后各组小鼠体质量,实验结束时取小鼠血清测定血脂水平,比较组间体重和血脂水平的变化情况。小鼠体重和血脂变化如表1所示。
组别 | 剂量(mg.kg<sup>-1</sup>) | 0w(g) | 8w(g) | TC(mmol/L) | TG(mmol/L) | HDL-C(mmol/L) | LDL-C(mmol/L) |
空白对照组 | / | 18.39±1.77 | 25.65±1.09 | 6.65±0.48 | 1.61±0.13 | 1.38±0.13 | 6.16±0.32 |
模型对照组 | / | 19.26±1.15 | 35.11±3.74## | 8.99±1.09## | 1.97±0.93 | 1.65±0.16 | 7.27±0.35# |
鲜地黄多糖组 | 400 | 19.16±1.17 | 32.71±1.90** | 8.04±1.79 | 1.86±0.22 | 1.45±0.52 | 6.83±0.64 |
鲜地黄寡糖组 | 400 | 19.14±1.11 | 33.35±1.28** | 7.65±1.73* | 1.90±0.91 | 1.55±0.13 | 6.95±0.36 |
组合物组 | 200+80 | 19.11±1.03 | 30.64±1.39** | 7.28±1.56** | 1.78±0.59 | 1.43±0.19 | 6.78±0.47 |
组合物组 | 210+120 | 19.08±1.01 | 31.55±1.72** | 7.09±1.44** | 1.82±0.53 | 1.45±0.18 | 6.71±0.61 |
组合物组 | 300+30 | 19.04±1.20 | 27.54±1.93** | 6.85±1.15** | 1.72±0.93 | 1.41±0.11 | 6.65±0.39 |
注:与空白对照组比较#P<0.05,##P<0.01;与模型对照组比较*P<0.05,**P<0.01。
由以上表1结果表明,各组小鼠的初始体重各组间无显著性差异(P>0.05),给予鲜地黄多糖、鲜地黄寡糖及鲜地黄多糖与鲜地黄寡糖按一定的配比制成的组合物8周后,肥胖小鼠的体重显著降低(P<0.01),且鲜地黄多糖与鲜地黄寡糖的组合物对肥胖小鼠的血清TC显著降低(P<0.01)。并且鲜地黄多糖与鲜地黄寡糖(10﹕1)的组合物与单个的鲜地黄多糖和单个的鲜地黄寡糖及其他配比相比,显示出了更好的降脂减肥效果,表明二者组合起到了明显的协同作用。
实施例3
鲜地黄多糖与鲜地黄寡糖的组合物对二型糖尿病小鼠血脂和体重的影响
取雄性C57BL/6J小鼠,体重20±2g,由上海斯莱克实验动物有限责任公司提供。随机分取10只为空白对照组,其余用于造模,分别给予标准饲料或高脂饮食(HFD,45%kcal来自脂肪)8周后,将喂食HFD的小鼠给予一次性经腹腔注射STZ柠檬酸溶液(90mg/kg.bw),14天后测定随机血糖水平,随机血糖浓度超过16.7mmol/L的小鼠被认为模型成功,按组间血糖无显著差异原则分为模型对照组,地黄多糖组、地黄寡糖组和地黄多糖组与地黄寡糖按一定的配比(200+80、210+120和300+30)制成的组合物组,每组10只。鲜地黄多糖组、鲜地黄寡糖组及组合物组的动物分别连续给予鲜地黄多糖组、鲜地黄寡糖组及鲜地黄多糖与鲜地黄寡糖组合物灌胃4周,空白对照组和模型对照组给予等容积的生理盐水,测量给药后各组小鼠体质量,实验结束时取小鼠血清测定血脂水平,比较组间体重和血脂水平的变化情况。小鼠体重和血脂变化如表2所示。
组别 | 剂量(mg.kg<sup>-1</sup>) | Bodyweight(g) | TC(mmol/L) | TG(mmol/L) | HDL-C(mmol/L) | LDL-C(mmol/L) |
空白对照组 | / | 30.49±1.73 | 7.65±0.35 | 2.31±0.53 | 1.42±0.24 | 1.26±0.28 |
模型对照组 | / | 37.11±1.34## | 8.99±1.80# | 3.87±0.73# | 1.15±0.27 | 1.82±0.37 |
鲜地黄多糖组 | 500 | 32.71±1.90** | 7.94±1.69 | 2.86±0.52 | 1.23±0.22 | 1.72±0.44 |
鲜地黄寡糖组 | 500 | 33.69±1.28** | 7.54±1.93* | 3.10±0.83 | 1.25±0.23 | 1.75±0.53 |
组合物组 | 200+80 | 31.02±1.85** | 7.22±1.61** | 2.82±0.36 | 1.26±0.19 | 1.77±0.36 |
组合物组 | 210+120 | 29.85±1.66** | 6.95±1.54** | 2.72±0.65 | 1.33±0.21 | 1.60±0.49 |
组合物组 | 300+30 | 31.66±1.43** | 7.40±1.37** | 2.95±0.71 | 1.31±0.31 | 1.72±0.28 |
注:与空白对照组比较#P<0.05,##P<0.01;与模型对照组比较*P<0.05,**P<0.01。
由以上表2结果表明,与模型组相比,给予鲜地黄多糖、鲜地黄寡糖及鲜地黄多糖与鲜地黄寡糖按一定的配比制成的组合物4周后,二型糖尿病小鼠的体重显著降低(P<0.01),且鲜地黄寡糖及鲜地黄多糖与鲜地黄寡糖按一定的配比制成的组合物均可显著降低二型糖尿病小鼠的血清TC水平(P<0.05和P<0.01)。并且鲜地黄多糖与鲜地黄寡糖(7﹕4)的组合物与单个的鲜地黄多糖和单个的鲜地黄寡糖及其他配比相比,显示出了更好的降脂减肥效果,表明二者组合起到了明显的协同作用。
实施例4
鲜地黄多糖与鲜地黄寡糖的组合物对非酒精性脂肪肝小鼠血脂和体重的影响
取雄性C57BL/6J小鼠,体重20±2g,由上海斯莱克实验动物有限责任公司提供。随机分取10只为空白对照组,其余用于造模,分别给予标准饲料或高脂饮食(HFD,60%kcal来自脂肪)8周后,将造模动物按组间体重无显著差异原则分为模型对照组、地黄多糖组、地黄寡糖组和地黄多糖组与地黄寡糖按一定配比(200+80、210+120和300+30)的组合物组,每组10只。鲜地黄多糖组、鲜地黄寡糖组及组合物组的动物分别连续给予鲜地黄多糖组、鲜地黄寡糖组及鲜地黄多糖与鲜地黄寡糖的组合物灌胃6周,空白对照组和模型对照组给予等容积的生理盐水,测量给药结束后各组小鼠体质量,实验结束时取小鼠血清测定血脂水平,比较组间体重和血脂水平的变化情况。小鼠体重和血脂变化如表3所示。
组别 | 剂量(mg.kg<sup>-1</sup>) | Bodyweight(g) | TC(mmol/L) | TG(mmol/L) | HDL-C(mmol/L) | LDL-C(mmol/L) |
空白对照组 | / | 31.26±1.12 | 1.35±0.18 | 1.42±0.23 | 1.18±0.11 | 4.21±0.42 |
模型对照组 | / | 47.18±3.45## | 2.90±0.22## | 2.89±0.42## | 1.96±0.18 | 6.03±0.45## |
鲜地黄多糖组 | 350 | 45.27±2.29** | 2.14±0.13 | 1.93±0.32 | 1.51±0.22 | 5.28±0.52 |
鲜地黄寡糖组 | 350 | 42.52±2.22** | 2.05±0.17 | 1.92±0.49 | 1.43±0.15 | 5.35±0.48 |
组合物组 | 200+80 | 37.34±1.83** | 1.68±0.20* | 1.54±0.26* | 1.21±0.07 | 4.61±0.26* |
组合物组 | 210+120 | 40.36±1.92** | 1.89±0.21 | 1.85±0.40 | 1.38±0.14 | 5.09±0.38 |
组合物组 | 300+30 | 41.09±2.03** | 1.96±0.17 | 1.90±0.27 | 1.41±0.18 | 5.12±0.41 |
注:与空白对照组比较#P<0.05,##P<0.01;与模型对照组比较*P<0.05,**P<0.01。
由以上表2结果表明,与模型组相比,给予鲜地黄多糖、鲜地黄寡糖及鲜地黄多糖与鲜地黄寡糖按一定的配比制成的组合物4周后,非酒精性脂肪肝小鼠的体重显著降低(P<0.01),且鲜地黄多糖与鲜地黄寡糖(5﹕2)的组合物显著降低了非酒精性脂肪肝小鼠血清TC、TG和LDL-C水平(P<0.05)。并且鲜地黄多糖与鲜地黄寡糖(5﹕2)的组合物与单个的鲜地黄多糖和单个的鲜地黄寡糖及其他配比相比,显示出了更好的减轻体重降低血脂效果,表明二者组合起到了明显的协同作用,取得了明显的技术效果。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (8)
1.一种具有降脂减肥作用的中药糖苷类组合物,其特征在于,它由鲜地黄制成。
2.根据权利要求1所述的具有降脂减肥作用的中药糖苷类组合物,其特征在于,它由重量比1~99﹕1~99的鲜地黄多糖和鲜地黄寡糖组成。
3.根据权利要求2所述的具有降脂减肥作用的中药糖苷类组合物,其特征在于,鲜地黄多糖和鲜地黄寡糖的重量份数比为10:1、7:4或5:2。
4.根据权利要求2所述的具有降脂减肥作用的中药糖苷类组合物,其特征在于,鲜地黄多糖通过如下方法制得:将鲜地黄打碎,过滤汁液得滤渣,滤渣冷冻干燥,加入60~80%乙醇,回流提取1-3次,每次1.0~2.0h,过滤;滤渣挥干乙醇,加蒸馏水,煎煮提取1~3次,每次1.0~2.0h,过滤,合并滤液,减压浓缩,浓缩液中加入乙醇使乙醇的浓度达到65%~85%,静置,沉淀后离心,得沉淀,沉淀挥去乙醇,干燥,得到鲜地黄多糖。
5.根据权利要求1所述的具有降脂减肥作用的中药糖苷类组合物,其特征在于,鲜地黄寡糖通过如下方法制得:将鲜地黄打碎,过滤得汁液,减压浓缩后冷冻干燥,冻干粉加蒸馏水溶解,过滤,滤液中加入乙醇使乙醇的浓度达到80%~90%,静置,沉淀后离心,分离沉淀和上清液;上清液中再加入乙醇使溶液中乙醇的浓度达到80%~90%,静置,沉淀后离心,收集上清液,减压浓缩,上大孔树脂柱,收集流出液和蒸馏水洗脱液,超滤处理,超滤膜截留分子量为3kDa,滤液减压浓缩,浓缩液冷冻干燥,得鲜地黄寡糖。
6.根据权利要求2所述的具有降脂减肥作用的中药糖苷类组合物,其特征在于,鲜地黄多糖分子量范围为5kD至1200kD,其由D-甘露糖、L-鼠李糖、D-葡萄糖醛酸、D-半乳糖醛酸、D-葡萄糖、D-半乳糖和L-阿拉伯糖构成;
D-甘露糖、L-鼠李糖、D-葡萄糖醛酸、D-半乳糖醛酸、D-葡萄糖、D-半乳糖和L-阿拉伯糖的摩尔比为0.01~0.05﹕0.05~0.10﹕0.01~0.07﹕0.5~1.5﹕0.10~0.25﹕0.22~0.75﹕0.21~0.68。
7.根据权利要求1所述的具有降脂减肥作用的中药糖苷类组合物,其特征在于,鲜地黄寡糖分子量范围为1kD至2kD,包括二糖和三糖两种寡糖,其由果糖、D-葡萄糖、D-半乳糖和D-甘露糖构成。
8.权利要求1至7任一项所述的具有降脂减肥作用的中药糖苷类组合物在制备降脂减肥的药物或特殊医学用途配方食品或保健品中的应用。
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