CN105998049A - 铁皮石斛多糖在制备防治代谢综合征药物及保健品中的应用 - Google Patents
铁皮石斛多糖在制备防治代谢综合征药物及保健品中的应用 Download PDFInfo
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- CN105998049A CN105998049A CN201610490394.2A CN201610490394A CN105998049A CN 105998049 A CN105998049 A CN 105998049A CN 201610490394 A CN201610490394 A CN 201610490394A CN 105998049 A CN105998049 A CN 105998049A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,属于医药技术领域。本发明中的铁皮石斛作为一种天然药物和食物,其作为传统药物和食物使用的时间久远,即铁皮石斛作为药物和保健品使用安全性高;本发明提供的铁皮石斛多糖具有较好的防治代谢综合征效果,从而能够将铁皮石斛多糖作为防治代谢综合征药物或防治代谢综合征保健品而用于制药生产或保健品生产,进而拓宽了防治代谢综合征天然药物和保健品的来源。
Description
技术领域
本发明涉及医药技术领域,具体涉及的是一种铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用。
背景技术
铁皮石斛(Dendrobium officinale Kimura et Migo)是兰科石斛属多年生草本植物,多在潮湿、温暖、半阴半阳的环境中生长,分布于福建、广西、云南等地,具有益胃生津和滋阴清热的功能。在民间,铁皮石斛被称为“救命仙草”、“寸金草”,用于养生保健的极品,为历代名家所推崇。
代谢综合征是指人体的蛋白质、脂肪、碳水化合物等物质发生代谢紊乱的病理状态,是一组复杂的代谢紊乱症候群,是导致糖尿病、心脑血管疾病的危险因素,代谢综合征具有以下特点:①多种代谢紊乱集于一身,包括肥胖、高血糖、高血压、血脂异常、高血黏、高尿酸、高脂肪肝发生率和高胰岛素血症,这些代谢紊乱是心、脑血管病变以及糖尿病的病理基础;②有共同的病理基础,目前多认为它们的共同原因就是肥胖尤其是中心性肥胖所造成的胰岛素抵抗和高胰岛素血症;③可造成多种疾病增加,如高血压、冠心病、脑卒中、甚至某些癌症,包括与性激素有关的乳腺癌、子宫内膜癌、***癌,以及消化***的胰腺癌、肝胆癌、结肠癌等;④有共同的预防及治疗措施,防治了其中一种代谢紊乱,也就有利于其他代谢紊乱的防治。
临床上目前有多种治疗代谢综合征的西药,但它们普遍存在一个缺点:仅仅纠正代谢综合征一个方面的紊乱,无法同时兼顾治疗其他方面的紊乱,因此疗效不尽如人意。如果同时使用针对不同方面紊乱的药物治疗,又会因药物相互作用产生诸如药品不良反应之类的不可控因素。与西药相比,中药具有多靶点和多途径特征,且更注重疾病的证候与整体状态不同层面的改善,因此十分契合代谢综合征的发病特点,在防治代谢综合征方面具有极大的发展潜力。
铁皮石斛化学成分多样,主要成分为多糖,此外还含有生物碱、氨基酸等化合物。药理研究证明铁皮石斛具有抗衰老、降血糖、抗肿瘤、提高免疫功能等作用,在治疗糖尿病、肿瘤及咽炎等方面有很好的疗效。但还未有铁皮石斛具有治疗代谢综合征的相关文献报道。
发明内容
本发明的目的是针对现有技术中的不足,提供一种铁皮石斛多糖的新用途。本发明所要解决的技术问题在于提供铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用。
为实现上述目的,本发明通过以下技术方案解决上述技术问题:铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用。
进一步地,所述铁皮石斛多糖通过水提醇沉法提取:将铁皮石斛洗净后每次加10~15倍体积的水进行煎煮,煎煮2~4次,每次2~5小时,得到铁皮石斛药液;将每次煎煮得到的铁皮石斛药液过滤后,合并多次煎煮所得的铁皮石斛药液,减压浓缩获得浸膏;再用95%乙醇沉淀3~5次,加水溶解,加Sevage试剂脱蛋白后再加95%乙醇沉淀,真空干燥即得铁皮石斛多糖。。(以上数值仍然建议用一定的范围来限定较佳)
进一步地,所述防治代谢综合征药物为单一成分的铁皮石斛多糖,或为所述铁皮石斛多糖与填充剂、粘合剂、润湿剂、崩解剂、吸收促进剂、溶剂、表面活性剂、香味剂、防腐剂、润滑剂、甜味剂和色素中的一种或多种组成的片剂,或为所述铁皮石斛多糖与缓冲剂、抗氧增效剂、矫味剂、甜味剂、溶剂、表面活性剂和防腐剂中的一种或多种组成的口服液制剂。
进一步地,所述防治代谢综合征保健品为单一成分的铁皮石斛多糖,或为所述铁皮石斛多糖与填充剂、粘合剂、润湿剂、崩解剂、吸收促进剂、溶剂、表面活性剂、香味剂、防腐剂、润滑剂、甜味剂和色素中的一种或多种组成的片剂,或为所述铁皮石斛多糖与缓冲剂、抗氧增效剂、矫味剂、甜味剂、溶剂、表面活性剂和防腐剂中的一种或多种组成的口服液制剂。
进一步地,以每1000片计,所述片剂的组分如下:
铁皮石斛多糖10g、微晶纤维素45g、硬脂酸4.2g、乳糖30g、微粉硅胶15g及硬脂酸镁0.8g,其中,所述微晶纤维素和所述乳糖为填充剂,所述硬脂酸和所述微粉硅胶为表面活性剂,所述硬脂酸镁为润滑剂。
进一步地,所述片剂的制备方法如下:取10g铁皮石斛多糖、45g微晶纤维素、4.2g硬脂酸、30g乳糖及15g微粉硅胶混匀并制成颗粒,接着于颗粒中加入0.8g硬脂酸镁,混匀,压片制成含量一致的所述片剂。
进一步,所述口服液制剂的组分如下,以口服液制剂的体积为1000mL计:
铁皮石斛多糖10g、柠檬酸3g及苯甲酸钠1g,余量为水;其中,所述柠檬酸为缓冲剂、矫味剂和抗氧增效剂,所述苯甲酸钠为防腐剂。
进一步地,所述口服液制剂的制备方法如下:取10g铁皮石斛多糖、3g柠檬酸及1g苯甲酸钠混匀形成混合物,接着于上述混合物中加水至1000ml,搅拌混匀,过滤除去杂质,最后在无菌条件下分装至安瓿瓶中得所述口服液制剂。
本发明的有益效果在于:
1、本发明中的铁皮石斛作为一种天然药物和食物,其作为传统药物和食物使用的时间久远,即铁皮石斛作为药物和保健品使用安全性高;
2、本发明提供的铁皮石斛多糖具有较好的防治代谢综合征效果,从而能够将铁皮石斛多糖作为防治代谢综合征药物或防治代谢综合征保健品而用于制药生产或保健品生产,进而拓宽了防治代谢综合征天然药物和保健品的来源。
附图说明
下面参照附图结合实施例对本发明作进一步的描述。
图1为铁皮石斛多糖对代谢综合征大鼠尾部静脉收缩压的结果统计柱状图;图中(1)代表正常对照组,(2)代表模型对照组,(3)代表低剂量铁皮石斛多糖组,(4)代表中剂量铁皮石斛多糖组,(5)代表高剂量铁皮石斛多糖组,(6)代表盐酸吡格列酮组。
具体实施方式
为了进一步解释本发明的技术方案,下面通过具体实施例来对本发明进行详细阐述。
本发明揭露了铁皮石斛多糖在制备防治代谢综合征药物和防治代谢综合征保健品中的应用。其中,通过水提醇沉法提取铁皮石斛多糖;并通过将铁皮石斛多糖与填充剂、粘合剂、润湿剂、崩解剂、吸收促进剂、溶剂、表面活性剂、香味剂、防腐剂、润滑剂、甜味剂和色素中的一种或多种组成的片剂;或将铁皮石斛多糖与甜味剂、溶剂、表面活性剂的一种或多种组成的口服液制剂。当防治代谢综合征药物和防治代谢综合征保健品为片剂时,其制备方法如下:取10g铁皮石斛多糖、45g微晶纤维素(填充剂)、4.2g硬脂酸(表面活性剂)、30g乳糖(填充剂)及15g微粉硅胶(表面活性剂)混匀并制成颗粒,接着于颗粒中加入0.8g硬脂酸镁(润滑剂),混匀,压片制成含量一致的所述片剂。当防治代谢综合征药物和防治代谢综合征保健品为口服液制剂时,其制备方法如下:取10g铁皮石斛多糖、3g柠檬酸(缓冲剂、矫味剂和抗氧增效剂)、1g苯甲酸钠(防腐剂)组成混合物,接着于上述混合物中加水至1000ml,搅拌混匀,过滤除去杂质,最后在无菌条件下分装至安瓿瓶中得所述口服液制剂。
为了更好的理解本发明,下面以高果糖诱导的代谢综合征模型为基础,结合铁皮石斛多糖给药,通过药效学研究来说明铁皮石斛多糖的防治代谢综合征作用。
另外,需要说明的是:下列各实施例的试验中,表和图中“#”表示P<0.05,“##”表示P<0.01,即与正常对照组相比有显著性差异;“*”表示P<0.05;“**”表示P<0.01,即与模型对照组相比有显著性差异。
实施例1铁皮石斛多糖提取
1.1将铁皮石斛剪成3mm长小段,称取铁皮石斛100g,洗净后每次加2L水进行煎煮,煎煮三次,每次二小时,得到铁皮石斛药液;将每次煎煮得到的铁皮石斛药液过滤后,合并三次煎煮所得的铁皮石斛药液,减压浓缩获得浸膏,再用95%乙醇沉淀五次之后,加200ml水溶解,加Sevage试剂(正丁醇∶氯仿为1∶4)100ml,脱蛋白,重复操作3次;最后再加95%乙醇沉淀,真空干燥即得铁皮石斛多糖,铁皮石斛多糖的得率为13.78%。
实施例2高果糖诱导的代谢综合征模型
2.1实验动物雄性SD大鼠,体重200-220g,购自福建中医药大学实验动物中心。每只大鼠单独一笼,整个实验过程中大鼠可以自由饮水饮食。环境温度为22±2℃,相对湿度为50±10%,每天12小时光照(07:00-19:00)。动物适应环境一周后开始正式实验。
2.2模型建立动物分为正常组(n=8)和模型组(n=40),以10%果糖水喂养4周后,将模型组动物分为5个给药组(n=8):模型空白组、低剂量铁皮石斛多糖组(150mg/kg)、中剂量铁皮石斛多糖组(300mg/kg)、高剂量铁皮石斛多糖组(600mg/kg)和盐酸吡格列酮组(10mg/kg)。铁皮石斛多糖和盐酸吡格列酮分别均匀分散于蒸馏水中配成相应的浓度,每天灌胃给药,连续4周。给药期间,所有模型组动物继续饮用果糖水。
2.3生物样本处死动物,收集血样分离血清,待测。在冰台上迅速分离腹部脂肪和睾丸脂肪,电子天平称重。
2.4血样指标的测定血清中瘦素、脂联素和肿瘤坏死因子(TNF-α)含量采用ELISA试剂盒检测,测定方法参照试剂盒说明书。血清葡萄糖、总胆固醇(TG)、甘油三酯(TC)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)的测定参照试剂盒说明书。
2.5大鼠尾部静脉血压的测定采用无创血压***测定大鼠尾部静脉血压。测定前,动物在37℃恒温箱预热30min,然后放置在测定箱中,大鼠尾部连接在感应装置上,待动物稳定后记录收缩压,每只动物连续测定5次,取平均值,单位为mmHg。
2.6统计学方法实验结果使用Graphpad Prism 5软件绘制结果统计柱状图,用平均值±标准误差值表示;对于两组间的比较采用单因素方差分析结合Dunnett’s事后分析;以P值小于0.05表示统计学差异显著性。
2.7对大鼠体重的影响如表1所示,在第8周时,与正常对照组相比,模型对照组大鼠体重增加,与模型对照组相比,低剂量铁皮石斛多糖组(150mg/kg)、中剂量铁皮石斛多糖组(300mg/kg)和高剂量铁皮石斛多糖组(600mg/kg)均能够降低大鼠体重,说明铁皮石斛多糖能够显著降低大鼠体重。
表1铁皮石斛多糖对代谢综合征大鼠体重的影响
2.8对大鼠体内脂肪含量的影响如表2所示,在第8周时,与正常对照组相比,模型对照组大鼠体内脂肪含量增加,与模型对照组相比,低剂量铁皮石斛多糖组(150mg/kg)、中剂量铁皮石斛多糖组(300mg/kg)和高剂量铁皮石斛多糖组(600mg/kg)均能够降低大鼠体内脂肪含量,说明铁皮石斛多糖显著降低了大鼠体内脂肪含量。
表2铁皮石斛多糖对代谢综合征大鼠体内脂肪含量的影响
2.9对大鼠血清脂类水平含量的影响如表3所示,与正常对照组相比,模型对照组的各项指标表明,果糖引起了大鼠血脂紊乱,表现为总胆固醇(TG)、甘油三酯(TC)、低密度脂蛋白胆固醇(LDL-C)含量的显著升高以及高密度脂蛋白胆固醇(HDL-C)水平的显著降低。低剂量铁皮石斛多糖组(150mg/kg)、中剂量铁皮石斛多糖组(300mg/kg)和高剂量铁皮石斛多糖组(600mg/kg)以及盐酸吡格列酮组的结果表明:与模型对照组相比,铁皮石斛多糖和盐酸吡格列酮均降低了TG、TC和LDL-C水平;以及升高HDL-C水平。
表3铁皮石斛多糖对代谢综合征大鼠体内脂肪含量的影响
2.10对大鼠血清葡萄糖、瘦素、脂联素和肿瘤坏死因子(TNF-α)水平的影响如表4所示,与正常对照组相比,模型对照组的各项指标表明,果糖引起了大鼠血糖、血清瘦素和TNF-α水平的显著升高,而脂联素水平显著下降。低剂量铁皮石斛多糖组(150mg/kg)、中剂量铁皮石斛多糖组(300mg/kg)和高剂量铁皮石斛多糖组(600mg/kg)以及盐酸吡格列酮组的结果表明:与模型对照组相比,铁皮石斛多糖和盐酸吡格列酮明显逆转了上述变化。
表4铁皮石斛多糖对代谢综合征大鼠体内脂肪含量的影响
2.11对大鼠尾部静脉收缩压的影响如图1所示,与正常对照组相比,模型对照组中果糖引起大鼠尾部静脉收缩压的显著升高。低剂量铁皮石斛多糖组(150mg/kg)、中剂量铁皮石斛多糖组(300mg/kg)和高剂量铁皮石斛多糖组(600mg/kg)以及盐酸吡格列酮组的结果表明:与模型对照组相比,铁皮石斛多糖和盐酸吡格列酮均显著抑制了果糖诱导的收缩压升高。
2.12由以上结果可知,盐酸吡格列酮可以改善血糖水平和血脂水平的异常变化,但对体重和脂肪则没有作用,说明西药盐酸吡格列酮对代谢综合征的治疗作用单一。而铁皮石斛多糖不仅改善血糖和血脂指标,还可显著降低肥胖大鼠的体重和脂肪含量,显示了中药多靶点的优势。
由此,本发明的有益效果在于:
1、本发明中的铁皮石斛作为一种天然药物和食物,其作为传统药物和食物使用的时间久远,即铁皮石斛作为药物和保健品使用安全性高;
2、本发明提供的铁皮石斛多糖具有较好的防治代谢综合征效果,从而能够将铁皮石斛多糖作为防治代谢综合征药物或防治代谢综合征保健品而用于制药生产或保健品生产,进而拓宽了防治代谢综合征天然药物和保健品的来源。
实施例3铁皮石斛多糖片剂
3.1提取:按实施例1所述的提取方法从铁皮石斛中提取铁皮石斛多糖,将所得到的提取液浓缩得到稠膏状铁皮石斛多糖,干燥备用;
3.2制粒:取上述稠膏状铁皮石斛多糖10g,加45g微晶纤维素、4.2g硬脂酸及15g微粉硅胶混匀并制成湿颗粒;
3.3干燥:将上述制得的湿颗粒放在干燥箱中干燥6h;
3.4压片:加入硬脂酸镁0.8g,混匀,压片制成含量一致的1000片即得1000片所述片剂。
实施例4铁皮石斛多糖口服液制剂
4.1提取:按实施例1所述的提取方法从铁皮石斛中提取铁皮石斛多糖,将所得到的提取液浓缩得到稠膏状铁皮石斛多糖,干燥备用;
4.2在10g上述稠膏状铁皮石斛多糖中加入少量蒸馏水,稍加热,不断搅拌使之溶解为铁皮石斛多糖溶液;
4.3将3g柠檬酸和1g苯甲酸钠溶解于少量蒸馏水中,并加入到铁皮石斛多糖溶液中,搅拌混匀得到混合溶液;
4.4在上述混合溶液中加蒸馏水至1000ml,搅拌使之溶解成透明溶液;
4.5将透明溶液过滤除去不溶性杂质,得到透明均一的液体制剂;
4.6在无菌条件下分装于消过毒的10ml安培瓶中密封保存,即得铁皮石斛多糖口服液制剂。
上述实施例和图式并非限定本发明的产品形态和式样,任何所属技术领域的普通技术人员对其所做的适当变化或修饰,皆应视为不脱离本发明的专利范畴。
Claims (8)
1.铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用。
2.根据权利要求1所述的铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,其特征在于:所述铁皮石斛多糖通过水提醇沉法提取:将铁皮石斛洗净后每次加10~15倍体积的水进行煎煮,煎煮2~4次,每次2~5小时,得到铁皮石斛药液;将每次煎煮得到的铁皮石斛药液过滤后,合并多次煎煮所得的铁皮石斛药液,减压浓缩获得浸膏;再用95%乙醇沉淀3~5次,加水溶解,加Sevage试剂脱蛋白后再加95%乙醇沉淀,真空干燥即得铁皮石斛多糖。
3.根据权利要求1所述的铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,其特征在于:所述防治代谢综合征药物为单一成分的铁皮石斛多糖,或为所述铁皮石斛多糖与填充剂、粘合剂、润湿剂、崩解剂、吸收促进剂、溶剂、表面活性剂、香味剂、防腐剂、润滑剂、甜味剂和色素中的一种或多种组成的片剂,或为所述铁皮石斛多糖与缓冲剂、抗氧增效剂、矫味剂、甜味剂、溶剂、表面活性剂和防腐剂中的一种或多种组成的口服液制剂。
4.根据权利要求1所述的铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,其特征在于:所述防治代谢综合征保健品为单一成分的铁皮石斛多糖,或为所述铁皮石斛多糖与填充剂、粘合剂、润湿剂、崩解剂、吸收促进剂、溶剂、表面活性剂、香味剂、防腐剂、润滑剂、甜味剂和色素中的一种或多种组成的片剂,或为所述铁皮石斛多糖与缓冲剂、抗氧增效剂、矫味剂、甜味剂、溶剂、表面活性剂和防腐剂中的一种或多种组成的口服液制剂。
5.根据权利要求3或者权利要求4所述的铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,其特征在于:以每1000片计,所述片剂的组分如下:
铁皮石斛多糖10g、微晶纤维素45g、硬脂酸4.2g、乳糖30g、微粉硅胶15g及硬脂酸镁0.8g,所述微晶纤维素和所述乳糖为填充剂,所述硬脂酸和所述微粉硅胶为表面活性剂,所述硬脂酸镁为润滑剂。
6.根据权利要求5所述的铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,其特征在于:所述片剂的制备方法如下:取10g铁皮石斛多糖、45g微晶纤维素、4.2g硬脂酸、30g乳糖及15g微粉硅胶混匀并制成颗粒,接着于颗粒中加入0.8g硬脂酸镁,混匀,压片制成含量一致的所述片剂。
7.根据权利要求3或者权利要求4所述的铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,其特征在于:所述口服液制剂的组分如下,以口服液制剂的体积为1000mL计:
铁皮石斛多糖10g、柠檬酸3g及苯甲酸钠1g,余量为水;所述柠檬酸为缓冲剂、矫味剂和抗氧增效剂,所述苯甲酸钠为防腐剂。
8.根据权利要求7所述的铁皮石斛多糖在制备防治代谢综合征药物及防治代谢综合征保健品中的应用,其特征在于:所述口服液制剂的制备方法如下:取10g铁皮石斛多糖、3g柠檬酸及1g苯甲酸钠混匀形成混合物,接着于上述混合物中加水至1000ml,搅拌混匀,过滤除去杂质,最后在无菌条件下分装至安瓿瓶中得所述口服液制剂。
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