CN114344326A - 植物果胶在治疗痛风症的制品中的应用 - Google Patents
植物果胶在治疗痛风症的制品中的应用 Download PDFInfo
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- CN114344326A CN114344326A CN202111445006.6A CN202111445006A CN114344326A CN 114344326 A CN114344326 A CN 114344326A CN 202111445006 A CN202111445006 A CN 202111445006A CN 114344326 A CN114344326 A CN 114344326A
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- pectin
- parts
- gout
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- A—HUMAN NECESSITIES
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- Medicinal Preparation (AREA)
Abstract
本发明提供了植物果胶片剂制品及其制备方法,包括植物果胶、麦芽糖糊精、超微稻壳粉、填充剂、崩解剂、润滑剂。本发明制备的果胶片剂形成一类新的具有治疗痛风作用的组合物,为痛风患者的治疗开辟了新的方向。制备该治疗痛风的组合物的原料均可用于食品,无副作用,制备方法简单易行,便于工业化生产。该植物果胶片剂一种辅料量小、果胶分散均匀、片剂崩解性好、片剂稳定性好、生物利用度高的能有效治疗痛风的片剂。本发明提供了果胶在制备抗高尿酸血症和抗痛风保健食品中的应用,扩大了抗高尿酸血症和抗痛风药物或保健食品的资源范围。
Description
技术领域
本发明属于天然产物活性成分提取以及应用领域,具体涉及植物果胶在治疗痛风症的制品中的应用。
背景技术
痛风是一组嘌呤代谢紊乱所致的疾病,其临床特点为高尿酸血症及由此而引起的痛风性急性关节炎反复发作、痛风石沉积、痛风石性慢性关节炎和关节畸形,常累及肾脏,引起慢性间质性肾炎和尿酸肾结石形成。痛风可分原发性和继发性两大类。原发性痛风指在排除其他疾病的基础上,由于先天性嘌呤代谢紊乱和(或)尿酸***障碍所引起;原发性者少数由于酶缺陷引起,常伴高脂血症、肥胖、糖尿病、高血压病、动脉硬化和冠心病等。继发性者可由肾脏病、血液病及药物等多种原因引起。
当血中尿酸浓度长期高于7.8毫克/100C.C,医学上就称为“高尿酸血症”。血中尿酸会因为尿酸的产量过多而***减少而升高,引起尿酸产量过多的原因包括先天性代谢异常、淋巴增生疾病等,这些原因占引起高尿酸血症的百分之十左右。而引至尿酸***减少的原因则包括肾功能障碍和药物引起的不良尿酸***。高尿酸血症是引起痛风的主因。研究指出在男性身上,血尿酸浓度愈高者,出现痛风症状的机会愈高。
现代医学对痛风的治疗方法多以消炎止痛、促进尿酸盐***、降低血尿酸为主。目前,对于痛风与高尿酸血症的常规治疗仍以西药为主,西医治疗痛风的药物为抗炎药和降尿酸药两大类。这些药物以不同的途径能够达到缓解或治疗痛风与高尿酸血症的目的,但通过临床观察发现,此类药物对胃肠道、肝脏、肾脏功能有损害,毒副作用大,不能依赖性服用;若病人长期服用,可导致骨髓抑制,肝细胞坏死,神经性反应和胃肠道不良反应。
果胶是人类自然饮食的一部分,一般从柑橘皮、苹果皮、葡萄皮、蚕砂和甜菜渣等植物细胞中提取。果胶的80%~90%用于食品工业,利用其凝胶性生产胶冻、果酱和软糖。还可用在医药方面作止血剂和***,也可用来治疗腹泻和重金属中毒等。果胶是羟基被不同程度甲酯化的线性聚半乳糖醛酸和聚L-鼠李糖半乳糖醛酸,其是FAO/WHO食品添加剂联合委员会推荐的安全无毒的天然食品添加剂,且无每日添加量限制。
发明内容
本发明的目的是提供一种植物果胶在治疗痛风症制品中的应用,并提供该制品的一种产品形式以及生产方式。
果胶是一种由D-半乳糖醛酸通过α-(1-4)糖苷键与半乳糖、鼠李糖和***糖等中性糖连接并聚合而形成的高分子多糖。苹果果胶含有部分甲氧基和乙酰基,具有一般果胶的结构;苹果果胶中除半乳糖醛酸外含有8种单糖,鼠李糖、岩藻糖、果糖、***糖、木糖、甘露糖、葡萄糖和半乳糖。柑橘果胶是一种以半乳糖为主要成分的多糖,分子量小,无抗原性,水溶性好;柑橘果胶中有鼠李糖、***糖、木糖、葡萄糖和半乳糖,柑橘皮中果胶含量为30%-35%。柚皮,特别是白皮层中果胶含量特别高。甜菜渣中果胶含量为16%-21%,因其分子量相对低,存在乙酸酯化,并且有大量的中性糖侧链,影响了甜菜渣果胶的内在质量稍差于柑橘果胶或苹果果胶。向日葵盘的果胶含量为17%-25%,其半乳糖醛酸含量为66%-80%;向日葵盘果胶具有典型的低甲氧基果胶特征。菠萝皮果胶含有乙酰基且为低酯果胶,含有鼠李糖、***糖、木糖、甘露糖、葡萄糖及半乳糖,以木糖及半乳糖居多。
为达到上述目的,本发明提供了一种植物果胶在治疗痛风症制品中的应用。
作为优选,所述植物果胶通过降低尿酸含量以及溶解痛风石来治疗痛风症。
本发明还提供了一种用于治疗痛风症的制品,以上述技术方案所述的植物果胶为主要有效成分,所述制品中植物果胶含量的占比超过80%。
作为优选,所述植物果胶选自苹果果胶、柑橘果胶、柚子果胶、菠萝果胶、芒果果胶、向日葵果胶、甜菜果胶中的至少一种,优选柑橘果胶。
作为优选,所述植物果胶的主链为α-(1,2)-D-半乳糖醛酸-α-(1,4)-L-鼠李糖组成的二糖重复单元,支链为含有直链和支链的a-L-***糖和/或b-D-半乳糖残基的聚合物形成的不同链长的***聚糖和***半乳聚糖,所述果胶的平均分子量为50,000-200,000。
作为优选,所述制品为片剂制品,由以下重量份的原料组分组成:植物果胶450-465份、麦芽糖糊精20-25份、超微稻壳粉10-50份、填充剂1-5份、崩解剂10-30份和润滑剂5-10份。
作为优选,所述填充剂为淀粉,或者淀粉与乳糖、木糖醇、山梨醇中的至少一种;所述崩解剂为微晶纤维素、羧甲基淀粉钠、聚维酮中的至少一种;所述润滑剂为硬脂酸镁、硬脂酸、二氧化硅的至少一种。
作为优选,所述制品通过降低尿酸含量以及溶解痛风石来治疗痛风症。
作为优选,所述制品的每日用量为每次3.0g,每日2次。
本发明还提供了一种根据上述技术方案所述的用于治疗痛风症的制品的制备方法,包括如下步骤:
a)以重量份计,将植物果胶450-465份、麦芽糖糊精20-25份、填充剂1-5份、崩解剂10-30份和润滑剂5-10份过100目筛,备用;
b)以重量份数计,将超微稻壳粉10-50份边研磨边加入a)中所得原料粉,充分混匀;
c)将b)中混匀的混合粉过100目筛,于1-10KN压力下压片,得到用于治疗痛风症的制品。
本发明的优点和技术效果:
果胶是一种天然的植物多糖,主要是一类以D-半乳糖醛酸(D-GalacturonicAcids,D-Gal-A)由α-1,4-糖苷键连接组成的酸性杂多糖,具有复杂的三维分子结构,有较强的生物活性,可应用于食品、医药保健品和化妆品。
目前压片技术多采用干法压片和湿法压片,均需要先将原料制粒后再压片,其中制粒过程中部分原料黏在制粒设备上而损耗,制得颗粒筛分时,也有部分粒度不合适的原料损耗,加工工艺复杂,周期长且损耗偏大。超微稻壳粉是一种纳米级超微稻壳粉末,其粒度均匀,粒径为10μm,经处理后形成一种可压性极高的可压性能,同时能提高果胶的可压性,与其他干燥辅料粉末混合后可直接压片,在1-10kN条件下即可成片,无需制粒,制得片剂崩解时间短,硬度适中,可大大缩短生产周期,提高效率,无原料损耗,降低生产成本。
本发明经过临床试验验证,本发明所用植物果胶能够有效降低病患尿酸含量并且溶解痛风石,从而有效改善痛风症状。果胶可促进尿酸盐的***,降低血尿酸浓度,所以,果胶应用到治疗痛风症的制品中无毒副作用,可长期服用,并且具有良好疗效,具有很大优势及良好前景。
本发明制备的果胶制品是一种新的具有治疗痛风作用的制剂,为痛风患者的治疗开辟了新的方向。制备该治疗痛风症制剂的原料均可用于食品,因此,无副作用,制备方法简单易行,便于工业化生产。该植物果胶片剂一种辅料量小、果胶分散均匀、片剂崩解性好、片剂稳定性好、生物利用度高的能有效治疗痛风症的片剂。本发明提供了果胶在制备抗高尿酸血症和抗痛风保健食品中的应用,扩大了抗高尿酸血症或抗痛风药物的资源范围。
具体实施方式
下面结合具体实施例进一步解释和说明本发明。
实施例1
按重量份计,由以下原料组成:苹果果胶450份、超微稻壳粉50份、麦芽糖糊精25份、淀粉5份、微晶纤维素10份、二氧化硅5份和硬脂酸镁5份。
制备方法:
a)称取处方量的原料(除超微稻壳粉)过100目筛,备用;
b)称取处方量的超微稻壳粉,边研磨边加入a)中所述原料粉,充分混匀;
c)将b)中混匀的混合粉过100目筛,于1-10KN压力下压片,得到用于治疗痛风症的片剂制品。
实施例2
按重量份计,由以下原料组成:柑橘果胶455份、超微稻壳粉15份、麦芽糖糊精25份、淀粉5份、微晶纤维素15份和硬脂酸镁5份。
制备方法同实施例1。
实施例3
按重量份计,由以下原料组成:柚子果胶454份、超微稻壳粉20份、麦芽糖糊精25份、淀粉2份、微晶纤维素15份、二氧化硅1份和硬脂酸镁5份。
制备方法同实施例1。
实施例4
按重量份计,由以下原料组成:甜菜果胶460份、超微稻壳粉41份、麦芽糖糊精20份、淀粉3份、微晶纤维素15份和硬脂酸镁5份。
制备方法同实施例1。
实施例5
按重量份计,由以下原料组成:菠萝果胶455份、超微稻壳粉32份、麦芽糖糊精20份、淀粉5份、微晶纤维素10份、二氧化硅5份和硬脂酸镁5份。
制备方法同实施例1。
实施例6
按重量份计,由以下原料组成:向日葵果胶465份、超微稻壳粉10份、麦芽糖糊精22份、淀粉2份、微晶纤维素30份和硬脂酸镁5份。
制备方法同实施例1。
临床试验
实验方法:研究对象为从2016年1月至2016年10月在青岛某医院接受治疗的慢性痛风患者,共240例。年龄30-60岁,均为男性,符合痛风的诊断标准,无严重躯体疾病、酒精或药物依赖,无其他严重精神疾病。所有患者均签署知情同意书。
应用区组随机分组方法,病程相近的患者随机分入研究组和对照组。共8组,每组30例,分为研究组食用实施例和对照组(对照组:服用安慰片剂,服用量为每次3.0g,每日2次,对照组1,服用添加了1%姬松茸多糖的安慰剂,服用量为每次3.0g,每日2次)。8组患者年龄、血尿酸水平等差异均无统计学意义(P>0.05)。在治疗前及治疗2、4周后测定患者的血尿酸水平。
表1.研究组和对照组治疗前后血尿酸水平(±S,μmol/L)
组别 | N | 治疗前 | 治疗2周 | 治疗4周 |
实施例1 | 30 | 514.22±86.44 | 444.62±71.86<sup>**</sup> | 371.95±69.43<sup>**</sup> |
实施例2 | 30 | 510.28±87.15 | 462.71±73.54<sup>**</sup> | 389.45±70.13<sup>**</sup> |
实施例3 | 30 | 513.22±84.31 | 465.22±74.31<sup>**</sup> | 380.13±69.77<sup>**</sup> |
实施例4 | 30 | 508.28±84.46 | 441.27±74.26<sup>**</sup> | 377.49±71.03<sup>**</sup> |
实施例5 | 30 | 504.22±87.45 | 462.68±70.06<sup>**</sup> | 382.05±71.14<sup>**</sup> |
实施例6 | 30 | 511.22±86.45 | 448.25±69.47<sup>**</sup> | 379.44±68.24<sup>**</sup> |
对照组 | 30 | 509.28±84.46 | 496.47±80.41 | 482.96±72.36 |
对照组1 | 30 | 510.45±84.23 | 488.36±77.89 | 445.13±75.96 |
**P<0.01VS.治疗前
实验结果:研究组和对照组的血尿酸水平见表1所示。在治疗2、4周后,对照组与治疗前相比无明显差异;研究组与治疗前相比差异均有统计学意义,P<0.01。食用实施例的研究组,血尿酸明显降低,尤其在服用4周后已达正常范围内。说明此治疗痛风的组合物具有显著的治疗痛风的作用。同时,服用只添加姬松茸多糖的安慰剂的对照组1经过4周后,血尿酸含量比治疗前明显降低,效果比对照组显著。
痛风是一种常见且复杂的关节炎类型,各个年龄段均可能罹患本病,男性发病率高于女性。痛风发作与体内尿酸浓度有关,痛风会在关节腔等处形成尿酸盐沉积,激活机体自身的免疫***,进而引发急性关节疼痛。而夜间人体处于相对缺水状态下,从而使尿酸更容易沉积并在关节等部位聚集,引起痛风。痛风与嘌呤代谢紊乱及(或)尿酸***减少所致的高尿酸血症直接相关,属代谢性风湿病范畴。痛风可并发肾脏病变,严重者可出现关节破坏、肾功能损害,常伴发高脂血症、高血压病、糖尿病、动脉硬化及冠心病等。高尿酸血症(HUA)是痛风发生的基础。国际上HUA定义为:正常嘌呤饮食状态下,非同日两次空腹血尿酸水平:男性血尿酸>420μmol/L,女性血尿酸>360μmol/L。
结合上述表1数据可见,本申请所提供的植物果胶制剂在服用2周时,相比于治疗前是有明显改善的,但是尚未达到治疗作用。而在服用4周后,血尿酸水平回归到<420μmol/L,因此能够积极地起到治疗作用。
在本文的最后,发明人想说的是,现有技术中对于果胶与痛风症之间相关性的探讨已有不少记载,但是这些记载都还只是停留在理论或者动物模型试验水平上,并没有真正的运用到人体。可以知晓的是,动物和人的生理不是完全相同的,本质上有着显著差别,即便动物实验结果良好,也只能是可望在临床上有效果,为临床提供理论依据,并不能作为真正运用到人体的坚实基础。而且,如上所述,痛风属于代谢性风湿病范畴,与嘌呤代谢紊乱及(或)尿酸***减少所致的高尿酸血症直接相关,但尿酸含量并不是引起痛风的唯一因素,饮食、饮酒、高血压、高血糖、肥胖、药物等均有着密切作用,而且如果痛风是内源性发病,那么在动物模型实验中,仅通过外部给予物质进行相关验证,显然结果也并不具有科学指导性。
Claims (10)
1.植物果胶在治疗痛风症的制品中的应用。
2.根据权利要求1所述的应用,其特征在于,所述植物果胶通过降低尿酸含量以及溶解痛风石来治疗痛风症。
3.用于治疗痛风症的制品,其特征在于,以权利要求1或2所述的植物果胶为主要有效成分,所述制品中植物果胶含量的占比超过80%。
4.根据权利要求3所述的制品,其特征在于,所述植物果胶选自苹果果胶、柑橘果胶、柚子果胶、菠萝果胶、芒果果胶、向日葵果胶、甜菜果胶中的至少一种,优选柑橘果胶。
5.根据权利要求3所述的制品,其特征在于,所述植物果胶的主链为α-(1,2)-D-半乳糖醛酸-α-(1,4)-L-鼠李糖组成的二糖重复单元,支链为含有直链和支链的a-L-***糖和/或b-D-半乳糖残基的聚合物形成的不同链长的***聚糖和***半乳聚糖,所述果胶的平均分子量为50,000-200,000。
6.根据权利要求3-5任一项所述的制品,其特征在于,所述制品为片剂制品,由以下重量份的原料组分组成:植物果胶450-465份、麦芽糖糊精20-25份、超微稻壳粉10-50份、填充剂2-5份、崩解剂10-30份和润滑剂5-10份。
7.根据权利要求6所述的制品,其特征在于,所述填充剂为淀粉,或者淀粉与乳糖、木糖醇、山梨醇中的至少一种;所述崩解剂为微晶纤维素、羧甲基淀粉钠、聚维酮中的至少一种;所述润滑剂为硬脂酸镁、硬脂酸、二氧化硅的至少一种。
8.根据权利要求3-5任一项所述的制品,其特征在于,所述制品通过降低尿酸含量以及溶解痛风石来治疗痛风症。
9.根据权利要求3-5任一项所述的制品,其特征在于,所述制品的每日用量为每次3.0g,每日2次。
10.权利要求3-9任一项所述的用于治疗痛风症的制品的制备方法,其特征在于,包括如下步骤:
a)以重量份计,将植物果胶450-465份、麦芽糖糊精20-25份、填充剂1-5份、崩解剂10-30份和润滑剂5-10份过100目筛,备用;
b)以重量份数计,将超微稻壳粉10-50份边研磨边加入a)中所得原料粉,充分混匀;
c)将b)中混匀的混合粉过100目筛,于1-10KN压力下压片,得到用于治疗痛风症的制品。
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