CN108969620A - 兼具抗氧化和抑制肝组织纤维化功能的药物及其制备方法 - Google Patents
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Abstract
本发明提供了兼具抗氧化和抑制肝组织纤维化功能的药物及其制备方法,该药物由如下中药成分制成:臭参、茴心草、旱田草、椰子;该药物由原粉或提取物制成;该药物由原粉制成时各组分含量如下:臭参原粉:30‑80%、茴心草原粉:15‑40%、旱田草原粉:5‑30%、余量为椰子原粉;该药物由提取物制成时各组分含量如下:臭参提取物:0.02‑10g/ml、茴心草提取物:0.02‑10g/ml、旱田草提取物:0.02‑10g/ml、椰子提取物:0.02‑10g/ml;本发明提供的药物能够使AD模型小鼠肝脏中的MAO降低,可以抑制肝组织纤维化;能够使AD模型小鼠血清中的MDA降低,具有一定的抗氧化效果。
Description
技术领域
本发明涉及医药技术领域,具体涉及兼具抗氧化和抑制肝组织纤维化功能的药物及其制备方法。
背景技术
阿尔茨海默病(AD)是一种起病隐匿的进行性发展的神经系统退行性疾病。临床上以记忆障碍、失语、失用、失认、视空间技能损害、执行功能障碍以及人格和行为改变等全面性痴呆表现为特征,病因迄今未明。65岁以前发病者,称早老性痴呆;65岁以后发病者称老年性痴呆。
肝纤维化是一个病理生理过程,是指由各种致病因子所致肝内结缔组织异常增生。任何肝脏损伤在肝脏修复愈合的过程中都有肝纤维化的过程,如果损伤因素长期不能去除,纤维化的过程长期持续就会发展成肝硬化。因此它不是一个独立的疾病。
在公开日为2018年9月4日公开的一篇中国公开的专利文件CN108478547A中公开了一种用于治疗阿尔兹海默症的药物及其制备方法,该药物的各个组成成分及其所占的质量百分比分别为:冰片15%、丹参酮IIA 4%、隐丹参酮4%、PLGA聚合物77%。本发明还公开了一种用于治疗阿尔兹海默症的药物的制备方法。本发明将载药纳米粒联合冰片使用,能够可逆性开发BBB,提高药物脑内浓度,改善AD治疗效果。将丹参中的脂溶性组分TanIIA和CTan作为模型药物制备聚合物载药纳米粒治疗AD;可对AD进行多靶点联合干预治疗。将聚乳酸-羟基乙酸PLGA作为纳米材料对模型药物进行包裹,具有生物可降解性、提高生物利用度、增强靶向性等优势,在药物释放的载体方面展示出巨大的应用潜力。
但现有治疗阿尔兹海默症的药物通常存在抗氧化性能低,治疗作用差的缺陷。
发明内容
针对现有技术中存在的问题,本发明提供了兼具抗氧化和抑制肝组织纤维化功能的药物及其制备方法,有效的弥补了现有技术存在的缺陷。
为实现以上目的,本发明通过以下技术方案予以实现:
兼具抗氧化和抑制肝组织纤维化功能的药物,该药物由如下中药成分制成:臭参、茴心草、旱田草、椰子。
优选的,所述药物由上述中药原粉或中药提取物制成。
优选地,所述药物由中药原粉制成时各组分含量如下:臭参原粉:30-80%、茴心草原粉:15-40%、旱田草原粉:5-30%、余量为椰子原粉。
兼具抗氧化和抑制肝组织纤维化功能的药物,该药物由原粉制成时,其制备方法包括如下几个步骤:
1)将臭参低温冷冻干燥后,采用机械冲击式粉碎机粉碎5-10min,过100-120目筛,得到臭参原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
2)取新鲜茴心草,洗净、分拣除杂、自然阴干后,采用机械冲击式粉碎机粉碎5-10min,过100-120目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
3)取新鲜旱田草,洗净、除杂、低温冷冻干燥后,采用机械冲击式粉碎机粉碎5-10min,过100-120目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
4)将二分之一椰子榨汁,微沸30min后,浓缩,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,冷冻干燥后粉碎,参照步骤1)中的方法制备椰肉原粉,将椰子冻干粉和椰肉原粉混合得椰子原粉;
5)将上述步骤所得原粉混合均匀,包装成粉剂、片剂或胶囊,即得。
优选的,所述药物由中药提取物制成时各组分含量如下:臭参提取物:0.02-10g/ml、茴心草提取物:0.02-10g/ml、旱田草提取物:0.02-10g/ml、椰子提取物:0.02-10g/ml。
优选的,中药提取物的制备方法为水提法或醇提法;
其中,水提法的步骤为:称取10-15g原料,按照液料比10:1加水,微沸30-35min后,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得水提取物;
其中,醇提法的步骤为:取新鲜原料或冷冻低温干燥鲜叶,粉碎后,加入质量分数为60-100%的乙醇回流、过滤,将滤液减压浓缩,得茴心草醇提取物。
兼具抗氧化和抑制肝组织纤维化功能的药物,该药物由提取物制成时,其制备方法包括如下几个步骤:
1)取臭参鲜根或鲜根冷冻低温干燥,粉碎后,加入质量分数为60-100%的乙醇回流、过滤,将滤液减压浓缩,得臭参醇提取物;
2)称取茴心草粉末10-15g,按照液料比10:1加水,微沸30-35min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得茴心草水提取物;
3)称取旱田草粉末10-15g,按照液料比10:1加水,微沸30-35min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得旱田草水提取物;
4)将二分之一椰子榨汁,微沸30min后,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,用匀浆机打碎后,过滤得滤液,将椰子汁冻干粉与滤液合并,低温减压浓缩,得椰子提取物;
5)取上述步骤所得提取物混合均匀,包装制成饮料、口服液、软胶囊或滴丸,即得。
本发明的有益效果是:
臭参性味甘,微苦,具有加强脾胃蠕动作用,促进肠道吸收,改善肠道环境,提高耐疲劳,耐缺氧能力。
茴心草含有挥发油和氨基酸等成分,能有效扩张脑血管,改善脑的血液循环,增强患者的反应性、兴奋性和记忆力,对阿尔茨海默病的认知障碍及部分精神症状具有明显的改善作用。
此外,本发明提供的药物能够使AD模型小鼠肝脏中的MAO降低,可以抑制肝组织纤维化;能够使AD模型小鼠血清中的MDA降低,具有一定的抗氧化效果。
附图说明
图1为小鼠完成水迷宫时间图;
图2为小鼠大脑切片观察;
其中:
A:药物治疗组脑切片;B:阳性对照组脑切片;C、D:模型组脑切片;E、F:健康小鼠脑切片。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例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:
兼具抗氧化和抑制肝组织纤维化功能的药物,药物由如下中药成分制成:臭参原粉:30%、茴心草原粉:15%、旱田草原粉:30%、椰子原粉:25%。
制备方法包括如下几个步骤:
1)将臭参低温冷冻干燥后,采用机械冲击式粉碎机粉碎10min,过100目筛,得到臭参原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
2)取新鲜茴心草,洗净、分拣除杂、自然阴干后,采用机械冲击式粉碎机粉碎10min,过100目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
3)取新鲜旱田草,洗净、除杂、低温冷冻干燥后,采用机械冲击式粉碎机粉碎10min,过100目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
4)将二分之一椰子榨汁,微沸30min后,浓缩,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,冷冻干燥后粉碎,参照步骤1)中的方法制备椰肉原粉,将椰子冻干粉和椰肉原粉混合得椰子原粉;
5)将上述步骤所得原粉混合均匀,包装成粉剂、片剂或胶囊,即得。
实施例2:
兼具抗氧化和抑制肝组织纤维化功能的药物,药物由如下中药成分制成:臭参原粉:80%、茴心草原粉:15%、旱田草原粉:5%。
制备方法包括如下几个步骤:
1)将臭参低温冷冻干燥后,采用机械冲击式粉碎机粉碎5min,过120目筛,得到臭参原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
2)取新鲜茴心草,洗净、分拣除杂、自然阴干后,采用机械冲击式粉碎机粉碎5min,过120目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
3)取新鲜旱田草,洗净、除杂、低温冷冻干燥后,采用机械冲击式粉碎机粉碎5min,过120目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
4)将上述步骤所得原粉混合均匀,包装成粉剂、片剂或胶囊,即得。
实施例3:
兼具抗氧化和抑制肝组织纤维化功能的药物,药物由如下中药成分制成:40%、旱田草原粉:20%、椰子原粉:10%。
制备方法包括如下几个步骤:
1)将臭参低温冷冻干燥后,采用机械冲击式粉碎机粉碎10min,过100目筛,得到臭参原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
2)取新鲜茴心草,洗净、分拣除杂、自然阴干后,采用机械冲击式粉碎机粉碎10min,过100目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
3)取新鲜旱田草,洗净、除杂、低温冷冻干燥后,采用机械冲击式粉碎机粉碎10min,过100目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
4)将二分之一椰子榨汁,微沸30min后,浓缩,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,冷冻干燥后粉碎,参照步骤1)中的方法制备椰肉原粉,将椰子冻干粉和椰肉原粉混合得椰子原粉;
5)将上述步骤所得原粉混合均匀,包装成粉剂、片剂或胶囊,即得。
实施例4:
兼具抗氧化和抑制肝组织纤维化功能的药物,药物由如下中药成分制成:臭参提取物:0.02g/ml、茴心草提取物:0.02g/ml、旱田草提取物:0.02g/ml、椰子提取物:0.02g/ml。
制备方法包括如下几个步骤:
1)取臭参鲜根或鲜根冷冻低温干燥,粉碎后,加入质量分数为60%的乙醇回流、过滤,将滤液减压浓缩,得臭参醇提取物;
2)称取茴心草粉末15g,按照液料比10:1加水,微沸30min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得茴心草水提取物;
3)称取旱田草粉末15g,按照液料比10:1加水,微沸30min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得旱田草水提取物;
4)将二分之一椰子榨汁,微沸30min后,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,用匀浆机打碎后,过滤得滤液,将椰子汁冻干粉与滤液合并,低温减压浓缩,得椰子提取物;
5)取上述步骤所得提取物混合均匀,包装制成饮料、口服液、软胶囊或滴丸,即得。
实施例5:
兼具抗氧化和抑制肝组织纤维化功能的药物,药物由如下中药成分制成:臭参提取物:10g/ml、茴心草提取物:10g/ml、旱田草提取物:10g/ml、椰子提取物:10g/ml。
制备方法包括如下几个步骤:
1)取臭参鲜根或鲜根冷冻低温干燥,粉碎后,加入质量分数为60-100%的乙醇回流、过滤,将滤液减压浓缩,得臭参醇提取物;
2)称取茴心草粉末10g,按照液料比10:1加水,微沸35min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得茴心草水提取物;
3)称取旱田草粉末10g,按照液料比10:1加水,微沸35min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得旱田草水提取物;
4)将二分之一椰子榨汁,微沸30min后,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,用匀浆机打碎后,过滤得滤液,将椰子汁冻干粉与滤液合并,低温减压浓缩,得椰子提取物;
5)取上述步骤所得提取物混合均匀,包装制成饮料、口服液、软胶囊或滴丸,即得。
按照上述实施例配方制得药物,随后进行以下药物对阿尔兹海默症的作用实验。利用D-半乳糖建立阿尔兹海默症模型。利用该药物进行治疗,用多奈哌齐进行治疗多奈哌齐进行治疗作为阳性对照,得到以下结果。
表1血清中MDA变化
药物能够使AD模型小鼠血清中的MDA降低,具有一定的抗氧化效果。
表2肝组织MAO变化
药物能够使AD模型小鼠肝脏中的MAO降低,可以抑制肝组织纤维化。
表3脑组织MAO变化
药物能够使AD模型小鼠脑组织中的MAO降低,可以抑制脑组织纤维化。
表4脑组织中GSH-PX变化
药物治疗组与阳性对照组的小鼠相较于模型组小鼠脑组织部分的GPX活力出现了显著提高,接近空白组,并且治疗组数据与对照组数据之间不显著,说明药物有一定程度的抗氧化能力,与阳性对照药物接近。
表5 T-SOD Dunnett-t检测
药物治疗组与阳性对照组的小鼠相较于模型组小鼠脑组织部分的SOD活力出现了明显提高,但略低于空白组,并且有显著性,其中治疗组小鼠的平均SOD活力略低于对照组SOD活力,说明药物有抗氧化的能力,且抗氧化能力与对照组药物相近。
由图1可知,通过拍摄的视频观察,模型组小鼠不仅找到平台的时间长,有些时候甚至120s时限到达以后也不能找到平台,在寻找平台的过程中模型组小鼠经常会出现放弃寻找,放弃游泳的行为,同时游泳时小鼠也不能做到身体协调,身体有时并不能达到平衡。而治疗组小鼠,在下水后表现十分活跃,一直进行游泳,直至找到平台,游泳时身体协调,能保持平衡。
药物治疗组小鼠和阳性对照组小鼠经过5天的训练,由最初的40s左右找到平台到第五天时平均能在3s左右找到平台,并且可以看到,治疗组和对照组小鼠上平台时间趋势相似,经过训练后均有明显下降,而模型组两只小鼠不仅第一天寻找时间较长,在训练后,寻找时间下降也不明显,21号小鼠甚至有大幅度反弹,说明这两只小鼠在记忆力和求生欲望方面也弱于治疗组与对照组小鼠。
由图2可知,从光学显微镜下,可以发现,模型组小鼠(C图和D图)海马体部分染色较浅,说明神经元细胞有明显减少,存在衰老现象。而治疗组(A图和B图)小鼠海马体部分染色较深,轮廓清晰,与正常健康小鼠(E图和F图)相似,可以看出核仁没有萎缩或者变少,神经元细胞排列紧密,说明有较好的治疗效果。
综上所述,该药物对阿尔兹海默症具有一定治疗作用。
以上实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
Claims (7)
1.兼具抗氧化和抑制肝组织纤维化功能的药物,其特征在于,所述药物由如下中药成分制成:臭参、茴心草、旱田草、椰子。
2.根据权利要求1所述的兼具抗氧化和抑制肝组织纤维化功能的药物,其特征在于,所述药物由上述中药原粉或中药提取物制成。
3.根据权利要求2所述的兼具抗氧化和抑制肝组织纤维化功能的药物,其特征在于,所述药物由中药原粉制成时各组分含量如下:臭参原粉:30-80%、茴心草原粉:15-40%、旱田草原粉:5-30%、余量为椰子原粉。
4.一种根据权利要求3所述兼具抗氧化和抑制肝组织纤维化功能的药物的制备方法,其特征在于,包括如下几个步骤:
1)将臭参低温冷冻干燥后,采用机械冲击式粉碎机粉碎5-10min,过100-120目筛,得到臭参原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
2)取新鲜茴心草,洗净、分拣除杂、自然阴干后,采用机械冲击式粉碎机粉碎5-10min,过100-120目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
3)取新鲜旱田草,洗净、除杂、低温冷冻干燥后,采用机械冲击式粉碎机粉碎5-10min,过100-120目筛,得到药物原粉,随后再用超微粉碎机粉碎,过300目筛得到药物超微粉,包装成粉剂、片剂或胶囊;
4)将二分之一椰子榨汁,微沸30min后,浓缩,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,冷冻干燥后粉碎,参照步骤1)中的方法制备椰肉原粉,将椰子冻干粉和椰肉原粉混合得椰子原粉;
5)将上述步骤所得原粉混合均匀,包装成粉剂、片剂或胶囊,即得。
5.根据权利要求2所述的兼具抗氧化和抑制肝组织纤维化功能的药物,其特征在于,所述药物由中药提取物制成时各组分含量如下:臭参提取物:0.02-10g/ml、茴心草提取物:0.02-10g/ml、旱田草提取物:0.02-10g/ml、椰子提取物:0.02-10g/ml。
6.根据权利要求5所述的兼具抗氧化和抑制肝组织纤维化功能的药物,其特征在于,所述中药提取物的制备方法为水提法或醇提法;
其中,水提法的步骤为:称取10-15g原料,按照液料比10:1加水,微沸30-35min后,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得水提取物;
其中,醇提法的步骤为:取新鲜原料或冷冻低温干燥鲜叶,粉碎后,加入质量分数为60-100%的乙醇回流、过滤,将滤液减压浓缩,得茴心草醇提取物。
7.一种根据权利要求6所述兼具抗氧化和抑制肝组织纤维化功能的药物的制备方法,其特征在于,包括如下几个步骤:
1)取臭参鲜根或鲜根冷冻低温干燥,粉碎后,加入质量分数为60-100%的乙醇回流、过滤,将滤液减压浓缩,得臭参醇提取物;
2)称取茴心草粉末10-15g,按照液料比10:1加水,微沸30-35min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得茴心草水提取物;
3)称取旱田草粉末10-15g,按照液料比10:1加水,微沸30-35min,取滤液,随后将滤渣重复加水、微沸、取滤液操作,反复三次,合并三次滤液,得旱田草水提取物;
4)将二分之一椰子榨汁,微沸30min后,低温干燥得椰子汁冻干粉,将剩余椰子椰肉取出,用匀浆机打碎后,过滤得滤液,将椰子汁冻干粉与滤液合并,低温减压浓缩,得椰子提取物;
5)取上述步骤所得提取物混合均匀,包装制成饮料、口服液、软胶囊或滴丸,即得。
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