CN105816798A - 一种保肝护肝的药物或保健食品组合物 - Google Patents
一种保肝护肝的药物或保健食品组合物 Download PDFInfo
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Abstract
本发明涉及一种保肝护肝的药用组合物或保健品。本发明在现有技术的基础上对配方,制备方法和辅料等进行了改进,特别是在制剂过程中加入了壳聚糖以及其他经过筛选的辅料和新的制备工艺,提供一种稳定性高,质量更容易控制,保质期长的具有保肝护肝功效的药物或保健食品组合物。本发明所述药物或保健食品组合物是由以下重量配比的中药原料药制成:野葛100‑1500份,枳椇子100‑1000份,丹参100‑1000份,甘草50‑800份,姜黄提取物1‑10份。
Description
技术领域
本发明涉及一种保肝护肝的药用组合物或保健品。
技术背景
肝脏是人体重要的五大生命器官之一,对维持人的正常生命活动有着不可替代的作用。肝脏也是人体最大的解毒器官,然而肝脏最敏感、脆弱。睡眠不足、肥胖、血糖过高、过度饮酒、吸烟、熬夜、滥用药物、油腻食品,都会加重肝脏的负担而伤害肝脏,进而转为慢性肝损伤、肝炎,最后发展为肝癌。肝脏疾病已经成为严重危害人体健康的“凶手”。由于肝病没有特别显著的症状,患者表现出的疲惫、腹胀、肚痛、黄疸、食欲不振、作呕、发烧等症状很容易被忽略,而被称为“最大的隐形杀手”,即使肝脏有点小毛病,也不会马上显露出来,因而早期发现肝病比较困难,然而,一旦显现出来就非常棘手。如近年来逐渐上升的脂肪肝、酒精肝已经成为一种严重影响人们身体健康的一种常见性疾病。保肝护肝对繁忙的现代人显得愈加重要。
现代医学在肝损伤的治疗方面并无特效药物,多采用休息、加强营养、补充维生素或对症治疗等。中药具有保健功能,通过辨证组方,科学配伍,寻找具有保肝护肝功效的复方中药保健食品,加强日常保健,防患于未然,对于预防肝病具有重要意义。
专利CN201410356846.9中涉及到了由葛根提取物、枳椇子提取物、丹参提取物、姜黄提取物、甘草酸铵组成的一种对酒精性肝损伤具有辅助保护作用的组合物及其制备方法,其中公开了组合物含有微晶纤维素、交联聚维酮、硬脂酸镁、糊精、蔗糖中的一种或几种辅料,或其他本领域常用的制剂辅料。本发明人经过研究发现,使用常规辅料和常规制备方法难以达到质量控制要求,特别有效成分是甘草酸铵不稳定,现有技术方法容易导致其降解,含量下降,造成保质期缩短。另外,专利CN201410356846.9使用的是市场上有售的原料,如葛根提取物、枳椇子提取物、丹参提取物、姜黄提取物、甘草酸铵等,这些原材料质量参差不齐,导致产品控制难度加大,常发生质量不达标的情况。
发明内容
本发明在现有技术的基础上对配方,制备方法和辅料等进行了改进,特别是在制剂过程中加入了壳聚糖以及其他经过筛选的辅料和新的制备工艺,提供一种稳定性高,质量更容易控制,保质期长的具有保肝护肝功效的药物或保健食品组合物。
本发明所述药物或保健食品组合物是由以下重量配比的中药原料药制成:
优选的由以下重量配比的中药原料药制成:
特别优选的由以下重量配比的中药原料药制成:
其中,野葛,枳椇子,丹参,甘草为药材,姜黄提取物为姜黄药材经过提取得到的姜黄提取物,姜黄提取物市场上有售,因其稳定性较高,市售产品足以满足制剂需求。
本发明所述的药物或保健食品组合物,其中含有作为辅助成分的壳聚糖5-15份,以及其他辅料。所述其他辅料如:三氯蔗糖,黄原胶,赤藓糖醇,淀粉,蔗糖,微晶纤维素、交联聚维酮、硬脂酸镁等。优选的为:三氯蔗糖,黄原胶,赤藓糖醇。
以上组成中,野葛,枳椇子,丹参,甘草的重量是以生药计算的,姜黄提取物则以提取物重量计算,以上组成可制成制剂1000剂,所述1000剂指,制成的成品制剂,如制成胶囊制剂1000粒,片剂1000片,颗粒剂1000克,口服液1000ml等。
以上组成,若以克为单位,可制成50-1000次服用剂量的制剂,如作为片剂,制成1000片,每次服用剂量可以是1-20片,共可服用50-1000次。如作为颗粒剂,制成125袋,每次服用1-2袋,共可服用62.5-125次。
以上组成是按重量份作为配比的,在生产时可按照相应比例增大或减少,如大规模生产可以以公斤为单位,或以吨为单位,小规模生产也可以以毫克为单位,重量可以增大或者减小,但各组成之间的生药材重量配比的比例不变。
以上重量配比的比例是经过科学筛选得到的,对于特殊病人,如重症或轻症,肥胖或瘦小的病人,可以相应调整组成的量的配比,增加或减少不超过100%,药效不变。
以上组成中的单味中药,尤其是臣药和佐药,也可以被适当的具有相同药性的中药替换,替换后的中药制剂其药物作用不变。
本发明的药物或保健食品组合物可以是任何可药用的剂型,这些剂型包括:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、膏剂、丹剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。本发明的制剂,优选的是口服剂型,如:胶囊剂、片剂、口服液、颗粒剂、丸剂、散剂、丹剂、膏剂等。最优选的是颗粒剂。
本发明的药物或保健食品组合物,其口服给药的制剂可含有常用的辅料,诸如粘合剂、填充剂、稀释剂、压片剂、润滑剂、崩解剂、着色剂、调味剂和湿润剂,本发明的制剂在使用时根据病人的情况确定用法用量,可每日服三次,每次1-20剂,如:1-20袋或粒或片。
本发明进一步提供本发明的药物或保健食品组合物的制备方法,所述方法,步骤如下:
本发明处方中的原料,以克为单位进行称量,枳椇子破碎,取葛根、破碎的枳椇子、丹参、甘草,加水提取,过滤,滤液浓缩得浸膏;将姜黄提取物和浸膏混合,加入壳聚糖和其他辅料,按照常规技术制备成制剂。
优选的,本发明的制备方法如下:取本发明处方中的原料,以克为单位进行称量,枳椇子破碎,取葛根、破碎的枳椇子、丹参、甘草,加水提取2次,第1次10倍量水,第2次加8倍量水,每次提取1.5h,200目过滤,合并滤液;取滤液减压浓缩(-0.08~-0.10MPa,60~70℃)至1.10~1.15(60℃测)的清膏,5000rpm/min离心,减压浓缩(-0.08~-0.10MPa,60~70℃)至1.25~1.30(60℃测)的稠膏;将稠膏减压干燥(-0.08~-0.10MPa,60~70℃),粉碎,过80目筛,得浸膏粉;姜黄提取物和浸膏粉混合,加入壳聚糖10g和其他辅料,按照常规技术制备成制剂。
以下通过实验数据说明本发明的有益效果:
本发明的核心技术在于在制剂过程中加入了壳聚糖,并意外的发现其对制剂中甘草酸铵具有稳定化作用,同时对丹参酮,葛根素以及枳椇子皂甙均有稳定化作用。
制剂稳定性实验:
表1恒温放置前的三种样品的含量测定结果
表2
在40℃温箱中放置6个月,三种样品中有关中药活性成分的含量
根据以上研究,表明本发明实施例1的制剂在稳定性上优于现有技术,特别是对甘草酸铵的稳定化作用上。
药效实验:
实验一:以CCl4制备肝损伤模型,
给药方法
小鼠随机分为正常对照组(常规饲料,饮自来水)、病理造模组(常规饲料,饮自来水)、本发明药物组(每天按体重1500mg/kg灌胃,自由饮水)、现有技术药物组(每天按体重1500mg/kg灌胃,自由饮水),每组10只。饲养7d,末次灌胃2h,正常对照组腹腔注射调和油溶液,其余各组腹腔注射0.15%CCl4调和油溶液(10ml/kg体重),24h后眼球取血,分离血清,用速率法测ALT、AST。实验结果:
1)对小鼠CCl4肝损伤模型鼠血清ALT和AST的影响
表1对小鼠CCl4肝损伤模型血清ALT和AST的影响:
分组 | ALT活性 | AST活性 |
正常对照 | 36.3±8.7 | 28.0±4.4 |
模型对照 | 199.3±18.4 | 120.0±2.8 |
本发明药物 | 188.8±20.1 | 106.6±6.4 |
现有技术药物 | 171.7±10.3 | 93.9±4.8 |
2)对小鼠CCl4肝损伤模型鼠肝体指数及肝匀浆MDA的影响
表2对CCl4肝损伤模型肝体指数及肝匀浆MDA的作用:
3)对CCl4肝损伤模型鼠SOD活性及GSH含量的影响
表3对CCl4肝损伤模型SOD活性及GSH含量的影响
分组 | SOD(U/mg pro) | GSH(mg/g pro) |
正常对照 | 23.74±4.21 | 33.82±5.14 |
模型对照 | 21.27±3.69 | 29.37±4.21 |
本发明药物 | 29.92±4.83 | 37.29±4.25 |
现有技术药物 | 31.54±4.47 | 35.61±4.81 |
结论:
综上,本发明的颗粒可通过降低CCl4肝损伤小鼠肝体指数,减轻炎性浸润,保护肝细胞膜和线粒膜的结构完整,降低血清中ALT和AST含量;诱导SOD的合成和增加GSH的含量,对抗脂质过氧化物的生成,降低MDA的含量并明显减轻肝细胞浊肿的程度,说明对肝实质损伤有保护作用,且强于现有技术药物。
具体实施方式
以下结合实施例对本发明进行详细说明。
实施例1:
野葛667g、枳椇子500g、丹参500g、甘草333g、姜黄提取物5g,辅料壳聚糖10g,三氯蔗糖1g、黄原胶30g、赤藓糖醇5g
1.前处理:取枳椇子破碎,备用。
2.提取:取葛根、枳椇子、丹参、甘草,加水提取2次,第1次10倍量水,第2次加8倍量水,每次提取1.5h,200目过滤,合并滤液;
3.浓缩:取滤液减压浓缩(-0.08~-0.10MPa,60~70℃)至1.10~1.15(60℃测)的清膏,5000rpm/min离心,减压浓缩(-0.08~-0.10MPa,60~70℃)至1.25~1.30(60℃测)的稠膏;
4.干燥:将稠膏减压干燥(-0.08~-0.10MPa,60~70℃),粉碎,过80目筛,得浸膏粉;
5.过筛:取姜黄提取物、赤藓糖醇、三氯蔗糖、黄原胶分别过80目筛,备用。
6.混合:将配方量的姜黄提取物、赤藓糖醇,打底套色混合均匀,得混合粉Ⅰ,将混合粉Ⅰ、浸膏粉与配方量的壳聚糖,三氯蔗糖,于混合机中混合30min,得混合粉Ⅱ。
7.制粒、干燥:混合粉Ⅱ用85%乙醇制软材,18目制粒,60℃干燥至水分5%以下,18目整粒,得干颗粒。
8.总混:取配方比例黄原胶加入到干颗粒中,置混合机混合15分钟,得总混颗粒。
9.灌装:取上述总混颗粒,灌装,即得。
Claims (10)
1.一种保肝护肝的药物或保健食品组合物,其特征在于,由以下重量配比的中药原料药制成:
2.根据权利要求1所述的药物或保健食品组合物,其特征在于,由以下重量配比的中药原料药制成:
3.根据权利要求1所述的药物或保健食品组合物,其特征在于,由以下重量配比的中药原料药制成:
4.根据权利要求1-3任意一项所述的药物或保健食品组合物,其特征在于,所述组合物中含有作为辅助成分的壳聚糖5-15份,以及其他辅料。
5.根据权利要求4所述的药物或保健食品组合物,其特征在于,所述组合物以药物制剂形式存在,所述制剂的剂型选自:片剂、胶囊剂、口服液、颗粒剂、丸剂、散剂、膏剂、丹剂、栓剂、膏剂、滴丸剂、贴剂。
6.根据权利要求4所述的药物或保健食品组合物,其特征在于,所述组合物中的其他辅料选自:三氯蔗糖,黄原胶,赤藓糖醇,淀粉,蔗糖,微晶纤维素、交联聚维酮、硬脂酸镁。
7.根据权利要求6所述的药物或保健食品组合物,其特征在于,所述组合物中的其他辅料选自:三氯蔗糖,黄原胶,赤藓糖醇。
8.权利要求1-7所述的任何一项药物或保健食品组合物的制备方法,其特征在于,所述方法,步骤如下:
原料称量,枳椇子破碎,取葛根、破碎的枳椇子、丹参、甘草,加水提取,过滤,滤液浓缩得浸膏;将姜黄提取物和浸膏混合,加入壳聚糖和其他辅料,按照常规技术制备成制剂,其中其他辅料选自:三氯蔗糖,黄原胶,赤藓糖醇,淀粉,蔗糖,微晶纤维素、交联聚维酮、硬脂酸镁。
9.根据权利要求8所述的制备方法,其特征在于,步骤如下:
原料称量,枳椇子破碎,取葛根、破碎的枳椇子、丹参、甘草,加水提取2次,第1次10倍量水,第2次加8倍量水,每次提取1.5h,200目过滤,合并滤液;取滤液减压浓缩(-0.08~-0.10MPa,60~70℃)至1.10~1.15(60℃测)的清膏,5000rpm/min离心,减压浓缩(-0.08~-0.10MPa,60~70℃)至1.25~1.30(60℃测)的稠膏;将稠膏减压干燥(-0.08~-0.10MPa,60~70℃),粉碎,过80目筛,得浸膏粉;姜黄提取物和浸膏粉混合,加入壳聚糖10g,三氯蔗糖1g、黄原胶30g、赤藓糖醇5g,按照常规技术制备成制剂。
10.根据权利要求9所述的制备方法,其特征在于,配方如下:
野葛667g、枳椇子500g、丹参500g、甘草333g、姜黄提取物5g,辅料壳聚糖10g,三氯蔗糖1g、黄原胶30g、赤藓糖醇5g
制备步骤如下:
1)前处理:取枳椇子破碎,备用;
2)提取:取葛根、枳椇子、丹参、甘草,加水提取2次,第1次10倍量水,第2次加8倍量水,每次提取1.5h,200目过滤,合并滤液;
3)浓缩:取滤液减压浓缩(-0.08~-0.10MPa,60~70℃)至1.10~1.15(60℃测)的清膏,5000rpm/min离心,减压浓缩(-0.08~-0.10MPa,60~70℃)至1.25~1.30(60℃测)的稠膏;
4)干燥:将稠膏减压干燥(-0.08~-0.10MPa,60~70℃),粉碎,过80目筛,得浸膏粉;
5)过筛:取姜黄提取物、壳聚糖、赤藓糖醇、三氯蔗糖、黄原胶分别过80目筛,备用;
6)混合:将姜黄提取物、赤藓糖醇,打底套色混合均匀,得混合粉Ⅰ,将混合粉Ⅰ、浸膏粉与壳聚糖,三氯蔗糖,于混合机中混合30min,得混合粉Ⅱ;
7)制粒、干燥:混合粉Ⅱ用85%乙醇制软材,18目制粒,60℃干燥至水分5%以下,18目整粒,得干颗粒;
8)总混:取配方比例黄原胶加入到干颗粒中,置混合机混合15分钟,得总混颗粒;
9)灌装:取上述总混颗粒,灌装,即得。
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