CN106215176A - 一种高效抗炎多酶组合物 - Google Patents
一种高效抗炎多酶组合物 Download PDFInfo
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- CN106215176A CN106215176A CN201610701659.9A CN201610701659A CN106215176A CN 106215176 A CN106215176 A CN 106215176A CN 201610701659 A CN201610701659 A CN 201610701659A CN 106215176 A CN106215176 A CN 106215176A
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
本发明涉及医药保健品领域,具体涉及一种高效抗炎多酶组合物,该多酶组合物包含一种或多种蛋白水解酶,还包括马铃薯提取物、谷胱甘肽和纳豆冻干粉。本发明的组合物可制备成片剂、硬胶囊剂、软胶囊剂或颗粒剂,也可以制备成药物制剂、保健品、功能食品。本发明的高效抗炎多酶组合物中马铃薯提取物、谷胱甘肽、纳豆冻干粉和蛋白水解酶协同增效,与现有技术中多酶组合物相比具有更好的抗炎效果,显著缩短恢复阶段所需时间。
Description
技术领域
本发明涉及医药、保健品领域,具体涉及一种高效抗炎多酶组合物。
背景技术
酶类物质是来自生物体的一类具有生物活性的大分子物质,其具有作用专一性、特异性、温和等特点。蛋白水解酶类组合物,具有明显的抗炎作用,已被医药学界广泛接受,并有大量的临床数据。现有报道单独使用某一种酶可以抗炎,但两种或两种以上蛋白酶共同作用效果更好。虽然大多数水解酶都能起到治疗炎症的作用,但是机理存在差别,各酶之间各司其职,互相配合才能更好的治疗炎症。
菠萝蛋白酶是从菠萝中提取的一种蛋白水解酶,属于半胱氨酸蛋白酶,能将蛋白质水解成寡肽和氨基酸。菠萝蛋白酶主要用作抗炎药和抗水肿药。菠萝蛋白酶能将血纤维蛋白酶原激活成血纤维蛋白酶,提高炎症部位的纤维蛋白水解,能阻止激肽原转化为激肽从而减少炎症部位的激肽,具有比其他蛋白酶更快的消肿效果。
木瓜蛋白酶又称木瓜酵素,也是一种含巯基的肽链内切酶,具有蛋白酶和酯酶的活性,可以起到消炎、利胆、止痛、助消化和抗癌的作用,广泛地存在于番木瓜的根、茎、叶和果实内,其中在未成熟的乳汁中含量最丰富。
胰酶是牛、猪、羊等动物胰脏提取得到的各种消化酶的混合物。主要含有胰蛋白酶、胰淀粉酶、胰脂肪酶。
胰蛋白酶来源于猪胰脏,是一种丝氨酸蛋白酶,以丝氨酸和组氨酸残基为水解的活性位点。胰蛋白酶能使脓、血凝块等消化变稀、易于引流排除,加速创面净化,促进肉芽组织新生,而不损伤正常组织或损伤极微。此外胰蛋白酶有抗炎及扩张血管的作用。
糜蛋白酶是一种典型的丝氨酸蛋白酶,能促进血凝块、脓性分泌物和坏死组织等的液化清除,作用与胰蛋白酶相似,比胰蛋白酶分解能力强、毒性低、不良反应小。
德国Mucos公司推出的Wobenzyn N产品是以胰蛋白酶、糜蛋白酶、胰酶、菠萝蛋白酶、木瓜蛋白酶为主要活性成分的复合蛋白水解酶片,主要用于治疗炎症疾病和创伤愈合的辅助治疗,尤其是风湿性关节炎,效果明显。中国专利申请CN 1787834A公开了一种或几种含酶的组合物,其中包括一种或多种水解酶和一种或多种抗氧化剂;一种或多种水解酶和一种或多种氨基酸;一种或多种水解酶和一种或多种多糖等组合物。但这些配方都存在有待改进之处:菠萝蛋白酶和木瓜蛋白酶都属于半胱氨酸蛋白酶,半胱氨酸作为活性中心,其结构中巯基是否处于还原状态十分关键,而巯基又易于被氧化,一旦氧化将失去酶活力。配方中并不含有能够保护蛋白酶巯基结构的组分;此外,炎症反应往往伴随着血栓的形成,这不利于炎症的消退,因此在溶血栓的基础上消炎效果会更好,然而配方中缺少有效溶血栓及预防血栓形成的成分。
中国专利申请CN 104955474A公开了一种用于预防和治疗静脉血栓状态的溶解纤维蛋白的组合物,菠萝蛋白酶和纳豆激酶组合使用活性要比单一酶活性高,起到更好的抗血栓作用。
纳豆冻干粉是用蒸煮后的黄豆,接种纳豆菌(枯草芽孢杆菌)经微生物发酵后得到的纳豆经冻干研磨制成。纳豆中不但富含许多具有生理活性的营养成份,如多糖、皂苷、多种人体必需氨基酸、不饱和脂肪酸、钙、磷、钠、钾及各种维生素等,而且其周围的粘性物质中还含有多种蛋白酶如纳豆激酶、多聚谷氨酸、大豆异黄酮、染料木素、维生素K2等,其中最重要的是具有溶血栓作用的纳豆激酶。纳豆激酶是一种枯草杆菌蛋白激酶,由日本的须见洋行等人于1987年首先发现并命名,纳豆激酶是一种丝氨酸蛋白酶,具有溶解血栓,降低血粘度,改善血液循环,软化血管弹性、防治关节炎等作用。
马铃薯性平味甘,具有利水消肿、生肌止痛的功用。现代医学证明,马铃薯中的龙葵碱有缓解痉挛、减少渗出的作用;马铃薯内的胆甾烷衍生物茄碱,可渗于皮下组织及血管内,加快血液流通起到较强的活血化瘀、消肿止痛作用。马铃薯中含有丰富的无机盐,而无机盐中的钾含量很高,钾不仅能帮助身体排出滞留在体内的钠,还能促进身体排出多余的水分,从而达到消肿的效果。维生素B1能激活胆碱乙酰化酶,有维持神经系统的功能及抗神经炎作用,维生素B2参与糖、蛋白及脂肪代谢,可保护组织免受炎症侵害。维生素C具有催化羟化酶的作用,促进脯氨酸和赖氨酸形成前胶原分子,对组织细胞的修复愈合非常重要。
谷胱甘肽是细胞内主要还原物质,在人体的生化防御体系中处于举足轻重的地位,其主要生理作用是能够清除人体内的自由基。谷胱甘肽中含有一个易被氧化脱氢的活泼巯基,这一特异性结构使其成为体内主要的自由基消除剂,从而保护细胞对抗氧化自由基的不断攻击,其特异的γ-肽键结构,与进入人体的毒素、重金属离子或致癌物质等相结合,并促进其代谢,因此具有一定解毒作用。谷胱甘肽同时还具有抗炎、抗血栓及血管保护、提高人体免疫力等作用。人工研制出的谷胱甘肽药物,已广泛应用于临床,除利用其巯基以螯合重金属、氟化物、芥子气等毒素中毒外,还用来治疗或辅助治疗肝炎、溶血性疾病以及角膜炎、白内障和视网膜疾病等。目前,谷胱甘肽广泛应用于医药、保健品、食品加工、动物饲料营养以及化妆品等领域。
目前,将谷胱甘肽、纳豆冻干粉、马铃薯提取物与蛋白酶组合预防治疗炎症的应用未见报道。
发明内容
本发明的目的在于提供一种高效抗炎多酶组合物。
为实现以上目的,本发明通过以下技术方案予以实现:
一种高效抗炎多酶组合物,包括一种或多种蛋白水解酶,所述多酶组合物还包括马铃薯提取物、谷胱甘肽和纳豆冻干粉。
所述蛋白水解酶除了可以从天然产物中获得,还可以通过合成或遗传操作获得。
进一步的,本发明组合物中所述蛋白水解酶为植物和/或动物蛋白酶,其中植物蛋白酶优选木瓜蛋白酶、菠萝蛋白酶。动物蛋白酶优选胰酶、胰蛋白酶、糜蛋白酶。植物蛋白酶和动物蛋白酶联合使用可活化静息单核细胞和NK细胞,从而刺激免疫系统。
进一步的,本发明组合物中蛋白水解酶优选为菠萝蛋白酶和胰蛋白酶。
本发明组合物中马铃薯提取物含有大量的糖苷生物碱属于胆甾烷生物碱,主要是茄碱和查茄碱两大类,具有降低血浆低密度脂蛋白和胆固醇、消炎活血、降压、平喘等作用;此外,马铃薯提取物中的多种氨基酸能够激活巨噬细胞,配合本发明中水解酶的抗炎作用,可以更好的清理多种炎症因子,提高炎症治疗的效果。
本发明中谷胱甘肽指还原型谷胱甘肽,是由谷氨酸、半胱氨酸和甘氨酸结合而成的三肽。谷胱甘肽提供的还原巯基能够保护酶分子中巯基不被氧化,巯基的稳定有利于酶活性的发挥,并且能恢复已经被破坏的酶分子中巯基的活性功能,使酶重新恢复活性,并对一些巯基酶有激活作用。谷胱甘肽的存在使该组合物在长期储存以及被人体摄入发挥疗效的过程中都能更好的保护蛋白酶的活性;除此之外,谷胱甘肽本身又能够清除人体内外的病原毒素和自由基,提高免疫力,从而更好的起到抗炎的作用。
本发明组合物中还包括纳豆冻干粉,纳豆冻干粉中的纳豆激酶降血栓的效果显著,其与菠萝蛋白酶协同作用,可以起到很好的溶血栓作用,有利于炎症的治疗。由于纳豆冻干粉中除了含有纳豆激酶外,还含有具有多种功效的营养物质,例如纳豆中氨基酸的含量配比完全符合人体最佳平衡需要,其种类和含量配比都远远超过了牛奶,纳豆中纳豆肽可以促进矿物质吸收、抗疲劳、抗氧化、降低血压、降低胆固醇和减少心血管病风险、增强免疫力、抗肿瘤等。因此本组合物选择加入纳豆冻干粉。
本发明的一种优选技术方案为本组合物加入酶稳定剂,所述酶稳定剂为一种或多种能够提供钙离子的物质,优选碳酸钙、葡萄糖酸钙、氯化钙、氨基酸螯合钙、磷酸钙、磷酸氢钙、谷氨酸钙、果糖酸钙、抗坏血酸钙、柠檬酸钙中的一种或多种。
本发明的另一种优选技术方案为本组合物中加入中药提取物,所述中药提取物包括黄酮类化合物,所述黄酮类化合物包括芦丁、槲皮素、杨梅黄酮等,优选芦丁。
本发明的另一种优选技术方案为本组合物中还同时含有酶稳定剂和中药提取物,中药提取物包括黄酮类化合物,所述黄酮类化合物可包括芦丁、槲皮素、杨梅黄酮等,优选芦丁。酶稳定剂为一种或多种能够提供钙离子的物质,优选碳酸钙、葡萄糖酸钙、氯化钙、氨基酸螯合钙、磷酸钙、磷酸氢钙、谷氨酸钙、果糖酸钙、抗坏血酸钙、柠檬酸钙中的一种或多种。
本发明的另一种优选技术方案为本发明的组合物中还包括抗氧化剂。抗氧化剂可以阻止或推迟活性物质的氧化分解作用,在人体中,他们可以保护细胞不受损伤并且具有抗癌作用,在本发明中抗氧化剂可以保护水解酶。所述抗氧化剂为维生素、类胡萝卜素、泛醌等具有抗氧化作用的物质,其中类胡萝卜素包括胡萝卜素、番茄红素、叶黄素、虾青素等,优选番茄红素。番茄红素是一种多不饱和多烯,其被证实是一种非常有效的天然自由基清除剂,可以在食物产品或药品中使用。
本发明特别优选的技术方案为水解酶为菠萝蛋白酶和胰蛋白酶,中药提取物为芦丁,酶稳定剂为氯化钙或葡萄糖酸钙。
本发明还涉及含有本发明所述组合物的制剂,所述制剂的剂型包括但不限于片剂、注射剂、硬胶囊剂、软胶囊剂或颗粒剂,其中片剂包括普通片、缓释片、控释片、肠溶片等;所述制剂可含有常规的辅料成分。
本发明还涉及含有本发明所述组合物的药物制剂、保健品、功能食品,可通过本领域公知方法制备成包含本发明组合物的药物制剂、保健品、功能食品。
可通过简单混合活性组分以及随后使其呈粉末形式来制备本发明的组合物,其可仅由所属活性成分组成,或包括后来添加的常规辅料。
本发明有益效果:本发明在现有多酶组合物的基础上加入马铃薯提取物、谷胱甘肽和纳豆冻干粉。其中,马铃薯提取物含有多种抗炎物质,与具有抗炎作用的蛋白水解酶协同作用,可以更好的清理多种炎症因子,提高了炎症治疗的效果;谷胱甘肽的加入不仅保护酶分子中的巯基不被氧化,保持酶的活力,更好的发挥抗炎作用,同时谷胱甘肽还能够清除人体内外的病原毒素和自由基,提高免疫力,从而配合蛋白水解酶更好的起到抗炎作用;纳豆冻干粉不仅能够预防和治疗血管栓塞性疾病,而且与其他药物相比,具有食用安全、没有相应的免疫原性、人体可以对其消化吸收、生产成本较低等优点,与蛋白水解酶协同发挥抗炎作用,同时纳豆冻干粉中还含有多种对人体有利的营养物质。本发明组合物中这几种物质协同增效,经药理学试验,本发明的组合物与现有技术中多酶组合物相比具有更好的抗炎效果,显著缩短恢复阶段所需时间。
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。
本发明中,所有的设备和原料等均可从市场获得或是本行业常用的,实施例中采用的用量为按照市售产品的实际标示含量折算获得,其中菠萝蛋白酶原料活力为2500GDU/g,木瓜蛋白酶原料活力为60000USP u/mg,胰蛋白酶原料活力为2700USP u/mg,糜蛋白酶原料活力为1200USP u/mg,胰酶原料中胰蛋白酶活力为4130U/g。如果使用的酶制剂原料的酶活力范围与上述范围不同,可进行相应的换算确定多酶复合物配方中使用的重量份。
所述水解酶可以在较宽的范围内使用,其下限值相应的浓度为低于该浓度则所需的健康效果或治疗效果不存在,上限值可被定义为超过其浓度则活性不再增加,从而仅仅导致产品制造的费用上升的浓度。
实施例1:口服片剂
以生产本发明片剂200片为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学片剂的常规工艺进行,每片重0.75g,每片含胰酶80mg、木瓜蛋白酶30mg、菠萝蛋白酶45mg、胰蛋白酶22mg、糜蛋白酶1mg。
实施例2:口服片剂
以生产本发明片剂200片为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学片剂的常规工艺进行,每片重0.75g,每片含胰酶80mg、木瓜蛋白酶30mg、菠萝蛋白酶45mg、胰蛋白酶22mg、糜蛋白酶1mg。
实施例3:口服片剂
以生产本发明片剂200片为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学片剂的常规工艺进行,每片重0.75g,每片含胰酶80mg、木瓜蛋白酶30mg、菠萝蛋白酶45mg、胰蛋白酶22mg、糜蛋白酶1mg。
实施例4:口服片剂
以生产本发明片剂200片为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学片剂的常规工艺进行,每片重0.75g,每片含胰酶80mg、木瓜蛋白酶30mg、菠萝蛋白酶45mg、胰蛋白酶22mg、糜蛋白酶1mg。
实施例5:口服片剂
以生产本发明片剂200片为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学片剂的常规工艺进行,每片重0.75g,每片含胰酶80mg、木瓜蛋白酶30mg、菠萝蛋白酶45mg、胰蛋白酶22mg、糜蛋白酶1mg。
实施例6:口服胶囊剂
以生产本发明胶囊剂200片为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学胶囊剂的常规工艺进行,每粒重0.75g,每片含菠萝蛋白酶90mg、胰蛋白酶44mg。
实施例7:口服颗粒剂
以生产本发明片剂200g为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学颗粒剂的常规工艺进行,每片袋重5g,每克含菠萝蛋白酶90mg、胰蛋白酶44mg。
实施例8:口服片剂
以生产本发明片剂200片为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学片剂的常规工艺进行,每片重0.75g,每片含木瓜蛋白酶30mg、菠萝蛋白酶90mg。
实施例9:口服胶囊剂
以生产本发明胶囊剂200粒为例所用原料和辅料及其质量配比如下:
制备工艺按照制剂学胶囊剂的常规工艺进行,每粒重0.75g,每粒含木瓜蛋白酶30mg、菠萝蛋白酶90mg。
实施例10:注射剂
以生产本发明注射剂200支为例所用原料和辅料及其质量配比如下:
木瓜蛋白酶 8.8g
菠萝蛋白酶 18g
注射用木糖醇 2g
其制备工艺按照制剂学注射剂的常规工艺进行,每粒重0.13g,每支含木瓜蛋白酶44mg、菠萝蛋白酶90mg。
实施例11:口服胶囊剂
以生产本发明胶囊剂200粒为例所用原料和辅料及其质量配比如下:
其制备工艺按照制剂学胶囊剂的常规工艺进行,每粒重0.75g,每粒含胰蛋白酶44mg、菠萝蛋白酶90mg。
药理学实验:
实验例1:组合物主成分药效检测
1实验材料
1.1实验药物
组1:实施例2制得的口服片剂。
组2:去除实施例2中的组分还原型谷胱甘肽,其他组分不变,微晶纤维素加至150g,按照实施例2的制备方法制得的口服片剂。
组3:去除实施例2中的组分纳豆冻干粉,其他组分不变,微晶纤维素加至150g,按照实施例2的制备方法制得的口服片剂。
组4:去除实施例2中的组分马铃薯提取物,其他组分不变,微晶纤维素加至150g,按照实施例2的制备方法制得的口服片剂。
组5:去除实施例2中的组分胰酶、木瓜蛋白酶菠萝蛋白酶、胰蛋白酶、糜蛋白酶,其他组分不变,微晶纤维素加至150g,按照实施例2的制备方法制得的口服片剂。
1.2对照组药物的选择及剂量设置
吲哚美辛组(1.17mg/kg):吲哚美辛肠溶片,上海信宜黄河制药有限公司,批号:130101。
模型组:鸡蛋清
1.3实验动物
清洁级SD大鼠,安徽医科大学实验动物中心提供。
1.4主要实验设备
足跖容积测量仪(YLS-7B),山东省医学科学院设备站生产。
1.5统计学方法
统计资料采用单因素方差分析,使用SPSS17.0统计软件完成。
2实验方法与结果
2.1十二指肠造瘘动物模型疗效比较
选用体重220-300g,雄性,清洁级SD大鼠。大鼠统一进行十二指肠造瘘,造瘘三天后将大鼠随机分成实验组、吲哚美辛组(1.17mg/kg)、模型组,每组8只。
分组标记称重后进行瘘管给药,各组大鼠按分组进行给药,模型组给予等量的蒸馏水,连续预防炎症给药3天。
各组大鼠末次给药后即刻测量其右后足足跖容积。各组大鼠末次给药后30min,于大鼠右后足脚掌皮下注射鸡蛋清0.1ml,分别于注射后30min、60min、90min、120min、150min测量各组大鼠足跖容积。
按以下公式计算肿胀度:肿胀度=致炎后足跖容积-致炎前足跖容积。
2.2实验结果见表1
表1:各组物质对大鼠急性足肿胀度的影响
注:与模型组比较,*p<0.05,**p<0.01。
结果如表1所示,与造模以前相比,模型组足肿胀明显;与模型组比较,吲哚美辛组在各个时间点均可以显著抑制大鼠足肿胀,组1-5与模型组比较有不同程度的抑制足肿胀的作用;其中组1较其他组对于足肿胀抑制效果最为明显。
实验例2:组合物优化配方药效检测
本实施例中实验药物为实施例1-5制得的口服片剂,分组为A-E,对照组药物的选择及剂量设置、实验动物、主要实验设备、统计学方法及实验方法与上述药理学实验实施例1相同。
实验结果:见表2
表2:各组物质对大鼠急性足肿胀度的影响
注:与模型组比较,*p<0.05,**p<0.01。
结果如表2所示,与造模以前相比,模型组足肿胀明显;与模型组比较,吲哚美辛组在各个时间点均可以显著抑制大鼠足肿胀,本发明各种不同成分组合物,与模型组比较有不同程度的抑制足肿胀的作用;组A到组E动物试验总体效果逐渐变好,组E较其他组对于足肿胀抑制效果最为明显,与吲哚美辛组效果最接近。
综上,本发明高效抗炎多酶组合物抗炎消肿效果好,安全副作用小。
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 (10)
1.一种高效抗炎多酶组合物,包括一种或多种蛋白水解酶,其特征在于,还包括马铃薯提取物、谷胱甘肽和纳豆冻干粉。
2.如权利要求1所述的高效抗炎多酶组合物,其特征在于,所述蛋白水解酶选自木瓜蛋白酶、菠萝蛋白酶、胰酶、胰蛋白酶、糜蛋白酶中的一种或多种。
3.如权利要求2所述的高效抗炎多酶组合物,其特征在于,所述蛋白水解酶为菠萝蛋白酶和胰蛋白酶的混合物。
4.如权利要求1所述的高效抗炎多酶组合物,其特征在于,所述多酶组合物还包括酶稳定剂;所述酶稳定剂为一种或多种能够提供钙离子的物质。
5.如权利要求4所述的高效抗炎多酶组合物,其特征在于,所述多酶组合物还包括中药提取物;所述中药提取物选自芦丁、槲皮素、杨梅黄酮中的一种或多种。
6.如权利要求5所述的高效抗炎多酶组合物,其特征在于,所述中药提取物为芦丁;所述酶稳定剂选自碳酸钙、葡萄糖酸钙、氯化钙、氨基酸螯合钙、磷酸钙、磷酸氢钙、谷氨酸钙、果糖酸钙、抗坏血酸钙、柠檬酸钙中的一种或多种。
7.如权利要求1所述的高效抗炎多酶组合物,其特征在于,所述多酶组合物还包括中药提取物;所述中药提取物选自芦丁、槲皮素、杨梅黄酮中的一种或多种。
8.如权利要求7所述的高效抗炎多酶组合物,其特征在于,所述中药提取物为芦丁。
9.一种含有权利要求1-8任一权利要求所述的高效抗炎多酶组合物的片剂、注射剂、硬胶囊剂、软胶囊剂或颗粒剂。
10.一种含有权利要求1-8任一权利要求所述的高效抗炎多酶组合物的药品制剂、保健品、功能食品。
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