CN102264376A - 用于封装的浓松针提取物组合物 - Google Patents

用于封装的浓松针提取物组合物 Download PDF

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CN102264376A
CN102264376A CN2009801480094A CN200980148009A CN102264376A CN 102264376 A CN102264376 A CN 102264376A CN 2009801480094 A CN2009801480094 A CN 2009801480094A CN 200980148009 A CN200980148009 A CN 200980148009A CN 102264376 A CN102264376 A CN 102264376A
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乔瑞斯·鲁宾斯
伊琳娜·达比特
伊尔泽·巴润
玛丽斯·岛歌威迪斯
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RIGAS STRADINA UNI
BF ESSE SIA
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Abstract

本发明涉及制药业以及医药和食品工业，尤其涉及刺激粘膜和皮肤改善以及增强生物体免疫力的组合物的制备。本发明旨在开发一种含有浓松针提取物的化合物，其具有改良的品质组成，用以增加呈胶囊形式的所述浓松针提取物组合物各组分的生物活性，并保留其加工特性和稳定性。这一目标是通过以下方式实现：将α-生育酚(维生素E)、视黄醇(维生素A)、萘醌(维生素K)、必需脂肪酸(维生素F)和微量元素(锌、硒)按规定组分比添加到所述浓松针提取物组合物中以供封装。

Description

用于封装的浓松针提取物组合物
技术领域
本发明涉及制药业、药剂制剂(parapharmaceutical preparation)和食品工业。其涉及改善皮肤和粘膜状态以及增强人体自我保护品质的组合物方面的问题。本发明的目标是开发一种含有高生物活性致密的针叶树针提取物的组合物，这种组合物具有最佳的技术质量和稳定的封装形式。
背景技术
此项技术中已知各种生物活性组合物，其含有维生素和刺激胃肠道保护因子的其它生物活性组分[1-6]。
制备成胶囊形式的组合物具有以下益处：易于使用、剂量精确、没有特殊味道、储存时稳定[7-11]。
复杂的药物制剂菲特斯坦(phitesten)(致密的针叶树针提取物)是完全按照拉脱维亚共和国标准US-000312820-08-99或ΓOCT 21769-84，从针叶树针和针叶树幼枝获得[12]。这一制剂是制备成致密的糊状物质形式。其记录在拉脱维亚的医药产品清单中，编号95-0002。
复杂组合物-致密的针叶树针提取物(dense conifer needle extract，DCNE)是一种高生物活性物质，并含有许多生物活性成分：类胡萝卜素、多萜醇、叶绿酸、异冷杉醇(isoabienol)、维生素C、K和E、双萜和三萜、sescvyterpenoids、半日花烷型二萜(labdanoid)、针叶树蜡、杀真菌剂、脂肪酸、硬脂(stearin)和聚合物化合物。这一制剂具有植物抗菌、抗氧化、生物刺激和肝保护品质。其还用作细胞膜保护剂和免疫调节剂[13-17]。DCNE和其某些成分，即多萜醇和异冷杉醇，被广泛用于改善胃肠道功能，以及增加免疫指标等。
DCNE致密、浓稠并呈深绿色。其具有特殊的气味和味道，使得其直接投药和剂量变得有些复杂。为了消除这些缺点，开发出一种特殊的DCNE组合物，具体说来，就是进行封装[18]。这一DCNE组合物是本发明的实际原型。
为了在封装前改良DCNE组合物的质量并增强其生物活性质量，推荐遵循某种百分比模式对所述组合物补充维生素和微量元素。
发明内容
本发明旨在开发一种DCNE组合物，其组分具有改良的质量和增强的生物活性，同时保持胶囊形式DCNE组合物的技术质量和稳定性。
上述目标已通过以下方式实现：将某些其它组分引入组合物中，即，α-生育酚(维生素E)、视黄醇(维生素A)、萘醌(维生素K)和必需脂肪酸(维生素F)，这些组分遵循以下组分比，以质量％计：
Figure BPA00001375144200021
这一组合物还可含有某些微量元素(锌、硒)，这些组分遵循以下组分比，以质量％计：
Figure BPA00001375144200031
α-生育酚(维生素E)具有抗氧化特性。其为自由基清除剂，因此有助于防止细胞膜损伤。α-生育酚(维生素E)含量减小可能会降低制剂的生物活性质量，并且不利地影响DCNE活性组分的稳定性。
视黄醇(维生素A)改善视觉功能，并有利地影响整个系统。其有助于使上皮组织分化过程正常化，并参与代谢调控。
萘醌(维生素K)：缺乏维生素K可能影响凝血过程。萘醌参与能量交换过程，其履行重要的辅酶功能并参与易于恢复的蛋白质(easy-to-restoreprotein)(消化性胞外酶)和其它酶的合成。
必需脂肪酸(维生素F)的投予将消除生长障碍、生物体发育障碍、皮肤功能和干燥障碍、湿疹复发(eczema backset)、脱发、指甲(趾甲)变脆和剥离(foliation)、对细菌感染的晚期胃肠道敏感、肺部感染、视力降低、肾功能障碍等。
锌(Zn)能够中和自由基，降低炎症反应，促进伤口愈合和使皮肤免疫系统活动稳定。
硒(Se)是数种激素和酶中所包括的生物活性微量元素，并因此与所有器官、组织和系统的功能关联。硒与维生素E一起支持细胞的生命活动，并防止其坏死。因此，硒直接涉及影响人体青春活力和寿命的过程。硒是一种强抗氧化剂，其刺激抗体生长，并由此增强对冷和传染病的抗性。缺乏硒可能导致对冷和癌症的不充分免疫性。
制备时，将DCNE加热到45到50℃，随后添加乳化剂和α-生育酚(维生素E)的油溶液，同时持续混合物质，直到出现均匀物质。另外，将视黄醇(维生素A)、萘醌(维生素K)、必需脂肪酸(维生素F)和微量元素(锌和硒)添加到组合物中。
完全遵照本发明中所述的技术获得的含有DCNE、乳化剂、植物油和其它生物活性成分的组合物，将成功用于制备软明胶胶囊形式的定量药物(0.3-1.0克)。
为了制备上述胶囊，需要能够借助旋转矩阵法(rotat ion-matrixmethod)压制胶囊的适宜设备。
具体实施方式
实例1
在制备组合物时，将20到70克DCNE放入实验室玻璃器皿中，并在45到50℃水浴上加热。单独混合2到10克乳化剂(如单油酸甘油酯)、5到20克α-生育酚(维生素E)、0.01到0.5克视黄醇(维生素A)、0.01到0.6克萘醌(维生素K)、2到5克必需脂肪酸(维生素F)和植物油，并在水浴上加热到45到50℃，随后倒入DCNE中。
实例2
在制备组合物时，将20到70克DCNE放入实验室玻璃器皿中，并在45到50℃水浴上加热。单独混合2到10克乳化剂(例如单油酸甘油酯)、5到20克α-生育酚(维生素E)、0.01到0.5克视黄醇(维生素A)、0.01到0.6克萘醌(维生素K)、2到5克必需脂肪酸(维生素F)、0.01到0.1克微量元素(锌、硒)和植物油，并在水浴上加热到45到50℃，随后倒入DCNE中。
组合物中每一成分都具有极为特殊的有益品质。组合这些品质将允许实现协同作用，从而使所得基于DCNE的组合物易于封装，并富含生物活性。
将DCNE的量减少到20克以下，可能会降低制剂的生物活性，但将DCNE的量增加到超过70克，会使制剂的技术工艺和储存明显变复杂。
乳化剂可降低分散系统各相之间分界线上的表面拉伸，并支持亲水性(DCNE)和亲脂性(植物油、α-生育酚、视黄醇等)组分的混合。单油酸甘油酯用作乳化剂。另外，甘油与最高级脂肪酸(highest fatty acid)的复杂醚、脱水山梨糖醇与单氧乙烯脱水山梨醇酯(monoxyethylen sorbitan)的醚、蒸馏的单酸甘油酯、天然磷脂和其组合都可用作乳化剂。将乳化剂含量减少到2克以下或将其量增加到超过10克，会使技术工艺变得复杂，并妨碍获得均匀混合物。
植物油是获得供填充到软明胶盖中的最佳DCNE稠度所必需的。
α-生育酚(维生素E)提供抗氧化品质。当α-生育酚的量减少到5克以下时，制剂的生物活性和DCNE活性成分的稳定性将降低。不推荐将α-生育酚含量增加到超过20克。
视黄醇(维生素A)会有利地影响整个系统。其可使上皮组织分化过程正常化。当视黄醇的量减少到0.01克以下时，制剂的生物活性品质和DCNE活性成分的稳定性将降低。不推荐视黄醇含量增加到超过0.5克。
实验和临床试验证实，DCNE刺激胃和十二指肠粘膜的保护因子。DCNE还具有抗氧化清除剂、抗细菌剂和免疫调节剂的特性。其有利地影响胃和十二指肠粘膜的炎性过程。
维生素和微量元素复合物的应用明显增强了DCNE的生物学和食品营养价值，以及其封装形式的稳定性。
完全遵照本发明中所述的技术获得的含有DCNE、乳化剂、植物油和其它生物活性成分的组合物，将成功用于制备软明胶胶囊形式的定量药物(0.3-1.0克)。
必要时，组合物的量可增加到10到100公斤，只要各成分的比例和制造技术完全遵照本发明描述即可。

Claims (2)

1.一种为封装作准备的致密的针叶树针提取物的组合物，其含有乳化剂和植物油，以及其它成分-α-生育酚(维生素E)、视黄醇(维生素A)、萘醌(维生素K)和必需脂肪酸(维生素F)，所述组分遵照以下组分比，以质量％计：
2.一种根据权利要求1所述的组合物的变化形式，其还含有微量元素(锌、硒)，所述组分遵循以下组分比，以质量％计：
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