CN108939040A - 一种抗辐射组合物及其制备方法和应用 - Google Patents
一种抗辐射组合物及其制备方法和应用 Download PDFInfo
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- CN108939040A CN108939040A CN201811217435.6A CN201811217435A CN108939040A CN 108939040 A CN108939040 A CN 108939040A CN 201811217435 A CN201811217435 A CN 201811217435A CN 108939040 A CN108939040 A CN 108939040A
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- resveratrol
- polypeptide
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- spirulina polysaccharide
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Abstract
本发明涉及一种抗辐射组合物，其组成包含白藜芦醇、扇贝多肽、螺旋藻多糖和鸡血藤提取物，本发明中组合物具有协同作用，且可以提高白藜芦醇的体内生物利用度。实验表明，本发明提供组合物的抗辐射效果显著优于单独使用各组分作用，本发明还提供了上述组合物的制备方法，通过本发明制备方法制备上述组合物，可以提高白藜芦醇的稳定性。
Description
技术领域
本发明涉及一种抗辐射组合物及其制备方法和应用，属于生物医药大健康领域。
背景技术
在现代社会环境中，人们在生活、工作中都会受到各种电磁辐射的影响，电磁辐射是一种非特异性的刺激，直接或间接地作用于机体的器官、组织、淋巴细胞，导致各种疾病的发生，如：白血病、再生障碍性贫血、各种肿瘤、眼底病变等。辐射防护剂又称为抗辐射药物，目前常见的抗辐射药物作用机制主要为清除自白基、保护DNA、保护免疫系统、保护造血系统及对细胞因子的诱生和调节等。现有研究发现：很多天然药物具有抗辐射作用，特别是一些来源于中草药的多糖类、生物碱、黄酮类、酚类和多肽类化合物等，但是由于作用机制单一、稳定性不好、生物利用度低等问题，这些物质单独开发成防辐射药物或健康产品时其抗辐射的效果并不理想，多数人群服用后表示感受不到效果。
发明内容
鉴于此，本发明要解决的技术问题在于提供一种抗辐射组合物及其制备方法，本发明提供的抗辐射组合物具有协同作用，能提高产品的稳定性和生物利用度，具有显著的抗辐射效果。
本发明提供了一种抗辐射组合物，其包含白藜芦醇、扇贝多肽、螺旋藻多糖和鸡血藤提取物，所述鸡血藤提取物中含总黄酮10％～30％。
进一步地，所述抗辐射组合物按重量计包含以下组分：白藜芦醇7.5～50份，扇贝多肽6～70份，螺旋藻多糖33～133份，鸡血藤提取物216～360份。
进一步地，所述抗辐射组合物按重量计包含以下组分：白藜芦醇10～48份，扇贝多肽15～65份，螺旋藻多糖50～100份，鸡血藤提取物220～300份。
其中，白藜芦醇是非黄酮类的多酚化合物，广泛存在于葡萄、中药虎杖、决明子等植物中，其具有三重抗辐射作用：抗免疫损伤、保护造血系统及清除自由基。但是其水溶性差、对光不稳定、生物利用度低，这些限制了白藜芦醇的推广应用。
扇贝多肽是来源于海洋栉孔扇贝废弃的内脏团中提取的一种小分子水溶性多肽，是一种良好的免疫细胞调节剂,可以显著增强免疫细胞的代谢和增殖，也对皮肤的紫外线氧化损伤有保护作用，还具有抗氧化活性,能清除羟自由基和超氧阴离子，有延缓自然衰老动物皮肤的老化的作用。
螺旋藻多糖能促进造血干细胞和各种造血祖细胞的增殖和分化,提高小鼠对辐射的耐受力,促进造血系统受辐射损伤后的恢复。
鸡血藤可刺激小鼠骨髓细胞增殖，并能提高IL-1，IL-2，IL-3的分泌能力；可促进辐射后小鼠外周血象的恢复，对辐射所致的造血功能损伤具有保护作用。
本发明将白藜芦醇、扇贝多肽、螺旋藻多糖和鸡血藤组合后，发现其可以发挥协同作用，通过多种作用机制起到防辐射的作用，并且动物实验研究发现口服给样本发明组合物，白藜芦醇生物利用度显著提高。
本发明还提供是所述抗辐射组合物的制备方法，其包含以下步骤：
A：白藜芦醇-扇贝多肽-螺旋藻多糖复合物制备：将扇贝多肽和螺旋藻多糖同时溶于去离子水中，搅拌30min后，边搅拌边滴入预先溶于乙醇的白藜芦醇溶液，继续搅拌30min后，冷冻干燥，即得白藜芦醇-扇贝多肽-螺旋藻多糖复合物。
B:取鸡血藤提取物，与步骤A制得的白藜芦醇-扇贝多肽-螺旋藻多糖复合物按等量递增方法混均。
上述制备方法中，在扇贝多肽与螺旋藻多糖溶液中，加入白藜芦醇乙醇溶液，由于分子间氢键作用和疏水作用，可形成白藜芦醇-扇贝多肽-螺旋藻多糖复合物，一方面扇贝多肽与螺旋藻多糖对白藜芦醇有包合作用，另一方面，其抗氧化活性也能对白藜芦醇有一定的保护作用，可显著提高白藜芦醇的稳定性，且还可以改善螺旋藻多糖的黏性，有利于制剂。
上述抗辐射组合物可添加或不添药品、食品可接受的辅料，进一步制成片剂、颗粒剂、胶囊、缓控释制剂等不同剂型。所述药品、食品可接受的辅料包括稀释剂、粘合剂、润湿剂、崩解剂、润滑剂、助流剂等。稀释剂可以是淀粉、糊精、蔗糖、葡萄糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素等。润湿剂可以是水、乙醇、异丙醇等。粘合剂可以是淀粉浆、糊精、糖浆、微晶纤维素、羟甲基纤维素钠、甲基纤维素、羟丙基甲基纤维素、乙基纤维素、丙烯酸树脂、聚乙烯吡咯烷酮、聚乙二醇等。崩解剂可以是干淀粉、微晶纤维素、低取代羟丙基纤维素、交联聚乙烯吡咯烷酮、羧甲基淀粉钠、碳酸氢钠与枸橼酸、十二烷基磺酸钠、交联羧甲基纤维素钠等。润滑剂和助流剂可以是滑石粉、硬脂酸盐、二氧化硅、酒石酸、液体石蜡等。可根据组合物的剂型选用不同的辅料进行组合。
本发明还提供了上述抗辐射组合物在制备抗氧化、保护造血系统、抗免疫损伤等药品、保健食品、功能性普通食品、特殊医学用途配方食品、特殊膳食食品方面的应用。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
实施例1
处方：白藜芦醇50g、扇贝多肽70g、螺旋藻多糖133g、鸡血藤提取物216g。
制备方法:
A：白藜芦醇-扇贝多肽-螺旋藻多糖复合物制备：将扇贝多肽和螺旋藻多糖同时溶于去离子水中，搅拌30min后，边搅拌边滴入白藜芦醇的乙醇溶液，继续搅拌30min后，冷冻干燥，即得白藜芦醇-扇贝多肽-螺旋藻多糖复合物。
B:取鸡血藤提取物，与步骤A制得的白藜芦醇-扇贝多肽-螺旋藻多糖复合物按等量递增方法混均，即得本发明组合物469g。
实施例2
处方：白藜芦醇7.5g、扇贝多肽6g、螺旋藻多糖50g、鸡血藤提取物300g。
按照实施例1方法制备得本发明组合物363.5g。
实施例3
处方：白藜芦醇10g、扇贝多肽15g、螺旋藻多糖33g、鸡血藤提取物360g。
按照实施例1方法制备得本发明组合物418g。
实施例4
处方：白藜芦醇48g、扇贝多肽65g、螺旋藻多糖100g、鸡血藤提取物220g。
按照实施例1方法制备得本发明组合物433g。
实施例5
处方：白藜芦醇30g、扇贝多肽50g、螺旋藻多糖80g、鸡血藤提取物240g。
按照实施例1方法制备得本发明组合物400g。
实施例6
处方：白藜芦醇35g、扇贝多肽70g、螺旋藻多糖70g、鸡血藤提取物220g。
按照实施例1方法制备得本发明组合物395g。
效果实施例1：加速稳定性试验
分别取样品白藜芦醇原料、本发明组合物(按实施例5制备)各100g,置于洁净的透明玻璃瓶中，按原料药与制剂稳定性试验指导原则(《中国药典》2015版四部9001)，置于温度为(40±2)℃，相对湿度为(75±5)％的条件下放置6个月。进行加速稳定性试验，分别于0个月、1个月、2个月、3个月和6个月取样，测定白藜芦醇含量。
表1加速稳定性试验考察结果
| 时间 | 白藜芦醇 | 本发明组合物 |
| 0个月 | 93.0％ | 6.97％ |
| 1个月 | 72.9％ | 6.83％ |
| 2个月 | 53.6％ | 6.79％ |
| 3个月 | 47.1％ | 6.53％ |
| 6个月 | 33.7％ | 6.48％ |
注：白藜芦醇原料的纯度为93％
由表1看出：白藜芦醇原料在6个月的加速稳定性试验中，白藜芦醇的含量衰竭了63.76％；本发明组合物在6个月的加速稳定性试验中，白藜芦醇的含量衰竭了7.03％。
试验结论：即本发明所述抗辐射组合物中白藜芦醇的稳定性显著提高。
效果实施例2：生物利用度实验
实验方法：取健康雄性Wistar大鼠16只，体重(200±20)g，随机平均分成两组，A组给与本发明抗辐射组合物(按实施例5制备)，B组给以白藜芦醇原料，给药剂量按白藜芦醇计为25mg/kg，两组均用0.5％羧甲基纤维素钠水溶液配制成含白藜芦醇5.0mg/ml的混悬液。给药前每组均禁食12h,不禁水，于灌胃给药后0.1、0.25、0.5、0.75、1、2、3、4、5、6、7、8h眼眶取血，采血1mL注入肝素化的试管，离心(4 000r/min)取血浆，测血药浓度，血药浓度与时间曲线图见图1。
附图说明：图1为白藜芦醇与本发明组合物在大鼠体内血药浓度-时间曲线
大鼠分别灌胃给予白藜芦醇原料和本发明组合物后，白藜芦醇原料在0.25h即达到最大血药浓度4.55μg/ml，随后血药浓度迅速降低，5h后基本检测不到，说明白藜芦醇在体内被迅速代谢。而本发明组合物在1h才达到最大血药浓度5.12μg/ml，且在给药8h后在血浆中还能检测到白藜芦醇。可以看出：相较于白藜芦醇原料而言，本发明组合物口服后缓慢释放进入血液循环，在血液中维持较长时间稳态血药浓度，生物利用度显著升高，这对白藜芦醇综合开发利用具有重要意义。
效果实施例3：抗辐射效果实施例
1.小鼠骨髓细胞微核试验
取40只雄性昆明小鼠，体重18～22g。按体重随机分成4组，每组10只：正常组、模型组、本发明组合物组和白藜芦醇组，其中本发明组合物组为实施例5制备样品，灌胃给药剂量为:本发明组合物0.67g/kg·d，白藜芦醇50mg/kg·d，用0.5％羧甲基纤维素钠水溶液配制成混悬液后给药，正常组和模型组同时给予等量的生理盐水。每天给药一次，连续给药20天。除正常组外其余组小鼠接受4Gy60Coγ射线全身照射，照射后第3天，颈椎脱臼处死小鼠，取出胸骨，用止血钳挤出骨髓液与玻片一端的小牛血清混匀，常规涂片自然干燥后甲醇固定10min，Giemsa染色蒸馏水冲洗晾干，光学显微镜下，每只动物计数1000个嗜多染红细胞中微核细胞数，微核率以千分率表示，结果见表2。
表2小鼠骨髓细胞微核率
由表2可知，与正常组比较，照射对照组小鼠骨髓细胞微核率显著增加，与模型组比较，本发明组合物组与白藜芦醇组小鼠骨髓细胞微核率均有降低，但是本发明组合物组小鼠骨髓细胞微核率降低更显著，说明本发明组合物对小鼠骨髓细胞损伤的保护作用效果更好。
2.小鼠外周白细胞计数实验
取60只雄性昆明小鼠，体重18～22g。按体重随机分成4组，每组15只：正常组、模型组、本发明组合物组和白藜芦醇组，其中本发明组合物组为实施例5制备样品，灌胃给药剂量为:本发明组合物0.67g/kg·d，白藜芦醇50mg/kg·d，用0.5％羧甲基纤维素钠水溶液配制成混悬液后给药，正常组和模型组同时给予等量的生理盐水。每天给药一次，连续给药30天，于第15天灌胃2h后除正常组外，其余组小鼠接受5Gy 60Coγ射线全身照射。各组于照射前、照射后第3天和第14天三次采末梢血20μl，计算各组白细胞总数，结果见表3。
表3小鼠外周血白细胞计数(×109/L)
| 组别 | 照射前 | 照射后3天 | 照射后14天 |
| 正常组 | 9.32±0.71 | 9.63±0.36 | 9.45±0.51 |
| 模型组 | 9.72±0.62 | 2.47±0.91 | 3.52±0.68 |
| 本发明组合物组 | 9.53±0.55 | 5.52±0.84 | 7.61±0.43 |
| 白藜芦醇组 | 9.49±0.64 | 3.82±0.67 | 6.02±0.74 |
正常组和模型组比较白细胞数显著减少，说明照射后，引起小鼠免疫应激效应，导致外周白细胞减少。相较于模型组，本发明组合物组和白藜芦醇组白细胞数量均有增加，但是本发明组合物组白细胞数量增加更显著，说明本发明组合物组效果更好。
以上所述仅为本发明的较佳实施例而已，并不用于限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
Claims (6)
1.一种抗辐射组合物，其组成包含白藜芦醇，其特征在于还包含扇贝多肽、螺旋藻多糖和鸡血藤提取物，所述鸡血藤提取物中含总黄酮10％-30％。
2.如权利要求1所述抗辐射组合物，其特征在于：所述组合物按重量计包含以下组分：白藜芦醇7.5～50份，扇贝多肽6～70份，螺旋藻多糖33～133份，鸡血藤提取物216～360份。
3.如权利要求1所述抗辐射组合物，其特征在于：所述组合物按重量计包含以下组分：白藜芦醇10～48份，扇贝多肽15～65份，螺旋藻多糖50～100份，鸡血藤提取物220～300份。
4.一种制备如权利要求1-3所述抗辐射组合物的制备方法，其特征在于，其制备方法包括以下步骤:
A：白藜芦醇-扇贝多肽-螺旋藻多糖复合物制备：将扇贝多肽和螺旋藻多糖同时溶于去离子水中，搅拌30min后，边搅拌边滴入预先溶于乙醇的白藜芦醇溶液，继续搅拌30min后，冷冻干燥，即得白藜芦醇-扇贝多肽-螺旋藻多糖复合物。
B:取鸡血藤提取物，与步骤A制得的白藜芦醇-扇贝多肽-螺旋藻多糖复合物按等量递增方法混均即得。
5.如权利要求1～4所述抗辐射组合物，其特征在于所述组合物可添加或不添加药品或食品可接受的辅料，进一步制成片剂、颗粒剂、胶囊、缓控释制剂等不同剂型。
6.如权利要求1-5所述抗辐射组合物在制备具有抗辐射、抗氧化、保护造血系统、抗免疫损伤等功能的药品、保健食品、功能性普通食品、特使医学用途配方食品、特殊膳食食品中的应用。
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