CN105596377A - 一种环糊精-黑木耳微粉组合物及其制备方法和制剂 - Google Patents
一种环糊精-黑木耳微粉组合物及其制备方法和制剂 Download PDFInfo
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- CN105596377A CN105596377A CN201610041264.0A CN201610041264A CN105596377A CN 105596377 A CN105596377 A CN 105596377A CN 201610041264 A CN201610041264 A CN 201610041264A CN 105596377 A CN105596377 A CN 105596377A
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Abstract
本发明公开了一种环糊精-黑木耳微粉组合物,其主要是由环糊精和黑木耳所制成。本发明还公开了所述组合物的制备方法、含有所述组合物的制剂以及该制剂的制备方法。相对于现有技术,本发明环糊精-黑木耳微粉组合物及其制剂,能够促进有效成分释放、提高有效成分水溶性、增强黑木耳蛋白成分稳定性、改善分散性、改进制剂性能。
Description
技术领域
本发明涉及一种环糊精-黑木耳微粉组合物及其制备方法和制剂,属于药物制剂领域。
背景技术
食用菌,是人类可以食用的大型真菌。自然界约有食用菌2000种,估计我国至少可达1500种或接近2000种。黑木耳是一种著名的食用菌,真菌学分类属担子菌纲,黑木耳目,黑木耳科。作为食品,黑木耳已有上千年的历史。食用黑木耳有黑木耳、毛黑木耳、燕耳、银耳、皱黑木耳、秋黑木耳、紫黑木耳等。黑木耳始载于《神农本草经》,收录有五黑木耳之名称。《吕氏春秋》提到:“味之美者,越骆之菌。”黑木耳不但是人们烹调必不可少的原料,也是亲朋互馈的珍贵礼品。俗话说得好“药补不如食补”。黑木耳药食同源,不但可以满足人们对美食的需求,长期食用,还能预防和减缓疾病的发生。
黑木耳含有丰富的多糖类物质、蛋白质及氨基酸、腺苷、纤维素、黄酮、维生素及矿物质。黑木耳约含多糖65~75%,黑木耳多糖可调节免疫力,降血脂,抗血栓,降血糖,抗肿瘤,延缓衰老,改善心肌缺氧,抗溃疡,抗辐射,抗肝炎、抗突变,对组织损伤具有保护作用,防治贫血,补气益智,凉血止血,辅助治疗慢性风湿性腰腿疼、心烦、失眠、食欲不振、痛经和月经量过多。除多糖外,黑木耳还含有丰富的蛋白质,含有人体必需的8种氨基酸,是良好的蛋白质来源。腺苷是黑木耳中重要成分之一,可以抑制血小板聚集,预防血栓。黑木耳中存在大量的纤维素,可以促进肠胃蠕动,加速机体废物排出体外,有清理肠胃的功能。黑木耳中的黄酮可以抗氧化、防衰老,并可阻止癌症的发生,改善血液循环,降低胆固醇,增进伤口愈合和止痛。黑木耳富含维生素,如B族维生素及维生素K。黑木耳所含的胡萝卜素可在人体内转化成为有活性的维生素A,防治夜盲症和视力减退,维护皮肤健康;硫胺素可预防并治疗脚气病;核黄素可预防口角唇炎、舌炎、眼结膜炎等,黑木耳中核黄素的含量是蔬菜的10倍以上;烟碱酸在人体多项代谢的过程里,担任辅酶的任务,其中最重要的则是参与糖代谢;维生素K可促进血液凝固并参与骨骼代谢,减少骨折危险。黑木耳还含有丰富的钙和铁,其中,铁是肉类的100倍、钙是肉类的30~70倍。此外,黑木耳中含有麦角甾醇、二氢麦角甾醇、卵磷脂、脑磷脂和鞘磷脂等。黑木耳具有致密的细胞结构,细胞壁主要由几丁质和β-葡聚糖组成,质地坚韧,不易被人体消化,细胞内的有效成分需要破壁才能释放,且黑木耳中的有效成分水溶性差,因此溶出难、溶解浓度小、生物利用度低。实验证明,黑木耳直接食用,其有效成分人体消化吸收利用率仅为10%左右,造成极大的浪费。
黑木耳由于其独特的风味,深受人们的喜爱,经炖、煮、拌、炒等方法,可烹制出不同风味的美味佳肴。除了传统的食用方法,目前市场上已有多种黑木耳相关的产品。如黑木耳多糖口服液、黑木耳多糖胶囊、黑木耳超微粉、黑木耳粉、黑木耳减肥粉,黄背黑木耳咀嚼片、黑木耳饮片等;复方产品如复方黑木耳胶囊、复方黑木耳咀嚼片、毛黑木耳复合营养片等。
有效成分类型的黑木耳产品,提取与分离纯化工艺繁琐,黑木耳中的其他成分资源得不到合理的充分利用,产品成本高。采用超微粉碎技术处理黑木耳,是目前应用较多的技术方法,微粉化有利于有效成分的释放和溶出,提高产品效率,但需使用昂贵的设备,加工过程技术要求也有很高要求。CN101732363B采用微粉化黑木耳制备咀嚼片,与黑木耳普通粉相比,虽然显示铁的溶出度有明显提高,但仍需配伍紫菜粉、乳酸亚铁、维生素B2等成分制成咀嚼片以提升产品价值;另有采用膨化技术的CN1803008,黑木耳经过膨化、粉碎研磨、过筛制成黑木耳粉,以纯黑木耳粉为原料制作保健食品。然而,黑木耳超微粉碎后,有效成分稳定性下降,还原性成分损失严重,产品难以长期保存,另外,粉碎后的微粉吸湿性强,且遇水极易结团成块而不易分散,严重制约有效成分的溶出释放,且服用时有严重粘牙现象影响口感舒适度,吸湿结团的特点还增加了后期制剂的难度,降低产品的实际应用价值,这些实际问题长期以来并未受到应有的重视。因此,找到一种既能充分利用黑木耳中的营养成分,促进黑木耳有效成分释放,又能增强其水溶性、提高稳定性、改善分散性、减少生产成本、利于保存且便于服用的黑木耳产品是目前黑木耳制品必须解决的重要技术难题。
发明内容
发明目的:本发明的目的提供一种环糊精-黑木耳微粉组合物,有效成分容易释放、水溶性好、稳定性强、分散性佳、易于制剂的黑木耳微粉。本发明还将提供这种微粉组合物的制备方法、以及这种微粉组合物的制剂及其制备方法。本发明是一种能够促进有效成分释放、提高有效成分水溶性、增强黑木耳蛋白成分稳定性、改善分散性、改进制剂性能的黑木耳新产品及其制备技术。
技术方案:为了实现上述发明目的,本发明提供了一种环糊精-黑木耳微粉组合物,其主要是由环糊精和黑木耳所制成。
作为优选,所述黑木耳与环糊精的质量比为1:(0.5~5)。
作为另一种优选,所述黑木耳与环糊精的质量比为1:(1~2)。
作为另一种优选,所述环糊精是β-环糊精或α-环糊精或羟丙基-β-环糊精。
作为另一种优选,所述微粉组合物中环糊精对黑木耳有效成分构成包合状态。
本发明还提供了所述环糊精-黑木耳微粉组合物的制备方法,,包括以下步骤:
(1)将黑木耳以温水浸泡,超声清洗后沥水,备用;
(2)将溶胀的黑木耳与环糊精按比例混合,先粗粉,然后再进行超微粉碎,得黑木耳超微粉浆料;
(3)将上述黑木耳超微粉浆料减压除水,再减压干燥,过筛,即得所述环糊精-黑木耳微粉。
具体地,包括以下步骤:
(1)将黑木耳以温水浸泡,超声清洗后沥水,备用;
(2)将溶胀的黑木耳与环糊精按比例混合,加入胶体磨中进行粗粉;形成均匀粗粉后调细机器间隙进行超微粉碎,得黑木耳超微粉浆料;
(3)将上述黑木耳超微粉浆料减压除水,再减压干燥,过200目筛,即得所述环糊精-黑木耳微粉。
本发明最后还提供了含有所述环糊精-黑木耳微粉组合物的制剂,其包括散剂、颗粒剂、片剂、胶囊、缓释片或分散片等。
上述环糊精-黑木耳微粉可直接以干法制粒制备颗粒剂,也可以配伍少量的常用食品或药物辅料制备成口服剂型。需要添加的辅料可以从以下物质中选用:微晶纤维素、淀粉、滑石粉、羧甲淀粉钠、羧甲基纤维素钠、硬脂酸镁、预胶化淀粉、乳糖、甘露醇、羟丙纤维素、微粉硅胶等,用常规方法制成片剂、胶囊剂、颗粒剂等多种制剂。
辅料的用量按现有的技术规范。
本发明技术特点如下:
1、包合可行性:
黑木耳充分干燥后粉碎成超微粉,取适量,加入15倍量0.3M磷酸盐缓冲液(pH7.00)中,超声处理10分钟,过滤,得黑木耳饱和水溶液。
(1)环糊精改变溶液中黑木耳成分的分子间作用(ITC谱)
黑木耳水溶液主要含有木耳多糖,强的水合作用和以氢键为主的多糖分子间作用导致溶液具有强的粘度特性。取500μl黑木耳饱和水溶液分别以20μl/480s速度间隔滴定纯水或β-环糊精溶液(100μg/ml),测定滴定热效应,对比两体系的ITC滴定图(见附图1),黑木耳饱和水溶液滴定纯水(实线),随滴定次数(浓度)的增加,滴定热逐步增强(峰高及峰面积增大),显示木耳多糖成分的水合作用和分子间作用随浓度增加而逐渐增大,放热逐步加剧;黑木耳饱和溶液滴定β-环糊精溶液(虚线),随滴定体积的增加体系热效应基本恒定变化不大,表明β-环糊精的存在明显削弱了多糖的分子间作用,这种降低多糖的分子间作用一是由于多糖分子链端与β-环糊精形成包合,妨碍多糖的分子间作用,二是β-环糊精与体系中其他分子包合,形成的分子混合体整体降低了多糖的分子间结合及其水合的发生几率,由于包合弱作用的热效应显著低于氢键,因此产生总热效应的降低。
(2)环糊精降低黑木耳溶液粘度
向黑木耳饱和水溶液加入β-环糊精,配制成浓度0~2.2×10-2g/ml的系列含有β-环糊精的黑木耳饱和溶液,分别测定各溶液粘度,发现随β-环糊精浓度的增大,溶液粘度持续明显的降低(见附图2),继续增加β-环糊精浓度(>2.2×10-2g/ml)时,溶液粘度基本稳定不变。黑木耳溶液粘度与体系中多糖分子间的相互作用相关,分子间作用越强体系粘度越大,加入环糊精使黑木耳溶液粘度降低,说明体系中多糖分子间作用受到环糊精的多种作用(内包合和外包合)而被削弱,这与ITC测定结果是一致的。降低粘度不仅有利于成分释放增加溶出,对改善产品可口特性也具有重要意义。
(3)环糊精包合黑木耳成分的表观包合常数(UV测定)
将黑木耳饱和水溶液作全波长扫描,在230~300nm间有较弱的紫外吸收,加入自身无紫外吸收的环糊精后,黑木耳有效成分水溶液紫外吸收随环糊精浓度的增大呈现规律性增强(见附图3),表明有效成分与环糊精能够形成有效的包合作用。通过环糊精浓度与黑木耳有效成分的紫外吸收强度变化的定量关系,测定黑木耳有效成分与环糊精的表观包合常数Ka如表1。
表1黑木耳水溶成分/环糊精的包合常数
较大的表观包合常数表明环糊精与黑木耳的有效成分包合作用较强,能形成稳定的包合物,包合有利于有效成分的水溶性和稳定性提高。本发明将环糊精与黑木耳在水中研磨,有效成分破壁溶出即与环糊精形成包合物,同时完成超微粉碎与包合,从而达到增加成分溶出又确保成分稳定的技术效果。
(4)样品热分析
β-环糊精:黑木耳的2:3环糊精-黑木耳微粉(微粉)与相应的2:3混合物的DTA谱如附图4:混合物72.71℃显示吸热脱水峰,229.77℃为混合物中的β-环糊精相变峰,样品在273.15℃开始缓慢吸热分解,338.12℃转为放热分解;β-环糊精-黑木耳微粉于61.37℃有脱水吸热峰,但脱水量减少,β-环糊精相变峰消失,微粉体系无游离环糊精,说明β-环糊精已参与成分的包合,243.18℃样品开始缓慢放热至311.85℃体系开始明显分解。结果显示,微粉物相已发生变化与混合物差异明显,样品分解温度明显升高,稳定性明显得到增强。
2、以蛋白为指标的增溶试验
方法:称取适量实施例2和实施例8的环糊精-黑木耳微粉,以及黑木耳量相当的纯黑木耳普通粗粉、纯黑木耳超微粉,加入0.3M磷酸盐缓冲液(pH7.00)中,180r/min,28℃振荡12h,取出。过滤,取滤液10ml,60r/min磁力搅拌,以0.3M磷酸盐缓冲液为透析液,3500透析袋透析4次,内液定容;取适量内液与考马斯亮蓝G-250试剂混合显色,595nm测定并计算蛋白含量,样品测定比较的结果如下表2:
表2样品的蛋白增溶倍数
普通超微粉碎处理可以提高黑木耳的蛋白溶出,但是增加幅度不大,环糊精-黑木耳微粉的蛋白溶出显著高于普通超微粉。本发明制备的微粉的蛋白水溶性增强、释放加快将有利于人体吸收利用。
3、以铁元素为指标的增溶试验
取硝酸、高氯酸,按4:1(v/v)配制混合酸消化液。称取实施例1黑木耳微粉,以及黑木耳量相当的黑木耳普通粗粉、黑木耳超微粉,分别用适量超纯水混合,180r/min,28℃振荡24h后过滤,取适量滤液于250mL烧杯,置于电热板上加热蒸干,加混合酸消化液消化至无色透明,冷却,加适量超纯水,加热除去多余的酸。待烧杯中液体余下1~2mL时取下,冷却。用0.5%硝酸定容。以不含试样的超纯水为空白。原子吸收火焰法测定样品吸光度,结果如下表3:
表3不同样品的铁元素溶解度和增溶倍数
普通的超微粉碎可以增加铁的溶解度,但加入环糊精的超微粉,由于环糊精的包合作用使铁更易于溶解,而有利于微粉中铁的吸收利用,从而提升产品营养价值。
4、蛋白稳定性试验
取实施例2制备的β-环糊精-黑木耳微粉,以及纯黑木耳粗粉、纯黑木耳超微粉,共3个样品,置于人工气候培养箱中,设置气候条件,温度(37.5±0.5)℃,相对湿度(75±5)%,于0d、15d和30d分别取样测定样品蛋白含量。
称取黑木耳含量相同的黑木耳粗粉、黑木耳超微粉、环糊精-黑木耳微粉适量,溶于0.3M磷酸盐缓冲液,180r/min,28℃振荡12h后过滤,取滤液,60r/min磁力搅拌,以0.3M磷酸盐缓冲液为外液,透析4h后定容,考马斯亮蓝G-250试剂混合显色测定蛋白含量,以0天样品含量为100%计算其相对含量,结果见表4。
表4蛋白稳定性试验结果
黑木耳粗粉蛋白质的稳定性略优于超微粉,但30天加速试验仍有11%以上蛋白分解损失,β-环糊精-黑木耳微粉的稳定性由于β-环糊精的加入而得到明显提高,30天后蛋白损失不足5%,产品稳定性明显优于普通超微粉。
5、加入环糊精对分散性、澄清度的影响试验
按下表5所示量依次称取纯黑木耳超微粉和β-环糊精,取研钵并按0~10编号,在研钵中混合超微粉和β-环糊精并充分研磨得均一的粉末,并取实施例2的环糊精-黑木耳微粉(编号:例2)产品对比测试。
表5试验样品的组分
取表5列总质量份的0~10和例2号样品(黑木耳量相同),分别加入到50ml纯水中,60r/min搅拌10min,观察记录样品在水中的分散性,有无结团现象;再加入200ml纯水继续搅拌2h,静置1h,观察记录溶液相的澄清度,结果见下表6。
表6分散性、澄清度考察结果
注:a:易分散,无结团,澄清;b:较易分散,极少量结团,微浑浊;c:不易分散,少量结团,明显浑浊;d:难分散,大量结团,严重浑浊。
纯黑木耳超微粉在水中难分散,大量结团,静置后体系严重浑浊;随着β-环糊精加入量的增加,样品在水中均匀的分散,结团现象减少,浑浊减少,澄清度佳。
6、加入环糊精的粉碎效果
本发明制备的β-环糊精-黑木耳微粉(实施例1)的显微图见图5,纯黑木耳超微粉(气引式粉碎机粉碎)见图6,显微放大相同倍数观察:β-环糊精-黑木耳微粉为无定型颗粒,没有规则的环糊精原料晶体,表明环糊精完全转化为包合物而无游离晶体存在,体系粒度分布多数为≤10μm范围,极个别≤20μm;纯黑木耳超微粉也是无定型颗粒,但其粉体粒度主要分布为30μm,个别达到约50μm,而且颗粒厚实块大。两种粉体差异十分明显,加入环糊精对黑木耳超微粉碎具有明显的促进作用。
技术效果:相对于现有技术,本发明具有以下优点:
(1)粉碎效果好,颗粒细粉体均匀,有效成分容易释放、水溶性好,有利于人体吸收利用;
(2)产品中的蛋白稳定性强,最大程度地解决蛋白类降解的问题;
(3)产品口感细腻、气味芳香,分散性好、不结团,无粘牙现象;
(4)粉粒性能优良,粒度细腻且流动性好,方便后续制剂加工;
(5)制备技术方法简单,设备简单,生产周期短,无污染,成本低廉。
附图说明
图1:黑木耳饱和水溶液分别滴定纯水(实线)及β-环糊精溶液(虚线)的ITC谱对比;
图2:黑木耳饱和水溶液粘度随β-环糊精浓度的变化;
图3:黑木耳水提液加入环糊精后,体系紫外吸收随环糊精浓度的变化;
图4:β-环糊精:黑木耳微粉(2:3)与相应混合物的DTA谱对比。
图5:β-环糊精:黑木耳微粉显微图
图6:纯黑木耳超微粉显微图
具体实施方式
下面结合附图进一步描述本发明的具体实施方案。
实施例1
黑木耳4000g,温水浸泡4h,超声清洗10min,去除根部及杂质,沥水,然后与4000gβ-环糊精混合,再加入少许水混合均匀投入胶体磨研磨,待大块黑木耳破碎体系均匀后调细机器间隙继续研磨10分钟至成为细腻浆状物,出料,投入耙式真空干燥机,控制60℃下减压搅拌除水,出料,以微波干燥机减压干燥0.5小时,过200目筛,得7134g环糊精-黑木耳微粉产品。
实施例2
与实施例1基本相同,但是加入4000g黑木耳与6000gβ-环糊精混合制备,得9072g环糊精-黑木耳微粉。
实施例3
与实施例1基本相同,但是以2000g羟丙基-β-环糊精代替β-环糊精制备,得5377g环糊精-黑木耳微粉。
实施例4
与实施例1基本相同,但是加入4000g黑木耳与20000gβ-环糊精制备,得21360g环糊精-黑木耳微粉。
实施例5
与实施例1基本相同,但是加入4000g黑木耳与4000g羟丙基-β-环糊精制备,得7083g环糊精-黑木耳微粉。
实施例6
与实施例1基本相同,但是加入4000g黑木耳与12000gβ-环糊精制备,得14336g环糊精-黑木耳微粉。
实施例7
与实施例1基本相同,但是加入4000g黑木耳与16000gβ-环糊精制备,得18320g环糊精-黑木耳微粉。
实施例8
与实施例1基本相同,但是加入4000g黑木耳与2000gα-环糊精制备,得5770g环糊精-黑木耳微粉。
实施例9
取实施例1制得的环糊精-黑木耳微粉7000g,干法制粒机调整压力6-7KN/cm2干法制粒过40目筛,以5g/包剂量分装,得1305包黑木耳颗粒剂。
Claims (9)
1.一种环糊精-黑木耳微粉组合物,其特征在于,其主要是由环糊精和黑木耳所制成。
2.根据权利要求1所述的环糊精-黑木耳微粉组合物,其特征在于,所述黑木耳与环糊精的质量比为1:(0.5~5)。
3.根据权利要求1所述的环糊精-黑木耳微粉组合物,其特征在于,所述黑木耳与环糊精的质量比为1:(1~2)。
4.根据权利要求1所述的环糊精-黑木耳微粉组合物,其特征在于,所述环糊精是β-环糊精或α-环糊精或羟丙基-β-环糊精。
5.根据权利要求1所述的环糊精-黑木耳微粉组合物,其特征在于,所述微粉组合物中环糊精对黑木耳有效成分构成包合状态。
6.权利要求1-5任一项所述环糊精-黑木耳微粉组合物的制备方法,其特征在于,包括以下步骤:
(1)将黑木耳以温水浸泡,超声清洗后沥水,备用;
(2)将溶胀的黑木耳与环糊精按比例混合,先粗粉,然后再进行超微粉碎,得黑木耳超微粉浆料;
(3)将上述黑木耳超微粉浆料减压除水,再减压干燥,过筛,即得所述环糊精-黑木耳微粉。
7.含有权利要求1-5任一项所述环糊精-黑木耳微粉组合物的制剂。
8.根据权利要求7所述的制剂,其特征在于,所述制剂包括散剂、颗粒剂、片剂、胶囊、缓释片或分散片。
9.权利要求7所述制剂的制备方法,其特征在于,主要包括以下步骤:以所述环糊精-黑木耳微粉组合物为主要成分,添加常规辅料,按照常规制剂方法制成制剂。
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