CN107496371B - 一种具有生物辅助性功能药理作用的淀粉基质空心胶囊 - Google Patents
一种具有生物辅助性功能药理作用的淀粉基质空心胶囊 Download PDFInfo
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- CN107496371B CN107496371B CN201610421414.0A CN201610421414A CN107496371B CN 107496371 B CN107496371 B CN 107496371B CN 201610421414 A CN201610421414 A CN 201610421414A CN 107496371 B CN107496371 B CN 107496371B
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- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
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Abstract
本发明公开了一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,所述的空心胶囊包括变性淀粉80‑95wt%、胶凝剂2.5‑10wt%、助凝剂0.01‑0.5wt%和功能性添加剂0.5‑10.0wt%,所述的功能性添加剂为枸杞多糖和桃胶的混合物,本发明的具有生物辅助性功能药理作用的淀粉基质空心胶囊中加入功能性添加剂枸杞多糖和桃胶,解决了淀粉基空心胶囊易脆碎、崩解时限长、稳定性差等问题,具备了现有明胶空心胶囊所不具备的显著功能特性,该功能性药理作用的植物基质空心胶囊可以广泛用于药品、保健品和食品行业。
Description
技术领域
本发明属于药品、保健品和食品行业的胶囊领域,具体地说,涉及一种具有生物辅助性功能药理作用的淀粉基质空心胶囊。
背景技术
传统的空心胶囊主要囊材是动物明胶,使用动物性明胶制备药用空心胶囊,有悠久的历史和成熟的工艺技术。由于该类空心胶囊具有包裹的药物成分可以避免药物本身对人体的感觉器官的刺激,并达到药物在体内的缓释效果的优势,长期以来以明胶为原料的空心胶囊在医药、食品领域得到了广泛的应用和认同。作为药物和保健品的主要包封材料,它的缺陷也为大家所公认。如自身的蛋白质易受酸、碱影响,限制了某些药物的使用。明胶分子内含有较多的活性基团,易于与接触的药物发生反应,从而改变了药物的性质。再有对环境的干燥、潮湿及温度变化的敏感,影响了胶囊的质量和使用,明胶胶囊对于易吸湿性药品,如中药提取物一般具有较强的吸湿性,易吸收明胶囊壳中的水分,导致胶囊内容物结块、囊壳***、变脆、崩解时限或溶出度不合格等质量问题,明胶易与含醛基药物反应,产生不溶物质,使胶囊崩解时间延长,甚至难崩解,并易使胶囊的颜色发生变化,动物传染性疾病的蔓延会直接影响明胶的质量,给胶囊剂带来安全隐患,明胶胶囊需要一定的温度和湿度储存条件,在高温和低湿条件下易失水硬化或脆碎等。
以植物为基础的胶囊可以从根本上避免明胶的缺陷,研究者和生产者的大量专利报道了这类工作的进展,中国专利CN101485643A公开了一种植物空心胶囊,是由纤维素醚为原料制备的空心胶囊,各组分重量百分比为羧甲基纤维素80-90%,固化剂1.5-10%,助凝剂1.5-10%,所述的固化剂选自植物胶或微生物胶或海藻胶中的一种或两种以上混合胶,所述的助凝剂选自柠檬酸钾或柠檬酸钠等。本发明虽然提高了稳定性,但是胶囊的崩解时限较长,以及低温脆粹度、30℃以上温度的储存等理化性能仍不尽人意。
中国专利CN1778304A公开了多司马酯胶囊及其制备方法,称取多司马酯、淀粉、微晶纤维素、低取代羟丙基纤维素、硬脂酸镁、甜菊糖,混合均匀,过筛。用自动填充机装填药物,即得所需多司马酯胶囊。本发明的多司马酯胶囊具有在胃肠液中分散快的特点,该制剂虽然提高了多司马酯的稳定性,且服用、携带方便,是治疗消化道溃疡的理想药物,但是胶囊的崩解时限较长,易脆碎。
中国专利CN1606978A一种植物胶空心胶囊及其生产工艺,涉及一种用于包装粉状制剂的空心胶囊的配方及工艺。其胶液的配比如下:植物胶16%-25%、增强剂2.0%-5.0%、表面活性剂0.02%-0.026%、保湿剂0.15%-0.20%、余量为水,所述的植物胶为果胶、卡拉胶中的一种或二种,所述的增强剂为壳聚糖、羧甲基淀粉、羟丙基纤维素中的一种或一种以上,所述的表面活性剂为十二烷基硫酸钠,所述的保湿剂为甘油。本发明的植物胶空心胶囊适用各种族人群;稳定性好,便于长久贮存,本发明可用明胶生产胶囊的设备,可节省投资。但是胶囊的崩解时限较长,易脆碎。
美国辉瑞公司以植物为原料的羟丙甲基纤维素(HPMC)为基质的非明胶胶囊Vcaps成功的推向了市场,并受到了广大消费者的认可。但是也有报道指出,这类胶囊的崩解时限较长,以及低温脆粹度、30℃以上温度的储存等理化性能仍不尽人意。
鉴于以上原因,特提出本发明。
发明内容
本发明要解决的技术问题在于克服现有技术的不足,提供了一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,该胶囊中加入功能性添加剂枸杞多糖和桃胶,解决了淀粉基空心胶囊易脆碎、崩解时限长、稳定性差等问题。
本发明的目的在于提供一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,所述的空心胶囊包括变性淀粉80-95wt%、胶凝剂2.5-10wt%、助凝剂0.01-0.5wt%和功能性添加剂0.5-10.0wt%,所述的功能性添加剂为枸杞多糖和桃胶的混合物。本发明的空心胶囊采用传统的蘸胶工艺进行制备,无需改变原有的工艺参数,本发明采用CN101023934A中的制备方法制备。
枸杞多糖(Lycium barbarum polysaccharide)简称LBP。是从枸杞中提取而得的一种水溶性多糖,由***糖、鼠李糖、木糖、甘露糖、半乳糖、葡萄糖与半乳糖醛组成的酸性杂多糖同多肽或蛋白质构成,是天然的大分子物质。经研究表明,枸杞多糖是枸杞子调节免疫、延缓衰老的主要活性成分。人体衰老主要是细胞氧化所致,枸杞多糖在体外可以直接清除羟自由基并能抑制自发或由羟自由基引发的脂质过氧化反应。研究表明通过灌服枸杞多糖能提高D一半乳糖致衰老小鼠体内谷胱甘肽过氧化物酶和超氧化物歧化酶活性,从而可以清除过量的自由基,起到延缓衰老的作用(《中药材》2004,27(8),《营养学报》2002,02)。
枸杞多糖对糖尿病有显著的保护作用,研究表明,它能明显增强受损胰岛细胞内SOD的活性,提高了胰岛细胞的抗氧化能力,减轻过氧化物对细胞的损伤。经动物实验显示,枸杞多糖对高血脂症兔的血脂有明显影响,能显著降低血清胆固醇(TC)及甘油三脂(TG)含量,降低脂肪肝指数。
现代医学已经证明:枸杞多糖有免疫调节、抗氧化、抗衰老、抗肿瘤、抗疲劳、降血脂、降血糖、降血压、补肾、保肝、明目、养颜、健脑、排毒、保护生殖***、抗辐射损伤十六项功能。(《安徽农业科学》2007,22,《齐鲁肿瘤杂志》(自然科学版)1996,02。)
桃胶是桃树山自然分泌出来的桃树油经化学反应而制得的浅黄色粘稠液体,经进一步干燥,粉碎为固体颗粒状,是一种浅黄色透明的固体天然树脂,桃胶的主要组成为半乳糖、鼠李糖、α-葡萄糖醛酸等,味甘苦,性平,无毒。入大肠、膀胱经,桃胶有足够的水溶性和适当的粘度,可用于配制水溶性胶粘剂,也可用作增稠剂、乳化剂。
枸杞多糖和桃胶作为药用空心胶囊或保健胶囊的功能性助剂,可以起到对多种疾病的辅助治疗作用,对于保健品的作用更是有着积极地促进病患的康复调整作用,可称为新一代功能性空心胶囊产品。
进一步的,所述的枸杞多糖与桃胶的重量百分比为1:10-10:1,本发明人经过大量的试验意外的发现,枸杞多糖与桃胶的重量百分比在1:10-10:1范围内制备的空心胶囊具有好的崩解时限,崩解时限短,提高了生物利用度,空心胶囊不易脆碎,吸湿率低,
进一步的,所述的变性淀粉包括羟丙基淀粉、羟乙基淀粉和羧甲基淀粉中的一种或多种。
进一步的,所述的羟丙基淀粉、羟乙基淀粉和羧甲基淀粉选自玉米淀粉、木薯淀粉、小麦淀粉、马铃薯淀粉或豆类淀粉。
进一步的,所述的胶凝剂包括卡拉胶、果胶、黄原胶、刺槐豆胶、结冷胶、琼脂胶、甘露聚糖和魔芋胶中的一种或多种。
进一步的,所述的助凝剂包括选自氯化钾、氯化钙、柠檬酸钾和乙酸钙中的一种或多种。
进一步的,所述的空心胶囊还包括增塑剂。
进一步的,所述的增塑剂包括丙三醇、木糖醇、山梨醇、聚乙二醇、聚乙烯醇、蔗糖等中的一种或多种。
与现有技术相比,本发明具有的有益效果如下:本发明的具有生物辅助性功能药理作用的淀粉基质空心胶囊中加入功能性添加剂枸杞多糖和桃胶,解决了淀粉基空心胶囊易脆碎、崩解时限长、稳定性差等问题,具备了现有明胶空心胶囊所不具备的显著功能特性,该功能性药理作用的植物基质空心胶囊可以广泛用于药品、保健品和食品行业。
具体实施方式
下述实施例中的实施方案可以进一步组合或者替换,且实施例仅仅是对本发明的优选实施例进行描述,并非对本发明的构思和范围进行限定,在不脱离本发明设计思想的前提下,本领域中专业技术人员对本发明的技术方案作出的各种变化和改进,均属于本发明的保护范围。
实施例1
将80g的羟丙基玉米淀粉与10g功能助剂(胶凝剂中桃胶和枸杞多糖的重量百分含量比为1:10)0.01g的氯化钾和10.0g的卡拉胶混合,得到用于制备空心胶囊的原料,然后投入一定量水中经加热糊化胶化后采用传统蘸胶工艺进行制备空心胶囊,制备得到了具有生物辅助性功能药理作用的淀粉基质空心胶囊。
实施例2
将95g的羟乙基木薯淀粉与0.5g功能助剂(胶凝剂中桃胶和枸杞多糖的重量百分含量比为1:5)0.5g的氯化钙和4g的结冷胶混合,得到用于制备空心胶囊的原料,然后投入一定量水中经加热糊化胶化后采用传统蘸胶工艺进行制备空心胶囊,制备得到了具有生物辅助性功能药理作用的淀粉基质空心胶囊。
实施例3
将87.5g的羟丙马铃薯基淀粉与10g功能助剂(胶凝剂中桃胶和枸杞多糖的重量百分含量比为10:1)0.02g的乙酸钙和2.5g的结冷胶混合,得到用于制备空心胶囊的原料,然后投入一定量水中经加热糊化胶化后采用传统蘸胶工艺进行制备空心胶囊,制备得到了具有生物辅助性功能药理作用的淀粉基质空心胶囊。
实施例4
将92.5g的羟丙马铃薯基淀粉与3.98g功能助剂(胶凝剂中桃胶和枸杞多糖的重量百分含量比为2:1)0.02g的乙酸钙和2.5g的结冷胶,1g魔芋胶混合,得到用于制备空心胶囊的原料,然后投入一定量水中经加热糊化胶化后采用传统蘸胶工艺进行制备空心胶囊,制备得到了具有生物辅助性功能药理作用的淀粉基质空心胶囊。
实施例5
将90g的羟丙马铃薯基淀粉与7.96g功能助剂(胶凝剂中桃胶和枸杞多糖的重量百分含量比为2:1)0.04g的乙酸钙和2.5g的结冷胶混合,并加入1g丙三醇得到用于制备空心胶囊的原料,然后投入一定量水中经加热糊化胶化后采用传统蘸胶工艺进行制备空心胶囊,制备得到了具有生物辅助性功能药理作用的淀粉基质空心胶囊。
试验例1
试验例1-5:实施例1-5制备得到的具有生物辅助性功能药理作用的淀粉基质空心胶囊。
对照例1:按照实施例1的方法制备的淀粉基质空心胶囊,不同之处在于,不加桃胶和枸杞多糖,其他组分和组成不变。
对照例2:按照实施例1的方法制备的淀粉基质空心胶囊,不同之处在于,将10g的桃胶和枸杞多糖替换为仅10g的桃胶。
对照例3:按照实施例1的方法制备的淀粉基质空心胶囊,不同之处在于,将10g的桃胶和枸杞多糖替换为仅10g的枸杞多糖。
1、崩解时限的检测
分别取试验例和对照例胶囊,装满滑石粉,锁合后,分别置于吊篮的玻璃管中(无需加挡板),照崩解时限检查法(中国药典2010年版二部规定的方法)检查,介质为自来水,水温为37±0.5℃,崩解时限见表1。
2、脆碎度的检测
分别取试验例和对照例的空心胶囊50粒,置表面皿中,移入盛有硝酸镁饱和溶液的干燥器内,置25±1℃恒温24小时,取出,立即分别逐粒放入直立在木板(厚度2cm)上的玻璃管(内径为24mm,长为200mm)内,将圆柱形砝码(材质为聚四氟乙烯,直径为22mm,重20±0.1g)从玻璃管口处自由落下,检测空心胶囊的脆碎度,结果见表1。
3、干燥失重
分别取试验例和对照例中的空心胶囊,在常压和规定的温度下,用电热干燥箱将样品干燥至恒重,检测方法:称取空心胶囊1.20g,将胶囊帽体分开,在105℃下干燥6h,测定减失重量。
表1空心胶囊的检测指标
从表1可以看出,本发明的空心胶囊的崩解时限短,不添加桃胶和枸杞多糖,或者仅加入其中的一种,崩解时限都会增加,崩解时限与制备胶囊的制备物有关,空心胶囊中加入桃胶和枸杞多糖使得其不易脆碎,干燥失重低,含水量少,均优于仅添加桃胶或枸杞多糖。
试验例2桃胶和枸杞多糖的重量百分比对检测指标的影响
本试验例的空心胶囊的制备方法与组成与实施例相同,不同之处,在于枸杞多糖和桃胶的重量百分比,其结果见表2。
表2枸杞多糖和桃胶的重量百分比对空心胶囊性能的影响
从表2可以看出,枸杞多糖和桃胶的重量百分比对空心胶囊的崩解时限、脆碎度和干燥失重影响较大,在本发明的枸杞多糖和桃胶的重量百分比范围内具有较好的崩解时限、脆碎度和干燥失重。
试验例3稳定性试验
本试验例和对照例中的空心胶囊中加入了阿莫西林,置于温度40±2℃,相对湿度75%±5%的条件下放置6个月,在试验期间分别于1、2、3、6个月末取样一次,进行加速试验,测试结果如表3:
从表3可以看出,试验例和对照例的崩解时间均略有降低,但变化非常小,可能是由于吸湿的原因,所填装的药物阿莫西林的含量,有关物质试验例的变化较小,而对照例的变化较大,说明本发明的空心胶囊对于药物的储存具有较好的稳定性的作用。
本发明人还对其它实施例做了上述实验,结果与上述试验相似,由于篇幅有限,不在一一列出。
Claims (7)
1.一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,其特征在于,所述的空心胶囊包括变性淀粉80-95wt%、胶凝剂2.5-10wt%、助凝剂0.01-0.5wt%和功能性添加剂0.5-10.0wt%,所述的功能性添加剂为枸杞多糖和桃胶的混合物,所述的枸杞多糖与桃胶的重量百分比为1:10-10:1。
2.根据权利要求1所述的一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,其特征在于,所述的变性淀粉包括羟丙基淀粉、羟乙基淀粉和羧甲基淀粉中的一种或多种。
3.根据权利要求2所述的一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,其特征在于,所述的羟丙基淀粉、羟乙基淀粉和羧甲基淀粉选自玉米淀粉、木薯淀粉、小麦淀粉、马铃薯淀粉或豆类淀粉。
4.根据权利要求1所述的一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,其特征在于,所述的胶凝剂包括卡拉胶、果胶、黄原胶、刺槐豆胶、结冷胶、琼脂胶、甘露聚糖和魔芋胶中的一种或多种。
5.根据权利要求1所述的一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,其特征在于,所述的助凝剂包括选自氯化钾、氯化钙、柠檬酸钾和乙酸钙中的一种或多种。
6.根据权利要求1所述的一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,其特征在于,所述的空心胶囊还包括增塑剂。
7.根据权利要求6所述的一种具有生物辅助性功能药理作用的淀粉基质空心胶囊,其特征在于,所述的增塑剂包括丙三醇、木糖醇、山梨醇、聚乙二醇、聚乙烯醇和蔗糖中的一种或多种。
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