CN115429771A - 一种胶囊用复合胶及其制备方法和应用 - Google Patents
一种胶囊用复合胶及其制备方法和应用 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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- Molecular Biology (AREA)
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Abstract
本发明提供了一种胶囊用复合胶及其制备方法和应用,属于药用辅料生产技术领域。本发明所述胶囊用复合胶包括如下重量份原料:纤维素衍生物20~50份、植物多糖10~30份、凝胶剂0.5~10份、增塑保湿剂1~10份、遮光剂0~2.5份、食用色素0~1.0份。本发明制备的胶囊用复合胶粘稠度适中,有良好的流动性,经该复合胶制备的胶囊壳保水性好且力学性能优异,用于药物灌装时破损率低,且灌装后的药物胶囊5min内均可崩解。
Description
技术领域
本发明涉及药用辅料生产技术领域,具体涉及一种胶囊用复合胶及其制备方法和应用。
背景技术
胶囊是用可食性材料包裹活性成分制成的一种药物剂型。目前市面上销售的胶囊壳主要是明胶胶囊壳、淀粉胶囊壳、羟丙基甲基纤维素胶囊壳、普鲁兰多糖胶囊壳。药用空心胶囊壳是一种特殊的药用辅料,它随着药物制剂一起进入人体的消化系统,为人体所吸收,所以药用空心胶囊壳的质量直接关系到药物成品的质量和安全。
市面上主要采用的是以明胶为原料的胶囊壳,但目前明胶原料来源参差不齐,有的甚至用皮革熬制明胶,导致明胶原料重金属含量超标,影响人的身体健康。另外明胶绝大多数是猪或牛的皮、骨制成的动物蛋白胶体明胶,含有一定的动物脂肪,容易由于动物源的疾病导致污染,也不为素食主义者等所接受。少部分的植物胶囊壳(淀粉胶囊壳、羟丙基甲基纤维素胶囊壳、普鲁兰多糖胶囊壳)虽然在市面上有销售,但是上述胶囊壳所用成分单一,成型后囊壳保水性低、机械性能差,用于药物灌装时,因机械冲击力易导致囊壳破碎,降低药物灌装效率和增加药物胶囊生产成本。研究文献中有关于复合材料制备的胶囊壳,但质量参差不齐,并未将其应用到药物灌装中,是否可以大规模生产和使用并未可知。且在复配体系中,组分种类和比例均影响其成膜性,以及各组分之间的相容性影响胶囊的性质,故组分的种类选择和比例设定成为研究的难点。目前采用纤维素衍生物和植物多糖结合凝胶剂为原料制备成性能优良且适应于大规模生产和使用的胶囊壳并未见相关报道。
发明内容
本发明的目的在于提供一种胶囊用复合胶及其制备方法和应用,本发明提供的复合胶制备成囊壳后,保水性好且可抵抗药物灌装的机械冲击力,不易破损,灌装后的药物5min内均可崩解。
为了实现上述发明目的,本发明提供以下技术方案:
本发明提供了一种胶囊用复合胶,包括如下重量份原料:纤维素衍生物20~50份、植物多糖10~30份、凝胶剂0.5~10份、增塑保湿剂1~10份、遮光剂0~2.5份、食用色素0~1.0份。
优选地,所述纤维素衍生物包括羧甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、纤维素羟丙基甲基醚中的一种或多种。
优选地,所述植物多糖包括海藻酸钠、普鲁兰多糖、银耳多糖、瓜尔豆胶中的一种或多种。
优选地,所述凝胶剂包括结冷胶、卡拉胶、明胶、琼脂中的一种或多种。
优选地,所述增塑保湿剂包括甘油、丙二醇、水溶性硅油、聚乙二醇、山梨醇中的一种或多种。
本发明提供了一种所述胶囊用复合胶的制备方法,包括如下步骤:称取纤维素衍生物、植物多糖、凝胶剂、增塑保湿剂,与去离子水混合,使其分散于水中,边搅拌边加热至各原料溶解于去离子水中,养胶脱气,即得胶囊用复合胶。
优选的,所述养胶脱气前还可加入遮光剂和食用色素,搅拌均匀。
优选的,所述加热温度为70~98℃。
优选的,所述养胶脱气的温度为50~85℃,所述养胶脱气的时间为3~7h。
本发明还提供所述胶囊用复合胶在制备空心胶囊中的应用。
与现有技术相比,本发明具有如下有益效果:
本发明将纤维素衍生物和植物多糖组合可降低植物多糖单独成膜的脆性,提高成膜的韧性和延伸性,选用凝胶剂可促使胶液在一定时间内快速成型,同时还可提高胶液成膜的延伸性,选用合适的增塑保湿剂可适当提高胶液的假塑性(非牛顿流体),同时还可保持复合胶成膜的含水量,使复合胶成膜不易在相对高温下失水易碎。
本发明选用适宜的原料和设定适宜的各原料用量可使复合胶粘度和流动性适中,利于在生产设备上大规模生产胶囊壳。
本发明胶囊用复合胶制备的胶囊壳,灌装药物时,可抵抗机械的冲击力,不易破损,经灌装后的药物胶囊在5min内可完全崩解。
具体实施方式
本发明提供了一种胶囊用复合胶,包括如下重量份原料:纤维素衍生物20~50份、植物多糖10~30份、凝胶剂0.5~10份、增塑保湿剂1~10份、遮光剂0~2.5份、食用色素0~1.0份;优选的,纤维素衍生物25~45份、植物多糖15~28份、凝胶剂2~8份、增塑保湿剂3~8份、遮光剂0~1.5份、食用色素0~0.8份。
在本发明中,所述纤维素衍生物包括羧甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、纤维素羟丙基甲基醚中的一种或多种;优选为羟乙基纤维素中的一种或两种。本发明所述纤维素衍生物可用作胶黏剂、表面活性剂、胶体保护剂、分散剂、乳化剂及分散稳定剂。在本发明所述羟乙基纤维素具有成膜性,在溶液中可与植物多糖结构相互嵌入,增强胶液成膜的力学性能和保水性。
在本发明中,所述植物多糖包括海藻酸钠、普鲁兰多糖、银耳多糖、瓜尔豆胶中的一种或多种,优选为海藻酸钠、瓜尔豆胶、银耳多糖中的一种或两种。本发明所述海藻酸钠选用低粘度海藻酸钠,粘度范围为30~50cP;所述海藻酸钠中的羟基可与羟乙基纤维素中的羟基形成氢键,使胶液成膜性脆性降低,延伸性增加。
在本发明中,所述凝胶剂包括结冷胶、卡拉胶、明胶、琼脂中的一种或多种,优选为明胶和结冷胶中的一种或两种。本发明所述结冷胶为低酰基结冷胶、高酰基结冷胶中的一种或两种。本发明所述低酰基结冷胶可形成坚硬、非弹性的脆性凝胶,所述高酰基结冷胶可形成柔软且弹性凝胶。本发明设定适宜的凝胶剂可使胶液在降低到室温状态下快速成型。本发明将低酰基结冷胶和高酰基结冷胶组合的比例为1:0.01~0.1,该组合可使胶囊壳制备中,蘸胶后胶液立即在模具上成型,不易滴落。
在本发明中,所述增塑保湿剂包括甘油、丙二醇、水溶性硅油、聚乙二醇、山梨醇中的一种或多种,优选为甘油、水溶性硅油、聚乙二醇中的一种或多种。本发明所述增塑保湿剂的加入可使复合胶呈假塑性,制备胶囊壳时,胶囊模具蘸胶时,胶液不易从模具上滴落。本发明所述增塑保湿剂还可使制备的胶囊壳保水性好,在一定高温下,不易失水破碎。
在本发明中,所述遮光剂包括二氧化钛、二氧化硅中的一种或两种,优选二氧化钛;所述食用色素包括天然β胡萝卜素、甜菜红、姜黄素、红花黄、紫胶红、越橘红、辣椒红、辣椒橙、红米红、萝卜红、苋菜红、苋菜红铝色淀、胭脂红、胭脂红铝色淀、赤藓红、赤藓红铝色淀中的一种或多种。
在本发明中,若无特殊说明,所有的原料组分均为本领域技术人员熟知的市售商品。
本发明还提供所述胶囊用复合胶的制备方法,其特征在于,包括如下步骤:称取纤维素衍生物、植物多糖、凝胶剂、增塑保湿剂,与去离子水混合,使其分散于水中,边搅拌边加热至各原料溶解于去离子水中,养胶脱气,即得胶囊用复合胶。本发明所述养胶脱气前还可加入遮光剂和食用色素,搅拌均匀。本发明所述加热温度为70~98℃,优选为75~96℃。本发明所述养胶脱气的温度为50~85℃,优选为55~75;所述养胶脱气的时间为3~7h,优选为3.5~5.5h。
本发明还提供所述胶囊用复合胶在制备空心胶囊中的应用。本发明采用所述复合胶制备的空心胶囊在一定高温下仍保持良好的保水性,不易破碎;进行机械药物灌装时,可抵抗机械冲击力,不易破碎,降低药物胶囊生产成本,灌装的药物胶囊在模拟胃液中5min内均可崩解,使药物快速释放、利于人体对药物的吸收。
下面将结合本发明中的实施例,对本发明中的技术方案进行清楚、完整地描述。显然,所描述的实施例仅仅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做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。
实施例1
一种胶囊用复合胶,由如下重量份原料组成:羟乙基纤维素40份、瓜尔豆胶20份、低酰基结冷胶5份、高酰基结冷胶0.05份、丙二醇5份。
一种胶囊用复合胶的制备方法包括如下步骤:称取上述重量份羟乙基纤维素、瓜尔豆胶、低酰基结冷胶、高酰基结冷胶、丙二醇,放入含400份去离子水的溶胶罐中,搅拌,使上述原料均匀分散于水中;加热溶胶罐,待温度升至65℃,边搅拌边加热,待温度升为95℃时,间隔15min搅拌一次,使各原料溶解于去离子水中,白色胶液状态完全变为半透明时,停止搅拌,温度降为55℃养胶脱气,即得胶囊用复合胶。
实施例2
一种胶囊用复合胶,由如下重量份原料组成:羟乙基纤维素50份、瓜尔豆胶30份、低酰基结冷胶5.5份、高酰基结冷胶0.08份、丙二醇8份。
一种胶囊用复合胶的制备方法与实施例1的区别在于去离子水的用量为550份,其余步骤均与实施例1相同。
实施例3
一种胶囊用复合胶,由如下重量份原料组成:羟乙基纤维素25份、瓜尔豆胶15份、低酰基结冷胶4.5份、高酰基结冷胶0.04份、丙二醇10份。
一种胶囊用复合胶的制备方法与实施例1的区别在于去离子水的用量为300份,其余步骤均与实施例1相同。
实施例4
一种胶囊用复合胶,由如下重量份原料组成:羧甲基纤维素40份、45cP的海藻酸钠20份、低酰基结冷胶4.5份、高酰基结冷胶0.03份、甘油6份。
一种胶囊用复合胶的制备方法与实施例1相同。
实施例5
一种胶囊用复合胶,由如下重量份原料组成:羟丙基甲基纤维素40份、银耳多糖20份、低酰基结冷胶4.5份、高酰基结冷胶0.03份、甘油6份。
一种胶囊用复合胶的制备方法与实施例1相同。
实施例6
一种胶囊用复合胶,由如下重量份原料组成:羧甲基纤维素40份、普鲁兰多糖20份、卡拉胶6份、山梨醇6份。
一种胶囊用复合胶的制备方法与实施例1相同。
对比例1
一种胶囊用复合胶,由如下重量份原料组成:羟乙基纤维素40份、瓜尔豆胶20份、低酰基结冷胶5.05份、丙二醇5份。
一种胶囊用复合胶制备方法与实施例1相同。
对比例2
一种胶囊用复合胶,由如下重量份原料组成:羟乙基纤维素60份、低酰基结冷胶5份、高酰基结冷胶0.05份、丙二醇5份。
一种胶囊用复合胶制备方法与实施例1相同。
对比例3
一种胶囊用复合胶,由如下重量份原料组成:瓜尔豆胶60份、低酰基结冷胶5份、高酰基结冷胶0.05份、丙二醇5份。
一种胶囊用复合胶制备方法与实施例1相同。
实施例7复合胶制备成的胶囊壳的性能测定
将实施例1~6和对比例1~3制备的复合胶倒入胶囊壳生产设备,进行蘸胶、干燥成型、脱模、切割、套合后制成空心胶囊壳。观察胶囊壳制备中的现象,测定胶囊壳的机械性能、干燥失重,结果见表1。
机械性能测定实验:在同样的条件下对胶囊壳进行拉伸实验,测定5次,每组分别测定10个,取平均值后计算出断裂伸长百分率、断裂强度。
干燥失重率的检测方法为:取实施例1~6和对比例1~3制备的胶囊壳10克,将帽、体分开,在105℃干燥6h后,测定减失重量。
表1胶囊壳的性能测定对比结果
由表1可知,实施例1~3制备的复合胶可在胶囊壳生产设备上顺利生产,且制备的胶囊壳机械性能和干燥失重明显优于其他实施例和对比例,证明经实施例1~3制备的胶囊壳相对于其他实施例和对比例具有良好的机械性能和保水性。经结果对比还可以看出,羟乙基纤维素和瓜尔豆胶组合配比明显提高胶液成膜的机械性能和保水性,低酰基结冷胶和高酰基结冷胶复配可使胶液顺利凝固,防止胶囊壳制备过程中胶液滴落无法立刻成型。
实施例8胶囊壳灌装药物后胶囊的性能测定
将实施例1~3制备的胶囊壳于胶囊灌装机中进行灌装,灌装物为与相应辅料混合的阿司匹林药物,流动性适宜胶囊灌装。观察灌装顺利程度、灌装成功率以及灌装后药物在模拟胃液中的崩解时间,结果见表2。
灌装成功率以如下公式计算:灌装成功率=灌装后完好无损的胶囊数/总胶囊壳数×100%。
模拟胃液的崩解时间测定:分别取上述灌装的胶囊6粒,于崩解仪中放入直径90mm、筛孔内径2.0mm的不锈钢丝筛网,置于1000mL的烧杯中,将每粒胶囊分别放入筛网空中,在模拟胃液中(取浓盐酸9mL,用蒸馏水稀释到1000mL,pH为1~2),37℃下检测。
表2药物胶囊性能测定结果
经上述表2可以看出,本发明制备复合胶制备的胶囊壳于胶囊灌装机中可顺利进行,灌装成功率高达98%,表明制备的胶囊壳可抵抗机械冲击力,不易破碎,有利于大规模胶囊生产中使用。同时制备的胶囊在5min内可完全崩解,表明利用本发明制备的胶囊壳灌装的药物可顺利被人体吸收利用,有利于药效的发挥。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种胶囊用复合胶,其特征在于,包括如下重量份原料:纤维素衍生物20~50份、植物多糖10~30份、凝胶剂0.5~10份、增塑保湿剂1~10份、遮光剂0~2.5份、食用色素0~1.0份。
2.如权利要求1所述的胶囊用复合胶,其特征在于,所述纤维素衍生物包括羧甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、纤维素羟丙基甲基醚中的一种或多种。
3.如权利要求1所述的胶囊用复合胶,其特征在于,所述植物多糖包括海藻酸钠、普鲁兰多糖、银耳多糖、瓜尔豆胶中的一种或多种。
4.如权利要求1所述的胶囊用复合胶,其特征在于,所述凝胶剂包括结冷胶、卡拉胶、明胶、琼脂中的一种或多种。
5.如权利要求1所述的胶囊用复合胶,其特征在于,所述增塑保湿剂包括甘油、丙二醇、水溶性硅油、聚乙二醇、山梨醇中的一种或多种。
6.如权利要求1~5任意一项所述的胶囊用复合胶的制备方法,其特征在于,包括如下步骤:称取纤维素衍生物、植物多糖、凝胶剂、增塑保湿剂,与去离子水混合,使其分散于水中,边搅拌边加热至各原料溶解于去离子水中,养胶脱气,即得胶囊用复合胶。
7.如权利要求6所述的制备方法,其特征在于,所述养胶脱气前还可加入遮光剂和食用色素,搅拌均匀。
8.如权利要求6所述的制备方法,其特征在于,所述加热温度为70~98℃。
9.如权利要求6所述的制备方法,其特征在于,所述养胶脱气的温度为50~85℃,所述养胶脱气的时间为3~7h。
10.如权利要求1~5任意一项所述的胶囊用复合胶在制备空心胶囊中的应用。
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Citations (3)
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US20050196436A1 (en) * | 2004-03-02 | 2005-09-08 | Arjnarong Chantranukul | Blends of different acyl gellan gums and starch |
US20070098779A1 (en) * | 2005-11-01 | 2007-05-03 | Andries Hanzen | Films and capsules made from modified carboxymethylcellulose materials |
CN112603903A (zh) * | 2020-12-28 | 2021-04-06 | 江苏力凡胶囊有限公司 | 一种植物空心胶囊及其制备方法 |
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US20050196436A1 (en) * | 2004-03-02 | 2005-09-08 | Arjnarong Chantranukul | Blends of different acyl gellan gums and starch |
US20070098779A1 (en) * | 2005-11-01 | 2007-05-03 | Andries Hanzen | Films and capsules made from modified carboxymethylcellulose materials |
CN112603903A (zh) * | 2020-12-28 | 2021-04-06 | 江苏力凡胶囊有限公司 | 一种植物空心胶囊及其制备方法 |
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