CN114672072B - 一种淀粉成膜组合物、软胶囊囊壳及其在软胶囊的应用 - Google Patents
一种淀粉成膜组合物、软胶囊囊壳及其在软胶囊的应用 Download PDFInfo
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- CN114672072B CN114672072B CN202210446867.4A CN202210446867A CN114672072B CN 114672072 B CN114672072 B CN 114672072B CN 202210446867 A CN202210446867 A CN 202210446867A CN 114672072 B CN114672072 B CN 114672072B
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- Prior art keywords
- starch
- soft capsule
- forming composition
- gellan gum
- capsule shell
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims abstract description 28
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Abstract
提供了一种淀粉成膜组合物、软胶囊囊壳及其在软胶囊中的应用。提供了一种淀粉成膜组合物,包含1‑8wt%结冷胶,16‑45wt%淀粉,10‑35wt%增塑剂和0.01‑0.2wt%碱性pH调节剂;其中淀粉成膜组合物还包含水;且其中碱性pH调节剂使得1%的从淀粉成膜组合物制备的软胶囊囊壳水溶液的pH值为6<pH≤8,且软胶囊囊壳中钾和钠元素的总含量低于500mg/100g;且其中结冷胶的每个重复单元包含25%至40%的乙酰基残基,且所述结冷胶具有单一凝胶温度。本发明的淀粉成膜组合物制备的软胶囊的成膜性能好,韧性好,成型性能好,并且具备肠溶效果。
Description
技术领域
本发明属于医药和膳食补充剂制造领域,具体涉及一种淀粉组合物以及该淀粉组合物在植物软胶囊中的应用。
背景技术
软胶囊指将定量的液体药物、营养成分直接包覆,或用适宜的赋形剂来溶解或分散固体药物、营养成分以制成溶液、悬浮液、乳液或半固体,密封于球形或椭圆形的软质囊材中的胶囊剂。软胶囊可以根据药物的性质制备成肠溶性软胶囊。尤其对于受胃液影响大的油脂、脂肪酸和益生菌等物质,可以通过制备肠溶性软胶囊以提高内容物的吸收和转化效率,降低功效物质的分解,使得功效物质更好地发挥效果,有效应用于高脂血症、心血管疾病等的治疗和预防。
关于肠溶性软胶囊,目前已经有诸多研究。例如,DE602014051284T2提出了一种包含高酰基结冷胶、淀粉和增塑剂的混合物,并且这种混合物制备的软胶囊具有肠溶效果。EP3010492A1公开了一种含高酰基结冷胶、淀粉和增塑剂的混合物,并且这种混合物制备的软胶囊不具备肠溶效果。CN100528950C公开了一种高酰基结冷胶、低酰基结冷胶、淀粉和增塑剂的组合物,该组合物制成的薄膜具有高模数以及优良强度和延伸性,制成的软胶囊具有较好的密封性。
本领域中仍然需要能够不含明胶,并且能够实现良好的成型性,不容易漏油的肠溶性软胶囊。
发明内容
发明人发现了特定的结冷胶、淀粉、增塑剂和水的成膜组合物制成的薄膜成型粘性高、强度大、韧性强,所制备的软胶囊成型效果好,接缝厚度大。本发明的成膜组合物中的结冷胶的每个重复单元可以包含25%至40%的乙酰基残基。但是,发明人发现了这种从结冷胶、淀粉、增塑剂和水组合物制成的软胶囊不具备肠溶效果。令人惊讶地,发明人在研究中发现,通过在配方中添加pH调节剂后,当1%的软胶囊囊壳水溶液的pH值为6<pH≤8时,软胶囊囊壳中结冷胶抵抗胃酸等酸性物质的性能得到增强。相反,当1%的含有结冷胶的软胶囊囊壳水溶液的pH小于6.0时,这可以增强结冷胶的凝胶能力,但降低了结冷胶抵抗胃酸等酸性物质的性能。另外,当制备的含有结冷胶成分的软胶囊囊壳中钾和钠元素的总含量低于500mg/100g,增强了结冷胶在胃酸等酸性物质中的抵抗能力,但是过高的钾、钠元素含量降低结冷胶的凝胶能力。令人惊讶地,发明人发现当1%的软胶囊囊壳水溶液的pH>6.0时,所制备的含有结冷胶成分的软胶囊囊壳中钾和钠元素的总含量低于500mg/100g,软胶囊囊壳中的结冷胶能够形成足够的凝胶强度,并且可以保证在胃酸等酸性物质中的抵抗性,具备肠溶释放的软胶囊,适合工业化生产。
在一方面,本发明提供了一种淀粉成膜组合物,其包含
1-8wt%结冷胶,
16-45wt%淀粉,
10-35wt%增塑剂,和
0.01-0.2wt%碱性pH调节剂;
其中淀粉成膜组合物还包含水;且
其中碱性pH调节剂使得1%的从淀粉成膜组合物制备的软胶囊囊壳水溶液的pH值为6<pH≤8,且软胶囊囊壳中钾和钠元素的总含量低于500mg/100g;且
其中结冷胶的每个重复单元包含25%至40%的乙酰基残基。
在一个实施方案中,碱性pH调节剂为氢氧化钠、氢氧化钾、氢氧化钙、氢氧化镁、磷酸钠、磷酸钾、磷酸钙、磷酸镁、碳酸钠、碳酸氢钠、碳酸钾、碳酸氢钾、碳酸钙、碳酸氢钙、碳酸镁或碳酸氢镁中的一种或多种。
在一个实施方案中,淀粉是羟丙基淀粉、羟丙基二淀粉磷酸酯、氧化淀粉、醋酸酯淀粉、氧化羟丙基淀粉、乙酰化氧化淀粉、乙酰化二淀粉磷酸酯或酸改性淀粉中的一种或多种。
在一个实施方案中,淀粉包含第一淀粉和第二淀粉,所述第一淀粉是羟丙基淀粉,并且第二淀粉是羟丙基二淀粉磷酸酯、氧化淀粉、醋酸酯淀粉、氧化羟丙基淀粉、乙酰化氧化淀粉、乙酰化二淀粉磷酸酯或酸改性淀粉中的一种或多种。
在一个实施方案中,按淀粉成膜组合物计,羟丙基淀粉的含量为20wt%-30wt%。
在一个实施方案中,增塑剂是甘油、山梨糖醇、甘露糖醇、赤藓糖醇、木糖醇和麦芽糖醇中的一种或多种。
在一个实施方案中,淀粉成膜组合物不添加除所述结冷胶外的食用胶。在一个实施方案中,所述食用胶是卡拉胶、黄原胶、瓜尔豆胶、琼脂、明胶、海藻酸钠、刺槐豆胶和魔芋胶中的一种或多种。
在一个实施方案中,淀粉成膜组合物中的水含量为35wt%-55wt%。
在另一方面,本发明提供了一种从本发明的淀粉成膜组合物制备肠溶性软胶囊囊壳的方法,其包括:溶胶、压丸和干燥步骤;其中溶胶步骤包括将结冷胶和增塑剂预混分散均匀,搅拌下加入到适量水中,在60~98℃下加热搅拌至结冷胶溶解;加入淀粉,继续在60~98℃下加热搅拌至淀粉溶解;除去气泡即得胶液。
在另一方面,本发明提供了一种肠溶性软胶囊囊壳,其通过本发明的方法制备。
在一个实施方案中,1%的软胶囊囊壳水溶液的pH值为6<pH≤8。在一个实施方案中,软胶囊囊壳中钾和钠元素的总含量低于500mg/100g。
在另一方面,本发明提供了一种肠溶性软胶囊,其包含本发明的肠溶性软胶囊囊壳和包囊的活性成分,所述活性成分在肠道中的释放是有利的。
在一个实施方案中,活性成分是油脂、脂肪酸、维生素、益生菌、激素或抗生素中的一种或多种。
在另一方面,本发明提供了本发明的淀粉成膜组合物、肠溶性软胶囊囊壳或肠溶性软胶囊在食品、营养保健食品和药品的应用。
本发明相对于现有技术具有如下的技术优点及有益效果:
1.本发明的淀粉成膜组合物制成的软胶囊成型性好,并且具有稳定的肠溶效果,凝胶温度较低,软胶囊囊壳成型表面光滑,不存在提前预凝胶、成型粘性和韧性低、形成的接缝小和易造成漏油的问题;
2.本发明的淀粉成膜组合物不含明胶,或不含结冷胶外的食用胶;和
3.本发明的淀粉成膜组合物成分简单,适合于工业化生产。
具体实施方式
为了进一步理解本发明,下面结合实施例对本发明优选实施方案进行描述,但是应当理解,这些描述只是为了进一步说明本发明的特征和优点,而不是对发明权利要求的限制。本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都被视为包括在本发明内。本发明的方法及应用已经通过较佳实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。虽然相信本领域普通技术人员充分了解以下术语,但仍陈述以下定义以有助于说明本发明所公开的主题。
如本文所使用,术语“包含”与“包括”、“含有”或“特征在于”同义,并且是包括端点在内或是开放式的,并且不排除额外的未叙述的要素或方法步骤。“包含”是权利要求语言中使用的技术术语,意思指存在所述要素,但也可以增加其它要素并且仍形成在所述权利要求范围内的构造或方法。
有研究表明,软胶囊包含第一和第二接缝;当软胶囊的第一和第二接缝大于250微米时,软胶囊具备肠溶效果;当软胶囊的第一和第二接缝小于250微米时,不具备肠溶效果。此外,当第一和第二接缝的厚度小于250微米时,软胶囊干燥完全后厚度将变小,更加不利于包装量较大的运输,甚至在成型干燥过程中存在漏油风险。DE602014051284T2的肠溶性软胶囊与EP3010492A1的非肠溶性软胶囊的差别主要就是软胶囊的第一和第二接缝的这种厚度差别。这两项专利也可进一步添加低酰基结冷胶,低酰基结冷胶的加入能够提高肠溶效果。然而,低酰基结冷胶的加入更加不利于软胶囊成型,接缝变差,更容易漏油。只有生产的软胶囊囊壳具备合适的强度、韧性和粘合性,才能制备出接缝厚度大,成型性好的软胶囊。制成的软胶囊成型性好,并且具有稳定的肠溶效果,这才是困扰着结冷胶基肠溶软胶囊的行业难题。为了解决该问题,现有技术采用的是高酰基结冷胶和低酰基结冷胶搭配的结冷胶,高酰基结冷胶和低酰基结冷胶搭配的凝胶性质差异大,尽管可以制成高模数以及优良强度的薄膜,但是高酰基结冷胶凝胶温度高带来提前凝胶的问题,并且低酰基结冷胶带来韧性差,导致所制成的软胶囊表面粗糙,接缝小,有严重的漏油风险的问题。另外,高酰基结冷胶制备肠溶软胶囊存在肠溶效果不稳定,高低酰基结冷胶体系的成型性差,容易漏油等的问题。
针对发明人在长期研究中发现的上述技术问题,相比于高酰基结冷胶搭配低酰基结冷胶制成的软胶囊,本发明的成膜组合物中的结冷胶的凝胶温度较低,软胶囊囊壳成型表面光滑(原因可能在于本发明的结冷胶具备单一胶凝温度或者具备相近的胶凝温度),不存在高酰基结冷胶与低酰基结冷胶复配后,由于凝胶性质不一致,高酰基导致胶液在成型过程中提前预凝胶,从而导致软胶囊囊壳表面粗糙的问题,以及低酰基结冷胶的加入导致软胶囊囊壳的成型粘性和韧性低,形成的接缝小,易造成漏油的问题。
如本文中使用,淀粉成膜组合物是指由淀粉作为组分,可以制备成软胶囊囊壳的组合物。在本文中,淀粉成膜组合物是肠溶性淀粉成膜组合物。在一个实施方案中,淀粉成膜组合物不包含明胶。
如本文中使用,结冷胶,又称凯可胶,洁冷胶,主要成分由葡萄糖、葡萄糖醛酸和鼠李糖按2:1:1的比例,四个单糖为重复结构单元所组成的线形多聚糖。在天然的高酰基结构中有乙酰基和甘油酰基存在,它们都位于同一个葡萄糖基上,且平均每一个重复结构有一个甘油酸基,而每两个重复结构有一个乙酰基。经用KOH皂化后,即转变成低酰基结冷胶。葡萄糖醛酸基上可被钾、钠、钙和/或镁盐中和。结冷胶在阳离子存在时,在加热后冷却时生成坚硬脆性凝胶。在本文中,本发明的淀粉成膜组合物可以包含适当量的阳离子,诸如钾、钠、钙和/或镁离子,但是软胶囊囊壳中钾和钠元素的总含量低于500mg/100g软胶囊囊壳。这些阳离子可以是由任何合适的盐提供的。这些盐可以包括但不限于碳酸钠、碳酸氢钠、碳酸钾、碳酸氢钾、碳酸钙、碳酸氢钙、碳酸镁、碳酸氢镁、氯化钠、氯化钾、氯化钙、氯化镁、磷酸钠、磷酸钾、磷酸钙、磷酸镁、柠檬酸钠、柠檬酸钾、硫酸钠、硫酸钾、硫酸钙或硫酸镁等中的一种或多种。在一些实施方案中,本发明的淀粉成膜组合物可以不包含盐。
如本文中使用,高酰基结冷胶是每重复单元具有超过40%乙酰基和/或超过45%甘油残基取代基的结冷胶。高酰基结冷胶的性质属于弹性高、凝胶温度高、并且可以不借助正价离子直接凝胶。如本文中使用,低酰基结冷胶是每重复单元具有低于25%乙酰基和/或低于15%甘油残基取代基的结冷胶。低酰基结冷胶的性质属于刚性高,弹性差,凝胶温度低,并且需要借助正价离子进行辅助凝胶。为了区分起见,本发明的淀粉成膜组合物中的这种结冷胶在本文中也可以称为部分脱酰基结冷胶,其弹性较高,凝胶温度介于高酰基结冷胶和低酰基结冷胶之间。部分脱酰基结冷胶的每个重复单元可以包含25%至40%的乙酰基残基。例如,部分脱酰基结冷胶的每个重复单元可以包含26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%或39%的乙酰基残基。令人惊讶地,发明人发现本发明的淀粉成膜组合物使用或包含一种或多种部分脱酰基结冷胶,特别是在使用仅一种部分脱酰基结冷胶时,可以实现优异的胶囊成型和软胶囊囊壳的稳定肠溶性的效果。
在淀粉成膜组合物中,结冷胶的含量为1-8wt%结冷胶。例如,结冷胶的含量为2wt%、2.5wt%、3wt%、3.5wt%、4wt%、4.5wt%、5wt%、5.5wt%、6wt%、6.5wt%、7wt%或7.5wt%。
本发明的淀粉成膜组合物还包含淀粉。淀粉的种类没有特别限制,可以是天然淀粉或变性淀粉,或者天然淀粉和变性淀粉的组合。天然淀粉可以选自蜡质玉米淀粉、豌豆淀粉、玉米淀粉、马铃薯淀粉、木薯淀粉中的一种或组合。变性淀粉可以选自酸处理淀粉、羟丙基淀粉、氧化淀粉、醋酸酯淀粉、氧化羟丙基淀粉、乙酰化氧化淀粉、羟丙基二淀粉磷酸酯、淀粉磷酸酯、乙酰化二淀粉磷酸酯、辛烯基琥珀酸淀粉酯、糊精和麦芽糊精中的一种或组合。在一个优选的实施方案中,淀粉为变性淀粉。在一个优选的实施方案中,淀粉可以是羟丙基淀粉、羟丙基二淀粉磷酸酯、氧化淀粉、醋酸酯淀粉、氧化羟丙基淀粉、乙酰化氧化淀粉、乙酰化二淀粉磷酸酯或酸改性淀粉中的一种或更多种。在一个优选的实施方案中,淀粉包含第一淀粉和第二淀粉,第一淀粉是羟丙基淀粉,第二淀粉可以是羟丙基二淀粉磷酸酯、氧化淀粉、醋酸酯淀粉、氧化羟丙基淀粉、乙酰化氧化淀粉、乙酰化二淀粉磷酸酯或酸改性淀粉中的一种或多种。按成膜组合物的总量计,淀粉的含量可以是16-45wt%,例如17wt%、18wt%、19wt%、20wt%、21wt%、22wt%、23wt%、24wt%、25wt%、26wt%、27wt%、28wt%、29wt%、30wt%、31wt%、32wt%、33wt%、34wt%、35wt%、36wt%、37wt%、38wt%、39wt%、40wt%、41wt%、42wt%、43wt%、44wt%或45wt%。在一个优选的实施方案中,按成膜组合物的总量计,第一淀粉的含量为15wt%-40wt%,例如16wt%、17wt%、18wt%、19wt%、20wt%、21wt%、22wt%、23wt%、24wt%、25wt%、26wt%、27wt%、28wt%、29wt%、30wt%、31wt%、32wt%、33wt%、34wt%、35wt%、36wt%、37wt%、38wt%或39wt%,和/或第二淀粉的含量为1wt%-35wt%,例如,2wt%、3wt%、4wt%、5wt%、6wt%、7wt%、8wt%、9wt%、10wt%、11wt%、12wt%、13wt%、14wt%、15wt%、16wt%、17wt%、18wt%、19wt%、20wt%、21wt%、22wt%、23wt%、24wt%、25wt%、26wt%、27wt%、28wt%、29wt%、30wt%、31wt%、32wt%、33wt%或34wt%。
本发明的淀粉成膜组合物还可以包含增塑剂。增塑剂可以是甘油、山梨糖醇、甘露糖醇、赤藓糖醇、木糖醇和麦芽糖醇中的一种或多种。按成膜组合物的重量计,增塑剂的含量为10-35wt%,例如11wt%、12wt%、13wt%、14wt%、15wt%、16wt%、17wt%、18wt%、19wt%、20wt%、21wt%、22wt%、23wt%、24wt%、25wt%、26wt%、27wt%、28wt%、29wt%、30wt%、31wt%、32wt%、33wt%或34wt%。
如本文中使用,碱性pH调节剂是指呈碱性的食用pH调节剂,用于增加淀粉成膜组合物或软胶囊囊壳的pH值。在本文中,碱性pH调节剂可以与提供阳离子的盐重叠,例如磷酸钠、磷酸钾、磷酸钙、磷酸镁、碳酸钠、碳酸氢钠、碳酸钾、碳酸氢钾、碳酸钙、碳酸氢钙、碳酸镁和/或碳酸氢镁。优选地,碱性pH调节剂是氢氧化钠、氢氧化钾、氢氧化钙或氢氧化镁中的一种或多种。在这种情况下,碱性pH调节剂还可以提供了阳离子,例如钾、钠、钙和/或镁阳离子。
在本文中,软胶囊囊壳中钾和钠元素的总含量可以低于500mg/100g软胶囊囊壳。在一个实施方案中,软胶囊囊壳中钾和钠元素的总含量可以低于或等于490mg/100g、480mg/100g、470mg/100g、460mg/100g、450mg/100g、440mg/100g、430mg/100g、420mg/100g、410mg/100g、400mg/100g、390mg/100g、380mg/100g、370mg/100g、360mg/100g、350mg/100g、340mg/100g、330mg/100g、320mg/100g、310mg/100g、300mg/100g、290mg/100g、280mg/100g、270mg/100g、260mg/100g、250mg/100g、240mg/100g、230mg/100g、220mg/100g、210mg/100g或200mg/100g。
在本文中,淀粉成膜组合物可以包含0.01-0.2wt%的碱性pH调节剂。例如,碱性pH调节剂的含量可以是0.01wt%、0.02wt%、0.03wt%、0.04wt%、0.05wt%、0.06wt%、0.07wt%、0.08wt%、0.09wt%、0.1wt%、0.11wt%、0.12wt%、0.13wt%、0.14wt%、0.15wt%、0.16wt%、0.17wt%、0.18wt%或0.19wt%。碱性pH调节剂可以使得1%的本发明的软胶囊囊壳的水溶液的pH大于6,只要该pH值适合于人服用,例如6.1、6.2、6.3、6.4、6.5、6.6、6.7、6.8、6.9、7.0、7.1、7.2、7.3、7.4、7.5、7.6、7.7、7.8、7.9、8.0、8.1、8.2、8.3、8.4、8.5、8.6、8.7、8.8、8.9或9。优选地,1%的本发明的软胶囊囊壳的水溶液的pH为6(不包括端点6)-8。
淀粉成膜组合物还可以包含水。水的含量可以为35wt%-55wt%,例如36wt%、37wt%、38wt%、39wt%、40wt%、41wt%、42wt%、43wt%、44wt%、45wt%、46wt%、47wt%、48wt%、49wt%、50wt%、51wt%、52wt%、53wt%或54wt%。
本发明的淀粉成膜组合物可以不包含食用胶。食用胶可以是卡拉胶、黄原胶、瓜尔豆胶、琼脂、明胶、海藻酸钠、刺槐豆胶和魔芋胶等中的一种或多种。
在本文中,“肠溶效果”在结合软胶囊使用时,是指软胶囊满足在胃中保持至少60分钟崩解不破裂,随后不超过60分钟内在模拟肠液中崩解的效果。《中国药典》中规定,肠溶性胶囊的崩解时限检查中,在盐酸溶液(9→1000)中不加挡板检查2h不得出现裂缝或崩解,在人工肠液(pH=6.8)中加挡板检查,1h内应全部崩解。按照《美国药典》USP<2040>膳食补充剂中软胶囊的规定,对延迟释放(肠溶衣)软胶囊进行崩解试验。在模拟胃液中,软胶囊在模拟胃液中保持至少60分钟崩解不破裂,随后不超过60分钟内在模拟肠液中崩解。按照欧洲药典EP<2.9.1>片剂和胶囊的崩解时限测试方法及有关抗胃酸胶囊崩解时限的规定,抗胃酸胶囊在0.1M盐酸中,保持至少120分钟不破裂。随后不超过60分钟内在pH6.8的磷酸缓冲溶液中崩解。本领域中需要满足所有标准的肠溶性软胶囊。在本文中,发明人根据测试发现本发明的肠溶性软胶囊满足任何或所有这些标准。优选地,肠溶性软胶囊满足所有三种标准以扩大适用范围,满足商业需要。本发明的肠溶性软胶囊还应当满足有效期内的肠溶稳定性,如本发明证明的,例如通过加速实验证明。
本发明提供了软胶囊囊壳,其从本发明的淀粉成膜组合物制备。在一个实施方案中,软胶囊囊壳具备以下特征:1%的软胶囊囊壳水溶液的pH为6.0(不包括端点)-8;和/或软胶囊囊壳中钾和钠元素的总含量低于500mg/100g。上文对本发明的淀粉成膜组合物描述的各个方面或实施方案同样适用于本发明的软胶囊囊壳。
软胶囊囊壳可以通过常规的工艺从本发明的淀粉成膜组合物制备。例如,制备方法可以包括:溶胶、压丸和干燥步骤。溶胶步骤可以包括将结冷胶和增塑剂预混分散均匀,搅拌下加入到适量水中,在60~98℃下加热搅拌至结冷胶溶解;加入淀粉,继续在60~98℃下加热搅拌至淀粉溶解;除去气泡即得胶液。压丸步骤可以包括采用软胶囊生产线,将胶液输送至软胶囊填充机的胶盒中,胶液在转鼓表面上冷却形成胶皮,经封装填充物压制成型,可进一步在转笼定型。制备得到的软胶囊囊壳经测试为肠溶性的,并且具有优异的成型性能。
本发明的淀粉成膜组合物制备的软胶囊囊壳可以具有以下特性:
1)胶皮强度指标(F,单位N)大于等于0.83N,例如0.9N、1N、1.1N、1.17N、1.2N、1.3N、1.4N、1.51N、1.6N、1.7N、1.8N、1.9N或2N;
2)韧性指标(T,单位mm)大于等于6mm,例如7mm、8mm、9mm、10mm、11mm、12mm或13mm;和/或
3)成型粘合指标(P,单位%)大于等于40%、45%、50%、55%、60%、70%、80%、90%或100%。
本发明的淀粉成膜组合物制备的软胶囊囊壳具有良好的综合评价,其中综合评价是由胶皮强度指标、韧性指标和成型粘合指标相加的综合指标。解决成型粘性是制备肠溶性软胶囊的关键步骤,因此成型粘合评估权重最大。例如,在综合评价中,成型粘合评估权重大于胶皮强度和/或韧性指标权重。成型粘合评估权重可以大于50%、60%、70%等。该权重的确定是本领域技术人员根据实际情况确定的。在本发明中使用综合评价评估软胶囊的成型效果。应当理解,也可以使用单独的指标进行评估,如使用成型粘合指标、胶皮强度指标和韧性指标中的一个或多个进行评估。
可以使用本发明的软胶囊囊壳包裹活性成分以制备成肠溶性软胶囊。活性成分的类型和内容物没有特别限制,本领域技术人员可以常规进行选择。胶囊内容物可以根据用途而适当地决定。内容物的形态可为溶液状、悬浊液状、糊状、粉末状、颗粒状等任意形态。活性成分可以选择为在肠道中的释放是有利的活性成分。例如,活性成分是油脂、脂肪酸、维生素、益生菌、激素或抗生素中的一种或多种。
油脂可以包括萼梨油、鱼油、藻油、磷虾油、大蒜油、杏仁油、亚麻仁油、茴香油、紫苏油、橄榄油、橄榄角鲨烯、甜油、芝麻油、蒜油、可可脂、南瓜种子油、洋甘菊油、胡萝卜油、青瓜油、牛油脂肪酸、夏威夷核果油、苔莓种子油、糙米胚芽油、米油、小麦胚芽油、红花油、牛油树油脂、液状牛油树油脂、紫苏油、大豆油、月见草油、山茶油、玉米油、菜籽油、锯叶棕萃取油、薏苡油、桃仁油、洋芹子油、蓖麻油、葵花籽油、葡萄籽油、琉璃苣油、澳洲胡桃油、白芒花籽油、棉籽油、花生油、龟油、貂油、蛋黄油、棕榈油、棕榈仁油、木蜡、椰子油、长链、中链、短链脂肪酸的三酸甘油酯、二酰基甘油酯、牛油、猪油、角鲨烯、角鲨烷。这些油脂具备多种功效,可用于多种目的。例如,月见草油的主要成分有:亚麻油酸、镁、锌、铜、维生素C、E、B6和B5,并且具有多项治疗、美白功能,制成胶囊内服可以治疗心血管疾病、经前症候群或更年期综合症。月见草油肠溶性软胶囊可以保护主要成分油酸等不被胃酸破坏,从而提高了月见草油的吸收和转化,大大增加产品效果。
脂肪酸可以包括月桂酸、肉豆蔻酸、棕榈酸、硬脂酸、山萮酸、油酸、亚麻油酸、共轭亚麻油酸、次亚麻油酸、二十二碳六烯酸、二十碳五烯酸、12-羟基硬脂酸、十一碳烯酸、妥尔油、羊毛脂脂肪酸等天然脂肪酸,以及异壬酸、己酸、2-乙基丁酸、异戊酸、2-甲基戊酸、2-乙基己酸、异戊酸等合成脂肪酸。
维生素可以包括维生素A:视黄醇、视黄醛(维生素A1)、去氢视黄醛(维生素A2)、胡萝卜素、茄红素(原维生素A);维生素B群:呋喃硫胺、盐酸硫胺素、硫酸硫胺素(维生素B1)、核黄素(维生素B2)、吡哆醇(维生素B6)、氰钴胺素、甲钴胺(维生素B12)、叶酸类、烟碱酸类、泛酸类、生物素类、胆碱、肌醇类;维生素C群:抗坏血酸或其衍生物;维生素D群:麦角钙化固醇(维生素D2)、胆钙化醇(维生素D3)、二氢速固醇;维生素E群:维生素E或其衍生物、泛醌类;维生素K群:植物甲萘醌(维生素K1)、甲萘醌(menaquinone)(维生素K2)、四烯甲萘醌、甲萘醌(menadione)(维生素K3)、甲萘二酚(维生素K4)等。
本发明的淀粉成膜组合物、肠溶性软胶囊囊壳或者肠溶性软胶囊根据所含的活性成分可以在食品、营养保健食品、药品和化妆品的应用。肠溶性软胶囊相比较于普通软胶囊的优势在于:肠溶性软胶囊可以耐受胃酸的反应,直接在肠道中释放内容物,从而提高内容物的吸收和转化。例如,可以制备鱼油肠溶性软胶囊,鱼油含有人体必需的脂肪酸DHA和EPA,适用于三高人群、有血栓、中风等患者。鱼油具有以下功效:调节血脂,清理血栓,防止血液凝固,预防脑血栓、脑溢血及中风;预防关节炎、缓解痛风、哮喘,暂时缓解由关节炎引起的肿痛;预防老年痴呆症、营养大脑、改善记忆;改善视力、防治老花眼;维护视网膜。胃液中含有脂肪酶、蛋白酶等,可以分解破坏油脂等内容物。肠溶性软胶囊可以避免软胶囊在胃液中破裂所带来的内容物反应造成的反胃,恶心等现象,特别适用于鱼油、藻油、大蒜油、磷虾油等。多烯酸乙酯是鱼油经精制、酯化而得的多不饱和脂肪酸乙酯化的产品,有不良的鱼腥味。具有降低血清甘油三酯和总胆固醇的作用,用于高脂血症。因此将多烯酸乙酯制备成多烯酸乙酯肠溶性软胶囊,可以避免不良气味,并且增加内容物的吸收和转化。肠道益生菌可以包覆于肠溶性软胶囊中,避免胃液中胃蛋白酶和胃酸的侵蚀,更好的保护了益生菌,益生菌肠溶性软胶囊在肠道释放后,直接作用于肠道,提高了益生菌的使用效率。
实施例
下面结合实施例对本发明的发明目的、技术特点和有益效果作进一步详细的描述,但本发明的实施方式不限于此。
相关淀粉制备方法可参见《变性淀粉》-华南理工大学出版社(1999),2001,第二版。
本实施例中使用以下结冷胶(购买自帝斯曼公司):
结冷胶a(部分脱酰基结冷胶,乙酰基含量20%);
结冷胶b(部分脱酰基结冷胶,乙酰基含量26%);
结冷胶c(部分脱酰基结冷胶,乙酰基含量29%);
结冷胶d(部分脱酰基结冷胶,乙酰基含量35%);
结冷胶e(部分脱酰基结冷胶,乙酰基含量39%);
结冷胶f(部分脱酰基结冷胶,乙酰基含量50%)。
为了更好说明本发明的效果,采用以下软胶囊性能指标进行评价说明:
(1)成型
1)胶皮强度(F)和韧性指标(T):采用物性测试仪,选择球形探头与穿刺模式,测试速度1.0mm/s,记录胶皮破裂力,破裂力越大,胶皮强度越好;胶皮破裂时对应的破裂距离(mm),破裂距离越大,胶皮的韧性越好。
2)成型夹缝粘合指标:从胶囊在非夹缝上剪开,挤压排空内容物,然后保持与夹缝垂直从中间剪取一个含有两条夹缝的环圈,使环圈置于载玻片上,并使两条夹缝垂直载玻片,在显微镜下测量两条夹缝处的厚度及囊壳的厚度,计算最薄夹缝厚度占囊壳厚度的比值P(%)。
表1软胶囊胶皮强度、韧性和成型粘合指标评价标准
以胶皮强度指标、韧性指标和成型粘合指标进行综合评价软胶囊生产可行性,其中胶皮强度、韧性两个指标分别≥3分且成型粘合指标≥3分,才能满足软胶囊工业生产,三个指标综合评价总分5分,分数越高表示综合性能越好。相比于胃溶软胶囊,肠溶性软胶囊中部分脱酰基的结冷胶凝胶性质较差,导致成型过程的综合性能中,解决成型粘性才是制备肠溶性软胶囊的关键步骤。综合评价是由胶皮强度占比20%,韧性指标占比20%,成型粘合占比60%,三者相加得到的,并且综合评价必须大于3才能实现软胶囊工业化生产。
(2)肠溶
对于本发明而言,软胶囊必须符合
1)按照美国药典USP<2040>膳食补充剂中软胶囊的规定,对延迟释放(肠溶衣)软胶囊进行崩解试验。在模拟胃液中,软胶囊在模拟胃液中保持至少60分钟崩解不破裂,随后不超过60分钟内在模拟肠液中崩解。
2)按照欧洲药典EP<2.9.1>片剂和胶囊的崩解时限测试方法及有关抗胃酸胶囊崩解时限的规定,抗胃酸胶囊在0.1M盐酸中,保持至少120分钟不破裂。随后不超过60分钟内在pH6.8的磷酸缓冲溶液中崩解。
(3)软胶囊囊壳中钾和钠元素的总含量的测定
对于本发明而言,将软胶囊囊壳按照“GB 5009.91-2017”的方法进行钾元素和钠元素含量的测定。
(4)1%的从淀粉成膜组合物制备的软胶囊囊壳的水溶液的pH值测定
将软胶囊囊壳溶解于80℃的纯化水中配制成1%的从淀粉成膜组合物制备的软胶囊囊壳的水溶液,将待测溶液冷却至室温后,使用pH计(准确度为0.01)对1%的从淀粉成膜组合物制备的软胶囊囊壳的水溶液进行pH值测定。
实施例1-8
使用表2和表3中的配方以及上述方法制备软胶囊囊壳,并且根据以上方法测定胶皮强度指标、韧性指标和成型粘合指标以及肠溶性特性。
表2:实施例1-8的淀粉成膜组合物的配方以及测定结果
表3:对照例1-9的淀粉成膜组合物的配方以及测定结果
√不破裂,×破裂,/未测试。
实施例1-6采用了氢氧化钾作为pH调节剂,与部分脱酰基结冷胶、淀粉、甘油和水的组合物制成软胶囊,其中实施例1-5的软胶囊囊壳中钾、钠元素的总含量分别为245、254、276、356和463mg/100g,均低于500mg/100g,并且成型综合评价分别为5、5、5、4.4和3.2,均高于3.0,适合软胶囊的工业化生产,但是实施例1中1%的软胶囊囊壳水溶液的pH为5.91(<6.0),最终软胶囊不具备肠溶效果。实施例2-6中1%的软胶囊囊壳水溶液的pH分别为6.02、6.17、6.41、6.57或6.61,pH均>6.0,实施例2-6的软胶囊均具备肠溶效果,但是实施例6的成型综合评价2.6(小于3.0),成型粘性差,漏油风险大,影响软胶囊无法大规模生产。
实施例7和8是采用氢氧化钠和氢氧化钙作为pH调节剂,其成型综合评价分别为5和3,高于3.0,适合软胶囊规模化生产,其1%的软胶囊囊壳水溶液的pH分别为6.21和6.11,pH>6.0,软胶囊囊壳中钾、钠元素的总含量分别为诶271和240,低于500mg/100g,并且也具备肠溶效果。相比氢氧化钾,氢氧化钙可以保证肠溶效果(增加pH),但是制备的软胶囊囊壳的成型性能差于氢氧化钾。
对照例1-4采用了二水柠檬酸钠作为pH调节剂,其成型综合评价分别为5、5、5和3,均高于3.0,适合软胶囊的规模化生产,对照例1和2中制成的软胶囊囊壳中钾、钠元素的总含量分别为251和356mg/100g,均低于500mg/100g,但是1%的软胶囊囊壳水溶液的pH为5.85和5.88,均<6.0。对照例3和4中制成的软胶囊囊壳中钾、钠元素的总含量分别为521和627,均高于500mg/100g,1%的软胶囊囊壳水溶液的pH分别为6.01和6.03,均>6.0;但是对照例1-4均不具备肠溶效果。对照例5采用柠檬酸作为pH调节剂,对照例6添加了氯化钾,对照例7不添加pH调节剂,其制成的软胶囊囊壳中钾、钠元素的总含量分别为240、266和241,均低于500mg/100g,1%的软胶囊囊壳水溶液的pH分别为5.80、5.86和5.85,均<6.0,并且制成的软胶囊均不具备肠溶效果。因此,发明人得到结论:pH值和钠钾元素含量共同影响软胶囊的成型性能。当pH值和/或钠钾元素含量越高,成型综合评价越低,当过高时,可能使得结冷胶无法凝胶;然而,pH值也会影响软胶囊的肠溶性,当pH低于6时,制备的软胶囊不是肠溶性软胶囊。
对照例8和9分别采用高酰基结冷胶和低酰基结冷胶,添加氢氧化钾作为pH调节剂后,对照例8制成的软胶囊囊壳中钾、钠元素的总含量均低于500mg/100g,1%的软胶囊囊壳水溶液的pH>6.0,满足美国药典的肠溶软胶囊崩解时限标准,但是不满足欧洲药典的肠溶软胶囊崩解时限标准,并且软胶囊在有效期内随着放置时间延长,肠溶效果有所下降,最终不满足美国药典肠溶软胶囊崩解时限标准,其肠溶效果不稳定,并且其成型综合评价低于3,因此不适合大规模生产;虽然对照例9制成的软胶囊囊壳中钾、钠元素的总含量均低于500mg/100g,1%的软胶囊囊壳水溶液的pH>6.0,但是其成型综合评价远低于3,几乎无法制成软胶囊。因此,当使用部分脱酰基结冷胶(乙酰基含量35%)和pH调节剂共同作用后,使得制成的软胶囊囊壳中钾、钠元素的总含量均低于500mg/100g,1%的软胶囊囊壳水溶液的pH>6.0,其成型综合评价远高于3,适合大规模工业化生产,并且具备稳定的肠溶效果。
实施例9-15
使用表4和表5中的配方以及上述方法制备软胶囊囊壳,并且根据以上方法测定胶皮强度指标、韧性指标和成型粘合指标以及肠溶性特性。
表4:实施例9-12的淀粉成膜组合物的配方以及测定结果
表5:实施例13-17的淀粉成膜组合物的配方以及测定结果
实施例9-15举例说明含有部分脱酰基结冷胶与不同种类淀粉组合制备软胶囊,技术效果明显优于现有技术,并且能实现肠溶效果。实施例16和17是分别采用较低乙酰基含量的部分脱酰基结冷胶和较高乙酰基含量的部分脱酰基结冷胶搭配pH调节剂,其制成的软胶囊囊壳中钾、钠元素的总含量均低于500mg/100g,1%的软胶囊囊壳水溶液的pH>6.0,成型综合评价均高于3.0,适合软胶囊的工业化生产,并且具备稳定的肠溶效果。
上述实施例为本发明较佳的实施方式,但本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (9)
1.一种淀粉成膜组合物,其包含
2-6wt%结冷胶,
25-35wt%淀粉,
13-23wt%增塑剂,和
0.01-0.09wt%碱性pH调节剂;
其中淀粉成膜组合物还包含水;且
其中碱性pH调节剂使得1%的从淀粉成膜组合物制备的软胶囊囊壳的水溶液的pH值为6<pH≤6.4,且软胶囊囊壳中钾和钠元素的总含量低于350mg/100g且高于250mg/100g;且
其中结冷胶的每个重复单元包含30%至40%的乙酰基残基;
碱性pH调节剂为氢氧化钠或氢氧化钾中的一种或多种;
其中淀粉是羟丙基淀粉、羟丙基二淀粉磷酸酯、氧化淀粉、醋酸酯淀粉、氧化羟丙基淀粉、乙酰化氧化淀粉、乙酰化二淀粉磷酸酯或酸改性淀粉中的一种或多种。
2.根据权利要求1所述的淀粉成膜组合物,其中淀粉包含第一淀粉和第二淀粉,所述第一淀粉是羟丙基淀粉,并且第二淀粉是羟丙基二淀粉磷酸酯、氧化淀粉、醋酸酯淀粉、氧化羟丙基淀粉、乙酰化氧化淀粉、乙酰化二淀粉磷酸酯或酸改性淀粉中的一种或多种,其中按淀粉成膜组合物计,羟丙基淀粉的含量为20wt%-30wt%。
3.根据权利要求1所述的淀粉成膜组合物,其中增塑剂是甘油、山梨糖醇、甘露糖醇、赤藓糖醇、木糖醇和麦芽糖醇中的一种或多种。
4.根据权利要求1所述的淀粉成膜组合物,其不添加除所述结冷胶外的食用胶,和/或水的含量为35 wt%-55wt%。
5.一种从权利要求1-4中任一项的淀粉成膜组合物制备肠溶性软胶囊囊壳的方法,其包括:溶胶、压丸和干燥步骤;其中溶胶步骤包括将结冷胶和增塑剂预混分散均匀,搅拌下加入到适量水中,在60~98℃下加热搅拌至结冷胶溶解;加入淀粉,继续在60~98℃下加热搅拌至淀粉溶解;除去气泡即得胶液。
6.一种肠溶性软胶囊囊壳,其通过权利要求5的方法制备。
7.一种肠溶性软胶囊,其包含根据权利要求6所述的肠溶性软胶囊囊壳和包囊的活性成分,所述活性成分在肠道中的释放是有利的。
8.根据权利要求7所述的肠溶性软胶囊,其中所述活性成分是油脂、脂肪酸、维生素、益生菌、激素或抗生素中的一种或多种。
9.权利要求1-4中任一项所述的淀粉成膜组合物、权利要求6的肠溶性软胶囊囊壳或权利要求7或8的肠溶性软胶囊在制备食品、营养保健食品和药品中的应用。
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