CN114983962B - 软胶囊囊壳组合物、软胶囊和其制备方法和用途 - Google Patents

软胶囊囊壳组合物、软胶囊和其制备方法和用途 Download PDF

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CN114983962B
CN114983962B CN202110231931.2A CN202110231931A CN114983962B CN 114983962 B CN114983962 B CN 114983962B CN 202110231931 A CN202110231931 A CN 202110231931A CN 114983962 B CN114983962 B CN 114983962B
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soft capsule
extract
shell composition
capsule shell
soft
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CN114983962A (zh
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杨旭腾
方素琼
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Sirio Pharma Co Ltd
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Sirio Pharma Co Ltd
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Abstract

本发明涉及软胶囊囊壳组合物、软胶囊和其制备方法和用途。本发明的软胶囊囊壳组合物以干燥后的囊壳重量计包含：6～17wt％胶原蛋白肽；45～62wt％明胶；24～37wt％增塑剂；和水。本发明通过选用低分子量的胶原蛋白肽与明胶按一定配比组合得到成膜强度高、粘合性好的囊皮，经压制成软胶囊，得到成型性好、透明度好、崩解更快等综合性能优异的软胶囊，并且可以应用于药品、食品、保健食品和/或化妆品。

Description

软胶囊囊壳组合物、软胶囊和其制备方法和用途
技术领域
本发明涉及医药与膳食补充剂制造领域，具体地涉及促进崩解的软胶囊囊壳组合物、软胶囊和其制备方法和用途。
背景技术
软胶囊剂指将一定量的药物或功能性营养物质加适宜的辅料经处理，密封于球形、橄榄形、圆柱形或其他形状的软质囊壳中制成的剂型。软胶囊剂具有生物利用度高、密封安全、含量精确、外型美观等特点，适用于填充各种液状油性物或固体药物、功能性营养物质溶解或分散在适宜的赋形剂中制成的溶液、混悬液、乳液或半固体。软胶囊具有外形美观、含量准确均匀、密封性好、生物利用度高、掩味性好等优点。软胶囊制剂适用于油溶性或难溶性的药物以及中药提取物、功能性营养成分等，对软胶囊的研究发展正逐渐成为新药及新的膳食补充剂开发的热点。
然而，软胶囊在贮存期间常会出现囊壳崩解或破裂迟缓现象，这也是软胶囊工业化生产中经常会遇到的问题。大量的研究资料显示，囊壳的老化主要是由囊壳的材料明胶交联老化所致，老化后的囊壳内壁会出现一层水不溶性的膜状物质，该膜状物质会明显延长软胶囊破裂和药物溶出时间。目前，崩解迟缓已成为制约国内外软胶囊产业化发展的技术难题。
本领域中仍然需要解决崩解迟缓问题的软胶囊囊壳组合物。
发明内容
为了克服现有技术的缺点和不足，本发明的主要目的在于提供一种促进崩解的软胶囊组合物，本发明通过选用低分子量的胶原蛋白肽与明胶按一定配比组合得到成膜强度高、粘合性好的囊皮，经压制成软胶囊，得到成型性好、透明度好、崩解更快等综合性能优异的软胶囊，并且可以应用于药品、食品、保健食品、和/或化妆品。本发明证明了本发明的软胶囊囊壳组合物在有效期内保持优异的崩解性。
在一方面，本发明提供了一种软胶囊囊壳组合物，所述软胶囊囊壳组合物以干燥后的囊壳重量计包含：
6～17wt％胶原蛋白肽；
45～62wt％明胶；
24～37wt％增塑剂；和
水。
在一个实施方案中，软胶囊囊壳组合物包含6～15wt％水。
在一个实施方案中，胶原蛋白肽的量为14～17wt％；
在一个实施方案中，明胶的量为50～60wt％；
在一个实施方案中，增塑剂的量为24～30wt％。
在一个实施方案中，胶原蛋白肽的平均分子量在500～2000Da。
在一个实施方案中，分子量≤500Da的胶原蛋白肽为胶原蛋白肽的10～40wt％。
在一个实施方案中，胶原蛋白肽的平均分子量在500～2000Da和分子量≤500Da的胶原蛋白肽为胶原蛋白肽的10～40wt％。
在一个实施方案中，增塑剂是甘油、山梨糖醇、麦芽糖醇、赤藓糖醇、木糖醇、结晶果糖和海藻糖中的一种或组合。
在一个实施方案中，软胶囊囊壳组合物不含崩解剂和/或氧化剂。
在一方面，本发明提供了一种软胶囊，其包含本发明的软胶囊囊壳组合物和填充物。
在一个实施方案中，填充物是油脂、混悬液和乳液中的一种。
在一个实施方案中，填充物会产生和/或含有羰基化合物，其包括醛类、酮类、还原糖类物质。这些物质会使软胶囊囊壳中的明胶发生老化交联，从而造成软胶囊囊壳的崩解问题。
在一个实施方案中，填充物含有化学药物、中药粉或中药提取物、植物提取物、氨基葡萄糖盐类、蜂胶类、聚乙二醇、植物油或动物油脂中的一种或多种；例如，中药粉或中药提取物是含酚酮基团的中药粉或中药提取物；植物提取物是含酚羟基及多糖类的植物提取物。
在一个实施方案中，所述化学药物是布洛芬、扑热息痛、或氯霉素。
在一个实施方案中，中药粉或中药提取物是水提取物或乙醇提取物中的一种或多种。
在一个实施方案中，植物提取物是葡萄籽提取物、绿茶提取物、越橘提取物、人参提取物、或枸杞提取物。
在一个实施方案中，植物油或动物油脂是含多不饱和脂肪酸的油脂，优选Omega3.6.9，优选橄榄油、沙棘果油、鱼油中的一种或多种。
在一个实施方案中，填充物含有维生素或矿物盐中的一种或多种。例如，矿物盐是二价或三价金属离子矿物盐。在一个实施方案中，所述维生素是β-胡萝卜素、维生素C中的一种或多种。在一个实施方案中，矿物盐是人需要的矿物盐，优选二价或三价金属离子矿物盐，优选氧化镁、硫酸铜、硫酸锰、富马酸亚铁中的一种或多种。
在一方面，本发明提供了本发明的软胶囊的制备方法，所述方法包括：
(A)将明胶、胶原蛋白肽、增塑剂和水在溶胶罐内加热搅拌至溶解，除去气泡即得胶液；
(B)将胶液输送至软胶囊填充机的胶盒中，在旋转的冷却转鼓上延展冷却1～2分钟形成胶皮，经过喷体时对胶皮重新加热，模具切割缝合过程中填充内容物形成软胶囊；和
(C)成型软胶囊在温度15-35℃，湿度10-30％条件下干燥，即得本发明的软胶囊。
在一个实施方案中，(C)步骤中成型软胶囊干燥至胶皮水分6-15％。
在一方面，本发明提供了本发明的软胶囊囊壳或软胶囊在食品、营养保健食品、药品和/或化妆品中的应用。
具体实施方式
提供以下内容以进一步说明本发明。
如本文中使用，“胶原蛋白肽”，也可以称为水解胶原蛋白或胶原蛋白水解物，是由动物皮肤、骨、肌膜、肌魅等结缔组织中的胶原部分降解而成为白色或淡黄色、半透明、微带光泽粉粒。在本文中，胶原蛋白肽的平均分子量为500～2000Da，例如，平均分子量有1000、1020、1100、1200、1300、1400、1500、1600、1680、1800、1900或1990Da。胶原蛋白肽的分子量分布多变，分子量≤500Da存在变化。例如，以干燥后的囊壳重量计，分子量≤500Da的胶原蛋白肽可以占比10～40wt％，例如11、14、15、17、18、或36wt％。
如本文中使用，“明胶”是利用猪、牛、羊、鱼等动物的骨和/或皮的胶原，通过加热提取加工而成。在本文中，明胶可以为食用胶原。以干燥后的囊壳重量计，明胶的含量可以是45～62wt％，例如46、47、50、54、56、59、或60wt％。
本文中使用的软胶囊囊壳还包含增塑剂。增塑剂可以是甘油、山梨糖醇、赤藓糖醇、木糖醇、麦芽糖醇、结晶果糖和海藻糖中的一种或多种。以干燥后的囊壳重量计，增塑剂的含量可以为24～37wt％，例如25、26、27、30或35wt％。
本文中使用的软胶囊囊壳含有一定量的水，例如以干燥后的囊壳重量计为6～15wt％水，例如7、9、11或13wt％。
本文中使用的软胶囊囊壳组合物具备良好的崩解效果，可以不含崩解剂和/或氧化剂。
可以在本发明的软胶囊囊壳内添加填充物以制备软胶囊。填充物可以是油脂、混悬液和乳液中的一种。填充物可以是或含有引起明胶交联反应的物质，例如产生羰基化合物的填充剂，包括醛类、酮类或还原糖类物质等。填充物可以是化学药物、中药粉或中药提取物、植物提取物、氨基葡萄糖盐类、蜂胶类、聚乙二醇、多不饱和脂肪酸油脂、二价或三价金属离子矿物盐中的一种或多种。例如，中药粉或中药提取物可以是含酚酮基团的中药粉或中药提取物。植物提取物可以是含酚羟基及多糖类的植物提取物。不饱和脂肪酸油脂可以是橄榄油、沙棘果油、鱼油。二价或三价金属离子矿物盐例如是人体需要的矿物盐。
本发明还提供了软胶囊的制备方法，所述方法包括：
(A)将明胶、胶原蛋白肽、增塑剂和水在溶胶罐内加热搅拌至溶解，除去气泡即得胶液；
(B)将胶液输送至软胶囊填充机的胶盒中，在旋转的冷却转鼓上延展冷却1～2分钟形成胶皮，经过喷体时对胶皮重新加热，模具切割缝合过程中填充内容物形成软胶囊；和
(C)成型软胶囊在温度15-35℃，湿度10-30％条件下干燥，即得本发明的软胶囊。例如，成型软胶囊可以干燥至胶皮水分6-15％。
软胶囊囊壳或软胶囊在诸多领域中可以进行应用。例如，可以在食品、营养保健食品、药品和/或化妆品中的应用。
关于本发明的软胶囊
对于软胶囊的崩解，目前国内外科研工作者做了大量的研究，通过不同的途径，期望解决该问题，取得了一定的成效。比较常见的解决方法是添加崩解剂与抗氧化剂，比如：选用淀粉、羧甲基淀粉钠、羟丙基淀粉等作为崩解剂，直接加在囊壳里，促进囊壳崩解速度。另外，也可以采用抗氧化剂，其能在一定程度延缓交联反应，主要是因为抗氧化剂能吸收明胶与辅料中的过氧化物，阻止由过氧化物使高分子降解引起的明胶交联反应。甘氨酸与焦亚硫酸钠是最常用的抗氧化剂。但是，这仍然无法完全解决交联问题。在国家食品药品监督管理部门发布的药品不合格通告中，一些中药软胶囊产品常常名列其中。部分无法解决崩解问题的软胶囊，被迫停产或改为其它剂型，如片剂、硬胶囊剂等，但又带来新的问题：消费者正常使用的产品无法获取，或者改剂型后，一些软胶囊含有的芳香油脂或功能性油脂，需要增加处理工艺，使其从液状变成固态，除了工艺繁琐与大幅度增加成本外，还存在功能性成分添加量降低，需要使用次数增加，降低消费者使用方便性的问题。因此，改善这些软胶囊产品的崩解问题迫在眉睫。
本发明经过长期研究获得了一种软胶囊囊壳组合物，所述软胶囊囊壳组合物以干燥后的囊壳重量计包含：6～17wt％胶原蛋白肽；45～62wt％明胶；24～37wt％增塑剂；和水，从而克服现有技术的缺点和不足。
实施例
为了更好说明和体现本发明的效果，采用以下指标评价实施例和对照例样品。
1、成型
采用以下软胶囊性能指标进行评价说明：
1)胶皮强度和韧性指标：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，记录胶皮在破裂时力值(g)，及对应的破裂距离(mm)。胶皮的破裂力表示胶皮强度，破裂力越大，说明胶皮强度越好；破裂距离表示胶皮韧性，破裂距离越大，说明胶皮的韧性越好。
2)成型夹缝粘合指标：取本发明实施例样品，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
以胶皮强度指标、韧性指标和成型粘合指标进行综合评分：
0分：无法制成软胶囊；
0＜X≤1分：软胶囊成型较差，易漏油；
1＜X≤2分：软胶囊成型差，易漏油；
2＜X≤3分：软胶囊成型良好；
3＜X≤4分：软胶囊成型优异；
4＜X≤5分：软胶囊成型非常优异。
2、透明度
实施例和对照例中的软胶囊通过胶皮透明度考察软胶囊的透明情况，具体方法：
原理：在指定条件下，测定试样带白板衬的内在光反射因数和带黑背衬的光反射因数之差与带白板衬的内在光反射因数的百分比。
透明度：样品的内在光反射因数和光反射因数之差与内在光反射因数的百分比。
测试仪器使用白度仪，方法参照QB/T 1913-2004。
结果与计算：透明度T(％)，数值以％表示，按如下式计算
T(％)＝{1-R0/R∞}*100，式中：T----试样透明度，％
R0---试样底衬黑背衬时光反射因数
R∞-试样底衬白板衬时内在光反射因数
运用上述方法，通过测定软胶囊胶皮的透明度(T)，按判定基准进行评分。
表2
3、崩解时限
将干燥好的囊壳胶皮或软胶囊，放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，检测其崩解时限。
崩解时限指标：按《中国药典》的有关规定，将实施例和对照例样品采用37±2℃介质水进行崩解测试，记录完全崩解的时间，60分钟内崩解完成合格。
实施例1-5
实施例1～5及对照例1～2，以大豆油为填充物，制备大豆油软胶囊，考察评估其成型性。
将明胶、胶原蛋白肽、增塑剂和水在溶胶罐内加热搅拌至溶解，除去气泡即得胶液；
将胶液输送至软胶囊填充机的左、右胶盒中，在旋转的冷却转鼓上延展冷却1～2分钟形成胶皮，经过喷体时对胶皮重新加热，模具切割缝合过程中填充大豆油形成软胶囊。
成型大豆油软胶囊在温度15-35℃，湿度10-30％条件下干燥至胶皮水分6～15％，即得本发明的软胶囊，置于密闭容器保存。
实施例1～5及对照例1～2，经干燥后制成软胶囊囊壳胶皮各组分比例，考察其成型性和透明度如下表。
表3
由上表可以得出，对照例2无法成膜，无法粘合成型制成软胶囊，实施例1～5及对照例1成型好。
将上述实施例1～5及对照例1制得的大豆油软胶囊浸泡在浓度为0.001％的戊二醛交联剂中，放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，分别于第0、1、2、3个月取出，检测其崩解时限。
表4
由上表的数据可以得出，对照例1的大豆油软胶囊浸泡交联剂在高温高湿环境下加速3个月，60分钟不崩解，本发明实施例1～5崩解时限均小于30分钟，崩解效果明显。
实施例6～10
实施例6～10选用平均分子量500～2000Da，分子量分布不同的胶原蛋白肽(分子量≤500Da占比)，以实施例4的配方组成，按上述方法制成大豆油软胶囊，考察其成型性、透明度、崩解效果。
表5
由上表可以得出，实施例6～10成型优异，透明度非常好。
将实施例6～10的大豆油软胶囊浸泡在浓度为0.001％的戊二醛交联剂中，放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，分别于第0、1、2、3个月取出，检测其崩解时限。
表6
由上表的数据可以得出，软胶囊囊壳选用胶原蛋白肽平均分子量500～2000Da，与明胶按一定配比组合，制成的软胶囊具有成型性优异、透明度好、崩解效果显著等优异的性能。
实施例11：藿香正气软胶囊
以藿香正气软胶囊内容物作为填充物，囊壳组成按对照例1与实施例4，根据上述软胶囊制成方法制作藿香正气软胶囊。
配制藿香正气软胶囊内容物，以苍术、陈皮、厚朴、白芷用乙醇提取二次，合并醇提取液，浓缩成清膏；茯苓、大腹皮加水煎煮二次，煎液滤过，滤液合并；生半夏用冷水浸泡，每8小时换水一次，泡至透心后，另加干姜16.5g，加水煎煮二次，煎液滤过，滤液合并；合并二次滤液，浓缩后醇沉，取上清液浓缩成清膏；甘草浸膏打碎后水煮化开，醇沉，取上清液浓缩制成清膏；将上述各清膏合并，加入广藿香油、紫苏叶油与适量辅料为内容物，按上述制备方法制备软胶囊，放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，考察其成型性、透明度、崩解时限。
实施例12：感冒软胶囊
以感冒软胶囊内容物作为填充物，囊壳组成按对照例1与实施例4，根据上述软胶囊制成方法制作感冒软胶囊。
配制感冒软胶囊内容物，以上十四味，荆芥穗、薄荷提取挥发油，并滤取药液；其余羌活等十二味，用80％乙醇加热回流二次，第一次2小时，第二次1小时，滤过，合并滤液，回收乙醇至无醇味，与上述滤液合并，浓缩至相对密度为1.30(50℃热测)的稠膏，减压干燥，粉碎成细粉，加入植物油及上述挥发油，混匀为内容物，按上述制备方法制备软胶囊，放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，考察其成型性、透明度、崩解时限。
实施例13：维D橄榄油软胶囊
以维生素D油、橄榄油作为填充物，囊壳组成按对照例1与实施例4，根据上述软胶囊制成方法制作维D橄榄油软胶囊，将维D橄榄油软胶囊放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，考察其成型性、透明度、崩解时限。
实施例14：营养软胶囊
以维生素D油、氧化镁、硫酸铜、硫酸锰、富马酸亚铁、维生素C、葡萄籽提取物、β-胡萝卜素、鱼油作为填充物，囊壳组成按对照例1与实施例4，根据上述软胶囊制成方法制作多维软胶囊，将多维软胶囊放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，考察其成型性、透明度、崩解时限。
实施例15：布洛芬软胶囊
以布洛芬、聚乙二醇PEG400作为填充物，囊壳组成按对照例1与实施例4，根据上述软胶囊制成方法制作布洛芬软胶囊，将布洛芬软胶囊放置在高温高湿环境下(40℃75％恒温恒湿箱)进行加速考察，考察其成型性、透明度、崩解时限。
测试结果
表7
表8
由上表的数据可以得出，与对照例比较，实施例11～15在高温高湿环境下加速3个月，促进崩解效果显著，崩解时限均小于60分钟，可推测本发明的软胶囊囊壳选用低分子量的胶原蛋白肽，与明胶按一定配比组合，制成软胶囊具有成膜性好、成膜强度高、透明度好、成型性好、崩解更快等优异的性能。
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 (27)

1.一种软胶囊囊壳组合物，所述软胶囊囊壳组合物以干燥后的囊壳重量计包含：
6~17wt% 胶原蛋白肽；
45~62wt%明胶；
24~37wt%增塑剂；和
水；
其中胶原蛋白肽的平均分子量在500~2000Da内，和分子量≤500Da的胶原蛋白肽为胶原蛋白肽的10~40wt%；
其中所述软胶囊囊壳组合物不含崩解剂。
2.根据权利要求1所述的软胶囊囊壳组合物，其中水的量为6~15wt%。
3.根据权利要求1所述的软胶囊囊壳组合物，其中胶原蛋白肽的量为14~17wt%。
4.根据权利要求1所述的软胶囊囊壳组合物，其中明胶的量为50~60wt%。
5.根据权利要求1所述的软胶囊囊壳组合物，其中增塑剂的量为24~30wt%。
6.根据权利要求1-5中任一项所述的软胶囊囊壳组合物，其中增塑剂是甘油、山梨糖醇、麦芽糖醇、赤藓糖醇、木糖醇、结晶果糖和海藻糖中的一种或组合。
7.根据权利要求1-5中任一项所述的软胶囊囊壳组合物，所述软胶囊囊壳组合物不含抗氧化剂。
8.一种软胶囊，其包含权利要求1-7中任一项的软胶囊囊壳组合物和填充物。
9.根据权利要求8所述的软胶囊，其中填充物是油脂、混悬液和乳液中的一种。
10.根据权利要求8所述的软胶囊，其中填充物产生和/或含有羰基化合物，包括醛类、酮类、还原糖类物质。
11.根据权利要求8所述的软胶囊，其中所述填充物含有化学药物、中药粉或中药提取物、聚乙二醇中的一种或多种。
12.根据权利要求11所述的软胶囊，其中所述化学药物是布洛芬、扑热息痛或氯霉素。
13.根据权利要求11所述的软胶囊，其中中药粉或中药提取物是水提取物或乙醇提取物中的一种或多种。
14.根据权利要求8所述的软胶囊，其中所述填充物是植物提取物、氨基葡萄糖盐类、蜂胶类、植物油或动物油脂中的一种或多种；其中植物提取物是葡萄籽提取物、绿茶提取物、越橘提取物、人参提取物或枸杞提取物。
15.根据权利要求14所述的软胶囊，其中植物油或动物油脂是含多不饱和脂肪酸的油脂。
16.根据权利要求15所述的软胶囊，其中所述油脂为Omega3.6.9。
17.根据权利要求15所述的软胶囊，其中所述油脂为橄榄油、沙棘果油、鱼油中的一种或多种。
18.根据权利要求8所述的软胶囊，其中填充物是维生素或矿物盐中的一种或多种。
19.根据权利要求18所述的软胶囊，其中所述维生素是β-胡萝卜素、维生素C中的一种或多种。
20.根据权利要求18所述的软胶囊，其中矿物盐是人需要的矿物盐。
21.根据权利要求20所述的软胶囊，其中所述矿物盐是二价或三价金属离子矿物盐。
22.根据权利要求20所述的软胶囊，其中所述矿物盐是氧化镁、硫酸铜、硫酸锰、富马酸亚铁中的一种或多种。
23.权利要求8-22中任一项的软胶囊的制备方法，所述方法包括：
(A) 将明胶、胶原蛋白肽、增塑剂和水在溶胶罐内加热搅拌至溶解，除去气泡即得胶液；
(B) 将胶液输送至软胶囊填充机的胶盒中，在旋转的冷却转鼓上延展冷却1~2分钟形成胶皮，经过喷体时对胶皮重新加热，模具切割缝合过程中填充内容物形成软胶囊；和
(C) 成型软胶囊在温度15-35℃，湿度10-30%条件下干燥，即得软胶囊。
24.根据权利要求23所述的制备方法，其中步骤(C)中干燥至胶皮水分6-15%。
25.权利要求1-4中任一项的软胶囊囊壳组合物或权利要求14-22中任一项的软胶囊在食品和/或化妆品中的应用。
26.根据权利要求25所述的应用，其中所述食品是营养保健食品。
27.权利要求1-4中任一项的软胶囊囊壳组合物或权利要求8-13中任一项的软胶囊在制备药品中的应用。
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