CN116235906A - 一种新型风味软胶囊制剂及其应用 - Google Patents

一种新型风味软胶囊制剂及其应用 Download PDF

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CN116235906A
CN116235906A CN202210910955.5A CN202210910955A CN116235906A CN 116235906 A CN116235906 A CN 116235906A CN 202210910955 A CN202210910955 A CN 202210910955A CN 116235906 A CN116235906 A CN 116235906A
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China
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soft capsule
flavor
powder
palatability
novel
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CN202210910955.5A
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常辉
刘爱玲
李守军
李亚玲
聂福贵
郝小妹
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Ringpu Hi Tech Tianjin Biotechnology Co ltd
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Ringpu Hi Tech Tianjin Biotechnology Co ltd
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Abstract

本发明公开了一种新型风味软胶囊制剂及其应用，属于软胶囊制剂技术领域。该风味软胶囊制剂由内容物、软质囊材、适口性风味包衣层组成。所述内容物中含活性成分；所述软质囊材由明胶、甘油、纯化水组成；所述适口性风味包衣层包含矫味剂、纯化水。本发明所提供的软胶囊制剂具有适口性好、口服顺应性强、稳定性好的优势，可有效解决宠物、儿童、经济动物软胶囊制剂喂食困难、繁琐的技术难题，市场前景广阔。

Description

一种新型风味软胶囊制剂及其应用
技术领域
本发明属于软胶囊制剂技术领域，具体涉及一种新型风味软胶囊制剂及其应用。
背景技术
软胶囊是一种崩解速度快、生物利用率高、便于储存和携带的剂型。对光敏感及不稳定的药物，可填装于不透光的胶囊中，以防止湿气或空气中的氧、光线对药物的作用，提高其稳定性。
现有技术中的胶囊，包括内容物和软质囊材，软质囊材组分包括明胶、甘油、纯化水，软胶囊按照如下方法制备：(1)对软质囊材进行加热，加热时对软质囊材进行抽真空处理，得到胶液，将胶液保温备；(2)将胶液固化并制成胶皮，然后将内容物注入两层胶皮之间，再对胶皮与内容物的复合物进行压丸处理和干燥，得到软胶囊。
以上胶囊的制备并未考虑到的采食习惯和爱好，在喂食过程中，需要进行强制灌服或者混合于主粮中服用，严重影响给药的精准性、及时性和顺应性。专利CN107412185A公开了一种含有诱食成分的犬、猫用软胶囊，在软胶囊的囊壳中含有诱食成分，将活性成分与辅料混合，经过压片机或挤压机被制成载药颗粒，然后与胶片捏合，被包裹在囊壳中，形成所述的犬、猫用软胶囊。该发明方法中采用胶囊壳与诱食剂直接混合的方式，且添加量在4-15％，软胶囊易出现渗漏或囊壳破裂现象，严重影响胶囊稳定性及效期，且明胶层本身遮蔽性能良好，诱食成分的气味被明胶所包裹遮盖，不能有效的刺激嗅觉，而进一步提高诱食剂添加量会导致更严重的渗漏和囊壳破裂现象，实际生产及应用中可行性较低。
基于以上，本领域急需开发一种高适口性的软胶囊来满足市场需求。
发明内容
本发明旨在解决以上技术问题，提供一种新型风味软胶囊制剂及其应用。
为达到以上目的，本发明具体技术方案如下：
本发明第一方面，提供了一种新型风味软胶囊制剂，所述风味软胶囊制剂从内到外由内容物、软质囊材、适口性风味包衣层组成。
所述内容物包含活性成分；所述软质囊材由明胶、甘油、纯化水组成；所述适口性风味包衣层中包含矫味剂、纯化水。
所述矫味剂为猪肝粉、鸡肝粉、牛肝粉、鸡肝水解物、牛肝水解物、鱼粉、牛肉粉、鸡肉粉、肉松粉、鸡软骨粉、牛软骨粉、罗非鱼皮粉、三文鱼粉、鳕鱼粉、蔗糖、葡萄糖、低聚果糖、水苏糖、木糖醇、全脂乳粉、苜蓿草粉、车前草粉、灰藜草粉、蚯蚓粉、黄粉虫粉中的一种或几种。优选矫味剂为牛肝脏水解粉、鸡软骨粉、罗非鱼皮粉、三文鱼粉、全脂乳粉、低聚果糖、苜蓿草粉、车前草粉中的一种或几种。
所述内容物中的活性成分包括但不限于辅酶Q10、EPA、DHA、矿物质、维生素、益生菌、氨基酸、酶、中药及其提取物、化学药物、疫苗中的一种或几种。
优选地，所述内容物中的活性成分选自辅酶Q10、维生素、益生菌中的一种或几种。更优选地，所述内容物中的活性成分选自辅酶Q10、维生素中的一种或两种。
所述内容物中还含有油性成分，优选小麦胚芽油、鱼油、橄榄油、大豆油、蓖麻油中的一种或几种。
所述风味软胶囊制剂中各组分所占份数为：内容物69-79％、软质囊材11-21％、适口性风味包衣层10-21％。
优选地，所述软胶囊制剂中各组分所占份数为：内容物70-78％、软质囊材12-16％、适口性风味包衣层10-18％。
更优选地，所述软胶囊制剂中各组分所占份数为：内容物72-76％、软质囊材13-15％、适口性风味包衣层11-13％。
优选软质囊材中各组分所占重量比为明胶35-48％、甘油15-27％、纯化水30-45％。
优选地，所述适口性风味包衣层还含有油脂、赋形剂，所述适口性风味包衣层中各组分及其所占重量百分比为：油脂3-5％、赋形剂2-4％、矫味剂81-90％、纯化水2-11％。
所述油脂为牛油、奶油、黄油、羊油、氢化大豆油、氢化棕榈油、氢化椰子油中的一种或几种组成。优选油脂为氢化椰子油、牛油中的一种或两种。
所述赋形剂为可得然胶、沙蒿胶、黄糊精、瓜尔胶、黄原胶中的一种或几种。优选赋形剂为可得然胶、沙蒿胶中的一种或两种。
本发明第二方面，提供了一种新型风味软胶囊制剂的制备方法，其步骤如下：
(1)制备软质囊材溶液：将组方量的明胶、甘油与水混合，用胶体磨充分研磨，直至固体粒径在30μm以下，将物料转移到化胶桶中，加热至65-80℃搅拌至明胶融化完全，经100目滤网过滤到脱气罐中，减压脱气，于60-70℃保温，得到软质囊材溶液，备用；
(2)制备含活性成分的内容物：按组方量称取含活性成分的内容物中各组分，置于配料罐中，混合均匀，用胶体磨充分研磨，直至固体物粒径到30μm以下，然后将研细的物料转移到具有搅拌装置的储液罐1中，得到含活性成分的内容物，备用；
(3)压丸：将步骤(1)制得的软质囊材溶液和步骤(2)制得的内容物上软胶囊机，采用压制法制备成胶丸，经定型、干燥、分检，备用；
(4)制备适口性风味包衣层：将组方量的油脂置于配料罐中加热至55-70℃，待油脂完全溶化为液态，加入赋形剂，混合均匀，将所得混合物转移到具有搅拌装置的储液罐2中，于50-60℃保温，备用；将组方量的矫味剂置于配料罐中，加入纯化水，混合均匀，将所得混合物转移到具有搅拌装置的储液罐3中，备用；使用高效包衣机，进风口温度调整至45-55℃，出风口温度调整至38-50℃，罐体转速控制在10r/min，将储液罐2中的混合物喷涂于步骤(3)制得的胶丸表面，高效包衣机进风口温度降低至30-35℃使壁材冷却凝固，得到半成品1，备用；进风口温度调整至45-55℃，出风口温度调整至38-50℃，罐体转速控制在15r/min，将储液罐3中的混合物喷涂于半成品1表面，充分干燥，形成适口性风味包衣层，得到软胶囊制剂。
步骤(1)中优选加热温度为75℃；步骤(4)中优选加热温度为60℃。
本发明第三方面，提供了所述新型风味软胶囊制剂在制备宠物、儿童、经济动物高适口性软胶囊制剂中的应用，优选经济动物为家畜，更优选经济动物为仔猪。
本发明提供了一种风味软胶囊制剂，该制剂在含活性成分的内容物外部包裹了软质囊材，将含矫味剂的适口性风味包衣层与软质囊材紧密粘合，形成稳定且高适口性的软胶囊制剂。
本发明有益效果：
1.本发明风味软胶囊制剂在软胶囊的软质囊材表面形成一层适口性风味包衣层，其能显著的提高胶囊制剂的适口性，可有效解决软胶囊喂食困难、繁琐，必须强制灌服才可服用的技术问题。
2.本发明制备的风味软胶囊制剂稳定性高，软胶囊不易出现渗漏或囊壳破裂现象，能极大满足市场需求。
具体实施方式
以下将通过实施例形式的具体实施方式，对上述内容做进一步的详细说明。但不应该将此理解为上述主题的范围仅限于以下实施例。凡基于本发明内容所实现的技术均属于范围内。
实施例1-3一种新型风味软胶囊制剂及其制备方法
Figure BDA0003773946680000031
Figure BDA0003773946680000041
所述新型风味软胶囊制剂的制备方法为：
(1)制备软质囊材溶液：将组方量的明胶、甘油与水混合，用胶体磨充分研磨，直至固体粒径在30μm以下，将物料转移到化胶桶中，加热至75℃搅拌至明胶融化完全，经100目滤网过滤到脱气罐中，减压脱气，于60-70℃保温，得到软质囊材溶液，备用；
(2)制备含活性成分的内容物：称取活性成分、油性成分，置于配料罐中，混合均匀，用胶体磨充分研磨，直至固体物粒径到30μm以下，然后将研细的物料转移到具有搅拌装置的储液罐1中，得到含活性成分的内容物，备用；
(3)压丸：将步骤(1)制得的软质囊材溶液和步骤(2)制得的内容物上软胶囊机，采用压制法制备成胶丸，经定型、干燥、分检，备用；
(4)制备适口性风味包衣层：将组方量的油脂置于配料罐中加热至60℃，待油脂完全溶化为液态，加入赋形剂，混合均匀，将所得混合物转移到具有搅拌装置的储液罐2中，于50-60℃保温，备用；将组方量的矫味剂置于配料罐中，加入纯化水，混合均匀，将所得混合物转移到具有搅拌装置的储液罐3中，备用；使用高效包衣机，进风口温度调整至45-55℃，出风口温度调整至38-50℃，罐体转速控制在10r/min，将储液罐2中的混合物喷涂于步骤(3)制得的胶丸表面，高效包衣机进风口温度降低至30-35℃使壁材冷却凝固，得到半成品1，备用；进风口温度调整至45-55℃，出风口温度调整至38-50℃，罐体转速控制在15r/min，将储液罐3中的混合物喷涂于半成品1表面，充分干燥，形成适口性风味包衣层，得到风味软胶囊制剂。
实施例4-6一种新型风味软胶囊制剂及其制备方法
Figure BDA0003773946680000042
Figure BDA0003773946680000051
所述风味软胶囊制剂的制备方法与实施例1-3中基本一致。
实施例7-8一种新型风味软胶囊制剂及其制备方法
Figure BDA0003773946680000052
所述风味软胶囊制剂的制备方法与实施例1-3中基本一致。
实施例9-11一种新型风味软胶囊制剂及其制备方法
Figure BDA0003773946680000053
所述风味软胶囊制剂的制备方法与实施例1-3中基本一致，其中，内容物中活性成分为维生素E，油性成分为橄榄油和鱼油；适口性风味包衣层中油脂为氢化椰子油，赋形剂为可得然胶；全脂乳粉、低聚果糖属于矫味剂。
实施例12-14一种新型风味软胶囊制剂及其制备方法
Figure BDA0003773946680000061
所述风味软胶囊制剂的制备方法与实施例1-3中基本一致，其中，内容物中活性成分为维生素A、维生素E，油性成分为大豆油和蓖麻油；适口性风味包衣层中油脂为氢化椰子油，赋形剂为可得然胶；苜蓿草粉、车前草粉属于矫味剂。
对比例1
对比例1产品组方用量与本发明实施例2一致，制备方法如下：
(1)制备含诱食剂的囊材液：将牛肝脏水解物、鸡软骨粉、甘油、水混合，用胶体磨充分研磨，使其中的固体物研细到20μm以下，然后将物料转移到化胶桶中，加入经粉碎的明胶粉，加热至70℃左右，搅拌至明胶融化溶胀完全，经100目滤网过滤到脱气罐中，减压(约-0.07mpa)脱气，即得制备软胶囊的囊材液。将囊材液于60-70℃保温，备用。
(2)制备含辅酶Q10的填充物：将小麦胚芽油、鱼油、辅酶Q10、维生素E置于配料罐中，混匀，用胶体磨充分研磨，使其中的固体物研细到20μm以下，然后将研细的物料转移到具有搅拌装置的储液罐中，备用。
(3)压丸：将步骤(1)制得的囊材液和步骤(2)制得的填充物上软胶囊机，采用压制法制备成软胶囊，经定型(在19-25℃于定型转笼中定型3-5小时)、干燥(在19-25℃、相对湿度小于35％的条件下，干燥24小时)、分检、包装，得含辅酶Q10的软胶囊制剂。
实施例15宠物适口性试验
遵循单盆适口性试验的试验方法，选择无呕吐、拉稀、软便等症状的统一健康标准的猫30只、犬20只进行适口性测试。试验显示，包衣层可大幅提高软胶囊制剂适口性。犬自主采食率达到100％，猫自主采食率达到96.7％。试验结果如下：
表1软胶囊适口性对比(猫)
Figure BDA0003773946680000071
注：采食则标记“√”，不采食标记“x”
表2软胶囊适口性对比(犬)
Figure BDA0003773946680000072
Figure BDA0003773946680000081
注：采食则标记“√”，不采食标记“x”。
实施例16儿童感官评价
遵循感官评价原则，选择13-15岁的健康儿童20名，从色泽、气味、口感、甜味、油腻度、异味六方面对实施例9-11软胶囊产品进行感官评价，结果显示，在软质囊材表面增加包衣层可使软胶囊制剂适口性明显提高，儿童接受度更高。评价结果如下：
表3儿童感官评价
Figure BDA0003773946680000082
实施例17家畜适口性试验
遵循单盆适口性试验的试验方法，选择统一健康标准的仔猪30头进行适口性测试，在仔猪正常进食半小时后，分别饲喂实施例12-14的软胶囊制剂，观察并记录仔猪采食情况，试验显示，在软质囊材表面增加包衣层可大幅提高软胶囊制剂适口性。试验结果如下：
表4软胶囊适口性对比(猪)
Figure BDA0003773946680000083
Figure BDA0003773946680000091
注：采食则标记“√”，不采食标记“x”
实施例18稳定性试验
取实施例2、实施例5与实施例7、对比例1软胶囊各150粒样品，分四份分别装于12个棕色玻璃瓶中，分别放置于50℃、40℃及室温条件下进行稳定性试验，分别于第0天、5天、10天取样观察，观察外观是否合格，判断标准为软胶囊是否出现龟裂现象。
表5稳定性试验结果
Figure BDA0003773946680000092
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Figure BDA0003773946680000101
结果显示，本发明实施例2、实施例5中的软胶囊分别于在50℃、40℃、常温条件下放置5天、10天，均未出现龟裂现象，而实施例7(油脂为大豆油)与对比例1出现了不同程度的龟裂，因而本发明产品具有良好的稳定性。

Claims (10)

1.一种新型风味软胶囊制剂，其特征在于，所述软胶囊制剂由内容物、软质囊材、适口性风味包衣层组成。
2.根据权利要求1所述的新型风味软胶囊制剂，其特征在于，所述内容物包含活性成分；所述软质囊材由明胶、甘油、纯化水组成；所述适口性风味包衣层中包含矫味剂、纯化水。
3.根据权利要求2所述的新型风味软胶囊制剂，其特征在于，所述矫味剂为猪肝粉、鸡肝粉、牛肝粉、鸡肝水解物、牛肝水解物、鱼粉、牛肉粉、鸡肉粉、肉松粉、鸡软骨粉、牛软骨粉、罗非鱼皮粉、三文鱼粉、鳕鱼粉、蔗糖、葡萄糖、低聚果糖、水苏糖、木糖醇、全脂乳粉、苜蓿草粉、车前草粉、灰藜草粉、蚯蚓粉、黄粉虫粉中的一种或几种。
4.根据权利要求2所述的新型风味软胶囊制剂，其特征在于，所述内容物中的活性成分为辅酶Q10、EPA、DHA、矿物质、维生素、益生菌、氨基酸、酶、中药及其提取物、化学药物、疫苗中的一种或几种。
5.根据权利要求4所述的新型风味软胶囊制剂，其特征在于，所述内容物中的活性成分为辅酶Q10、维生素、益生菌中的一种或几种。
6.根据权利要求1所述的新型风味软胶囊制剂，其特征在于，所述软胶囊制剂中各组分所占重量百分比为：内容物69-79％、软质囊材11-21％、适口性风味包衣层10-21％。
7.根据权利要求2所述的新型风味软胶囊制剂，其特征在于，所述适口性风味包衣层还含有油脂、赋形剂。
8.根据权利要求7所述的新型风味软胶囊制剂，其特征在于，所述油脂为牛油、奶油、黄油、羊油、氢化大豆油、氢化棕榈油、氢化椰子油中的一种或几种组成；所述赋形剂为可得然胶、沙蒿胶、黄糊精、瓜尔胶、黄原胶中的一种或几种。
9.根据权利要求7所述的新型风味软胶囊制剂，其特征在于，所述软质囊材中各组分及其所占重量百分比为：明胶35-48％、甘油15-27％、纯化水30-45％；所述适口性风味包衣层中各组分及其所占重量百分比为：油脂3-5％、赋形剂2-4％、矫味剂81-90％、纯化水2-11％。
10.如权利要求1-9中任一所述的一种新型风味软胶囊制剂在制备高适口性软胶囊制剂中的应用，其特征在于，所述高适口性软胶囊制剂用于宠物、儿童、经济动物。
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CN102614153A (zh) * 2012-04-16 2012-08-01 广东仙乐制药有限公司 一种天然肠溶软胶囊及其制备方法
CN107412185A (zh) * 2016-06-16 2017-12-01 北京中农华威生物医药研究院 一种含有诱食成分的犬、猫用软胶囊
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CN102614153A (zh) * 2012-04-16 2012-08-01 广东仙乐制药有限公司 一种天然肠溶软胶囊及其制备方法
CN107412185A (zh) * 2016-06-16 2017-12-01 北京中农华威生物医药研究院 一种含有诱食成分的犬、猫用软胶囊
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