CN114099456A - 一种含有s-腺苷蛋氨酸的胶囊及其制备方法与用途 - Google Patents
一种含有s-腺苷蛋氨酸的胶囊及其制备方法与用途 Download PDFInfo
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- CN114099456A CN114099456A CN202111429903.8A CN202111429903A CN114099456A CN 114099456 A CN114099456 A CN 114099456A CN 202111429903 A CN202111429903 A CN 202111429903A CN 114099456 A CN114099456 A CN 114099456A
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- adenosylmethionine
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Abstract
本发明提供一种含有S‑腺苷蛋氨酸的胶囊，所述胶囊至少包括：按重量份计，25～65％的活性成分、35～75％的脂质体和0～15％的辅料；所述活性成分为S‑腺苷蛋氨酸类物质。本发明还提供一种含有S‑腺苷蛋氨酸的胶囊的制备方法，其将生理环境与胶囊的活性成分分隔开，不仅能够延长生理环境条件下活性成分S‑腺苷蛋氨酸的保存时间，而且不会干扰用药后活性成分的效力；本发明的含有S‑腺苷蛋氨酸的胶囊可用于抑郁症、肝病、炎症性疾病和周围神经病变以及视网膜微血管疾病领域。
Description
技术领域
本发明涉及营养制剂领域，特别是涉及一种含有S-腺苷蛋氨酸的胶囊及其制备方法与用途。
背景技术
S-腺苷蛋氨酸(SAMe)，是含硫氨基酸-蛋氨酸和人体主要的能量物质三磷酸腺苷结合的代谢物，其存在于人体所有组织和体液中。SAMe可以参与人体中200多种生化反应，不仅能够作为良好的肝脏营养剂，而且具有消炎、减轻疼痛及组织修复功能，且随着研究的深入，SAMe在临床中的应用已被广泛发现，例如用于抗肿瘤、治疗肝病、治疗抑郁症等等，SAMe在疾病的治疗中发挥着巨大的作用。
然而，SAMe在常温、生理pH以及湿润的环境条件下极不稳定，所以，如何使含有SAMe的药剂能够保持SAMe的活性同时不影响其药效的发挥成为首要的问题。目前欧美国家采用的是将其制成肠溶型片剂的形式，但是肠溶片剂的生产加工方法是极其复杂的，且由于活性成分具有的吸湿水解的特点，使其在片剂中有效浓度降低，导致生产成本增加，同时对片剂成品影响也很大。此外，还有一个重要因素在于，肠溶型片剂的影响不仅在于片剂中活性成分的溶出时间长，而且对活性成分的吸收也有影响。
发明内容
鉴于以上所述现有技术的缺点，本发明的目的在于提供一种含有S-腺苷蛋氨酸的胶囊及其制备方法与用途，用于口服全身给药，以解决现有技术存在的片剂成本高、活性成分溶出时间长以及吸收效率低的问题。
为实现上述目的及其他相关目的，本发明一方面提供一种含有S-腺苷蛋氨酸的胶囊，所述胶囊至少包括：按重量份计，25～65％的活性成分、35～70％的脂质体和0～15％的辅料；所述活性成分为S-腺苷蛋氨酸类物质。
优选地，所述S-腺苷蛋氨酸类物质为S-腺苷蛋氨酸或其盐。
优选地，所述脂质体为天然产物、半合成脂质物、合成的脂质物中的一种或多种。
优选地，所述脂质体为由赋形剂辅助的脂质载体；所述脂质载体为临床证明具有药理活性的脂质成分；所述赋形剂为二价金属盐或一价金属盐。
优选地，所述辅料为抗氧化剂、维生素、肌醇、5-HTP、氨基酸、叶酸、叶酸盐和矿物质中的一种或多种。
优选地，所述胶囊的重量为450～950mg。
本发明另一方面提供一种含有S-腺苷蛋氨酸的胶囊的制备方法，包括以下步骤：将活性成分及辅料添加到脂质体中，加热至40～60℃，搅拌至混合均匀，制备成胶囊，胶囊密封后在其表层涂覆涂层形成包衣。
优选地，所述包衣为天然高分子树脂、纤维素及其衍生物以及丙烯酸树脂中的一种或多种。
本发明还提供一种含有S-腺苷蛋氨酸的胶囊的用途，可用于抑郁症、肝病、炎症性疾病和周围神经病变以及视网膜微血管疾病领域。
如上所述，本发明的含有S-腺苷蛋氨酸的胶囊及其制备方法与用途，具有以下有益效果：本发明的含有S-腺苷蛋氨酸的胶囊将活性成分分散在脂质载体中，将生理环境与胶囊的活性成分分隔开，不仅能够延长生理环境条件下活性成分S-腺苷蛋氨酸的保存时间，同时不会干扰用药后活性成分的效力，并且解决了片剂制备成本高、活性成分溶出时间长以及吸收效率低的问题。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。
本发明一方面提供一种含有S-腺苷蛋氨酸的胶囊，胶囊至少包括：按重量份计，25～65％的活性成分、35～70％的脂质体和0～15％的辅料；所述活性成分为S-腺苷蛋氨酸类物质。
本发明所提供的含有S-腺苷蛋氨酸的胶囊，可以包括：S-腺苷蛋氨酸类物质为S-腺苷蛋氨酸或其盐。例如为S-腺苷蛋氨酸对甲苯磺酸酯、S-腺苷蛋氨酸硫酸盐、S-腺苷蛋氨酸1,4-丁二磺酸盐。
本发明所提供的含有S-腺苷蛋氨酸的胶囊，可以包括：脂质体为天然产物、半合成脂质物、合成的脂质物中的一种或多种。脂质体可以为矿物油、长链或中链脂肪酸的甘油三酯、植物或动物蜡以及萜烯烃类化合物中的一种或多种。其中，矿物油可以为液体石蜡；植物或动物蜡可以为蜂蜡；萜烯烃类化合物可以为角鲨烯或角鲨烷；长链或中链脂肪酸的甘油三酯优选植物来源，且可以在其自然状态下使用或部分或完全氢化的，例如为芝麻油、甜杏仁油、椰子油、玉米油、橄榄油、蓖麻油或荷荷巴油。
本发明所提供的含有S-腺苷蛋氨酸的胶囊，可以包括：脂质体为由赋形剂辅助的脂质载体；脂质载体为临床证明具有药理活性的脂质成分；赋形剂为二价金属盐或一价金属盐。脂质成分可以为多不饱和脂肪酸，例如为ω-3脂肪酸和ω-6脂肪酸；其中，ω-3脂肪酸又称PUFA n-3，可以是α-亚麻酸(ALA)、二十碳五烯酸(EPA)或二十二碳六烯酸(DHA)；ω-6脂肪酸可以是y-亚麻酸(GLA)；脂质成分也可以为植物来源例如亚麻籽油、琉璃苣油或豆油；脂质成分也可以为动物来源，例如为鱼油或磷虾。二价金属盐可以为镁盐或钙盐，优选硫酸镁；一价金属盐可以为钠盐或其混合物。赋形剂还可以为聚甘油-3二油酸酯。
本发明所提供的含有S-腺苷蛋氨酸的胶囊，还可以包括：辅料为抗氧化剂、维生素、肌醇、5-HTP、氨基酸、叶酸、叶酸盐和矿物质中的一种或多种。其中矿物质可以为硒、锌、镁、铜或碘，硒、锌、镁、铜或碘均以盐或复合物的形式存在于脂质体中。
本发明所提供的含有S-腺苷蛋氨酸的胶囊，还可以包括：胶囊的重量为450～950mg；例如为450～550mg、550～650mg、650～700mg、700～750mg、750～800mg、800～850mg、850～900mg或900～950mg。
本发明另一方面提供一种含有S-腺苷蛋氨酸的胶囊的制备方法，包括以下步骤：将活性成分及辅料添加到脂质体中，加热至40～60℃，搅拌至混合均匀，制备成胶囊，胶囊密封后在其表层涂覆涂层形成包衣。
本发明提供的含有S-腺苷蛋氨酸的胶囊的制备方法可以为充液硬胶囊的标准制备方法。
本发明提供的含有S-腺苷蛋氨酸的胶囊的制备方法，可以包括：包衣为天然高分子树脂、纤维素及其衍生物以及丙烯酸树脂中的一种或多种。天然高分子树脂包括虫胶、海藻酸盐；纤维素及其衍生物包括羟丙基甲基纤维素邻苯二甲酸酯、醋酸羟丙甲纤维素琥珀酸酯、醋酸邻苯二甲酸纤维素和羟甲基以及纤维素；丙烯酸树脂包括I号丙烯酸树脂乳液、II号丙烯酸树脂和III号丙烯酸树脂。
本发明还提供一种含有S-腺苷蛋氨酸的胶囊的用途，可用于抑郁症、肝病、炎症性疾病和周围神经病变以及视网膜微血管疾病领域。
实施例1
按重量份计，脂质载体65％、S-腺苷蛋氨酸35％，脂质载体可由植物油、动物油、矿物油或中长链甘油三酯组成。将S-腺苷蛋氨酸与脂质载体混合搅拌均匀，制备成胶囊后表层涂覆肠溶性包衣。
实施例2
按重量份计，350mgS-腺苷蛋氨酸，300mg DHA，100mg琉璃苣油，.将S-腺苷蛋氨酸、DHA与琉璃苣油混合搅拌均匀，形成重量为750mg的混合液，将混合液填充到硬胶质胶囊壳中，随后用明胶溶液密封并在胶囊表层涂覆肠溶性包衣，制备为重量810mg的胶囊。
实施例3
按重量份计，400mgS-腺苷蛋氨酸，400mg DHA，30mg硫酸镁，40mg聚甘油-3二油酸酯。将S-腺苷蛋氨酸、DHA、硫酸镁与聚甘油-3二油酸酯混合搅拌均匀，形成重量为870mg的混合液，将混合液填充到硬胶质胶囊壳中，随后用明胶溶液密封并在胶囊表层涂覆肠溶性包衣，制备为重量930mg的胶囊。
实施例4
按重量份计，300mgS-腺苷蛋氨酸，450mg中链甘油三酯，50mg甘油基二本甲酸酯，将中链甘油三酯与甘油基二本甲酸酯在一个容器中熔融，温度设定在80℃左右，熔融后，混合物在温和搅拌下冷却至约50℃。然后加入S-腺苷蛋氨酸，并在45～50℃的条件下搅拌混合，形成重量为800mg的混合液。将混合液填充到胶质胶囊壳中，制备胶囊的过程中由于温度降低，混合液停止搅拌，混合液自身硬化，不需密封及涂覆肠溶性包衣，最终形成重量为900mg的胶囊。
对上述实施例1～4制备的的含有S-腺苷蛋氨酸的胶囊进行了稳定性的研究，实施例1～4制备的含有S-腺苷蛋氨酸的胶囊在常温、生理pH以及湿润的环境条件下均具有良好的稳定性。
综上所述，本发明含有S-腺苷蛋氨酸的胶囊在常温、生理pH以及湿润的环境条件下，其活性成分S-腺苷蛋氨酸均能稳定存在，所以，本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。
上述实施例仅例示性说明本发明的原理及其功效，而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下，对上述实施例进行修饰或改变。因此，举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本发明的权利要求所涵盖。
Claims (10)
1.一种含有S-腺苷蛋氨酸的胶囊，其特征在于，所述胶囊至少包括：按重量份计，25～65％的活性成分、35～75％的脂质体和0～15％的辅料；所述活性成分为S-腺苷蛋氨酸类物质。
2.根据权利要求1所述的含有S-腺苷蛋氨酸的胶囊，其特征在于，所述S-腺苷蛋氨酸类物质为S-腺苷蛋氨酸或其盐。
3.根据权利要求1所述的含有S-腺苷蛋氨酸的胶囊其特征在于，所述脂质体为天然产物、半合成脂质物、合成的脂质物中的一种或多种。
4.根据权利要求1所述的含有S-腺苷蛋氨酸的胶囊，其特征在于，所述脂质体为由赋形剂辅助的脂质载体；所述脂质载体为临床证明具有药理活性的脂质成分；所述赋形剂为二价金属盐或一价金属盐。
5.根据权利要求1所述的含有S-腺苷蛋氨酸的胶囊，其特征在于，所述辅料为抗氧化剂、维生素、肌醇、5-HTP、氨基酸、叶酸、叶酸盐和矿物质中的一种或多种。
6.根据权利要求1所述的含有S-腺苷蛋氨酸的胶囊，其特征在于，所述胶囊的重量为450～950mg。
7.一种根据权利要求1～6任一项所述的含有S-腺苷蛋氨酸的胶囊的制备方法，其特征在于，包括以下步骤：将活性成分及辅料添加到脂质体中，加热至40～60℃，搅拌至混合均匀，制备成胶囊，胶囊密封后在其表层涂覆涂层形成包衣。
8.根据权利要求7所述的含有S-腺苷蛋氨酸的胶囊的制备方法，其特征在于，所述包衣为天然高分子树脂、纤维素及其衍生物以及丙烯酸树脂中的一种或多种。
9.根据权利要求8所述的含有S-腺苷蛋氨酸的胶囊的制备方法，其特征在于，所述天然高分子树脂包括虫胶、海藻酸盐；所述纤维素及其衍生物包括羟丙基甲基纤维素邻苯二甲酸酯、醋酸羟丙甲纤维素琥珀酸酯、醋酸邻苯二甲酸纤维素和羟甲基以及纤维素；所述丙烯酸树脂包括I号丙烯酸树脂乳液、II号丙烯酸树脂和III号丙烯酸树脂。
10.一种根据权利要求1～6任一项所述的含有S-腺苷蛋氨酸的胶囊的用途，其特征在于，可用于抑郁症、肝病、炎症性疾病和周围神经病变以及视网膜微血管疾病领域。
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| WO2002049637A1 (en) * | 2000-12-18 | 2002-06-27 | Orchid Chemicals And Pharmaceuticals Limited | A novel soft-gelatin capsule comprising s-adenosylmethionine and a method for producing the same |
| EP3257502A1 (en) * | 2016-06-17 | 2017-12-20 | Giorgio Stramentinoli | Formulations in the form of capsules for oral systemic administration comprising s-adenosylmethionine and polyunsaturated fatty acids, preparation and use thereof |
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| WO2002049637A1 (en) * | 2000-12-18 | 2002-06-27 | Orchid Chemicals And Pharmaceuticals Limited | A novel soft-gelatin capsule comprising s-adenosylmethionine and a method for producing the same |
| EP3257502A1 (en) * | 2016-06-17 | 2017-12-20 | Giorgio Stramentinoli | Formulations in the form of capsules for oral systemic administration comprising s-adenosylmethionine and polyunsaturated fatty acids, preparation and use thereof |
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Application publication date: 20220301 |