CN112335812A - 一种成人补充维生素k2的片剂 - Google Patents
一种成人补充维生素k2的片剂 Download PDFInfo
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- DKHGMERMDICWDU-GHDNBGIDSA-N menaquinone-4 Chemical compound C1=CC=C2C(=O)C(C/C=C(C)/CC/C=C(C)/CC/C=C(C)/CCC=C(C)C)=C(C)C(=O)C2=C1 DKHGMERMDICWDU-GHDNBGIDSA-N 0.000 title claims abstract description 87
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- OCKGFTQIICXDQW-ZEQRLZLVSA-N 5-[(1r)-1-hydroxy-2-[4-[(2r)-2-hydroxy-2-(4-methyl-1-oxo-3h-2-benzofuran-5-yl)ethyl]piperazin-1-yl]ethyl]-4-methyl-3h-2-benzofuran-1-one Chemical compound C1=C2C(=O)OCC2=C(C)C([C@@H](O)CN2CCN(CC2)C[C@H](O)C2=CC=C3C(=O)OCC3=C2C)=C1 OCKGFTQIICXDQW-ZEQRLZLVSA-N 0.000 description 1
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- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
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Abstract
本发明属于保健品技术领域，具体涉及一种成人补充维生素K2的片剂。该片剂由维生素K2粉、预胶化淀粉、麦芽糊精、微晶纤维素、二氧化硅和硬脂酸镁制成，其中，维生素K2粉为预混型维生素K2粉，可以从多方面显著减少维生素K2的降解损耗，使制得的片剂稳定性显著提高，且制备的片剂在成片硬度、脱模等方面性能良好，在符合的硬度要求下，可按需要迅速崩解，易于吸收。
Description
技术领域
本发明属于保健品技术领域，具体涉及一种成人补充维生素K2的片剂。
背景技术
维生素K族化合物是上个世纪二十年代丹麦科学家发现的脂溶性凝血维生素，由于其首次在德国杂志发表并被称为“Koagulationsvitamin”(德文意为凝血维生素)，故取其第一个字母K命名了该类维生素。在以后的几十年中，一直广泛用作治疗新生儿、婴儿及孕妇由于缺乏维生素造成的出血症，后来还发现维生素K族化合物参与人体骨代谢，可以抗骨质疏松、预防老年性骨折、防止并逆转心血管钙化、预防肝癌及肝硬化、预防老年痴呆、抗风湿性关节炎等作用。可见，维生素K2作为一种人体内重要的基础必需营养成分，有十分积极的科学和现实意义。
随着维生素K2越来越受重视并被广泛应用，其不稳定性问题也日益凸显，目前市面上的维生素K2基本上均为提取、纯化后的维生素K2产物直接添加，在应用时，维生素K2对光、热、氧气或部分金属离子非常敏感，容易造成其迅速降解，造成有效成分的大量损失。如中国专利申请CN101534807A公开了一种含有维生素K2的药品和类药剂营养品，将维生素K2或维生素K2类化合物与一种或多种纯化形式或作为海产油(即鱼油和/或磷虾油)的多不饱和脂肪酸组合，制成药品和类药剂营养品，成为具有长储存期限的稳定制剂，但是油脂类物质非常容易被空气中的氧气氧化，产生酸臭的气味。
因此，迫切需要提供一种稳定性高的成人补充维生素K2的片剂。
发明内容
本发明旨在提供一种稳定性高的成人补充维生素K2的片剂。
为了达到上述目的，本发明采用以下技术方案：
一种成人补充维生素K2的片剂，由以下组分及其重量百分数制成：维生素K2粉5-9％、预胶化淀粉30-42％、麦芽糊精30-40％、微晶纤维素5-18％、二氧化硅1-2.5％和硬脂酸镁0.5-1.25％。
进一步地，由以下组分及其重量百分数制成：维生素K2粉7-9％、预胶化淀粉35-42％、麦芽糊精35-40％、微晶纤维素10-18％、二氧化硅1-2％和硬脂酸镁0.5-1％。
更进一步地，由以下组分及其重量百分数制成：维生素K2粉8％、预胶化淀粉37％、麦芽糊精37％、微晶纤维素15％、二氧化硅2％和硬脂酸镁1％。
进一步地，所述维生素K2粉为预混型维生素K2粉。
更进一步地，所述预混型维生素K2粉由维生素K2 0.1-0.5％、食用玉米淀粉55-70％、大豆油10-20％、乙基纤维素8-15％、乙基纤维素5-12％、辛烯基琥珀酸淀粉1-2％、单硬脂酸甘油酯0.5-1％和抗坏血酸棕榈酸酯0.25-0.55％制成。
进一步地，所述预混型维生素K2粉由维生素K2 0.1-0.2％、食用玉米淀粉60-70％、大豆油15-20％、乙基纤维素10-15％、酪蛋白酸钠5-10％、辛烯基琥珀酸淀粉1.5-2％、单硬脂酸甘油酯0.6-1％和抗坏血酸棕榈酸酯0.3-0.5％制成。
更进一步地，所述预混型维生素K2粉的制备方法包括以下步骤：
将相应量食用玉米淀粉、乙基纤维素、酪蛋白酸钠和辛烯基琥珀酸淀粉混合均匀，得混合物I；将相应量维生素K2、大豆油、单硬脂酸甘油酯和抗坏血酸棕榈酸酯混合均匀，得混合物II；将所得混合物I和混合物II混合均匀，干燥，即得。
进一步地，所述预胶化淀粉的淀粉为薯类、谷类淀粉或薯类和谷类淀粉的混合物，含水量小于15％。
更进一步地，所述片剂的制备方法包括以下步骤：
取相应量预胶化淀粉、麦芽糊精、微晶纤维素、二氧化硅、硬脂酸镁和维生素K2粉混合均匀，以25-35KN的压力压片，即得。
另外的，本申请还提供了一种所述成人补充维生素K2的片剂的制备方法，包括以下步骤：
取相应量预胶化淀粉、麦芽糊精、微晶纤维素、二氧化硅、硬脂酸镁和维生素K2粉混合均匀，以25-35KN的压力压片，即得。
本发明具有以下优点：
(1)本发明采用酪蛋白酸钠、乙基纤维素、抗坏血酸棕榈酸酯等原料与维生素K2先预混合，一方面，酪蛋白酸钠和乙基纤维素可以在维生素K2外形成一层保护膜，隔绝外界因子对维生素K2降解的影响；另一方面，抗坏血酸棕榈酸酯可从内减少维生素K2的氧化降解，从多方面减少维生素K2的降解损耗，使制得的片剂稳定性显著提高。
(2)本发明选用预胶化淀粉、麦芽糊精、微晶纤维素三者搭配，使片制在成片硬度、脱模等方面性能良好，不仅如此，本发明采用二氧化硅与硬脂酸镁按一定比例混合，一方面使压片时，物料具有良好的流动性和脱模能力，同时使片制在符合的硬度要求下，可按需要迅速崩解，易于吸收。
具体实施方式
以下通过实施例形式的具体实施方式，对本发明的上述内容作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下实施例。
其中，所用试剂均为本领域常用试剂，均可购于常规试剂生产销售公司。
实施例1一种成人补充维生素K2的片剂
由以下组分及其重量百分数制成：维生素K2粉8％、预胶化淀粉37％、麦芽糊精37％、微晶纤维素15％、二氧化硅2％和硬脂酸镁1％；其中，维生素K2粉为预混型维生素K2粉，由维生素K2 0.2％、食用玉米淀粉60％、大豆油20％、乙基纤维素10％、酪蛋白酸钠6.3％、辛烯基琥珀酸淀粉2％、单硬脂酸甘油酯1％和抗坏血酸棕榈酸酯0.5％制成；
制备方法：
将相应量食用玉米淀粉、乙基纤维素、酪蛋白酸钠和辛烯基琥珀酸淀粉混合均匀，得混合物I；将相应量维生素K2、大豆油、单硬脂酸甘油酯和抗坏血酸棕榈酸酯混合均匀，得混合物II；将所得混合物I和混合物II混合均匀，干燥，得预混型维生素K2粉；
取相应量预胶化淀粉、麦芽糊精、微晶纤维素、二氧化硅、硬脂酸镁和预混型维生素K2粉混合均匀，以30KN的压力压片，即得。
实施例2一种成人补充维生素K2的片剂
由以下组分及其重量百分数制成：维生素K2粉6％、预胶化淀粉40.7％、麦芽糊精38％、微晶纤维素12％、二氧化硅2.5％和硬脂酸镁0.8％；其中，维生素K2粉为预混型维生素K2粉，由维生素K2 0.1％、食用玉米淀粉55％、大豆油15％、乙基纤维素15％、酪蛋白酸钠12％、辛烯基琥珀酸淀粉2％、单硬脂酸甘油酯0.5％和抗坏血酸棕榈酸酯0.4％制成；
其余参数及制备方法参考实施例1。
实施例3一种成人补充维生素K2的片剂
由以下组分及其重量百分数制成：维生素K2粉9％、预胶化淀粉37.3％、麦芽糊精35％、微晶纤维素16％、二氧化硅1.5％和硬脂酸镁1.2％；其中，维生素K2粉为预混型维生素K2粉，由维生素K2 0.2％、食用玉米淀粉65％、大豆油10％、乙基纤维素12％、酪蛋白酸钠10％、辛烯基琥珀酸淀粉1.6％、单硬脂酸甘油酯1％和抗坏血酸棕榈酸酯0.2％制成；
其余参数及制备方法参考实施例1。
对比例1一种维生素K2片剂
与实施例1不同之处在于，对比例1的维生素K2粉由0.2％维生素K2和99.8％的食用玉米淀粉混合而成，其余参数及操作参考实施例1。
对比例2一种维生素K2片剂
与实施例1不同之处在于，对比例2去掉维生素K2粉中的酪蛋白酸钠，增加食用玉米淀粉至66.3％，其余参数及操作参考实施例1。
对比例3一种维生素K2片剂
与实施例1不同之处在于，对比例3去掉维生素K2粉中的抗坏血酸棕榈酸酯，增加食用玉米淀粉至60.5％，其余参数及操作参考实施例1。
试验例1维生素K2片剂的加速稳定性试验
参考《中国药典》(2015年版)第四部通则9001原料药与制剂稳定性试验指导原则对实施例1-3和对比例1-3制备的维生素K2片剂进行加速稳定性试验，测定第0、1、2、3个月的维生素K2含量，其中，维生素K2以七烯甲萘醌计，限值为64.0-100.0μg/片，实验结果参见表1。
表1维生素K2加速稳定性试验结果
由表1可见，本申请实施例1-3制备的维生素K2片剂含量在加速稳定性试验的1-3月中基本保持不变，均在限值范围内，稳定性高，而对比例1-3制备的维生素K2片剂在加速稳定性试验3个月后含量显著减少55％左右，稳定性显著降低。
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)
1.一种成人补充维生素K2的片剂，其特征在于，由以下组分及其重量百分数制成：维生素K2粉5-9％、预胶化淀粉30-42％、麦芽糊精30-40％、微晶纤维素5-18％、二氧化硅1-2.5％和硬脂酸镁0.5-1.25％。
2.根据权利要求1所述成人补充维生素K2的片剂，其特征在于，由以下组分及其重量百分数制成：维生素K2粉7-9％、预胶化淀粉35-42％、麦芽糊精35-40％、微晶纤维素10-18％、二氧化硅1-2％和硬脂酸镁0.5-1％。
3.根据权利要求2所述成人补充维生素K2的片剂，其特征在于，由以下组分及其重量百分数制成：维生素K2粉8％、预胶化淀粉37％、麦芽糊精37％、微晶纤维素15％、二氧化硅2％和硬脂酸镁1％。
4.根据权利要求1-3任一所述成人补充维生素K2的片剂，其特征在于，所述维生素K2粉为预混型维生素K2粉。
5.根据权利要求4所述成人补充维生素K2的片剂，其特征在于，所述预混型维生素K2粉由维生素K2 0.1-0.5％、食用玉米淀粉55-70％、大豆油10-20％、乙基纤维素8-15％、乙基纤维素5-12％、辛烯基琥珀酸淀粉1-2％、单硬脂酸甘油酯0.5-1％和抗坏血酸棕榈酸酯0.25-0.55％制成。
6.根据权利要求4所述成人补充维生素K2的片剂，其特征在于，所述预混型维生素K2粉由维生素K2 0.1-0.2％、食用玉米淀粉60-70％、大豆油15-20％、乙基纤维素10-15％、酪蛋白酸钠5-10％、辛烯基琥珀酸淀粉1.5-2％、单硬脂酸甘油酯0.6-1％和抗坏血酸棕榈酸酯0.3-0.5％制成。
7.根据权利要求4所述成人补充维生素K2的片剂，其特征在于，所述预混型维生素K2粉的制备方法包括以下步骤：
将相应量食用玉米淀粉、乙基纤维素、酪蛋白酸钠和辛烯基琥珀酸淀粉混合均匀，得混合物I；将相应量维生素K2、大豆油、单硬脂酸甘油酯和抗坏血酸棕榈酸酯混合均匀，得混合物II；将所得混合物I和混合物II混合均匀，干燥，即得。
8.根据权利要求1-3任一所述成人补充维生素K2的片剂，其特征在于，所述预胶化淀粉的淀粉为薯类、谷类淀粉或薯类和谷类淀粉的混合物，含水量小于15％。
9.根据权利要求1-3任一所述成人补充维生素K2的片剂，其特征在于，所述片剂的制备方法包括以下步骤：
取相应量预胶化淀粉、麦芽糊精、微晶纤维素、二氧化硅、硬脂酸镁和维生素K2粉混合均匀，以25-35KN的压力压片，即得。
10.根据权利要求1-9任一所述成人补充维生素K2的片剂的制备方法，其特征在于，包括以下步骤：
取相应量预胶化淀粉、麦芽糊精、微晶纤维素、二氧化硅、硬脂酸镁和维生素K2粉混合均匀，以25-35KN的压力压片，即得。
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| CN115836701A (zh) * | 2022-10-26 | 2023-03-24 | 郑州路路通医药科技有限公司 | 一种调节胃肠功能的糖及其制备方法 |
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| CN112971148A (zh) * | 2021-04-20 | 2021-06-18 | 郑州路路通医药科技有限公司 | 一种钙维生素d维生素k片剂及其制备方法 |
| CN115836701A (zh) * | 2022-10-26 | 2023-03-24 | 郑州路路通医药科技有限公司 | 一种调节胃肠功能的糖及其制备方法 |
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