CN104244738A - 固体的颜色稳定的l-抗坏血酸组合物 - Google Patents
固体的颜色稳定的l-抗坏血酸组合物 Download PDFInfo
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- CN104244738A CN104244738A CN201380020926.0A CN201380020926A CN104244738A CN 104244738 A CN104244738 A CN 104244738A CN 201380020926 A CN201380020926 A CN 201380020926A CN 104244738 A CN104244738 A CN 104244738A
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Abstract
本发明涉及粉末或颗粒形式的固体的、颜色稳定的L-抗坏血酸组合物。这些改进的组合物具有高量的维生素C，并且它们具有极佳的颜色稳定性。
Description
本文提供的是粉末或颗粒形式的固体的、颜色稳定的L-抗坏血酸组合物。这些组合物可以提供高量的维生素C并且可另外地具有极佳的颜色稳定性，尤其是当用于压缩片剂(compressed tablet)时。
L-抗坏血酸本身是已知的。许多L-抗坏血酸的盐也是已知的。最普遍的L-抗坏血酸的盐中的一种是抗坏血酸钠。有许多形式的用于高效能片剂应用的维生素C的颗粒形式，例如C90、C95、C97和抗坏血酸钠99％(Sodium Ascorbate 99％)(来自DSM Nutritional Products)。
L-抗坏血酸和抗坏血酸钠都是白色和无气味的固体。抗坏血酸钠可以由抗坏血酸合成。L-抗坏血酸可以以工业规模生产，即通过莱氏法(Reichstein process)。
如果防潮湿，结晶L-抗坏血酸是稳定的，但是其对热稍敏感。抗坏血酸钠对空气、热和潮湿稍敏感。L-抗坏血酸的稳定性问题是，当其暴露于湿度时，白色调变暗。这是产品的问题，例如即包含L-抗坏血酸和/或其盐的片剂、胶囊等。
高剂量抗坏血酸片剂中不相容的因素是通常使用的润滑剂，硬脂酸镁。在短的储存期内，这样的制剂就已产生微黄色调并且失去其白色。
出乎意料地是，已经发现当抗坏血酸组合物(粉末或颗粒)包含特定的润滑剂(或润滑剂的混合物)和合适的粘合剂时，颜色稳定性提高(尤其用于片剂时)。
在一些实施方式中，抗坏血酸棕榈酸酯(ascorbyl palmitate)以及抗坏血酸棕榈酸酯(作润滑剂)与至少一种特定的润滑剂的组合可以提供颜色稳定的高效能抗坏血酸片剂。
在一些实施方式中，抗坏血酸棕榈酸酯以及抗坏血酸棕榈酸酯与至少一种特定的润滑剂的混合物不影响片剂的物理性质，包括压缩谱(compression profile)和崩解时间(DT)，同时弹射力(ejection force)相当。
因此，本文提供的是粉末或颗粒形式的组合物(I)，其包含：
(a)基于粉末或颗粒的总重量的75重量％(wt％)-99wt％的L-抗坏血酸和/或其盐，
(b)基于粉末或颗粒的总重量的0.1wt％-10wt％的抗坏血酸棕榈酸酯或抗坏血酸棕榈酸酯和至少一种选自以下的化合物的混合物：氢化植物油、山嵛酸甘油酯、单硬脂酸甘油酯、棕榈酸硬脂酸甘油酯、硬脂酸、棕榈酸、肉豆蔻酸、滑石(talc)、月桂基硫酸钠、蜡、硬脂富马酸钠和聚乙二醇，以及
(c)基于粉末或颗粒的总重量的0.9wt％-10wt％的至少一种粘合剂，以及
(d)任选的辅料，其量在基于粉末或颗粒的总重量的0.05wt％-5wt％的范围，前提条件是该组合物基本不含硬脂酸镁。
可以这样使用或以合适的制剂(例如片剂)使用的这些组合物可以提供当暴露于压力环境例如高湿度和/或高温条件下时改进的颜色稳定性。
所有的百分数总是相加成100。
具体的组合物(II)是其中使用抗坏血酸钠的组合物(I)。
粘合剂的功能是使固体组合物(例如颗粒或片剂)中的组分保持在一起。粘合剂可以确保利用需要的机械力，颗粒和片剂能够形成，并且为低活性剂量片剂提供体积和良好的内含物均匀性。
本文提供的粘合剂可以包含(尤其适合颗粒化目的)
糖类及其衍生物，蛋白质和合成的聚合物。
本文提供的糖类的特别的组包括：
-二糖，例如蔗糖和乳糖，
-多糖及其衍生物，例如阿拉伯树胶、黄芪胶、果胶(pectin)和淀粉，
-糖醇，例如木糖醇、山梨糖醇或麦芽糖醇。
本文提供的蛋白质的特别的组包括明胶(gelatine)(即鱼、猪肉、牛肉)。
本文提供的合成的聚合物的特别的组包括，即聚乙烯吡咯烷酮(PVP，聚乙烯吡啶酮)和聚乙二醇(PEG)，甲基-或乙基纤维素或改性纤维素(例如羧甲基纤维素钠)，聚乙烯醇，和纤维素醚例如羟丙基纤维素(HPC)。
本文进一步提供了适合的粘合剂(尤其适合片剂化目的)，其包括微晶纤维素、硅化微晶纤维素、羟丙基纤维素、淀粉、乳糖、磷酸二钙、蔗糖、葡萄糖(dextrose)，和糖醇。
一些粘合剂可以适用于颗粒化以及片剂化。
本文提供的一个具体的组合物是组合物(III)，它是组合物(I)和/或(II)，其中粘合剂选自糖类及其衍生物、蛋白质、合成的聚合物、微晶纤维素、硅化微晶纤维素、羟丙基纤维素、淀粉、乳糖、磷酸二钙、蔗糖、葡萄糖，和糖醇。
本文提供的另一实施方式是以粉末或颗粒形式的组合物(IV)，其包含
(a)基于粉末或颗粒的总重量的84wt％-99wt％的L-抗坏血酸和/或其盐，
(b)基于粉末或颗粒的总重量的0.1wt％-8wt％的抗坏血酸棕榈酸酯或抗坏血酸棕榈酸酯和至少一种选自以下的化合物的混合物：氢化植物油、山嵛酸甘油酯、单硬脂酸甘油酯、棕榈酸硬脂酸甘油酯、硬脂酸、棕榈酸、肉豆蔻酸、滑石、月桂基硫酸钠、蜡、硬脂富马酸钠和聚乙二醇，以及
(c)基于粉末或颗粒的总重量的0.9wt％-8wt％的至少一种粘合剂，以及
(d)任选的辅料，其量在按重量计(根据组合物的总重量计算)0.05％-5％的范围，前提条件是该组合物基本不含硬脂酸镁。
本文提供的一个具体的实施方式是组合物(V)，它是组合物(I)，(II)，(III)和/或(IV)，其中粘合剂选自糖类及其衍生物、蛋白质、合成的聚合物、微晶纤维素、硅化微晶纤维素、羟丙基纤维素、HPC、淀粉、乳糖、磷酸二钙、蔗糖、葡萄糖和糖醇。
本文提供的粉末或颗粒可以使用公知的工艺生产，例如流化床造粒、高剪切造粒、挤出、喷雾干燥或其他的干或湿造粒工艺。
本文提供的粉末或颗粒可以这样使用或者其可以被进一步加工。当进一步加工时，其可以被压制成片剂。
其可以这样被压制成片剂或者与在压片中普遍使用的辅料一起被压制成片剂。
在片剂中L-抗坏血酸和/或其盐的粉末或颗粒的含量可以包括基于片剂的总重量的80wt％-99wt％，特别是84wt％-99wt％，更特别是90wt％-99wt％。
在一些实施方式中，片剂中抗坏血酸棕榈酸酯的含量是基于片剂的总重量的0.3wt％-5wt％，。
在一些实施方式中，片剂中硬脂酸的含量是基于片剂的总重量的0.3wt％-5wt％。
在一些实施方式中，片剂的粘合剂的含量(优选微晶纤维素、硅化微晶纤维素、羟丙基纤维素、HPC、淀粉、乳糖、磷酸二钙、蔗糖、葡萄糖和/或糖醇类)是基于片剂的总重量的0.5wt％-8wt％。
本文提供的粉末或颗粒以及任何进一步加工的形式可以这样或与其他组分相组合用于膳食补充剂、食品、饲料或个人护理制剂。
因此，本文也提供了至少一种组合物(I)，(II)，(III)，(IV)和/或(V)在膳食补充剂、食品、饲料或个人护理制剂中的用途。
因此，本文还提供了包含至少一种组合物(I)，(II)，(III)，(IV)和/或(V)的膳食补充剂、食品、饲料或个人护理制剂。
图1：在开放式托盘中在40℃/75％RH下7天实施例9(比较实施例)和实施例1(本发明)片剂的颜色稳定性数据。片剂的颜色用HunterLab色度计以WIE来测量。图1显示了白度值(WIE)。
图2：在开放式托盘中在40℃/75％RH下7天实施例9(比较实施例)和实施例1(本发明)的颜色稳定性数据。片剂的颜色用HunterLab色度计以YIE值来测量。图2显示了黄度值(YIE)。
下面的实施例用于阐述本文要求的本发明一些特定的实施方式。所有给出的百分数与重量相关，所有的温度以摄氏度给出。
实施例
所有实施例根据下面的工艺制备：
将抗坏血酸(97％颗粒的形式，可购自DSM)放到搅拌器中。然后将微晶纤维素(MCC 102)和二氧化硅过20目筛并且也转移到搅拌器中。然后将硬脂酸和抗坏血酸棕榈酸酯过30目筛并且也转移到搅拌器中。将该混合物混合10分钟并且倒入容器中。
实施例1
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1031 | 91.24 |
| 微晶纤维素 | 70.75 | 6.26 |
| 硬脂酸 | 16.95 | 1.50 |
| 抗坏血酸棕榈酸酯 | 11.30 | 1.00 |
实施例2
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1031 | 91.24 |
| 微晶纤维素 | 76.40 | 6.76 |
| 二氧化硅 | 5.65 | 0.50 |
| 硬脂酸 | 11.30 | 1.00 |
| 抗坏血酸棕榈酸酯 | 5365 | 0.50 |
实施例3
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1031 | 91.24 |
| 微晶纤维素 | 70.75 | 6.26 |
| 二氧化硅 | 5.65 | 0.50 |
| 硬脂酸 | 11.30 | 1.00 |
| 抗坏血酸棕榈酸酯 | 11.30 | 1.00 |
实施例4
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1031 | 91.24 |
| 微晶纤维素 | 65.10 | 5.76 |
| 二氧化硅 | 5.65 | 0.50 |
| 硬脂酸 | 11.30 | 1.00 |
| 抗坏血酸棕榈酸酯 | 16.95 | 1.50 |
实施例5
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1031 | 91.24 |
| 微晶纤维素 | 59.45 | 5.26 |
| 二氧化硅 | 5.65 | 0.50 |
| 硬脂酸 | 11.30 | 1.00 |
| 抗坏血酸棕榈酸酯 | 22.60 | 2.00 |
实施例6
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1031 | 91.24 |
| 微晶纤维素 | 53.80 | 4.76 |
| 二氧化硅 | 5.65 | 0.50 |
| 硬脂酸 | 11.30 | 1.00 |
| 抗坏血酸棕榈酸酯 | 28.25 | 2.50 |
实施例7
实施例8
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1031 | 91.24 |
| 微晶纤维素 | 67.93 | 6.01 |
| 二氧化硅 | 2.83 | 0.25 |
| 硬脂酸 | 16.95 | 1.50 |
| 抗坏血酸棕榈酸酯 | 11.30 | 1.00 |
实施例9(比较实施例)
| 组分 | g | wt-％ |
| 抗坏血酸(97％) | 1082.5 | 94.75 |
| 微晶纤维素 | 40.00 | 3.5 |
| 聚乙烯吡咯烷酮(PVP XL) | 14.00 | 1.23 |
| 硬脂酸镁 | 6.00 | 0.52 |
相比现有技术的一个优点在于，由上述公开的实施例压制的片剂比现有技术的片剂更加潮湿稳定和热稳定。
为此目的，实施例1和实施例9的组合物被用于压制片剂并且关于白度和黄度进行测试。
将片剂在开放式托盘中在40℃/75％RH(相对湿度)下储存7天。利用HunterLab色度计以WIE和YIE值测量片剂的颜色。7天后，视觉观察到现有技术制剂组成的片剂变成褐色，然而包含本发明制剂的片剂的白度没有降低那么多。
Claims (12)
1.粉末或颗粒形式的组合物，其包含：
(a)基于粉末或颗粒的总重量的75wt-％-99wt-％的L-抗坏血酸和/或其盐，
(b)基于粉末或颗粒的总重量的0.1wt-％-10wt-％的抗坏血酸棕榈酸酯或抗坏血酸棕榈酸酯和至少一种选自以下的化合物的混合物：氢化植物油、山嵛酸甘油酯、单硬脂酸甘油酯、棕榈酸硬脂酸甘油酯、硬脂酸、棕榈酸、肉豆蔻酸、滑石、月桂基硫酸钠、蜡、硬脂富马酸钠和聚乙二醇，以及
(c)基于粉末或颗粒的总重量的0.9wt-％-10wt-％的至少一种粘合剂，以及
(d)任选的辅料，其量在基于粉末或颗粒的总重量的0.05wt-％-5wt-％的范围内，前提是所述组合物基本上不含硬脂酸镁。
2.根据权利要求1的组合物，其中L-抗坏血酸的盐是抗坏血酸钠。
3.根据权利要求1或2的组合物，其中粘合剂选自糖类及其衍生物、蛋白质、合成的聚合物、微晶纤维素、硅化微晶纤维素、羟丙基纤维素、淀粉、乳糖、磷酸二钙、蔗糖、葡萄糖和糖醇。
4.根据权利要求1-3任意一项的组合物，其通过流化床造粒、高剪切造粒、挤出、喷雾干燥或湿造粒制成。
5.根据权利要求1-4任意一项的组合物在膳食补充剂、食品、饲料或个人护理制剂中的用途。
6.压缩片剂形式的根据权利要求1-4任意一项的组合物。
7.根据权利要求6的片剂，其中L-抗坏血酸和/或其盐的含量是基于片剂的总重量的80wt-％-99wt-％。
8.根据权利要求6和7的片剂，其中抗坏血酸棕榈酸酯的含量是基于片剂的总重量的0.3wt-％-5wt-％。
9.根据权利要求6-8任意一项的片剂，其中硬脂酸的含量是基于片剂的总重量的0.3wt-％-5wt-％。
10.根据权利要求6-9任意一项的片剂，其中粘合剂的含量是基于片剂的总重量的0.5wt-％-8wt-％。
11.根据权利要求1-6任意一项的组合物在膳食补充剂、食品、饲料或个人护理制剂中的用途。
12.包含根据权利要求1-6任意一项的组合物的食品、饲料或个人护理制剂。
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| CN105030690B (zh) * | 2015-07-08 | 2018-01-16 | 泰州市澳华生物科技有限公司 | 维生素c缓释颗粒剂及其生产方法 |
| CA2937365C (en) | 2016-03-29 | 2018-09-18 | F. Hoffmann-La Roche Ag | Granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone and method of making the same |
| JP6189567B1 (ja) * | 2017-05-16 | 2017-08-30 | 森永製菓株式会社 | タンパク質含有顆粒の製造方法 |
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- 2013-04-18 CN CN201810203487.1A patent/CN108434108A/zh active Pending
- 2013-04-18 PL PL13718828T patent/PL2838380T3/pl unknown
- 2013-04-18 TR TR2018/09996T patent/TR201809996T4/tr unknown
- 2013-04-18 EP EP13718828.0A patent/EP2838380B1/en active Active
- 2013-04-18 ES ES13718828.0T patent/ES2678620T3/es active Active
- 2013-04-18 CN CN201380020926.0A patent/CN104244738A/zh active Pending
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- 2013-04-18 KR KR1020147032377A patent/KR102121082B1/ko active IP Right Grant
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| Publication number | Publication date |
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| ES2678620T3 (es) | 2018-08-14 |
| PL2838380T3 (pl) | 2018-09-28 |
| WO2013156543A1 (en) | 2013-10-24 |
| KR102121082B1 (ko) | 2020-06-10 |
| EP2838380A1 (en) | 2015-02-25 |
| TR201809996T4 (tr) | 2018-08-27 |
| EP2838380B1 (en) | 2018-04-18 |
| US9216149B2 (en) | 2015-12-22 |
| JP2015519885A (ja) | 2015-07-16 |
| KR20140146662A (ko) | 2014-12-26 |
| CN108434108A (zh) | 2018-08-24 |
| US20150141503A1 (en) | 2015-05-21 |
| JP6322873B2 (ja) | 2018-05-16 |
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