CN104302194A - 含水的无菌维生素制剂 - Google Patents
含水的无菌维生素制剂 Download PDFInfo
- Publication number
- CN104302194A CN104302194A CN201380023109.0A CN201380023109A CN104302194A CN 104302194 A CN104302194 A CN 104302194A CN 201380023109 A CN201380023109 A CN 201380023109A CN 104302194 A CN104302194 A CN 104302194A
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- CN
- China
- Prior art keywords
- cobastab
- vitamin
- preparation
- water soluble
- aqueous compositions
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 229930003231 vitamin Natural products 0.000 title claims abstract description 39
- 235000013343 vitamin Nutrition 0.000 title claims abstract description 39
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- 150000003722 vitamin derivatives Chemical class 0.000 title claims description 38
- 238000009472 formulation Methods 0.000 title abstract 2
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
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- DQOCFCZRZOAIBN-WZHZPDAFSA-L hydroxycobalamin Chemical compound O.[Co+2].[N-]([C@@H]1[C@H](CC(N)=O)[C@@]2(C)CCC(=O)NC[C@@H](C)OP([O-])(=O)O[C@H]3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)\C2=C(C)/C([C@H](C\2(C)C)CCC(N)=O)=N/C/2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O DQOCFCZRZOAIBN-WZHZPDAFSA-L 0.000 description 1
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- JEWJRMKHSMTXPP-BYFNXCQMSA-M methylcobalamin Chemical compound C[Co+]N([C@]1([H])[C@H](CC(N)=O)[C@]\2(CCC(=O)NC[C@H](C)OP(O)(=O)OC3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)C)C/2=C(C)\C([C@H](C/2(C)C)CCC(N)=O)=N\C\2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O JEWJRMKHSMTXPP-BYFNXCQMSA-M 0.000 description 1
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- KYMBYSLLVAOCFI-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SCN1CC1=CN=C(C)N=C1N KYMBYSLLVAOCFI-UHFFFAOYSA-N 0.000 description 1
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Classifications
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Abstract
本发明涉及包含水溶性维生素的无菌含水制剂的生产方法。这种制剂作为用于生产食品、饲料和个人护理品的预混合料是有用的。此外,本发明还涉及这种无菌含水制剂以及它们在生产经巴氏灭菌的食品、饲料或个人护理品中的用途。
Description
本发明涉及包含水溶性维生素的无菌含水制剂的生产方法。这种制剂作为生产食品、饲料和个人护理品的预混合料是有用的。此外,本发明还涉及这种无菌含水制剂以及它们在生产经巴氏灭菌的食品、饲料或个人护理品中的用途。
由本文中描述和要求保护的方法得到的含水且无菌的维生素制剂非常稳定(贮存稳定),其作为制备饲料、食品或个人护理品的预混合料(premix)十分有用。
富含维生素的产品分布广泛。大量应用领域中都能发现这类产品。维生素满足终端市场产品的不同目的,例如抗氧化效果和/或健康益处。
本发明涉及包含维生素C和至少一种其它水溶性维生素的制剂。
水溶性维生素易于溶解在水中。
重要的水溶性维生素为维生素B1(硫胺素)、维生素B2(核黄素)、维生素B3(烟酸、烟酰胺)、维生素B5(泛酸)、维生素B6(吡哆醇、吡哆胺、吡哆醛)、维生素B7(生物素)、维生素B9(叶酸、亚叶酸)、维生素B12(氰钴胺、羟钴胺、甲钴胺)和维生素C(抗坏血酸)。
所有的终端市场产品(即在例如杂货店销售的产品)必须贮存稳定,它们(尤其是食品)非常经常是经过巴氏灭菌的。在必要的巴氏灭菌步骤中,总是会损失一些成分(也包括水溶性维生素)的浓度。
由于这种不期望的副作用,必须要“过量加入(overdose)”未经巴氏灭菌的产品以使终产品中存在所需(和指示)量的水溶性维生素。
本发明的目标是找到在经巴氏灭菌产品的生产中如何避免维生素损失的方法,这允许减少所使用的水溶性维生素的量。
出乎意料地,已发现定义明确(well-defined)的包含水溶性维生素的含水无菌制剂能够被用作预混合料,其在巴氏灭菌后被加入到食品、饲料和/或个人产品中。
因此,本发明涉及无菌含水制剂的生产方法,其中所述含水制剂包含
(i)至少20g/L的维生素C,和
(ii)至少10g/L的至少一种其它水溶性维生素,和
(iii)水,并且其中
所述方法的特征在于,通过使用孔径≥0.22μm的过滤器过滤所述含水制剂。
本发明所述的含水制剂(=预混合料)是无菌的。这是通过利用无菌过滤实现的。在本发明的上下文中,术语无菌过滤指的是使用膜滤器的微量过滤(microfiltration)。膜滤器的孔径通常为0.22μm。这种膜的确有效地除去微生物,这使得含水制剂无菌。
膜滤器通常由例如混合酯纤维素(mixester cellulose)或聚醚砜(PES)的材料制成。过滤设备和过滤器本身可商购获得。
作为该过滤步骤的结果,过滤之后含水制剂中仅包含小于0.22μm的颗粒。
根据本发明的含水制剂包含至少20g/L的维生素C。优选地,根据本发明的含水制剂包含20g/L-50g/L的维生素C。
优选地,根据本发明的含水制剂包含至少30g/L-60g/L的至少一种其它水溶性维生素。
因此,本发明还涉及无菌含水制剂的生产方法,其中所述含水制剂包含
(i)20g/L-50g/L的维生素C,和
(ii)至少30g/L-60g/L的至少一种其它水溶性维生素,和
(iii)水,其中
所述方法的特征在于,通过使用孔径≥0.22μm的过滤器过滤所述含水制剂。
过滤步骤不影响水溶性维生素的浓度。过滤前和过滤后水溶性维生素的浓度基本相同。
无菌含水制剂还稳定贮存数月。
预混合料中每种水溶性维生素的含量可以取决于掺入所述预混合料的产品。
本发明的含水制剂包含水溶性维生素。含水制剂总是包含20g/L的维生素C和至少一种其它水溶性维生素。
优选地,根据本发明的含水制剂包含至少20g/L的维生素C和至少10g/L的至少一种选自维生素B1、维生素B2、维生素B3、维生素B5、维生素B6、维生素B7、维生素B9和维生素B12的水溶性维生素。
因此,本发明还涉及无菌含水制剂的生产方法,其中所述含水制剂包含
(i)至少20g/L的维生素C,和
(ii)至少10g/L的至少一种选自维生素B1、维生素B2、维生素B3、维生素B5、维生素B6、维生素B7、维生素B9和维生素B12的水溶性维生素,和
(iii)水,其中
所述方法的特征在于,通过使用孔径≥0.22mm的过滤器过滤所述的含水制剂。
根据本发明的含水制剂还可以包含其它成分。这些成分(=助剂)可以有益于含水无菌制剂的性能和/或有益于其中掺入了所述含水无菌制剂的食品、饲料和/或个人护理品的性能。
这些助剂可以是抗氧化剂、染料、脂溶性维生素、芳香剂、填充剂(例如蔗糖、麦芽糖糊精)和缓冲物。
为了保证制剂是(或者保持)无菌,应该在过滤步骤之前向无菌含水制剂中加入其它成分,或者如果在过滤步骤之后加入其它成分,那么其必须是无菌形式。
为了维持制剂的无菌性,优选地将上述无菌含水制剂填充并贮存在能够确保无菌的包装中。
显然,上述无菌含水制剂被制造之后可立即用于食品、饲料和/或个人护理品的生产。这种情况不需要贮存,因此也就不需要无菌包装。
然而,需要提供适合的生产环境以确保最终的食品、饲料和个人护理品无菌(或者满足期望产品的标准)。
利用所述方法获得的制剂也是本发明的一部分。对方法所描述的所有优选同样适用。
因此,本发明还涉及利用方法可得到的无菌含水制剂,其中通过使用孔径≥0.22μm的过滤器过滤包含以下的含水制剂:
(i)20g/L-50g/L的维生素C,和
(ii)至少30g/L-60g/L的至少一种其它水溶性维生素,和
(iii)水。
上述无菌含水制剂也不是现有技术中已知的那些。因此,本发明的另一实施方式是上述含水无菌制剂。
因此,本发明还涉及无菌含水制剂(I),其中所述制剂包含
(i)至少20g/L的维生素C,和
(ii)至少10g/L的至少一种其它水溶性维生素,和
(iii)水,其中
所述制剂仅包含粒径小于0.22μm的颗粒。
此外,本发明还涉及无菌含水制剂(II),其是包含20g/L-50g/L维生素C的制剂(I)。
此外,本发明还涉及无菌含水制剂(III),其是包含以下的制剂(I)和/或制剂(II):
(i)至少10g/L的至少一种选自维生素B1、维生素B2、维生素B3、维生素B5、维生素B6、维生素B7、维生素B9和维生素B12的水溶性维生素,和
(ii)至少20g/L的维生素C。
此外,本发明还涉及无菌含水制剂(IV),其是包含至少一种助剂的制剂(I)、(II)和/或(III)。
制剂(I)、(II)、(III)和(IV)被用作预混合料。这种预混合料被用于掺入食品、饲料和/或个人护理品中。
由于这些无菌含水制剂的性能(贮存稳定、无菌),它们在巴氏灭菌步骤后被加入(掺入)到产品中。
因此,本发明还涉及制剂(I)、(II)、(III)和/或(IV)在生产经巴氏灭菌的食品、饲料和/或个人护理品的方法中的用途,其特征在于所述制剂(I)、(II)、(III)和/或(IV)在巴氏灭菌后被加入至产品中。
生产方法可以根据所生产的食品、饲料和/或个人护理品而不同。
基本特征在于制剂(I)、(II)、(III)和/或(IV)总是在巴氏灭菌后加入。可以在加入制剂(I)、(II)、(III)和/或(IV)之后实施其它步骤。
还可需要多于一次的巴氏灭菌步骤,在这种方法中,制剂(I)、(II)、(III)和/或(IV)总是在最后的巴氏灭菌步骤之后加入。
优选地,制剂(I)、(II)、(III)和/或(IV)被掺入液体或凝胶样产品形式中。
这些液体产品可以是经巴氏灭菌的食品、饲料或个人产品。任何需要含有水溶性维生素和需要被巴氏灭菌的产品都可以被生产。
优选的经巴氏灭菌的产品是饮料(例如果汁)、乳制品(例如酸乳、乳饮料)。
因此,本发明还涉及通过生产食品、饲料或个人产品可得到的经巴氏灭菌的食品、饲料或个人产品,其中该过程至少实施一次巴氏灭菌步骤且其中在最后的巴氏灭菌步骤之后加入制剂(I)、(II)、(III)和/或(IV)。
实施例
实施例1
通过向1L去离子水中加入1430mg维生素B1、1705mg维生素B2、1480mg维生素B3、5760mg维生素B5、2070mg维生素B6、125mg维生素B7、850mg维生素B12和22520mg维生素C来生产含水制剂。
搅拌溶液直至获得均一溶液。之后,使用膜尺寸为0.2μm的过滤器过滤溶液。
得到了无菌含水制剂。
包装制剂并在室温下贮存6个月。
6个月后,无菌含水制剂具有下述的水溶性维生素含量:1368mg维生素B1、1533mg维生素B2、1201mg维生素B3、5170mg维生素B5、2034mg维生素B6、116mg维生素B7、444mg维生素B12和19930mg维生素C。
实施例2
通过如下生产含水制剂:首先向1L水中混合下述水溶性维生素(干燥形式):24g维生素B1、36.3g维生素B2、21.6g维生素B3、66.6g维生素B5、34.1g维生素B6、168.6g维生素B7、12g维生素B12和533g维生素C。
此外加入168.66g蔗糖。
将62.5g干燥的混合物溶解在1L去离子水中,之后通过孔径为0.2μm的膜滤器过滤。
得到了无菌含水制剂。
向经巴氏灭菌的果汁(橙汁)中加入2.0g这种无菌含水溶液。市售的基础橙汁(orange juice base)被用于这种目的。
实施例3
使用与实施例2相同的步骤生产经巴氏灭菌的橙汁,其具有下述的水溶性维生素含量:2.51mg/L维生素B1、1.75mg/L维生素B2、2.80mg/L维生素B3、8.9mg/L维生素B5、3.37mg/L维生素B6、240μg/L维生素B7、1.90μg/L维生素B12和295mg/L维生素C。
将果汁(在果汁容器中)贮存1个月,然后再次检测水溶性维生素的含量:2.40mg/L维生素B1、1.80mg/L维生素B2、2.75mg/L维生素B3、10.9mg/L维生素B5、3.21mg/L维生素B6、200μg/L维生素B7、1.890μg/L维生素B12和283mg/L维生素C。
可见包含本发明所述制剂的橙汁非常稳定。
Claims (11)
1.用于生产无菌含水制剂的方法,其中所述含水制剂包含
(i)至少20g/L的维生素C,和
(ii)至少10g/L的至少一种其它水溶性维生素,和
(iii)水,其中
所述方法的特征在于,通过使用孔径≥0.22μm的过滤器过滤所述含水制剂。
2.根据权利要求1所述的方法,其中所述含水制剂包含20g/L-50g/L的维生素C。
3.根据前述权利要求中任一项所述的方法,其中所述含水制剂包含至少30g/L-60g/L的至少一种其它水溶性维生素。
4.根据前述权利要求中任一项所述的方法,其中所述含水制剂包含至少20g/L的维生素C和至少10g/L的至少一种选自维生素B1、维生素B2、维生素B3、维生素B5、维生素B6、维生素B7、维生素B9和维生素B12的水溶性维生素。
5.根据前述权利要求中任一项所述的方法,其中所述含水制剂包含其它成分。
6.无菌含水制剂,其中所述制剂包含
(i)至少20g/L的维生素C,和
(ii)至少10g/L的至少一种其它水溶性维生素,和
(iii)水,其中
所述制剂仅包含粒径小于0.22μm的颗粒。
7.根据权利要求6所述的制剂,其中所述制剂包含20g/L-50g/L的维生素C。
8.根据权利要求6或权利要求7所述的制剂,其中所述制剂包含至少10g/L的至少一种选自维生素B1、维生素B2、维生素B3、维生素B5、维生素B6、维生素B7、维生素B9和维生素B12的水溶性维生素,以及至少20g/L的维生素C。
9.根据权利要求6、权利要求7或权利要求8所述的制剂,其中所述制剂包含至少一种助剂。
10.权利要求6-9中任一项所述的制剂在生产经巴氏灭菌的食品、饲料和/或个人护理品的方法中的用途,其中所述制剂在巴氏灭菌之后被加入到产品中。
11.包含权利要求6-9中任一项所述的制剂的经巴氏灭菌的食品、饲料或个人产品。
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CN101780100B (zh) * | 2010-02-10 | 2011-12-21 | 北京国仁堂医药科技发展有限公司 | 一种注射用水溶性维生素组合物及其制备方法 |
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- 2013-05-02 KR KR1020147030604A patent/KR20150005946A/ko not_active Application Discontinuation
- 2013-05-02 JP JP2015509434A patent/JP2015518377A/ja active Pending
- 2013-05-02 EA EA201401198A patent/EA029207B1/ru not_active IP Right Cessation
- 2013-05-02 US US14/396,649 patent/US20150086676A1/en not_active Abandoned
- 2013-05-02 CN CN201380023109.0A patent/CN104302194A/zh active Pending
- 2013-05-02 WO PCT/EP2013/059087 patent/WO2013164382A1/en active Application Filing
- 2013-05-02 AU AU2013255887A patent/AU2013255887B2/en not_active Ceased
- 2013-05-02 EP EP13724180.8A patent/EP2844084A1/en not_active Withdrawn
- 2013-05-02 BR BR112014027388A patent/BR112014027388A2/pt not_active IP Right Cessation
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CN111511220A (zh) * | 2017-12-25 | 2020-08-07 | 好侍健康食品株式会社 | 维生素b族化合物的稳定性优异的含有维生素b族化合物的酸性组合物 |
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Publication number | Publication date |
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EA201401198A1 (ru) | 2015-04-30 |
KR20150005946A (ko) | 2015-01-15 |
BR112014027388A2 (pt) | 2017-06-27 |
EA029207B1 (ru) | 2018-02-28 |
EP2844084A1 (en) | 2015-03-11 |
JP2015518377A (ja) | 2015-07-02 |
AU2013255887A1 (en) | 2014-11-13 |
AU2013255887B2 (en) | 2017-03-23 |
US20150086676A1 (en) | 2015-03-26 |
WO2013164382A1 (en) | 2013-11-07 |
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