CN1304006C - 化妆或皮肤用霜剂组合物、其制备和应用 - Google Patents
化妆或皮肤用霜剂组合物、其制备和应用 Download PDFInfo
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- CN1304006C CN1304006C CNB018115039A CN01811503A CN1304006C CN 1304006 C CN1304006 C CN 1304006C CN B018115039 A CNB018115039 A CN B018115039A CN 01811503 A CN01811503 A CN 01811503A CN 1304006 C CN1304006 C CN 1304006C
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- cream composition
- carnitine
- skin
- orotic acid
- vitamin
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
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Abstract
本发明涉及含有B13，即乳清酸和/或BT，即L-肉毒碱的霜剂组合物。本发明还涉及一种制备上述组合物的方法，其可以优选被注射到凝胶内，由此形成适宜具有不同颜色的串珠状球，它们可以用于皮肤目的。
Description
本发明涉及下面定义的提高活性成分的吸收作用并含有维生素BT(即肉毒碱)和B13(即乳清酸)的化妆或皮肤用霜剂组合物、其制备和应用。
肉毒碱衍生物本身或有关物质业已应用在皮肤用组合物和处理中。专利公报US 5,639,767、US 5,637,305和US 5,627,212涉及了此类处理的实例。专利公报将从L-肉毒碱的O-酯和芳香酸制备的医用化合物、L-肉毒碱的酸式壬二酸酯、L-肉毒碱的酯和酰基肉毒碱以及羟基羧酸应用在皮肤病，例如牛皮癣的治疗和化妆学用途中。在所有这些处理和使用方式中肉毒碱被结合或者成为化合物，而不是游离的肉毒碱。另一方面，从专利公报US 5,008,288得知当肉毒碱衍生物和磺基丙氨酸结合成药学活性化合物时用肉毒碱衍生物和磺基丙氨酸作为载体来转运这些化合物至机体内的预期位点，如四肢肌肉和心脏。虽然肉毒碱衍生物将药学活性剂传导至细胞内的性能业已公知，但用肉毒碱作为皮肤用霜剂组合物的活性成分的载体的用途不为人们所知。
乳清，尤其是初乳乳清，已经用作皮肤用产品(GB 2052979)。虽然提及乳清酸是含乳清饮料的重要营养物质，但人们不知道乳清酸作为皮肤用活性成分的重要性。乳清和尤其是初乳乳清的皮肤学效果业已可以从pH、乳酸菌、生长因子和维生素如B1、B2、B12、烟酸、泛酸、生物素(biothine)和叶酸的结果看出。
在皮肤用霜剂组合物中，重要的是发现了一种组合物，其具有有效的细胞保健促进作用并且具有细胞葆春作用。此外重要的是这种细胞条件促进活性成分被携带至靶细胞。
本发明描述了这样的有效组合物，其产生皮肤保健促进作用且同时有效迁移至靶细胞。本发明的霜剂组合物的特征、其制备和应用如权利要求书中所述。
图1公开了肉毒碱和酰基肉毒碱在脂肪酸向线粒体转移中的比例。
图2公开了乳清酸盐的形成反应和线粒体酶，即二氢-乳清酸脱氢酶对这个反应的贡献。
图3公开了凝胶中不同颜色的刺冠样霜剂组合物。
下面详细描述本发明。说明书和权利要求书中所用的术语与在皮肤病学、生物化学和皮肤用活性霜剂组合物的制备技术中常用的术语具有相同的意义，但本文中一些术语略有不同并且这些更加宽泛或解释不同的术语在下面准确解释：
“活性成分”是指化合物，其促进细胞的复原或恢复并且防止它们老化。
“吸收作用”是指活性成分从例如皮肤的表面穿过细胞膜和细胞器的侧壁进入该表面下细胞内的迁移作用。
“化妆”是指在美容学和卫生学中对健康皮肤使用的试剂和操作。化妆品试剂可以，例如在皮肤细胞方面帮助皮肤保持更长久的活力和弹性。
“皮肤用”是指用于治疗不同皮肤病(如牛皮癣和变应性皮疹)和皮肤损伤(如腿部溃疡)的药物或手术。皮肤用产品用于例如促进被损伤细胞的复原并且恢复弹性。
“霜剂组合物”是指除了常规基质霜剂组合物以外可以含有多种化妆品或皮肤用活性剂的组合物。所述的霜剂组合物业已公开在例如专利公报EP 577 516、EP 705 593和EP 716 849。
“基质霜剂组合物”是指其中可以加入必要的化合物来制备皮肤用或化妆霜剂组合物的霜剂组合物。疾病霜剂组合物含有皮肤用产品中常用的试验霜剂组合物。
“凝胶”是指油膏状组合物，但它不含有油脂。凝胶可以含有与含油脂霜剂组合物相同的活性成分和/或保护活性剂的化合物。凝胶可以含有例如透明质酸及其聚合物或甲基纤维素衍生物。
“维生素BT，即肉毒碱”是指一种药物，其将长链脂肪酸转运穿过线粒体的内膜以进行借助于β-氧化的能量生产(图1)。在本世纪初期就已发现了肉毒碱。肉毒碱的化学名称是3-羧基-2-羟基-N，N，N-三甲基-1-丙烷氢氧化铵并且其化学式是(CH3)3N+CH2CH-(OH)CH2COO-。名称维生素BT来自大黄粉虫；肉毒碱是该虫的生长因子。
“维生素B13，即乳清酸”是指乳清中存在的一种维生素。奶乳清，其在希腊称作“oros”(拉丁文是“serum lactis”)已经被用来生成乳清饮料数个世纪。只有牛乳含有乳清酸(约80mg/l)，其也被称作维生素B13。乳清酸是重要的应用成分(Sienkiewicz和Riedel，1990，Whey and whey utilization，Possibilities for utilization inagriculture and foodstuffs production，p.26-39，85-88，165-205，231-238，275-277，320-328，2版，Gelsenkirhen-Buer，Germany(1990).Verlag Th.Mann 379p.)，其几乎完全溶解在乳清中。
本发明的霜剂组合物当与现有已知组合物相比时具有显著的益处。L-肉毒碱和乳清酸的组合获得令人惊奇的协同作用。在霜剂组合物中用作活性成分的L-肉毒碱能够迁移穿过细胞膜和细胞器的侧壁并且帮助其他小分子的迁移作用，例如组合物中加入的乳清酸。乳清酸可以促进受损细胞的复原，这在皮肤细胞的情况中意味着使皮肤的生命力更长久且使不健康的皮肤快速复原并恢复弹性。
本发明是基于肉毒碱在线粒体中的作用及其穿过膜的迁移作用，如图1所示。在图1中(1)是指酰基-CoA-合酶，(2)是指外部肉毒碱酰基转移酶，(3)是指内部肉毒碱酰基转移酶，和(4)是指肉毒碱/酰基肉毒碱移位酶。在图1中缩写AMP是指三磷酸腺苷，缩写CoA是指辅酶A，缩写Ppi是指无机焦磷酸并且缩写RCOO-是指长链脂肪酸。
从鲎的肌肉和大鼠附睾液中可以分离和提纯出肉毒碱，已经证明在动物中它们具有最大的内毒碱含量。哺乳动物的心脏和骨骼肌中肉毒碱的含量最高。植物中肉毒碱很少。最常见的肉毒碱是乙烯基和异戊酰基肉毒碱。乙烯基和异戊酰基肉毒碱的大量出现是肉毒碱转运的分离或浓缩机理的一部分。在用本发明的霜剂组合物之前，乙酰基和异戊酰基肉毒碱已经被水解。最新的研究发现将肉毒碱转运穿过细胞膜并作用于膜的载体蛋白。发现肉毒碱向不同类型的细胞内的转运可以是主动转运和被动转运。
乳清酸是RNA-和DNA-嘧啶化合物两者生物合成的必需起始原料，并且因此在细胞的再生和作用中是非常核心的因子。乳清酸在细胞内从二氢乳清酸以这样的方式形成，氢原子从C-5和C-6位转移到烟酰胺腺嘌呤二核苷酸(NAD+)，从而导致双键的形成，由此生成乳清酸(图2)。该反应是由线粒体二氢乳清脱氢酶催化的。嘧啶类化合物的生物合成中的所有其他酶是胞质性的。
如果细胞的线粒体缺损或者其数量因老化或其他因素(例如霉菌毒素或其他环境毒素)降低，就无法形成必要量的乳清酸并且严重干扰细胞的作用，细胞将会死亡。
如果由于储备或线粒体的功能减弱导致细胞自身不再能够合成足够的乳清酸，这种缺乏可以被外来的乳清酸替代并且在正常情况中设法使受损细胞复原。在皮肤细胞的方面，这意味着皮肤保持更长的生命力，同时不健康皮肤复原且快速恢复弹性。肉毒碱因其特性在这里面发挥了乳清酸载体的作用。所以重要的是将这两种维生素以正确的比例和足够的浓度加入到霜剂组合物中但不损失组合物的其他重要特性。
用肝细胞培养物进行的试验证实，L-肉毒碱能够防止细胞死亡。该作用基于L-肉毒碱能够预防由电子转运抑制剂引起的线粒体膜的渗透性的改变的事实。同时，它还证实L-肉毒碱的作用不需要ATP，即能量并且它不会引起线粒体的膜电位的损失，即它不会改变膜电位。本发明霜剂组合物中含有的肉毒碱通过维持脱酰化作用和再酰化活性之间的平衡来保护细胞膜。虽然维生素BT和维生素B13含在本发明的霜剂组合物中，但它们是天然形式，即肉毒碱是纯L-形式，由此避免了D-和D，L-形式引起的不期望的作用。
本发明涉及一种提高活性成分吸收作用的化妆和皮肤用霜剂组合物，其在基质霜剂组合物内同时或分开含有维生素B13(即乳清酸)和/或BT(即L-肉毒碱)。轻霜剂型、水包油型乳液搅拌霜剂组合物可以含有花生油、肉豆蔻酸异丙酯、甘油、甘油一硬脂酸酯、甲基对羟基苯、丙基对羟基苯和约70％水。霜剂型、水包油型乳液疾病霜剂组合物可以含有甘油一硬脂酸酯、甘油、油酸的癸酯、肉豆蔻酸异丙酯、甲基对羟基苯、丙基对羟基苯和约70％水。一种油腻、软的、油包水型乳液基质霜剂组合物可以含有白蜂蜡、中性植物油、甘油、油酸的烷基酯、肉豆蔻酸异丙酯、甲基对羟基苯、丙基对羟基苯和水。
本发明的霜剂组合物含有共存和/或分开的维生素B13和/或BT使两者的浓度是1-10％。有效该霜剂组合物可以含有一定量的共存或分开的维生素B13和/或BT使其浓度相当于在组织和体液中的最大浓度。
本发明的霜剂组合物含有共存和/或分开的维生素B13和/或BT，使B13的浓度至少0.1％并且BT的浓度至少0.2％。
在本发明的霜剂组合物中B13和/或BT存在于同一霜剂组合物中或者存在于分开的霜剂组合物中，并且所述的霜剂组合物可以在同一包装内或在独立包装内。
在本发明的优选实施方式中，如图3所示，含有B13(1)和/或BT(2)的霜剂组合物分开成为串珠状排列的球，优选具有不同的颜色，它们是通过注射到同一带盖(5)包装或容器中的凝胶(1)内来制成。当霜剂组合物(1)和(2)被注射到凝胶(1)中其形成具有尽可能最小体积的霜剂组合物。注射针的痕迹像球之间的细线(4)。
本发明还涉及一种制备提高活性成分吸收作用的皮肤用霜剂组合物的方法，该方法通过把B13和/或BT加入到同一霜剂组合物中或者分开的霜剂组合物中，其含有皮肤用产品中常用的任选试剂。如果想提高产品的作用，该霜剂组合物可以浓缩肉毒碱BT和乳清酸B13。更加可取地，将含有B13(1)和/或BT(2)的颜色不同的霜剂组合物注射到带盖(5)包装的凝胶(1)内，例如罐或容器内。
而且，本发明涉及一种提高化妆或皮肤用霜剂组合物中的活性成分吸收作用方法，该方法通过使含有分开或共存B13和/或BT的霜剂组合物与被处理皮肤接触。
本发明涉及一种方法，其中将含有B13和/或BT的霜剂组合物同时或以最适合活性成分转运的顺序分开依次涂敷在皮肤或被处理皮肤区域。
本发明的霜剂组合物可以用作化妆产品来保持更长久的皮肤生命力或者用于皮肤病症的治疗中，优选例如特异性皮疹或大腿溃疡的治疗中。本发明的霜剂组合物也可以用作例如延缓皮肤老化和皱纹形成的产品，用于干性和被刺激皮肤、用于防晒、冷冻或风吹。
本发明的霜剂组合物适宜在被处理的区域连续使用。将该霜剂组合物根据需要每天一次涂敷在被处理的区域。在多数严重皮肤问题的情况中，可以将该霜剂组合物在一天内涂敷数次。所述维生素的浓度可以根据最终使用的需要来单独确定。
下面在实施例中举例说明本发明的用途，其不应该被视为限定本发明。所属领域技术人员显而易见的是本发明可以用于其它目的。
实施例1
在儿童特异性皮疹的治疗中在预备性试验中使用本发明的霜剂组合物。使用7天后皮肤恢复正常。该霜剂组合物的使用是连续的，每天将该霜剂组合物在皮肤上涂敷一次。
实施例2
在老年人出现的大腿溃疡的治疗中使用本发明的霜剂组合物。开始治疗4天后已经出现该霜剂组合物的溃疡复原作用。每天使用，每天在皮肤上涂敷2-3次。
Claims (5)
1.提高活性成分吸收作用的化妆和皮肤用霜剂组合物，其特征在于它在基质霜剂组合物中含有维生素B13，即乳清酸和BT，即L-肉毒碱，所述基质霜剂组合物含有皮肤用产品中常用的任选试剂。
2.按照权利要求1的霜剂组合物，其特征在于它在基质霜剂组合物中含有维生素B13，即乳清酸和BT，即L-肉毒碱，其含量使它们两者的浓度分别为1-10％。
3.提高活性成分吸收作用的化妆和皮肤用组合物，其特征在于它在基质霜剂组合物中含有维生素B13，即乳清酸和BT，即L-肉毒碱，所述基质霜剂组合物含有皮肤用产品中常用的任选试剂，并且B13，即乳清酸和BT，即L-肉毒碱在同一包装中的凝胶内分开的串珠状球。
4.一种制备提高活性成分吸收作用的皮肤用霜剂组合物的方法，其特征在于将维生素B13，即乳清酸和BT，即L-肉毒碱一起加入到同一基质霜剂组合物中，该基质霜剂组合物含有皮肤用产品中常用的任选试剂。
5.一种制备提高活性成分吸收作用的皮肤用霜剂组合物的方法，其特征在于将维生素B13，即乳清酸和BT，即L-肉毒碱一起加入到同一基质霜剂组合物中，该基质霜剂组合物含有皮肤用产品中常用的任选试剂，并且该含有B13，即乳清酸和BT，即L-肉毒碱的霜剂组合物被注射到一个包装中的凝胶内。
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| US4839159A (en) * | 1988-02-08 | 1989-06-13 | Topicarn, Inc. | Topical L-carnitine composition |
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| IT1261984B (it) * | 1993-06-22 | 1996-06-11 | Avantgarde Spa | Uso di esteri della l-carnitina o di acil l- carnitine con idrossiacidi per produrre composizioni farmaceutiche per il trattamento di affezioni cutanee. |
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| US3544684A (en) * | 1966-12-31 | 1970-12-01 | Arthur Scherm | Cosmetic composition containing uracil-4-carboxylic acid |
| US4839159A (en) * | 1988-02-08 | 1989-06-13 | Topicarn, Inc. | Topical L-carnitine composition |
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| ATE337776T1 (de) | 2006-09-15 |
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| FI20000956A (fi) | 2001-10-21 |
| DE60122701D1 (de) | 2006-10-12 |
| JP2003531159A (ja) | 2003-10-21 |
| AU2001256384A1 (en) | 2001-11-07 |
| EP1276459B1 (en) | 2006-08-30 |
| CN1437461A (zh) | 2003-08-20 |
| EP1276459A1 (en) | 2003-01-22 |
| FI111686B (fi) | 2003-09-15 |
| US20030171388A1 (en) | 2003-09-11 |
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