CN1212847C - 含有维生素b系列的改进的眼科和隐型眼镜用溶液 - Google Patents

含有维生素b系列的改进的眼科和隐型眼镜用溶液 Download PDF

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CN1212847C
CN1212847C CNB01821813XA CN01821813A CN1212847C CN 1212847 C CN1212847 C CN 1212847C CN B01821813X A CNB01821813X A CN B01821813XA CN 01821813 A CN01821813 A CN 01821813A CN 1212847 C CN1212847 C CN 1212847C
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弗朗西斯·泽维尔·史密斯
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Abstract

本发明涉及到改进的眼科用溶液，内含维生素B、吡哆素及其盐、硫胺素及其盐以增强溶液的防腐效果，并减少阳离子型防腐剂在隐形眼镜上的沉积。眼科用溶液在此可理解为包括隐型眼镜护理溶液，如清洁、浸泡、调节、储藏和润湿溶液以及眼睛护理用的溶液。

Description

含有维生素B系列的改进的眼科和隐型眼镜用溶液
本申请要求于2000年11月8日提交的美国临时专利申请No.60/246,689、No.60/246,707、No.60/246,708和No.60/246,709的权益。
技术领域
本发明涉及到眼科用溶液及其用途，尤其是涉及到隐形眼镜清洁溶液、隐形眼镜漂洗溶液和保藏溶液、将活性药物释放到眼睛的溶液、眼科器具及类似物品的消毒溶液。
背景技术
本发明涉及到眼科用溶液，尤其是有关在长期使用后防腐效果和舒适性方面的内容。这些眼科用溶液已经使用了一定时间，并且可以从许多产品中得到。这些溶液使用时会直接与角膜组织接触，如将活性药物成分释入眼睛；或间接地与角膜组织接触，比如清洁、调节或保藏有待与角膜组织接触的器具如隐形眼镜。很有必要确保这些溶液不引入细菌或其它微生物感染源。因而，在这些溶液中加入防腐剂，以降低溶液中微生物的活性，从而减少使用者造成溶液污染的机会，因为许多溶液被购买、打开、使用、密封和再使用。
目前工艺水平的防腐剂，包括聚亚己基双胍(PHMB)、polyquadtm、洗必泰和洁尔灭及类似物质，这些物质在一定浓度下会刺激角膜组织，引起使用者不舒服的感觉。因而，在含有一定量防腐剂的溶液中加入一种非防腐剂成分，从而提高溶液防腐性能是很有必要的。
发明内容
本发明涉及到改进的眼科用溶液，内含维生素B、吡哆素及其盐、硫胺素及其盐以增强溶液的防腐效果，并减少阳离子型防腐剂在隐形眼镜上的沉积。眼科用溶液在此可理解为包括隐型眼镜护理溶液，如清洁、浸泡、调节、储藏和润湿溶液以及眼睛护理用的溶液。
本发明所述溶液中含有0.001-1％的维生素B类物质、吡哆素及其盐、硫胺素及其盐，它们与眼科用溶液的其它活性组分复合使用。这些组分包括张力剂、缓冲试剂、防腐剂、表面活性剂和抗微生物制剂。
维生素B家族中包括硫胺素(VB1)、核黄素(VB2)、尼克酸(VB3)、泛酸(VB5)、吡哆素(VB6)和氰钴胺素(VB12)。虽然每种维生素B都有明确的化学结构，但都来源于同样的营养源，因而当缺乏某种成分时，别的成分也会缺乏。从代谢角度讲，它们会共同作用于代谢系统，增强免疫力和神经系统功能，保持皮肤健康和肌肉弹性、促进细胞生长和分化。它们还可以减缓压力，减轻心血管疾病。缺乏某种维生素B常意味着所有维生素B成分的低攝入量，这就是为什么维生素B作为一营养源，常是以复合维生素或复合维生素B来提供的。
尼克酸对于人的身体活动贡献很大。在维生素B中，尼克酸有助于将食物转化为能量、生成血红细胞、合成激素、脂肪酸和类固醇。人体活动时利用尼克酸将碳水化合物转化为能量。人体还需要尼克酸来将碳水化合物转换成脂肪，生成醇类物质。尼克酸还有助于调节胆固醇。
吡哆素用于合成5-羟色胺、褪黑素和多巴胺。维生素B6在调节人精神情绪方面是必需的营养素，很可能在人的情绪活动及许多健康方面有协助作用。
氰钴胺素对正常的神经细胞活动是必需的。人体还需要维生素B12用于DNA复制，生成与情绪活动相关的叫做SAMe(S-腺苷-L-甲硫氨酸)的物质。维生素B12与叶酸作用可以控制高半胱氨酸水平。高半胱氨酸是一种氨基酸(蛋白质生成阻断剂)，过量的高半胱氨酸能增加人发生心脏病、中风、骨质疏松症和阿尔茨海默氏综合症的风险。
其它化合物如叶酸或叶酸盐在与维生素B类物质复合作用时也是有生理活性的，如在DNA合成中是必需的物质。DNA是细胞正常复制的物质基础。当一个女人怀孕时，叶酸对于胚胎细胞尤为重要。叶酸在人体合成SAMe时是必需的，并且能保持血液中高半胱氨酸的水平，避免其升高。叶酸本身在人体哺乳器官中没有活性，但可以通过酶催化作用降解成四氰叶酸(THFA)，成为辅酶。维生素B12和叶酸盐代谢产物包括维生素B6的内在关系是：叶酸辅酶参与大量的代谢反应，这些反应中有一种一碳单位传递物。
泛酸有时被称为辅酶A，具有生理活性，作为辅酶，在代谢过程中扮演着重要角色，参与许多涉及乙酰基(二碳)集团转移的酶催化反应。令人惊奇的是，泛酸对于各种微生物的生长也是必需的，包括许多致病菌菌株。
在隐形眼镜漂洗溶液和/或眼药水中，溶液还包含有重量比为0.0001-1.0％某种维生素B或是某种维生素B代谢产物，可以从一组化合物中选取：硫胺素(VB1)、核黄素(VB2)、尼克酸(VB3)、泛酸(VB5)、吡哆素(VB6)和氰钴胺素(VB12)、叶酸和肉(毒)碱。
特别有用的防腐剂包括阳离子型防腐剂如聚亚己基双胍(PHMB)，polyquadtm、洗必泰和洁尔灭以及其它在本发明中也证明有用的阳离子型防腐剂。阳离子型防腐剂的加入量应保障其有防腐作用，如PHM的用量按重量比为0.0001％到0.01％。
研究发现，当肌醇与阳离子型防腐剂合用时，溶液会有出人意料的防腐效果。溶液中其它组分的加入量在正常水平，用以提高镜片的耐磨性，在直接用于眼睛时用来增加抗感染性。在一定的组方中，肌醇和其它单糖类能增强眼科用溶液的防腐功效，增加眼角膜组织的抗感染性，并且在一定组方中能改善滴眼液的质量。
这些组方中也可以有缓冲试剂如磷酸盐、碳酸氢盐、柠檬酸盐、硼酸盐，N-(2-乙酰氨基)-2-氨基乙磺酸(ACES)、N，N-双(2-羟乙基)-2-氨基乙磺酸(BES)、N，N-双(2-羟乙基)氨基乙酸(BICINE)、2，2-双(羟甲基)-2，2，2-次氨基三乙醇胺(BIS-Tris)、1，3-双(三(羟甲基)甲氨基)丙烷(BIS-TrisPropane)、2-(4-(2-羟乙基)-1-哌嗪基)乙磺酸(HEPES)、N-(2-羟乙基)哌嗪-N’-3-丙磺酸(HEPPS)、咪唑、2-(N-吗啉)乙磺酸(MES)、3-(N-吗啉)丙磺酸(MOPS)、哌嗪-1，4-双(2-乙磺酸)(PIPES)、N-三(羟乙基)甲基-3-氨基丙磺酸(TAPS)、N-三(羟乙基)甲基-2-氨基乙磺酸(TES)和三羟甲基甲基甘氨酸(Tricine)。
组方中也可加入表面活性剂如聚山梨醇酯表面活性剂、聚氧乙烯表面活性剂、膦酸酯、皂角苷和聚乙氧基蓖麻油，但最好是聚乙氧基蓖麻油。这些表面活性剂都是工业用品。聚乙氧基蓖麻油购买的是BASF公司的商标为Cremaphor的产品。
本发明的溶液中可以包含其它添加剂，包括但不限于比如缓冲试剂、张力剂、润湿剂、润药、防腐剂、螯合剂、表面活性剂和酶等。
同时，溶液中可以添加其它方面的试剂，包括0.001-1％重量比的螯合剂(最好是EDTA二钠)，和/或抗微生物剂，(最好是0.00001-0.1％或0.00001-0.01％)重量比的聚亚己基双胍、N-烷基-2-吡咯烷酮、洗必泰、聚季铵盐-1、六氢嘧啶(取代)(hexetidine)、2-溴-2-硝基-1，3-丙二醇、1，1’-亚己基-二(5-[2-乙基己基]双胍)、低浓度的过氧化氢和其它对眼睛无伤害的盐类。
本发明中有用的眼科允许的螯合剂包括氨基羧酸类化合物或其形成的水溶盐，它们有乙二胺四醋酸、次氮基三醋酸、二乙基三乙胺五醋酸、羟乙基乙二胺三醋酸、1，2-二氨基环己基四醋酸、乙二醇双乙胺醚-N，N’-四乙酸(EGTA)、氨基二醋酸和羟乙基氨基二醋酸。这些酸可以以水溶性盐，尤其是碱金属盐的形式使用。特别指出的是，乙二胺四醋酸(EDTA)的二钠、三钠和四钠盐作为螯合剂效果较好，最好是EDTA二钠。
其它螯合有剂如柠檬酸盐、多聚磷酸盐也可以在本发明中使用。本发明中可使用的柠檬酸盐包括柠檬酸及其单、双和三碱金属盐。使用的多聚磷酸盐包括焦磷酸盐、三聚磷酸盐、四聚磷酸盐、三聚偏磷酸盐、四聚偏磷酸盐以及更高聚合度的磷酸盐。这些磷酸盐都以中性或酸性碱金属盐形式加入，比如钠盐、钾盐和铵盐。
溶液的pH应当调节到与眼睛和隐形眼镜相适应的范围，比如6.0和8.0之间，最好是6.8到7.8或7.0到7.6。偏离中性(pH 7.3)较大的溶液会引起某些隐形眼镜的物理参数(如直径)的改变；较低的pH(＜5.5)会导致眼睛灼伤和刺痛；而很低或很高的pH(＜3.0或＞10)能引起视觉损伤。
本发明中添加的防腐剂是已知的，例如有聚亚己基双胍、N-烷基-2-吡咯烷酮、洗必泰、1，1’-亚己基-二(5-[2-乙基己基]双胍)、聚季铵盐-1、六氢嘧啶(取代)(hexetidine)、2-溴-2-硝基-1，3-丙二醇和很低浓度(例如30-200ppm)的双氧水。
本发明溶液在贮藏、清洗、浸湿、浸泡、漂洗和消毒时与渗透性刚性气体和亲水性隐形眼镜是相适应的。
本发明的一个典型的水溶液中可以添加某些组分，它们不影响上面所提到的活性成分的基本特征和新颖特点。例如张力剂、表面活性剂和增稠剂。它们有助于清洗隐形眼镜，或能润滑眼睛。合适的张力剂包括氯化钠、氯化钾、甘油或其混合物。溶液的张力剂一般按每公斤溶液大约240-310毫渗透分子(mOsm/kg)的量进行调节，用以保障溶液与视觉组织和亲水性隐形眼镜相适应。在一个具体例子中，溶液中含有0.01-0.2％重量比的氯化钠。重要的因素是保证这些添加剂的浓度达到不会提供大于约0.2％摩尔氯化钠的浓度的程度。
合适的增稠剂可包括卵膦脂或纤维素衍生物，比如羟甲基纤维素、羟丙基纤维素和甲基纤维素。其加入量与上面提到的表面活性剂用量相似。
具体实施方式
例1
                          吡哆素
本组方中含有吡哆素盐酸盐(Spectrum公司)和硫胺素盐酸盐(Fisher公司)，将它们溶于0.2％的磷酸缓冲溶液，溶液用氯化钠制成等渗透压溶液，并用0.0001％聚亚己基双胍防腐。用1N氢氧化钠或1N盐酸将溶液pH调节至7.2。溶液抗菌活性的检测方法是：将白色棒状杆菌(C.albicans)接入10ml各种溶液，并在室温下放置4小时，然后将每种溶液等分地进行系列稀释，涂布于琼脂平板上，在更高的温度下培养48小时。培养期结束后，检测各平板上生长的菌落数。通过与培菌液对照样比较确定对数下降值。下表给出了试验研究结果：
添加剂     4小时对数下降值
吡哆素盐酸盐(0.5％)     2.0
缓冲溶液对照样     0.8
与缓冲溶液对照样相比较，含有吡哆素盐酸盐和硫胺素盐酸盐的溶液抗菌(C.albicans)活性更强。
2.专利：扩展的硫胺素和吡哆素(B类维生素和B类维生素前体)
例2
                   含有D-泛酸的组方
本组方中含有D-泛酸，将其溶于0.2％的磷酸缓冲溶液中，溶液用氯化钠制成等渗透压溶液，并用0.0001％聚亚己基双胍防腐。用1N氢氧化钠或1N盐酸将溶液pH调节至7.2。溶液抗菌活性的检测方法是：将白色棒状杆菌(C.albicans)接入10ml各种溶液，并在室温下放置4小时，然后将每种溶液等分地进行系列稀释，涂布于琼脂平板上，在更高的温度下培养48小时。培养期结束后，检测各平板上生长的菌落数。通过与培菌液对照样比较确定对数下降值。下表给出了(试管)试验研究结果：
  对数下降值   缓冲试剂   防腐剂   电解质   添加剂
  2.16   无   PHMB 0.0001％   无   无
  3.41   Bis-tris propane0.2％   PHM 0.0001％   无   D-泛酸
数据显示，添加了D-泛酸的溶液比单独使用一种防腐剂的溶液防腐效果更好。

Claims (6)

1、一种隐形眼镜用溶液，含有重量比为0.5％的防腐增强剂吡哆素盐酸盐和重量比为0.0001％的阳离子型聚合物防腐剂聚亚乙基双胍。
2、如权利要求1的隐形眼镜用溶液，其特征是，进一步含有一种生理适应性的缓冲试剂，该缓冲试剂可以从一组化合物中选取：磷酸盐、碳酸氢盐、柠檬酸盐、硼酸盐、N-(2-乙酰氨基)-2-氨基乙磺酸、N，N-双(2-羟乙基)-2-氨基乙磺酸、N，N-双(2-羟乙基)氨基乙酸、2，2-双(羟甲基)-2，2，2-次氨基三乙醇胺、1，3-双(三(羟甲基)甲氨基)丙烷、2-(4-(2-羟乙基)-1-哌嗪基)乙磺酸、N-(2-羟乙基)哌嗪-N’-3-丙磺酸、咪唑、2-(N-吗啉)乙磺酸、3-(N-吗啉)丙磺酸、哌嗪-1，4-双(2-乙磺酸)、N-三(羟乙基)甲基-3-氨基丙磺酸、N-三(羟乙基)甲基-2-氨基乙磺酸和三羟甲基甲基甘氨酸。
3、如权利要求1的隐形眼镜用溶液，其特征是，进一步包含有0.01-5.0％的甘油。
4、如权利要求1的隐形眼镜用溶液，其特征是，进一步包含有0.01-2.0％的癸二酸。
5、如权利要求1的隐形眼镜用溶液，其特征是，进一步包含有一种润湿剂，可从一组化合物中选取：聚山梨醇酯表面活性剂、聚氧乙烯表面活性剂、膦酸酯、皂角苷和聚乙氧基酯蓖麻油。
6、如权利要求1的隐形眼镜用溶液，其特征是，进一步包含有一种螯合剂，可从一组化合物中选取：乙二胺四醋酸、膦酸酯柠檬酸盐、葡糖酸盐和酒石酸盐。
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