CN1777406A - 填充了药液的塑料安瓶及其制造方法 - Google Patents
填充了药液的塑料安瓶及其制造方法 Download PDFInfo
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- CN1777406A CN1777406A CN 200480010684 CN200480010684A CN1777406A CN 1777406 A CN1777406 A CN 1777406A CN 200480010684 CN200480010684 CN 200480010684 CN 200480010684 A CN200480010684 A CN 200480010684A CN 1777406 A CN1777406 A CN 1777406A
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Abstract
本发明提供一种具有对气体、水蒸汽、光线的阻隔性和药物透过、吸收、吸附防止功能的填充药液的塑料安瓶及其制备方法。本发明的填充药液用的塑料安瓶10包括容器主体部分11、封闭其开口部位12的熔合部分13和连在其上的扭断用的把持部分14。该安瓶10是使用带有2个以上的层的型坯来形成的,其中至少1个层是具有选自防止气体透过、防止水蒸汽透过、防止光线透过、防止药物透过和防止药物吸收、吸附的至少1种特性的功能性层。即,从多层吹型模具挤出该型坯,在用下方可分模夹住形成容器主体部分11,在其中填充药液15后,用上方可分模夹住开口部位12,制成熔合部分13和把持部分14,从而制得本发明的产品。
Description
技术领域
本发明涉及一种塑料制的预先填充了药液的安瓶。更详细的,涉及一种可以防止水蒸汽、水蒸汽以外的气体、光线或药物(药剂、药液、它们的溶剂等)向安瓶内部浸入或向安瓶外部浸出,或者能防止在安瓶内容纳的药剂、药液、溶剂等向安瓶内表面吸收、吸附的填充药液的塑料安瓶及其制造方法。
背景技术
目前,容纳药液的安瓶大多是用玻璃制的。但是玻璃安瓶在容纳的药液pH高时会引起碱性薄片溶解的问题。而且,还有在开封安瓶时手指容易被割伤的问题,和安瓶破损的危险性、开封时产生的碎片混入药液中的危险性等问题。进而,在玻璃安瓶中所含的铝溶解在药液中的危险性也出现在美国食品医药品局(FDA)的警告中。因此,近年来不断用没有上述危险性的塑料制的安瓶来取而代之。
形成安瓶的塑料一般使用有柔软性、且确认安全的聚乙烯(PE)、聚丙烯(PP)等聚烯烃。PE和PP是对酸性和碱性药物非常稳定的材料,但是因为其对氧气、空气、二氧化碳等的吸收、透过性非常高,不适合作为容纳易氧化的药剂、药液的安瓶的形成材料。特别是在小容量的安瓶的情况下,因为伴随水分的透过内容量会减少,会产生药液浓度显著增大的问题。
因此,对于输液袋等薄膜成形制品和输液瓶等吹塑成形制品的成形材料,正在进行各种研究来采用赋予防止气体和水蒸汽透过容器中的能力(阻隔性)的多层体(叠层体)。
塑料的叠层体在薄膜和薄板的制造时广泛采用,但是因为在安瓶的制造中使用薄膜或薄板是不合适的,在安瓶的制造中必然要采用吹塑成形。
根据吹塑成形形成的安瓶记载于专利第2914826号公报和特开昭60-24844号公报。前者记载的安瓶(卫生品用容器)是使用聚环烯烃吹塑成形的制品,后者记载的安瓶(封入注射药剂用的容器)是具有由乙烯-醋酸乙烯酯共聚物(EVA)的皂化产物等制得的防气层作为中间层的制品。
但是,这些文献中只不过记载了仅通过吹塑成形形成安瓶的主题。而且,这些文献中安瓶的密封是通过在注入药液或投入药剂后,用不产生接合的热封来封闭该开口部位,这样来完成密封。这种情况下,会有在形成热封部分时伴随加热多层结构被破坏的担心,其结果会有采用聚环烯烃和EVA的多层结构时伴随而来的防止气体透过等作用、效果受到损害的担心。
另一方面,作为填充药液的塑料安瓶的其他制造方法能列举有所谓的吹塑、填充、封口法(参照特开昭33-8078号公报,特公昭36-5985号公报,rommelag公司的主页“Welcome to rommelag(R),”“BTS Process-The bottelpack(R)Process”,“2003年3月19日的检索”,互联网<URL;http://www.rommelag.com/>)。
吹塑、填充、封口法是通过用主模夹住筒状的熔融塑料型坯来形成安瓶本身,接着填充药液后,用头模连续进行安瓶头部的形成和密封,因为安瓶的成形、药液的填充、安瓶的密封是连续进行的,不仅和只用吹塑成形法相比是大不相同的方法,而且可以进一步实现无菌的药液注入,具有可以大量生产的优点。
但是,通过吹塑、填充、封口法制造的安瓶公知的是由PE和PP等聚烯烃制备的单层体。因而,现有情况是对于通过吹塑、填充、封口法制造多层结构的安瓶,以及形成该叠层结构的1层对于气体、水蒸汽、光线和药物的防止透过的能力(阻隔性)和对药物的吸收吸附的防止能力都没有任何的相关研究(参照特公昭33-8078号公报、特公昭36-5985号公报、前述的rommelag公司的主页、mutual公司的主页(“包装设备-容器成形无菌填充系统”、“2003年3月19日检索”、互联网<URL;http://www.mutual.co.jp>)、日新制药公司的主页(“聚乙烯瓶”、“2003年3月19日检索”、互联网<URL;http://www.yg-nissin.co.jp/BFS.htm>))。
为了赋予对气体、水蒸汽、光线和药物的防止透过(阻隔性)、对药物吸收吸附的防止能力,考虑有例如在具有耐气体透过性的袋中容纳保存安瓶,或用具有防止光线透过能力(光线阻隔性)的材料覆盖安瓶表面,或进行外包装的方法。但是这些方法必须分开使用容纳袋和覆盖表面的材料,因而制造步骤变得复杂,会有制造成本上升等问题。
发明内容
本发明的目的在于提供能防止水蒸汽、水蒸汽以外的气体、光线或药物向安瓶内部浸入或向安瓶外部浸出,或者在安瓶内容纳的药剂、药液、溶剂等向安瓶内表面的吸收吸附的药液填充塑料安瓶及其制造方法。
为了解决上述课题,本发明的填充药液塑料安瓶的特征如下,其具有柔软性的容器主体部分、封闭该容器主体部分的开口部位的熔合部分和连在该熔合部分上扭断熔合部分用的把持部分,上述容器主体部分、熔合部分和把持部分是用具有2层或以上的筒状型坯一体成形制得的,上述容器主体部分是用可分模夹住上述型坯成形,在其内部填充药液,然后封闭开口部位来制得的,并且上述型坯的至少1层为具有选自防止气体透过、防止水蒸汽透过、防止光线透过、防止药物透过和防止药物吸收吸附的能力的至少1种特性的功能性层。
根据上述填充药液的塑料安瓶,因为在安瓶的制造中采用吹塑、填充、封口法,可以在无菌条件下实现药液的注入、密封。另外,上述本发明的填充药液用塑料安瓶与通过向吹塑成形形成的中空的安瓶中填充药剂后,以不产生接合的方式熔合开口部位来制备的产品(参照专利第2914826号公报或特开昭60-24844号公报中的记载)不同,在开口部位的熔合处,不会有层构成受到破坏的担心。因此,本发明的填充药液塑料安瓶还可以充分发挥安瓶成形后所期望的特性(气体阻隔性等)。
本发明的功能性层所要求的特性可列举有防止气体透过(气体阻隔性)、防止水蒸汽透过(水蒸汽阻隔性)、防止光线透过(光线阻隔性)、防止药物透过(药物阻隔性)和防止药物吸收吸附的能力。这些特性如下所述根据作为型坯中功能性层使用的部分中的塑料材料和其配混剂的种类来决定。
另外,在特开2001-70399号公报中记载了可以扭断把持部分来开封的填充药液的塑料安瓶,进而记载了该安瓶可以用吹塑、填充、封口法制造的主题和可以根据需要多层化、或赋予其遮光性的主题(段[0007]、[0012])。但是,该公报中对关于多层化型坯本身,或通过在型坯中混合具有上述功能的材料制得的层而赋予安瓶整体期望的阻隔性没有任何具体的记载和建议。
本发明的填充药液塑料安瓶在其成形中所用的型坯的最内层优选通过含有聚烯烃或聚环烯烃的树脂来形成。
通过用含有聚烯烃或聚环烯烃的树脂作为型坯的最内层,填充药液用塑料安瓶的最内层也可以是使用含有聚烯烃或聚环烯烃的树脂制得的层。聚烯烃和聚环烯烃是稳定的、安全性得到确认的材料,因而在其最内层设置聚烯烃或聚环烯烃制得的填充药液用塑料安瓶适合用作医疗用容器。
本发明的填充药液用塑料安瓶,其成形中使用的型坯是除了最内层至少有1层是混合了选自着色剂、紫外线吸收剂和氧吸收剂的至少1种药剂制得的层,并且比该层更内侧的层优选是具有防止药物透过能力的层。
将除了型坯最内层的至少1层制成混合着色剂和/或紫外线吸收剂来形成的层,由此可以赋予填充药液用塑料安瓶以防止光线透过能力(光线阻隔性,具体来说是对光、紫外线等的阻隔性)。而且,通过将除了型坯最内层的至少1层制成混合氧吸收剂来形成的层,由此能赋予填充药液用塑料安瓶以防止氧气透过能力(氧气阻隔性)。
混合了着色剂、紫外线吸收剂或氧吸收剂制得的层在和药液等直接接触时会有其内部所含的着色剂等溶出的担心。但是,根据上述的填充药液塑料安瓶,因为在混合了着色剂等的层内侧设置了具有防止药物透过能力的层,可以防止产生着色剂等溶解在安瓶容纳的药液中这样的问题。
作为在混合了上述着色剂等的层内侧设置的、具有防止药物透过能力的层能列举有后述的多元醇层、聚酯层和聚环烯烃层。
本发明的填充药液用塑料安瓶,其成形中所用的型坯的功能性层优选为
(i)含有聚酰胺层的制品,
(ii)含有多元醇层的制品,
(iii)含有聚酯层的制品,或者
(iv)含有聚环烯烃层的制品。
制备含有上述(i)的聚酰胺层的功能性层时,能赋予填充药液用塑料安瓶防止气体透过和防止水蒸汽透过的能力。因而,该安瓶可以适合于容纳例如易氧化、在氧气存在下不能保存的药液和由于水分含量的变化药效等发生显著变化的药液。
制备含有上述(ii)的多元醇层的功能性层时,能赋予填充药液用塑料安瓶防止气体透过、防止水蒸汽透过、防止药物透过和防止药物吸收吸附的能力。因而,该安瓶可以适合用于容纳例如在氧气存在下不能保存的药液和由水分含量的变化药效等能发生显著变化的药液。
例如,在安瓶带有含着色剂、紫外线吸收剂、氧吸收剂等药剂的层时,通过在该层内侧设置多元醇层,可以防止上述试剂溶解在安瓶内填充的药液中。
制备含有上述(iii)的聚酯层的功能性层时,能赋予填充药液用塑料安瓶防止气体透过、防止水蒸汽透过、防止药物透过和防止药物吸收吸附的能力。因而,该安瓶可以适合用于容纳例如在氧气存在下不能保存的药液和由水分含量的变化药效等能发生显著变化的药液。而且,通过使用聚酯层作为安瓶的最内层,可以防止药物向安瓶最内层的吸收或吸附。
聚环烯烃因为具有防止药剂吸收、吸附的能力、防止药物透过的能力(药物阻隔性)、防止水蒸汽透过的能力,并且透明性优良,已经有尝试将其用于医疗用容器的形成材料(特开平5-277154号公报)。因而,制备含有上述(iv)的聚环烯烃层的功能性层时,能赋予填充药液用塑料安瓶防止药物透过(药物阻隔性)、防止药物吸收吸附、防止水蒸汽透过的能力。
而且,例如,在安瓶带有含着色剂、紫外线吸收剂、氧吸收剂等药剂的层时,通过在该层内侧设置聚环烯烃层,可以防止上述试剂溶出到填充在安瓶内的药液中。
使用聚环烯烃层作为安瓶最内层时,可以防止药物对安瓶最内层的吸收或吸附。进而,这种情况下,作为形成最内层的聚环烯烃优选使用玻璃化转变温度(Tg)为110℃或以下的产品。通过在最内层使用玻璃化转变温度在上述范围的聚环烯烃,对于用吹塑、填充、封口法的成形模的接合(主模和头模的接合)部分,能防止在内容液填充、密封后产生液漏。聚环烯烃的玻璃化转变温度在上述范围内特别优选60~105℃,更优选为60~80℃。
另外,在特开平5-293159号公报中记载了使用聚环烯烃成形的安瓶的例子,但是该文献中对于用吹塑、填充、封口法制造安瓶没有任何记载,对于上述液漏问题的产生及其解决方法液没有教导和暗示。
顺便说一下,聚环烯烃的玻璃化转变温度超过110℃的话,一般具有缺乏对弯曲应力的耐性、本身较脆的特征。因而,使用具有用玻璃化转变温度在110℃或以下的聚环烯烃制备的最内层和含有玻璃化转变温度超过110℃的聚环烯烃的层的多层体来形成填充药液用塑料安瓶,可以防止在内容液的填充、密封后产生液漏,并且通过弯曲或扭曲安瓶的熔合部分(薄的地方)等,可以容易地进行安瓶的开封操作。
另外,用非环状的烯烃制得的聚合物一般和聚环烯烃相比,其成形体的柔软性更高,耐冲击性优良。因而,当形成塑料安瓶的层合体不仅具有含环状烯烃的层,还具有含非环状聚烯烃的层时,能提高塑料安瓶整体的抗冲击性。
本发明的填充药液塑料安瓶也可以是用可折断的薄部分连接的多个安瓶的连接体,制备这样的连接体例如可以容易地进行容纳同种药液的多个安瓶的管理。
本发明的填充药液塑料安瓶在功能性层为具有防止水蒸汽透过或防止药物吸收吸附能力的层时,可以用作内容量为0.5~20mL的安瓶。即,对于具有上述(i)的聚酰胺层、上述(ii)的多元醇层、上述(iii)的聚酯层或上述(iv)的聚环烯烃层作为功能性层的塑料安瓶来说,适合用于内容量为0.5~20mL的小容量安瓶。内容量为0.5~20mL的安瓶因其容纳溶液的绝对量少,在安瓶容纳期间伴随溶剂的挥发、或药剂被吸收吸附到安瓶上,会产生所谓的容纳溶液的性状显著变化的问题,通过设置防止水蒸汽透过、防止药物吸收吸附能力等优良的聚酰胺层、多元醇层、聚酯层或聚环烯烃层等,可以防止该问题的发生。
本发明的填充药液用塑料安瓶的制造方法其特征在于包括下列步骤:用容器主体部分成形用的下方可分模夹住带有2个或以上的层的筒状型坯,其中至少1个层是具有选自防止气体透过、防止水蒸汽透过、防止光线透过、防止药物透过和防止药物吸收、吸附的至少1种特性的功能性层,在筒状型坯的内部形成空洞来成形容器主体部分后,
在该容器主体部分内填充药液,接着,
用上方可分模夹住该容器主体部分的开口部位,形成封闭该开口部位的熔合部分和与该熔合部分相连用于扭断熔合部分的把持部分。
根据上述制造方法,可以在无菌条件下实现向填充药液用塑料安瓶内注入、密封药液。而且,在填充药液后,熔合封闭安瓶的开口部位时,可以不破坏多层塑料的层结构,形成熔合部分。
因而,上述的本发明的制造方法非常适合于制造能防止气体、水蒸汽、光线和药剂向内部或外部透过、或安瓶内的药剂、药液、溶剂等向内表面吸收或吸附的填充药液用塑料安瓶。
本发明的填充药液用塑料安瓶的制造方法中的型坯优选使用(a)其最内层由含有聚烯烃或聚环烯烃的树脂来形成,或者(b)除了其最内层的至少1层为混合了选自着色剂、紫外线吸收剂和氧吸收剂的至少1种药剂的层,且该层内侧的层为具有防止药物透过能力的层。
上述(a)的情况下,通过上述方法得到的填充药液用塑料安瓶能更安全地制作医疗用容器。
上述(a)中,最内层是由含有聚环烯烃的树脂形成的情况下,根据与上述相同的理由,作为该聚环烯烃优选使用玻璃化转变温度在110℃或以下的产品,更优选使用玻璃化转变温度为60~105℃的产品。
而且,上述(a)的情况下,根据与上述相同的理由,作为型坯优选使用具有由玻璃化转变温度在110℃或以下的聚环烯烃形成的最内层和由玻璃化转变温度超过110℃的聚环烯烃形成的层的产品。
上述(b)的情况下,能赋予由上述方法得到的填充药液用塑料安瓶以防止光线透过能力(对光、紫外线等的阻隔性)。
附图的简要说明
图1是表示本发明的填充药液用塑料安瓶的一个实施方式的部分截面图,(a)是正面图,(b)为右侧面图。
图2是表示本发明的填充药液用塑料安瓶的其他实施方式的部分截面正面图。
具体实施方式
接着参照附图详细说明本发明的填充药液用塑料安瓶及其制备方法。
<填充药液用塑料安瓶>
图1和图2是表示本发明的填充药液用塑料安瓶的一个实施方式的附图。
图1中所示的填充药液用塑料安瓶10具有柔软性的容器主体部分11、和封闭容器主体部分开口部位12的熔合部分13、连在熔合部分13上的把持部分14。
图2中所示的填充药液用塑料安瓶18和图1所示的安瓶10一样,具有柔软性的容器主体部分11、和封闭容器主体部分开口部位12的熔合部分13、连在熔合部分13上的把持部分14。对于该安瓶18,在侧边缘部分17之间通过可以扭断的连接部分19连接。
填充药液用塑料安瓶的把持部分14能通过弯曲或扭曲从熔合部分13分离。扭断把持部分14,使其从熔合部分13和容器主体部分11分离,这样可以使容器主体部分11的开口部分12打开,能获取、排出容器主体部分11内密封、填充的药液15。
另外,形成安瓶10、18的多层体具有含玻璃化转变温度超过110℃的聚环烯烃的层时,根据前述理由,可以从熔合部分13简易地进行分离操作。
形成填充药液用塑料安瓶的塑料16其特征为其至少1层为具有选自防止气体透过、防止水蒸汽透过、防止光线透过、防止药物透过和防止药物吸收吸附能力的至少1种特性的功能性层。
填充药液用塑料安瓶的侧边缘部分17为通过该安瓶的吹塑、填充、封口法成形时,用模头夹入型坯来形成。填充药液用塑料安瓶18例如可以使用带有与连接的安瓶的数目相应的模头和模具的多头式模头来成形。
<安瓶成形材料>
对于本发明的填充药液用塑料安瓶,在该安瓶中含有的功能性层如上所述具有下列特征,其具有选自防止气体透过、防止水蒸汽透过、防止光线透过、防止药物透过和防止药物吸收吸附能力的至少1种特性。关于该特性与在该功能性层中使用的塑料材料的种类的对应,如上所述。
作为本发明中可以使用的聚酰胺在此没有限制,能列举有例如尼龙-6、尼龙-6,6、尼龙-6,12、尼龙-12、苯二甲基二胺聚酰胺等。
作为本发明中可以使用的聚酯在此没有限制,但是能列举有例如聚对苯二甲酸乙二酯(PET)、聚萘二甲酸乙二酯、聚对苯二甲酸丁二酯(PBT)等。
作为本发明中可以使用的多元醇在此没有限制,但是能列举有例如聚乙烯醇(PVOH)、乙烯-乙烯醇共聚物(EVOH)等。
作为本发明中可以使用的聚环烯烃在此没有限制,可以列举有乙烯和二环戊二烯类的共聚物、乙烯和降冰片烯类化合物的共聚物、环戊二烯衍生物的开环聚合物、多个环戊二烯衍生物的开环共聚物及其氢化产物等。
本发明中,上述例举的聚环烯烃中特别优选使用乙烯和降冰片烯类化合物的共聚物的加氢产物、或者1种或以上的环戊二烯衍生物的开环(共)聚合物的加氢产物。通过使用该聚环烯烃,能制备安瓶强度和防止水分透过能力更好的层,而且还能赋予安瓶防止气体透过的能力。
对于上述聚环烯烃,能列举有例如具有用通式(1)表示的重复单元和通式(1’)表示的重复单元的聚合物,具有用通式(2)表示的重复单元的聚合物。
(式(1)和式(1’)中,R1、R1’、R2和R2’可以相同或不同,表示氢、烃残基或卤素、酯基、硝基、吡啶基等极性基团。R1、R1’、R2和R2’也可以相互结合成环。m和m’为1或1以上的整数,n和n’为0或1或1以上的整数。)
(式(2)中,R3和R4可以相同或不同,表示氢、烃残基或卤素、酯基、硝基、吡啶基等极性基团。R3和R4也可以相互结合成环。x和z为1或1以上的整数,y为0或1或1以上的整数。)
具有通式(1)和(1’)表示的重复单元的聚合物是通过公知的开环聚合方法聚合1种或2种或其以上的单体,或者接着用常规方法将这样得到的开环聚合物加氢制得的产品。作为该聚合物的具体例子能列举有日本ゼオン公司制造的商品名为“ゼオノア(注册商标)”、日本合成橡胶公司制造的商品名为“ARTON(注册商标)”等的商品。
具有通式(2)表示的结构单元的聚合物是通过公知的方法加成共聚作为单体的1种或2种或其以上的降冰片烯系单体和乙烯,和/或将其用常规方法加氢制备的产品。作为该聚合物的具体例子能列举有三井化学公司制造的商品名为“アペル(注册商标)”、テイコナGmbH公司制造的商品名为“トパス(注册商标)”等的商品。
具有上述通式(1)、(1’)和(2)表示的重复单元的聚合物中,因为其加氢产物的任何一种都是饱和的聚合物,其除了有气体遮蔽性和水分遮蔽性以外,从耐热性和透明性、进一步从稳定性来看也优良。
本发明中使用的聚环烯烃的熔体流动指数(MFR)从安瓶的成形性和成形制品的力学特性等观点来看优选4~30g/10分钟(190℃)。
本发明中使用的聚环烯烃的分子量没有特别限制,但是数均分子量(Mn)优选1万~10万,更优选2万~5万。需要说明的是,分子量例如可以通过环己烷作溶剂的凝胶渗透色谱法(GPC)分析来测定。
本发明中,作为可以在功能性层的成形中使用的树脂除了上述例子以外,还能列举有例如改性聚烯烃、聚偏氯乙烯(具有防止气体透过、防止水蒸汽透过的能力)、聚丙烯腈(具有防止气体透过、防止水蒸汽透过、防止药物透过、防止药物吸收吸附的能力)等。
作为改性的聚烯烃能列举有在非极性聚合物聚乙烯或聚丙烯等聚烯烃中加成羧基等官能团的产物(例如接枝聚合马来酸等不饱和羧酸的改性聚烯烃等)等。具体的例子有例如三井化学公司制造的粘接性聚烯烃[商品名“アドマ-(R)LB540”、“アドマ-(R)NF510”、“アドマ-(R)UF300”等];三菱化学公司制造的高粘接性树脂[商品名“モデイツク-AP(R)P512V”、“モデイツク-AP(R)L103”等]等。这些改性聚烯烃可以根据粘附层的树脂种类来适宜地选择。
在具有防止光线透过能力(光线阻隔性)的层的形成中,可以在塑料中混合下述颜料、紫外线吸收剂。作为在光线阻隔性材料的形成中使用的颜料在此没有限制,能列举有例如氧化钛、氧化锌、碳黑、铁红、二氧化硅等无机颜料和酞菁系、偶氮系、喹吖酮系有机颜料等。
另一方面,作为在光线阻隔性材料的形成中使用的紫外线吸收剂在此没有限制,能列举有例如水杨酸苯酯、水杨酸p-辛基苯酯等水杨酸系紫外线吸收剂;2,4-羟基二苯甲酮、双(2-甲氧基-4-羟基-5-苯并基苯基)甲烷等二苯甲酮系紫外线吸收剂;2-乙基己基-2-氰基-3,3-二苯基丙烯酸酯和乙基-2-氰基-3,3-二苯基丙烯酸酯等氰基丙烯酸酯系紫外线吸收剂;2-(5-甲基-2-羟基苯基)苯并三唑、2-(3-叔丁基-5-甲基-2-羟基苯基)-5-氯代苯并三唑等苯并三唑系等。上述颜料或紫外线吸收剂在构成光线阻隔性层的塑料中优选以0.01~5重量%左右来添加。
具有防止气体透过能力(气体阻隔性)的层中,特别是具有氧气阻隔性的层的形成中,可以在塑料中混合铁、亚硫酸氢钠、亚硫酸钠、邻苯三酚、抗坏血酸、生育酚等氧吸收剂。氧吸收剂在形成氧气阻隔性层的塑料中优选以0.15~5重量%左右来添加。
对于本发明中填充药液用的塑料安瓶,除了该功能性层以外的层一般使用聚烯烃来形成是适合的。作为该聚烯烃能列举有聚乙烯、聚丙烯等现有医疗用塑料容器中所用的各种聚烯烃。而且,根据需要在层间还可以混合不饱和羧酸改性聚乙烯、乙烯-丙烯酸共聚物、乙烯-醋酸乙烯酯共聚物等粘接性树脂。对于形成这些其他层的塑料,配合层结构和容器的形状等,密度、MFR等性状能在较宽范围内适宜选择。
本发明中可以使用的聚烯烃没有特别限制,可以采用目前公知的各种聚烯烃。另外,在各种聚烯烃中特别优选使用聚乙烯或聚丙烯。
在聚乙烯(PE)中,可以使用所谓的高压法(支链状)低密度聚乙烯(HP-LDPE)、直链状低密度聚乙烯(LLDPE)、中密度聚乙烯(MDPE)、高密度聚乙烯(HDPE)等各种PE。PE的密度可以在0.900g/cm3~0.965g/cm3的PE塑料的一般范围内适宜选择。从与用聚环烯烃制得的层的成形性或安瓶的力学特性等观点考虑,优选在比较低密度的范围内,具体为0.910~0.930g/cm3的范围内选择。PE的熔体流动指数(MFR)从用聚环烯烃制得的层的成形性和安瓶的力学特性等观点来考虑优选为0.2~20g/10分钟(190℃)。
PE不限于均聚物,也可以是共聚物。此时作为共聚单体优选1-丁烯、1-戊烯、1-己烯、4-甲基-1-戊烯、1-辛烯、1-癸烯等α-烯烃类。共聚单体的含量比例优选在20摩尔%或以下,更优选在3~20摩尔%左右。
聚丙烯(PP)的种类、性质也没有特别限制,作为PP采用一般的全同立构PP或间规PP(即结晶性均聚物)、或者以其作主要成分的结晶性共聚物是适合的。该结晶性共聚物中的共聚单体优选为乙烯、1-丁烯等α-烯烃类。共聚单体的含有比例优选在30摩尔%或以下,更优选为2~30摩尔%左右,进一步优选为3~25摩尔%左右。PP的熔体流动指数(MFR)从与用聚环烯烃制得的层的成形性和安瓶的力学特性等观点来考虑优选为0.2~20g/10分钟(190℃)。
为了赋予本发明的塑料安瓶防止氧气透过的能力(氧气阻隔性),可以在塑料中混合铁、亚硫酸氢钠、亚硫酸钠、邻苯三酚、抗坏血酸、生育酚等氧吸收剂。氧吸收剂在形成氧气阻隔性层的塑料中优选以0.15~5重量%左右的量来添加。而且,形成本发明的塑料安瓶的塑料中可以适宜适量地混合丁基羟基甲苯、八癸基-3-(3,5-二叔丁基-4-羟基苯基)丙酸酯等稳定剂;银-沸石、扁柏油酚等抗菌剂;苯二甲酸酯等增塑剂等。在使用混合这些添加剂的塑料的情况下,优选将安瓶制成多层体,且将混合了上述添加剂的塑料层制成内壁面以外的层。
<安瓶的层结构>
本发明的填充药液的塑料安瓶的最内层优选使用以聚乙烯或聚丙烯为代表的聚烯烃或聚环烯烃。聚烯烃或聚环烯烃如上所述要有对药剂、药液的安全性和稳定性,进而要求溶合性也优良。
具有防止药物透过能力(药物阻隔性)的层设置在塑料安瓶的最内层外侧,且在其他功能性层的内侧,能充分发挥药物阻隔性层的作用效果,所以优选。
<混合剂等>
形成本发明的填充药液用塑料安瓶的塑料根据需要也可以混合。而且,根据需要可以适宜适量地混合丁基羟基甲苯、八癸基-3-(3,5-二叔丁基-4-羟基苯基)丙酸酯等稳定剂;银-沸石、扁柏油酚等抗菌剂;苯二甲酸酯等增塑剂等。
对于混合这样的添加剂制得的层优选设置在药物阻隔性层的外侧。
<制造方法等>
本发明的填充药液用塑料安瓶可以使用带有多层挤出机和多层吹模的吹塑、填充、封口机来制造。
具体来说,首先使用多层吹模通过挤出成形形成有2个以上层的筒状型坯。该型坯中至少1层使用具有选自防止气体透过(气体阻隔性)、防止水蒸汽透过(水分阻隔性)、防止光线透过(光学阻隔性)、防止药物透过(药剂阻隔性)和防止药物吸收吸附的能力的至少1种特性的功能性层。接着,用容器主体部分成形用的下方可分模夹住该筒状型坯,将空气压入其内部,或者以模面孔吸引型坯来形成容器主体部分,在该容器主体部分填充规定和规定量的药液。进而,用上方可分模夹住该容器主体部分的开口部,通过形成封闭该开口部位的熔合部分和连在该熔合部分上的扭断熔合部分用的把持部分,可以制造本发明的填充药液用塑料安瓶。型坯的层结构可以根据填充药液的塑料安瓶所要求的层结构来适宜设定。
根据吹塑、填充、封口法的安瓶制造条件没有特别限制,可以根据通常的制造条件。型坯的熔融挤出温度或熔融挤出速度可以根据所用的树脂和目的容器的形状等适宜设定。
填充药液的塑料安瓶的总厚度优选300~2000μm左右。功能性层的厚度没有特别限制,可以根据该层所具有的功能的种类和使用目的等来适宜选择,通常优选为10~300μm左右。
<可以容纳的药剂、药液>
本发明的塑料安瓶中容纳的药液没有特别限制,可以根据功能性层具有的功能特性来适宜选择。
例如对于易氧化药剂的溶液,本发明的塑料安瓶中,可以用带有防止气体透过能力(气体阻隔性)的层的制品来容纳。作为易氧化药剂能列举有例如维生素A等维生素类;半胱氨酸、色氨酸等氨基酸;还原型谷胱甘肽、脂肪乳剂、脂质体制剂等。
对于光劣化药剂的溶液,本发明的安瓶中,可以用带有防止光线透过能力(光线阻隔性)的层的制品来容纳。作为光劣化性药剂能列举有例如维生素B2、维生素B12等维生素类;盐酸必消痰、含糖氧化铁剂、硫酸阿托品、新斯的明、二甲基氨基丙酰氨基安替比林、氟哌啶醇、盐酸麻黄素等。
对于吸收吸附性药剂的溶液,本发明的安瓶中可以用带有防止药物吸收吸附能力的层的制品来容纳。作为吸收吸附性药剂能列举有例如维生素D等维生素类;硝化甘油;依降钙素(elcatonin)等。
[实施例]
接着列举实施例来说明本发明的药液填充用的塑料安瓶。
对于药液填充用的塑料安瓶的形成材料,在下面示出其简称、物性等。
(聚烯烃)
·PE1:乙烯·1-丁烯共聚物(密度0.92g/cm3、熔体流动指数(MFR)1.0g/10min(190℃),商品名“ウルトゼツクス2010B”,三井化学公司制造)
·PE2:在PE1中每份各混合0.2重量%的有机颜料(商品名“クロモフタルイエロ-GR”和“クロモフタルイエロ-AGR”,都是チバガイギ-公司制造的)的制品。(具有防止紫外线透过功能(紫外线阻隔性)的塑料)
·PE3:在PE1中混合10重量%的作为氧吸收剂的亚硫酸钠(平均粒径为约8μm)的制品。(具有防止氧气透过功能(氧气阻隔性)的塑料)
·PP1:等规聚丙烯(密度0.91g/cm3,MFR1.6g/10min(230℃),品号“J704”,三井化学公司制造)
·PP2:在PP1中每份各混合0.2重量%的有机颜料(商品名“クロモフタルイエロ-GR”和“クロモフタルイエロ-AGR”)的制品。(具有防止紫外线透过功能的塑料)
(改性聚烯烃)
·AD1:马来酸改性聚乙烯(密度0.92g/cm3,MFR0.9g/10min(190℃),商品名“アドマ-NB550”,三井化学公司制造)
(多元醇)
·EVOH1:乙烯·乙烯醇共聚物(熔点175℃,MFR1.6g/10min(190℃),商品名“エバ-ルEP-H101”,クラレ公司制造)
(聚环烯烃)
·COP1:降冰片烯系单体的开环聚合物加氢产物(比重1.01,MFR20g/min(280℃),玻璃化转变温度(Tg)105℃,商品名“ゼオノア1020R”,日本ゼオン公司制造)
·COP2:降冰片烯系单体的开环聚合物加氢产物(比重1.01,MFR27g/min(280℃),Tg为70℃,商品名“ゼオノア750R”,日本ゼオン公司制造)
·COP3:降冰片烯系单体的开环聚合物加氢产物(比重1.01,MFR20g/min(280℃),Tg为136℃,商品名“ゼオノア1420R”,日本ゼオン公司制造)
·COC1:乙烯和四环十二烯的共聚物(比重1.03,MFR25g/10min(260℃),Tg为105℃,商品名“アペルAPL6011T”,三井化学公司制造)
·COC2:乙烯和四环十二烯的共聚物(比重1.02,MFR40g/10min(190℃),Tg为80℃,商品名“アペルAPL6509”,三井化学公司制造)
·COC3:乙烯和四环十二烯的共聚物(比重1.02,MFR40g/10min(190℃),Tg为70℃,商品名“アペルAPL8008”,三井化学公司制造)
(聚酰胺)
·NY1:间二甲苯二胺-己二酸缩聚物(熔点243℃,商品名“MX尼龙6001”,三菱瓦斯化学公司制造)
(聚酯)
·PET1:聚对苯二甲酸乙二酯(商品名“三井PET”,三井化学公司制造)
<填充药液的塑料安瓶的制造>
(实施例1)
使用带有2层吹模的吹塑、填充、封口机,由COP1(聚环烯烃)制备内层、PE1(聚烯烃)制备外层,且在其内部填充0.005%的硝化甘油水溶液10mL,制造有2层结构的填充药液用塑料安瓶(内容积10mL)。该安瓶10具有图1所示的形状,管壁厚为内层100μm,外层700μm。
(实施例2)
使用带有2层吹模的吹塑、填充、封口机,由COP1(聚环烯烃)和PE1(聚烯烃)以50∶50(重量比)的比例混合的塑料制备内层、PP1(聚烯烃)制备外层,且在其内部填充0.005%的硝化甘油水溶液20mL,制造有2层结构的填充药液用塑料安瓶(内容积20mL)。该安瓶10具有图1所示的形状,管壁厚为内层100μm,外层700μm。
(实施例3)
使用带有3层吹模的吹塑、填充、封口机,由PE1(聚烯烃)制备内层、COP1(聚环烯烃)制备中间层、PE1制备外层,且在其内部填充0.005%的硝化甘油水溶液10mL,制造有3层结构的填充药液用塑料安瓶(内容积10mL)。该安瓶10具有图1所示的形状,管壁厚为内层50μm,中间层100μm,外层700μm。
(实施例4)
作为形成中间层的塑料,使用COP1和PE1(聚烯烃)以50∶50(重量比)的比例混合的塑料来代替只使用COP1(聚环烯烃),安瓶的内容积为5mL,且在安瓶中填充的0.005%硝化甘油水溶液的量为5mL,除此以外进行和实施例3相同的操作,制造具有3层结构的填充药液用塑料安瓶。
(实施例5)
使用带有5层吹模的吹塑、填充、封口机,由PE1(聚烯烃)制备内层、COP1(聚环烯烃)和PE1以50∶50(重量比)的比例混合的塑料制备中间层(内层侧)、COP1制备中间层(中间部)、COP1和PE1以50∶50(重量比)的比例混合的塑料制备中间层(外层侧)和PE1制备外层,且在其内部填充0.005%的硝化甘油水溶液20mL,制造有5层结构的填充药液用塑料安瓶(内容积20mL)。该安瓶10具有图1所示的形状,管壁厚为内层50μm,中间层(内层侧、中间层和外层侧)各为100μm,外层700μm。
(实施例6)
作为形成中间层(中间部)的塑料,使用COP1和PE1(聚烯烃)以80∶20(重量比)的比例混合的塑料代替只用COP1(聚环烯烃),安瓶的内容积为10mL,且在安瓶内部填充的0.005%的硝化甘油水溶液的量为10mL,除此以外进行和实施例5相同的操作,制造具有5层结构的药液填充用塑料安瓶。
<塑料安瓶的性能评价>
对实施例1~6的填充药液用塑料安瓶分别在106℃下实施高压蒸气灭菌40分钟,然后在60℃下保存2周,测定在安瓶内填充的硝化甘油水溶液的硝化甘油的含量。测定结果、塑料安瓶的层结构等一并示于表1中。另外,硝化甘油是吸收、吸附性高的药剂。
任何一个安瓶的测定结果都是保存2周后的硝化甘油的残存量为95重量%以上,硝化甘油向安瓶内壁面的吸收、吸附和向安瓶外部的浸透、排出也明显得到了充分的抑制。即,实施例1~6的安瓶任何一个的防止药物吸收吸附和防止药物透过的能力都良好。这认为是因为实施例1~6的安瓶都有聚环烯烃层。
<表1>
上面:物质 中间:树脂的混合比例(重量比) 下面:层厚度
内层 | 中间层 | 外层 | 容积(mL) | |||
内层侧 | 中间部 | 外层侧 | ||||
实施例1 | COP1100μm | - | - | - | PE1700μm | 10 |
实施例2 | COP1+PE1(50∶50)100μm | - | - | - | PP1700μm | 20 |
实施例3 | PE150μm | - | COP1100μm | - | PE1700μm | 10 |
实施例4 | PE150μm | - | COP1+PE1(50∶50)100μm | - | PE1700μm | 5 |
实施例5 | PE150μm | COP1+PE1(50∶50)100μm | COP1100μm | COP1+PE1(50∶50)100μm | PE1500μm | 20 |
实施例6 | PE150μm | COP1+PE1(50∶50)100μm | COP1+PE1(80∶20)100μm | COP1+PE1(50∶50)100μm | PE1500μm | 10 |
<填充药液的塑料安瓶的制造>
(实施例7)
使用带有3层吹模的吹塑、填充、封口机,由PE1(聚烯烃)制备内层、EVOH1(多元醇)制备中间层、PE1制备外层,且在其内部填充0.1%的色氨酸水溶液10mL,制造有3层结构的填充药液用塑料安瓶(内容积10mL)。该安瓶10具有图1所示的形状,管壁厚为内层50μm,中间层100μm,外层700μm。
(实施例8)
使用带有5层吹模的吹塑、填充、封口机,由PE1(聚烯烃)制备内层、AD1(改性聚烯烃)制备中间层(内层侧)、EVOH1(多元醇)制备中间层(中间部)、AD1制备中间层(外层侧)和PE1制备外层,且在其内部填充0.1%的色氨酸水溶液5mL,制造有5层结构的填充药液用塑料安瓶(内容积5mL)。该安瓶10具有图1所示的形状,管壁厚为内层50μm,中间层(内层侧和外层侧)各为10μm,中间层(中间部)为100μm,外层700μm。
(实施例9)
使用带有4层吹模的吹塑、填充、封口机,由PE1(聚烯烃)制备内层、PE3(有氧气阻隔性的塑料)制备中间层(内层侧)、EVOH1(多元醇)制备中间层(外层侧)和PE1制备外层,且在其内部填充0.1%的色氨酸水溶液10mL,制造有4层结构的填充药液用塑料安瓶(内容积10mL)。该安瓶10具有图1所示的形状,管壁厚为内层50μm,中间层(内层侧和外层侧)各为100μm,外层600μm。
<塑料安瓶的性能评价>
对实施例7~9的填充药液用塑料安瓶分别在106℃下实施高压蒸气灭菌40分钟,然后在60℃下保存2周,测定在安瓶内填充的色氨酸水溶液的色氨酸的含量。测定结果、塑料安瓶的层结构等一并示于表2中。另外,色氨酸是易氧化的药剂。
任何一个安瓶的测定结果都是在保存2周后色氨酸的残存量为95重量%以上,表明色氨酸的氧化劣化得到了充分的抑制。即,表明实施例7~9的安瓶任何一个的防止气体透过(气体阻隔性,特比是氧气阻隔性)和防止药物透过的能力都良好。这认为是因为实施例7~9的安瓶都有多元醇层。
<填充药液的塑料安瓶的制造>
(实施例10)
使用带有3层吹模的吹塑、填充、封口机,由PE1(聚烯烃)制备内层、COP1(聚环烯烃)制备中间层、PE2(紫外线阻隔性塑料)制备外层,且在其内部填充0.05%的维生素B2水溶液10mL,制造有3层结构的填充药液用塑料安瓶(内容积10mL)。该安瓶10具有图1所示的形状,管壁厚为内层50μm,中间层100μm,外层700μm。
<塑料安瓶的性能评价>
对实施例10的填充药液用塑料安瓶在106℃下实施高压蒸气灭菌40分钟,然后在60℃下保存2周,测定在安瓶内填充的维生素B2水溶液的维生素B2的含量。另外,维生素B2是光降解性的药剂。
测定结果是在保存2周后维生素B2的残存量为95重量%以上,表明其光降解性明显得到了充分的抑制。即,实施例10的安瓶防止光线透过的能力(光学阻隔性)良好。这认为是因为实施例10的安瓶带有混合了着色剂(有机颜料)制得的层。
而且,维生素B2水溶液对外层中所含颜料的溶解也明显得到了充分抑制。这认为是因为混合着色剂(有机颜料)制得的层内侧具有聚环烯烃层。
<填充药液的塑料安瓶的制造>
(实施例11)
使用带有5层吹模的吹塑、填充、封口机,由PE1(聚烯烃)制备内层、AD1(改性聚烯烃)制备中间层(内层侧)、NY1(聚酰胺;间二甲苯二胺-己二酸缩聚物)制备中间层(中间部)、AD1制备中间层(外层侧)和PP2(紫外线阻隔性塑料)制备外层,且在其内部填充400IU/mL的棕榈酸(パルチミン酸)维生素A溶液化液2mL,制造有5层结构的填充药液用塑料安瓶(内容积2mL)。该安瓶10具有图1所示的形状,管壁厚为内层50μm,中间层(内层侧和外层侧)各为10μm,中间层(中间部)为100μm,外层700μm。
<塑料安瓶的性能评价>
对实施例11的填充药液用塑料安瓶在106℃下实施高压蒸气灭菌40分钟,然后在60℃、60%RH下保存2周,测定在安瓶内填充的棕榈酸维生素A溶液化液的棕榈酸维生素A的含量。另外,棕榈酸维生素A是易氧化性和光降解性的药剂。
测定结果是在保存2周后棕榈酸维生素A的残存量为95重量%以上,表明其氧化劣化和光降解性得到了充分的抑制。即,实施例11的安瓶防止气体透过的能力(气体阻隔性,特别是氧阻隔性)和防止光线透过的能力(光线阻隔性)良好。这认为是因为实施例11的安瓶带有聚酰胺层和混合着色剂(有机颜料)制得的层。
而且,表明棕榈酸维生素A溶液化液对外层中所含颜料的溶解得到了充分抑制。这认为是因为混合着色剂(有机颜料)制得的层内侧具有聚酰胺层。
另外,实施例7~11中获得的塑料安瓶的层结构等汇总在表2中。
<表2>
上面:材质 中间:树脂的混合比例(重量比) 下面:层厚度
内层 | 中间层 | 外层 | 容积(mL) | |||
内层侧 | 中间部 | 外层侧 | ||||
实施例7 | PE150μm | - | EVOH1100μm | - | PE1700μm | 10 |
实施例8 | PE150μm | AD110μm | EVOH1100μm | AD110μm | PE1700μm | 5 |
实施例9 | PE150μm | PE3100μm | - | EVOH1100μm | PE1600μm | 10 |
实施例10 | PE150μm | - | COP1100μm | - | PE2700μm | 10 |
实施例11 | PE150μm | AD110μm | NY1100μm | AD110μm | PP2500μm | 2 |
<填充药液的塑料安瓶的制造>
(实施例12)
使用带有2层吹模的吹塑、填充、封口机,由COP2(聚环烯烃)制备内层、PE1(聚烯烃)制备外层,且在其内部填充生理盐水10mL,制造有2层结构的填充药液用塑料安瓶。该安瓶18具有图2所示的5连体形状,管壁厚为内层200μm,外层500μm。
(实施例13)
使用带有2层吹模的吹塑、填充、封口机,由COP2(聚环烯烃)制备内层、COP3(聚环烯烃)制备外层,且在其内部填充生理盐水10mL,制造有2层结构的填充药液用塑料安瓶。该安瓶18具有图2所示的5连体形状,管壁厚为内层200μm,外层500μm。
(实施例14)
使用带有2层吹模的吹塑、填充、封口机,由COCl(聚环烯烃)制备内层、PE1(聚烯烃)制备外层,且在其内部填充生理盐水10mL,制造有2层结构的填充药液用塑料安瓶。该安瓶18具有图2所示的5连体形状,管壁厚为内层200μm,外层500μm。
(实施例15)
使用带有2层吹模的吹塑、填充、封口机,由COC2(聚环烯烃)制备内层、PE1(聚环烯烃)制备外层,且在其内部填充生理盐水10mL,制造有2层结构的填充药液用塑料安瓶。该安瓶18具有图2所示的5连体形状,管壁厚为内层200μm,外层500μm。
(实施例16)
使用带有2层吹模的吹塑、填充、封口机,由COC3(聚环烯烃)制备内层、PE1(聚烯烃)制备外层,且在其内部填充生理盐水10mL,制造有2层结构的填充药液用塑料安瓶。该安瓶18具有图2所示的5连体形状,管壁厚为内层200μm,外层500μm。
(比较例1)
使用吹塑、填充、封口机,由COP3(聚环烯烃,Tg为136℃)制备,且在其内部填充生理盐水10mL,制造单层结构的塑料安瓶。该安瓶18具有图2所示的5连体形状,管壁厚为800μm。
(参考例1)
使用吹塑、填充、封口机,由COP2(聚环烯烃,Tg为70℃)制备,且在其内部填充生理盐水10mL,制造单层结构的塑料安瓶18。该安瓶18具有图2所示的5连体形状,管壁厚为800μm。
(参考例2)
使用吹塑、填充、封口机,由COC1(聚环烯烃,Tg为105℃)制备,且在其内部填充生理盐水10mL,制造单层结构的塑料安瓶18。该安瓶18具有图2所示的5连体形状,管壁厚为800μm。
<塑料安瓶的性能评价>
对于上述实施例12~16、比较例1和参考例1~2中得到的塑料安瓶目测确认有无液漏发生。其结果是形成内层的塑料是聚环烯烃、且玻璃化转变温度(Tg)在110℃或以下的实施例12~16的50支安瓶(10个5连体的安瓶)全部没有检测出有液漏。与此相对,比较例1的50支安瓶的8成即40个安瓶均检出有液漏。
另外,如参考例1和2所示,塑料安瓶在实际使用中也可以是由1种聚环状烯烃制得的单层体。这时,形成安瓶整体的聚环烯烃优选使用玻璃化转变温度在110℃或以下的聚环烯烃。聚环烯烃的玻璃化转变温度优选为60~105℃,更优选为60~80℃。
实施例12~16、比较例1和参考例1~2中获得的塑料安瓶的层结构等汇总在表3中。
<表3>
上面:材质(玻璃化转变温度℃) 下面:层厚度
内层 | 外层 | 容积(mL) | |
实施例12 | COP2(70℃)200μm | PE1500μm | 10 |
实施例13 | COP2(70℃)200μm | COP3(70℃)500μm | 10 |
实施例14 | COC1(105℃)200μm | PE1500μm | 10 |
实施例15 | COC2(70℃)200μm | PE1500μm | 10 |
实施例16 | COC3(70℃)200μm | PE1500μm | 10 |
比较例1 | COP3(136℃)800μm | 10 | |
参考例1 | COP2(70℃)800μm | 10 | |
参考例2 | COCl(105℃)800μm | 10 |
如上所述,本发明提供的塑料安瓶可以用于无菌且稳定地保管、保存易氧化药剂、光降解性药剂、吸收吸附制剂等,进而可适用于该塑料安瓶的制造。
Claims (18)
1、一种用于填充药液的塑料安瓶,其特征在于该填充药液的塑料安瓶具有柔软性的容器主体部分、和封闭该容器主体部分开口部位的熔合部分、连在该熔合部分上的用于扭断熔合部分的把持部分,上述容器主体部分、熔合部分和把持部分是使用具有2层或2层以上的筒状型坯一体成形制得的,上述容器主体部分是用可分模夹住上述型坯来成形,在其内部填充药液,然后封闭开口部位制得的,并且上述型坯的至少1层是具有选自防止气体透过、防止水蒸汽透过、防止光线透过、防止药物透过和防止药物吸收、吸附功能的至少1种特性的功能性层。
2、如权利要求1记载的填充药液的塑料安瓶,其中上述型坯的最内层是由含有聚烯烃或聚环烯烃的树脂形成的。
3、如权利要求1记载的填充药液的塑料安瓶,其中除上述型坯的最内层以外的至少1层是通过混合选自着色剂、紫外线吸收剂和氧吸收剂的至少1种药剂来制得的层,且比该层更内侧的层是具有防止药物透过功能的层。
4、如权利要求1记载的填充药液的塑料安瓶,其中上述功能性层含有聚酰胺层。
5、如权利要求1记载的填充药液的塑料安瓶,其中上述功能性层含有多元醇层。
6、如权利要求1记载的填充药液的塑料安瓶,其中上述功能性层含有聚酯层。
7、如权利要求1记载的填充药液的塑料安瓶,其中上述功能性层含有聚环烯烃层。
8、如权利要求7记载的填充药液的塑料安瓶,其中至少最内层使用玻璃化转变温度在110℃或以下的聚环烯烃。
9、如权利要求8记载的填充药液的塑料安瓶,其中上述聚环烯烃的玻璃化转变温度为60~105℃。
10、如权利要求8记载的填充药液的塑料安瓶,其具有使用玻璃化转变温度在110℃或以下的聚环烯烃制得的最内层和包含玻璃化转变温度超过110℃的聚环烯烃的层。
11、如权利要求8记载的填充药液的塑料安瓶,其为由可以折断的薄壁部连接的多个安瓶的连接体。
12、如权利要求1记载的填充药液的塑料安瓶,其中上述功能性层为具有能防止水蒸汽透过和防止药物吸收、吸附功能的层,且其内容量为0.5~20mL。
13、一种填充药液用的塑料安瓶的制造方法,其特征在于包括下列步骤:在用容器主体部分成形用的下方可分模夹住带有2个或以上的层的筒状型坯,其中至少1个层是具有选自防止气体透过、防止水蒸汽透过、防止光线透过、防止药物透过和防止药物吸收、吸附的至少1种特性的功能性层,在筒状型坯的内部形成空洞来成形容器主体部分后,在该容器主体部分内填充药液,接着用上方可分模夹住该容器主体部分的开口部位,形成封闭该开口部位的熔合部分和连在该熔合部分上用于扭断熔合部分的把持部分。
14、如权利要求13记载的填充药液用的塑料安瓶的制造方法,其中作为上述型坯是使用最内层为含有聚烯烃或聚环烯烃的树脂来形成的制品。
15、如权利要求13记载的填充药液用的塑料安瓶的制造方法,其中作为上述型坯是使用除最内层之外至少有1层是混合了选自着色剂、紫外线吸收剂和氧吸收剂的至少1种药剂来制得的层,且比该层更内侧的层是具有防止药物透过功能的层。
16、如权利要求14记载的填充药液用的塑料安瓶的制造方法,其中作为上述型坯是使用其最内层是通过玻璃化转变温度在110℃或以下的聚环烯烃形成的制品。
17、如权利要求14记载的填充药液用的塑料安瓶的制造方法,其中作为上述型坯是使用其最内层是通过玻璃化转变温度为60~105℃的聚环烯烃形成的制品。
18、如权利要求14记载的填充药液用的塑料安瓶的制造方法,其中作为上述型坯是使用具有由玻璃化转变温度在110℃或以下的聚环烯烃形成的最内层和由玻璃化转变温度超过110℃的聚环烯烃形成的层的型坯。
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