CN1143667C - 多室医疗用容器 - Google Patents

多室医疗用容器 Download PDF

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CN1143667C
CN1143667C CNB998057282A CN99805728A CN1143667C CN 1143667 C CN1143667 C CN 1143667C CN B998057282 A CNB998057282 A CN B998057282A CN 99805728 A CN99805728 A CN 99805728A CN 1143667 C CN1143667 C CN 1143667C
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江崎知彦
大竹功
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齐藤仁
坂田明彦
水尾隆之
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Ajinomoto Co Inc
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Showa Denko Plastic Products Co Ltd
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Abstract

一种多室医疗用容器，所述容器在由合成树脂制成的袋状容器的上下端部的至少一端上，设有注入或取出药液用的口部件，袋状容器内面通过闭锁密封部液密性良好地间隔成多个室。该闭锁密封部的树脂，用差示扫描型热量计测定的熔化温度曲线上的主熔化峰值温度的最高点的高度(h1)、与115℃温度下的该温度曲线的高度(h2)的高度比(h2/h1)为0.05～0.4。具有这种特征的多室医疗用容器，通过对袋部的按压操作可顺利地剥离闭锁密封部，且其柔软性、透明性良好。

Description

多室医疗用容器
技术领域
本发明涉及一种具有可单独存放多种药液或输液的多个间隔、且在使用前将各间隔室相互连通，使药液混合的多室医疗用容器。
技术背景
在预先将多种药液或输液混合会引起变色或变质等时效变化的不稳定药剂等情况下，采用将药剂存放在间隔为多个室的容器内，使用时将间隔部打开使各种药剂混合的方法。作为该方法的例子，列举这样一种方法，即用熔点不同的树脂混合而成的树脂组成物的薄膜制作容器，在低熔点树脂与高熔点树脂之间的温度下，对作为该容器密封部(间隔部)的带状部分进行热密封，这样便形成可剥离的密封部。
具体地说，例如多室容器使用了由聚丙烯和聚乙烯的混合树脂制成的薄膜(特开平2-4671号公报)、或密度不同的直链状聚乙烯和高密度聚乙烯的混合物制成的薄膜(特开平8-229101号公报)等。这些多室容器的间隔部的剥离强度基本上是根据混合的树脂的比例决定的。
但是，为了得到任意的剥离强度而改变树脂的混合比率的话，薄膜的柔软性及透明性就会发生变化，使之难以得到保持一定质量的制品。而且，在开封时也有不能顺利地剥离间隔部的情况。
发明的目的
本发明的目的在于提供一种多室医疗用容器，使用前，该容器将多种药液或输液不泄漏、不混合地存放在多个间隔室内，使用时使间隔室连通，在这种多室医疗用容器上，通过对袋部的按压操作，可确实地使间隔室连通，且可保持容器的柔软性和透明性。
本发明者们经反复锐意研究的结果，发现采用由具有特定的热性状态的树脂制成的闭锁密封可达到上述目的，基于这种见解而完成了本发明。
也就是说，本发明所述容器是一种在合成树脂制成的袋状容器的上下端部的至少一端上设有注入或取出药液用的口部件，袋状容器内面通过闭锁密封部密性良好地被间隔成多个室。另外，该闭锁密封部的树脂在熔化温度曲线上的主熔化峰值温度的最高点的高度(h1)与温度为115℃时的该温度曲线的高度(h2)的高度比(h2/h1)为0.05～0.4，该熔化温度曲线是用差示扫描型热量计测定的。
附图的简单说明：
图1是表示本发明的多室医疗用容器的一个实施例的主视图。
图2是在本发明的多室医疗用容器中使用的树脂的DSC曲线的例子。
实施本发明的最佳形态
以下，参照附图对本发明进行详细说明。
图1是表示本发明的多室医疗用容器的一个实施例的主视图。
该多室医疗用容器1是在热可塑性树脂制的筒状薄膜上实施热密封2而形成的袋部的内面，通过闭锁密封部3液密性良好地间隔成多个间隔室4、5而构成的袋状容器，是在袋状容器的上下端部的至少一端上具有注入或取出药液用的口部件6的容器，各间隔室4、5内装有种类不同的药液或输液。闭锁密封部3的树脂是具有下述热特性的树脂，即用差示扫描型热量计测定的熔化温度曲线(下称“DSC”曲线)上的主熔化峰值温度(下称“Tpm”)的最高点的高度(h1)与115℃温度下的该温度曲线的高度(h2)的高度比(h2/h1)为0.05～0.4。
在本发明中，所谓DSC曲线，系指采用JSK 7121(1987)中规定的方法测得的。
作为测定方法，是对试片进行状态调节后再进行一定的热处理，然后测定熔化温度。具体地说，用化学天平称量5mg左右的试片后，在温度为23℃、相对湿度为50％的气氛下进行24小时的状态调节。状态调节后，将试片装入DSC装置的容器内，进行加热熔化，直至比熔化峰值终了时约高30℃的温度为止，在该温度下保温10分钟后，按每分钟10℃的冷却速度进行冷却，直至比出现的转移峰值至少约低50℃的温度为止。在该温度下保持10分钟后，再一次以每分钟10℃的加热速度进行加热熔化，直到比熔化峰值终了时约高30℃的温度为止，描绘DSC曲线。
图2所示为本发明使用的树脂的较理想的DSC曲线的例子。
上述高度比(h2/h1)最好为0.1～0.35，特别是0.15～0.3较为合适。高度比低于0.05，则闭锁密封部不能获得足够的开通强度。若超过0.4，则开通作业困难，故不希望出现这种情况。
在本发明中，作为闭锁密封部用的树脂，最好上述Tpm在120℃～135℃的范围内。这种情况下，该树脂成为具有可进行115℃以上的灭菌处理的耐热性树脂，也可作为高温灭菌用。这种树脂的耐热温度，就聚烯烃系树脂来说是非常好的，故可望进一步扩大其用途。
在本发明中，闭锁密封部最好用聚乙烯系中的一种树脂。具体例子有链状低密度聚乙烯(LLDPE)、高密度聚乙烯(HDPE)等聚乙烯系树脂，但是，最好是用聚合法制造的LLDPE，该聚合法使用了金属茂催化剂之类的单面催化剂。另外，柔软性虽不好，但根据用途不同也可使用丙烯系树脂，例如，对乙烯等其他α-烯进行了少量共聚合的丙烯不规则共聚体(无规则PP)。
作为本发明的多室医疗用容器，最好是用符合上述条件的树脂的单层构成，但是，也可用符合上述条件的树脂作内层，在其外侧上层叠其他树脂的多层体构造。作为多层体的外层用的树脂，只要是在不影响作为医疗用容器的透明性及柔软性的范围内，没有什么特别限制。理想的树脂例子有聚丙烯(均聚丙烯、丙烯片共聚体等)、聚酰氨树脂(聚酰氨6、聚酰氨66、聚酰氨6-66共聚体等)等。要做成多层，利用粘结树脂或粘结剂且采用本业界周知的方法(膨胀成形、挤压层叠成形法等)进行层叠即可。因此，例如可用符合上述条件的树脂的单层薄膜、或以该树脂作为最里层的层叠薄膜作材料。构成容器的树脂薄膜的厚度一般为0.10～0.80mm，最好为0.15～0.70mm，特别是0.15～0.50mm最为合适。厚度小于0.10mm，在强度上存在着实用性问题。若厚度大于0.80mm，则柔软性降低，故用途会受到限制。
所谓闭锁密封，就是指在低于该树脂的Tpm以下的温度下进行热密封而获得的半熔敷密封。半熔敷密封，系指在微观上熔敷部和非熔敷部混合存在的状态。即，本发明容器的闭锁密封部，虽在微观上熔敷部和非熔敷部混合存在，但在液密性方面需要保持密封状态。闭锁密封温度根据树脂和密封方法不同而不同，但容器内面需要将密封温度设定为比构成该容器内面的树脂的熔点温度低的温度。
在DSC曲线上存在着多个顶峰的情况下，最好是在比最低温度顶峰的温度低的温度下进行闭锁密封。
闭锁密封部的宽度为2mm以上，最好为5～20mm。
上述结构的闭锁密封部具有这种功能，即在容器的保管中或输送中，用通常能承受的轻微力量不会产生剥离现象，但在使用时通过对袋部的按压操作可确实剥离，使间隔室之间相互连通。这时的开通强度最好为10～80kgf，15～60kgf则更好。开通强度小于10kgf时，则在搬运或保管中存在着误开通的危险性。若大于80kgf，则用女性的力量难以进行开通操作。
作为开通时的剥离性，最好是一下子将整个闭锁密封部剥离，或在开通后，通过抽吸操作将整体剥离，该抽吸操作是为了对储存的药剂进行混合。有一部分部位未被剥离的容器使用时会产生不良情况，这是不希望的。
本发明的医疗用容器，需要具有可确认储存的药剂中是否有异物的透明性，用分光光度计测定的透过率最好大于55％。
以下，用实施例进一步对本发明加以详细说明。
DSC曲线是用差示扫描热量计(PERKIN-ELMER DSC 7型)、按JISK7121的规定测定的。
开通强度是这样测定的，即用不锈钢板夹住在一侧的室内装有食盐水的容器，用拉伸试验机、按500mm/分的速度加压，测定闭锁密封部开通时的最高强度(kgf)。
剥离性，是用肉眼观察测定开通强度后的闭锁密封部的剥离状况，按以下三种情况进行评价。
○……全部开通
△……部分开通
×……未开通(100kgf以上)
透明性的测定是用分光光度计(日立制作所制、U-3300型)，将蒸馏水装入参考容器和测定用容器内，将试样(9mm×40mm的薄长方形)装入测定用容器内，测定波长为450nm条件下的透过率。
作为树脂材料，使用通过单面系催化剂聚合的LLDPE(超低密度聚乙烯)[密度：0.923g/cm3、MFR(在JIS K7210、温度190℃及载荷2.16kgf的条件下进行测定，下同)：2.7g/10分](下称“LL-1”)及LLDPE(密度：0.920g/cm3、MFR：2.0g/10分)(下称“LL-2”)、出光石油化学公司制造的LLDPE(商品名：モアテック3500Z)(下称“LL-A”)、日本聚烯烃公司制造的LDPE(低密度聚乙烯)(商品名：ジエイレクスF22)(下称“LD”)、该公司制造的HDPE(高密度聚乙烯)(商品名：ジエイレクスF5030ME)(下称“HD”)以及该公司制造的不规则的聚丙烯(商品名：ジエイアロマ-PM921Y)(下称“PP”)。
对上述各树脂的DSC进行了测定，其结果示于表1。LL-1的DSC曲线示于图2。
表1
    种类     Tpm(℃)     h1(mW)     h2(mW)     h2/h1
    LL-1LL-2LL-ALDHDPP     123.5124.0120.4109134.6150     20.7812.666.1710.625.527.66     4.42.713.22-2.050.73     0.210.210.52-0.080.095
实验例1～6
用上述各树脂作材料，用充气薄膜成形机制造厚250μm、折径210mm的筒状薄膜。将制成的薄膜裁断为360mm长，用10mm宽的热板对其中央部进行热密封，形成闭锁密封部。闭锁密封，其密封圈的设定温度为105～125℃，设定压力在0.3～0.5MPa范围内，调整密封时间进行密封，使杀菌之前的开通强度达到20～50kgf。接着，使两端和口部件一起进行通常的热密封，制造多室容器。
将800ml日本药局制的生理盐水装入一侧的室内，密封起来。然后，利用热水式高压蒸汽杀菌装置(日阪制作所制造)，在115℃温度下进行30分钟的杀菌处理。杀菌处理后，在23℃温度下进行24小时的状态调整后，对开通强度、剥离性及透明性进行评价。得到的结果示于表2。
表2
    树脂   开通强度(kgf) 剥离性   透明性(％)
  实验例1实验例2实验例3实验例4实验例5实验例6     LL-1LL-2LL-ALDHDPP     5149大于100-429 ○○×-○○     626460-小于3075
实施例4是由于杀菌时袋破了，故不能进行后面的评价。
产业上利用的可能性
本发明的多室医疗用容器，使用前可不泄漏、不混合地储存多种药液或输液，使用时通过对袋部的简单按压操作，便可对无菌药液进行混合，而且柔软性和透明性良好。
因此，本发明的多室医疗用容器可适用于作无菌液的混合所必需的输液(糖质、电解质制剂+氨基酸制剂)、及药液等的储存容器。

Claims (6)

1.一种多室医疗用容器，所述容器在用合成树脂制成的袋状容器的上下端部的至少一端上设有药液注入或取出用的口部件，袋状容器内面通过闭锁密封部液密性良好地间隔成多个间隔室，其特征在于：该闭锁密封部的树脂，在用差示扫描型热量计测定的熔化温度曲线上的主熔化峰值温度的最高点的高度h1、与115℃温度下的该温度曲线的高度h2的高度比h2/h1为0.05～0.4。
2.如权利要求1所述的多室医疗用容器，其特征在于：闭锁密封部是用聚乙烯树脂制成的。
3.如权利要求1或权利要求2所述的多室医疗用容器，其特征在于：容器是由单层薄膜构成的。
4.如权利要求1所述的多室医疗用容器，其特征在于：不同的输液装在各间隔室内密封起来，在115℃以上的杀菌温度下进行处理。
5.如权利要求2所述的多室医疗用容器，其特征在于：不同的输液装在各间隔室内密封起来，在115℃以上的杀菌温度下进行处理。
6.如权利要求3所述的多室医疗用容器，其特征在于：不同的输液装在各间隔室内密封起来，在115℃以上的杀菌温度下进行处理。
CNB998057282A 1999-03-02 1999-03-02 多室医疗用容器 Expired - Fee Related CN1143667C (zh)

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