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CN1090538C - 用于不含推进剂的计量气雾剂的药筒及用于药筒容器的封盖 - Google Patents

用于不含推进剂的计量气雾剂的药筒及用于药筒容器的封盖 Download PDF

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CN1090538C
CN1090538C CN97194153A CN97194153A CN1090538C CN 1090538 C CN1090538 C CN 1090538C CN 97194153 A CN97194153 A CN 97194153A CN 97194153 A CN97194153 A CN 97194153A CN 1090538 C CN1090538 C CN 1090538C
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迪特尔·霍克莱纳
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Abstract

一种用于不含推进剂的计量气雾剂的药筒，它由一个带有封盖(3)并用于装入液体的容器(4)组成，在液体中设有一装置(接管)(5)，在封盖(3)推套到容器(4)的颈部时，能排出容器的一部分内容物，其特征在于，所述封盖(3)至少包含一个容室(2)，该容室(2)通过两个可刺穿的隔离件(13)和(14)相对于容器(4)的外部和内部封闭。

Description

用于不含推进剂的计量气雾剂的药筒及用于药筒容器的封盖
本发明涉及一种用于液体的双室药筒，尤其用于供不含推进剂的计量气雾剂的使用的配制药剂。
在WO 91/14468号国际专利申请“雾化装置及方法”中记载了一种装置，用于在不含推进剂的状态下供给已经定好剂量的供吸入用的液态药剂。该配药装置的一种改进实施例在PCT/EP96/04351号国际专利申请中有说明。在应用上必须做到，将含有活性物质的溶液注入容器内时仅包含少量的残留空气和气体，因为气泡会在准确计量活性物质时产生不确定性。这些容器已在PCT/EP95/03183号国际专利申请中公布。它们首先适用于可长期以水溶液或者乙醇溶液形式可靠保存的药物。
但是对于在其溶液中几个月后即分解的活性物质，至今尚无合适的具有商业使用价值的容器供在不含推进剂的计量气雾剂中灵敏配药用。
因此本发明涉及一种药筒，它有两个容室将活性物质和溶剂分开贮存。药筒在结构上可在其插入一装置用于配制气雾剂时，用一针管刺穿含有活性物质的容室，使活性物质与溶剂接触并溶解在内。由于活性物质与溶剂分开贮存，使药物配制品的存放时间显著延长。
活性物质可以粉末状，颗粒状或片状存在于容室中。同时也可存有药理上能接受的辅助物质。通常以按药典配制的能够促使活性物质在溶剂中溶解的物质为佳。以药片为例，可添加能够使药片更好地溶解的辅助物质。同样也可添加能够提高活性物质稳定性的物质。在某些情况下，活性物质也可以溶解状态存在于容室内，只要活性物质在溶剂中稳定而且该溶剂可以同另一个容室中的溶剂混合即可，该容室以后也称作容器。
下面将借助附图所示实施例来详细说明本发明，附图中：
图1示出沿本发明药筒1的纵轴方向的轴向剖面图，药筒具有用于容纳活性物质的容室2，而容室2是封盖3的一体组成部分；
图2示出药筒处于封闭状态下的具有容室2的封盖3的另一实施形式，其中只是指示出容器4；
图3a至3c示出符合本发明的具有容室2的封盖3的又一实施形式；
图4示出沿符合本发明的一种结构形式的封盖的纵向的剖面图，其中容室2装有一微型药片16a作为贮存的活性物质。
图1示出，符合本发明的药筒1由一个容器4和一个封盖3组成。该封盖具有一个装置(在此是一个埋入式接管5)，通过它可以在封闭过程中使容器4的一部分内容物被排出，从而在不产生气泡的情况下填充容器。一个位于封盖3下缘的内置环状凸缘6卡锁在位于环绕在容器颈部外侧的一个圆柱状环7下部的封闭位置处。在该封闭位置，封盖3的平坦部分与容器颈部顶缘之间的空隙可用一个密封环11来填充，从而将容器3内部完全封闭，而容器颈部的顶缘装有一个环状肋条10，以增强密封性。在选择密封环11的内径尺寸时，要使其能够紧套在接管5上。通气孔8可设于封盖外侧其它地方，例如在封盖的圆柱形部分的侧面。
在另一个实施例中(图2a)，封盖3被一个做成褶皱状的铝制套筒20封闭。套筒20在设计上留出一个中心孔21，以利于针管22插入。该孔可用一隔膜封闭，以防止进入灰尘和其它污物。该封闭技术为众所周知，例如已用在注射药瓶上。
在一个特别的实施例中，容器4包含了一个由弹性材料制成的皱缩式内容器4a。在一个优选实施例中，该内容器通过一装置固定于容器4的底部。
容室2位于接管5的底部，而容室通过一隔离件，例如一层隔膜13与外界隔绝，并通过一隔离件，例如一层薄膜14与容器内部4b隔开。隔膜13与薄膜14由一种材料制成，该材料易被尖或圆末端针管刺穿。隔膜13最好由这样一种材料制成，即使它被针管刺穿，仍能使内部4b对外保持密封。通常隔离件由塑料薄膜或铝薄膜构成。在一实施例中，隔膜13可在其与接管5侧壁的连接处有易裂点，当此隔离件被刺穿时，使它能够在易裂点处裂开。薄膜14最好是一种熔焊上去的防渗透封闭膜，可在被刺穿时撕开并让活性物质进入容器内部4b。易裂点也可设于接管5底部侧壁上，以使接管5的侧壁底部一起被撕开。
隔离件(隔膜13)的位置可在接管5内部的较大范围内变动，但最好按照活性物质16的量来设定，以使由两隔离件13和14所够成的内部空间除了药粉以外，所装纳的气体(空气)量尽可能少。
图2也示出一个容器颈部的轴向剖面，容器上罩着封盖3，而容室2的结构形式不同。
图3a示出符合本发明的封盖的另外一种实施例，其中埋入式接管内部要设计出一个供针管抽取液体的导引件17。在这一实施例中，通气孔8设置于容器4顶部。如前所述，通气孔也可设置在封盖上。而用来容纳活性物质的容室2则单独设置于接管5的底部。可用易裂点18来代替可被刺穿的隔离件14，使得容室当隔离件13被刺穿时，因作用于隔离件14上的压力而于易裂点18处被撕裂。在这一实施例中，隔离件14可构成接管5的底部。
图3b，3c示出在其它实施例中有关埋入式接管5与供针管抽取液体的导引件17的结构情况。
在图3b示出的一个实施例中，导引件17过渡到一个压接件19中。对压接件的直径与长度进行设计，使得一方面针管推过时所遇到的阻力保持最小，而另一方面在接管与针管之间有一个足够的密封。
图3c所示实施例在接管与刺入的针管(图中未显示出)之间具有一个弹性O形密封环20。图中也未示出用于防止O形密封环意外脱落的装置。
图3b和3c示出，具有隔离件14的埋入式接管的末端可适度地截成斜角，最好与接管轴线呈20度至60度的夹角。这将有助于“钝头”针管刺穿隔离件，所谓钝头针管是指针管端面与针管轴线垂直。“钝头”针管与“尖头”针管相比，其优点在于使用者受伤的危险性减少，制造针管端面的成本降低以及连针管插入时与接管壁面产生甚至最微小磨损的可能性也减少。
图4所示大部分与图3a一致，容室2内盛入的是微型药片状活性物质。相对于粉末状活性物质而言，符合本发明的微型药片形式的活性物质显然能更容易地放置在容室2中，另外药片的优点还在于，当隔膜13被针管刺穿和随后药片16a顶破薄膜14时，一方面保证了较硬的药片不会堵塞针管，另一方面保证了容室内的所有活性物质全部进入容器4内。就今天普遍应用于计量气雾剂的高效药剂而言，其活性物质溶液的精确计量对安全用药至关重要。另外，容室2中盛入片剂不会象盛入粉剂那样使封面受到灰尘的污染。
符合本发明的药片直径在2-3毫米间，最好在2.2-2.3毫米间，其长度在1.8-3.5毫米间，而其抗压强度应为2-10N/mm2。测定抗压强度时，将药片夹在平面间并增加压力直至药片破裂，药片沿两条外轮廓线与平面接触(而非以顶面与底面)。抗压强度由压力除以截面积(即直径乘以圆柱形药片的长度)得出。
符合本发明的药片由活性物质和一般的药片辅助物质组成。活性物质最好能够小剂量应用，比如每次用量不超过100毫克的活性物质。包括阿托芬(Atrovent)，抗胆碱能药(Anticholinergica)，β-拟交感神经作用药(β-Sympatikomi-metika)，如Formoterol。优选的辅助物质为乳糖(200纲目)，葡萄糖(200纲目)及成形分隔剂。
符合本发明的容器容积为4毫升，可在其中用20毫克的微型药片配制出0.5％的活性物质溶液。溶剂则优选用水或乙醇或二者的混和物。其它生理上能接受的溶剂也适用。
要从符合本发明的药筒1内抽取药液需用一针管刺穿隔离件13和14。在优选的实施例中，容器4有一个容易变形的内袋4a，而且当抽出药液时，针管末端位于容器的中部。此时，气泡的干扰作用最小。最好使用符合本发明的微型药片16a来贮存活性物质。
容器与封盖通常用塑料制成。因盛入的液体实际上不可压缩，所以当液体受热膨胀时，容器与封盖组成的系统必须能够充分地变形。同样，当抽出药液时，容器壁必须能够充分地随之变形皱缩。隔离件14一般由塑料薄膜构成，最好由封闭的镀膜铝箔构成。
制造这种容器和封盖可用适于专业人员使用的塑料，如聚乙烯或优选为聚丙烯。
符合本发明的用于一吸入器配制药剂所使用的药筒应当能长期储存。为此，在使用之前内容器4a里面的溶剂不能渗进盛有活性物质的容室2内。容室除了要有一层足够厚的壁外，还可在其内外表面敷设一层铝膜。应该强调的是，在将具有容室2的药筒装进病人的吸入器时不需要有比装一般的药筒更多的操作。

Claims (15)

1.一种用于不含推进剂的计量气雾剂的药筒，它包括一个具有封盖(3)并用来容纳液体的容器(4)，一个在封盖(3)的下缘构成的内置环状凸缘(6)，该凸缘卡锁在处于容器(4)外侧上一个环下方的封闭位置处，以及一个与封盖(3)结合的接管(5)，该接管在封盖(3)被推至容器(4)的颈部时，能排出容器的一部分内容物，
其特征在于，所述接管(5)至少包含一个容室(2)，该容室(2)通过两个可刺穿的隔离件(13)和(14)相对于容器(4)的外部和内部封闭。
2.如权利要求1所述的药筒，
其特征在于，所述容室(2)内含有药物。
3.如权利要求2所述的药筒，
其特征在于，所述容器(4)内盛有溶剂。
4.如上述任一项权利要求所述的药筒，
其特征在于，所述容室(2)内含有适合供吸入用的活性物质。
5.如权利要求1-3中任一项所述的药筒，
其特征在于，所述活性物质以药片形式存在。
6.如权利要求1-3中任一项所述的药筒，
其特征在于，所述容室(2)与外界的隔离由一隔膜(13)，与内容器的隔离由一封闭薄膜(14)构成。
7.如权利要求1-3中任一项所述的药筒，
其特征在于，所述容室(2)在其与接管(5)的连接处有易裂点，当隔膜(13)被刺穿时，容室通过作用于容室(2)内的压力会在易裂点处撕裂。
8.如权利要求1所述的药筒，其特征在于，所述的容室(2)含有供吸入用的活性物质以及可能还有药理上能接受的不让人担心的辅助物质，所述活性物质和辅助物质以微型药片形式存在，该微型药片的硬度在2至10N/mm2之间。
9.如权利要求8所述的药筒，其特征在于，所述微型药片的直径为2至3毫米，长度为1.0至4.0毫米。
10.一种用于不含推进剂的计量气雾剂所用容器(4)的封盖(3)，它包括一个在封盖(3)的下缘构成的内置环状凸缘(6)，该凸缘卡锁在处于容器(4)外侧上一个环下方的封闭位置处，以及一个与封盖(3)结合的接管(5)，该接管在封盖(3)被推至容器(4)的颈部时能排出容器的一部分内容物，
其特征在于，所述接管(5)至少包括一个容室(2)，它通过两个隔离件(13)和(14)相对于容器(4)的外部和内部封闭。
11.如权利要求10所述的封盖，
其特征在于，所述容室(2)中含有适合吸入用的活性物质。
12.如权利要求10或11所述的封盖，
其特征在于，所述活性物质以药片的形式存在。
13.如权利要求10或11所述的封盖，
其特征在于，所述容室(2)与外界的隔离由一隔膜(13)，与内容器的隔离由一封闭薄膜(14)构成。
14.如权利要求10或11所述的封盖，
其特征在于，所述容室(2)在其与接管(5)的连接处有易裂点，当隔膜(13)被刺穿时，容室因作用于容室(2)上的压力会在易裂点处撕裂。
15.如权利要求10或11所述的封盖，
其特征在于，所述隔膜由一种弹性材料制成，使得容器内部即使在被针管刺穿的情况下也能保持对外界的密封。
CN97194153A 1996-04-19 1997-04-18 用于不含推进剂的计量气雾剂的药筒及用于药筒容器的封盖 Expired - Fee Related CN1090538C (zh)

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DE19615422.7 1996-04-19

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