CN1202796C - 用聚合材料薄膜制造胶囊的方法以及胶囊 - Google Patents

用聚合材料薄膜制造胶囊的方法以及胶囊 Download PDF

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CN1202796C
CN1202796C CNB998141690A CN99814169A CN1202796C CN 1202796 C CN1202796 C CN 1202796C CN B998141690 A CNB998141690 A CN B998141690A CN 99814169 A CN99814169 A CN 99814169A CN 1202796 C CN1202796 C CN 1202796C
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thin film
welding
capsule
described method
electrode
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CN1329478A (zh
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A·德雷西
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Bioprogress Technology Ltd
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Stanelco RF Technologies Ltd
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    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract

一种用聚合材料薄膜制造胶囊(80)的方法以及胶囊。该方法包括如下各加工步骤：(a)令薄膜(39，85)发生变形以形成多个凹陷(60)；(b)用可流动性物质(62、89)填充上述凹陷(60)；(c)在焊接工段(16、92)将薄膜焊接到一起以形成多个填有填充物质的封闭体；以及(d)将填充好的封闭体从薄膜的剩余部分上切下，以形成多个独立的胶囊；其中焊接加工步骤为在两个相对的电极(14、95)之间进行的电介质焊接加工步骤。本发明方法中采用两层水溶性聚合材料薄膜(39、85)。

Description

用聚合材料薄膜制造胶囊的方法以及胶囊
技术领域
本发明涉及一种制造胶囊的方法和设备及其所制成的胶囊，这些胶囊应用于分送药剂等场合。
背景技术
很多种药剂和其他物质用胶囊来分送。当内容物为微粒状物质如粉末时，可以采用一种硬胶囊来封装，其一般是一种两端为圆形的细长圆柱胶囊，这种胶囊由两半构成，在将内容物填充好后将其装配到一起。而当内容物为液态和微粒状物质时，均可用软胶囊来盛装，这种胶囊用一种弹性聚合物薄膜制成，两层或多层薄膜通过表面带凹陷的旋转模具压合到一起。填充到胶囊中的物质在薄膜沿凹陷变形的过程中从两层薄膜之间送进；随着模具的移动，薄膜被带动相贴合并通过模具上相应的加热和/或加压而密封到一起。通常上述两种胶囊均用明胶膜制成。用电介质加热(或射频加热)来连接热塑性聚合物膜的方法已经有许多年的历史了。在这种方法中，两片热塑性材料被放置在两个正负电极(或一个电极和一块基板)之间，两个电极被压到一起，然后在两个电极之间加上射频电压。这种方法只适用于那些电介质损耗指数很高的材料，例如在20-60MHz范围内该指数大于0.2的材料，如聚氯乙烯。迄今为止，用电介质焊接法焊接水溶性聚合物的方法还未被认为是适用的，而这种聚合物是一种制造药剂颗粒胶囊的理想材料。
在专利GB-A-908 344中Lavaud阐述了电介质加热法在用可热焊材料制作胶囊过程中的应用，薄膜带从模具中间通过时，薄膜被吸入模具中以形成两组相对的凹陷，而后上述凹陷中充入欲填充的物质，然后通过在两半模具之间加上高频电流而将薄膜焊接到一起，最后胶囊从薄膜带上被切下。用明胶以外的其它薄膜来包装药品的方法以为人们所用很多年了，例如美国专利US-A-4 154 636(Motoyama等人)中所述的，薄膜通过电脉冲加热器的加热产生热粘结而连接到一起；该专利中提到水溶性聚合物，如羟丙基甲基纤维素，而且也提到聚合物可以食用。相似地在专利EP-A-0 211 079中也阐述了一种用明胶或混合有明胶以提供不同溶解度的羟丙基甲基纤维素邻苯二甲酸酯等材料制成的薄膜以制造具有两个分隔区的软胶囊的方法。
发明内容
本发明提供一种用聚合材料薄膜制造胶囊的方法以及胶囊。该方法包括如下各加工步骤：(a)令薄膜发生变形以形成多个凹陷；(b)用可流动性物质填充上述凹陷；(c)在焊接工段将薄膜焊接到一起以形成多个填有填充物质的封闭体；以及(d)将填充好的封闭体从薄膜的剩余部分上切下，以形成多个独立的胶囊；其中焊接加工步骤为在两个相对的电极之间进行的电介质焊接加工步骤；其特征在于，该方法中采用两层水溶性聚合材料薄膜。
利用上述步骤可对薄膜在多个不同的位置上或一个位置上进行操作。但仅在一个位置上进行上述所有步骤的操作可以免去凹陷与焊接或切割装置之间的对中操作及相应问题。焊接位置由两个相反电极确定，这两个电极可压合在一起，并通过一个供电装置向这两个电极提供高频电源。
上述电源的频率大致在1MHz-200MHz的范围内，通常为10MHz-100MHz，但所发射的任何射电波均受到严格的限制。因而在实际应用中，频率的选择范围可能更窄。例如，电源频率可能27.12MHz，或40.68MHz。在至少一个电极上还电连接有一个调谐回路，例如该调谐回路可连接在一个电极和地电势之间。例如，一个由电感和电容串联而成的调谐回路可连接在一个电极和地电势之间，优选地，该调谐回路在与电源频率大致相同的频率上发生共振。
确定焊接位置的电极优选地可以彼此相向或相离地移动，以使薄膜可被夹住并压在两个电极之间。在上述两个电极的至少一个上装有一个加热器，用以对薄膜进行加热。至少一个电极上具有凹陷，这些凹陷的形状与薄膜上凹陷的形状互补。电极上还可能装有一个保持装置，用于在焊接过程中将薄膜保持在一个或每个电极上，该保持装置可通过抽吸力来操纵。
优选地，在焊接加工步骤之前将聚合物制成一个袋子，然后将填充材料在焊接前填入两片薄膜形成的袋中。这个袋的至少一条接缝是通过将薄膜焊接到一起而形成的，而上述焊接是通过加热或电介质焊接的方法来实现的。该袋子的一条接缝可通过将一条较宽的聚合物材料薄膜折叠以构成两个相对的薄膜来形成。凹陷可通过模压的方法形成，优选地通过将薄膜放置在模具上而形成，该模具上具有多个与将要形成的凹陷相对应的凹陷。薄膜可被抽吸到模具上的凹陷内而被模压成形。薄膜在模压之前也可能通过例如加热的方法进行软化。如前所述，本方法的各个步骤可在同一位置进行，此时模压凹陷可被确定在焊接电极上。胶囊的落模优选地用冲切的方法实现，因此在焊接电极上也可装上冲切装置。
填充物质可能是一种药剂颗粒，但优选地是一种液体。上述聚合材料可能是聚乙烯醇，尽管这种材料不能食用，但它是水溶性的生物可降解材料。如果这种胶囊被吞咽(例如当其中装有药剂颗粒或一种营养增补剂时)，那么这种聚合材料应当是可食用的。此时这种材料可以是如明胶、或是水溶性纤维素衍生物等，比如羟丙基甲基纤维素，它被批准用于药剂颗粒和食品(在欧洲这种材料的编号为E464)。这种聚合材料不能含有任何有害或有毒的添加剂，但可以含有增塑剂，如甘油(E422)、单乙酸甘油酯、对乙酸甘油酯或三乙酸甘油酯，或单硬脂酸甘油酯(E471)等化合物，这些化合物也是可食用的并且可分散或溶解于水中；还可以含有防腐剂如甲烷基-4-羟基苯甲酸酯(E218)等。其他合适的纤维素类衍生物还有羟基丙基纤维素(E463)和甲基乙基纤维素(E465)等。
本发明还提供一种利用上述方法制成的胶囊，该胶囊填充有可流动的填充材料，其中该胶囊具有围绕着其内侧的焊接接缝的焊道。
附图说明
下面将参照附图说明本发明的实施例，以使本发明得以进一步和更详细地阐述。
图1是一种电介质焊接设备的示意图；
图2是生产胶囊的设备的示意图(与图3至6相比为比例缩小图)；
图3是图2中设备沿袋形成工段的纵剖面示意图；
图4是图2中设备沿已填充的袋子的纵剖面示意图；
图5是图2中设备沿焊接工段的纵剖面示意图；
图6是图2中设备沿冲切工段的纵剖面示意图；
图7是沿用图2设备制成的胶囊的纵剖面放大图；
图8是生产胶囊的一个替代设备的示意图；
图9是图8中设备的部分纵剖面图。
具体实施方式
图1中概略地示出一种用于焊接聚合材料12的焊接设备10，上述材料是可吸收的、药用级材料，例如一种纤维素衍生物如羟丙基甲基纤维素。两个电极14在其间确定了一个焊接位置或焊接工段16。一个电源18向两个电极14提供高频电源。在本说明书中高频一词是指聚合物工业中常用的含义，特别地要包含一个可在欧洲使用的用电介质焊接方法焊接聚合材料的频率，如27.12MHz。两个电极14A，14B由同一个电源供电，但其中一个电极14B通过一个调谐回路20与地电势相连。该调谐电路20包括串联在一起的一个电感22和一个电容24，其中电感22与电极14B相连，而电容24与地电势相连。该回路20具有一个共振频率，在这个频率上该回路阻抗最小，选择合适的回路元件以使该回路的共振频率与电源18的频率相同或相近。这样就可使相对较大的电流通过，而不会在电极14附近产生高的高频电压。
电极14上也带有两个驱动器26，可使电极14沿双箭头28所指方向相向或相离移动。这两个驱动器26可以是液动、气动或电动的。(很显然，也可以将一个电极固定而让另一个电极移动。)
装置10按下述方式工作：首先，两层聚合材料12被放置在电极14之间，然后这两个电极14由驱动器26带动合在一起夹持两层聚合材料12。电源18被接通，而后在电极14之间的聚合材料由于聚合物中的电介质损耗而被加热。两层聚合材料12的相对表面变得很热，足以使其熔合到一起，而其与电极14相接触的外表面仍保持在电极14的温度。这样，两层薄膜12在其被夹持在电极14之间的位置上被焊接到一起，经过一段合适的时间，电极14退回，将焊好的薄膜12释放。一个实施例中，电源18的工作频率为27.12MHz，电压为6kV，采用这种工况可在3秒中之内在厚度为0.1-0.2mm的羟丙基甲基纤维素层上形成一条满意的焊缝。众所周知，焊接可以在多种频率下实现，例如在1-100MHz的范围内，且薄膜的厚度可增大到约为1mm，焊接时间随焊接厚度的增加而增加。这个方法可提供良好的焊接性，而不会损坏聚合材料，特别是未发现材料发生离子化、起弧、燃烧和降解的问题。
下面参照图2，图中示出一个用来制造填充好的胶囊的设备29，特别地适用于制药工业。该图概略地示出聚合材料(如羟丙基甲基纤维素)带39通过连续的加工工段的路径，该连续加工工段包括：袋形成工段30、凹陷形成工段32、填充工段34、焊接工段16、冲切工段36。材料从图中左侧进入设备29，并在设备29中向前移动，最后从图中右侧出来。在进入袋形成工段30之前，两条细长的带状聚合材料薄膜在一个大致垂直的平面内被送到一起并相互对齐。起初这两层薄膜可以是分开的，但优选地可通过沿较宽带39的长度方向上进行折叠形成一个折叠边38来形成，从而该折叠边38形成了折叠后的带39的底部，因而该折叠后的带39沿其上边缘40是打开的。
在袋形成工段30，两对电极42被送到一起以沿两条横线44将带39夹紧。电极42布置得如图1中所示的设备10那样，以便在横线44处进行焊接，从而在区域48处形成一个由两侧的焊缝和底部的折叠边38围成的上开口袋子。横线44一直延伸到折叠边38处，但并不延伸到带39的上缘40处。形成上述袋子后，带39由位于其长度方向上的合适的辊子50(或其他驱动装置)带动向前移动。辊子50的排列方式使其可对带39的每个运动提供精确地分度。
带39随后移动到凹陷形成工段32。在这一工段32中，如图3中截面所示，在工段30中形成的袋子被两个模具块52夹持，这两个模具块上具有多个凹陷54，形成了沿其表面的凹陷阵列。加热元件56安装在模具块52的后面。在两模具块52中设有空气道58，该空气道与每个凹陷54相连通，且在每个空气道末端均与一个泵P相连。当带39被夹持在两个模具块52之间时，加热元件56使材料12软化，以使其通过泵P的抽吸作用被吸入凹陷54中而发生变形。所需的加热温度和抽吸力的大小取决于凹陷54的尺寸和带39的材料特性。上述材料被吸入凹陷54后，在该工段32保持一段时间进行冷却，以使材料保持其新的形状，其新形状为在袋子的每个壁上均形成了多个凹陷60。(很显然，在袋子的两个相对壁上均将形成多个凹陷60，因此最终的胶囊将会是对称的，但胶囊也可通过仅在袋子的一个壁上形成的凹陷而制成。)图2中表示形成6个这样的凹陷60，但实际上可以同时形成很多凹陷如25个凹陷60，或200个凹陷。
具有凹陷的袋子接下来被送入填充工段34，在该工段，袋子内部被填充上胶囊内所要填充的物质。图2概略地示出该步骤中胶囊填充物质62从烧杯66中被倒入袋64中的情形。袋子可能被装得溢满以保证每个凹陷60均被物质62完全填满，如图4中所示，同时在袋子中还剩下大量的物质62。此时这些剩余的物质62将袋子的两壁68相互分开。
接下来填充好的袋子进入焊接工段16，如图5所示。在该工段，两个焊接电极14移动到一起将袋子夹住。每个电极14的表面都有一个凹陷70的阵列，当袋子与焊接工段对准后，这些凹陷70与袋子上的凹陷60相对准。由于要生产的这种药剂颗粒胶囊的尺寸相对较小，而且要求袋子上的凹陷60与电极上的凹陷70相对准，因此对驱动机构50的精确对中有很高的要求。图5中示出在焊接工段16，电极14移动到一起将袋子两个相对的壁夹持到一起的情形(该夹持位置与袋子壁上的凹陷60有一定距离)。这种夹持使得袋中剩余的物质62向袋子的开口顶部72处聚集，但凹陷60仍然填充有物质62。(如果需要可配置与在凹陷形成工段32中采用的加热器和/或空气道和泵相似的装置，以确保凹陷60保持其在焊接工段60处被夹持后的形状。)如上所述该焊接工段如图1所示具有电气连接，以便当电源18接通后，两层带39上除凹陷60部位以外的袋子壁的整个面积上均被焊接到一起。这样就使填充好的胶囊阵列中的每个胶囊均得到密封，而且它们相互之间通过一条焊合带39构成的网相连。
焊接完成后，胶囊阵列被带动向冲切工段36移动。当焊好的袋子离开焊接工段16，位于带39两侧的辊子74夹住袋子的上缘72，从而将多余的物质62沿带39压回，并流动到将要在填充工段34中被填充的下一个袋子中，这样就减少或消除了由初始填充袋子过满而造成的浪费。在冲切工段36也需要精确的对中，此时是为了将冲切模的凸模75和凹模76对准。凸模75上具有与凹陷60的尺寸和形状相同的切刃。凹模76形成相应形状大小的孔，以使凸模75和凹模76可以结合到一起，将填充好的胶囊从焊好的带39上切下或冲下。
下面参照图7，在上述各工段中形成的胶囊80包括由两层相对的带39形成的两半77A和77B，在一条连续的缝78处被焊在一起，从而构成了一个填充有物质62的封闭体。由于在焊接过程中聚合材料发生熔化，因此在各胶囊80内壁焊缝的周围形成了一条熔融材料焊道，以使当该胶囊被冲切下后，在焊缝78周围的壁厚要比其他地方略厚一些。胶囊80的密封方法本身允许内容物质62可以是液体，这样可利用这种胶囊80分送很多种药剂颗粒。例如，这种胶囊80可以为椭圆形，长轴为10mm，短轴为7mm。采用纤维素衍生物(如羟丙基甲基纤维素)制作层进而形成胶囊的壁，在制药场合中使用已证明有很多好处，而且在其水溶性和没有毒副作用等方面都有显著的优越性。
胶囊壁的溶解性意味着胶囊在病人体内会很快分解，使药剂颗粒得以很快地释放。在某些场合，释放速度可能相对过快。此时，出于美学考虑或味觉和处理方便等考虑，胶囊可能被包在一层额外材料内，如糖衣等来改善味道，或一种溶解性较差的外壳以减慢释放速度。
从以上对焊接装置的描述中可以看出，两个电极14和待焊的材料层是直接接触的。因此在电介质焊接方法中常用的隔离膜就不需要或不使用了。这样就避免采用一种潜在的污染源，尤其是当常用隔离膜为纤维膜时更容易产生污染，从而提高了这种方法在制药场合的可接受性。本发明的一个突出优点是胶囊80内可填充液体。这种液体可以是一种药物活性物质的溶液、或液态的药品、或液态的药物乳化物质、或药物活性油或其它液体。应当明了填充物质必须与带39的材料相容，特别地，水和水溶液不适于装在由高水溶性纤维素衍生物构成的胶囊中。
在不超出本发明范围的情况下，可对本发明的设备进行多种变通和修改。例如，袋形成工段30和凹陷形成工段32的顺序可以颠倒。此时，凹陷形成工段32中可能包括位于各层之间的加热元件，并有适当的预防措施防止加热后的材料粘到一起。袋子和胶囊的大小、凹陷的分布情况、每个袋子上形成的凹陷数目，以及最终形成胶囊的体积均可被较大地变动。此外，显然也可在一次焊接操作中将三层薄膜焊接到一起，使具有凹陷的薄膜在外层，这样就可制成一种有两个分隔区的胶囊，其中每个分隔区内装有不同的物质。三层薄膜可由三条单独的薄膜构成，也可由一条薄膜折为两层后在其中平行地夹入另一层薄膜而构成。优选地，薄膜材料采用制药级纤维素衍生物，但也可采用其它材料如明胶等。也可以在胶囊中填入粉末，但此时焊接特性需要调整，因为粉末在电介质焊接中的变化与液体大不相同。上述图2中的设备适用于加工单条带39的场合。或者，每个袋子均可单独地制成，而后通过一次次处理使其在不同工段间移动。但优选地采用连续带送进，这样可以减少对单个袋子的处理操作。如果能在一个工段或者是同时地或者是顺序地实现一个以上的操作，则可减少工段的数目。事实上，在一个位置上可以实现所有的操作，但本发明中需要有对一系列工段在这种情况下工作方式的参考说明来辅助对本发明的理解。
下面参照图8对一种替代设备82进行描述，其原理与图2中设备29的不同之处在于：它只包括两个加工工段，而且聚合材料的薄膜在设备82中垂直移动。辊子84将两条连续的带85送进一个焊缝形成工段86，该带是由含增塑剂的羟丙基甲基纤维素膜形成。在焊缝形成工段86，带85的两边被压到长度为105mm被加热至175℃的可缩棒88之间，从而使两边被焊到一起。因而，带85在工段86以下的整个长度就形成了一个管或袋子。胶囊的填充物质89通过一个导管91从一个储藏容器90中倒入上述管中。在焊缝形成工段86下面是凹陷形成和焊接工段92，其高度为100mm。焊缝形成工段86和焊接工段92的操作是同步的，然后传送机构94将由带85形成的管向下移动100mm。
凹陷形成和焊接工段92包括两个相对的可退回黄铜电极95，其相对的表面确定了相匹配的孔阵列，例如，三十个椭圆孔。每个电极95均安装在一个电加热器96上以使其温度保持在75℃。一个电极95接地，而另一个通过一个铜片与高频发电机98相连。下面参照图9进行说明，该图为工段92的部分剖面图，仅示出电极95上的一对孔。紧配合在每个孔中的为一个硬塑料(聚醚甲酮)棒100，其末端被弯成凹陷式的以限定电极95表面上的凹陷102，该棒100的长度方向上有一个贯通轴孔104。棒100与各个孔紧密配合，但可沿轴线方向压缩弹簧(未示出)而移动约1mm。
这样，在工段92的操作中，由带85形成的一段管由机构94带动向下移动进入工段92。电极95朝向带85移动，经过几秒钟(以使薄膜85被加热并软化)后，用泵(未示出)对每个轴孔104进行抽吸。从而使得每层薄膜85发生变形而形成一个三十个凹陷的阵列。所有这些凹陷中均充满物质89。
接下来，两个电极95压实到一起(因此多余的材料89就被挤入管子在工段92上方的部分中)，然后高频发电机98起动，产生频率为40.68MHz的信号。这一信号的功率在例如1KW-6KW的范围内，并持续1-6秒。这样，在电极95除凹陷102以外的整个面积上实现对带85的电介质焊接。其结果是填充好的胶囊阵列均被由焊合的带85构成的网所密封并连接。棒100然后向侧面移动(如图9中向右侧移动)1mm，然后释放，此时胶囊被与右边电极95上的孔相啮合的棒100的末端从电极95左边的带85上冲下。最后电极95被移动而分开，将已冲出许多孔的网和与图7所示大致相同的胶囊释放出来。
应当明了设备82避免了设备29中所必需的凹陷与孔的对中操作，但工段92要比设备29中的相应工段复杂得多。此外，研究还发现，在水溶性纤维素衍生物薄膜85中加入增塑剂、如单硬脂酸甘油脂可以改善焊接方法。应当明了：可对设备82进行多种方式的修改，如形成不同数目的凹陷、或用其它硬质材料如不锈钢来制作棒100。

Claims (14)

1.一种用聚合材料薄膜制造胶囊(80)的方法，该方法包括如下各加工步骤：
(a)令薄膜(39，85)发生变形以形成多个凹陷(60)；
(b)用可流动性物质(62、89)填充上述凹陷(60)；
(c)在焊接工段(16、92)将薄膜焊接到一起以形成多个填有填充物质的封闭体；以及
(d)将填充好的封闭体从薄膜的剩余部分上切下，以形成多个独立的胶囊；
其中焊接加工步骤为在两个相对的电极(14、95)之间进行的电介质焊接加工步骤；
其特征在于，该方法中采用两层水溶性聚合材料薄膜(39、85)。
2.权利要求1中的方法，其特征在于，薄膜(39)在多个不同工段(32、34、16、36)上完成上述各加工步骤，在每个工段完成一个所述加工步骤。
3.权利要求1中的方法，其特征在于，薄膜(85)在一个工段(92)上完成上述各加工步骤。
4.权利要求1至3中任一项所述的方法，其特征在于，电介质焊接加工步骤的频率在1MHz-100MHz之间。
5.权利要求1至3中任一项所述的方法，其特征在于，在至少一个电介质焊接电极(14B)上电连接有一个调谐回路(20)。
6.权利要求1至3中任一项所述的方法，其特征在于，在至少一个电极上装有加热器，以对薄膜进行加热。
7.权利要求1至3中任一项所述的方法，其特征在于，薄膜在焊接加工步骤之前被制成袋，而且在焊接加工步骤之前将填充物质装入袋中。
8.权利要求1至3中任一项所述的方法，其特征在于，聚合材料为可食用的。
9.权利要求8所述的方法，其特征在于，聚合材料为羟丙基甲基纤维素。
10.权利要求1至3中任一项所述的方法，其特征在于，在电介质焊接加工步骤中两个电极之间的电压是受限的。
11.权利要求1至3中任一项所述的方法，其特征在于，上述薄膜(39、85)中还含有增塑剂。
12.权利要求1至3中任一项所述的方法，其特征在于，进行焊接加工步骤时无需在电极和被焊接的薄膜之间采用隔离膜。
13.一种用权利要求1至3中任一项所述的方法制成的胶囊(80)，该胶囊填充有可流动的填充材料，其中该胶囊具有围绕着其内侧的焊接接缝的焊道。
14.权利要求13所述的胶囊，其特征在于，聚合材料包括水溶性纤维素衍生物。
CNB998141690A 1998-10-06 1999-09-30 用聚合材料薄膜制造胶囊的方法以及胶囊 Expired - Fee Related CN1202796C (zh)

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