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CN1262456C - 由活性成分薄膜生产小的薄片的方法和设备 - Google Patents

由活性成分薄膜生产小的薄片的方法和设备 Download PDF

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CN1262456C
CN1262456C CNB028049721A CN02804972A CN1262456C CN 1262456 C CN1262456 C CN 1262456C CN B028049721 A CNB028049721 A CN B028049721A CN 02804972 A CN02804972 A CN 02804972A CN 1262456 C CN1262456 C CN 1262456C
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CN1525853A (zh
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沃尔夫冈·撒弗尔
罗纳尔德·海克贝斯
迪特勒夫·努兰德
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Abstract

本发明涉及由活性成分薄膜(2)生产小的薄片的方法和设备，其中，此活性成分薄膜通过将薄膜材料注入基质材料或通过将一层薄膜材料涂覆在基质材料上，在含或不含基质材料的情况下将其储存在卷轴上，再将其从卷轴上剥离并进行切割而生产。本发明的目的是设计一种尽可能精确地按预定大小生产小薄片的方法。为达到这一目的，活性成分薄膜(2)被自动剥离而与存在的基质材料分离，且处于张紧状态的活性成分薄膜被送到切割台以沿着进料方向切割成具有预定宽度的长而狭的带(7)，且此长狭带(7)沿进料方向聚集并由另一进料装置(10)输送到横向切割器(11)，该横向切割器按预定间距切割聚集在一起的长狭带(7)。

Description

由活性成分薄膜生产小的薄片的方法和设备
技术领域
本发明涉及生产具有一或多种活性成分的小薄片的方法和设备，特别是用作药物计量(metering)和给药形式。
背景技术
除了已知的药物计量形式，如片剂、胶囊、滴剂或类似的给药形式外，还有“薄片”的给药形式。这种给药形式为一种包含或含有预定量的活性成分的小薄片，其厚度和大小与要给予的活性成分的量相适应。因为薄片的接触面积与活性成分的计量直接相关，所以其大小必须尽可能与计算的尺寸一致并在耐受范围之内。因此，薄片的生产是相当复杂的。
已知可通过浇铸方法或涂覆方法生产活性成分薄膜，通常，在含或不合基质材料的情况下，活性成分薄膜被浇铸或以其它的一些方式被涂覆到薄膜材料上，然后被缠绕成卷并储存。如果活性成分薄膜与基质材料一起缠绕，在活性成分薄膜形成小薄片的后续处理过程中，基质材料从活性成分薄膜脱离并分别缠绕起来。切割薄的具有弹性的活性成分薄膜，获得的实际大小常常不能与所需的按照药物的计量设定的尺寸公差一致，这反映为活性成分的耐受性高于面积。
发明内容
本发明的目的是提供一种由活性成分薄膜生产小的薄片的方法，使尽可能精确地按预定尺寸生产小薄片成为可能。
本发明对由活性成分薄膜生产小的薄片的方法和完成该方法的装置进行详细说明。
因此，由活性成分薄膜生产小的薄片的方法中，通过浇铸薄膜材料到基质材料上或涂覆一层薄膜材料到基质材料上生产该薄膜并在基质材料存在或不存在的情况下将该薄膜储存在卷轴上，其中该活性成分薄膜从储存卷轴上剥离并被切割。该活性成分薄膜自动从储存卷轴上剥离，并与存在的基质材料分离，且处于张紧状态的活性成分薄膜被输送到狭带切割台，并于此相对于进料方向被沿纵轴方向开始切割成具有预定宽度的长狭带，然后，多个狭带沿进料方向聚集在一起，并通过另一进料装置成组地输送到横向切割器，按预定间距切割该组狭带。对活性成分薄膜的纵向切割和横向切割在物理顺序和时间上是彼此跟随进行的，并产生多边形，特别是长方形或正方形，的小薄片。该活性成分薄膜至少在其宽度方面是按这样一种方式切割的，即按预定的尺寸切割成小薄片而没有任何残留或浪费。小薄片的尺寸会影响到计量。活性成分薄膜在一预加的压力下被输送到狭带切割台的情况有助于切割操作的进行，同样，沿纵向切割的薄膜狭带被聚集在一起以形成狭带组的情况也帮助和简化横向切割，而且在生产小薄片时增加了工艺的可靠性和尺寸的精确性。
有利的是，将活性成分薄膜从储存轴上剥离和将其输送到纵向切割台，及将其纵向切割成薄膜狭带的操作是连续发生的。
为帮助纵向切割，在活性成分薄膜中产生一预压力，使该薄膜平展并因此进行精确的纵向切割操作，为此，可简单地对活性成分薄膜施加一与进料方向横切的负荷，特别是通过一确定重量的重物，其与活性成分薄膜的宽度一起确定预压力的大小。
被切割的薄膜狭带优选被聚集在一起以形成叠层，因而平展地彼此相叠排列。薄膜狭带的进一步进料按简单的方式间歇性地进行，且可进行可靠的设计。为输送叠层并将其推向横向切割器，通过夹住其上下侧的夹爪抓住和夹紧叠层，并间歇性地推向横向切割器。为使该方法步骤也能在高工艺可靠性和尺寸精确性的情况下进行，在夹持装置的下游，为保证狭带精确地相叠排列，结合进一步的平展和产生预压力，叠层以滑动方式被引导以保持其尺寸，且在通过进料装置剥离和输送至横向切割器的过程中，各狭带间的相对运动及材料或狭带的延伸差异受到抑制。
在实施该方法的装置中，包括用于带薄膜材料的储存卷轴的固定装置、由电动机驱动用于将活性成分薄膜剥离储存卷轴以拉出至少该卷轴的宽度进料辊、由进料辊和与其相互作用的切削刀片装置构成的狭带切割装置、聚集并叠加所说的切割薄膜狭带的装置(堆叠装置)和用于切割薄膜狭带的另一进料装置，及横向切割装置。用于平展狭带叠层的装置及与另一进料装置结合的用于产生预压力的装置被设置在堆叠装置和另一进料装置之间。
两个用于活性成分薄膜的导辊被设置在储存卷轴和进料辊之间的进料区域，并与这些部件平行排列，这两个导辊之间的跳动辊被安置在活性成分薄膜上以在该薄膜中产生压力。切削刀片装置具有圆形的切削盘，它们相互间隔一段距离转动，且平行于进料方向相互间隔一段距离被固定在固定装置上并施压于在进料辊上前进的活性成分薄膜上。切削盘之间的间距是可调的。
用于被切割的进料狭带的联合和堆叠装置构成整个装置的一个部分，这一类型的装置在德国专利19925339 A1中有所描述。
被聚集到一起并堆叠起来的薄膜狭带通过夹持进料系统被间歇性地进料，该夹持进料系统间歇性地抓取叠层并在其上施加张力，也将该叠层推向横向切割器。
一U形的三侧滑轨被设置在堆叠装置和夹持进料系统之间，在其中叠层通过夹持进料系统移动。保持在静止位置但使其能在垂直导轨中移动并停留在移动的叠层上，因此使叠层在进料移动中平展的重物被设置在该滑轨上。该滑轨向一与进料方向横切的轴作凸弯曲，如叠层的俯视图中所示，以使在叠层中产生确定的预压力，而夹持进料系统必须以精确的抵抗力克服该预压力。夹持进料系统的进料部分决定小薄片的长度。
夹持进料系统具有两个夹爪，它们通过传送凸轮与驱动装置联结，并相对于进料方向前后移动。为达到向前移动的目的，从叠层位于横向切割器的一侧的一端按一定距离夹住叠层的夹爪与在滑轨上产生的阻力相反将叠层拉出滑轨，同时将位于夹持进料系统前方的确定长度的叠层部分沿进料方向推送到横向切割器。传送凸轮被偏心安装，并与夹爪连续咬合，以使传送凸轮的连续放置转化成固定的夹爪的前后平移运动。传送凸轮大小或形状的改变会导致该平移运动幅度的改变，并因此在进料中导致叠层的切割长度和小薄片的长度能被预先确定。
附图说明
下面将参照示范性的实施例对本发明进行说明。附图显示了由活性成分薄膜生产小薄片的装置，部分是图解性的。
图1为本发明的整体装置的示意图。
具体实施方式
本装置包括一具有位于未显示的固定装置中的厚度约为0.05mm的活性成分薄膜2材料的储存区域1、一电动机驱动(M)的真空辊3和一用于将活性成分薄膜2从储存卷轴1剥离的进料辊、一由真空辊3和与其相互作用的切削刀片装置4构成的纵向切割装置5、一用于被切割的长狭带7的堆叠装置6、一横切面为U形的用于由长狭带7形成的叠层9的三侧滑轨8、一夹持进料系统10和一用于叠层9的横向切割装置11。两个用于活性成分薄膜2的导辊12被设置在储存卷轴1和纵向切割装置5之间，与储存卷轴1平行，而一作用在该活性成分薄膜2上以拉紧该薄膜的跳动辊13被设置在这两个导辊12之间。
切削刀片装置4包含一固定装置14，其未被详细显示，和可旋转的圆形切削盘15，其彼此间隔一段可调的距离固定在该固定装置上，并平行于活性成分薄膜2的进料方向定位，向活性成分薄膜2上施加压力，当活性成分薄膜2被真空辊3向前推动时，依照圆形切削盘15的排列沿纵向切割薄膜。在本示范性的实施例中，切削盘15之间的距离是20mm。
在堆叠块16中，堆叠装置6具有相应于各长狭带7的真空传送通道17，其与一真空装置(未显示)联结并与其它的真空传送通道17一起相邻排列，被连接到一共同入口18。在该堆叠块16中，通道17按这样一种方式延伸，即它们集合并在共同出口19彼此相叠排列。
堆叠装置6之后是三侧滑轨8，它环绕与进料方向横切或平行于真空辊3或辊1、12和13的轴向的轴A弯曲，并容纳叠层9以引导其侧面，三侧滑轨8的侧壁间的宽度实际上相当于叠层9的宽度。在一未显示的垂直导轨中，自叠层9的120g的重物20搁置在叠层上，而因此使其紧密和平展。
沿进料方向，夹持进料系统10被设置在三侧滑轨8的下游，该夹持进料系统具有两个夹爪21和22，它们上下相叠排列，间歇性地抓取叠层9并通过一可替换的偏心传送凸轮23与驱动装置24联结。这些部件(23、24)相对于进料方向前后移动夹爪21、22，在这一运动过程中夹爪21和22在其后死点位置I夹住叠层9并在其前死点位置II释放该叠层。
夹持进料系统10之后是引导爪25，叠层9在引导爪之间滑动到横向切割装置11，其中叠层9在两个切割刀片之间被横向切割。叠层段的预定长度是25mm，其结果薄片的尺寸为20×25mm。
生产出来的薄片随后在包装机上被包装在药袋(dispensers)、薄膜包装或管状袋中。

Claims (14)

1、由活性成分薄膜生产小的薄片的方法，其中此活性成分薄膜通过将薄膜材料浇铸到基质材料上或通过将薄膜材料涂覆在基质材料上，在含或不含基质材料的情况下将其储存在卷轴上，再将其从轴上剥离并进行切割而生产，其中该活性成分薄膜被自动剥离而与存在的基质材料分离，分离后处于张紧状态的活性成分薄膜被送到切割台以沿着进料方向切割成具有预定宽度的长而狭的带，且此长狭带沿进料方向聚集并由另一进料装置输送到横向切割器，该横向切割器按预定间距切割聚集在一起的长狭带。
2、如权利要求1所述的方法，其中该活性成分薄膜通过一驱动辊剥离储存卷轴并连续进料到切割台，其间该活性成分薄膜被引导并被切割成长狭带。
3、如权利要求1所述的方法，其中该长狭带被聚集在一起并相互堆叠排列以形成叠层。
4、如权利要求1或3所述的方法，其中该叠层被另一进料装置拉动通过一滑动导轨，并在此过程中使其平展。
5、如权利要求1所述的方法，其中该叠层是间歇性地被推进到横向切割器。
6、一种完成权利要求1所述的方法的装置，其中该装置具有一固定装置，用于定位具有活性成分薄膜的卷轴，一驱动进料辊，用于将薄膜剥离储存卷轴；一纵向切割装置，由进料辊和切削刀片装置构成；及一用于切割的长狭带的横向切割装置；一堆叠装置，具有排列在一起的传送通道；和使已切割的狭带平展并进料至横向切割装置，位于纵向切割装置和横向切割装置之间的装置。
7、如权利要求6所述的装置，其特征在于活性成分薄膜的两个导辊被设置在储存卷轴和纵向切割装置之间，且与储存卷轴平行，在两导辊之间跳动辊作用在该薄膜上。
8、如权利要求7所述的装置，其中切削刀片装置由一固定装置和若干按一可调的间隔相邻排列在该固定装置上的，并与活性成分薄膜的进料方向平行地排列的圆形的切削盘组成。
9、如权利要求6所述的装置，其中用于堆叠的装置包括排列在一起的真空传送通道，通道的进口横向彼此相邻排列，而通道的出口纵向彼此相叠排列，且各长狭带具有一与之相联系的真空输送通道。
10、如权利要求9所述的装置，其中用于所形成的叠层的、横切面为U形的三侧滑轨被设置在堆叠装置的下游，且在该滑轨上至少有一个固定在处于静止状态的导轨中的重物，该重物滑过沿滑轨滑动的叠层，因而使长狭带平展。
11、如权利要求10所述的装置，其中该三侧滑轨绕与进料方向横切的轴向下弯曲。
12、如权利要求10或11所述的装置，其中一夹持进料系统被设置在沿进料方向的三侧滑轨的下游，该系统间歇性地抓取叠层并将其输送到横向切割装置。
13、如权利要求12所述的装置，其中该夹持进料系统具有两个用于抓取叠层的夹爪，其通过一可替换的沿进料方向前后移动夹爪的偏心传送凸轮与驱动装置联结，而在向前移动过程中夹爪牢牢地夹住叠层。
14、如权利要求13所述的装置，其中在夹持进料系统和横向切割装置之间设置一导向部件。
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