CN1212825C - 制造胶囊的方法 - Google Patents

制造胶囊的方法 Download PDF

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CN1212825C
CN1212825C CNB018065813A CN01806581A CN1212825C CN 1212825 C CN1212825 C CN 1212825C CN B018065813 A CNB018065813 A CN B018065813A CN 01806581 A CN01806581 A CN 01806581A CN 1212825 C CN1212825 C CN 1212825C
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A·德赖西
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Stanelco RF Technologies Ltd
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Abstract

胶囊，例如用于药物传送的胶囊，是通过将两片水溶性聚合材料的薄膜(18)变形而形成多个凹槽，并向凹槽中填入易流动的填充材料而制成的。这是利用相邻的两个具有使薄膜(18)在内变形的凹槽(16)的旋转模具(14、15)来完成的。模具(14、15)还充当通过介电焊接将薄膜焊在一起以形成充满的胶囊(30)的电极。胶囊(30)能够容易地与合成网膜分离开。聚合材料可以是明胶，或者是如羟丙基甲基纤维素的水溶性纤维素衍生物，而且还可以包含增塑剂。

Description

制造胶囊的方法
技术领域
本发明涉及一种形成胶囊(例如用于传送药物的胶囊)的方法和装置，还涉及由此得到的胶囊。
背景技术
多种药物以及其它材料是通过胶囊传送的。当材料是微粒材料例如粉末时，它可以密封在硬囊里，典型的是伸长的圆头圆柱形且为了围着材料装配而制成两片。液体和微粒材料都可以密封在软胶囊里，这些胶囊由软弹性聚合物薄膜在表面上有孔的旋转模具之间集合而制成。当薄膜变形进入空腔时，将胶囊填充材料供应到薄膜之间；此时模具将薄膜集合并通过施加在模具上的热和/或压力将薄膜密封在一起。每类胶囊通常都由明胶薄膜制成。利用介质加热(或射频加热)的热塑性聚合物薄膜的结合技术也是多年来公知的技术。在这种方法中，将两片热塑性材料定位在相对的电极(或一电极和一底座)之间，将电极压在一起且在电极之间施加上射频电压。然而该方法仅适用于那些有显著介质损耗指数的材料，例如大于0.2，超过假定20-60MHz的范围的，如聚氯乙烯。迄今为止介电焊接仍被认为不适合焊接适宜用于制造药物胶囊的水溶性聚合物。
发明内容
根据本发明，提供了一种由聚合材料的薄膜制造胶囊的方法，该方法使用一对相互邻接并设有相对凹槽的旋转模具，该方法包括以下步骤：
(a)将两片薄膜通过所述模具，每一薄膜邻接一模具，从而使两片薄膜合在一起；
(b)使薄膜进入模具的凹槽而变形，从而在每一薄膜上形成多个凹槽；
(c)通过在薄膜合在一起处之上并对准一凹槽的位置处的薄膜之间的间隙引入填充材料，而将薄膜的凹槽填满可流动填充材料；
(d)将薄膜焊接在一起以形成多个包含有填充材料的胶囊；以及
(e)将充填好的胶囊从薄膜的其余部分离出来以形成多个所述胶囊；
其中所述焊接是在所述一对旋转模具上将薄膜焊在一起的介电焊接，
其特征在于，所述方法使用了水溶性或可消化的聚合材料的薄膜，该材料是可吸收的。
旋转模具还充当提供高频电源的相对电极。该电源大致可以介于1MHz和200MHz之间，通常介于10MHz和100MHz之间，但是对任何发射的无线电波是有严格限制的。因此实际上频率的选择可能更有限。例如电源频率可以是27.12MHz，或者40.68MHz。优选地两个旋转模具通过电容耦合进行电连接。作为选择，耦合还可以通过滑动接触例如用电刷。调谐电路可以电连接到至少一个电极，例如调谐电路可以连接在一个电极和地电位之间。例如调谐电路可以包括电容耦合连接到一个电极和地电位的电感，调谐电路优选地直接以电源频率调谐。调谐电路可以是匹配网络。
每个旋转模具可以是实质上为圆柱体的，并且绕旋转固定轴旋转。作为选择，每个旋转模具还可以具有实质上为多边形的横截面，例如八边形的，旋转轴彼此相对弹性地安装。可以布置模具使得当模具旋转接连形成多个凹槽时每次形成一个胶囊。作为选择，还可以布置模具以同时形成沿薄膜宽度方向一个挨着一个排列的多个胶囊。加热器可以与旋转模具结合从而在薄膜变形成为凹槽之前加热它们使之软化。薄膜可以通过被吸入模具内的匹配凹槽而变形。胶囊的切除可以通过冲压来完成，但是作为选择，模具还可以至少围着每个凹槽的外围充分地靠近在一起，每个胶囊周围的薄膜十分薄所以胶囊能够容易地从剩余的网膜挤出；例如在每个胶囊外围的周围，薄膜的厚度可能介于10和20μm之间。
填充材料可以是药物，而且优选地是液体。当胶囊是为了吞咽(例如当它们包含药物或营养补充物)，聚合材料应该是可吸收的。它可以是例如明胶，或者水溶性纤维素衍生物。例如它可以是经批准可在药物和食物中使用的羟丙基甲基纤维素(在欧洲由代码E464表示)。其它适合的聚合材料可以是可食用的海藻衍生聚合物例如海藻酸钠(E401)、藻酸丙二醇酯(E405)或者琼胶(E406)。聚合材料绝对不能含有任何有害或有毒的添加剂，但是可以含有如甘油(E422)或甘油单硬脂酰脂(E471)的化合物作为增塑剂，这些化合物也是可食用的且在水中可分散或可溶。其它适合的纤维素衍生物是羟丙基纤维素(E463)和甲基乙基纤维素(E465)。不需要任何水加到薄膜中，而且实际上薄膜优选地应该至少表面是干燥的，也就是说与周围条件相平衡。例如薄膜可以在25℃的温度和40％的相对湿度下与空气相平衡。例如它可以在湿度受控的环境中使用之前被存储，相对湿度优选地在30％到70％的范围内。在这种环境下，薄膜将明显地混合有一些水分但是看起来十分干燥，这些混合的水分将会起到增塑剂的作用。
本发明还提供一种利用上述方法制造和填充胶囊的装置，它包括用来使薄膜变形并将它们介电焊接在一起的旋转模具。在另一方面，本发明提供一种通过本发明的方法或装置加工而成的胶囊。
本发明现在将仅通过一个例子并参照显示形成胶囊的装置的局部片段侧视图的附图进行进一步和更详细的说明。
附图说明
图1示意性地显示了本发明用于形成胶囊的装置和方法。
具体实施方式
参照图1，它示意地显示了用于制造可吸收的药物级材料例如羟丙基甲基纤维素的胶囊的装置10，胶囊内充满非水的液体填充材料12。该装置包括两个相邻的旋转模具14和15，每一个通常都具有圆柱状的外形，在其圆周上设置多个椭圆凹槽16(如图所示，沿着圆周路径有八个凹槽)，模具14和15的旋转是同步的，所以凹槽16总是彼此相对的。加热器(未显示)安排用来使模具14和15保持在温度50℃到70℃之间，例如60℃。两片聚合材料(在该例中是含有作为增塑剂的甘油脂的羟丙基甲基纤维素)的薄膜18从辊20输送到模具14和15，每片薄膜18具有均匀厚度0.2mm。模具14和15的长度与薄膜18的宽度一样，而且还可以具有沿它们的长度轴向间隔开的其它组凹槽，例如六组。模具14和15是中空的，内部限定了与各凹槽16的底部相通的窄管道(未显示)，因此阀(未显示)能在模具14和15夹紧位置的即刻上方对那些凹槽16施加抽吸。模具14和15的旋转轴弹性地彼此相对安装，所以当薄膜18经过模具14和15之间时它们会受到压缩，所以安排使得在它们最靠近的时候模具在每个凹槽16周围立刻分开12μm。
在两个模具14和15上方直接是绝缘导块22，薄膜18从导块22的下曲面和模具14和15的外表面之间通过。在薄膜18刚好会合在一起时之前填充材料12通过导块22里的管道24输送到它们之间的间隙内，每个管道24与整套外围凹槽16中的一组相联合。薄膜18通过与模具14或15的热表面相接触而软化，并在夹紧点之上被吸入凹槽16内而变形。因此，填充材料12在该点充满凹槽16。
高频发生器26经电容耦合器27连接到模具15，它在27.12MHz的频率下发出电流。另一个模具14经另一个电容耦合器28和一个电感器29连接到地电位。电容耦合器28和电感器29一起形成了当阻抗最小时具有谐振频率的调谐电路，选择电感器的值以使谐振频率为(或接近于)发生器26的频率。在装置10的操作过程中发生器26连续供应这种高频信号，所以当薄膜18经过模具14和15之间时它们受到介电焊接。薄膜18的反面变得足够热从而焊在一起，而与模具相接触的外面仍保持在模具14和15的温度上。于是在一排充满的胶囊30的运行中，密封的且与整片焊接薄膜18连在一起的每一个胶囊都从旋转模具下面露出来。每个胶囊30外围的网膜仅有12μm厚，所以胶囊30能够容易地从剩余的网膜上分离下来。
由于聚合材料在焊接过程中熔化，一串熔料在每个胶囊30内部的焊缝周围形成，所以当胶囊被切掉后，缝周围的壁厚就稍微厚些。胶囊30的密封属性允许材料12为液体，所以大部分的药物都能通过胶囊30传送。作为该例，每个胶囊30可能是长10mm宽7mm的椭圆形。纤维素衍生物(例如羟丙基甲基纤维素)在薄膜18以及胶囊壁上的运用是有优势的，这是鉴于该材料在药物应用上的证实过的用途以及它在水中的可溶性和无毒作用。
胶囊壁的可溶性意味着胶囊在患者的胃里会迅速地分解，从而引起药物的迅速释放。对于一些应用，释放的速度可能过于迅速。如果那样的话，或由于审美的原因或由于味觉和手感的原因，胶囊可以裹入例如为了改善口感的糖衣或减慢释放的可溶性较差的壳的附加材料中。
从对焊接装置的描述中可以明显地看出模具14和15以及焊接材料的薄膜18之间的直接接触。隔离片一般在不需要或不用介电焊接时使用。由于避免了污染势源的使用，尤其是考虑到普通隔离材料的纤维属性，因此这就提高了该方法对于药物使用的可接受性。本发明的特别优势在于胶囊30能够装入液体。液体可以是药物活性材料的溶液、或液态药、或药材的液体乳胶、或药物活性油或其它液体。这将很容易理解，就是填充材料12必须与薄膜18的材料相容，特别是鉴于纤维衍生物高度可溶的属性，水和含水溶液是不合适的。作为选择，填充材料还可以是例如易流动的粉末。
可以对上述装置做出多种不违背本发明范围的变动和修改。例如在一个操作中可以将三片外侧具有凹槽的薄片焊在一起，所以两隔室的胶囊可以制成每个隔室里容纳有不同的材料。药物级纤维素衍生物是最合适的，但是其它材料例如明胶也可以用。无论如何，高分子膜中增塑剂的存在对于凹槽的形成和焊接的过程都是有益的。旋转模具可以在整个焊接部位将薄膜压缩为假定0.3mm的厚度，所以在焊接过程中熔融聚合物将趋向于流动以致于在每个凹槽边缘的焊缝周围生成一串熔料。旋转模具可以结合冲压机构将胶囊30从网膜上分离出，而不是仅仅在每个胶囊30的周围形成一层薄膜。

Claims (9)

1.一种由聚合材料的薄膜(18)制造胶囊的方法，该方法使用一对相互邻接并设有相对凹槽(16)的旋转模具(14，15)，该方法包括以下步骤：
(a)将两片薄膜(18)通过所述模具(14，15)，每一薄膜邻接一模具(14，15)，从而使两片薄膜合在一起；
(b)使薄膜(18)进入模具的凹槽(16)而变形，从而在每一薄膜(18)上形成多个凹槽；
(c)通过在薄膜合在一起处之上并对准一凹槽的位置处的薄膜(18)之间的间隙引入填充材料(12)，而将薄膜的凹槽填满可流动填充材料；
(d)将薄膜焊接在一起以形成多个包含有填充材料(12)的胶囊(30)；以及
(e)将充填好的胶囊(30)从薄膜(18)的其余部分离出来以形成多个所述胶囊；
其中所述焊接是在所述一对旋转模具(14，15)上将薄膜(18)焊在一起的介电焊接，
其特征在于，所述方法使用了水溶性或可消化的聚合材料的薄膜(18)，该材料是可吸收的。
2.如权利要求1所述的方法，其特征在于，介电焊接的步骤包括利用电容耦合器(27、28)将电信号运用到旋转模具(14、15)上。
3.如权利要求1所述的方法，其特征在于，至少一个旋转模具(14)的电连接结合调谐电路(29)。
4.如权利要求1所述的方法，其特征在于，每片薄膜(18)包含水溶性纤维素衍生物。
5.如权利要求1所述的方法，其特征在于，每片薄膜(18)包含水溶性或可消化的增塑剂。
6.如权利要求1所述的方法，其特征在于，每片薄膜(18)是干燥的，并与含有湿气的环境大气基本保持平衡。
7.如权利要求1至6中任何一项所述的方法，其特征在于，在薄膜(18)变形以形成凹槽之前将其加热。
8.如权利要求1至6中任何一项所述的方法，其特征在于，在焊接过程中模具(14、15)至少在围绕每个凹槽(16)处充分地靠近在一起，焊接以后每个胶囊(30)周围的薄膜十分薄以致于胶囊(30)能够容易地从剩余的网膜上分离开。
9.如权利要求1至6中任何一项所述的方法，其特征在于，所述焊接在模具和焊接薄膜之间不用隔离片的情况下进行。
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