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固体药物制剂工艺的混合过程


  对于固体药物而言,除去具有治疗效果的活性物质之外,还包括一些药物辅料。这些辅料可以帮助药物成型,便于上市流通,方便病人使用,或让药物的生产成为可能,也或者能够减小副作用提高药效。总之,这些辅料对药物的生产也必不可少。
  药物生产的第一步往往是将活性物质与特定的辅料混合均匀,这样才能保证每一颗药物都具有同等的效果。固体制剂生产中的混合过程,往往涉及到两种甚至多种固体粉末的混合,这些混合粉末也可以称之为粉体。目前常用于固体制剂生产的辅料一般是采用特殊工艺制备的颗粒,颗粒大小在微米级别。由于这些颗粒的具有较大的比表面积,同时很多类型辅料在表面或内部拥有细小孔洞,能够进一步吸附水分,或吸附更为微小的粒子。这些颗粒与颗粒之间的气体一同组成了粉体。除非在较大的压力下,粉体颗粒很难形成永久连接,这使得粉体具有类似液体一样的流动性,但其颗粒本身没有液体分子那样的热运动能力,只能在外力作用下移动。
  粉体的组成和性质较为多样,粉体性质也随组成不同而变化,而粉末的均匀混合是保证最终制剂产品质量均一的关键因素。为了更好地选择辅料,设计工艺,准确而全面地理解粉末混合过程对制剂研究者而言十分必要。
  固体制剂的生产中,混合是最为常见的操作,但实际上,却很多有人去思考在混合过程中粉体发生了什么。正如上文所述,粉末虽然在宏观上具有流动性,但在微观上却无法自发移动。混合过程的本质,是粉体在外力作用下,粉体中各种组分根据自身性质和处于的环境情况再分布的过程。如果忽略颗粒间的作用力,粉体中各个组分的在外力作用的呈现随机分布。
  下面以最为简单的二维混合机描述一般粉体混合过程。将待混合组分加入混合容器中,容器开始转动,混合便开始,转动停止,混合便结束。在这期间,混合分为以下阶段:
  (1)混合开始之前,物料加入容器中,物料由于重力的而沉积形成粉床。
  (2)仪器开始运转,容器的运动对粉末中粒子产生了作用力,粒子之间的作用力被激活,粒子之间形成间隙,这些间隙使得不同组分的粒子的穿插和交织成为可能。
  (3)仪器持续运转,粒子持续受到来自于设备提供的机械力、自身的重力和其他颗粒的压力或剪切力。在这些力的作用下,粒子持续运动。这些粉末的粒子的运动一般有三种形式,对应三种混合机理,即所谓的对流、剪切和扩散。某种粒子以粒子聚集团的形式运动(对流),在不同粒子团接触面因为粒子的运动速率的不同,粒子产生相对滑动(剪切),进而造成相邻粒子间的位置交换(扩散)。一般而言,混合初始阶段,粉料运动以对流为主,而剪切是减小粒子聚集团的主要方式,而扩散是混合体系中最微观的混合,能够实现最为均匀的混合。
  粉料的混合与溶液混合或溶解过程不同,因为后者分子的布朗运动可以使的体系朝着熵增的方向自发运动,而混合过程是在外力作用下粒子运动演变,混合终点是不同粒子在空间中的分布,这更多地是由“概率”控制的。因此,不同的粒子的运动可以在空间上形成较为均匀的分布,那么这些运动过程也可能使的粒子在空间的分布并不均匀。混合的后期便是在这种“均匀”与“不均匀”之间的平衡。但这种平衡的背后,也可能酝酿着其他变化趋势,例如某种粒子在剪切作用下发生自聚成团、或者与在强压力下粘附于容器壁,这些过程都可以造成不同粒子之间的分离,使得均一性的下降。
  (4)设备停止运行,额外的机械力消失,粒子也静止下来,各种力的平衡将粒子暂时固定在仪器空间的某个位点。或许些许外界扰动,就将会造成粒子位置的再次改变。如何维持已经达到的混合状态,防止粒子发生分离,也是混合工艺设计中需要考虑的重要问题。

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湿法混合制粒机的制粒成品会受哪些因素的影响?

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