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如何确保固体制剂产品质量?


  在医药产品中,固体制剂是应用广泛、品种较多的一种剂型,约占七到八成。由于固体制剂的起始原料是药粉,为了保证固体制剂的产品质量和生产过程的顺利进行,往往需要对药物进行加工和处理,包括粉碎、分级、混合、制粒、干燥、压片等,每一步单元操作都渗透着粉体技术的应用。
  业内指出,制剂技术和制药设备是粉体操作顺利进行的保障,也是保证制剂产品质量的重要工具。因此,选择适宜辅料以及采用适宜的制备技术与设备至关重要。
  以片剂的制备工艺为例,这是一种将药物与适宜的辅料混合均匀压制而成的片状固体制剂。归纳片剂的制备过程可分为:物料的充填、压缩和推片这三个步骤。为了保证片剂的质量,在处方设计和辅料的筛选中,一般还需要考虑压片物料的粉体学性质对片剂成型性的影响,包括对压片物料流动性、压缩成型性、可量化进行分析。
  随着新型辅料、高效压片设备的发展,片剂生产进入高效、节能、高质量时代。其中在压片时,根据粉体性质的不同,一般采用制粒压片法或直接压片法。其中,制粒压片法又可以分为湿法制粒压片法和干法制粒压片法。
  具体来看,湿法制粒压片法对原料或辅料的粉体性质的要求不高,可以解决原辅料粉体性质不足的问题,获得流动性好的颗粒,显著提高药物的压缩成形性。不过湿法制粒的缺点是对湿热不稳定的药物不适用,可能在压片过程中会出现粘冲、顶裂等情况。
  干法制粒压片法则是将原辅料的混合物压制成薄片状或大片状后粉碎制粒的方法。制粒后也可以显著改善流动性和压缩成形性,主要是对湿热不稳定的药物需要制粒时所采取的有效方法。不过这种方法对辅料粉体性质的要求较高,辅料应具备较好的塑性变形,压缩成形性好或具有干粘合剂的作用,否则压片后粉碎制粒时容易碎成粉状,颗粒的产率不高。
  近年来,随着现代科技的不断发展,以及GMP规范化和QbD理念的推广,粉体处理方法不断渗入到固体制剂的制备过程中。同时由于制剂技术和制药设备直接影响到制剂产品的质量,因此在当前医药工业对制剂产品要求越来越高的背景下,升级制剂工艺技术、改进制药设备成为趋势。
  目前,国内的固体制剂设备市场主要由德国、意大利等国外厂商占据,一些厂家还计划在华建立固体制剂工艺中心,为国内的客户提供包括提高客户的生产工艺,帮助客户做到大批量生产的贴身服务,同时为客户提供设备、工艺方面的培训等。
  相比较而言,国产固体制剂设备厂家还主要集中于中低端市场,竞争手段以低价战为主,数量不多。随着仿制药一致性评价的推进、带量采购常态化,医药工业加快升级,国产的固体制剂设备将具备较大的成长空间。
  从趋势来看,业内认为,连续生产模式是目前很多固体制剂企业探索和实践的发展模式,即即从原材投入生产到成品制成时止,按照工艺要求,各个工序均按顺序连续进行。预计这种模式在未来5年左右或将成为行业需要研究的一个发展方向。
  在此背景下,国内一些固体制剂设备厂家近年来也积极展开布局。如有的企业表示,2020年,公司将围绕“固体制剂智能工厂整体解决方案供应商”和大健康产业战略布局,继续深耕制药装备市场和智能物流行业,力争成为制药装备智能工厂整线解决方案供应商,并继续向大健康产业纵深持续推进。
  也有的企业通过多年布局,推进一纵一横一平台战略,不断丰富产品线,增强在固体制剂领域的竞争优势,打造有竞争力的固体制剂整体解决方案和打造医药智慧工厂。

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中药提取设备特点

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现代制药装备行业生产模式已焕然一新,新型理念助推生产和研发!

社会发展过程中,改变是恒定的真理。任何商品如果不与时俱进的进行改造,注入新元素,那么这款产品将被市场淘汰,制药装备亦是如此。在日趋现代化的制药装备行业中,设备的制造模式摆脱了旧有的方式,开始新的探索。


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自动高效包衣机主机及清洗系统与热风柜、排风柜、恒温搅拌桶均采用进口不锈钢精工制造,符合GMP要求。


湿法混合制粒机的制粒成品会受哪些因素的影响?

湿法混合制粒机是一种混合制粒设备,可以用以药物成分的混合。在工艺上,湿法混合制粒机是在把混合、制粒两步工艺合在一起,既节约了时间又满足了GMP要求,减少了交叉污染,提高了效率,是一种多快好省的办法,深受用户欢迎。

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