Discussion on avoiding visible foreign matters in the production of freeze-dried powder injection
探析冻干粉针剂产品生产中对可见异物的避免

摘要

在我国社会发展水平不断提升的大背景下，我国药品生产领域的发展速度也在不断加快。其中，在进行针剂药品生产的过程中，相关企业应该重点关注生产过程中，对于各个生产环节与生产步骤的控制，这样才能够有效规避针剂药品污染问题的产生，并且能够对针剂药品的纯度做出有效的保证。这种对于药品纯度和质量的保证，才能够为药品生产领域的稳定可持续发展提供更强的助力。其中冻干粉针剂是一种质量较高的产品，低温干燥冷冻的工艺，能够使其的保存变得更加稳定，但是，冻干粉针剂中可见异物的产生，一直是困扰相关研究人员的重点问题，在冻干粉针剂中所产生的可见异物包含白点、玻璃以及纤维等，这种可见异物的产生极易导致肉芽肿、堵塞毛细血管、组织栓塞等情况的发生，对人体造成明显的危害，因此，相关工作人员就需要针对这些可见异物的规避，做出积极的研究与探索，以保证人们的身体健康。基于此，本文将针对冻干粉针剂产品生产中对可见异物的避免，做出详细的阐述与探析。

Abstract

In the context of the continuous improvement of China's social development level, the development speed of China's drug production is also accelerating. Among them, in the process of production of injection drugs, relevant enterprises should focus on the control of each production link and production step in the production process, so as to effectively avoid the problem of injection drug pollution and effectively ensure the purity of injection drugs. This kind of guarantee for the purity and quality of drugs can provide stronger support for the stable and sustainable development of drug production. The freeze-dried powder injection is a high-quality product. The low-temperature drying and freezing process can make its preservation more stable. However, the generation of visible foreign matters in the freeze-dried powder injection has been a key problem puzzling relevant researchers. The visible foreign matters produced in the freeze-dried powder injection include white spots, glass and fibers. The generation of such visible foreign matters is very likely to lead to granuloma, capillary blockage The occurrence of tissue embolism and other situations will cause obvious harm to the human body. Therefore, relevant staff need to make active research and exploration on the avoidance of these visible foreign bodies to ensure people's health. Based on this, this article will make a detailed description and analysis of the avoidance of visible foreign matters in the production of freeze-dried powder injection products.