真空冷冻干燥技术在生物制药方面的应用

Biological drugs manufacture on vacuum freezing and drying technology

目的阐述真空冷冻干燥技术在生物制药方面的应用。方法查阅真空冷冻干燥技术在生物制药方面的应用、冻干机械设备等有关资料,说明冻干技术的发展史、冻干机的性能选择、冻干机附属装置、真空冷冻干燥过程,并提出该技术的应用前景。结果与结论有些学者认为,20世纪的科学技术是以物理学和化学的成就占主导地位,而21世纪的科学技术是以生物学的成就占主导地位。无论这种说法是否得到普遍的认同,生物技术是当今高技术中发展最快的领域似乎是不争的事实。而冻干的固体物质由于微小的冰晶体的升华而呈现多孔结构,并保持原先冻结时的体积,加水后极易溶解而复原,制品在升华过程中温度保持在较低温度状态下(一般低于-25℃),因而对于那些不耐热的物质,诸如酶、激素、核酸、血液和免疫制品等的干燥尤为适宜。干燥的结果能排出95%～99%以上的水份,有利于制品的长期保存。制品干燥过程是在真空条件下进行的,故不易氧化。针对部分生化药物的化学、物理、生物的不稳定性,冻干已被实践证明是一种非常有效的手段。随着生化药物与生物制剂的迅速发展,冻干技术将越来越显示其重要性与优越性。

Some scholars believe that the 20th century, science and technology is based on the achievements of physics and chemistry of the dominant, and the 21 st century biological science and technology is dominated by the achievements. Regardless of whether or not this is universally recognized,biotechnology is the fastest growing high-tech areas appears to be an indisputable fact. Freeze-dried solids of tiny ice crystals as a result of sublimation and a porous structure, and maintain the original size when the freezing of water can easily dissolve and after recovery, the process of sublimation products in the temperature maintained at a relatively low temperature conditions （ typically less than - 25℃）, so for those who do not heat-resistant material, such as enzymes, hormones, nucleic acids, such as blood and immune products are particularly suitable for drying. The result of drying from 95 - 99% of water is conducive to long-term preservation of products. Products in a vacuum drying process is carried out under the conditions, it is not easy oxidation. Some biological and chemical substances for the chemical, physical, biological instability, freeze-drying has been proved in practice to be a very effective means. With chemical and biological drugs and the rapid development of biological agents, freeze-drying technology will become more and more to demonstrate its importance and the advantages.