This technology maximizes the retention of a drug's active ingredients while enhancing product stability. Due to their extremely low moisture content, lyophilized powder injections effectively mitigate the adverse effects of environmental factors-such as temperature, humidity, and light-on the medication, thereby extending shelf life and facilitating storage and transport. The incorporation of lyoprotectants (such as trehalose and mannitol), along with rigorous process control, plays a pivotal role in determining the efficacy of the lyophilization process and the stability of the final product.
In terms of application, lyophilization technology was initially employed to manufacture heat-sensitive drugs, as well as biological products such as enzymes and plasma. Lyophilized powder injections are primarily utilized for specific antibiotics, peptide- and protein-based drugs, and vaccines (e.g., the attenuated live vaccine for Japanese encephalitis). In the cosmetics sector, this technology is used to preserve unstable active ingredients, such as peptides and Vitamin C; however, according to regulations issued by China's National Medical Products Administration (NMPA), products formulated with-or claiming to contain-Human Oligopeptide-1 (EGF) are deemed illegal.