Study on the Stability of Human Growth Hormone for Injection After Cold Chain Interruption

OBJECTIVE To investigate the stability of human growth hormone for injection under different temperature conditions.

METHODS The long-term stability of human growth hormone for injection stored at (5±3)℃ for 0, 15, 40 d, accelerated stability at (25±2)℃ for 0, 7, 15, 30, 40 d, and high-temperature stability at (40±2)℃ for 0, 1, 3, 5, 7 d were evaluated. Based on the Chinese Pharmacopoeia(2020 Edition) standards, quality assessment indicators included human growth hormone content, high molecular proteins and related proteins. The size exclusion chromatography-high performance liquid chromatography method was used to determine human growth hormone and high molecular protein contents, while the reverse phase-high performance liquid chromatography method was employed to analyze related protein contents.

RESULTS After storing the human growth hormone for injection at (5±3)℃ for 40 d, (25±2)℃ for 40 d, and (40±2)℃ for 7 d, the following results were observed: the content of human growth hormone was within the range of 90.0%−110.0%, and the contents of high molecular proteins and related proteins was less than 6.0% and 12.0%, respectively. These parameters met the quality standards specified in the Chinese Pharmacopoeia(2020 Edition).

CONCLUSION After storing the human growth hormone for injection at (5±3)℃ for 40 d, (25±2)℃ for 40 d, and (40±2)℃ for 7 d, no significant abnormalities were observed in the content of human growth hormone, high molecular proteins and related proteins. This can provide a reference for evaluating the quality of human growth hormone for injection in the event of cold chain interruption during actual circulation, storage, or use.