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.