Determination of Citrate ion Content and Analysis of Related Factors of Aluminum Content in Human Albumin Products / 中国药学杂志

ABSTRACT

OBJECTIVE: To determine the citrate ion and aluminum contents in human albumin products and investigate the related factors of aluminum content. METHODS: Sixty-five batches of human albumin products which were very close to the end of shelf life or would be expired within not more than 2 m, including 54 batches of imported ones and 11 batches of domestic ones, were analyzed. The content of citrate ion was determined using the enzyme reaction method, and aluminum content was determined using the atomic absorption method. Factors related to human albumin production, such as ultrafiltration time, glass bottles, sample storage conditions, and the initial value of aluminum content were investigated and analyzed, especially the relationship with the aluminum content at the end of the shelf life. RESULTS: The overall mean content of citrate ion in 65 batches of human albumin was 24 μmol•L-1 (0 - 144 μmol• L-1), the mean content of citrate ion in 54 batches of domestic human albumin was 24 μmol•L-1, and that in 11 batches of imported human albumin was 23 μmol•L-1. The linear correlation coefficients between final aluminum content and citrate ion content of 65 batches of human albumin, 54 batches of domestic human albumin and 11 imported human albumin were 0.315 5, 0.331 8 and 0.746 6, respectively. The linear correlation coefficients between the final aluminum content and storage time of 65 batches of human albumin, 54 batches of domestic human albumin and 11 imported human albumin were 0.102 6, 0.059 3 and - 0.037 4, respectively. The linear correlation coefficient between the final and initial aluminum contents of 54 batches of domestic human albumin was 0.325 5. The linear correlation coefficients between final aluminum content and ultrafiltration process time, citrate ions and ultrafiltration process time of 54 batches of domestic human albumin were 0.011 8 and - 0.108 2, respectively. CONCLUSION: Citrate ion content in human albumin retention samples are lower than 150 μmol•L-1. Citrate ion content and final aluminum content are weakly correlated, however, the correlation coefficient between the two indexes of imported human albumin is much higher than that of domestic samples. The initial and final aluminum contents shows low correlation, and ultrafiltration time shows very weak correlation with storage time.