Quality Evaluation and Research of Human Albumin / 中国药学杂志

ABSTRACT

OBJECTIVE: To understand the quality status and problems of human albumin. METHODS: A total of 153 batchs human albumin samples from 33 manufacturers were analyzed according to the legal quality standard. Three exploratory researches on human parvovirus B19 screening, protein impurity and influencing factors of alum inumion content were conducted. RESULTS: The qualified rate of the 153 batches of samples was 100.0%. The positive rate of B19 DNA in 60 batches from 33 manufacturers was zero. Twenty-three types of other plasma protein were identified in 28 batches of samples from 27 manufacturers. The increase in aluminum contents was related with glass bottle and citrate ion content.CONCLUSION: The overall quality of human albumin is good. However, the content of aluminium ion increases significantly during storage. It is suggested to conduct further study on the influencing factors of aluminium ion content.