Information Statistics and Discussion on the Results of Aluminumion Content Determination of Retention Samples of Human Albumin / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the quality of human albumin products, and determine the content of aluminumion in the upcoming expired human albumin samples of both domestic and imported products for batch release. METHODS: Statistics was carried out for domestic and imported human albumin products in 2017 about the approved registration, import approval number, storage conditions, aluminumion content of batch release and other information. Aluminumion contents of the samples were detected by National Institutes for Food and Drug Control which banded with 7 authorized agencies for batch release of blood products according to the atomic absorption spectrometry or verified inductively coupled plasma mass spectrometry (ICP-MS)method for the determination of aluminumion content in China Pharmacopoeia 2015. RESULTS: There were a total of 28 domestic manufacturers of blood products and 158 human albumin drug approval numbers (totally 40 for daily production, 2017), among which 21 were approved for the storage condition of "room temperature" and 7 for "refrigerate". A total of 185 batches of human albumin samples from 25 domestic manufacturers were sampled. The mean aluminumion content in the batch release reports was 61 μg·L-1(8-134 μg·L-1), while that in the samples of the upcoming expired products was 137 μg·L-1(20-487 μg·L-1). The mean aluminumion content increased by about 1 time after the storage period. There were about 17.8% (33/185)samples having aluminumion content over 200 μg·L-1. There were a total of 13 manufacturers of imported human albumin with a total of 17 import specifications in 2017. The approved storage condition was all "room temperature". A total of 78 batches of human albumin products for batch release from 11 import enterprises were sampled. The mean aluminumion content in the batch release reports was 27 μg·L-1(7-60 μg·L-1), while that in the samples of the upcoming expired products was 50 μg·L-1(1-175 μg·L-1). The overall mean increased about 1 time after the storage period, which was consistent with the domestic human albumin products. But the two parameters of the imported products were both lower than the domestic ones. None (0/78)of the samples having aluminumion content over 200 μg·L-1. CONCLUSION: The aluminumion contents of some batches of upcoming expired domestic human albumin products are over 200 μg·L-1. The overall aluminumion contents in the initial batch release and the upcoming expired products in the import albumin products are lower than the domestic ones.