The invention relates to the technical field of medicines, in particular to a preparation process of xantinol nicotinate injection and an
impurity control method of the xantinol nicotinate injection. According to the process, water for injection is subjected to
nitrogen deoxidation treatment, a whole-process
nitrogen-sealed environment is maintained, xantinol nicotinate is gradually added in three times, and a multi-component synergistic
stable system including hydroxypropyl-beta-
cyclodextrin, N-acetyl-L-
cysteine, L-
methionine,
diethylenetriamine pentaacetic acid,
sodium metasulfite,
sodium thiosulfate and the like is matched, so that the xantinol nicotinate injection is prepared. Double-molecular-weight
dextran is introduced to regulate and control a microenvironment, an
acetic acid-
sodium acetate buffer
system is introduced to optimize pH, and finally, high stability and low
impurity generation of the finished injection at high temperature are realized through
nitrogen replacement subpackaging and precise sterilization conditions. According to the method, the content and the purity of the xantinol nicotinate injection are remarkably improved, the
impurity content during sterilization and storage is remarkably reduced, the safety and the effectiveness of drugs are guaranteed, and the method has important significance on optimization of a heat-sensitive injection process.