At present, there is no uniform standard for enoxaparin sodium injection in the pharmacopoeia, and
enoxaparin sodium injection belongs to the species with safety risks. Therefore, it is very important to supervise its quality.
A follow-up inspection of the product for 3 consecutive years was carried out. The sampling range was wide, the sample
specifications were complete, and the representativeness was strong, so the inspection results could better reflect the
quality status of enoxaparin sodium injection nationwide. According to the daily supervision and sampling test, combined
with the existing research results of national evaluation sampling test, the quality status of more than 200 batches of
samples from 8 manufacturers was summarized in this paper, and the quality difference of enoxaparin sodium injection
from different enterprises was evaluated. In addition, the quality consistency between the products of domestic enterprise
and reference listed drug(RLD) was inspected for the first time; and the quality of RLD marketed in the Chinese market,
the US market and the European market was also compared and analyzed for the first time, so as to provide references for
the improvement of quality standards and the safety of clinical medication. Through investigations, inspections according
to current legal standards, and exploratory research, combined with the comprehensive analysis of the scientificity and
rationality of the current standards, it was found that enoxaparin sodium injection still had inconsistencies in quality
standards, inconsistencies between prescription and production processes in individual enterprises, and other problems.
Therefore, the current quality standards still have defects and need to be further unified and improved.