Quality evaluation of pharmaceutical excipient dextrin
OBJECTIVE To investigate the current situation of the quality status and the existing problems of the pharmaceutical excipient dextrin.METHODS A total of 167 batches of samples from 18 manufacturers were tested based on the current quality standard.Exploratory research were carried out and the quality differences of dextrin were evaluated.RESULTS According to the current standard,1 batch of sample was unqualified.The exploratory research is found that the high contents of mycotoxins in dextrin and the quality was inhomogeneous.Attention should be paid to avoid the quality risks.CONCLUSION The acceptance rate of dextrin is 85.6％according to the current quality standard and the exploratory research.An example has been set for the following pharmaceutical preparation research.It is of great significance for the development of traditional Chinese medicine preparation.
DextrinQuality evaluationHomogeneityMycotoxinClarity of the solutionElemental impuritiesReducing sugarPesticide residue
NETL
NSTL
万方数据
