Author(s): Hu Chang-qin, Jin Shao-hong and Sun Xue-lan
Pages: 102-107
Year: 1990 Issue:  2
Journal: Chinese Journal of Antibiotics
Keyword:  Ampicillin; Amaphylazis; Allergen; Drug’s control; Pattern recognition; Gel filtration;
Abstract: Different kinds of allergenic impurities were found out from the ampicillin preparations made by different techniques. The preparation by spray drying contained both ampicillin polymers and non-polymer impurities, but the preparation by solvent crystallizing mainly non-polymer impurities. The affinity between the impurities and the anti-ampicillin antibody had a considerable influence upon the PCA reaction on guinea pigs. The larger the affinity was, the stronger the PCA reaction could be. Using gel filtration, 54 batches ampicillin preparations made in China and made in abroad were investigated for the content of non-polymer impurities, which showed a great diversity.A model in which two sorts of allergenic impurities, ampicillin polymers and non-polymer impurities, were synthesized for evalution of allergenicity of ampicillin preparation was established by employing the concept of pattern recognition. An ampicillin preparation could be conviniently evalued by using the model.