摘要
溶媒结晶工艺和喷雾干燥工艺生产的氨苄青霉素中致敏性杂质的种类不同。前者主要为非聚合物类杂质,后者含有聚合物类杂质和非聚合物类杂质。豚鼠PCA试验证明两类杂质引发过敏反应的能力和与其作用的氨苄青霉素抗体的匹配程度有关。用凝胶过滤法,对54批国产和进口的氨苄青霉素样品进行了考察。结果表明,各批样品间非聚合物类杂质的含量差异很大。以聚合物类杂质含量和非聚合物类杂质含量二个指标来评价氨苄青霉素的致敏性,在广泛考察样品的基础上,用模式识别(Pattern recognition)法建立了评价商品氨苄青霉素致敏性的数学模型,可以方便地对不同样品的致敏性进行评价、比较。
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.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
1990年第2期102-107,共6页
Chinese Journal of Antibiotics
关键词
氨苄青霉素
致敏杂质
药品质量控制
Ampicillin
Amaphylazis
Allergen
Drug's control
Pattern recognition
Gel filtration
