目的：验证细菌计数培养基(PYA)在微生物限度检查中的实用价值。方法：按《中国药典》2000年版微生物限度检查法细菌计数的规定,比较PYA和营养琼脂培养基在细菌数检查中的差异。结果：通过对丸剂、片剂、颗粒剂和胶囊四种剂型168批样品PYA和营养琼脂细菌数检查结果表明,有7批样品(4.2%)PYA有细菌生长,而营养琼脂无细菌生长。未发现相反的现象；PYA细菌计数高于营养琼脂21%以上的样品数为32批,远多于营养琼脂高于PYA的21批；此外,PYA比营养琼脂细菌数平均增加了11.5%。结论：PYA在药品细菌数检查中优于营养琼脂,可替代营养琼脂用于药品微生物限度检查。
Objective:To determine the utility of bacterial count media(PYA)in examination of microbial limit.Methods:To compare the bacterial counts of PYA with nutrition agar(NA)based on the method of bacterial count in the Chinese Pharma- copoeia.Results:According to the results of examination with 168 lots of drugs including pill,tablets,granule and capsule,7 lots of drug had bacterial growth on PYA,but no growth on NA;Drug samples that the bacterial counts on PYA were more than 21% than that on NA were 32,which wa... |