PYA与营养琼脂培养基细菌计数比较

Comparison of PYA with Nutritional Agar on Bacterial Count

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 Pharmacopoeia. 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 was much more NA that more than that counts on PYA;In addition,the bacterial counts on PYA increased 11.5% on average than that on NA. Conclusions：PYA media is useful for drug examination of microbial limit,and it can substitute for NA for examination of microbial limit.