摘要
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.
出处
《中国药品标准》
CAS
2006年第2期7-9,共3页
Drug Standards of China