【摘要】 目的检查和分析血液制品原料混合血浆的微生物限度。方法按照《中华人民国和国药典》(2010年版)三部微生物限度检查法,采用薄膜过滤法检查10批混合血浆的微生物限度情况,分析混合血浆的微生物状况。结果 10批混合血浆的微生物总数量在170～330 cfu/mL之间。在检查的三种微生物中,细菌总数最多,霉菌次之,酵母菌数量最少。结论成功采用薄膜过滤法检查了混合血浆中微生物限度状况。更多还原

【Abstract】 Objective To test and analyse the microbial limit of pooled plasma as a raw material in preparation blood products.Methods Detection of the microbial limit of 10 batches of pooled plasma was carried out by using a membrane filtration method on the basis of requirement from Chinese Pharmacopoeia(Volume III,2010 edition) and analysis of the condition for microbial presence in pooled plasma was processed.Results The total microbial amount of 10 batches pooled plasma is in a range equal to 170-330 CFU/mL,three kinds of microbials were detected,the order in amount of them is as bacteria the most,mold the next and yeast the least.Conclusion The test for microbial limit of pooled plasma was successfully developed by using a membrane filtration method.更多还原