薄膜过滤法检查血液制品原料混合血浆微生物限度的分析  

Analysis on microbial limit of pooled plasma in blood products manufacturing using membrane filtration method

作　　者：张璘[1] 张继鹏[1] 刘晓[1] 杨晓东[1] 张安山[1] 何彦林[1] 胡军[1] 

机构地区：[1]兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心,兰州730046

出　　处：《微生物学免疫学进展》2013年第3期37-40,共4页Progress In Microbiology and Immunology

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《中华人民共和国药典》(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。Objective To test and analyse the microbial limit of pooled plasma as a raw material in preparation blood prod- ucts. Methods Detection of the microbial limit of 10 batches of pooled plasma was carried out by using a membrane filtra- tion method on the basis of requirement from Chinese Pharmacopoeia （Volume II1,2010 edition ） and analysis of the condi- tion for microbial presence in pooled plasma was processed. Results The total microbial amount of 10 batches pooled plas- ma is in a range equal to 170-330 CFU/mL, three kinds of microbials were detected,the order in amount of them is as bac- teria the most j mold the next and yeast the least. Conclusion The test for microbial limit of pooled plasma was success- fully developed by using a membrane filtration method.

关 键 词：薄膜过滤法 混合血浆 微生物限度 

分 类 号：R927[医药卫生—药学]