[目的]通过对来自生物医药集聚区废水细菌种群构成和诱变效能的检测,以期在生物医药研发企业排放废水的处置和管理中,应用有针对性的技术手段来改进和完善其检测与监测方法。[方法]生物医药企业排放污水中所含细菌总数和大肠菌群数量的检测,采用3M细菌总数测试片和快速大肠菌群测试片;致突变能力检测采用鼠伤寒沙门氏菌回复突变试验(Ames试验)进行;同时采用PCR克隆技术建立排放污水中细菌16S rRNA基因文库,通过对文库构成的分析,监测排放污水中细菌种群的构成。[结果]部分污水排放点细菌总数超过108CFU/mL,最低为105CFU/mL:其中大肠菌群在不同排放点基本一致,约为103~104个/mL。16S rRNA基因克隆文库序列经与GeneBank 16S rRNA序列比对,共鉴定出23个属的细菌,主要为红环菌科、丛毛单胞菌科和黄杆菌科内的菌属,并从其中一份废水检出人类致病菌军团菌。3份污水浓缩样能直接抑制测试菌的生长,2份Ames试验显示含有移码型直接突变物,另有2份Ames试验显示可能含有移码型直接突变物,碱基置换型突变物均阴性。[结论]对生物医药研发废水的管理策略的制订需要建立在长期、稳定、多方面监测的基础上,采用16S rRNA基因文库分析了解菌群构成和变迁,采用Ames试验检测菌群致突变能力的变化,从而由整体效应评估污水的污染状况,可以应用于生物医药研发企业污水监测。 [Objective] Through the detection of bacterial population composition and mutagenic efficiency in wastewater from biomedical gathering area, it is expected to improve and perfect its detection and monitoring by applying targeted technical means in the disposal and management of wastewater from biomedical research and development enterprises method. [Method] The total number of bacteria and coliform bacteria contained in the effluent of biomedical enterprises were detected by using 3M bacterial total test piece and rapid coliform test piece. Mutagenicity test was performed by Salmonella typhimurium reversion mutation test (Ames test) Meanwhile, the 16S rRNA gene library of bacteria in sewage was established by PCR cloning. The composition of bacterial population in wastewater was monitored by analyzing the library composition. [Result] The total number of bacteria discharged from some sewage exceeded 108CFU / mL, the lowest was 105CFU / mL. Among them, coliform bacteria were basically the same at different discharge points, about 103 ~ 104 / mL. The sequences of the 16S rRNA gene clone library were compared with that of GeneBank 16S rRNA sequence, and 23 species of bacteria were identified, mainly Rhodocystis, Comamonastrum and Flavobacterium, Wastewater detection of human pathogens Legionella. Three samples of sewage concentrate could directly inhibit the growth of test bacteria. Two Ames tests showed that there were direct frameshift mutants. Another two Ames tests showed that there might be a direct mutant of frameshift, and all of the base substitution mutants were negative . [Conclusion] The management strategy of biopharmaceutical wastewater should be established on the basis of long-term, stable and multi-monitoring. 16S rRNA gene library was used to analyze the composition and changes of flora. The Ames test was used to detect the mutagenic ability of bacteria Changes, so as to assess the overall effect of sewage pollution status, biomedical research and development companies can be applied to sewage monitoring.