[1] 中华人民共和国药典2020年版. 四部[S]. 2020: 156
ChP 2020. Vol Ⅳ[S]. 2020: 156
[2] 郭晓敏, 彭先芬. 影响无菌制剂无菌保证水平的因素[J].医药导报, 2015, 34(9): 1220
GUO XM, PENG XF. Factors affecting the level of aseptic assurance of sterile products[J].Her Med, 2015, 34(9): 1220
[3] 孙雅梅. 二项式分布理论研究无菌检查法的局限性[J].天津药学, 2006, 18(3): 74
SUN YM. The limitation of sterility test by binomial distribution theory[J].Tianjin Pharm, 2006, 18(3): 74
[4] 梁毅. 论药品生产过程中的污染成因与防范[J].中国药房, 2011, 22(41): 3847
LIANG Y. Contamination formation reason and prevention during the process of pharmaceutical production[J].China Pharm, 2011, 22(41): 3847
[5] 陈伟盛, 关倩明, 朱荣峰, 等. 药品微生物限度检查中微生物污染的鉴定和溯源分析[J].药物分析杂志, 2014, 34(1): 58
CHEN WS, GUAN QM, ZHU RF, et al. Identification and characterization of bacterial contamination isolated by microbial limit test[J].Chin J Pharm Anal, 2014, 34(1): 58
[6] 杨燕, 孙梦家, 蒋波, 等. 药品无菌检查中污染微生物的鉴定与OOS调查分析[J].中国医药工业杂志, 2016, 47(12): 1559
YANG Y, SUN MJ, JIANG B, et al. Identification and out-of-specification survey for contaminated from sterility test[J].Chin J Pharm, 2016, 47(12): 1559
[7] SANDLE T. A review of cleanroom microflora: types, trends, and patterns[J].PDA J Pharm Sci Technol, 2011, 65(4): 392
[8] EISSA ME, ASHOUR MS ED, MANSY MS. Microbiological environmental monitoring in pharmaceutical facility[J].Egypt Acad J Biol Sci, 2011, 3(1): 63
[9] 范一灵, 冯震, 钟玮, 等. 无菌药品生产企业核心区微生物污染调查与分析[J].中国药事, 2014, 28(6): 586
FAN YL, FENG Z, ZHONG W, et al. Investigation and analysis of microbiological contamination in core area of sterile drug manufacturing enterprises[J].Chin Pharm Aff, 2014, 28(6): 586
[10] 马仕洪, 胡昌勤, 戴翚, 等. 判断无菌检查阳性结果有效性的实验探讨[J].药物分析杂志, 2008, 28(5): 727
MA SH, HU CQ, DAI H, et al. Discuss on judging the validity of the positive result in sterility test[J].Chin J Pharm Anal, 2008, 28(5): 727
[11] 蔡叶, 杨卫东. 傅里叶变换红外光谱(FT-IR)技术用于口腔微生物的初步鉴别[J].口腔医学研究, 2017, 33(10): 1048
CAI Y, YANG WD. Preliminary identification of oral microorganisms by Fourier transform infrared spectroscopy(FT-IR)[J].J Oral Sci Res, 2017, 33(10): 1048
[12] AlATOOM AA, CUNNINGHAM SA, IHDE SM, et al. Comparison of direct colony method versus extraction method for identification of gram-positive cocci by use of Bruker Biotyper matrix-assisted laser desorption ionization-time of flight mass spectrometry[J].J Clin Microbiol, 2011, 49(8): 2868
[13] 李东菊, 朱元祺, 梁冰. MALDI-TOF MS用于肺炎克雷伯菌同源性分析的初步研究[J].中国微生态学杂志, 2016, 28(5): 528
LI DJ,ZHU YQ, LIANG B. Homology analysis of Klebsiella pneumonia by MALDI-TOF MS[J].Chin J Microecol, 2016, 28(5): 528
[14] FOX GE, STACKEBRANDT E, HESPELL RB, et al. The phylogeny of prokaryotes[J].Science, 1980, 209: 457
[15] 焦振泉, 刘秀梅. 细菌分类与鉴定的新热点:16S-23SrDNA间区[J].微生物学通报, 2001, 28(1): 85
JIAO ZQ, LIU XM. A new hotspot for bacterial classification and identification: 16S-23SrDNA intermediate zone[J].Microbiol China, 2001, 28(1): 85
[16] SADER HS, HOLLIS RJ, PFALLER MA, et al. The Use of Molecular Techniques in the epidemiology and control of infectious diseases[J].J Clin Lab Med, 1995, 15: 407
[17] TENOVER FC, ARBEIT R, ARCHER G, et al. Comparison of traditional and molecular methods of typing isolates of Staphylococcus aureus[J].J Clin Microbiol, 1994, 32: 407
[18] HOLLIS RJ, BRUCE JL, FRITSCHEL SJ, et al. Comparative evaluation of an automated ribotyping instrument versus pulsed-field gel electrophoresis for epidemiological investigation of clinical isolates of bacteria[J].Diagn Microbiol Infect Di, 1999, 34(4): 263
[19] GRISOLD AJ, ZARFEL G, STRENGER V, et al. Use of automated repetitive-sequence-based PCR for rapid laboratory confirmation of nosocomial outbreaks[J].J Infect, 2010, 60: 44
[20] LEE I, KIM YO, PARK SC, et.al. OrthoANI: an improved algorithm and software for calculating average nucleotide identity[J].Int J Syst Evol Microbiol, 2016, 66(2): 1100
[21] VARGHESE NJ, MUKHERJEE S, IVANOVA N, et.al. Microbial species delineation using whole genome sequences[J].Nucleic Acids Res, 2015, 43(14): 6761
[22] MAIDEN MCJ. Multilocus sequence typing of bacteria[J].Annu Rev Microbiol, 2006, 60: 561
[23] 孙雪奇, 张庆芬, 刘程智, 等. 注射剂微生物污染的全基因组测序溯源分析研究[J].药物分析杂志, 2021, 41(7): 1237
SUN XQ, ZHANG QF, LIU CZ, et al. Whole-genome sequence(WGS) and homology analysis of microbiological contamination in injection[J].Chin J Pharm Anal, 2021, 41(7): 1237
[24] 王亚南, 高晶晶, 钟桥, 等. MALDI-TOF MS技术在鲍曼不动杆菌鉴定及同源性分析中的应用[J].临床检验杂志, 2015, 33(6): 430
WANG YN, GAO JJ, ZHONG Q, et al. Identification and homology analysis of Acinetobacter baumannii by use of matrix assisted laser desorption/ionization time-of-flight mass spectrometry[J].Chin J Clin Lab Sci, 2015, 33(6): 430
[25] JANDA JM, ABBOTT SL. 16SrRNA gene sequencing for bacterial identification in the diagnostic laboratory: pluses, perils and pitfalls[J].J Clin Microbiol, 2007, 45(9): 2761
[26] MORA RR, AMANN R. The species concept for prokaryotes[J].FEMS Microbiol Rev, 2001, 25(1): 39
[27] STACKEBRANDT E, FREDERIKSEN W, GARRITY GM, et al. Report of the ad hoc committee for the re-evaluation of the species definition in bacteriology[J].Int J Syst Evol Microbiol, 2002, 52: 1043
[28] FOX GE, WISOTZKEY JD, JURTSHUK P. How close is close: 16S rRNA sequence identity may not be sufficient to guarantee species identity[J].Int J Syst Evol Microbiol, 1992, 42(1): 166
[29] KIM M, OH HS, PARK SC, et al. Towards a taxonomic coherence between average nucleotide identity and 16S rRNA gene sequence similarity for species demarcation of prokaryotes[J].Int J Syst Evol Microbiol, 2014, 64(2): 346
[30] SCHLEIFER KH, BELL JA. Bergey’s Manual of Systematics of Archaea and Bacteria:Staphylococcus[DB/OL]. [2019-06-28]. https://onlinelibrary.wiley.com/doi/abs/10.1002/9781118960608.gbm00569
