LAL test and RPT for endotoxin detection of CPT-11/DSPE-mPEG 2000 nanoformulation: What if traditional methods are not applicable?

Asian Journal of Pharmaceutical Sciences - Tập 13 - Trang 289-296 - 2018
Yanan Jin1, Juanjuan Jia2, Chan Li3,4, Jianqi Xue5, Jiabei Sun2, Kaiyuan Wang3,4, Yaling Gan3,4, Jing Xu3,4, Yaqin Shi2, Xingjie Liang1,3,4,6
1College of Chemistry & Environmental Science, Key Laboratory of Medicinal Chemistry and Molecular Diagnosis of the Ministry of Education, Hebei University, Baoding 071002, China
2National Institutes for Food and Drug Control, No. 5, Huatuo Rd., Daxing District, Beijing 102629, China
3Laboratory of Controllable Nanopharmaceuticals, Chinese Academy of Sciences (CAS) Center for Excellence in Nanoscience, No. 11, First North Road Zhongguancun, Beijing 100190, China
4CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, National Center for Nanoscience and Technology of China, No. 11, First North Road Zhongguancun, Beijing 100190, China
5Laboratory of Molecular Iron Metabolism, College of Life Science, Hebei Normal University, Shijiazhuang 050024, China
6University of Chinese Academy of Sciences, Beijing, 100049, China

Tài liệu tham khảo

Su, 2015, Methods of endotoxin detection, J Lab Autom, 20, 354, 10.1177/2211068215572136 Keith Esch, 2010, Endotoxin contamination of engineered nanomaterials, Nanotoxicology, 4, 73, 10.3109/17435390903428851 Li, 2016, Endotoxin contamination: A key element in the interpretation of nanosafety studies, Nanomedicine (Lond), 11, 269, 10.2217/nnm.15.196 Das, 2014, Recent advances in biosensor based endotoxin detection, Biosens Bioelectron, 51, 62, 10.1016/j.bios.2013.07.020 Pardo-Ruiz, 2016, Soluble β-(1,3)-glucans enhance lps-induced response in the monocyte activation test, but inhibit lps-mediated febrile response in rabbits: Implications for pyrogenicity tests, Eur J Pharm Sci, 81, 18, 10.1016/j.ejps.2015.09.018 Takahashi, 1983, A highly sensitive pyrogen test for antibiotics i: Detection of trace amounts of endotoxin in injectable sodium ampicillin preparations, J Pharm Sci, 72, 739, 10.1002/jps.2600720706 Unger, 2014, Human endothelial cell-based assay for endotoxin as sensitive as the conventional limulus Amebocyte lysate assay, Biomaterials, 35, 3180, 10.1016/j.biomaterials.2013.12.059 Chauhan, 2013, Strategies for advancing cancer nanomedicine, Nat Mater, 12, 958, 10.1038/nmat3792 Peer, 2007, Nanocarriers as an emerging platform for cancer therapy, Nat Nanotechnol, 2, 751, 10.1038/nnano.2007.387 Duncan, 2006, Polymer conjugates as anticancer nanomedicines, Nat Rev Cancer, 6, 688, 10.1038/nrc1958 Dobrovolskaia, 2015, Pre-clinical immunotoxicity studies of nanotechnology-formulated drugs: Challenges, considerations and strategy, J Control Release, 220, 571, 10.1016/j.jconrel.2015.08.056 Smulders, 2012, Contamination of nanoparticles by endotoxin: evaluation of different test methods, Part Fibre Toxicol, 9, 10.1186/1743-8977-9-41 Dobrovolskaia, 2013, 77 Bromberg, 2010, Binding of functionalized paramagnetic nanoparticles to bacterial lipopolysaccharides and DNA, Langmuir, 26, 8829, 10.1021/la904589p Darkow, 1999, Functionalized nanoparticles for endotoxin binding in aqueous solutions, Biomaterials, 20, 1277, 10.1016/S0142-9612(99)00022-8 Vetten, 2014, Challenges facing sterilization and depyrogenation of nanoparticles: Effects on structural stability and biomedical applications, Nanomedicine: Nanotechnology, Biology, and Medicine, 10, 1391, 10.1016/j.nano.2014.03.017 Dobrovolskaia, 2010, Ambiguities in applying traditional limulusAmebocyte lysate tests to quantify endotoxin in nanoparticle formulations, Nanomedicine (Lond), 5, 555, 10.2217/nnm.10.29 Dobrovolskaia, 2010, Ambiguities in applying traditional limulus amebocyte lysate tests to quantify endotoxin in nanoparticle formulations, Nanomedicine: Nanotechnology, Biology, and Medicine, 5, 555, 10.2217/nnm.10.29 Li, 2016, Development and validation of a method for determination of encapsulation efficiency of CPT-11/DSPE-mPEG2000 nanoparticles, Medicinal Chemistry, 6, 345, 10.4172/2161-0444.1000368 Ahowesso, 2011, Sex and dosing-time dependencies in irinotecan-induced circadian disruption, Chronobiol Int, 28, 458, 10.3109/07420528.2011.569043 Jiang, 2011, Researches on bacterial endotoxin test for breviscapin injection, Drug Standards of China, 12, 430 Zhang, 2016, Study on pyrogen test method for amifostine, Chin J Pharm Anal, 36, 1299 Zhu, 1998, Discussion on dosage of pyrogen test, China Academic Journal, 12, 234