期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 98, 期 12, 页码 4684-4694出版社
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.21780
关键词
biodegradable; thermosensitive; hydrogel; sol-gel-sol transition; acute toxicity evaluation
资金
- National 863 Project [2007AA021902, 2006AA03Z356]
- National Natural Science Foundation [NSFC20704027]
- Specialized Research Fund for the Doctoral Program of Higher Education (SRFDP) [200806100065]
- Sichuan Prominent Young Talents Program [07ZQ026-033]
- Sichuan Key Project of Science and Technology [2007SGY019]
- Chinese Key Basic Research Program [2004CB518807]
In this work, biodegradable PCL-PEG-PCL (PCEC) triblock copolymers were successfully synthesized at one-step. Aqueous solution of PCEC copolymer displayed thermosensitive sol-gel-sol transition behavior, which is flowing sol at low temperature and turns into non-flowing gel at body temperature. The cytotoxicity of PCEC copolymer was evaluated by cell viability assay using HEK293 and WISH cells. In vivo gel-formation, degradation test, acute toxicity tests, and histopathological study of PCEC hydrogels were performed in BALB/c mice by subcutaneous administration. In acute toxicity test, the mice were observed continuously for 21 days. For histopathologic study, samples including heart, liver, spleen, lung, kidneys, and tissue of injection site were histochemical prepared and stained with hematoxylin-eosin. No mortality or significant signs of acute toxicity was observed during the whole observation period and there is no significant lesion to be shown in histopathologic study of major organs and tissue of injection site. The maximum tolerance dose (MTD) of PCEC hydrogel (20 wt%) by subcutaneous administration was calculated to be higher than 25 g/kg b.w. The results indicated that the obtained PCEC hydrogel was non-toxic after subcutaneous administration, and could be a safe candidate for in situ gel-forming controlled drug delivery system. (C) 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:4684-4694, 2009
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