史一杰,程刚
SHI Yi-jie,CHENG Gang(School of Pharmacy

• 1:沈阳药科大学药学院

摘要(Abstract)：

目的对纳米制剂生物安全性评价研究进行了综述。方法查阅相关文献33篇,从纳米制剂的给药途径,结构与粒径,纳米材料或载体以及生物学评价方法等多个角度对纳米制剂的安全性评价研究进展进行了分别综述,并对中药纳米制剂的特点及潜在性安全进行相关评价。结果不同纳米制剂的给药途径、粒径、结构,应用的纳米载体或纳米材料不同均会对细胞或组织的损害具有不同程度影响,同时,评价手段不同也会对评价结果乃至结论产生影响;对于多组成多成分的中药纳米制剂,更应尽快找出有效评价方法对其毒性作用做出有效评价,避免盲目的进行中药纳米制剂的开发。结论纳米制剂为一类新型有效的药物制剂,研究者不仅应致力于其制剂学的开发研究,也应从安全性角度对其进行有效评价,制定统一的评价标准是目前纳米制剂科研人员亟待解决的问题。
Objective To summarize recent researches of biological safety evaluation for nanopreparation.Methods At least 33 papers recently published covered the effects of different routes of administration,different particle sizes/structures and carrying agents or materials,method of safety evaluation and the potential safety problems of nanomized traditional Chinese medicine were consulted,analyzed and summarized.Results and conclusions All above factors could affect the toxicity and safety of the nanopreparation,moreover unified and standard evaluated methods or instruments were needed during the judgment process.

关键词(KeyWords)： 纳米制剂;安全性;粒径;纳米中药
nanopreparation;safety;particle size;nano traditional Chinese medicine

Abstract:

Keywords:

基金项目(Foundation): 国家重点基础研究发展计划项目(2009CB930300)

作者(Author): 史一杰,程刚
SHI Yi-jie,CHENG Gang(School of Pharmacy

DOI: 10.14066/j.cnki.cn21-1349/r.2010.12.009

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