羟乙基淀粉质量研究进展

Overview of the Quality Study on Hydroxyethyl Starches

羟乙基淀粉(hydroxyethyl starches,HES)是支链淀粉经改性而得的一种高分子聚合物,具有强效快速的持续扩容效果,现被广泛应用于治疗和预防血容量不足,急性等容血液稀释(ANH)等。但由于存在肾脏及凝血功能等方面的潜在威胁,近年来一直备受关注与争议。笔者将对国内外HES产品的发展及质量研究概况进行阐述,以现行的国内各企业标准及《欧洲药典》(EP)标准为基础,着重介绍重均相对分子质量(M_w)与相对分子质量分布、羟乙基化程度(摩尔取代度MS)、羟乙基化具体位点(C2/C6)和含量测定的质控现状,并结合本课题组的探索性研究工作,给出各项目的质控方法建议,为该产品的质量标准提高及研究提供一定的思路,以保证其安全有效。

Hydroxyethyl starches（HES） are modified natural polymer of amylopectin with volume expansion properties. It has been widely used in the treatment for prevention of hypovolemia and acute normovolemic hemodilution（ANH）. However, the potential threats to kidney and coagulation have attracted much attention and controversy in recent years. This review will focus on the specification development and quality study of HES. The article will mainly talk about some quality control items： molecular weight （Mw） and molecular weight distribution, degree of hydroxyethyl （molar substitution, MS）, the specific sites of hydroxyethylation （C2/C6 ratio） and assay, all of those are based on the domestic enterprise standards and Europe Pharmacopoeia（EP）, and we will combine with the experimental data to give some suggestions on these items quality control. Hopefully to provide some ideas for improving and unifying the quality standard of hydroxyethyl starches.