不同厂家依达拉奉注射剂中有关物质及不溶性微粒的比较Related substances and particulate matter comparability of different edaravone injections
沙先谊;马光磊;张娜娜;方晓玲;
摘要(Abstract):
目的对5个厂家不同批次的依达拉奉注射剂进行质量考察。方法以HPLC法测定样品中依达拉奉的含量和有关物质,用显微镜计数法和光子相关光度法测定不溶微粒。结果 A、B、C、D、E 5个厂家各3批样品中依达拉奉的含量分别相当于对照品的99.35%~100.21%、98.78%~99.24%、99.76%~101.76%、97.65%~99.12%和97.98%~100.04%;有关物质中单杂分别是0.33%、0.64%、0.58%、0.59%和0.80%;总杂分别是0.08%、0.12%、0.27%、0.07%和0.4%;不溶性微粒(≥10μm和≥25μm)均符合2010版《中国药典》要求。结论 5个厂家样品虽然都符合规定,但其中A厂样品中的有关物质的含量显著少于其他厂家(P<0.05),且不溶性微粒的平均粒径最小以及粒子总数最少,因此A厂应加强内部质量控制。
关键词(KeyWords): 依达拉奉;有关物质;高效液相法;显微镜计数法;光子相关光度法;不溶微粒;质量评价
基金项目(Foundation):
作者(Authors): 沙先谊;马光磊;张娜娜;方晓玲;
DOI: 10.19577/j.cnki.issn10074406.2010.05.009
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