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

作　　者：沙先谊[1] 马光磊[2] 张娜娜[1] 方晓玲[1] 

机构地区：[1]复旦大学药学院药剂学教研室,上海201203 [2]杭州九源基因工程有限公司,杭州310018

出　　处：《中国临床药学杂志》2010年第5期295-299,共5页Chinese Journal of Clinical Pharmacy

摘　　要：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。AIM To evaluate the qualifies of edaravone injections of different batch numbers from five different manufacturers. METHODS The contents and related substances of edaravone injections were determined by HPLC. The insoluble micro-particles were determined by microscopic count and photon correlation spectroscopy. RESULTS In three batches of products manufactued by manufacturers A, B, C, D and E, the contents of edaravone were 99.35% - 100.21% ,98.78% - 99.24%, 99.76% - 101.76%, 97.65% - 99.12% and 97.98% - 100.04%, respectively. The average related substances were 0.33%, 0.64%, 0.58%, 0.59% and 0.80%, respectively. The average maxi- mum related substances were 0.08%, 0.12%, 0.27%, 0.07% and 0.14%, respectively. The particulate matter of 5 manufacturers all met a criterion of 2010 edifion《Chinese Pharmacopoeia》. CONCLUSION Mthough the quality of the samples of 5 manufacturers are all qualified, the contents of related substances in manufacture A are significantly less than other manufacturers （ P 〈 0.05）. The mean diameter and total count of particulate matter in the products manufactured by A are lower than other products （manufactured by B, C,D and E）. Therefore, it is necessary, to control the quality in production.

关 键 词：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 

分 类 号：R927.2[医药卫生—药学]