中国临床药学杂志

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 qualities 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 spectioscopy.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 maximum 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 edition《Chinese Pharmacopoeia》.CONCLUSION Although 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.