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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。
Objective To examine the quality of edaravone injection from 5 batches of different manufacturers. Methods HPLC method was used to determine the content of edaravone in the sample and related substances. The insoluble particles were determined by microscopy and photon correlation spectrophotometry. Results The contents of edaravone in three batches of samples from A, B, C, D and E were 99.35% ~ 100.21%, 98.78% ~ 99.24%, 99.76% ~ 101.76% and 97.65% ~ 99.12% and 97.98% ~ 100.04%, respectively; the related impurities were 0.33%, 0.64%, 0.58%, 0.59% and 0.80% respectively; the total impurities were 0.08%, 0.12%, 0.27%, 0.07% and 0.4% ; Insoluble particles (≥10μm and ≥25μm) are in line with the 2010 edition of “Chinese Pharmacopoeia” requirements. Conclusion Although the samples from 5 factories are in compliance with the regulations, the contents of related substances in factory A samples are significantly less than those in other factories (P <0.05), and the average particle size of insoluble particles is the smallest and the total number of particles is the smallest. Internal quality control.