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目的考察不同温度、时间、贮存条件下注射用顺苯磺酸阿曲库铵(库泰)的质量稳定性和药效学,使其利于保存和运输。方法实验室考察低温(2～10℃)和常温(25,35,40℃)条件下贮存,对注射用顺苯磺酸阿曲库铵有关物质检测的影响;临床观察低温(2～10℃)和常温(25℃,30 d)贮存条件下,单次静脉注入注射用顺苯磺酸阿曲库铵成人麻醉诱导的药效学。结果常温贮存条件(25℃,60 d;35℃,30 d;40℃,10 d)药品对样品中有关物质含量无影响(P>0.05)。常温(25℃,30 d)与低温贮存药品的临床药效学参数无明显差异(P>0.05)。结论作为新型肌肉松弛药,顺苯磺酸阿曲库铵在常温(25℃,30 d)贮存,可安全地用于临床全身麻醉诱导且药效稳定。
OBJECTIVE To investigate the quality stability and pharmacodynamics of atracurium cisatracurium for injection under different temperature, time and storage conditions, which is beneficial to preservation and transportation. Methods The effect of atracurium cisatracurium for injection on the detection of related substances in injection of cisatracurium was investigated in laboratory at low temperature (2 ~ 10 ℃) and room temperature (25, 35, 40 ℃) ) And room temperature (25 ℃, 30 d) storage conditions, a single intravenous injection of atracurium cisplatin for adult anesthesia-induced pharmacodynamics. Results The room temperature storage conditions (25 ℃, 60 d; 35 ℃, 30 d; 40 ℃, 10 d) had no effect on the related substances in the samples (P> 0.05). There was no significant difference in the clinical pharmacodynamics parameters between normal temperature (25 ℃, 30 d) and low temperature storage medicine (P> 0.05). Conclusion As a new type of muscle relaxant, atracurium cis-sulfonate is stored at room temperature (25 ℃, 30 d), which can be safely used in clinical general anesthesia induction and has stable pharmacodynamics.