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门冬氨酸注射液热原与致敏物质研究

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目的 考察门冬氨酸钾镁注射液对家兔给药后是否有热原反应及对豚鼠给药后是否有全身过敏反应,评价该品种安全性,为临床用药提供技术支撑.方法 设置(0.5 mL·kg-1)和(1.0 mL·kg-1)两组给药剂量,考察18 个生产企业18 批样品对家兔的热原反应;致敏试验参照Chp 2020 年版四部附录1147 和《药物非临床研究质量管理规范》方法,考察18 批样品、原辅料及主要杂质对豚鼠的致敏反应,通过建立高血钾模型,结合豚鼠血钾浓度进行结果分析.结果 门冬氨酸钾镁注射液对家兔给药后无热原反应,18 批样品及门冬氨酸钾辅料有致敏反应.结论 建议现行标准中热原检查项统一给药剂量(1.0 mL·kg-1);门冬氨酸钾镁注射剂导致豚鼠发生的过敏症状为高钾血症所致,提示用该品种进行治疗时应关注血钾浓度.
Study on Pyrogen and Sensitization of Potassium Magnesium Aspartate Injection
OBJECTIVE To investigate whether potassium magnesium aspartate injection has pyrogen reaction after administration to rabbits and systemic anaphylaxis to guinea pigs,evaluate its safety and provide technical sup-port for clinical use.METHODS Set two dosage groups(0.5 mL·kg-1)and(1.0 mL·kg-1)to investigate the pyrogen reactions of 18 batches of samples from 18 production enterprises to rabbits;The sensitization test was con-ducted by referring to the methods of Appendix 1147 of Chp 2020,Part Ⅳ,and the Good Management Practice for Non-clinical Study of Drugs.The sensitization reaction of 18 batches of samples,raw and auxiliary materials and main impurities to guinea pigs was investigated.The results were analyzed by establishing a hyperkalemia model combined with the blood potassium concentration of guinea pigs.RESULTS Potassium magnesium aspartate injection had no pyrogen reaction to rabbits after administration,and 18 batches of samples and potassium aspartate excipients had sensitization reaction.CONCLUSION It is suggested that the pyrogen test item in the current standard should be uniformly administered(1.0 mL·kg-1);The anaphylactic symptoms of guinea pigs caused by potassium magnesium aspartate injection are caused by hyperkalemia,suggesting that attention should be paid to the blood potassium con-centration when using this product for treatment.

Potassium magnesium aspartate injectionPyrogenSensitization

何晓艳、周辉、扈麟、李子珊

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湖南省药品审核查验中心,湖南长沙 410001

湖南省药品检验研究院,湖南长沙 410001

门冬氨酸钾镁注射液 热原 致敏

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(4)
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