注射用唑来膦酸浓溶液配伍稳定性考察  

Study on Compatibiliy Stability of Zoledronic Acid Concentrated Solution for Injection

作　　者：许俊博 赵海英 尚淑霞 寇同欣 金珠 刘茜英 贾小兰 金鑫 XU Junbo;ZHAO Haiying;SHANG Shuxia;KOU Tongxin;JIN Zhu;LIU Qianying;JIA Xiaolan;JIN Xin(China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing 100102,China)

机构地区：[1]华润双鹤药业股份有限公司,北京100102

出　　处：《山东化工》2025年第2期149-152,共4页Shandong Chemical Industry

摘　　要：目的:考察不同稳定性条件下放置的注射用唑来膦酸浓溶液与不同溶媒配伍后的溶液稳定性。方法:将注射用唑来膦酸浓溶液0时和效期末样品分别与葡萄糖注射液、氯化钠注射液配伍,在冷藏(2~8℃)放置24 h、室温30℃放置6 h条件下,以性状、不溶性微粒、pH、渗透压、5-羟甲糠醛、可见异物、含量及有关物质(包含阴离子杂质)等指标来考察配伍溶液的稳定性。结果:不同稳定性条件下放置的样品配伍后的溶液性状、不溶性微粒、pH值、渗透压、5-羟甲糠醛、可见异物、含量及有关物质(包含阴离子杂质)等指标均未发生显著变化。结论:不同稳定性条件下注射用唑来膦酸浓溶液的样品配伍时,在冷藏(2~8℃)放置24 h、室温下放置6 h相对稳定,说明注射用唑来膦酸浓溶液与葡萄糖注射液、氯化钠注射液相容性良好,可满足临床使用要求。Objective:Study the stability of concentrated solutions of zoledronic acid for injection placed under different stability conditions in combination with different solvents.Methods:Mix the concentrated solution of zoledronic acid for injection with glucose injection and sodium chloride injection at 0 and the end of the efficacy period,respectively.Under the conditions of refrigeration(2~8℃)for 24 h and room temperature of 30℃for 6 h,evaluate the stability of the compatible solution based on its properties,insoluble particles,pH,osmotic pressure molar concentration,5-hydroxymethylfurfural,visible foreign matter,content,and related substances(including anionic impurities).Results:The properties of the solution,insoluble particles,pH,osmotic pressure molar concentration,5-hydroxymethylfurfural,visible foreign matter,content,and related substances(including anionic impurities)did not show significant changes after the compatibility of samples placed under different stability conditions.Conclusion:When the samples of concentrated solution of zoledronic acid for injection are mixed under different stability conditions,they are relatively stable when stored in refrigeration(2~8℃)for 24 h and at room temperature for 6 h.This indicates that the compatibility of concentrated solution of zoledronic acid for injection with glucose injection and sodium chloride injection is good and can meet the clinical requirements.

关 键 词：唑来膦酸 配伍稳定性 含量 有关物质 

分 类 号：R974.1[医药卫生—药品] R927.11[医药卫生—药学] TQ460[化学工程—制药化工]