注射用血栓通(冻干)与24种常用注射剂的配伍稳定性研究  

Compatible stability study of 24 different injectables in combination with Xueshuangtong Injection(lyophilized)

作　　者：李娜 王萌[2] 任晓亮[1] LI Na;WANG Meng;REN Xiao-liang(School of Chinese Materia Medica,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;State Key Laboratory of Component-based Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

机构地区：[1]天津中医药大学中药学院,天津301617 [2]天津中医药大学组分中药国家重点实验室,天津301617

出　　处：《中华中医药杂志》2022年第5期2608-2615,共8页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金面上项目(No.81473543)。

摘　　要：目的:研究临床常与注射用血栓通(冻干)(XST)联合使用的7种中药、16种化药注射剂,1种生物制品共24种注射剂进行配伍后的物理化学指标随时间变化情况,探讨配伍稳定性对临床用药的影响。方法:采用超高效液相色谱法(UPLC)、气相色谱法(GC)、液质联用色谱法(LC-MS)等分析技术,测定24种配伍注射液中的主成分含量随时间变化情况。遵循国家药品监督管理局及人用药品注册技术要求国际协调会议(ICH)稳定性研究指导原则及2020年版《中华人民共和国药典》中注射剂制剂通则,通过测定渗透压、粒径、pH值、不溶性微粒、颜色、澄明度6项与临床用药不良反应相关的主要制剂分析指标,综合评价药物配伍联合使用稳定性变化。结果:配伍后,20种注射液各项指标稳定,仅有4种(醒脑静注射液、痰热清注射液、甲钴胺注射液、胞磷胆碱钠注射液)主成分含量有所下降,但其余5项指标仍保持稳定,推测其可能与自身稳定性有关。结论:XST与中药、化药注射剂以及生物制品配伍基本稳定,但在实际应用中,应谨慎选择配伍注射液所用的输液基质、现配现用,密切关注患者用药情况。Objective:To explore the influence of compatibility stability on clinical medication by studying the physical chemistry indexes of 24 different injectables(7 Chinese medicine injectables,16 chemical medicine injectables,1 biological medicine procluct)in combination with Xueshuantong Injection(lyophilized,XST)over time.Methods:The UPLC,GC,or LCMS were used to determine changes of index component content in 24 kinds of combination injections over time.Six indexes(osmotic pressure,particle size,pH value,insoluble particles,color and clarity)related to adverse reactions of compatibility were examined following guidelines issued by the International Conference on Harmonization(ICH),Chinese Pharmacopoeia 2020 edition.Results:All indexes of 20 injectables were stable.The content of principal components decreased in 4 injectables(Xingnaojing Injection,Tanreqing Injection,Mecobalamin Injection and Crticoine Sodium Injection),but other 5 indexes were stable,which could be attributed to their instability.Conclusion:Although the compatible stability of XST with traditional Chinese medicine,chemical injection,and biological products is generally stable,in practice,the injectables solution should be prepared when using,the infusion matrix for compatible injection should be carefully selected,and patient medication should be closely monitored.

关 键 词：注射用血栓通 稳定性 配伍 中药注射剂 化药注射剂 输液基质 不良反应 临床用药 

分 类 号：R289[医药卫生—方剂学]