注射用血栓通与临床常用输液溶媒的配伍稳定性考察

Study on compatibility stability of Xueshuantong for injection with different common solvents

[目的]考察注射用血栓通与5种常用溶媒配伍后的稳定性,优选出最佳溶媒配伍方案,为促进临床合理安全用药提供依据。[方法]按照药品说明书规定的用量,将注射用血栓通与5种常用溶媒配伍,定时考察配伍溶液的外观、pH值和不溶性微粒。[结果]注射用血栓通与5种临床常用的不同溶媒配伍混合配制后,外观和pH值均无明显变化,但不溶性微粒均随着配伍时间的增加而增多,6h后≥10μm不溶性微粒数均超出2015年版《中国药典》规定的限度,且与0.9%的氯化钠注射液配合4h后≥10μm和≥25μm不溶性微粒数均已超出2015年版《中国药典》规定的限度。[结论]静脉滴注给药时,注射用血栓通最佳配伍溶媒是10%葡萄糖注射液,其次为5%葡萄糖注射液和葡萄糖氯化钠注射液,且配伍后的溶液应在6h内使用完毕,若用于糖尿病患者,需用0.9%的氯化钠注射液溶媒配制,配伍后的溶液应在4h内使用完毕。

[Objective]To investigate the stability of compatibility of Xueshuantong for injection with 5 kinds of common solvents and optimize the best solvent compatibility program to provide basis for promoting clinical rational and safe drug use.[Methods]According to the prescription of drugs,the injection of thrombosis with 5 kinds of commonly used solvents compatibility,regular inspection compatibility appearance,pH and insoluble particles.[Results]There was no obvious change in the appearance and pH value of Xueshuantong for injection after mixing with five kinds of commonly used different solvents.However,the insoluble particles increased with the increase of compatibility time,and the number of insoluble particles≥10μm exceeded after 6 h 2015 edition of Chinese Pharmacopoeia limits,and with 0.9%sodium chloride injection with 4 h≥10μm and≥25μm insoluble particles have exceeded the 2015 edition of the Chinese Pharmacopoeia limits.[Conclusion]The optimal compatibility of injection of Xueshuantong for injection is 10%glucose injection,followed by 5%glucose injection and glucose and sodium chloride injection,and the solution after compatibility should be used within 6 h,If used in patients with diabetes,need 0.9%sodium chloride injection vehicle preparation,the compatibility of the solution should be used within 4 h.