肾康注射液与5种溶媒配伍的稳定性考察  

Stability of Shenkang Injection Respectively in Five Different Solutions

作　　者：朱亚宁[1] 张鹏[1] 李巧如[1] 李茁[1] 杨乐婷 

机构地区：[1]陕西省人民医院药学部,西安710068

出　　处：《中国药师》2015年第8期1420-1423,共4页China Pharmacist

摘　　要：目的:通过考察肾康注射液与5种常用溶媒配伍的稳定性,选择最佳溶媒配伍方案,以便临床合理用药。方法:将肾康注射液与5种不同溶媒配伍后,定时考察配伍后溶液的p H、不溶性微粒数、有效物质原儿茶醛的含量变化情况。结果:5种溶媒按药品说明书比例配伍2 h后不溶性微粒数均有所增加,其中0.9%氯化钠注射液中的不溶性微粒数最多,且2 h后不溶性微粒数明显增加。5种配伍溶液的p H无明显变化。原儿茶醛的含量随时间的延长而下降,6 h内原儿茶醛的含量变化率:0.9%氯化钠注射液>5%果糖注射液>10%转化糖注射液>5%葡萄糖注射液>10%葡萄糖注射液,其中0.9%氯化钠注射液中的原儿茶醛含量下降近20%。结论:肾康注射液在不同溶媒中稳定性不同,用0.9%的氯化钠注射液配伍的注射液中原儿茶醛含量下降明显且不溶性微粒数较多。临床应选择稳定性更好的葡萄糖以及转化糖注射液作为溶媒,配伍后的溶液应尽可能在2 h内用完。Objective： To explore the stability of Shenkang injection respectively in five different solutions to choose the best com- patibility program and improve the rational drug use. Methods： The pH value, insoluble particles and the content of protocatechuic al- dehyde in Shenkang injection were determined after mixed with five solutions. Results： In the 6-hour mixing, the change order of proto- catechuic aldehyde content was 0.9% sodium chloride injection 〉 5% fructose injection 〉 10% invert sugar injection 〉 5% dextrose injection 〉 10% glucose injection, especially in 0.9% sodium chloride injection, the content was decreased by 20%. The number of insoluble particles was increased after the 2-hour mixing except in 10% invert sugar injection solution, and the increase in the four so- lutions was beyond the requirement in the 2010 edition of Chinese Pharmacopoeia, and the number of insoluble particles in 0.9% sodi- um chloride injection was the highest with the fastest change. During the experimental process, the pH value was stable. Conclusion： The five solutions show influence on stability of Shenkang injection in varying degrees. Shenkang injection in 0.9% sodium chloride in- jection is the least stable, which should be used with caution in clinics, while invert sugar injection and glucose injection can be the best choice for Shenkang injection and the mixed solution should be used up in 2h.

关 键 词：肾康注射液 溶媒 配伍 稳定性 

分 类 号：R942[医药卫生—药剂学]