摘要
目的:考察大株红景天注射液在常用的4种溶媒(0.9%氯化钠注射液、5%葡萄糖注射液、果糖注射液、木糖醇氯化钠注射液)中配伍的稳定性。方法:采用《中国药典》2010年版规定的方法考察大株红景天注射液与4种溶媒配伍后分别在0,0.5,1,2,4,8 h内产生不溶性微粒数量和p H的变化。结果:在8 h内大株红景天注射液与4种溶媒配伍后的外观及p H无明显变化。在0.9%氯化钠注射液,5%葡萄糖注射液中的不溶性微粒数符合药典规定。0.9%氯化钠注射液中不溶性微粒数量小于5%葡萄糖注射液。在果糖注射液中不溶性微粒数超过药典标准,尤其在4h不溶性微粒数明显增多。在木糖醇氯化钠注射液中不溶性微粒数略高于药典标准。结论:建议大株红景天注射液选用0.9%氯化钠注射液,5%葡萄糖注射液做溶媒。不推荐果糖注射液,木糖醇氯化钠注射液做溶媒。虽然说明书未提及大株红景天注射液用0.9%氯化钠注射液做溶媒。本试验可为糖代谢异常患者用药提供一个参考依据。
Objective： To research the stability of Dazhu Hongjingtian injection combined with four different infusion solutions（0.9% sodium chloride injection,5% glucose injection,fructose injection,xylitol and sodium chloride injection）. Methods： The insoluble particles and p H value of Dazhu Hongjingtian injection in 0,0. 5,1,2,4 and 8h after the combination were detected by the methods described in China Pharmacopeia（ 2010 edition）. Results： Dazhu Hongjingtian injection combined with the four infusion solutions showed no significant changes in appearance and p H value in 8h. The number of insoluble particles in Dazhu Hongjingtian injection combined with 0. 9% sodium chloride injection and 5% glucose injection met the requirement in the pharmacopeia,and that in 0. 9%sodium chloride injection was lower than that in 5% glucose injection. The quantity of insoluble particles in Dazhu Hongjingtian injection combined with fructose injection exceeded the standard level,and showed remarkable change in the fourth hour. The quantity of insoluble particles in xylitol and sodium chloride injection slightly exceeded the standard. Conclusion： Dazhu Hongjingtian injection can be mixed with 0. 9% sodium chloride injection and 5% glucose injection,and fructose injection and xylitol and sodium chloride injection are not suitable for the solvent of Dazhu Hongjingtian injection. Although there is no instruction indicating that 0. 9% sodium chloride injection can be used as the suitable solvent for Dazhu Hongjingtian injection,the results of the experiment can be reasonable reference for diabetes patients treated with Dazhu Hongjingtian injection.
出处
《中国药师》
CAS
2016年第3期599-601,共3页
China Pharmacist
关键词
大株红景天注射液
不溶性微粒
输液
配伍
Dazhu Hongjingtian injection
Insoluble particles
Infusion solution
Compatibility
