注射用盐酸罗沙替丁醋酸酯与注射用头孢曲松钠配伍的稳定性研究

Study on the Stability of the Compatibility of Roxatidine Acetate Hydrochloride for Injection and Ceftriaxone Sodium for Injection

目的:考察注射用盐酸罗沙替丁醋酸酯与注射用头孢曲松钠在0.9%氯化钠注射液和5%葡萄糖注射液中配伍的稳定性。方法:参考临床用药浓度,取注射用盐酸罗沙替丁醋酸酯与注射用头孢曲松钠适量置聚丙烯离心管中,分别加入0.9%氯化钠注射液和5%葡萄糖注射液制得配伍液,在室温和高温下,于0,1,2,4,6,8 h取样,采用高效液相色谱法测定盐酸罗沙替丁醋酸酯与头孢曲松钠的含量,测定配伍液pH值和不溶性微粒数并观察外观。结果:在高温和室温条件下,8 h内两药配伍后的外观、pH值均无明显变化,盐酸罗沙替丁醋酸酯含量相对降低14.71%,12.54%,14.29%,13.87%;头孢曲松钠含量相对降低8.45%,6.16%,9.54%,8.45%。结论:注射用盐酸罗沙替丁醋酸酯不能与注射用头孢曲松钠在0.9%氯化钠注射液和5%葡萄糖注射液中配伍使用。

Objective To investigate the compatible stability of roxatidine acetate hydrochloride for injection with ceftriaxone sodium for injection in 0.9% sodium chloride and 5% glucose. Methods Referring to the clinical drug concentration, the amount of roxatidine hydrochloride acetate for injection and ceftriaxone sodium for injection were placed in a polypropylene centrifuge tube, and 0.9% sodium chloride and 5% glucose were added to prepare a compatibility solution. The samples were taken at 0, 1, 2, 4, 6, 8 h at room temperature and high temperature, the content of roxatidine hydrochloride and ceftriaxone sodium were determined by high performance liquid chromatography. pH value of the compatibility solution and the number of insoluble particles were measured, and the appearance was observed. Results Under the condition of high temperature and room temperature, the appearance and pH value of the two drugs in 8 h were not obviously changed. The content of rosutidine acetate hydrochloride was decreased by 14.71%, 12.54%, 14.29%, 13.87%, and the content of ceftriaxone sodium was decreased by 8.45%,6.16%, 9.54% and 8.45%, respectively. Conclusion Roxatidine hydrochloride acetate for injection can not be used in combination with ceftriaxone sodium for injection in 0.9% sodium chloride and 5% glucose.