喜炎平注射液与15种药物配伍稳定性考察  

Study on the compatible stability of Xiyanping injection with fifteen injections

作　　者：杨小玲 程帆 刘艳红 刘地发 刘尧奇 欧阳婷 吕武清[2] 

机构地区：[1]江西青峰药业有限公司,赣州341000 [2]江西省中医药研究院,南昌330046

出　　处：《中国新药杂志》2013年第20期2374-2378,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2011ZX09101-201-04)

摘　　要：目的：考察喜炎平注射液与利巴韦林注射液等15种药物配伍后在5％葡萄糖或0．9％氯化钠注射液中的稳定性。方法：室温下，将喜炎平注射液分别与15种药物配伍后，考察配伍后0—6h内药液的性状、pH值、不溶性微粒、主要成分磺化物E含量的变化情况。结果：配伍液的外观颜色在6h内无显著变化；注射用头孢唑啉钠和头孢趺辛钠与喜炎平注射液配伍后的pH在6h内逐渐上升，其他药物配伍后pH无显著变化；喜炎平注射液与15种药物配伍后不溶性微粒数量明显增多，且均超出药典规定；注射用阿昔洛韦和注射用更昔洛韦与喜炎平注射液配伍后主要成分磺化物E含量在6h内显著下降，其他药物无显著变化。结论：喜炎平注射液在临床上可用5％葡萄糖或0．9％氯化钠稀释静脉滴注，但需严格避免与所述15种药物在同一容器内混合使用。Objective：To study the compatible stability of Xiyanping injection with fifteen injections such as ribavirin injection at different dosages in 5% glucose injection or 0.9% sodium chloride injection. Methods：At room temperature, the changes of color, clarity, pH,insoluble particles and main ingredients were observed after admixture of Xiyanping injection with fifteen selected injections in 5% glucose injection or 0.9% sodium chloride in- jection. Results：There was no significant change in color within 6 h. The pHs of Cefazolin Sodium for Injection and Cefuroxime Sodium for Injection rose gradually within 6 h,while the other injections had no significant change. The numbers of insoluble particles in the mixture of Xiyanping injection with fifteen selected injections increased and ex- ceeded the limits set by Chinese Pharmacopoeia. There were no changes in the content of sulfonate E in Xiyanping injection within 6 h after admixture with the fifteen selected Ganciclovir for Injection, for which the content of sulfonate E injections except declined gradually the Acyclovir for Injection and the within 6 h. Conclusion ： Xiyanping Injection is compatible with 5% glucose injection or 0. 9% sodium chloride injection within 6 h,but it is strictly prohibited to be mixed with the fifteen selected injections.

关 键 词：喜炎平注射液 配伍 稳定性 

分 类 号：R969.2[医药卫生—药理学]