热毒宁注射液与溶媒配伍稳定性研究  

Compatible stability of reduning injection with solvents

作　　者：王永香[1] 刘涛[1] 王振中[1] 张静[1] 萧伟[1] 

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《中国中药杂志》2010年第22期2990-2993,共4页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09313-032)

摘　　要：目的：研究不同用量的热毒宁注射液与5%葡萄糖注射液和0.9%氯化钠注射液配伍药液的稳定性。方法：将热毒宁注射液与5%葡萄糖注射液和0.9%氯化钠注射液分别按5∶250,10∶250,20∶250,30∶250,40∶250,50∶250,62.5∶250的比例配伍后,考察配伍后06 h内药液的色泽、澄明度、pH、不溶性微粒、主要成分含量、液相指纹图谱的变化情况。结果：配伍药液色泽、澄明度、pH、主要成分含量、液相指纹图谱相似度在配伍后的06 h内没有显著差异,不溶性微粒有显著差异。结论：热毒宁注射液与5%葡萄糖注射液和0.9%氯化钠注射液配伍4 h内稳定,为了保证临床用药安全建议配伍使用控制在2 h内,与5%GS或0.9%NS配伍时,热毒宁注射液用量不宜大于50 mL。Objective： To investigate the compatible stability of Reduning injection in different dosages with 5% glucose injection and 0.9% sodium chloride injection.Method： The changes before and after compatible application of Reduning injection with 5% glucose injection and 0.9% sodium chloride injection（5∶250,10∶250,20∶250,30∶250,40∶250,50∶250,62.5∶250） on color,clarity,pH,main ingredients and atlas of HPLC were determined.Result： There were no difference in the color,clarity,pH,the main ingredients and liquid fingerprints of the mixture solutions,but the insoluble particles in them showed significant difference within 6 h.Conclusion： Reduning injection is compatible in different concentrations with 5% glucose injection or 0.9% sodium chloride injection within 4 h,in clinic,it should be used within 2 h,the volume of Reduning injection with 5% glucose injection or 0.9% sodium chloride injection should be no more than 50 mL.

关 键 词：热毒宁注射液 溶媒 配伍 稳定性 高效液相色谱法 

分 类 号：R289.1[医药卫生—方剂学]