中国中药杂志

2010, v.35(22) 2990-2993

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热毒宁注射液与溶媒配伍稳定性研究
Compatible stability of reduning injection with solvents

王永香;刘涛;王振中;张静;萧伟;
WANG Yongxiang,LIU Tao,WANG Zhenzhong,ZHANG Jing,XIAO Wei(Jiangsu Kanion Pharmaceutical Co.,Ltd.,Lianyungang,Lianyungang 222001,China)

摘要(Abstract):

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0~6 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0~6 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(KeyWords): 热毒宁注射液;溶媒;配伍;稳定性;高效液相色谱法
Reduning injection;compatibility;stability;HPLC

Abstract:

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基金项目(Foundation): 国家“重大新药创制”科技重大专项(2009ZX09313-032)

作者(Author): 王永香;刘涛;王振中;张静;萧伟;
WANG Yongxiang,LIU Tao,WANG Zhenzhong,ZHANG Jing,XIAO Wei(Jiangsu Kanion Pharmaceutical Co.,Ltd.,Lianyungang,Lianyungang 222001,China)

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