丹参川芎嗪注射液与常用溶媒配伍稳定性研究  

Stability of Compatibility of Radix Salivae Miltiorrhizae Ligustrazine Injection with Used Solvents

作　　者：李峥[1] 郎轶咏[1] 张晓莉[1] 戴华[1] 王强[1] 

机构地区：[1]解放军202医院药剂科,辽宁沈阳110003

出　　处：《解放军药学学报》2012年第4期339-341,352,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立同时测定丹参川芎嗪注射液中丹参素和盐酸川芎嗪的含量,考察丹参川芎嗪注射液与常用溶媒配伍后的稳定性情况。方法采用HPLC法测定丹参素和盐酸川芎嗪含量,并进行方法学研究,根据临床应用,按比例将丹参川芎嗪注射液与常用溶媒混合,观察配伍后的外观变化、pH值及含量变化。结果该方法能准确测定丹参川芎嗪注射液中丹参素和盐酸川芎嗪含量,丹参川芎嗪注射液与常用溶媒配伍后的稳定性受储藏时间、温度的影响。结论丹参川芎嗪注射液不宜在高温、长时间光照的条件下使用。Objective To establish a content determination method of Salivae Miltiorrhizae and Ligustrazine hydrochloride in Radix Salivae Miltiorrhizae Ligustrazine injection（RSML） under the same chromatogratic condition and to study the stability of RSML with used solvents.Methods HPLC system was used in the analysis of Salivae Miltiorrhizae（SM） and Ligustrazine hydrochloride（LH）.The changes of mixed solution after matching in external appearance,pH and contents of RSML were observed.Results The content of Salivae Miltiorrhizae and Ligustrazine hydrochloride was determined accurately.The stability of compatibility of RSML with used solvents was affected by storage time and temperature.Conclusion RSML should not be used at high temperature or in strong light.

关 键 词：丹参川芎嗪注射液 配伍 稳定性 HPLC 

分 类 号：R927.2[医药卫生—药学]