丹参注射液对小牛血去蛋白提取物稳定性的影响  

Influence of Danshen Injection on the Compatibility of Deproteinized Calf Blood Extract

作　　者：陈艳春 单爱云 李春红 颜晗[2] 

机构地区：[1]广东省深圳市福田区中医院,广东深圳518034 [2]广东省深圳市药品检验所,广东深圳518057

出　　处：《中国药业》2016年第8期29-33,共5页China Pharmaceuticals

摘　　要：目的考察丹参注射液对小牛血去蛋白提取物(DCBE)在0.9%氯化钠注射液中稳定性的影响。方法采用高效液相色谱法测定丹参注射液与小牛血去蛋白提取物注射液配伍液中氨基酸的含量变化,Folin-酚法测定多肽的含量,同时观察配伍液的外观、p H、微粒数变化。结果配伍液在6 h内的外观、p H、含量均无明显变化;不溶性微粒在2 h内符合药典规定,2 h后不符合药典规定。结论在临床使用中,为了安全起见,丹参注射液和小牛血去蛋白提取物应分开在不同输液瓶中使用,且需使用间隔液。Objective To study the influence of Danshen Injection on the compatibility of deproteinized calf blood extract in 0.9% sodium chloride. Methods HPLC method was used to determine the content change of amino acids in the mixture of deproteinized calf blood extract injection and Danshen Injection. Folin- phenol method was used to determine the content of polypeptide, and the changes of the physical appearance, pH and particle count in the mixture were also examined. Results No significant changes in content, pH, or physical appearance were found within 6 h in the mixture; the amount of insoluble patieles accorded with the Chinese Pharmacopoeia within 2 h, and exceeded beyond which was permitted after 2 h. Conclusion For clinical safety concerns, deproteinized calf blood extract injection cannot be mixed with Danshen Injection,and the two should be separated by an infusion solution.

关 键 词：丹参注射液 小牛血去蛋白提取物 稳定性 高效液相色谱法 

分 类 号：R969.2[医药卫生—药理学] R977.6[医药卫生—药学]