甘露聚糖肽注射液与常用中药注射液的配伍稳定性研究

摘要

Objective: Study on the stability of Mannatide Injection compatibility with 13 kinds of traditional Chinese medicine injection.Methods:The Mannatide Injection and 12 kinds of Chinese traditional medicine injection were compatibility,then carried out respectively:1.Determine the change of apprearance and pH in 0,0.5,1,2 hours at the temperature of 25℃ and 37℃ ;2.Using physiological saline as solvent,detemine the cotent changes of measured drug in 0,0.5,1,2 hours at the temperature of 25℃ by UV spectrophotometric.3.Detect the content of tannin in each injection.Results:1.After mannatide Injection and the traditional Chinese medicine injection were compatible,no significant precipitation,crystallization,turbidity,bubble,discoloration produced,but with part of drug compatibility,pH value and color changed; 2.The content of drug changed obviously by UV spectrophotometry; 3.tannin content conformed to the "China Pharmacopoeia" provisions.Conclusion:Mannatide combined with commonly used traditional Chinese medicine injection,has effect on pH and appearance,at the same time the change of content is bigger,therefore the two used at interval are suggested in order to ensure safety.%目的:研究甘露聚糖肽注射液与13种常用中药注射液配伍的稳定性.方法:将甘露聚糖肽注射液与12种中药注射液进行配伍,分别进行:(1)25℃和37℃下,测定0、0.5、1、2h外观和pH变化;(2)以生理盐水为溶媒,紫外分光光度法检测25℃下,0,0.5,1,2h待测药品含量变化;(3)各注射液鞣质含量.结果:(1)甘露聚糖肽注射液与各中药注射液配伍后,无明显沉淀、结晶、浑浊、气泡、变色产生,但与部分药品配伍后,pH值及颜色发生变化;(2)紫外分光光度法检测药品含量变化明显;(3)鞣质含量符合《中国药典》规定.结论:甘露聚糖肽与常用中药注射液配伍,对pH和外观存在影响,同时紫外检测含量变化较大,因此建议临床上将二者间隔使用,以确保安全性.