【摘要】 探讨注射用水飞蓟宾葡甲胺质量标准及初步安全性评价研究.实验针对该剂的干燥失重、不溶性微粒、炽灼残渣以及安全性评价中的溶血、刺激、过敏反应进行研究.该制剂的回归曲线为Y=47 741X+531.19,r=0.999 9.精密度:测得平均峰面积为11 182.42,RSD为0.479 6%.稳定性试验表明在14 h内稳定性良好,RSD为1.030 9%.加样回收率:平均回收率为99.84%,RSD为0.593 5%.样品质量分数测定:质量分数均在标示量95%-105%范围内,平均含量40.749 9 mg/支.检查的其他项目符合药典的有关规定.试验证明此质量标准符合国家药典有关规定,在实际生产中可有效指导生产的进行.更多还原

【Abstract】 To research the quality standard and preliminary secure research of silybin-meglumine for injection.This paper carries on by the weight loss,insolubility particle,ignition dregs,content determining and hemolysis,penicillin allergy,irritating of preliminary secure.The results indicated that regression curve was Y=47 741X+531.19,r = 0.999 9;the precision:average peak area 11 182.42,RSD 0.479 6%(n=6);stability: the stability which RSD was 1.030 9% in 14 hours;The average recovery was 99.84%,the RSD was 0.593 5%.The sample average content was 40.749 9 mg/bottle.Every item in the experiment was fit in with the pharmacopoeia and the quality standard can be the reference to the production.更多还原