注射剂常用增溶性药用辅料的安全与增溶研究

Study on Safety and Solubilization of Solubilizing Excipients Used in Injections

目的:研究聚氧乙烯脱水山梨醇单油酯、聚乙二醇-12-羟基硬脂酸酯、聚乙二醇300等辅料的安全与增溶情况。方法:采用高效液相法检测辅料的增溶情况,采用溶血性和刺激性试验评价辅料的安全性。结果:辅料的安全性与增溶情况相差较大。结论:为更客观地筛选注射剂的增溶性辅料,应将其放入制剂中进行研究。

Objective：To study the safety and solubilization of excipients solubilizing excipients used in injections.Method：Solubilization was measured by HPLC and hemolysis and irritation were used for the safety evaluation of excipients.Result：Safety and solubilization of solubilizing excipients were different.Conclusion：As more objective screening for injection solubilizing excipients,it should be researched into the preparation.