摘要
目的考察银杏内酯B注射液(一类新药)不溶性微粒检查方法的可行性,并以不溶性微粒的变化为指标考察药液稀释后的物理稳定性。方法参照2005年版《中国药典》中不溶性微粒检测的光阻法及其指导原则中静脉注射用浓溶液的检测方法。结果该制剂(1mL/支)至少应稀释于200mL稀释液方能溶解,3批检品的不溶性微粒均符合规定。结论光阻法可用于银杏内酯B注射液的不溶性微粒检查;稀释液体及稀释后存放温度不应低于16℃。
Objective To study the particulate determination of Ginkgolide B injection and its stability. Methods The light blockage method was used and the tests were conducted according to Chinese Pharmacopoeia 2005. Results The particulate determination of Ginkgolide B injection was eligible after the Ginkgolide B injection was diluted to 0. 1 mg/mL. Conclusion The light blockage method is suitable for the detection of the particulate matter in Ginkgolide B injection. The diluent solution and the storing temperatnre after dilution is not less than 16℃.
出处
《中国药业》
CAS
2007年第3期29-30,共2页
China Pharmaceuticals
