摘要
目的:考察丹红注射液与说明书规定输液的配置稳定性。方法:参考药品说明书、质量标准和《中国药典》相关检查方法,分别考察丹红注射液与说明书中规定的输液配置后的外观性状、pH、不溶性微粒、丹参酮Ⅱ_A、丹参素钠、原儿茶醛含量的变化。结果:配置4 h外观性状、pH、不溶性微粒、主成分变化不大,但6 h后丹参酮Ⅱ_A含量下降明显,其他成分基本上稳定。结论:丹红注射液与输液配置后宜在4 h内使用。
Objective： To study on stability of Danhong injections mixed with transfusion solution rated in drug insert. Method： The appearance characters, pH,insoluble particles were observed, The contents of Tanshinone Ⅱ A, tanshinol sodium, Protocatechuic Al- dehyde was determined based on quality criteria, drug insert and Chinese Pharmacopoeia. Result： No significant differences were found in appearance characters, pH, insoluble particles, tbe contents of Tanshinone ⅡA, tanshinol Na, Protocatechuic Aldehyde after mixture within 4 hours, while insoluble particles was exceeds the limit of Chinese Pharmacopoeia 2005, The contents of Tanshinone Ⅱ A was de- clined markedly after 6 hours.Conclusion： Danhong Injections should be administered within 4 hours.
出处
《中国药师》
CAS
2010年第11期1623-1624,共2页
China Pharmacist
关键词
丹红注射液
配置稳定性
丹参酮ⅡA
Danhong injection
Compatible stability
Tanshinone Ⅱ A
