三种含丹参中药注射液的配伍稳定性研究

Study on compatible stability of 3 traditional Chinese Medicine Injections containing salvia

目的:考察含丹参的中药注射液与说明书规定输液的配伍稳定性。方法:参考药品说明书、质量标准和相关文献、中国药典相关检查方法,分别考察3种含丹参药材的中药注射液与说明书中规定的输液配伍后的外观性状、pH值、不溶性微粒、丹参酮ⅡA、丹参素钠、原儿茶醛含量的变化。结果:配伍4 h内外观、pH值、不溶性微粒变化不大,主成分变化不大,但6 h后不溶性微粒不合格,丹参酮ⅡA含量下降明显,其他成分基本上稳定。结论:这3种含丹参药材的中药注射液宜在4 h内使用。

Objective： To study the stability of 3 Traditional Chinese Medicine injections containing Salvia mixed with transfusion solution rated in drug insert.Methods： The appearance characters,pH,insoluble particles,The contents of Tanshinone ⅡA,tanshinol sodium,Protocatechuic Aldehyde was determined as the methods of quality criteria,pertinent literature and and Chinese Pharmacopoeia within 6 hours.Results： No significant differences were found in appearance characters,pH,insoluble particles,the contents of Tanshinone ⅡA,tanshinol Na,Protocatechuic Aldehyde after mixture within 4 hours,while insoluble particles exceeds the limit of Chinese Pharmacopoeia 2005,The contents of Tanshinone IIA declined markedly after 6 hours.Conclusion： Traditional Chinese Medicine Injections Containing Salvia should be admin-istered within 4 hours.