5种中药注射剂在输液中不溶性微粒考察

Detection of Insoluble Particles in 5 Traditional Chinese Medicine Injections

目的:考察5种中药注射剂加入输液后不溶性微粒的变化。方法:模拟临床用量在2种常用溶媒中稀释成输液,测定5种中药注射剂在输液不溶性微粒。结果:5种中药注射剂的原药不溶性微粒符合规定,但配成输液后其不溶性微粒大量增加,其中2种不符合《中国药典》对静脉注射剂的要求。结论:输液加入中药注射液后不溶性微粒的明显增加应引起高度重视,避免不良反应的发生。

Objective： To study the changes of the insoluble particles in 5 TCDI Methods： 5 TCDIS were into solution separately. Each was dissolved in 2 the common solvents in the practical concentration according its clinical usage. The he insoluble particles in 5 TCDI were detected by light blockage method specified in China Pharmacopeia（2010 edition）l. Results： The number of the original particles in the 5 TCDIS reached the standard of corresponding requirement, after being prepared into solution, the number of particles increased dramatically. In 2 injections, the amount of particles increased to the extent which was not permitted by the requirement for IV injection according to China Pharmacopeia（2010 edition）l. Conclusion：The increase of insoluble particles in 5 TCDI should be focused during clinical use. So the adverse reactions can avoid as far as possible.