Effects of Different Concentrations of 4 Traditional Chinese Medicine Injections on Insoluble Particles / 中国药师

ABSTRACT

Objective:To investigate the change of insoluble particles in 4 traditional Chinese medicine injections at different con-centrations in 0. 9% NaCl injection. Methods:Fufang Kushen injection, Shuxuetong injection, Lugua Duotai injection and Honghua Huangsesu injection were diluted by 0. 9% sodium chloride injection to obtain low concentration and high concentration solutions. The insoluble particles number of initial injections and dilutions at different time points(0,2,4,and 5 h) was detected according to the in-soluble particles test described in the fourth principle 0903 of China Pharmacopoeia (2015 edition). Results:The number of insoluble particles in 4 traditional Chinese medicine injections and 0. 9% sodium chloride injection met the requirements. The insoluble particles (≥25 μm) in 4 traditional Chinese medicine injections at different concentrations were few and almost stable with time, the insoluble particles(≥10 μm) showed an increasing trend in a concentration-dependent manner and varied with time. Conclusion:The insoluble particles(≥10 μm) in traditional Chinese medicine injections at high concentration are more than those at low concentration, which suggests that the concentration of traditional Chinese medicine injections should be restricted strictly according to the prescriptions and used up as soon as possible.