[Study on selecting the suitable solubilizing excipients for Shengmai injection].

Objective: To select the suitable solubilizing excipients for Shengmai injection by the mean of hemolysis.

Methods: The hemolysis ratio of Shengmai injection, solubilizing excipients and different proportion of them were determined by absorption spectrometry.

Results: In the experimental concentration, Shengmai injection itself had no hemolytic effect. Polysorbate 80, Polyethylene glycol 400, Polyethylene glycol 600, Poloxamer 188 solution had no hemolytic effect to appear, but all the experimental concentrations of Polysorbate 20 had hemolytic effect. When combining with different proportion of Polysorbate 20, Polyethylene glycol 400, Polyethylene glycol 600, Poloxamer 188 and Polysorbate 80 of high concentration (0.75% - 1%), Shengmai injection had hemolytic effect.

Conclusions: The absorption spectrometry is more reliable for the judgement of hemolysis than macroscopic observation, and it is helpful to improve the accuracy to select the solubilizing excipients for the TCM injection. Polysorbate 80 can be used as solubilizing excipient of Shengmai injection, which is safe in the concentration range of 0.1% to 0.5%.