[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%.
Zhang
Shao-Feng
SF
China Military Institute of Chinese Materia Medica, 302 Military Hospital of China, Beijing 100039, China. zhshf319@126.com
Yan
Dan
D
Tang
Hui-Ying
HY
Li
Han-Bing
HB
Wang
Yue-Sheng
YS
Xiao
Xiao-He
XH
Yang
Ming
M
D002626:Chemistry, Pharmaceutical; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry*; D006461:Hemolysis; D020442:Poloxamer / Q000737:chemistry; D011092:Polyethylene Glycols / Q000737:chemistry*; D011136:Polysorbates / Q000737:chemistry; D012995:Solubility; D013678:Technology, Pharmaceutical
D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; D005079:Excipients; D011136:Polysorbates; D020442:Poloxamer; D011092:Polyethylene Glycols