title: [Study on selecting the suitable solubilizing excipients for Shengmai injection].
abstract: 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%.
authors.affiliation: China Military Institute of Chinese Materia Medica, 302 Military Hospital of China, Beijing 100039, China. zhshf319@126.com
authors.forename: Shao-Feng
authors.initials: SF
authors.lastname: Zhang
authors.forename: Dan
authors.initials: D
authors.lastname: Yan
authors.forename: Hui-Ying
authors.initials: HY
authors.lastname: Tang
authors.forename: Han-Bing
authors.initials: HB
authors.lastname: Li
authors.forename: Yue-Sheng
authors.initials: YS
authors.lastname: Wang
authors.forename: Xiao-He
authors.initials: XH
authors.lastname: Xiao
authors.forename: Ming
authors.initials: M
authors.lastname: Yang
mesh_terms: 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
chemical_list: D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; D005079:Excipients; D011136:Polysorbates; D020442:Poloxamer; D011092:Polyethylene Glycols