Research on the Feasibility of Bacterial Endotoxin Test for Compound Jiagaimei Solution / 中国药房

ABSTRACT

OBJECTIVE: To establish bacterial endotoxin test for cardioplegic solution (compound jiagaimei solution).METHODS: Semi-quantitative analysis stated in volume Ⅱ of Chinese Pharmacopoiea (2005 edition) was used to detect 3 batches of compound jiagaimei solution with tachypleus amebocyte lysate (TAL).RESULTS: The interference factors of bacterial endotoxin test could be overcome through 6-fold dilution of cardioplegic solution.The content of bacterial endotoxin in 3 batches of samples were 0.36,0.36 and 0.255 EU?mL-1,respectively.They were all lower than the limitation of bacteria endotoxin of 1.5 EU?mL-1.CONCLUSION: It is feasible to detect bacterial endotoxin of compound jiagaimei solution using semi-quantitative analysis.