Objective:To establish a quality standard for the bacterial endotoxin test method of fructose sodium diphosphate injections(FDP injections),so as to provide reference for the formulation and revision of the national standard for this drug.Methods:The interference test and bacterial endotoxins test of 22 batch samples of FDP in-jections from nine manufacturers were performed with TALs,and the bacterial endotoxins of samples were tested and the results were judged.Results:A bacterial endotoxin limit value of 0.72 EU·mg-1 for fructose sodium diphos-phate was established,which was suitable for 22 batches of FDP injections met the requirements.Conclusion:The bacterial endotoxin test method established in this study can be used to substitute the rabbit pyrogen test and meet the quality control requirements of FDP injections.

Objective:To establish a quality standard for the bacterial endotoxin test method of fructose sodium diphosphate injections(FDP injections),so as to provide reference for the formulation and revision of the national standard for this drug.Methods:The interference test and bacterial endotoxins test of 22 batch samples of FDP in-jections from nine manufacturers were performed with TALs,and the bacterial endotoxins of samples were tested and the results were judged.Results:A bacterial endotoxin limit value of 0.72 EU·mg-1 for fructose sodium diphos-phate was established,which was suitable for 22 batches of FDP injections met the requirements.Conclusion:The bacterial endotoxin test method established in this study can be used to substitute the rabbit pyrogen test and meet the quality control requirements of FDP injections.

Objective:To study the nephrotoxicity induced by triptolide ( TP) on MDCK cell model and investigate its effect on oxidative stress. Methods:Aristolochic acid was chosen as the positive control. After the MDCK cells were incubated with 0. 5, 5, 50 and 500 nmol·L-1 TP for 24h, MTT method was used to observe the cell inhibiting rate and lactate dehydrogenase (LDH) release test was used to detect the cell membrane damage caused by TP. The cell morphology was observed under an inverted microscope. After the MDCK cells were incubated with 500 nmol·L-1 TP respectively for 30min, 1h, 2h, 4h and 6h, the level of reactive oxygen species ( ROS) was detected using 2′,7′-dichlorodihydro-fluorescein diacetate ( DCFH-DA) as the fluorescent probe. Results:Compared with those of the negative control group, the cell inhibiting rates and the relative LDH release rates in TP-treated group were increased sig-nificantly(P<0. 01). The cells in TP-treated group were creased, turned into the round shape and began to shed off. After the MDCK cells were incubated with TP for 30min, the level of ROS reached the highest value, and then began to decrease (P<0. 01). Conclu-sion:TP can induce the toxic effects on MDCK cells and the mechanism may be related to oxidative stress.