Objective: To analyze and compare the components of 4 brands of Tween-80 excipient and of Tween-80 in 4 docetaxel injection products, and also to evaluate the influence of component differences on the binding ability of Tween-80 to docetaxel in the blood. Methods: HPLC-ELSD was employed to analyze the components of Tween-80. Separation was achieved using an Eclipse-XDB C18 column(150 mm×4.6 mm, 3.5 μm) and a gradient elution system with acetonitrile-water (50∶50) as mobile phase A and tetrahydrofunan as mobile phase B. The binding ability of Tween-80 with drugs in blood was investigated by hemo-equilibrium dialysis using cellulose easter memberane with a 20 kD molecular weight cut-off, where the docetaxel was detected by a SunfireTM C18 column (150 mm×4.6 mm, 5 μm) and acetonitrile-water gradient elution system. Results: Some differences in components were observed from different brands of Tween-80 excipient and also from Tween-80 in different brands of docetaxel injection. The result of hemo-equilibrium dialysis experiment showed that the binding ability of Tween-80 to docetaxel was far less than that of blood components and drugs. No significant change, caused by components difference of Tween-80, in binding ability of Tween-80 to docetaxel was found with the blood samples. The difference in the bindling ability of Tween-80 to docetaxel in the blood from different manufacturers of docetaxel injection was not found to be significant. Conclusion: No significant influence on the drug distribution of docetaxel in blood is caused Tween-80 from different manufactures of docetaxel injection. The result of this study is more biologically reliable than the result of the equilibrium dialysis experiment in saline.
DONG Mei-yang, XU Hui, SHI Ya-qin, SUN Jia-bei
. Study on equilibrium dialysis of docetaxel injection in blood[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(4)
: 636
-643
.
DOI: 10.16155/j.0254-1793.2023.04.13
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