Objective  To screen the formulation and process of paclitaxel injection and its characterization.

Methods  According to the formulation of the reference standard products, combined with the feasible amplified production process, Minitab software was used to design and analyze the optimization experiment of the formulation dosage, taking the related substances as inspection indicators, the full factorial experimental design and analysis were carried out. The characterization of particle size, particle size distribution and Zeta potential of paclitaxel injection was investigated.

Results  The optimized formulation and process of paclitaxel injection were confirmed. Water content was less than 0.3%. No citrate was added to the formulation. Residual oxygen content was less than 6%. Related substances of the optimized formulation and process of paclitaxel injection were less than 0.4%. Characterization of the sample and the reference standard solution were the same.

Conclusion  The screened formulation of paclitaxel injection is reasonable, and the process is feasible.

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