氧化槐定碱冻干粉针剂的制备及质量控制

Preparation and Quality Control of Oxysophoridine Freeze-dried Powder Injection

目的:制备氧化槐定碱冻干粉针,建立质量控制方法并考察制剂质量稳定性。方法:采用正交设计试验方法,对处方及工艺进行优选;运用HPLC法,测定其含量。结果:优选的处方及工艺制成的冻干制品外观及溶解性良好。结论:处方设计合理,工艺可行,质量控制方法可靠。

Objective： To study the preparation process, quality control and stability of oxysophoridine freeze-dried powder injection. Method： The formulation and preparation process were optimized by orthogonal test. HPLC method was used for the determination of oxysophoridine in the injection. Result： With optimal formulation and preparation process, the freeze-dried products had promising solubility and appearance. Conclusion： The formulation is reasonable, the preparation phoeess is feasible and the quality control method is reliable.