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目的:制备复合脂溶性维生素冻干粉针,建立质量控制方法并考察制剂质量稳定性。方法:采用单因素考察法,对处方及工艺进行优选;采用高效液相色谱法,同时测定4种维生素的含量,考察制剂的稳定性。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,经影响因素、加速、室温留样考察质量稳定。结论:处方设计合理,工艺可行,质量稳定,质量控制方法可靠。
OBJECTIVE: To prepare the compound fat-soluble vitamins lyophilized powder, establish the quality control method and study the stability of the preparation quality. Methods: The single factor method was used to optimize the prescription and process. The contents of four vitamins were determined simultaneously by high performance liquid chromatography (HPLC), and the stability of the preparation was investigated. Results: The appearance and solubility of the freeze-dried products prepared by the preferred prescription and process were good. Conclusion: The prescription design is reasonable, the process is feasible, the quality is stable and the quality control method is reliable.