复合脂溶性维生素冻干粉针的制备及质量考察

Preparation and quality investigation of compound fat-soluble vitamin for injection

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 study preparation, quality control and stability of compound fat-soluble vitamin for injection. METHODS The formula and preparation process were optimized by the investigation of simple factor. HPLC was used for simultaneous determination of four vitamins in compound fat-soluble vitamin for injection. Stabilities of compound fat-soluble vitamin for injection were investigated. RESULTS Using optimal formula and preparation process, the freeze drying products had good solubility and shape. The samples were stable in the influential factor tests, accelerated tests and ordinary temperature storage tests. CONCLUSION The formula is reasonable. The preparation is feasible. The quality is stable. The quality control method is reliable.