聚山梨酯80对维生素K_1注射液质量的影响

Effect of polysorbate 80 on the quality of vitamin K_1 injection

目的:考察不同厂家聚山梨酯80对维生素K_1注射液质量的影响。方法:采用气相色谱法测定聚山梨酯80中脂肪酸的含量,并考察使用不同厂家聚山梨酯80制备的维生素K_1注射液的稳定性。结果:聚山梨酯80中油酸含量越高,其他脂肪酸含量越低表明其纯度越高,质量越好,制备的维生素K_1注射液产品越稳定。结论:聚山梨酯80的质量是影响维生素K_1注射液质量的重要因素。

Objective： To evaluate the effect of polysorbate 80 on vitamin K1 injection by comparing the quality of polysorbate 80 from different manufacturers. Methods： The content of fatty acids in polysorbate 80 was determined by gas chromatography and the stability of vitamin K1 injection prepared with polysorbate 80 from different manufacturers was investigated. Results： The higher the oleic acid content in polysorbate 80, the lower the other fatty acid content, the higher is the quality of vitamin K1 injection and furthermore the prepared vitamin K1 product is more stable. Conclusion： Polysorbate 80 is an important factor affecting the quality of vitamin K1 injection.