注射用盐酸头孢噻呋混悬乳剂制备及品质考察

Preparation and Quality Observation of Ceftiofur Hydrochloride Suspoemulsions for Injection

通过预试验确定盐酸头孢噻呋混悬乳剂的各组成成分,并确定其使用范围。采用正交试验对混悬乳剂的配方进行优化,并通过各指标对混悬乳剂进行品质考察。最终得到其最优配方为注射用大豆油、乳化剂、增稠剂和抗氧化剂质量分数分别为6%、3%、0.02%和0.5%,注射用水加至所需量。最佳处方的黏度为2 s（垂直流出0.4 mL所需的时间）,通针性良好,大部分粒径为0.15~0.25μm,且粒径不大于0.35μm,盐酸头孢噻呋平均回收率为100.36%。说明制备的盐酸头孢噻呋注射用混悬乳剂品质良好,符合相关标准。

This experiment was to make-up the Ceftiofur Hydrochloride Suspoemulsions,and evaluate its quality.The preliminary experiment was conducted to select the component of Ceftiofur Hydrochloride Suspoemulsions,and to confirm their range of application.Use the orthogonal test to optimize the formula of Ceftiofur Hydrochloride Suspoemulsions,and observe its quality through various indicators.The results showed that the best formula is soybean oil for injection 6%,emulsifier 3%,thickener 0.02%,antioxidant 0.5%,add water to the injection requirement,the amount of each component is the mass fraction.The quality observation indicated that the viscosity of the best formula is 2 s（the required time for 0.4 mL flow-out vertically）,syringeability is well,most particle size distribution in 0.15 μm to 0.25 μm,and the particle size is not more than 0.35 μm,the average recovery rate of Ceftiofur Hydrochloride is 100.36%.The Ceftiofur Hydrochloride Suspoemulsions is of good quality,and all aspects in conformity with the relevant standards,easy to popularize.