多西环素注射液的研制及其含量测定

为开发盐酸多西环素新制剂,根据单因素试验,采用正交设计试验法筛选出盐酸多西环素注射液最优配方,以高效液相色谱法测定制剂含量。所研制注射液的外观色泽、澄明度、pH等指标均符合《中国兽药典》2005版注射液项的要求。高效液相色谱测定多西环素含量显示,在5~100 μg/mL浓度范围内,峰面积与药物浓度的线性关系良好(R²＝0.9992),平均回收率为99.87%,日内变异系数≤0.42%,日间变异系数≤0.96%。注射液含量为98.3%。结果表明含量测定方法稳定、可靠,最终配方合理,含量符合要求。

Preparation of Doxycycline Injection and Its Concentration Determination

In order to develop the new doxycycline prepration,the best formula of doxycycline injection was selected by orthogonal experiments on the basis of single factor experiment and determined by high perfomance liquid chromatography with ultraviolet detector. The injection’s appearance, clarity, pH value and so on all meet the requirement of Veterinary Pharmacopoeia of the People’s Republic of China. The calibration curve was linear in the concentration range of 5 to 100 μg/mL, R²＝0.9992, with the average recovery rate of 99.87%,the intra-day CV≤0.42%, the extra-day CV≤0.96%. The concentration of doxycycline injection is 98.3%. The results show that the determination method is steady reliable, the final formula is reasonable and the content meets the requirement.