妥布霉素地塞米松磷酸钠滴眼液的制备及质量控制

Preparation and Quality Control of Tobramycin Dexamethasone Sodium Phosphate Eye Drops

目的制备妥布霉素地塞米松磷酸钠滴眼液并建立其质量控制方法。方法以妥布霉素、地塞米松磷酸钠为主药配制滴眼液,采用抗生素微生物检定法测定妥布霉素,高效液相色谱法测定地塞米松磷酸钠的含量,并考察加速试验、室温留样12个月内的药物含量及稳定性。结果所制制剂为无色澄明液体,且鉴别、检查等均符合2005版《中国药典》相关规定;地塞米松磷酸钠检测浓度的线性范围6.25～200μg/m(lr=0.9997),平均回收率100.01%(RSD=0.23%);加速试验及室温留样12个月内妥布霉素和地塞米松磷酸钠的含量均稳定。结论该制剂处方工艺简单可行,质量稳定。

Objective To prepare tobramycin dexamethasone sodium phosphate eye drops and establish a quality control method for this preparation. Methods Tobramycin dexamethasone sodium phosphate eye drops was prepared using tobramycin. The content of this preparation was determined by microbial assays of antibiotics, and the content of dexamethasone sodium phosphate was determined by HPLC. The content and stability of the preparation within 12 mon under room temperature and accelerated test were investigated. Results The prepared eye drops was limpid colorless liquid, and it met the related standards that stated in China Pharmacopeia （2005 edition） in identification as well as tests etc. Dexamethasone sodium phosphate showed a good linear relation in the range of 6.25-200 μg/ml （r=0.9997）, with an average recovery rate of 100.01% （RSD=0.23%）. This preparation was stable within 12 mon under room temperature and in the accelerated test. Conclusion This preparation method is simple and feasible in preparation technology, and its quality is stable.