伏立康唑滴眼液的制备及质量控制

Preparation and Quality Control of Voriconazole Eye-drops

摘要: 目的制备伏立康唑滴眼液并建立其质量控制方法。方法伏立康唑采用被制成羟丙基-β-环糊精包合物的方法来制备滴眼液，并采用高效液相色谱法测定主药含量。结果所得制剂为无色透明液体，鉴别、检查结果均符合中国药典2005年版中的相关规定。伏立康唑检测浓度的线性范围为0.100 0～0.900 0 mg·8729;mL-1 (r=0.999 9)，平均回收率为99.78％(RSD=0.47%，n=9)。结论该制备工艺简单，质量可控，值得临床推广。

Abstract: BJECTIVE To prepare voriconazole eye-drops and to establish its method of quality control. METHODS Voriconazole was included by HP-β-CD in order to prepare voriconazole eye-drops. The content of voriconazole was determined by HPLC. RESULTS The eye-drops was colorless and transparent liquid. Its identification and test conformed to the related standards stated in Ch.P (2005). There was a good linear relationship with the concentration range of 0.100 0- 0.900 0 mg·8729;mL-1(r=0.999 9) for voriconazole, and its average recovery was 99.78% (RSD=0.47%, n=9). CONCLUSION The preparation process of voriconazole eye-drops is simple, its quality control method is reliable and worth using in clinic.