盐酸更昔洛韦壳聚糖滴眼液的制备及质量控制

Preparation and Quality Control of Ganciclovir Hydrochloride Chitosan Eye Drops

目的:制备更昔洛韦壳聚糖滴眼液并建立其质量控制方法。方法:以壳聚糖为增稠、增效剂,更昔洛韦为主药制备滴眼液;采用高效液相色谱法测定其中主药的含量,并对其稳定性进行考察。结果:所制制剂为无色透明微黏澄明液体,鉴别、检查项符合2005年版《中国药典》中的相关规定;更昔洛韦检测浓度的线性范围为5～80mg·L-1(r=0·9999),平均回收率为99·02%(RSD=0·71%);该制剂对光稳定,加速试验考察6个月各项指标无明显变化。结论:本制剂制备工艺简便可行,质量稳定可控,有效期暂定为2a。

OBJECTIVE： To prepare ganciclovir hydrochloride chitosan eye drops and establish its quality control method. METHODS： The eye drops was prepared using chitosan as thickening agent and synergist with ganciclovir as principal agent. The content of ganciiclovir was determined by HPLC. The stability of the preparation was investigated as well. RESULTS： The prepared eye drops was colorless transparent glutinous limpid liquid with its identification items all up to the related standards stipulated in Chinese Pharmacopoeia （2005 edition）. The linear range of ganciclovir was 5--80 mg·L^-1（r = 0.999 9） with average recovery of 99.02% （RSD = 0.71% ）. The preparation was stable under light with all its indexes showed no obvious change in the accelerated test at 6 month. CONCLUSION： The preparation technology is simple and feasible and the quality of preparation is stable and controllable with a validity duration tentatively set at 2 years.