盐酸司帕沙星原位胶化滴眼剂的制备及质量控制

目的:制备盐酸司帕沙星原位胶化滴眼剂并建立其质量控制方法。方法:以硼酸为渗透压调节剂、海藻酸钠为胶化剂制备滴眼剂;采用紫外分光光度法测定其中主药的含量,并考察其稳定性。结果:所制制剂为无色或淡黄色澄明液体,鉴别、检查均符合2005年版《中国药典》中的相关规定;盐酸司帕沙星检测浓度的线性范围为3·0～8·0μg·mL-1,平均回收率为99·82(RSD=0·236%,n=6)。本品加速、留样试验中各指标无明显变化,温度和光照对样品有轻微影响。结论:本制剂制备工艺简便可行,质量稳定可控。

Preparation and Quality Control of in-situ Gelling of Hydrochloride Sparfloxacin Eye Drops

OBJECTIVE： To prepare in- situ gelling of hydrochloride sparfloxacin eye drops and establish its quality control method. METHODS： The in- situ gelling of hydrochloride sparfloxacin eye drops were prepared with boric acid as buffer to regulate the pH and osmotic pressure and with sodium polymannuronate as peptizer. The content of hydrochloride sparfloxacin was determined by ultraviolet spectrophotometry. The stability of the sustained- release eye drops was investigated as well. RESULTS： The sustained-release eye drops were colorless or yellowish limpid liquid with its test and identification results all in conformity with the related stipulation stated in Chinese Pharmacopeia （2005 edition） . There was a good linear relationship within the concentration range of 3.0--8.0μg·mL^-1 for hydrochloride sparfloxacin, and its average recovery was 99.82% （RSD ： 0.236%, n = 6）. There was no significant change for indexes in the accelerate test and sample test, yet the temperature and lighting did have slight impact on the viscosity, osmotic pressure and pH of the solution. CONCLUSION ： The preparative method is simple and feasible and the quality of in - situ gelling of hydrochloride sparfloxacin eye drops is stable and controllable.