司帕沙星耳用凝胶的制备及质量控制

Preparation and Quality Control of Sparfloxacin Ear Gel

目的:探讨司帕沙星耳用凝胶的制备及建立其质量控制方法。方法:以司帕沙星为主药,以卡波姆-940为基质制备耳用凝胶,采用紫外分光光度法测定其中司帕沙星的含量,并考察制剂的稳定性。结果:在298 nm波长处,司帕沙星检测浓度在2～12μg·ml^(-1)范围内与吸光度呈良好的线性关系(r=0.9999),平均回收率为99.66%,RSD为0.63%(n=5)。室温放置2个月,样品均未发生分层,其颜色、pH及含量均无明显变化。结论:本制剂制备工艺简单、可行,质量控制方法操作快速,结果准确可靠。

Objective： To prepare sparfloxaein ear gel and establish quality control method. Method： Carbomer-940 was used as matrix to prepare sparfloxacin ear gel. The content of sparfloxacin was determined by ultraviolet spectrophotometer at the wavelength of 298 nm, and the stability of the gel was observed. Result： A linear calibration curve for assay of sparfloxaein in the gel was obtained within the range of 2-12 μg·ml^-l （r =0. 999 9） and the average recoveries and RSD were 99. 66% and 0. 63% （n =5） ,respectively. At normal room temperature the delamination of the gel was not observed and the colour, pH and sparfloxacin content of it were not obviously changed in 2 months. Conclusion： Preparation technique of sparfloxacin ear gel is simple, the quality can be eontroled, and the quality control method is accurate and fast.