加替沙星眼用胶体溶液的研制及质量控制

Preparation and quality control of gatifloxacin ophthalmic gel-forming solution

目的:研究加替沙星眼用胶体溶液的制备及质量控制。方法:采用家兔眼滞留试验筛选卡波姆的浓度,建立了高效液相色谱法测定本品含量及有关物质。结果:本品粘度为26mPa.s,渗透压为312mOsm/kg.H2O,pH值为7.57。制剂的初步稳定性试验结果表明稳定性较好。结论:制订的质量标准达到《中国药典》2000版要求。

Objective： To study the preparations and to evaluate the quality control of gatifloxacin ophthalmic gel-forming solution. Methods： The suitable concentration of gatifloxacin in the eyes of rabbit was screened. The HPLC method was established and could be used for the determination of gatifloxacin. Results： The stability of the preparation was studied. The viscosity, osmotic pressure and pH of the solution were 26 mPa·s, 312 mOsm/kg H2O and 7.57 respectively. Conclusion： The product was stable, and the quality control was conformed to the requirement of China Pharmacopoeia.