乳酸依沙吖啶溶液的制备及质量标准研究

目的:制备消毒防腐药乳酸依沙吖啶溶液并对其质量进行评价。方法:以乳酸依沙吖啶为主药制备制剂,采用蒸汽灭菌法灭菌,高效液相色谱法测定依沙吖啶含量:色谱柱为Calesil ODS,流动相为甲醇-乙腈-0.05%十二烷基磺酸钠(pH=3.0,20∶20∶60),检测波长为270nm,柱温为30℃,进样量为10μL;同时观察灭菌对制剂含量的影响。结果:所制制剂为黄色澄明液体,鉴别和菌检等结果合格;依沙吖啶检测浓度线性范围为5～50μg·mL-1(r=0.9999),平均回收率为101.47%(n=9),平均RSD=1.32%;灭菌前后依沙吖啶的含量无明显变化。结论:所制备的乳酸依沙吖啶溶液质量合格。

Study on Preparation and Quality Standard of Ethacridine Lactate Solution

OBJECTIVE： To prepare ethacridine lactate solution and to evaluate its quality.METHODS： The solution was prepared with ethacridine lactate as principal components and sterilized by steam sterilization.HPLC method was used for the determination of ethacridine.Calesil ODS column was used with mobile phase consisted of methanol-acetonitrile-0.05% sodium laurysulfonate （pH=3.0,20 ∶ 20 ∶ 60） at detection wavelength of 270 nm.The column temperature was set at 30 ℃ and injection volume was 10 μL.The effect of sterilization on the content of preparation was determined.RESULTS： The preparation assumed as yellow transparent solution.The linear range of ethacridine was 5～50 μg·mL-1（r=0.999 9） with an average recovery of 101.47% （RSD=1.32%,n=9）.The content of ethacridine in the solution was not changed after sterilization.CONCLUSION： The quality of prepared ethacridine lactate solution is up to the standard.