【摘要】 目的研究氯霉素滴眼液的稳定性,改进其处方工艺。方法采用加速试验,利用HPLC法测定氯霉素二醇物的含量。色谱柱为L ichrospher C18(250 mm×4.6 mm,5μm);流动相为甲醇-0.4%磷酸溶液(52:48);流速1.0 m l.m in-1;检测波长272 nm;进样量20μl。结果氯霉素滴眼液加速试验90 d后二醇物含量分别为11.77%(市售处方)和7.36%(改进处方)(≤8.0%,符合药典规定)。结论改进后的处方工艺可显著增强氯霉素滴眼液的稳定性,并提高制剂质量。更多还原

【Abstract】 OBJECTIVE To study the stability of Chloramphenicol eye drop and improve its formulation and preparation.METHODS The content of 2-amino-1-（4-nitrophenyl）-propane-1,3-diol in Chloramphenicol eye drop was determined with HPLC method and accelerated tests.Chromatographic conditions included Lichrospher C₁₈ column,the mobile phase consisted of methanol-0.4% phosphoric acid（52:48）and 20 μl for injection on to the column.The detective wavelength was 272 nm.RESULTS The content of 2-amino-1-（4-nitrophenyl）-propane-1,3-diol in Chloramphenicol eye drop was 11.77% after 3 months accelerated tests,while that in the improved formulation and preparation was 7.36%.CONCLUSION The improved formulation and preparation can significantly improve stability and quality of Chloramphenicol eye drop.更多还原