氯霉素滴眼液的稳定性及其处方工艺的改进  

The stability of Chloramphenicol eye drop and its improvement of formulation and preparation

作　　者：陈国广[1] 陈振华[1] 李学明[1] 任丽莉[1] 韦萍[1] 

机构地区：[1]南京工业大学制药与生命科学学院,江苏南京210009

出　　处：《华西药学杂志》2006年第5期443-445,共3页West China Journal of Pharmaceutical Sciences

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。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 p.1 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.

关 键 词：氯霉素滴眼液 稳定性 高效液相色谱法 二醇物 

分 类 号：R914[医药卫生—药物化学]