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

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.