甘草酸二钾滴眼液的研制

Development of Dipotassium Glycyrrhizinate Eye Drops

目的研制用于治疗非感染性眼部炎症的甘草酸二钾滴眼液。方法优化处方、工艺,制定质量标准;建立HPLC含量测定法;进行稳定性考察和局部刺激性试验。结果含量测定的高、中、低浓度平均回收率分别为100.32%,100.18%和100.12%,RSD分别为0.38%,0.31%和0.34%;加速6个月和长期放置24个月质量稳定;对兔眼无明显刺激作用。结论研制的甘草酸二钾滴眼液处方合理,制备工艺稳定,质量可控,对兔眼无刺激,可用于临床。

Objective To prepare dipotassium glycyrrhizinate eye drops for the treatment of non-infectious ocular inflammation. Methods The formula and preparation process of the eye drops were optimized, and the quality standard was drafted. The determination of dipotassium glycyrrhizinate by HPLC was established. The stability and local irritation tests were performed. Results The average recoveries of dipotassium glycyrrhizinate eye drops with high, medium and low concentrations were 100.32 %, 100.18 % and 100.12 % with RSD of 0.38 %, 0.31% and 0.34 %, respectively. The samples were stable for 24 months in a long-term test and 6 months in an accelerated test, and had no irritation on rabbits＇ eyes. Condusion With a reasonable formula, stable preparation process, controllable quality and non-irritation, the dipotassium glycyrrhizinate eye drops prepared in this study can be applied in clinical trials.