呋喃西林溶液处方和制备方法的改进及其质量控制

Improvement of Prescription and Preparation of Furacilin Solution and Its Quality Control

目的探讨呋喃西林溶液的处方和制备方法改进及其含量测定方法。方法按改进的处方组成,将苯甲酸钠先配制成浓溶液,加入呋喃西林使完全溶解后,再加入其他药物配制。采用高效液相色谱(HPLC)法测定呋喃西林溶液中呋喃西林的含量。结果改进后的处方和配制方法所制备的呋喃西林溶液稳定性好,放置6个月以上不析出沉淀。呋喃西林质量浓度在10.2～101.6mg/L范围内与峰面积线性关系良好(r=0.9999),平均回收率为98.9%,RSD为1.24%。结论改进后的处方科学,配制方法操作简单、准确,具有很好的实用价值。

Objective To discuss the prescription, perparation and detemination of Furacilin Solution. Methods The new prescription of Furacilin Solution was stated as the following： a concentrated solution was prepared from sodium benzoate, which was then added with furacilin for complete lysis before been added with other agents. The contents of furacilin was determined by HPLC. Results The new Furacilin Solution prepared in the improved prescription and preparative technology proved to be stable in quality, without separation of sediments after storing for more than 6 months. Good linear relation ship was achieved when the concentration range of Furacilin Solution was within 10. 2 - 101.6 mg/L（ r = 0. 999 9）, with the average recovery rate of 98.9% , RSD = 1.24%. Conclusion The improved prescription of Furacilin Solution is scientific,and its preparative method is simple and accurate, which is of good pracivcal value.