微波-超声法制备呋喃西林滴耳液

Preparation of Furacilin Ear Drops by Microwave-ultrasound Method

目的:改进医院制剂呋喃西林滴耳液的制备工艺,以缩短制备时间,提高呋喃西林滴耳液的稳定性。方法:采用微波-超声法制备呋喃西林滴耳液,其中丙三醇先用微波(输出功率:700 W,微波频率:2 450 Hz)加热80 s进行预处理;另以传统工艺制备为对照,比较两种制备方法的耗时。采用高效液相色谱法比较两种呋喃西林滴耳液24个月时的呋喃西林损失百分率,显微镜下观察其结晶情况。结果:微波-超声法和传统工艺制备耗时分别为12、140 min;24个月时呋喃西林损失百分率分别为0.9%、29.1%,传统方法所制制剂有肉眼可见黄棕色结晶析出,微波-超声法所制制剂无结晶析出。结论:微波-超声法制备具有耗时短、制剂含量均匀度好、稳定性高的特点,可为该制剂的工业化大生产提供技术参考。

OBJECTIVE： To improve the preparation technology of Furacilin ear drops （FED）, and promote its stability by shortening the preparation time. METHODS： FED was prepared by microwave-ultrasound method with glycerol pretreated by heat- ing 80 s with microwave （output power 700 W, microwave frequency 2 450 Hz）. Using traditional technology as control, the time consumption of 2 methods were compared. HPLC method was adopted to compare the percentage of furaeilin loss between 2 kinds of FED at 24th month. The crystallization of FED was observed with microscope. RESULTS： The time consumption of micro- wave-ultrasound method and traditional technology were 12 and 140 min. The loss of furacilin were 0.9% and 29.1% respectively in the 24 months. Yellowish-brown crystal was separated out from the drops prepared by traditional technology, and no crystal was found in the drops prepared by microwave-ultrasound method. CONCLUSIONS： The method is characterized with short time-con- suming, good content uniformity and sound stability. It provides technical reference for industrial production.