复方罗红霉素凝胶剂的制备与质量控制

Preparation and Quality Control of Compound Roxithromycin Gel

目的研制复方罗红霉素凝胶剂。方法以壳聚糖为凝胶材料按药剂学原理制备复方罗红霉素壳聚糖凝胶剂;采用紫外分光光度法测定复方罗红霉素含量;采用容量法测定谷氨酸锌含量。结果该凝胶剂制备工艺简单,质量控制方法可行,质量稳定。结论本品符合中国药典凝胶剂项下有关的各项规定。

Objective To study the preparation method of compound roxithromycin gel. Methods Chitosan was used to prepare roxithromycin gel according to pharmaceutics principle . Ultraviolet spectrophotometry was used to detemined its content. The content of glutamic zinc was assayed by volumetry method. Results The preparation method is easy and the quality control method is reliable. The quality posses a good stability. Conclusion The quality of the preparation conforms to the relevant regulations in gel preparation of China Pharmacopoeia.