聚维酮碘泡腾滴丸与醋酸洗必泰泡腾滴丸的制备及其稳定性考察

Study on Preparation and Stability of Pvidone-iodine Effervescent Dropping Pill and Chlorhexidine Acetate Effervescent Dropping Pill

目的:研制泡腾滴丸并考察其稳定性。方法:选取聚维酮碘、醋酸洗必泰为模型药物,聚乙二醇为赋形剂,碳酸氢钠、酒石酸为泡腾崩解剂,制备泡腾滴丸;以制剂颜色外观、含量、溶散时限等为指标考察其在室温下贮存6个月的稳定性,并与相应制备的泡腾片及普通滴丸比较。结果:与普通滴丸(约10min)比较,泡腾滴丸的溶散时限约为1min;与泡腾片比较,泡腾滴丸外观未见起泡现象;3种制剂主药含量均变化不大。结论:新剂型泡腾滴丸的制备工艺简单,稳定性好。

OBJECTIVE： To prepare effervescent dropping pills and to investigate their stability. METHODS： These effervescent dropping pills were prepared using povidone-iodine and chlorhexidine acetate as material, polyethylene glycol as excipient and sodium bicarbonate and tartaric acid as effervescent disintegrants. The stability of effervescent dropping pills was investigated at room temperature with appearance, content and disintegration as indexes. Related effervescent tablets and dropping pills were compared with the prepared effervescent pills. RESULTS： Compared with dropping pills （10 min）, effervescent dropping pills were dissolved within 1 min; compared with effervescent tablets, no bubble was found on the surface of effervescent dropping pills; there was no obvious change in main components of 3 kinds of preparations. CONCLUSION： The new preparation method of effervescent dropping pills is simple and stable.