阿奇霉素分散片处方的工艺研究

Study on the Preparation Process of Azithromycin Dispersible Tablets

建立了以粉末直压方式生产阿奇霉素分散片的新工艺。以性状、溶出度、有关物质、含量等一些列的关键质量参数对其稳定性进行了考察,得出完全符合药典要求并生产工艺稳定的处方制剂。

A new process for preparing azithromycin dispersible tablets from powder by direct compression was established. The stability of prepared azithromycin dispersible tablets was investigated through analyzing key quality parameters, such as characteristics, dissolution, related substances content and so on. The results showed that it fully met the requirements of pharmacopoeia and the production process was stable.