罗红霉素渗透泵型控释片处方工艺研究

目的：探讨罗红霉素渗透泵型控释片的处方工艺。方法：以罗红霉素（RXM）为模型药物，通过测定药物的释放度，考察促渗透剂、渗透聚合物种类及其用量、片芯硬度、释药孔径、包衣膜组成、包衣膜厚度对药物释放的影响。结果：PVP和增塑剂用量、包衣膜厚度和释药孔径对渗透泵型控释片的药物释放具有显著影响，一定范围内片芯硬度对药物释放的影响不明显。结论：选用500mg／mL的蔗糖作为渗透促进剂；200mg／mL的聚维酮-K30（PVP）为促渗透聚合物；包衣膜选用200mg／mL的PEG-6000。

Formulation Study on Roxithromycin Osmotic Pump Controlled Release Tablet

Objective： The preparation of roxithromycin osmotic pump controlled release tablet was studied. Methods： Roxithromycin was selected as the model to prepare the osmotic pump controlled release tablet. The influential factors of drug release from the osmotic pump tablet were studied by measuring the release of drugs, including the variety and amount of osmotic pressure accelerant and oplymers, hardness of tablet core, the size of release orifice, and the composition and thickness of the coating. Results： The amount of povidone and plasticizer, the coating thickness and the size of release orifice have significant influence on the drug release. The hardness of tablet core in a certain range was insignificant to the release of drug. Conclusion： The 500 mg/mL sugar was chosen as the penetration enhancer, 200 mg/mL K30 （PVP） chosen as polymers of infiltration, and 200 mg/mL PEG-6000 chosen as coated films.