依托红霉素片制备工艺优化的研究

摘要

目的：考察依托红霉素片溶出的影响因素，优化处方工艺，提高依托红霉素片的溶出度。方法通过影响因素试验考察优化工艺与原工艺的含量变化；采用正交试验法优选崩解剂的用量，崩解剂的类型、片剂的硬度。结果碳酸氢钠能显著提高依托红霉素片的溶出度。结论优化的工艺质量稳定，重现性良好。%OBJECTIVE To study factors that affecting Erythromycin Estolate Tablets dissolution , optimizing formulation process ,improving dissolution rate of Erythromycin Estolate Tablets.METHODS Using stress testing ( influence factors test ) to study the change of assay between optimizing process and original process.Using orthogo-nal test to optimize the dosage , type of disintegrating agent , tablets hardness.RESULTS Sodium bicarbonate can improve dissolution rate of Erythromycin Estolate Tablets significantly.CONCLUSION optimized process is steady and has good reproducibility.