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目的筛选安立生坦片的最佳处方。方法通过原料辅料的相容性试验筛选辅料,采用正交试验考察不同处方对颗粒流动性、外观、溶出度的影响,确定最优处方,与市售安立生坦片在4种溶出介质中进行累积溶出曲线对比研究,并考察制剂的加速稳定性。结果开发出最优处方,产品与市售安立生坦片在4种溶出介质中溶出曲线相似,6个月的加速试验结果与0个月时比较无明显变化。结论该处方设计合理、制备工艺可靠。
Objective To screen the best prescription of Andersen tablets. Methods The materials were screened through the compatibility test of raw materials and excipients. The effects of different prescriptions on the fluidity, appearance and dissolution of the granules were investigated by orthogonal test. The optimal prescriptions were determined and compared with the commercial Anritsu tablets in four dissolution media Cumulative dissolution curve comparison study, and study the accelerated stability of the preparation. Results The optimal prescription was developed. The dissolution profiles of the products and the commercial Anritsu tablets in the four dissolution media were similar. The results of six months’ acceleration test showed no significant changes compared with those of 0 months. Conclusion The prescription design is reasonable, the preparation process is reliable.