摘要
目的优化处方工艺,制备稳定的坎地沙坦酯片。方法通过影响因素试验考察不同处方坎地沙坦酯片的含量及有关物质变化,筛选合适的辅料;以与参比制剂(必洛斯)的溶出曲线相似因子f2为指标,采用正交设计法优选原料粒径、崩解剂的用量和片剂硬度。结果聚乙二醇6000能显著提高坎地沙坦酯处方的稳定性,原料粒径和崩解剂的比例是影响相似因子f2的关键因素,有关参数被确定。结论处方工艺质量稳定,重现性良好。
Objective To optimize the formulation technology for preparing stable Candesartan Cilexetil Tablets.Methods The stress testing was performed to investigate the changes of content and related substances of Candesartan Cilexetil Tablets and screen the appropriate auxiliary materials.Then,with the similarity factor f2 of the dissolution curve in the reference preparation（Blopress） as the index,the orthogonal design method was adopted to optimize the particle size of raw materials,the dosage of disintegrating agent and the hardness of the tablets.Results PEG6000 could obviously improve the stability of candesartan cilexetil prescription.The proportion of the particle size of raw materials and the dosage of disintegrating agent was the key factor influencing the similarity factor f2.The related parameters were determined.Conclusion The optimized formulation technology is stable in quality with good reproducibility.
出处
《中国药业》
CAS
2012年第22期62-63,共2页
China Pharmaceuticals
