苯磺酸氨氯地平口腔黏附片的制备与质量标准研究

摘要

Objective To study preparation technology of Amlodipine Besylatc Buceal Adhesive Tablets, and to establish its quality eonlrol method. Study a kind of continuously time is longer Amlodipine Besylaie Buceal Adhesive Tablets. Methods Select MCC for diluents or fillers, Carhopol for adhesive material, ITPMC for slow release framewor. asipatan for flavoring, magnesium stearate for adhesives, ITPLC was used to determine content of amlodipine besy3ate,and observing its adhensive force and adhesive time. Results Results of orthogonal experimental design show thai when the amount weight percentage of carbopol was 37.5% and and HPMC was 25% -the adhensive force was 7. 9 N. and the adhesive time was 4. 9 h. Conclusion The preparation technology is reliable,The methods are simple,accurate,which can he used in hospital production and using.%目的 研究苯磺酸氨氯地平口腔黏附片的制备及质量控制方法.方法 以微晶纤维素(MCC)为稀释剂或填充剂,卡波姆为黏附材料,羟丙基甲基纤维素(HPMC)为缓释骨架,阿斯帕坦(asipatan)为矫味剂,硬脂酸镁(magnesium)为润滑剂,制备苯磺酸氨氯地平口腔黏附片;采用高效液相色谱法测定含量,考察其黏附力和黏附时间.结果 正交试验结果表明,卡波姆和HPMC在处方中的比例分别为37.5%和25%时,黏附力为7.9N,黏附时间达4.9 h.结论 本制剂处方工艺成熟,检测方法简便、准确、可靠,适于医院制剂室配制和应用.