【作者】 刘理南；

【导师】 田景振；

【作者基本信息】 山东中医药大学 ， 中药制剂， 2003， 硕士

【摘要】 目的：研制复方替米沙坦双层片的制备工艺和建立质量检测的方法。方法：采用正交实验，以氢氯噻嗪的溶出度参数Td为指标，优选氢氯噻嗪层的处方工艺；用均匀设计法，以双层片的脆碎度和崩解时限为指标，筛选替米沙坦层的辅料配比；采用高效液相测定氢氯噻嗪和替米沙坦的含量并制订质量标准。结果：复方替米沙坦双层片的最佳处方组成为内层含氢氯噻嗪12.5mg，乳糖46mg，微晶纤维素16mg，羧甲基淀粉钠4mg，以2％HPMC为粘合剂制粒，加入1％硬脂酸镁，压片；外层则为替米沙坦40mg，氢氧化钠3.36mg，葡甲胺12mg，山梨醇180mg，聚维酮k30 11.2mg，加入2％硬脂酸镁，压片。结论：所定双层片的处方合理，工艺可行，质量控制方法简便可靠。更多还原

【Abstract】 Objective: To screen the best formulation composition of compound telmisartan bilayer tablets and to establish an analysis method to control quality. Method: The composition of hydrochlorothiazide layer were selected by orthogonal experiment, regarding the parameter of dissolution degree(Td) as index; the proportion of excipients of telmisartan layer were choosed by means of uniform design; Used HPLC method to determine the content of telmisartan and hydrochlorothiazide in compound telmisartan bilayer tablets simultaneously and established the quality standard. Result : Hydrochlorothiazide layer contained hydrochlorothiazide 12.5mg, lactose 46mg, microcrystalline cellulose 16mg, sodium starch glycolate 4mg, converting the whole to granules in the presence of 2% HPMC; telmisartan layer contained telmisartan 40mg, sodium hydroxide 3.36mg, meglumine 12mg, sorbitol 180mg, povidoneK30 11.2mg. Conclusion: The formulation of the bilayer tablets is reasonable, the preparation technology is feasible; the method of quality control is simple and reliable.更多还原