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目的考察盐酸贝那普利分散片制备工艺并优化处方,确定适合工业生产的最佳处方。方法采用单因素法分别考察崩解剂及用量、填充剂种类对盐酸贝那普利分散片崩解时间、分散均匀性、溶出度的影响,得到最优处方。结果盐酸贝那普利分散片的处方组成为:填充剂为微晶纤维素,崩解剂为5%羧甲基纤维素钠(cCMC-Na),黏合剂为5%羟丙基纤维素(HPC)的水溶液,助流剂为滑石粉,润滑剂为硬脂酸镁。结论制备的盐酸贝那普利分散片各项指标均符合规定,工艺稳定可靠。
Objective To study the preparation process of benazepril hydrochloride dispersible tablets and optimize the prescription to determine the best prescription for industrial production. Methods The single factor method was used to investigate the effect of disintegrant, dosage and type of filler on disintegration time, dispersion uniformity and dissolution of benazepril hydrochloride dispersible tablets respectively. Results The formulation of benazepril hydrochloride dispersible tablets was as follows: the filler was microcrystalline cellulose, the disintegrant was 5% sodium carboxymethylcellulose (cCMC-Na) and the binder was 5% hydroxypropylcellulose HPC) in water, the glidant is talc and the lubricant is magnesium stearate. Conclusion The prepared benazepril hydrochloride dispersible tablets meet the specifications, the process is stable and reliable.