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目的采用熔融法制备水中易溶药物酒石酸美托洛尔缓释片,并联合速释片,以期抑制第一个血压高峰,减缓第二血压高峰。方法采用熔融制粒法,将药物、羟丙基甲基纤维素(hydroxypropyl methyl cellulose,HPMC)和羧甲基纤维素钠(carboxymethyl cellulose sodium,CMC-Na)混合粉末加入到熔融状态下的硬脂酸中,制备缓释片。考察缓释骨架的用量、不同型号HPMC对药物释放的影响,并采用正交设计对实验进行优化。结果当处方中含有质量分数为25%的酒石酸美托洛尔、质量分数为10%的HPMC K100M、质量分数为30%的硬脂酸和质量分数为35%的CMC-Na时,基本达到缓释效果。结论水中易溶药物采用熔融制粒法制备缓释片,缓释效果较好。结合速释,可实现速释和缓释双释效果。
OBJECTIVE To prepare the metoprolol sustained-release tablets of soluble drugs in water and combine with immediate-release tablets by melting method in order to restrain the first peak of blood pressure and slow the second peak of blood pressure. Methods The melt granulation method was used to add drug, hydroxypropyl methyl cellulose (HPMC) and carboxymethyl cellulose sodium (CMC-Na) mixed powder to melted stearin Acid, preparation of sustained release tablets. The amount of sustained-release scaffolds and the effect of different types of HPMC on drug release were investigated. The orthogonal design was used to optimize the experiment. Results When the prescription contained metoprolol 25%, HPMC K100M with mass fraction 10%, stearic acid with mass fraction 30% and CMC-Na with mass fraction 35% Release effect. Conclusions The soluble drug in water is prepared by melt granulation method, and sustained release is better. Combined with immediate release, can achieve immediate release and sustained release double release effect.