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以预胶化淀粉为主要辅料,采用全粉末直接压片,解决主要因阿斯匹林由于湿法制粒促使水解的问题。通过用正交试验法筛选处方,对制剂的质量和稳定性进行考察,结果表明,采用本法制备的肠溶阿斯匹林片在考察期间的硬度、崩解时限、含量及游离水杨酸均符合中国药典规定。本法具有工艺简单,增加片剂的稳定性等优点。
Pre-gelatinized starch as the main excipients, the whole powder direct compression, mainly due to aspirin due to wet granulation to promote hydrolysis problems. The quality and stability of the preparation were investigated by screening the prescription by orthogonal test. The results showed that the hardness, disintegration time and content of enteric-coated aspirin tablets prepared by the method and the content of free salicylic acid Are in line with the provisions of the Chinese Pharmacopoeia. This method has the advantages of simple process, increasing the stability of the tablet.