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目的:探讨纯化膨润土和一些常用片剂崩解剂的吸水特性,考察纯化膨润土作为片剂崩解剂的崩解性能。方法:设计吸水装置,分别测定各种崩解剂的吸水过程,同时测定其吸水溶胀性;考察纯化膨润土粉末在不同用量下,对3种不同性质主药分别压制片剂的崩解效果;将纯化膨润土与微晶纤维素低取代羟丙基纤维素、交联聚乙烯吡咯烷酮和羧甲基淀粉钠以不同比例混合作为混合崩解剂,试制布洛芬分散片。结果:纯化膨润土吸水速度较慢,但具有良好的吸水膨胀性。膨润土对3种不同性质的主药的崩解效果均与目前认为是性能较好且普遍使用的片剂崩解剂基本相同,膨润土与常用的国产辅料合用可制备出合格的分散片。结论:纯化膨润土可作为片剂的崩解剂。
OBJECTIVE: To investigate the water absorption characteristics of purified bentonite and some commonly used tablet disintegrants and investigate the disintegration behavior of purified bentonite as tablet disintegrant. Methods: The water absorption device was designed to measure the water absorption of various disintegrants, and the water absorption and swelling were measured simultaneously. The disintegration effect of the three different types of the main drugs on tablets was investigated under different dosage of purified bentonite powder. Purified bentonite and microcrystalline cellulose low-substituted hydroxypropylcellulose, crosslinked polyvinylpyrrolidone and sodium carboxymethyl starch were mixed in different proportions as a mixed disintegrant to manufacture ibuprofen dispersible tablets. Results: Purified bentonite had slower water absorption but good water swell. Bentonite on the three different nature of the main drug disintegration effect is currently considered to be better and commonly used tablet disintegrant is basically the same, commonly used domestic additives and bentonite can be prepared qualified dispersible tablets. Conclusion: Purified bentonite can be used as a tablet disintegrant.