卡马西平口腔速崩片的制备及质量评价  

Preparation and Quality Evaluation of Carbamazepine Orally Disintegrating Tablets

作　　者：卫晓晓[1,2] 焦海胜[1] 

机构地区：[1]兰州大学第二医院药剂科,兰州市730030 [2]兰州大学药学院,兰州市730000

出　　处：《中国药房》2011年第5期424-427,共4页China Pharmacy

摘　　要：目的:制备卡马西平(CBZ)口腔速崩片并评价其质量。方法:选用CBZ为主药,微晶纤维素(MCC)、交联羧甲基纤维素钠(CCNa)为崩解剂,以直接粉末压片法制备片剂;以MCC、CCNa、乳糖用量为考察因素,崩解时间为考察指标设计正交试验筛选处方;采用紫外分光光度法测定制剂中主药的含量,同时以崩解时间、溶出度及稳定性等指标进行质量评价,并与普通片剂比较溶出度,与原料药比较稳定性。结果:优选处方为MCC75mg、CCNa9mg、乳糖30mg。所制制剂含量均匀度符合规定,崩解时间为(21±3)s,溶出迅速,2min内累积溶出率达81.46%;普通片剂90min累积溶出率为71.46%。与原料药比较,该制剂在高温下吸收峰略有变化。结论:该制剂制备方法简单,质量稳定可控,应于低温干燥环境下贮存。OBJECTIVE： To prepare Carbamazepine （CBZ） orally disintegrating tablets and to evaluate the quality standard of it. METHODS： The tablets were prepared by directly powder compression method using microcrystaline cellulose （MCC） and croscarmellose sodium （CCNa） as disintegrants. The preparation method was optimized by orthogonal test using amount of MCC, CCNa and lactose as factors and with disintegrating time as index. The content of main components was determined by UV spectrophotometry, and the properties of the tablets were evaluated using dissolution rate and stability as index. The dissolution rate of CBZ orally disintegrating tablets was compared with common tablet, and the stability of CBZ orally disintegrating tablets was compared with raw material. RESULTS： The optimal formula was as follows： MCC 75 mg, CCNa 9 mg, lactose 30 mg. The quality of prepared tablets was in line with the standard. The disintegration time was （21±3） s and the accumulative dissolution rate was 81.46% within 2 min. The accumulative dissolution rate was 71.46% within 90 min. Compared with raw material, the absorption peak of prepared tablets changed slightly. CONCLUSION： The preparation technology of orally disintegrating tablets is simple, controllable in quality. It should be kept in drug and cold environment.

关 键 词：卡马西平 口腔速崩片 制备 质量评价 

分 类 号：R927.2[医药卫生—药学] R971.6