摘要
目的使用光纤药物溶出度实时测定仪（FODT）,比较三个厂家提供的四种肠溶胶囊壳性能。方法以甲硝唑为填充物,分别于盐酸溶液（9-1 000 ml）中277 nm处和磷酸盐缓冲液（pH 6.8）中320 nm处使用FODT对所提供的胶囊壳肠溶性进行考察。结果4号胶囊壳中甲硝唑在酸中溶出。1号、2号和3号胶囊壳中甲硝唑在酸中未溶出且在缓冲液中45 min后全部溶出。本实验选用3号胶囊为参照根据溶出曲线计算相似因子f2,分别为58.3和46.1。结论以f2因子在50-100范围内则溶出曲线相似为标准,通过结果可以看出,1号囊壳和参比囊壳对甲硝唑的溶出情况相似,而2号囊壳具有与参比囊壳不同的溶出特性。
Objective To compare the property of four kinds of entertic capsule loricas with fiber-optic dissolution test system.Methods As Metronidazole was packing material,the detection wavelength in solutions of 0.1N hydrochloric acid and phosphate buffer（pH6.8） were at 277 and 320 nm respectively.The property of capsule loricas was analyzed.Results The Metronidazole in the NO 4 entertic capsule loricas was dissolved in acid solution.NO 1,NO 2 and NO 3 capsule loricas were not dissolved,but dissolved totally in phosphate buffer.According to the dissolution curve,we could calculate the similarity factor（f2）.The NO 3 capsule was selected as reference.The f2 was 58.3 and 46.1.Conclusion As the dissolution curves were similar while the f2 in range of 50-100 is standard.According to the result we could find that the dissolution curve of metronidazole in the NO 1 capsule is the same as the reference but the NO 2 is different.
出处
《新疆医科大学学报》
CAS
2010年第2期116-118,共3页
Journal of Xinjiang Medical University
基金
国家科技支撑计划(2007BAI30B02-4)
国家中小企业创新基金(07C26216502091)
新疆维吾尔自治区科技支疆项目(200891124)
关键词
甲硝唑
光纤药物溶出度测定仪
肠溶胶囊
metronidazole
fiber-optic dissolution test system
enteric capsule lorica
