摘要
比较替莫唑胺国产胶囊与原研胶囊的溶出曲线和稳定性。在4种溶出介质中考察溶出曲线相似性,装置采用转篮法,转速100 r/min。替莫唑胺国产胶囊与原研胶囊在四种溶出介质中的溶出曲线均相似。稳定性影响因素实验表明,国产胶囊在高温(60℃)和高湿(相对湿度92.5%)条件下不稳定,有关物质量增加,而原研胶囊的稳定性良好。
To compare the dissolution profile and stability between domestic and original preparations of temozolomide capsules. Similarity of dissolution curve of two preparations in four different types of dissolution media was evaluated by the basket method at 100 r/min. The dissolution profiles of domestic preparation were similar to those of original preparation in all 4 dissolution media. The study of the stability-influencing factors showed that domestic preparation was unstable with the significant increase in the amount of related substances under high temperature（60℃） and high humidity（RH 92.5%） while original preparation was stable under the same conditions.
出处
《上海医药》
CAS
2015年第19期76-79,共4页
Shanghai Medical & Pharmaceutical Journal
关键词
替莫唑胺胶囊
溶出曲线
相似性
稳定性
temozolomide capsules
dissolution profiles
similarity
stability
