CAJ | 학술논문

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。
비교체막서알국산효낭여원연효낭적용출곡선화은정성。재4충용출개질중고찰용출곡선상사성，장치채용전람법，전속100 r/min。체막서알국산효낭여원연효낭재사충용출개질중적용출곡선균상사。은정성영향인소실험표명，국산효낭재고온（60℃）화고습（상대습도92.5%）조건하불은정，유관물질량증가，이원연효낭적은정성량호。
To compare the dissolution proifle 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-inlfuencing factors showed that domestic preparation was unstable with the signiifcant 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.