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目的研究莫达非尼胶囊制备工艺并测定其含量。方法通过处方筛选并优化工艺后,将莫达非尼与适宜的辅料制成胶囊,采用HPLC测定其中莫达非尼含量,并进行溶出度检查。结果通过处方筛选和优化后制得的胶囊剂内容物装量差异、溶出度等指标符合胶囊剂的质量要求。所建立的莫达非尼HPLC测定方法在200～600μg·mL-1峰面积与浓度呈线性关系(r=0.999 9),平均回收率为101.4%,RSD为0.023%,采用该方法检验3批胶囊,结果其含量、溶出度等均符合要求。结论该胶囊处方工艺切实可行,所建立的检测方法可作为莫达非尼胶囊的质量控制标准。
Objective To study the preparation and determination of modafinil capsules. Methods After screening and optimizing the prescription, modafinil and appropriate excipients were made into capsules, and the content of modafinil was determined by HPLC and the dissolution test was performed. Results Through the prescription screening and optimization of the content of the capsule content difference, dissolution and other indicators in line with the quality requirements of capsules. The established modafinil HPLC method showed a linear relationship (r = 0.999 9) with an average recovery of 101.4% and a RSD of 0.023% at a concentration range of 200-600 μg · mL-1. Three batches were tested by this method Capsule, the results of its content, dissolution, etc. are in line with the requirements. Conclusion The prescription of the capsule is feasible. The established detection method can be used as the quality control standard of modafinil capsules.