f因子法考察萘普生胶囊溶出度

目的:考察2种市售萘普生胶囊的溶出曲线,研究《中国药典》和《日本药局方》规定的溶出务件下溶出度的差异,分析现行溶出方法的质量可控性.方法:采用溶出仪测定萘普生胶囊在水,pH1.2,pH4.0,pH6.8,pH7.4等5种介质中的溶出曲线,对试验结果进行分析并用f因子法评估溶出曲线的相似性.结果:2种市售萘普生胶囊溶出曲线与日本标准溶出曲线相比存在较大差异,且国产萘普生制剂溶出较慢.2种市售萘普生胶囊的溶出度均符合《中国药典》的规定,但不同厂家生产的萘普生胶囊之间溶出曲线差异较大,不同厂家产品存在质量差异.结论:现行药典的溶出限度(Q值)不能反映制剂质量的内在差异,建议生产企业采用溶出曲线对制剂产品进行生产工艺、处方、质量评估.

Study on the Dissolution of Naproxen Capsules by / Factor Method

Objective：To examine the dissolution curves of naproxen capsules from different manufacturers,study the dissolution difference determined respectively under the conditions of Japanese pharmacopoeia and Chinese Pharmacopoeia,and analyze the quality controllability of the current dissolution methods.Method：The dissolution of naproxen capsules was studied by rotating basket method respectively in distilled water,pH1.2,pH4.0,pH6.8 and pH7.4 medium.The similarity of the dissolution curves was evaluated with /factor method.Result：Compared with the Japanese standard dissolution curve,the dissolution curves of naproxen capsules from different manufacturers were significantly different,and the domestic naproxen capsules showed slower dissolution.The two marketed products both met the requirements of Chinese Pharmacopoeia,however still with significant difference in the dissolution curves,suggesting the quality differences.Conclusion：The existing dissolution limiting（Q） can not reflect the inherent differences in the preparation quality.It is recommended that manufacturers apply drug dissolution curves to assess the production process,formulation and quality of the preparations.