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目的制备美洛昔康控释片并对其进行质量检查。方法采用正交设计法确定最佳处方,以甘露醇为主要辅料制备美洛昔康控释片,并对崩解时限、口感、溶出度进行了考察。结果最佳处方为1000片用交联聚乙烯吡咯烷酮(PVPP)20g,甘露醇140g,聚乙烯吡咯烷酮(PVP)3.0g,聚山梨酯-80 0.2 s,崩解时限小于30 s,控释片在10m in左右完全溶出,而普通市售片在45m in溶出80%。结论本研究制备的美洛昔康控释片为快速崩解型片剂,累积溶出度快于市售片。
Objective To prepare meloxicam controlled release tablets and conduct quality control. Methods Orthogonal design was used to determine the optimal prescription. Mannitol was used as the main excipient to prepare meloxicam controlled release tablets. Disintegration time, taste and dissolution were investigated. Results The optimal prescription was 1000g PVP 20g, mannitol 140g, polyvinylpyrrolidone (PVP) 3.0g, polysorbate-80 0.2s, the disintegration time was less than 30s, controlled release tablets 10m in about complete dissolution, while the ordinary commercial dissolution of 45% in 80%. Conclusion The meloxicam controlled release tablets prepared in this study are rapidly disintegrating tablets with a higher cumulative dissolution rate than the commercially available tablets.