美洛昔康片的工艺研究与质量控制

Preparation and quality control of Meloxicam Tablets

目的制备美洛昔康片，并测定美洛昔康片的含量和溶出度。方法采用正交试验法，以溶出度作为指标，对处方中碱化剂、黏合剂和崩解剂进行筛选，采用紫外分光光度法测定美洛昔康片的含量和溶出度。结果美洛昔康片的最佳处方是每片含柠檬酸钠20mg，聚维酮K3018mg，交联聚维酮12mg。美洛昔康线测定性范围为1．96～19．6μg·mL^-1，回收率为99．84％，RSD为0．81％。自制片溶出度能在45min内能达到75％以上，与对照片莫比克相比，两者溶出相似。结论关洛昔康片工艺可行，且质量稳定。

OBJECTIVE To prepare Meloxicam Tablets and determine the content and the dissolution of Meloxicam Tablets. METHODS Three factors including alkalizing agents,disintcgrants and binders,which distinctly affected tablets quality,was selected for tablet according to orthogonal test by determining dissolution. The content and the dissolution of the experimental preparation were determined by UV. RESULTS The optimal formulation was sodium citrate 20mg, PVP-K30 18mg, CPVP 12mg per tablets. The linear range was 1.96-19.6μg·mL^-1 ;Average recovery was 9.84% ; RSD was 0.81%. Release rate of meloxicam in tablets was up to 75% in 45 minutes,which is similar to the reference tablets Mobic. CONCLUSION The experimental formulation was feasible and stable, which can accord with quality control.