伊曲康唑片处方工艺及质量检测标准的研究

Prescription craft and quality control standard of itraconzole tablets

目的筛选和优化伊曲康唑片处方工艺,并对片剂进行质量评定,建立伊曲康唑片的质量检测标准。方法以颗粒流动性、片重差异、片面光洁度、硬度、崩解时限为考察指标,以粘合剂(淀粉浆)浓度、崩解剂(CMS-Na)加入量为因素,采用L9(32)正交试验表设计试验方案,并考虑崩解剂(CMS-Na)的加入方式,对伊曲康唑片处方工艺进行筛选,进而进行质量评定。结果按本处方和工艺制成的片剂片重差异小,片子表面细腻,光滑,有光泽,质量评定均符合要求。结论优化处方达到《中国药典》规定要求。

Aim To optimize the preparation technics and the formula of itraconazole tablets, and to evaluate the quality of the tablets, establish itraconazole tablets quality testing standards. Methods A L9 （ 3^2 ） orthogonal design was performed to optimize the preparation technics and the formula of itraconazole tablets with particle flows, unit weight difference, a one - sided finish, hardness and disintegrating time as parameter of investigation,and with the concentration of binder（starch） and the dosage of disintegrant （CMS -Na） as factors. Meanwhile, the method of its addition was considered, before conducting quality evaluation. Results With the above prescription and process, tablets made had small differences in weight, the film surface detail, smooth. Its shiny. Its quality assessment had complied with the requirements. Conclusion The dissolution of the optimized tablets is up to the standard of Chinese Pharmacopoeia.