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目的:制备塞来昔布栓剂并拟定其质量控制标准。方法:以塞来昔布为主药,混合脂肪酸甘油酯为栓剂基质制备直肠栓。依据《中国药典》附录栓剂项下的有关规定,对其重量差异、融变时限、微生物限度进行检查,采用HPLC法测定塞来昔布的含量。结果:制得的栓剂药物与基质混合均匀,栓剂为乳白色光滑的圆锥形;平均粒重为1.499 3 g,3粒均在30 min内融化,微生物限度符合规定;塞来昔布浓度在2.134~213.400μg/m L范围内与峰面积呈良好的线性关系。结论:该栓剂的制备方法简单,质量标准能满足该栓剂的质量控制需要。
Objective: To prepare celecoxib suppositories and to develop their quality control standards. Methods: Celecoxib was used as the main drug, and mixed fatty acid glycerides as suppository base to prepare rectal suppository. According to the appendix of “Chinese Pharmacopoeia” suppository under the relevant provisions of their weight differences, melting time limit, microbial limits were checked by HPLC determination of celecoxib content. Results: The prepared suppository was mixed well with the matrix and the suppository was milky white with a smooth conical shape. The average particle weight was 1.499 3 g, and the three granules all melted within 30 min. The limits of microorganisms were within the limits. The concentration of celecoxib was between 2.134 ~ 213.400μg / m L range and peak area showed a good linear relationship. Conclusion: The preparation of the suppository is simple and the quality standard can meet the quality control requirements of the suppository.