| 摘要: |
| 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2.134~213.400 μg/mL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。 |
| 关键词: 塞来昔布 栓剂 制备 质量标准 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2016.09.016 |
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| 基金项目: |
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| Preparation and Quality Standard of Celecoxib Suppositories |
| Zheng Jiangping, Liang Jun, Huang Liangyong |
| (Taihe Hospital, Hubei University of Medicine, Hubei Shiyan 442000, China) |
| Abstract: |
| Objective: To study the preparation process of celecoxib suppositories and establish its quality control standard. Methods: The suppositories were prepared by using celecoxib as the primary drug and mixed-fatty-glyceride as the suppository matrix. The weight variation, melting time and microbial limit of prepared suppositories were checked according to the standard of Chinese Pharmacopoeia. The content of celecoxib was determined by HPLC. Results: The primary drug was mixed well with the suppository matrix. The suppositories showed milky white and smooth cone. The average suppository weight was 1. 499 3 g. Three suppositories were melted within 30 minutes. Microbial limit was in accordance with the standard of Chinese Pharmacopoeia. The linear range of celecoxib was 2.134 to 213.400 μg/mL. Conclusion: The method established by this research for suppository preparation is simple. The quality can be controlled by the established quality standard. |
| Key words: celecoxib suppository preparation quality standard |
