| 摘要: |
| ［目的］制备头孢克肟栓剂并评价其质量。［方法］热熔法制备头孢克肟栓剂，采用RP-HPLC法，色谱柱为HYPERSIL C18柱（4.6 mm×250 mm，5 μm），用乙腈:0.25%四丁基氢氧化铵溶液（1∶2）为流动相，检测波长为288 nm处测定自制头孢克肟栓剂的含量和体外溶出度。［结果］制备的头孢克肟栓剂质量稳定，质控方法准确可靠。头孢克肟在栓剂中的含量为10.2%（RSD=1.57%），30 min时头孢克肟栓剂和市售头孢克肟硬胶囊的体外溶出度分别为（90.3±1.31）%和（81.2±1.59）%（P<0.05）。［结论］制备的头孢克肟栓剂外观性状好，重量差异小，含量准确，体外溶出度得到了明显提高。 |
| 关键词: 头孢克肟 栓剂 RP-HPLC法 质量 |
| DOI：10.11724/jdmu.2011.04.24 |
| 分类号:R965.3 |
| 基金项目: |
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| Preparation and quality evaluation of Cefixime suppositories |
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JIANG Ni1, BAO Xu2, GAO Meng2, HE Yan2, TIAN Ge2, TIAN Yan2
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1.Department of Pharmaceutics, Dalian Children Hospital, Dalian 116012, China;2.Pharmaceutical College, Dalian Medical University, Dalian 116044, China
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| Abstract: |
| ［Objective］To prepare Cefixime Suppositories and evaluate their quality. ［Methods］Cefixime Suppositories were prepared by fusion method. The content and dissolution rates of Cefixime Suppositories were determined by RP-HPLC on HYPERSIL C18 column (4.6 mm×250 mm, 5 μm) with acetonitrile and 0.25% tetrabutyl-ammonia (1 : 2) as the mobile phase, and the detective wavelength was 288 nm. ［Results］Cefixime Suppositories had good quality and stability, and the method for quality control was accurate. The content of Cefixime in suppositories was 10.2%(RSD=1.57%), the in vitro dissolution rates of Cefixime Suppositories and Cefixime Hard Capsules were (88.3±1.31)% and (81.2±1.59)% (P<0.05) respectively at 30 min. ［Conclusions］Cefixime Suppositories has good appearance, weight difference and concentration, and their dissolution rates have been improved definitely. |
| Key words: Cefixime suppositories RP-HPLC quality |
