头孢克肟栓剂的制备及质量评价  

Preparation and quality evaluation of Cefixime suppositories

作　　者：蒋妮 鲍旭[2] 高萌[2] 何艳[2] 田舸[2] 田燕[2] 

机构地区：[1]大连儿童医院药剂科,辽宁大连116012 [2]大连医科大学药学院,辽宁大连116044

出　　处：《大连医科大学学报》2011年第4期409-412,共4页Journal of Dalian Medical University

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,5μm),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288nm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。[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.

关 键 词：头孢克肟 栓剂 RP—HPLC法 质量 

分 类 号：R944[医药卫生—药剂学]