伊立替康中空栓剂的制备研究  

Study on the Preparation of irinotecan Cornell hollow suppository

作　　者：缴万里[1] 刘海洁[2] 张熙杰[1] 张桂荣[3] 王玉红[4] 曹德英[5] 

机构地区：[1]唐山市工人医院药学部,河北唐山063000 [2]河北联合大学校医院 [3]开滦(集团)有限责任公司医院肿瘤科 [4]开滦(集团)有限责任公司医院药剂科 [5]河北医科大学药学院

出　　处：《现代预防医学》2012年第14期3639-3642,共4页Modern Preventive Medicine

摘　　要：目的为使患者用药更加方便、安全,试制了伊立替康中空栓,对其质量进行考查。方法制备伊立替康中空栓,每枚含伊立替康80 mg,并对伊立替康中空栓的融变时限、重量差异进行考查。采用高效液相色谱法测定伊立替康中空栓样品中的伊立替康的含量。结果伊立替康中空栓的融变时限、重量差异均符合规定。采用HPLC法测得的回归方程为A=11.592C＋0.802 4（r=1,n=6）,伊立替康在5~200μg.ml-1浓度范围内呈良好线性关系。最低检测限为0.2μg.ml-1。低、中、高3种浓度的日内精密度分别为1.57%、0.69%、1.42%;日间精密度分别为2.44%、1.01%、1.53%;平均回收率分别为97.65%、99.74%、100.58%。经稳定性试验,伊立替康供试品溶液在48 h内稳定。伊立替康中空栓5批样品中主药伊立替康含量均符合制剂含量要求。结论伊立替康中空栓制备方法设计合理、操作简单、工艺可行。OBJECTIVE To examine the quality of irinotecan Cornell hollow suppository to ensure the convenience and safety for patients.METHODS We formulated the irinotecan hollow bolt,and each contained 80mg irinotecan.We examined the time limit for Sport hollow bolt thaw and weight difference of the Hong hollow bolt.A HPLC method was taken to determine the main drug irinotecan’s content.RESULTS Irinotecan Kang hollow bolt financial changed the time limit,and the weight differences were in line with regulations.HPLC regression equation was A = 11.592C ＋ 0.802 4（r = 1,n = 6）,and irinotecan showed good linearity within the range of 5 to 200 μg·ml-1 concentration.The detection limit was 0.2 μg·ml-1.The low,medium and high concentrations of intra-day precision were 1.57%,0.69% and 1.42%,respectively;The day precisions were 2.44%,1.01% and 1.53%,respectively;The average recoveries were 97.65%,99.74% and 100.58%,respectively.The stability test,the test solution of irinotecan stabilized within 48 hours.The irinotecan content of the cornell hollow bolt was in line with the preparation content requirements.CONCLUSION The formulation of irinotecan Kang hollow bolt is reasonable,simple and feasible.

关 键 词：伊立替康 中空栓剂 制备 

分 类 号：R115[医药卫生—公共卫生与预防医学]