光纤原位动态倍率系数法监测头孢克肟分散片溶出度-中国现代应用药学.PDF

光纤原位动态倍率系数法监测头孢克肟分散片溶出度 姚军 1 2 1 1 ，沈静 ，李新霞 ，陈坚 (1.新疆医科大学药学院，乌鲁木齐 830054 ；2.新疆医科大学第五附属医院药剂科，乌鲁木齐 830054) 摘要：目的 建立头孢克肟分散片体外溶出度的原位过程分析方法。方法 采用动态倍率系数法消除赋形剂的干扰，利 用六通道光纤化学传感原位过程分析仪(FOCSDT)在线监测头孢克肟分散片溶出度。结果 FOCSDT 的平均标准曲线方程 为 Y =179 X + 0.43 ，回归系数 r=0.999 9。头孢克肟分散片的溶出数据与美国药典方法对照无统计学差异。结论 FOCSDT 法无需取液、稀释等手工操作，能实时监测药物溶出全过程，为药物的内在质量提供了良好的检测手段。 关键词：头孢克肟分散片；溶出度；光纤原位过程分析；动态倍率系数法 中图分类号：R917.4 文献标志码：B 文章编号：1007-7693(2010)06-0535-04 Fober-Optical In-situ Montor Dissolution Rate of Cefixime Dispersible Tablets Using Method of Dynamic Multiplying Factor 1 2 1 1 YAO Jun , SHEN Jing , LI Xinxia , CHEN Jian (1.College of Pharmacy, Xinjiang Medical University, Urumqi 830054, China; 2.Department of Pharmacy, The Fifth Affiliated Hospital, Xinjiang Medical University, Urumqi 830054, China) ABSTRACT : OBJECTIVE To develop an in-situ and process monitoring method for dissolution rate of cefixime dispersible tablets. METHODS Using the six channel fiber optical chemical sensor monitored the dissolution rate of cefixime dispersible tablets by method of dynamic multiplying factor to eliminate interference of excipient. RESULTS The average standard curve equation was Y=179X +0.43, r=0.999 9. The dissolution results of measurement using the instrument have not significant difference compared with the United States Pharmacopoeia(USP30-NF25). CONCLUSION The method does not need sampling, dilution, manual operation, shows the real dissolution of immediate release drug and is a accurate and reliable method. KEY WORDS: cefixime dispersible tablets; dissolution rate; fiber optic in-situ process analysis; dynamic multiplying factor 头孢克肟(cefixime，CFIX)为口服的第三代头 散片体外溶出度过程分析方法。 孢类抗生素，具有广谱抗菌特点，对链球菌、肺 1 仪器与试剂 炎球菌、淋球菌、大肠杆菌等有良好的抗菌作用，