引用本文: | 杨淑梅,姚军,脱鸣富,李新霞,陈坚.紫外光纤法过程监测头孢克肟5种固体剂型的体外溶出度[J].中国现代应用药学,2011,28(9):854-856. |
| YANG Shumei,YAO Jun,TUO Mingfu,LI Xinxia,CHEN Jian.UV Fiber-optical Process Monitoring for Dissolution Behavior of 5 Solid Dosage Forms of Cefixime[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(9):854-856. |
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摘要: |
目的 建立紫外光纤监测头孢克肟5种固体剂型的溶出度的方法。方法 采用美国药典中头孢克肟片溶出度测定方法,结合六通道光纤传感原位过程分析仪原位、在线监测头孢克肟5种不同固体制剂溶出度。结果 原位光纤法测定头孢克肟固体制剂的溶出数据与美国药典方法对照无统计学意义。结论 原位光纤法无需取液、稀释等手工操作,能实时监测药物溶出全过程,为药物内在质量的检测提供良好的手段。 |
关键词: 头孢克肟 溶出度 光纤原位过程分析 |
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基金项目:十一五国家科技支撑计划重大项目(2006BAK03A16) |
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UV Fiber-optical Process Monitoring for Dissolution Behavior of 5 Solid Dosage Forms of Cefixime |
YANG Shumei1, YAO Jun2, TUO Mingfu2, LI Xinxia2, CHEN Jian2
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1.The Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi 830011, China;2.College of Pharmacy, Xinjiang Medical University, Urumqi 830054, China
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Abstract: |
OBJECTIVE To develop an UV fiber-optical process monitoring method for dissolution behavior of five solid dosage forms of cefixime. METHODS Using the six channel fiber optical chemical sensor linked with-dissolving apparatus the dissolution rate of cefixime dispersible tablets was monitored by dynamic multiplying factor to eliminate interference of excipient. RESULTS The dissolution results measured by the instrument have no significant difference compared with the USP30-NF25. CONCLUSION The method needs no sampling and dilution. It can monitor the drug dissolution real-time. |
Key words: cefixime dissolution rate fiber optical in situ process analysis |