郑现强,吕双凤,陈灏,张锐珍
ZHENG Xianqiang,LV Shuangfeng,CHEN Hao,ZHANG Ruizhen

• 1:丽珠集团丽珠制药厂

摘要(Abstract)：

目的考察光纤溶出仪用于本厂口服固体制剂溶出度检查的可行性。方法用光纤溶出仪进行溶出度检测,同时取样、过滤、稀释用紫外可见分光光度计检测,二者进行结果比较,计算单粒差值和平均差值。结果 12个品种的溶出度最大单粒差值4%,平均差值最大3%。结论光纤溶出仪可用于本厂12个品种的溶出度检测。
OBJECTIVE To inspect the feasibility of the dissolution test using fiber-optic dissolution tester for oral solid preparation in a factory. METHODS Detect the dissolution test with fiber-optic dissolution tester,while sampling,filtering and diluting were detected by uv-vis spectrophotometer,then the single grain difference and the average difference between the two results were calculated. RESULTS For the dissolution of 12 varieties in the factory,the maximum difference of single grain was 4%,while3% on average. CONCLUSION The fiber-optic dissolution tester can be used in dissolution test for 12 varieties in the factory.

关键词(KeyWords)： 光纤溶出仪;溶出度检查;应用
fiber-optic dissolution tester;dissolution test;application

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作者(Author): 郑现强,吕双凤,陈灏,张锐珍
ZHENG Xianqiang,LV Shuangfeng,CHEN Hao,ZHANG Ruizhen

参考文献(References)：

• [1]李新霞,陈坚.光纤药物溶出度过程分析仪的应用[J].中国医药工业杂志,2011,42(1):70-72.
• [2]国家药典委员会.中华人民共和国药典[S].二部.北京:化学工业出版社,2010:附录87.