国产地氯雷他定片的溶出曲线考察  

Investigation on Dissolution Curve of Domestic Desloratadine Tablets

作　　者：陈承贵 李美芳 庞发根 李玉兰 王铁杰 CHEN Chenggui;LI Meifang;PANG Fagen;LI Yulan;WANG Tiejie(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,Shenzhen,Guangdong,China518057)

机构地区：[1]广东省深圳市药品检验研究院.深圳市药品质量标准研究重点实验室,广东深圳518057

出　　处：《中国药业》2019年第1期24-27,共4页China Pharmaceuticals

摘　　要：目的探讨国内地氯雷他定片与原研片剂体外溶出曲线的一致性。方法按2015年版《中国药典(四部)》通则0931溶出度与释放度测定法,采用自动溶出仪和高效液相色谱仪测定6种溶出介质下的溶出曲线;采用f_2因子法对溶出曲线的相似度进行评价。结果 0. 1 mol/L盐酸溶液中,受试片剂与原研片剂溶出行为相似;其余5种溶出介质下,部分厂家受试片剂与原研片剂的溶出行为有差异。结论原研片剂在6种溶出介质下的溶出行为不同,但更能评价出部分厂家地氯雷他定片与原研片剂溶出行为的差异。建议采取多条溶出曲线进行一致性评价,为国内企业加强工艺研究提供参考。Objective To investigate the consistency of in vitro dissolution curves between domestic Loratadine Tablets and original tablets.Methods According to the dissolution and release assay in general principles0931of Chinese Pharmacopoeia(2015edition,Volume V),the6kinds of the dissolution curve in the dissolution medium were determined by automated dissolution apparatus and high performance liquid chromatograph(HPLC)spectrometer,the similarity of dissolution curves was evaluated by f2factor method.Results In0.1mol/L HCL solution,the dissolution behavior of the tested tablets was similar to that of the original tablets.In the rest of the five kinds of dissolution medium,the test tablets from some manufacturers were different from the original tablets.Conclusion The dissolution behavior of the original tablets in6kinds of dissolution medium is different,but it can better evaluate the difference of dissolution behavior between Desloratadine Tablets from some manufacturers and the original tablets.It is suggested that several dissolution curves should be used for consistency evaluation,in order to provide reference for domestic enterprises to strengthen technological research.

关 键 词：地氯雷他定 溶出曲线 F2因子 一致性评价 

分 类 号：R927.11[医药卫生—药学] R976