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法罗培南钠片的制备及体外溶出研究
引用本文:陈小伟,;郝贵周. 法罗培南钠片的制备及体外溶出研究[J]. 食品与药品, 2014, 0(4): 233-235
作者姓名:陈小伟,  郝贵周
作者单位:[1]鲁南制药集团股份有限公司,国家手性制药工程技术研究中心,山东临沂276006; [2]沈阳药科大学药学院,辽宁沈阳110016
基金项目:国家科技支撑计划(项目编号:2014BA116800):手性药物大品种质量升级
摘    要:目的优化法罗培南钠片的制备工艺。方法采用湿法制粒工艺制备法罗培南钠片,以自制片与原研制剂体外溶出的相似因子(f2)为考察指标,用正交设计进行处方优化。结果按优化后工艺制备的法罗培南钠片在4种溶出介质中与原研制剂溶出相似因子分别为86,76,74,81。结论自制片与原研制剂在不同溶出介质中的溶出行为相似。

关 键 词:法罗培南钠片  溶出  相似因子

Study on Preparation and Dissolution of Sodium Faropenem Tablets
Affiliation:CHEN Xiao-wei, HAO Gui-zhou (1. Lunan Pharmaceutical Group Co., Ltd., National Chiral Pharmaceuticals Engineering and Technology Research Center, Linyi 276006, China; 2. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract:Objective To optimize the formulation ot Sodmm ~aropenem xaol~t~. ~,l~ w*-.---- Tablets were prepared by wet granulation method, and the formulation was optimized by an orthogonal design, using dissolution similarity factors (f2) between self-made preparation and branded drug as assess index. Results In different dissolution media, the dissolution curves of self-made preparation were compared with those of branded drug and the similarity factors (f2) were 86, 76, 74, 81, respectively. Conclusion In different dissolution media, the dissolution behavior of self-made preparation and branded drug is similar.
Keywords:Sodium Faropenem Tablets  dissolution  similarity factor
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