曲安奈德益康唑乳膏处方及微观结构特性评价的比较研究  

Comparative study on the ingredients and microstructure arrangement of triamcinolone acetonide and econazole nitrate cream

作　　者：沈丹丹 吴群 沈川 姜学美 Shen Dan-dan;Wu Qun;Shen Chuan;Jiang Xue-mei(Chongqing Institute for Food and Drug Control,Chongqing 401121;Chongqing Research Center for Drug Process and Quality Control Engineering,Chongqing 401121;Chongqing Qijiang District Hospital,Chongqing 401420)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121 [2]重庆市药物过程与质量控制工程技术研究中心,重庆401121 [3]重庆綦江区人民医院,重庆401420

出　　处：《中国抗生素杂志》2022年第7期691-696,共6页Chinese Journal of Antibiotics

基　　金：重庆市科研机构绩效引导专项(No.cstc2019jxj1130034)。

摘　　要：目的为曲安奈德益康唑乳膏一致性评价参比制剂(reference listed drug,RLD)的选择及质量等同性评价提供依据。方法采用逆向工程解析不同产地上市的原研产品、地产化产品派瑞松®和国产仿制药产品邦力®处方,比较处方(Q_(1))和关键功能性辅料的处方用量(Q_(2))的差异;并采用光学显微镜和冷镜露点法考察微观结构特性(Q_(3))差异。结果地产化产品派瑞松®与法国上市产品Pevisone®Q_(1)相同但Q_(2)不同;国产仿制药产品邦力®与地产化产品派瑞松®Q_(1)、Q_(2)及Q_(3)均不一致,两者产品Q_(3)的差异可能是由于Q_(1)和Q_(2)不同引起的。结论地产化产品派瑞松®不适宜作为本品一致性评价的RLD,建议国内生产企业选择Pevisone®为RLD,实现与参比制剂的Q_(1)、Q_(2)及Q_(3)一致,从而豁免生物等效性研究。Objective To provide the research basis for the selection of reference listed drug(RLD)and quality equivalence evaluation of triamcinolone acetonide and econazole nitrate cream.Methods The ingredients of the original product listed in different origins,localized product,and domestic generic drug were analyzed by reverse engineering,and the difference between qualitative(Q_(1))and quantitative(Q_(2))composition of inactive ingredients were compared;the difference of microstructure arrangement(Q_(3))were investigated by the optical microscope and chilled-mirror dew-point method.Results The Q_(1) of localized product派瑞松®was the same as the French marketed product Pevisone®,but the Q_(2) was different;the Q_(1),Q_(2),and Q_(3) were not the same between the domestic generic drug and the localized product,and the difference in Q_(3) between the two products might be due to Q_(1) and Q_(2).Conclution The localized product派瑞松®is not suitable as the RLD for the consistency evaluation of this product.Pevisone®is recommended as the RLD,and generic drugs may be suitable for a biowaiver by demonstrating similar Q_(1),Q_(2),and Q_(3) as the RLD.

关 键 词：曲安奈德益康唑乳膏 处方(Q1) 处方用量(Q2) 微观结构特性(Q3) 

分 类 号：R917[医药卫生—药物分析学]