具明胶交联现象的氟伐他汀钠胶囊溶出度方法研究  

Dissolution Method Study of Cross-linked Fluvastatin Sodium Capsules

作　　者：李煜 邱晓霞 张淼 梅梅[3] 洪利娅 LI Yu;QIU Xiaoxia;ZHANG Miao;MEI Mei;HONG Liya(Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Zhejiang Provincial Center for Medical Science&Education Development,Hangzhou 310006,China;College of Chemical Engineering of Zhejiang University of Technology,Hangzhou 310014,China)

机构地区：[1]浙江省食品药品检验研究院,杭州310052 [2]浙江省医学科技教育发展中心,杭州310006 [3]浙江工业大学化学工程学院,杭州310014

出　　处：《中国现代应用药学》2019年第18期2275-2279,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：国家药典会化学药品2014年标准提高项目(2014-60)

摘　　要：目的针对氟伐他汀钠胶囊交联现象建立溶出度试验方法,为修订现行氟伐他汀钠胶囊溶出度标准提供依据。方法通过比较氟伐他汀钠胶囊国内外现行标准中溶出度方法,比对国内2家公司样品在4种pH条件下的溶出曲线相似度,考察样品在水和木瓜蛋白酶溶液(酶活力≥550 U·mL^-1)这2种溶出介质中的平均溶出度,确定溶出度检查方法:桨法,50 r·min^-1,溶出介质为500 mL水,30 min取样,HPLC测定,限度为标示量的80%;若出现不符合规定情况,以含木瓜蛋白酶溶液(酶活力≥550 U·mL^-1)为溶出介质,照上述方法重新试验,应符合规定。结果本品未发生交联样品批次在水和木瓜蛋白酶溶液中的溶出结果一致,发生交联样品批次在加酶溶出介质中平均溶出量提高5%~7%。结论该方法重现性好、准确、可靠,能客观反映本品的溶出情况,为统一和修订本品现行标准中溶出度项目提供了依据。OBJECTIVE To establish a dissolution method of fluvastatin sodium capsules,which deal with the possible cross-linking of gelatin capsules in dissolution test in vitro.It helps provide reference for revising the current quality standards.METHODS Dissolution methods in current standards at home and abroad,consistency evaluation of two domestic products in four media with different pH condition and the average dissolution in water and papain solution were compared to establish the dissolution method.The paddle method was used with rotational speed of 50 r·min^-1,using 500 mL of water as the dissolution medium.The dissolution solution was taken at 30 min and analyzed by HPLC.The dissolution limit was set at 80%.If it does not meet the limit,add another test according to the above method with enzyme solution which contain papain more than 550 U·mL^-1.It should be meet the limit.RESULTS The dissolution results for batches without cross-linking were consistent in both water and the above papain solution dissolution media,and the average dissolution of cross-linked batches in papain solution increased by 5%to 7%.CONCLUSION The determination method is highly reproducible,accurate and reliable,which can objectively reflect the dissolution of fluvastatin sodium capsules.It can provide a basis for the reasonable unification and revision of the dissolution test of the current quality standards.

关 键 词：氟伐他汀钠胶囊 溶出度 明胶胶囊 交联 木瓜蛋白酶 

分 类 号：R917.101[医药卫生—药物分析学]