维生素D_(3)软胶囊溶出度测定方法的建立  

Establishment of a dissolution method of vitamin D_(3) soft capsules

作　　者：周璟明[1] 徐兰[1] 陈秀明[1] 林斌[1] 陈有钟[1] 方东升[1] ZHOU Jing-ming;XU Lan;CHEN Xiu-ming;LIN Bin;CHEN You-zhong;FANG Dong-sheng(Fujian Institute of Microbiology,Fujian Key Laboratory of Screening for Novel Microbial Products,Fuzhou 350007,China)

机构地区：[1]福建省微生物研究所,福建省新药(微生物)筛选重点实验室,福州350007

出　　处：《药物分析杂志》2021年第3期543-550,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：福建省属公益类科研院所基本科研专项(2018R1009-1)资助。

摘　　要：目的:建立维生素D_(3)软胶囊溶出度测定方法。方法:考察不同搅拌装置、不同溶出介质(表面活性剂种类/浓度、碱浓度)、不同挽拌速度对维生素D_(3)软肢囊溶出行为的影响,采用H PLC法对溶出样品进行测定并计算累积溶出度。结果:采用桨法(沉降篮)、转速100 r·min^(-1)、37℃、0.3 mol·L^(-1)氢氧化钠-10%曲拉通X-100为溶出介质对维生素D_(3)软胶囊(400、800 IU)进行溶出实验。结论:以上溶出方法可有效运用于维生素D_(3)软胶囊的溶出度检测,能区分国产与进口制剂的溶出行为以及同厂家不同批次间溶出行为差异,该溶出方法可为油溶性软胶囊的溶出方法开发及维生素D_(3)软胶囊的仿制药一致性评价工作提供参考。Objective:To establish a discriminative method for the dissolution test of vitamin D_(3) soft capsules.Methods:The effects of different stirring devices,different dissolution media,different stirring speeds on the dissolution behavior of vitamin D_(3) soft capsules were investigated,and the cumulative dissolution were calculated by measuring the dissolution samples with HPLC method.Results:The dissolution test of vitamin D_(3) soft capsules(400/800 IU)was carried out by paddle method(with sinker),rotation speed of 100 r·min^(-1),temperature of 37℃,and 0.3 mol·L^(-1) NaOH-10% TritonX-100 as dissolution medium.Conclusion:This dissolution method can be effectively applied to the dissolution test of vitamin D_(3) soft capsules,and can distinguish the dissolution behavior of domestic and imported preparations and the dissolution behavior of different batches from the same manufacturer.It provides a reference for the dissolution method development of oil-soluble soft capsules and further quality consistency evaluation of Vitamin D_(3) soft capsules.

关 键 词：维生素D_(3)软胶囊 曲拉通 溶出方法 溶出行为 一致性评价 

分 类 号：R917[医药卫生—药物分析学]