膜剂用漏槽式溶出装置的初步验证与应用  

Preliminary Verification and Application of Flow-through Cell Apparatus for Pharmaceutical Films

作　　者：李铭岩 王兵[1] 何军焘 张惠平[1] 陈芳[1] LI Mingyan;WANG Bing;HE Juntao;ZHANG Huiping;CHEN Fang(National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203;Huanghai Instruments Co.,Ltd.,Shanghai 200070)

机构地区：[1]中国医药工业研究总院医药先进制造国家工程研究中心,上海201203 [2]上海黄海药检仪器有限公司,上海200070

出　　处：《中国医药工业杂志》2024年第3期335-343,共9页Chinese Journal of Pharmaceuticals

基　　金：国家药典委员会2021年度国家药品标准制修订研究课题项目“膜剂通则修订”(2021Y29)。

摘　　要：研制了膜剂用漏槽式溶出装置,以探索建立膜剂溶出度的测定方法。取样精确度和温度控制测试结果表明,在1、2和5 mL/min的流速条件下,取样精度和温度控制符合使用要求。选取盐酸格拉司琼口溶膜、马来酸阿塞那平舌下膜、甲磺酸雷沙吉兰舌下膜和他达拉非口溶膜为模型药物,对药膜的固定方式、流体形态及溶出池密封性进行了验证分析,并做出改进。结果表明,以滤芯结构分散溶出介质,以筛网固定膜剂并实现密封性增强的溶出池设计可实现基础溶出检测功能,且具有一定的应用普适性,以及满足不同种类药膜和不同流速条件下溶出度测试需求的潜力。In this study,a flow-through cell based apparatus was developed to explore the method of dissolution determination for pharmaceutical films.The results of accuracy tests on sampling and temperature controlling showed that the apparatus performed well on accuracy control under different flow rate conditions of 1,2 and 5 mL/min.Granisetron hydrochloride orodispersible film,asenapine maleate sublingual film,rasagiline mesylate sublingual film and tadalafil orodispersible film were selected as model drugs to verify the fixed method of film,fluid morphology,and tightness of the dissolution cell,and corresponding improvements were proposed.The results indicated that through dispersing the dissolution media with a filter core,fixing the film with a screen mesh,and enhancing the tightness of dissolution cell,this apparatus could achieve primary functions on dissolution with the potential of application universality for different pharmaceutical films and flow rates.

关 键 词：溶出装置 膜剂 流通池法 应用普适性 

分 类 号：R944.9[医药卫生—药剂学] R917[医药卫生—药学]