氯化钾缓释片在不同介质中溶出曲线的对比研究  

A comparative study on dissolution curves of potassium chloride sustained-release tablets in different dissolution mediums

作　　者：王荪璇 妙苗 王嫦鹤 刘雪峰 邓颖鹏 WANG Sunxuan;MIAO Miao;WANG Changhe;LIU Xuefeng;DENG Yingpeng(Shaanxi Institute for Food and Drug Control,Xi’an,Shaanxi 710065,China)

机构地区：[1]陕西省食品药品监督检验研究院,陕西西安710065

出　　处：《安徽医药》2020年第8期1509-1512,共4页Anhui Medical and Pharmaceutical Journal

基　　金：国家科技重大专项⁃重大新药创制(2017ZX09101001)。

摘　　要：目的通过考察氯化钾缓释片在4种不同溶出介质中的溶出行为,为全面评价该药品体外溶出提供数据支持。方法以水、pH4.5缓冲液、pH 6.8缓冲液和pH 1.2盐酸溶液为溶出介质,采用浆法(转速50 r/min),采用自动电位滴定法及火焰原子吸收法测定累积溶出量,绘制体外多条溶出曲线,并采用相似因子(?2)法评价溶出曲线的相似性。结果氯化钾缓释片在4种不同溶出介质中的?2因子均大于50。结论氯化钾缓释片在4种不同溶出介质中的溶出特性相似。Objective To explore the dissolution behaviors of Potassium Chloride Sustained-release Tablets in the 4 kinds of dissolution medium,and to provide basis for a comprehensive evaluation of drug dissolution in vitro of Potassium Chloride Sustained-release Tablets.Methods The dissolution curves of Potassium Chloride Sustained-release Tablets were determined in water,pH 4.5 buffer solution,pH 6.8 buffer solution and pH 1.2 hydrochloric acid solution by stirring paddle method(rotating rate 50 r/min).Profiles were determined with automatic potentiometric titration and flame atomic absorption.Multiple dissolution curves in vitro were drawn and the similarity of dissolution profiles was evaluated by the similarity factor(?2)method.Results The ?2 factors of the dissolution profiles of Potassium Chloride Sustained-release Tablets in the 4 kinds of dissolution medium were all more than 50.Conclusion The dissolution characteristics of Potassium Chloride Sustained-release Tablets were similar in the four kinds of dissolution medium.

关 键 词：氯化钾/分析 迟效制剂 氯化钾缓释片 溶出曲线 自动电位滴定法 火焰原子吸收法 f_(2)因子 

分 类 号：R927.1[医药卫生—药学]