摘要
选用盐酸阿拉莫林为模型药物,采用光纤固有溶出度实时测定系统测定了盐酸阿拉莫林在4种介质中的固有溶出度。并制备了盐酸阿拉莫林片剂,进行了4种介质中的溶出试验。结果表明,在pH1.2、pH4.5、pH6.8的介质和水中,盐酸阿拉莫林的固有溶出度分别为25.27、23.48、25.58、27.30mg/(cm^2·min),>1mg/(cm^2·min),提示溶出不会成为药物吸收的限速过程。阿拉莫林片在4种介质中均为快速溶出,溶出速度:水>pH6.8介质>pH1.2介质>pH4.5介质,与固有溶出度测定大小顺序相同。结果显示,固有溶出度能够在一定程度上预测药物从片剂中溶出的行为,为药物的剂型选择和处方设计提供参考。
Anamorelin hydrochloride was selected as a model drug and its intrinsic dissolution in four media was determined by an optical fiber intrinsic dissolution real-time measurement system. The dissolution test of home-made anamorelin hydrochloride tablets was performed in four media. The results showed that its intrinsic dissolution was 25.27, 23.48, 25.58, 27.30 mg/（cm^2·min） in pH 1.2, pH 4.5, pH 6.8 media and water, respectively, suggesting that the dissolution would not be the limit in drug absorption. Anamorelin tablets could be rapidly dissolved in all four media and its dissolution rate was the fastest in water following by in pH 6.8, pH 1.2 and pH 4.5 media with the same rank as the measurement of intrinsic dissolution, which suggested that intrinsic dissolution test could predict the dissolution of drug from tablets to some extent and could provide a reference for the formulation selection and prescription design of drugs.
作者
刘婧
LIU Jing(Research Institute,Shanghai Pharmaceuticals Holding Co.,Ltd.,Shanghai 201203,China)
出处
《上海医药》
CAS
2018年第11期93-97,共5页
Shanghai Medical & Pharmaceutical Journal
关键词
盐酸阿拉莫林
固有溶出度
转盘法
溶出
anamorelin hydrochloride
intrinsic dissolution
rotating disk system
dissolution
