摘要
目的:制备金荞麦分散片,建立质量控制方法,并与市售薄膜衣片的溶出度进行比较。方法:使用湿法制粒制备金荞麦分散片,并参照2010版《中华人民共和国药典》标准中分散片的各项指标进行检测,以纯水为介质,采用小杯法测定表儿茶素在金荞麦分散片与薄膜衣片中的溶出度,计算溶出参数m(线性方程斜率值)、T50(累积溶出量为50%时的时间)、Td(累积溶出量为63.2%时的时间)。结果:制备的金荞麦分散片符合要求,金荞麦分散片的溶出速度比薄膜衣片快。结论:所制备的分散片处方合理,不仅崩解符合要求,而且在10 min时累积溶出率达到75%,明显优于市售片,为将金荞麦制备成分散片提供依据。
Objective：To prepare the Jinqiaomai dispersible tablets,establish the quality control standard and compare the vitro dissolution with film coating tablets. Methods：The dispersible tablets were prepared by compressing moist granulation, then the indices of dispersible tablets were measured according to Chinese Pharmacopeia of 2010 edition. Epicatechin in release between Jinqiaomai dispersible tablets and film coating tablets was investigated in water by the third meth- od for the release determination, and the dissolution parameters ： m （ slope of linear equation）, Ts0 （ cumulate dissolution rate reaches to 50% ）, T~ （cumulate dissolution rate reaches to 63.2% ）were calculated. Results：Jinqiaomai dispersible tablets were up to the mustard and dissolved faster than film coating tablets. Conclusion：The Jinqiaomai dispersible tablets were reasonable. Not only the disintegration was up to the standard, but also obviously superior to film coating tablets in vitro dissolution by reaching the 75% in 10 min. All the above could provide the basis for Jinqiaomai dispersible tablets.
出处
《中华中医药学刊》
CAS
2013年第2期361-363,共3页
Chinese Archives of Traditional Chinese Medicine
基金
浙江省中医药科技计划资助项目(2010ZB130)
关键词
金荞麦片
质量控制
溶出度
Jinqiaomai tablets
quality control
dissolution
