复方丹参片溶出速率的研究

对不同厂家生产的复方丹参片用转蓝法进行了溶出速率的测定,经方差分析表明不同厂家生产的样品间相对累积释放量有显著性差异(P<0.01)。其中T_(50)最快与最慢相差10倍。结果还提示,崩解时限与T_(50)无显著相关性。表明各地的生产工艺、原料、辅料的来源不同是影响溶出速率的主要原因。

Study on Dissolution Rate of Compound Danshen Tablets

The dissolution rate of Compound Danshen Tablets made by different factories was determined with rotatory-basket method, The variance analysis showed obvious differential among the relative accumulation releasing amounts from samples of different factories (P<0.01). The fastest T_(50), was 10 times off the slowest. It was also suggested that no obvious correlation was between disintegration time and T_(50), but the production process of various factories, raw and auxiliary materials from different places could be responsible for the dissolution rate.