水飞蓟素胶囊溶出度一致性评价研究

Evaluation of the dissolution consistency of silymarin capsules

考察试制品水飞蓟素胶囊在四种不同溶出介质中的溶出状况,对比参比药物作一致性评价研究,同时与原料药作比较,分别考察不同制剂在不同溶出介质中六种组份的溶出度改善与变化情况。结果显示,试制品与参比药物对比,各试验条件下,各组份f2因子均大于50,显示二者溶出度具有相似性。

As compared with the reference drug, dissolution behavior of trial product silymarin capsules was observed in four different dissolution media for the study of consistency evaluation. Furthermore,control bulk drugs, the dissolution rate and dissolution improvement of six groups of different preparations were investigated in different media, respectively. The results showed that f2 factors of each component in trial product are greater than 50 compared with the reference drug, indicating their similarities in dissolution behavior.