滑膜炎固体制剂的溶出度评价

Evaluation of dissolution of synovitis solid formulations

目的通过体外溶出度试验评价滑膜炎胶囊剂和片剂的体外溶出特性和成分溶出差异。方法采用小杯法溶出,通过HPLC法测定滑膜炎固体制剂中丹参素、新绿原酸、丹酚酸B等8个指标性成分的溶出,并通过相似因子法及指纹图谱进行不同固体制剂溶出的相似性评价。结果各制剂中指标性成分的溶出均较为完全,但溶出速率存在差异;从剂型角度分析溶出速率胶囊剂>片剂。相似因子法分析结果显示不同剂型之间的溶出度存在差异。各制剂溶出样品的指纹图谱整体性分析显示,不同厂家的片剂溶出样品的指纹图谱较为相似,胶囊剂与片剂之间也较为相似。结论滑膜炎固体制剂各成分的体外溶出较好,不同剂型指标性成分的溶出特性存在一定差异,但各制剂之间的溶出从复方组分整体性上较为相似。

Objective To evaluate the dissolution characteristics and composition dissolution differences of synovitis capsules and tablets by in vitro dissolution test.Methods Small cup method was used for the dissolution of eight indicator components,such as salvinorin,neochlorogenic acid and salvianolic acid B.The solid formulations of synovitis was determined by HPLC,and the similarity of the dissolution of different solid formulations was evaluated by the similarity factor method and fingerprinting.Results The dissolution of the index components in all formulations was complete,but the dissolution rates varied.The dissolution rates of capsules were higher than those of tablets from the perspective of dosage forms.The similarity factor analysis showed that the dissolution rates of the different dosage forms varied.The holistic analysis of fingerprints of the dissolved samples of each formulation showed that the fingerprints of dissolved tablets from different manufacturers were more similar,and between capsules and tablets were also similar.Conclusion The in vitro dissolution of each component of synovitis solid formulations is good,with difference in the dissolution characteristics of the indicator components of different dosage forms.The dissolution between the formulations is similar in terms of the overall nature of compound components.