复方山楂滴丸物相稳定性评价

Stability of physical state on compound hawthorn dropping pills

目的:评价复方山楂滴丸在制备前后以及稳定性加速试验的物相变化情况。方法:采用扫描电镜、TG-DTA,FT-IR和XRD等检测手段。结果:药物在聚乙二醇4000中呈不定形、微晶和分子状态并存,两者间没有明显反应发生。随着时间延长滴丸中药物可能少量会从不定形状态逐渐向微晶或分子状态转变。结论:复方山楂滴丸固体分散体提高了药物稳定性和溶解性。

Objective： To evaluate the stability of physical state with accelerate test and dropping in process before and after on compound hawthorn dropping pills. Method： Scanning electron microscope, TG-DTA, FT-IR and XRD were used. Result： The active components presented amorphous, tiny crystal and molecular state in dropping pills, and it had no obvious reaction between PEG 4000 and active components. With time prolonging, a little of active components changed from amorphous state to tiny crystal or molecular state. Conclusion： Solid dispersion improved the stability and dissolution of compound hawthorn dropping pills.