龙胆泻肝丸溶出特性研究

目的研究龙胆泻肝丸中4种成分的溶出,评价该制剂的溶出特性。方法建立龙胆苦苷、黄芩苷、栀子苷和阿魏酸HPLC测定方法以考察龙胆泻肝丸、龙胆泻肝胶囊的溶出特性,并进行对比;拟合其溶出模型,求算溶出参数。结果 4 h时,丸剂中栀子苷、龙胆苦苷溶出较完全,黄芩苷、阿魏酸分别溶出66.51%、61.68%;Weibull模型拟合龙胆泻肝丸中上述4种成分的溶出情况效果最好,Ritger-Peppas模型、Higuchi模型、一级反应模型的拟合效果亦佳。结论丸剂中上述4种成分的溶出速率明显慢于胶囊剂;龙胆泻肝丸中栀子苷、龙胆苦苷溶出较黄芩苷、阿魏酸充分;该过程兼有Fick’s扩散机制和骨架溶蚀机制。

Dissolvable characteristics of Longdan Xiegan Pills

AIM To compare the dissolvable characteristics and the effective constituents of pills and capsules of Longdan Xiegan.METHODS The HPLC method of assaying gentiopicrin,baicalin,jasminoidin and ferulic acid in Longdan Xiegan Pills and Longdan Xiegan Capsules was established to study the dissolution conditions and the dissolution models.RESULTS In 4 hours,jasminoidin and gentiopicrin had been almost dissolved out while the dissolution of baicalin and ferulic acid were 66.51% and 61.68% respectively in Longdan Xiegan Pills.All four compounds fitted in with Weibull model,Ritger-Peppas model,Higuchi model and the first order reaction kinetics model.CONCLUSION The dissolution of four compouds in Longdan Xiegan Pills is much slower than that in Longdan Xiegan Capsules.Gentiopicrin and jasminoidin dissolve out faster than baicalin and ferulic acid in Longdan Xiegan Pills.Both Fick’s diffusion and frame erosion may happen during the process.