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目的确定益智亲水凝胶骨架片的体外释放度测定方法,考察影响体外释放的因素,研究体外释放机制。方法以羟丙甲基纤维素K15M和K4M为骨架材料,粉末直接压片法制备骨架片,以栀子苷、三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1为评价指标,考察其在不同释放度测定方式、释放介质和转速的体外释放度,以f2相似因子法评价释放的差异,并进行释药方程拟合,研究其释药机制。结果释放度测定方式、释放介质和转速对益智亲水凝胶骨架片体外释放均有影响,释药机制符合零级动力学方程和Ritger-Peppas方程,其中栀子苷以非Fick扩散方式释放,三七中3种成分以骨架溶蚀方式释放。结论确定了益智亲水凝胶骨架片的体外释放度测定方法,且药物释放机制符合释放动力学模型,值得进一步开发研究。
OBJECTIVE: To determine the in vitro release of puzzle hydrophilic gel matrix tablets, to investigate the factors that affect the release in vitro and to investigate the mechanism of release in vitro. Methods Hydroxypropylmethylcellulose K15M and K4M were used as matrix materials and the powder tablets were directly compressed to prepare the matrix tablets. Geniposide, notoginseng saponin R1, ginsenoside Rg1 and ginsenoside Rb1 were used as evaluation indexes to investigate the effects of jasminoidin, Degree of determination of release medium and speed in vitro release of f2 similarity factor method to evaluate the release of the difference, and the drug release equation fitting study of its drug release mechanism. The results of the determination of release, release medium and speed on the release of the hydrophilic matrix gel tablets in vitro have an impact release mechanism consistent with zero-order kinetic equation and Ritger-Peppas equation, in which geniposide released by non-Fick diffusion , Notoginseng in the three components released by skeleton dissolution. Conclusion The method for determination of in vitro release of puzzle hydrophilic gel matrix tablets was established, and the drug release mechanism accords with the release kinetic model, which deserved to be further developed.