复方愈创木酚甘油醚双层缓释片释放度及释药机制研究

Evaluation of double layer tablets release and its kinetics of compound guaifenesin and phenylpropanolamine hydrochloride

目的：比较双层缓释片与Ｓｉｄｍａｋ 缓释片的释放度，并进行动力学分析。方法：建立复方愈创木酚甘油醚双层缓释片溶出度实验方法，用紫外法和比色法分别测定该制剂中愈创木酚甘油醚（ＧＦ） 及盐酸苯丙醇胺（ＰＰＡ）的释放度。结果：双层缓释片起始释药量减低，在４ ～８ ｈ 释药量明显增加，呈现２ 次释药；对照缓释片在整个释药过程符合一级动力学。结论：双层片药物滞后释放，增加了缓释特性，特别适合水溶性大半衰期短的药物缓释制剂的制备。

OBJECTIVE: The release behaviors and kinetics of two complex tablets were compared The one was a double layer tablet; another was a homogeneous matrix tablet METHOD: A Spectrophotometric method was developed to determine guaifenesin (GF) and phenylpropanolamine hydrochloride (PPA) in the release process of two sustained release tablets RESULTS: The double layer tablet showed biphasic release The amount of release at beginning was low, and then increased in the period of 4～8 hour obviously CONCLUSION: The release behavior of the double layer tablet improved the property of sustained release, which is especially suitable to the soluble and shorter t 1/2 drugs