舒筋活血分散片溶出度的研究

Study on dissolution test of Shujinhuoxue Dispersible Tablets

目的建立舒筋活血分散片的溶出度测定方法,并比较舒筋活血分散片、舒筋活血片及舒筋活血胶囊在胃肠道中溶出的差异。方法应用溶出度测定法,以水200 mL为溶剂,转速为60 r/min依法操作,测定舒筋活血分散片中4-甲氧基水杨醛的溶出度,并与其它两种制剂比较。结果舒筋活血分散片批间的溶出度结果差异较小,30 min后样品的累积释放百分率趋于平稳(大于95%),且在3种制剂中,舒筋活血分散片体外溶出速率较快,且能达到最大溶出百分率。结论舒筋活血分散片溶出度测定方法简便、准确,重复性好,可用于舒筋活血分散片的质量控制;在相同条件下,舒筋活血分散片的溶出速率快于胶囊剂与普通片剂。

Objective To establish the method of dissolution test for Shujinhuoxue Dispersible Tablets, and research the difference of dissolution rate and absorption among Shujinhuoxue dispersible tablets, Shujinhuoxue capsules and Shujinhuoxue tablets. Methods Applying the method of dissolution rate in pharmacopoeia with 200 mL water as the solvent and the rotation speed of 60r/min, the dissolution rate of the content of 4- methoxy salicylaldehyde of three kinds of preparation were determined,and was compared with each other.Results The cumulate dissolution rate of Shujinhuoxue Dispersible Tablets had little difference between batches.The cumulate dissolution percentage tended to be stable after 30 minutes （〉95%）. The Shujinhuoxue Dispersible Tablets had the faster dissolution speed and the higher dissolution rate in vitro than the two others. Conclusion The method established is simple,accurate and repeatable for the quality control of Shujinhuoxue Dispersible Tablets. The dissolution of Shujinhuoxue Dispersible Tablets was quicker than that of the marketed capsules and that of the common tablets.