盐酸胺碘酮片的溶出度研究

Study on Dissolution of Amidarone Hydrochloride Tablets

目的 :建立盐酸胺碘酮片的溶出度测定方法。方法 :以 1%十二烷基硫酸钠为溶出递质 ,转速 10 0r·min 1 ;对进口及国产 5个厂家的样品进行了溶出度测定。结果 :不同厂家样品的溶出度差异极显著 (P <0 .0 1)。结论 :有必要对该产品进行溶出度检查 。

Objective: To establish a method for the determination of dissolution of amiodarone hydrochloride tablets. Methods: Samples from five different factories were tested by the paddle method with the dissolving medium of 1% SLS. Results: The results showed that there were very significant differences(P<0.01) in dissolution parameters among the tested samples. Conclusion: It is necessary for testing the dissolution of the amiodarone product to control its quality and ensure clinical efficacy and safety.