【摘要】 目的:考察光纤化学传感仪实时、在线过程监测多潘立酮片体外溶出度测定方法的可行性。方法:采用DT-601型光纤传感药物溶出度/释放度原位过程监测仪,同时监测6片多潘立酮片体的药溶出过程,双波长法(284/350 nm)消除赋形剂干扰,计算机处理数据、实时显示药物溶出/释放曲线及打印结果,并与部颁标准WS1-(X-185)-97Z规定方法作比较。结果:本法自动监测药物溶出的全过程,实时显示完整的药物溶出曲线及数据,直接提取溶出度参数,与部颁标准方法比较,Td、T50及累积溶出百分率差异均无统计学意义(P>0.05)。结论:光纤药物溶出度过程监测法能够有效测定药物的溶出度。免除了补液、过滤、稀释等手续,减少人为操作误差,结果准确。更多还原

【Abstract】 Objective:To study an in time and in situ monitoring method of the dissolution rate of drug solid preperations-fiber-optic chemical sensoring in situ release rate test method,and examine the difference of this method with WS₁-（X-185）-97Z method.Methods:Fiber-optic in situ dissolution test method can determinate simultaneously the dissolution procession of six tablets,and cancel the interference of adjuvants by two wavelengthes.Data handled and experiment report printed were completed by the computer.Results:This way can test the whole dissolution process of drugs,and show dissolution graph and data,and obtain directly the dissolution parameters.The parameters of the dissolution and all results of measurement using the instrument had no significant difference compared with WS₁-（X-185）-97Z method（P>0.05）.Conclution:Fiber-optic chemical sensoring in situ dissolution test method can determine effectively the dissolution rate of drugs and reduce the man-made error,and results are accurate.更多还原