光纤药物溶出仪在线考察和评价头孢克洛颗粒溶出度

目的利用光纤药物溶出仪实时在线过程分析的特点,测定头孢克洛颗粒溶出度,评价药品内在质量。方法采用桨法对头孢克洛颗粒在4种溶出介质中的溶出行为进行测定,溶出介质体积均为900mL,温度37℃,转速50 r·min-1,光纤探头规格0.5 mm,测定波长264 nm,数据采集时间间隔30 s,并将测定结果与《中国药典》方法进行比较。结果在线光纤溶出法的测定结果均符合《中国药典》的规定,同一厂家不同批次之间的头孢克洛颗粒溶出曲线基本一致,但在不同溶出介质之间的溶出行为有差异。结论与《中国药典》方法相比,光纤药物溶出仪能连续提供药品溶出过程的信息,可更好的为药品生产工艺和内在质量提供有效的评价依据。

Real-time online monitoring the dissolution of cefaclor granules by fiber-optic dissolution test system

Objective To monitor the instantaneous dissolution of cefaclor granules by fiber-optic dissolution test system and evaluate its quality.Method The paddle method was used to determine the dissolution of cefaclor granules.The volume of four different menstruums were all 900 mL at 37 ℃.The fiber optic probe of 2 mm was used with the rotate speed of 50 r·min-1.The detection wavelength was set at 264 nm and the data were collected every 30 seconds.The results were compared with the method stated in ChP.Results The detection results of the fiber-optic dissolution test system could meet the standard of ChP.The dissolution curves of different batches are identical,but there are slightly different between different menstruums.Conclusion Compared with the method stated in ChP,the fiber-optic dissolution test system is capable of monitoring the real dissolution process of drug,and it is better to provide the efficient way for the drug productive technology and inherent quality.