光纤药物溶出度实时测定仪监测乙酰螺旋霉素片实时溶出度

目的建立乙酰螺旋霉素片体外溶出过程的监测方法,评价其内在质量。方法利用光纤药物溶出度实时测定仪,采用《中华人民共和国药典》2010年版中乙酰螺旋霉素片溶出度测定条件,对5个厂家6个批次的乙酰螺旋霉素片进行实时溶出度测定。结果 5个厂家6个批次的乙酰螺旋霉素片符合《中华人民共和国药典》2010年版的规定,但实时溶出曲线存在较大差异。结论光纤药物溶出度实时测定仪可反映药物的真实溶出过程,是评价药物制剂的安全性和有效性,提高药品监管水平的有效手段。

Fiber.optic Real.time Dissolution Detector in Detection of Real.time Dissolution of Acetylspiramycin Tablets

Objective To establish a monitoring method for the vitro dissolution of Acetylspiramycin tablets, and to evaluate its intrinsic quality. Methods Real-time dissolution of Acetylspiramycin tablets in six batches from five manufactures were determined by the dissolution condition specified in Chinese Pharmacopoeia （ChP） 2010 with fiber-optic dissolution test system （FODT）. Results The resuhs of all samples were complied with regulations in ChP 2010, but there were significant differences in real-time dissolution curves. Conclusion The real-time FODT can reflect real pharmaceutical dissolution processes, and can provide an effective method to evaluate pharmaceutical safety and validity, which may improve the drug monitoring level.