不同厂家生产的替硝唑薄膜衣片实时溶出度结果分析

Analysis of Real-time Dissolution Rate of Tinidazole Tablets from Different Pharmaceutical Factories

目的利用光纤药物溶出度测定仪建立原位、实时监测替硝唑薄膜衣片的溶出度检查方法,并比较测定不同厂家替硝唑薄膜衣的体外溶出过程。方法采用FODT601型光纤药物实时溶出度测定仪对3个厂家生产的6批次替硝唑薄膜衣片进行溶出度测定,通过改变标准方法的测定光程波长实现溶出度的原位分析,同时与《中国药典》2010年版(二部)规定的方法进行对比。结果选定1 mm为测定光程,314 nm为测定波长,替硝唑浓度在80～600μg/ml范围内吸收度与浓度线性关系良好,r=0.9999,平均回收率99.8%,精密度值为1.0%。本法的溶出度检查结果与依照《中国药典》2010年版(二部)规定方法测定的该制剂溶出度结果差异无统计学意义(P>0.05),但3个厂家生产的替硝唑薄膜衣片的溶出曲线存在一定的差异。结论 3个厂家生产的替硝唑薄膜衣片质量均合格,但存在差异。通过选择适宜的光程和测定波长,替硝唑薄膜衣片样品无需过滤和稀释等处理过程即可实现原位在线溶出度的检查,减少了操作步骤,测定结果准确、可靠。

Objective To establish situ and detect the real-time dissolution rate of tinidazole tablets by fiber-op- tic dissolution test system （FODT） , and to study the parameters for dissolution tests of different manufacturers. Methods The real-time dissolution rates of tinidazole tablets of six batches from three manufactures were monitored with FODT601, and wave length of light path and situ analysis were detected by changing wavelength. At the same time the methods provided by the Chinese Pharmacopoeia （ChP, 2010 Edition, Ⅱ ） were compared. Results Tinidazole tablets was monitored at light path 1 mm and wave length 314 nm, and its absorbability was better with concentration at range of 80-600 μg/ml, r = 0. 9999 and the average recovery 99.8% with precision value 1.0%. The results of dissolution rates by FODT had no statistical differen with those of by the methods prescribed in ChP （2010 Edition, Ⅱ ） （P 〉0. 05） , but the dissolution curves of three manufactures had qualification and significant differences. Conclusion The Tinnidazole tablets of three manufactures are qualified. Without complex sample processing the analysis may quantitatively monitor the dissolution rate at real-time with FODT by choosing adaptive light path and wave length.