双溶出-HPLC系统在盐酸特拉唑嗪片一致性评价中的应用

Application of double-bath dissolution HPLC system in consistency evaluation of terazosin hydrochloride tablets

目的研究一致性评价品种"盐酸特拉唑嗪片"溶出曲线检测的全自动方法,证明方法的有效性和可行性。方法盐酸特拉唑嗪片在绘制其溶出曲线时,要求同时测量12片样品,在多个时间点进行采样以及在多种pH介质中进行检测,工作量大幅度增加,传统方法很难满足要求,为此,作者采用全自动溶出检测系统进行了其溶出曲线的方法研究,整套方案在符合《中华人民共和国药典》(2015年版)要求的情况下,实现溶出、采样、稀释、进样、读数、溶出曲线绘制和分析等整个溶出过程全自动化。结果此方法所采取的措施与管理方法能保证数据真实、同步、准确、可靠、可追溯,即满足数据可靠性的ALCOA(A—attributable,L—legible and permanent,C—contemporaneous,O—original,A—accurate)原则。结论采用全自动方法对4种介质中盐酸特拉唑嗪片的溶出曲线的分析结果验证了该方法的有效性和可行性。

Objective To research on automatic dissolution curve method of consistency evaluation sample＂terazosin hydrochloride tablets＂,and prove the feasibility and effectiveness of the method. Methods Thepreparation of dissolution curves of terazosin hydrochloride tablets in consistency evaluation requires the simultaneous measurement of 12 samples,at multiple time points for sampling and detection in a variety of pH media,which makes a substantial increase in workload. Therefore, the traditional method is difficult to meet the requirements. Automatic methods have been studied for solving this problem. Automatic double dissolution HPLC system meets the requirements of Chinese pharmacopoeia（2015 version）,and could achieve dissolution, sampling,dilution, injection, readings,dissolution curve drawing,automated analysis in the whole process of dissolution. Results This method ensure data are true,contemporaneous,accurate,reliable, traceable,and meet the principles of ALCOA（A—attributable,L—legible and permanent,C—contemporaneous,O—original,A—accurate）. Conclusions The results show that using the automatic method to analyze the dissolution curves of terazosin hydrochloride in four kinds of dissolution medium is effective and feasible.