双溶出-HPLC系统在盐酸特拉唑嗪片一致性评价中的应用

发布时间：2018-05-05 10:09

本文选题：盐酸特拉唑嗪片 + 溶出曲线　；参考：《沈阳药科大学学报》2017年11期

【摘要】：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《中华人们共和国药典》(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。
[Abstract]:Objective to study the automatic method for detecting the dissolution curve of terazosin hydrochloride tablets, and to prove the effectiveness and feasibility of the method. Methods when drawing the dissolution curve of terazosin hydrochloride tablets, 12 samples should be measured simultaneously, sampled at multiple time points and detected in a variety of pH media. The workload of terazosin hydrochloride tablets was greatly increased, and the traditional methods were difficult to meet the requirements. The method of dissolution curve was studied by using automatic dissolution detection system. Under the condition of meeting the requirements of the Pharmacopoeia of the people's Republic of China (2015 edition), the whole system can realize dissolution, sampling, dilution, sample injection, reading, and so on. The whole dissolution process is fully automated, such as drawing and analyzing the dissolution curve. Results the measures taken by this method and the management method can ensure that the data are true, synchronous, accurate, reliable and traceable, that is, the ALCOAX A-attributable L-legible and permanentant C-Conceptual New O-originaln A-accurate. which satisfies the reliability of the data. Conclusion the dissolution curve of terazosin hydrochloride tablets in four media was analyzed by automatic method, and the results showed that the method was effective and feasible.
【作者单位】：河北省药品检验研究院;石家庄市食品药品检验中心;北京清研思创科学仪器有限公司;
【分类号】：R927.1

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