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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。
Objective To study the fully automated method for the determination of the conformal test sample “Texacil hydrochloride tablets”, and to prove the effectiveness and feasibility of the method. Methods Tratezolam hydrochloride tablets require simultaneous measurement of 12 samples at the time of their dissolution profile, sampling at multiple time points, and testing in multiple pH media, resulting in a significant increase in workload and difficulty in meeting the requirements of traditional methods To this end, the author used the automatic dissolution testing system to carry out the dissolution curve of the method study, the package of programs in line with the “People’s Republic of China Pharmacopoeia” (2015 edition) requirements, to achieve dissolution, sampling, dilution, injection, , Dissolution curve drawing and analysis of the entire dissolution process fully automated. Results ALCOA (A-attributable, L-legible and permanent, C-contemporaneous, O-original, ALCOA) that can ensure data authenticity, synchronization, accuracy, reliability and traceability, A-accurate) principle. Conclusion The results of the analysis of the dissolution profile of terazosin hydrochloride tablets in four media by the automatic method demonstrate the effectiveness and feasibility of the method.