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目的:使用Weibull分布模型拟合艾司唑仑片的溶出曲线,通过比较6条曲线参数来评价制备工艺,并为评价艾司唑仑体外溶出行为提供新的方法。方法:利用DDSolver软件分别对来自市场抽验的6个不同厂家的样品进行溶出数据拟合。以自制样品G为参比,利用OriginPro 8.0对各参数进行双侧t-检验。结果:与样品G进行比较,由t-检验结果发现:样品B仅T_d值表现出明显差异;样品A的T_(50)和T_d值均有明显差异;而样品D除了T_(50)和T_d值外,形状参数β也表现出了明显差异;C、E、F 3批样品除了位置参数T_i外,其余各参数均有明显差异。结论:每批样品需要达到较高的溶出速率才能使溶出曲线与样品G一致。因此,样品A通过优化粒径,样品D经过优化工艺参数和辅料,均可以获得较高的溶出速率;而C、E、F 3批样品要想达到此目的有点困难,需对工艺参数和处方进行改进。
OBJECTIVE: Weibull distribution model was used to fit the dissolution curve of eszotazone tablets. The preparation process was evaluated by comparing the six curve parameters, and a new method was provided to evaluate the dissolution behavior of eszolamide in vitro. Methods: DDSolver software was used to perform the dissolution data fitting on samples from 6 different manufacturers. Using self-made sample G as a reference, OriginPro 8.0 was used to perform bilateral t-test on each parameter. Results: Compared with the sample G, the results of t-test showed that only the T_d value of sample B showed obvious difference; the value of T_ (50) and T_d of sample A were significantly different; while the sample D except T_ (50) and T_d In addition, the shape parameter β also showed a significant difference; C, E, F 3 batches of samples in addition to the position parameter T_i, the rest of the parameters were significantly different. Conclusion: The higher dissolution rate required for each batch of samples should be consistent with Sample G. Therefore, the sample A through the optimization of particle size, sample D through the optimization of process parameters and excipients, can obtain a higher dissolution rate; and C, E, F 3 batches of samples to achieve this goal a bit difficult to process parameters and prescription Improve.