艾司唑仑片溶出数据的Weibull分布

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T₅₀ 和T_d 值均有明显差异;而样品D 除了T₅₀ 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Ti 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: To evaluate the producing process by comparing the parameters of six profiles through fitting dissolution profiles of estazolam tablets with Weibull distribution model,so as to provide a new method for evaluating estazolam tablets in vitro dissolution behavior. Methods: Respectively,the profiles of estazolam tablets samples from 6 different manufacturers were fitted by DDSolver software. Taking the homemade sample G as the reference product,the parameters were tested by the bilateral t-test using OriginPro 8.0.Results: According to t-test results,compared with product G,there was no statistical difference in all parameters of sample B except T_d;while the T₅₀ and T_d of sample A were significantly different. Furthermore,the shape parameter βof sample D showed a significant difference besides T₅₀ and T_d,while all other parameters of samples C,E and F exhibited obvious difference except Ti. Conclusion: Each sample needs a higher dissolution rate to make its dissolution profile consistent with sample G. To achieve this purpose,sample A should be optimized at the particle size,sample D should be improved at both process parameters and excipients;however,the other three samples are difficult to achieve the purpose as both process parameters and prescription need to be improved.