左乙拉西坦缓释片的处方及制备工艺研究

发布时间：2018-03-15 11:26

本文选题：左乙拉西坦　切入点：缓释片　出处：《中国新药杂志》2015年12期 　论文类型：期刊论文

【摘要】：目的:制备左乙拉西坦缓释片,并对其处方进行深入研究。方法:以自制品的释放曲线及其与左乙拉西坦参比制剂(Keppra XR)释放行为相似因子(f2)为考察指标,选取缓释片最优处方组成,确定制备工艺关键步骤,并与参比制剂的释放曲线进行对比,对左乙拉西坦的自制处方进行评价。结果:自制左乙拉西坦缓释片的处方为:左乙拉西坦1 000 mg、山嵛酸甘油酯363.2 mg、乳糖25.5 mg、硬脂酸镁21.3 mg、片重1 420.0 mg。供试品溶液浓度在0.2~1.2 mg·m L-1范围内,浓度与峰面积线性关系良好,r=0.998 1。本品释放度测定方法的平均回收率为99.08%,表明本方法准确度良好。精密度试验测得相对标准偏差(RSD)为0.6%,供试品在室温条件下放置8 h内保持稳定。结论:通过低熔点缓释辅料山嵛酸甘油酯及其最优处方组成和熔融制粒工艺等得到的自制品与市售参比制剂在p H 4.5醋酸盐缓冲液释放介质中的释放行为基本相似。
[Abstract]:Objective: to prepare levoethoxetam sustained-release tablets and to study its formulation. Methods: the release curve of the self-prepared tablets and its release behavior similar to those of the levoethylacetam reference preparation (Keppra XR2) were used as an index. The optimal formulation composition of sustained-release tablets was selected and the key steps of preparation were determined and compared with the release curve of reference preparation. The self-made prescription of levoethylacetam was evaluated. Results: the formulation of levoethylacetam 1 000 mg, glyceryl hind 363.2 mg, lactose 25.5 mg, magnesium stearate 21.3 mg, tablet weight 1 420.0 mg. The concentration was in the range of 1.2 mg 路mL ~ (-1). The linear relationship between the concentration and the peak area is good. The average recovery of this method is 99.08, which indicates that the method is accurate. The relative standard deviation (RSDs) measured by the precision test is 0.6, and the sample is placed at room temperature. Conclusion: through low melting point sustained release excipient, glycerol docyanate and its optimum prescription composition and melting granulation process, the self-made products and the commercial reference preparation were obtained in the release medium of pH 4.5 acetate buffer solution. The release behavior is basically similar.
【作者单位】：中国医药工业研究总院上海医药工业研究院;
【基金】：上海市科委基金(11431920201)
【分类号】：R943

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