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一种简单且廉价的图像分析技术,用于研究崩解剂浓度和稀释剂类型对崩解的影响。

A Simple and Inexpensive Image Analysis Technique to Study the Effect of Disintegrants Concentration and Diluents Type on Disintegration.

机构信息

Department of Pharmaceutical Sciences and Pharmaceutics, Faculty of Pharmacy, Applied Science Private University, Amman 11931, Jordan.

Department of Pharmaceutics and Pharmaceutical Technology, School of Pharmacy, The University of Jordan, Amman 11942, Jordan.

出版信息

J Pharm Sci. 2018 Oct;107(10):2643-2652. doi: 10.1016/j.xphs.2018.06.008. Epub 2018 Jun 20.

DOI:10.1016/j.xphs.2018.06.008
PMID:29935295
Abstract

Tablets disintegration is often the result of a size expansion of the tablets. In this study, we quantified the extent and direction of size expansion of tablets during disintegration, using readily available techniques, that is, a digital camera and public domain image analysis software. After validating the method, the influence of disintegrants concentration and diluents type on kinetics and mechanisms of disintegration were studied. Tablets containing diluent, disintegrant (sodium starch glycolate, crospovidone, or croscarmellose sodium), and lubricant were prepared by direct compression. Projected area and aspect ratio of the tablets were monitored using image analysis techniques. The developed method could describe the kinetics and mechanisms of disintegration qualitatively and quantitatively. Sodium starch glycolate and crospovidone acted purely by swelling and shape recovery mechanisms. Instead, croscarmellose sodium worked by a combination of both mechanisms, the extent of which changed depending on its concentration and the diluent type. We anticipate that the method described here could provide a framework for the routine screening of tablets disintegration using readily available equipment.

摘要

片剂崩解通常是片剂尺寸膨胀的结果。在这项研究中,我们使用现成的技术,即数码相机和公共领域的图像分析软件,定量评估了片剂在崩解过程中的尺寸膨胀程度和方向。在验证该方法后,我们研究了崩解剂浓度和稀释剂类型对崩解动力学和机制的影响。通过直接压缩制备含有稀释剂、崩解剂(交联羧甲淀粉钠、交联聚维酮或交联羧甲基纤维素钠)和润滑剂的片剂。使用图像分析技术监测片剂的投影面积和纵横比。所开发的方法可以定性和定量地描述崩解的动力学和机制。交联羧甲淀粉钠和交联聚维酮仅通过溶胀和形状恢复机制起作用。相反,交联羧甲基纤维素钠通过两种机制共同作用,其作用程度取决于其浓度和稀释剂类型。我们预计,这里描述的方法可以为使用现成设备对片剂崩解进行常规筛选提供框架。

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