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复合形成法改善漂壳聚糖肠溶包衣材料的性能。

Improvement of Bleached Shellac as Enteric Coating by Composite Formation.

机构信息

Department of Pharmaceutical Technology, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom, 73000, Thailand.

Pharmaceutical Biopolymer Group (PBiG), Faculty of Pharmacy, Silpakorn University, Nakhon Pathom, 73000, Thailand.

出版信息

AAPS PharmSciTech. 2021 Sep 29;22(7):241. doi: 10.1208/s12249-021-02127-2.

Abstract

The objective of this study was to stabilize the enteric property of bleached shellac by composite formation with ethyl cellulose. The composite film at the ratio of 9:1, 8:2, 7:3, 6:4, and 5:5 was prepared by the film casting method. The physicochemical properties were acid value, insoluble solid, water permeability coefficient, % polarity, mechanical property, FTIR, PXRD, DSC, % solubility in aqueous, and various pH (1.2 and 7.4). All the films were able to protect against the low pH and water. The total solubility at pH 7.4 was reported for the low ratio of ethyl cellulose (9:1 and 8:2). The stability of all films was then investigated for 180 days. The results demonstrated that the ethyl cellulose could stabilize the bleached shellac indicated by the low changes in acid value and insoluble solid. The higher ratio of ethyl cellulose contributed to the lower polymerization during storage. The results were due to the protection of the bleached shellac's active sites. The entanglement of ethyl cellulose caused interaction difficulties between active groups leading to stabilized bleached shellac. The proper ratio was 7:3 because of high solubility, and low polymerization. The findings demonstrated that the composite film could improve the enteric property of bleached shellac for a long period.

摘要

本研究的目的是通过与乙基纤维素复合形成来稳定漂壳素的肠溶性。采用膜铸法制备了质量比为 9:1、8:2、7:3、6:4 和 5:5 的复合膜。通过酸值、不溶性固体、水渗透系数、%极性、机械性能、FTIR、PXRD、DSC、%在水和各种 pH 值(1.2 和 7.4)中的溶解度等方法对其物理化学性质进行了研究。所有的膜都能够防止低 pH 值和水的渗透。报道了低乙基纤维素比例(9:1 和 8:2)下在 pH 7.4 时的总溶解度。然后对所有薄膜进行了 180 天的稳定性研究。结果表明,乙基纤维素可以通过降低酸值和不溶性固体来稳定漂壳素。乙基纤维素的比例越高,在储存过程中的聚合度越低。这是由于保护了漂壳素的活性位点。乙基纤维素的缠结导致活性基团之间的相互作用困难,从而使漂壳素稳定。适当的比例为 7:3,因为它具有高溶解度和低聚合度。研究结果表明,复合膜可以改善漂壳素的肠溶性,并能长期保持。

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