黄麻纤维溶解纤维素制备微晶纤维素及其在盐酸非索非那定片剂剂型中的应用

A. A. Chowdhury, M. Haque, Md. Sohel Rana, M. S. Amran
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引用次数: 0

摘要

简介:最实惠的片剂形式是微晶纤维素(MCC),一种流行的药用辅料,在立即可压缩片剂中用作填料或粘合剂。方法:采用0.1 N的盐酸溶液和20% w/w的氢氧化钠溶液,在高温高压下提取黄麻纤维中的可溶性纤维素。将溶解的纤维素用2n盐酸在100℃下酸水解2h。通过红外光谱(FT-IR)和聚合度的测定证实了MCC的性质。通过测定体积、密度、攻丝密度、Hausner指数、Carr指数和休止角来评价其流动特性。通过制作盐酸非索非那定片对所制MCC的片性进行评价。结果与讨论:可溶性纤维素中α-纤维素的含量为94.67%;粉末的堆积密度、出丝密度、Hausner指数、Carr指数、休止角值等性能均与Avicel PH102标准粉末相当。其硬度、脆度、崩解时间和30 min溶出率分别为5.6 kg、0.34%、178.17 sec和83.89%。所有这些数值都在美国药典的范围内,并与Avicel PH102制剂和非索非那定市售片相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PREPARATION OF MICROCRYSTALLINE CELLULOSE FROM DISSOLVING CELLULOSE OBTAINED FROM JUTE FIBERS AND ITS APPLICATION IN THE FORMULATION OF FEXOFENADINE HYDROCHLORIDE TABLET DOSAGE FORM
Introduction: The most affordable tablet form is microcrystalline cellulose (MCC), a popular pharmaceutical excipient that is utilized as a filler or binder in immediately compressible tablets. Methods: In the present study, we extracted dissolving cellulose from jute fibers by treatment with 0.1 N hydrochloric acid solution and 20% w/w sodium hydroxide solution at high temperature and pressure. The dissolving cellulose was subjected to acid hydrolysis at 100 0C for 2 h with 2 N hydrochloric acid. The identity of the MCC was confirmed by FT-IR and by determining the degree of polymerization. To evaluate the flow property, we determined the bulk, density, tapped density, Hausner index, Carr’s index and angle of repose. The tableting property of the prepared MCC was evaluated by making fexofenadine hydrochloride tablets. Result and Discussion: The dissolving cellulose contains 94.67% α-cellulose The DP of the MCC was found 191. The powder properties such as bulk density, tapped density, Hausner index and Carr’s index, angle of repose values are comparable with that of standard Avicel PH102. The hardness, friability, disintegration time and % dissolved in 30 minutes were dissolution value of the tablets 5.6 kg, 0.34%, 178.17 sec and 83.89%, respectively. All these values are within the United State Pharmacopoeia range and are comparable with the tablets prepared from Avicel PH102 and marketed fexofenadine tablets.
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