研究纯化的丁香五味子胶的结合特性:合成聚合物的天然替代品

M. Archer, K. Ofori-Kwakye, Raphael Johnson, Isaac Yaw Attah, Emmanuel Adakudugu, Frederick William Akuffo Owusu, Esther Oppong Eshun, D. Kumadoh, Akwasi Sodzi
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引用次数: 0

摘要

摘要:近年来,大多数药物研究的重点都是使用天然产品(如树胶)作为药用辅料,因为它们更安全、经济且易于获得。本研究旨在探讨从丁香五加皮茎皮渗出物中提取的树胶作为粘合剂在常规释放片剂中的适用性,并以刺槐胶作为参照聚合物。纯化的五倍子丁香树胶(PBG)是用 96% 的乙醇从粗胶黏液中析出的。使用七(7)种不同浓度的 PBG 粘液(0.5 - 6 %w/w)作为粘合剂,通过湿法制粒(PB1 - PB7)配制出常规缓释扑热息痛片剂。同样的方法也用于常规释放扑热息痛片剂(AC1-AC7)。使用傅立叶变换红外光谱对药物-辅料和辅料-药胶的相容性进行了评估。使用药典和非药典测试对配制的片剂进行了评估。采用适当的数学模型来确定试验制剂和参照制剂溶出曲线的相似系数(f2)和差异系数(f1)。批次 PB1、AC1、PB2、AC2 和 AC3 的颗粒具有一般的流动性,而其余批次则具有良好的流动性。傅立叶变换红外光谱研究表明,药物与辅料之间没有相互作用。除了 PB1、PB2、PB3 和 AC1 没有通过易碎性测试,PB1 和 AC1 没有通过硬度测试,AC7 也没有通过崩解测试外,所有配方都通过了药典和非药典测试。胶的浓度增加,片剂的机械性能也相应增加。比较研究表明,试验片剂和参照片剂的硬度和拉伸强度没有明显差异。由于 f1 > 50 和 f2 < 15,除 PB6 外的所有配方都与参考配方相似。总之,PBG 表现出了与刺槐胶相当的良好结合特性。
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Investigation of the binding properties of purified Pentadesma butyracea gum: Anatural alternative to a synthetic polymer
Abstract: The focus of most pharmaceutical research in recent times has been the use of natural products like gums as pharmaceutical excipients because they are safer, economical and readily available. This study aimed to investigate the applicability of gum extracted from the exudates from the stem bark of Pentadesma butyracea as a binder in conventional release tablets using acacia gum as a reference polymer. The purified Pentadesma butyracea gum (PBG) was precipitated from the crude gum mucilage using 96% ethanol. Conventional-release paracetamol tablets were formulated using seven (7) different concentrations of the PBG mucilage (0.5 – 6 %w/w) as a binder via wet granulation (PB1 – PB7). The same approach was used for the reference conventional release paracetamol tablets (AC1- AC7). The drug-excipients and excipients-gum compatibility studies were evaluated using the FTIR. The formulated tablets were evaluated using both pharmacopoeia and non-pharmacopoeia tests. Appropriate mathematical models were used to determine the similarity (f2) and the difference (f1) factors of the dissolution profiles of the test and reference formulations. Granules for batches PB1, AC1, PB2, AC2 and AC3 had fair flow properties, whereas the rest had good flow properties. The FTIR studies showed no interactions between the drug and excipients. All formulations passed the pharmacopoeia and non- pharmacopoeia tests except for formulations PB1, PB2, PB3 and AC1 which failed the friability test, PB1 and AC1 which failed the hardness test, and AC7 which also failed the disintegration test. An increase in gum concentration led to a corresponding increase in the mechanical properties of the tablets. A comparative study showed no significant difference in the hardness and tensile strength of the test and reference tablets. All formulations except PB6 were similar to their reference formulations since f1 > 50 and f2 < 15. In conclusion, the PBG exhibited a good binding property comparable to acacia gum.
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