基于白水山药(Dioscorea alata L.)预糊化淀粉和磷酸化改性淀粉的片剂的理化性质

E. Sulastri, Y. Yusriadi, M. Ma’rifa, M. Mulyani, N. Aanisah
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引用次数: 0

摘要

摘要 背景 白水山药(Dioscorea alata L.)是淀粉的潜在来源之一,但尚未用于商业用途。此外,原生白水山药淀粉(WS)的流动性、机械性能较差,在高温和酸性条件下不稳定,因此功能有限。因此,本研究旨在对淀粉进行改性,以改善其特性,使其成为制备片剂的有用辅料。材料和方法 WS 的改性是通过物理和化学处理实现的,特别是预糊化和磷酸化。预糊化 WS 需要加热,而磷化 WS 则是用三聚磷酸钠处理 WS 得到的。结果 结果表明,改性 WS 的粉末具有良好的特性,根据密度、孔隙率、压缩指数和膨胀力的测定,可以改善粉末混合物作为颗粒的流动性。未改性 WS 的直链淀粉含量为 11.92±0.61%,预糊化 WS 的直链淀粉含量为 10.41±0.90%,磷酸化 WS 的直链淀粉含量为 12.61±1.75%。此外,还将颗粒作为辅料配制成片剂,并在湿法制粒后对配方进行压缩。片剂的机械性能通过质量和尺寸的均匀性、硬度、易碎性和崩解时间进行了评估。当用作粘合剂时,WS 的改性会影响片剂的硬度。建议在湿法制粒中使用磷化 WS 作为粘合剂,因为它生产的片剂崩解时间更长,这意味着粘合能力更强。不过,与使用未改性粘合剂的片剂相比,使用预胶化和磷酸化改性 WS 的片剂脆性较低,崩解时间仍符合快速崩解片剂的要求(<15 分钟)。结论 所研究的所有物理性质都表明,改性 WS 是一种很有前途的片剂药用辅料。
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Physicochemical properties of tablet dosage form based on pre-gelatinized- and phosphorylated-modified starches from white-water yam (Dioscorea alata L.)
Abstract Background White-water yam (Dioscorea alata L.) is one of the potential sources of starch; however, it is not yet available for commercial purposes. Besides, native white-water yam starch (WS) presents limited functionality due to poor flowability, mechanical properties and instability at high temperature and acidic conditions. Therefore, this study aims to modify the starch to improve its characteristics and make it useful as an excipient for the preparation of the tablets. Materials and methods The modification of WS was achieved by physical and chemical treatments, specifically pre-gelatinization and phosphorylation, respectively. Pre-gelatinization WS involves heating, meanwhile phosphorylation WS is obtained by treating WS with sodium tripolyphosphate. Results The results showed that the powder of the modified WS has good characteristics which improved the flowability of the powder mixture as a granule based on density, porosity, compressibility index and swelling power determination. The WS granules were found to display the oval or irregular (polygonal) shape with the amylose content 11.92±0.61% for unmodified WS, 10.41±0.90% for pre-gelatinized WS and 12.61±1.75% for phosphorylated WS. Furthermore, the granule was formulated as an excipient in tablet preparations, and the formulas were compressed after wet granulation. The mechanical properties of the tablets were assessed using uniformity of mass and size, hardness, friability and disintegration time. WS modification affects the hardness of tablets when used as a binder. Phosphorylated WS is recommended to be used as a binder in wet granulation formulations because it produces tablets with a longer disintegration time, which means better binding ability. However, the utilization of modified WS with both pre-gelatinization and phosphorylation leads to tablets with low brittleness compared to others with unmodified binder with the disintegration time still met the requirement of fast disintegrating tablet (<15 minutes). Conclusion All the physical properties studied indicated that the modified WS is a promising pharmaceutical excipient in tablets.
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来源期刊
European Pharmaceutical Journal
European Pharmaceutical Journal Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
0.60
自引率
0.00%
发文量
16
期刊介绍: European Pharmaceutical Journal publishes only original articles not previously published and articles that are not being considered or have not been submitted for publication elsewhere. If parts of the results have been published as conference abstract or elsewhere, it should be stated in references. The ethical standards of the Helsinki-Tokio Declaration should be kept. This should be mentioned in the Methods of manuscript. Reviews are published only on request. Authors, whose submitted research work was performed with the support of a company, should indicate this in Conflict of Interest.
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