月桂酸甘油酯片辅料及颗粒剂对片剂质量的影响

M. Špaglová, M. Papadakos, M. Čuchorová, D. Krchňák, V. Šimunková, D. Matúšová
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引用次数: 0

摘要

月桂酸甘油酯(GL)是一种具有抗病毒和抗菌活性的天然或合成表面活性剂,不仅对普通感冒或流感有效,而且对猪流感、单纯疱疹、带状疱疹或慢性疲劳也有效。本研究旨在将GL颗粒配制为片剂压缩的半成品,并评价糖酯(Sisterna®)取代月桂酸蔗糖(Ryoto®)对颗粒组成的影响以及颗粒大小对压缩片剂质量的影响。采用熔融造粒法制备了不同粒径和不同表面活性剂类型的四种颗粒。采用传统药典试验方法评价片剂的质量。颗粒大小显著影响所有评估参数:硬度,质量均匀性,脆性和崩解。用蔗糖酯代替月桂酸蔗糖,片剂强度略有下降,崩解时间缩短。然而,它对质量的脆性和均匀性没有显著影响。由于这个原因,赋形剂蔗糖酯可以被评价为GL片剂的适当替代品。
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Glyceryl Laurate Tablets: Effect of the Excipients and Granule Size on the Tablet Quality
Abstract Glyceryl laurate (GL) is a natural or synthetic surfactant with antiviral and antimicrobial activity and is not only effective in common colds or flu, but also against swine flu, herpes simplex, shingles, or chronic fatigue. The study aimed to formulate the GL granules as a semi-product for the compression of tablets and evaluate the influence of the substitution of sucrose laurate (Ryoto®) with sucrose ester (Sisterna®) in the composition of the granules and the effect of granule size on the quality of the compressed tablets. Four types of granules, varying in grain size and the type of additional surfactant, were prepared by melt granulation. The traditional pharmacopoeia tests were used to assess tablets’ quality. The granule size significantly affected all evaluated parameters: hardness, uniformity of mass, friability, and disintegration. The replacement of sucrose laurate with sucrose ester caused a slight decrease in tablet strength and a shortening of disintegration. However, it did not significantly impact friability and uniformity of mass. For this reason, the excipient, sucrose ester, can be evaluated as an adequate replacement in the composition of GL 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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