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叶下珠喷雾干燥提取物制剂的压缩行为

Compression behavior of formulations from Phyllanthus niruri spray dried extract.

作者信息

De Souza T P, Gómez-Amoza J L, Martínez-Pacheco R, Petrovick P R

机构信息

PPGCF, Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Natal-RN, Brazil.

出版信息

Pharmazie. 2006 Mar;61(3):213-7.

Abstract

The aim of this study was to evaluate the compression behavior of Phyllanthus niruri spray dried extract as well as the influence of excipients on the properties of tablets containing a high dose (70% by weight) of this product. The effect of excipients was studied by a 22 factorial design. The factors investigated were the type of disintegrant (croscarmellose sodium and sodium starch glycolate) and the type of filler/binder (microcrystalline cellulose and dibasic dicalcium phosphate). The tablets were produced on a single punch tablet press using a constant compression force of 5000 N. The tablets formulated with microcrystalline cellulose presented a plastic behavior while the tablets containing dibasic dicalcium phosphate disclosed a fragmentary behavior. The disintegration time was significantly influenced by both factors, however, the tensile strength was only affected by the filler/binder. Additional experiments considering the influence of the compression force (2500 N and 5000 N) and the proportion of croscarmellose sodium (1.5%, 3.0% and 6.0%) on the mechanical properties of the tablets were performed by a 2 x 3 factorial design. Both factors significantly affected the tensile strength, friability and disintegration time of the tablets.

摘要

本研究的目的是评估叶下珠喷雾干燥提取物的压缩行为,以及辅料对含有高剂量(70%重量)该产品的片剂性能的影响。通过2×2析因设计研究辅料的作用。所研究的因素为崩解剂类型(交联羧甲基纤维素钠和淀粉乙醇酸钠)和填充剂/黏合剂类型(微晶纤维素和磷酸氢钙二水合物)。片剂在单冲压片机上压制,使用5000 N的恒定压力。用微晶纤维素制备的片剂呈现塑性行为,而含有磷酸氢钙二水合物的片剂表现出破碎行为。崩解时间受两个因素的显著影响,然而,拉伸强度仅受填充剂/黏合剂的影响。通过2×3析因设计进行了额外实验,考虑压力(2500 N和5000 N)和交联羧甲基纤维素钠比例(1.5%、3.0%和6.0%)对片剂机械性能的影响。这两个因素均显著影响片剂的拉伸强度、脆碎度和崩解时间。

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