De Souza T P, Gómez-Amoza J L, Martínez-Pacheco R, Petrovick P R
PPGCF, Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Natal-RN, Brazil.
Pharmazie. 2006 Mar;61(3):213-7.
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.
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。