Chorilli Marlus, Leonardi Gislaine Ricci, Salgado Hérida Regina Nunes, Scarpa Maria Virgínia
UNESP, Programa de Pós-graduação em Ciências Farmacêuticas, Faculdade de Ciências Farmacêuticas, Rodovia Araraquara-Jaú, km 1, CEP 14801-902, Araraquara-SP, Brazil.
J AOAC Int. 2011 Jan-Feb;94(1):118-27.
The objective of this work was to evaluate the preservative effectiveness of liquid crystalline systems containing retynil palmitate (RP) by the challenge test (CT) and D-value. A system was developed containing water, silicon glycol copolymer, and polyether functional siloxane with 1% RP added. The analyses were carried out by methods in the U.S. Pharmacopeia (USP 31, 2008) using the microorganisms Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger. The CT showed that after 7 days, all microorganisms were eliminated except A. niger, which maintained viability for at least 28 days after inoculation. Moreover, the microorganisms E. coli, P. aeruginosa, S. aureus, C. albicans, and A. niger presented different growth behaviors, evidenced by differences among the D-values calculated. It was concluded that the CT and D-value were efficient methods for evaluation of the preservative property of these formulations.
本研究的目的是通过挑战试验(CT)和D值评估含有棕榈酸视黄酯(RP)的液晶体系的防腐效果。开发了一种含有水、硅二醇共聚物和聚醚功能硅氧烷并添加1% RP的体系。使用大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌和黑曲霉等微生物,按照美国药典(USP 31, 2008)中的方法进行分析。挑战试验表明,7天后,除黑曲霉外所有微生物均被消除,黑曲霉在接种后至少28天仍保持活力。此外,大肠杆菌、铜绿假单胞菌、金黄色葡萄球菌、白色念珠菌和黑曲霉呈现出不同的生长行为,这通过计算得出的D值差异得以证明。得出的结论是,挑战试验和D值是评估这些制剂防腐性能的有效方法。