Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of São Paulo, Brazil.
AAPS PharmSciTech. 2011 Jun;12(2):732-7. doi: 10.1208/s12249-011-9635-9. Epub 2011 Jun 4.
Even though the synthetic preservatives may offer a high antimicrobial efficacy, they are commonly related to adverse reactions and regarded as having potentially harmful effects caused by chronic consumption. The development of natural preservatives provides a way of reducing the amount of synthetic preservatives normally used in pharmaceutical and cosmetic preparations. In addition, these agents have less toxic effects and represent a possible natural and safer alternative of the preservatives. The purpose of this research was to evaluate the Rubus rosaefolius Smith extract efficiency as a natural preservative in base formulations. Of the extract, 0.2% (w/w) was assayed for its effectiveness of antimicrobial protection in two different base formulations (emulsion and gel). The microbial challenge test was performed following the standard procedures proposed by The United States Pharmacopoeia 33nd, European Pharmacopoeia 6th, Japanese Pharmacopoeia 15th, and the Cosmetics, Toiletries, and Fragrance Association using standardized microorganisms. The results demonstrated that R. rosaefolius extract at the studied concentration reduced the bacterial inocula, satisfying the criterion in all formulations, even though it was not able to present an effective preservative behavior against fungi. Thus, the investigation of new natural substances with preservative properties that could be applied in pharmaceutical and cosmetic products is relevant due to the possibility of substituting or decreasing the concentration of synthetic preservatives, providing a way for the development of safer formulas for the use of consumers.
尽管合成防腐剂可能具有高效的抗菌效果,但它们通常与不良反应有关,并被认为具有潜在的有害影响,这些影响是由慢性消耗引起的。天然防腐剂的开发为减少药物和化妆品制剂中通常使用的合成防腐剂的数量提供了一种方法。此外,这些防腐剂的毒性作用更小,代表了防腐剂的一种更天然、更安全的替代选择。本研究的目的是评估玫瑰覆盆子提取物作为天然防腐剂在基础配方中的效率。在两种不同的基础配方(乳液和凝胶)中,对提取物的 0.2%(w/w)进行了抗菌保护效果的测试。微生物挑战测试按照美国药典第 33 版、欧洲药典第 6 版、日本药典第 15 版和化妆品、个人卫生用品和香水协会提出的标准程序进行,使用标准化微生物进行。结果表明,研究浓度的玫瑰覆盆子提取物减少了细菌接种物,满足了所有配方的标准,尽管它不能对真菌表现出有效的防腐行为。因此,由于有可能替代或减少合成防腐剂的浓度,因此研究具有防腐剂特性的新天然物质,并将其应用于药物和化妆品产品是相关的,这为消费者提供了更安全的配方开发途径。