Laboratório de Desenvolvimento e Ensaios de Medicamentos, Centro de Ciências Biológicas e da Saúde, Universidade Estadual da Paraíba, Campina Grande, Paraíba, Brasil.
Departamento de Farmácia, Centro de Ciências Biológicas e da Saúde, Universidade Estadual da Paraíba, Campina Grande, Paraíba, Brasil.
PLoS One. 2018 May 24;13(5):e0197323. doi: 10.1371/journal.pone.0197323. eCollection 2018.
Herbal medicines currently represent an important part of the world pharmaceutical market, which shows growing interest in the use of herbal medicines. However, the production of such medicines involves a complex series of steps, which determine the production viability and the quality of the final product. Ximenia americana L. is a plant occurring in several regions of the world, with well-known and applied medicinal properties. Thus, the aim of this work was to develop and evaluate the physical and physical-chemical quality of tablets produced with X. americana L. extract. The extract was spray-dried from a hydroethanolic extractive solution and characterized as to its phytochemical composition. The chemical marker was determined and quantified using validated chromatographic methods. These methods indicated the presence of gallic acid at a concentration of 1.61 mg g(-1). Formulations were proposed and analyzed for their flow and compaction properties. The best formulation was used to obtain a batch of tablets, which was evaluated for its quality characteristics and showed to be within the pharmacopoeial specifications for average weight, hardness, friability, and disintegration time. The dissolution profile of the tablets produced was obtained, showing the release of about 70% of the vegetable extract content within 30 minutes. Results showed that it was possible to obtain herbal tablets containing a high content of vegetal extract by direct compression, developing a rapid process of formulation and production and guaranteeing the quality characteristics of the final product.
草药目前是世界制药市场的重要组成部分，人们对草药的使用越来越感兴趣。然而，这种药物的生产涉及一系列复杂的步骤，这些步骤决定了生产的可行性和最终产品的质量。西门美洲茶是一种在世界上多个地区都有分布的植物，具有众所周知的药用特性。因此，本工作的目的是开发和评估用西门美洲茶提取物生产的片剂的物理和物理化学质量。提取物是从水醇提取液中喷雾干燥得到的，并对其植物化学成分进行了表征。采用经过验证的色谱方法测定和定量了化学标志物。这些方法表明，提取物中没食子酸的浓度为 1.61mg/g。提出了配方并对其流动和压实性能进行了分析。使用最佳配方获得了一批片剂，对其质量特性进行了评估，结果表明其平均重量、硬度、脆碎度和崩解时间均符合药典规定。获得了所制片剂的溶出曲线，表明在 30 分钟内释放了约 70%的植物提取物。结果表明，通过直接压缩可以获得含有高含量植物提取物的草药片剂，从而开发出快速的配方和生产工艺，并保证最终产品的质量特性。
