叶酸混合物与市售维生素糖浆复配的启示

F. Anslem, R.B. Oloyede, A.A. Kassim, A. Bashir, Z.S. Yahaya
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引用次数: 0

摘要

稳定性评估对于确定复方制剂的保质期和质量至关重要。叶酸是一种必需的 B 族维生素,被广泛用于预防和治疗叶酸缺乏症。然而,由于患者的特定需求或定制剂量要求,复方叶酸糖浆经常用于儿童患者。本研究旨在检测使用一些市售维生素糖浆配制的复方叶酸混合物的稳定性。本研究使用了三种市售维生素糖浆作为叶酸片的复方载体,以确保在没有常规复方载体的情况下,医院复方制剂中常用产品的代表性。为模拟实际情况,将复方叶酸混合物分别储存在常温(21-25 ºC)和冷藏(2-8 ºC)条件下,并在第 7、14 和 30 天时使用感官特征、沉淀率、pH 值、微生物生长和药物含量测定等参数进行测试。在 30 天的研究期间,维生素糖浆中的复方叶酸临时制剂总体上保持了其物理特性。不过,在第 7 天时,叶酸浓度有所下降或制剂受到微生物污染。因此,复方叶酸维生素糖浆的稳定性一般不超过 7 天。所获得的数据将有助于医疗保健专业人员和复方药房在选择载体、复方制剂实践和策略方面做出决策,以确保制备出健康的即用产品。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Insights into folic acid mixtures compounded with commercially available vitamin syrups
Stability assessments are crucial in determining the shelf-life and quality of compounded pharmaceutical products. Folic acid, an essential B-vitamin, is widely used to prevent and treat folate deficiency-related conditions. However, because of patient-specific demands or customised dose requirements, compounded folic acid syrups are frequently used in pediatric patients. This study aims to examine the stability of compounded folic acid mixtures prepared with some commercially available vitamin syrups. Three commercially available vitamin syrups were utilized as compounding vehicles for folic acid tablets, ensuring a representative sample of products commonly used in compounding practices in hospitals when conventional compounding vehicles are not available. The compounded folic acid mixtures were stored under ambient (21- 25 ºC) and refrigerated conditions (2-8 ºC), to simulate real-life scenarios, and tested using parameters such as, organoleptic characteristics, sedimentation rate, pH, microbial growth and drug content determination at day 7, 14 and 30. The extemporaneous preparations of the compounded folic acid in vitamin syrups generally maintained their physical characteristics over the 30-day study period. However, there was either decrease in folic acid concentration or microbial contamination of the preparations at day 7. Therefore, folic acid compounded in vitamin syrups are generally stable for less than seven days. The data obtained will aid healthcare professionals and compounding pharmacies in decision making concerning the choice of vehicle, compounding practices and strategies to ensure the preparation of wholesome extemporaneous products.
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