Santoro M I, Hackmann E R, Moudatsos K M
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas, Departamento de Farmácia, Brasil.
Bol Oficina Sanit Panam. 1993 Oct;115(4):310-6.
The aim of this research was to provide data to select an ideal packing material to preserve the integrity of oral rehydration salts (ORS), a therapeutic formulation that is essential in developing countries. Previous research had verified that water is the factor that most affects ORS stability. For this research, a pharmaceutical industry prepared an ORS batch that was packed in six different types of packing materials. The humidity determination was made after storage of samples during 36 weeks at room temperature, at room temperature with 76% relative humidity, and at 40 degrees C with 80% relative humidity. The moisture in the samples was measured at pre-determined intervals using methods like loss on drying at 50 degrees C and the Karl Fischer method. The results indicated that the most efficient packing material was composed of 18g polyester, 35 g aluminum, and 50 g polyethylene (packing material no. 6).
本研究的目的是提供数据,以便选择一种理想的包装材料来保持口服补液盐(ORS)的完整性,ORS是一种在发展中国家至关重要的治疗制剂。先前的研究已证实,水是对ORS稳定性影响最大的因素。在本研究中,一家制药企业制备了一批ORS,分别用六种不同类型的包装材料进行包装。在样品于室温、相对湿度76%的室温以及40摄氏度、相对湿度80%的条件下储存36周后,测定湿度。使用50摄氏度干燥失重法和卡尔费休法等方法,在预定的时间间隔测量样品中的水分。结果表明,最有效的包装材料由18克聚酯、35克铝和50克聚乙烯组成(包装材料编号6)。