York P
Pharmazie. 1977 Feb;32(2):101-4.
Accelerated storage tests have been carried out to predict the shelf life of several commercial preparations stored directly under temperate and tropical climatic conditions. Two brands each of sulphathiazole tablets, tetracycline hydrochloride capsules and chloramphenicol capsules were studied over a period of three months. Shelf lives ranging from 6.2. to 29.7 months were predicted for temperate storage conditions (20 degree C/31% R.H.), whilst these periods were reduced giving values from 3.8 to 13.9 months for tropical conditions of 30 degree C/31% R.H and from 2.5 to 9.2. months when stored at 30 degree C/75% R.H. A decrease in the rate of drug dissolution was also observed for preparations stored directly under conditions of elevated temperature and humidity. The results indicate the need for stringent control over storage conditions for antibiotic preparations in tropical climates to ensure adequate drug stability and dissolution characteristics.
已进行加速储存试验,以预测直接储存在温带和热带气候条件下的几种商业制剂的保质期。对磺胺噻唑片、盐酸四环素胶囊和氯霉素胶囊各两个品牌进行了为期三个月的研究。预测在温带储存条件(20摄氏度/相对湿度31%)下保质期为6.2至29.7个月,而在热带条件30摄氏度/相对湿度31%下,这些期限缩短为3.8至13.9个月,在30摄氏度/相对湿度75%下储存时为2.5至9.2个月。对于直接储存在高温高湿条件下的制剂,还观察到药物溶解速率降低。结果表明,在热带气候下,需要严格控制抗生素制剂的储存条件,以确保足够的药物稳定性和溶解特性。