Dentinger Paul J, Swenson Chad F, Anaizi Nasr H
Department of Pharmacy, Strong Memorial Hospital, University of Rochester Medical Center (URMC), Rochester, NY, USA.
Am J Health Syst Pharm. 2003 May 15;60(10):1019-22. doi: 10.1093/ajhp/60.10.1019.
The stability of nifedipine in an extemporaneously compounded oral solution is described. A solution of nifedipine 10 mg/mL was prepared from commercially available nifedipine powder with polyethylene glycol 400, glycerin, and peppermint oil. Four samples were stored in amber glass bottles at room temperature under fluorescent lighting and analyzed in duplicate. Samples were analyzed immediately and at 7, 14, 23, and 35 days. Eight samples were stored in amber oral syringes and eight in amber oral syringes wrapped in aluminum foil; all were stored at room temperature under fluorescent lighting. Samples from foil-wrapped syringes were analyzed at 7 and 14 days; samples not wrapped in foil were analyzed after 7 days. Nifedipine concentrations were measured with a modified stability-indicating high-performance liquid chromatographic method. Excessive degradation was defined as a greater than 10% loss of initial drug concentration. There were no detectable changes in color or odor and no visible solids or microbial growth was observed in any sample. Samples in amber glass bottles and amber oral syringes wrapped in aluminum foil retained more than 90% of the initial nifedipine for 35 and 14 days, respectively. Samples packaged in amber oral syringes not wrapped in foil lost over 20% of the initial nifedipine concentration within 7 days. Nifedipine 10 mg/mL was stable in an oral solution prepared from commercially available powder in a peppermint-flavored vehicle for at least 35 days when stored at 22-25 degrees C in amber glass bottles and for at least 14 days when stored in amber oral syringes wrapped in aluminum foil.
描述了硝苯地平在临时配制的口服溶液中的稳定性。用市售硝苯地平粉末与聚乙二醇400、甘油和薄荷油制备了10mg/mL的硝苯地平溶液。四个样品储存在琥珀色玻璃瓶中，室温下置于荧光灯下，一式两份进行分析。样品在立即、第7、14、23和35天进行分析。八个样品储存在琥珀色口服注射器中，八个储存在用铝箔包裹的琥珀色口服注射器中；所有样品均在室温下置于荧光灯下保存。来自铝箔包裹注射器的样品在第7天和第14天进行分析；未用铝箔包裹的样品在第7天后进行分析。用改良的稳定性指示高效液相色谱法测定硝苯地平浓度。过度降解定义为初始药物浓度损失超过10%。在任何样品中均未检测到颜色或气味变化，也未观察到可见固体或微生物生长。储存在琥珀色玻璃瓶和用铝箔包裹的琥珀色口服注射器中的样品，分别在35天和14天内保留了超过90%的初始硝苯地平。包装在未用铝箔包裹的琥珀色口服注射器中的样品在7天内损失了超过20%的初始硝苯地平浓度。当在22-25摄氏度下储存在琥珀色玻璃瓶中时，10mg/mL的硝苯地平在由市售粉末在薄荷味载体中制备的口服溶液中至少稳定35天；当储存在用铝箔包裹的琥珀色口服注射器中时，至少稳定14天。
