Groeschke J, Solassol I, Bressolle F, Pinguet F
Oncopharmacology Laboratory, Val d'Aurelle Anticancer Centre, Parc Euromédecine, Montpellier, France.
J Pharm Biomed Anal. 2006 Sep 26;42(3):362-6. doi: 10.1016/j.jpba.2006.04.011. Epub 2006 Jun 5.
Amphotericin B and nystatin are two polyene antibiotics that are potent antifungal agents. These drugs are active against most pathogenic fungi like Aspergillus and Candida. Mouthrinses containing these drugs are used for preventive and curative treatment of fungal infections like oral candidiasis, which can cause multiple diseases in cancer patients. Because there were no marketed antifungal mouthrinses available, their preparations were performed at the hospital and town pharmacies. To date, there are no data available on the stability of both these drugs in the form of mouthrinses. Therefore, each mouthrinse had to be prepared extemporaneously. The aim of this study was to investigate the stability of amphotericin B (Fungizone) and nystatin (Mycostatine) in the form of mouthrinses containing 1.4% sodium hydrogen carbonate. The stability of these solutions was tested at different temperatures (4-37 degrees C) with or without electric- or sunlight exposure and in two types of containers (glass and polypropylene) over a 15-day period. The admixtures were also monitored for colour change and pH. Amphotericin B and nystatin were quantified by high-performance liquid chromatography. At 4 degrees C, amphotericin B and nystatin were stable for 15 days in polypropylene. When stored in polypropylene at room temperature, with or without light protection, amphotericin B and nystatin were stable for 3 and 4 days, respectively.
两性霉素B和制霉菌素是两种多烯类抗生素，它们是强效抗真菌剂。这些药物对大多数致病真菌如曲霉菌和念珠菌具有活性。含有这些药物的漱口水用于预防和治疗真菌感染，如口腔念珠菌病，这种疾病可在癌症患者中引发多种病症。由于没有市售的抗真菌漱口水，它们的制剂是在医院和城镇药房配制的。迄今为止，尚无关于这两种药物以漱口水形式存在时稳定性的数据。因此，每种漱口水都必须临时配制。本研究的目的是研究两性霉素B（两性霉素B注射剂）和制霉菌素（制霉菌素）在含有1.4%碳酸氢钠的漱口水形式下的稳定性。在15天的时间内，在不同温度（4 - 37摄氏度）、有无电或阳光照射以及两种类型的容器（玻璃和聚丙烯）中测试这些溶液 的稳定性。还监测混合物的颜色变化和pH值。两性霉素B和制霉菌素通过高效液相色谱法定量。在4摄氏度时，两性霉素B和制霉菌素在聚丙烯中15天内保持稳定。当在室温下储存在聚丙烯中时，无论有无光照保护，两性霉素B和制霉菌素分别稳定3天和4天。
