Department of Renal Medicine, The Canberra Hospital, Woden, ACT, Australia.
Nephrol Dial Transplant. 2011 Oct;26(10):3344-9. doi: 10.1093/ndt/gfr005. Epub 2011 Feb 15.
Peritoneal dialysis (PD)-associated peritonitis is treated by administration of antibiotics mixed with the PD solution. Data on antibiotic stability for solutions in current use are limited. The aim of this study was to determine the stability of cefepime, cephazolin and ampicillin in three commercial PD solutions.
Antibiotics were added to the non-glucose compartment of the Gambro (Gambrosol®) and Fresenius (Balance®) multi-compartment systems and Baxter (Dianeal®) single-compartment (glucose 2.5%) PD solutions in a sterile suite. Antibiotic stability over 3 weeks was determined using both a bioassay of bacterial inhibition and antibiotic concentrations. The influence on stability and sterility of storage conditions was determined.
The bioassay demonstrated the stability of all antibiotics for 9 days at room temperature and 3 weeks when refrigerated, except ampicillin in the Gambro solution, which displayed no bioactivity after 4 days. However, a ceiling effect in bacterial inhibition at higher antibiotic concentrations limited the ability of the bioassay to detect antibiotic degradation at relevant concentrations. Antibiotic concentrations varied with time but were comparable to the bioassay and supported stability in refrigerated solutions, except ampicillin in the Gambro solution. No bacterial contamination, marked colour change or precipitation occurred.
This study supports the stability of cephazolin and cefepime in all three PD solutions and ampicillin in only the Baxter and Fresenius PD solutions. Antibiotic stability studies should ideally be conducted prior to registration and marketing of new PD solutions.
腹膜透析（PD）相关性腹膜炎的治疗方法是将抗生素与 PD 溶液混合使用。目前关于溶液中抗生素稳定性的数据有限。本研究旨在确定三种商业 PD 溶液中头孢吡肟、头孢唑林和氨苄西林的稳定性。
将抗生素加入 Gambro（Gambrosol®）和 Fresenius（Balance®）多腔系统以及 Baxter（Dianeal®）单腔（含 2.5%葡萄糖）PD 溶液的非葡萄糖腔中，在无菌室中进行。使用细菌抑制的生物测定法和抗生素浓度来确定 3 周内抗生素的稳定性。确定储存条件对稳定性和无菌性的影响。
生物测定法表明，除 Gambro 溶液中的氨苄西林在 4 天后无生物活性外，所有抗生素在室温下稳定 9 天，冷藏下稳定 3 周。然而，在较高抗生素浓度下，细菌抑制的上限效应限制了生物测定法在相关浓度下检测抗生素降解的能力。抗生素浓度随时间变化，但与生物测定法相当，支持冷藏溶液中的稳定性，除 Gambro 溶液中的氨苄西林外。没有细菌污染、明显的颜色变化或沉淀发生。
本研究支持头孢唑林和头孢吡肟在三种 PD 溶液中以及氨苄西林仅在 Baxter 和 Fresenius PD 溶液中的稳定性。抗生素稳定性研究最好在新 PD 溶液注册和上市前进行。
