Highsmith A K, Greenhood G P, Allen J R
J Clin Microbiol. 1982 Jun;15(6):1024-8. doi: 10.1128/jcm.15.6.1024-1028.1982.
The extent to which microbial contamination of medications dispensed in multiple-dose vials might serve as a source of infection to patients has not been fully investigated. To characterize the effects of microbial contamination, we studied the growth-supporting properties of eight medications dispensed in multiple-dose vials. Two medications, procainamide and methohexital, demonstrated no survival of any microbes 24 h after inoculation. Succinylcholine chloride, regular insulin, potassium chloride, heparin, and thiopental slowly killed or allowed limited survival of several of the microorganisms used as contaminants. Lidocaine allowed survival or proliferation of several microbial strains suspended in 0.25% peptone water in saline, but slowly killed all strains except Pseudomonas cepacia suspended in 0.9% saline. Endotoxin, measured by the Limulus amebocyte lysate assay, was found in the two medications tested, lidocaine contaminated with Pseudomonas cepacia and insulin contaminated with enterococci. Inadvertent microbial contamination of at least some parenteral medications in multiple-dose vials may result in the exposure of patients to viable organisms. The potential, however, for medications such as lidocaine to support growth of organisms under selected circumstances should be noted by those responsible for preparing and administering these drugs. The potential hazard to patients from endotoxin in contaminated medications under these circumstances has not been assessed. Additional studies of this type should be pursued to provide more complete information about the risk of microbial contamination of products for parenteral use.
多剂量瓶中分发的药物的微生物污染对患者而言可能成为感染源的程度尚未得到充分研究。为了描述微生物污染的影响，我们研究了多剂量瓶中分发的八种药物的生长支持特性。两种药物，普鲁卡因胺和甲己炔巴比妥，在接种后24小时没有任何微生物存活。氯化琥珀胆碱、正规胰岛素、氯化钾、肝素和硫喷妥钠能缓慢杀死用作污染物的几种微生物或使其有限存活。利多卡因能使悬浮于含0.25%蛋白胨水的盐水中的几种微生物菌株存活或增殖，但能缓慢杀死悬浮于0.9%盐水中除洋葱伯克霍尔德菌之外的所有菌株。通过鲎试剂法检测发现，在两种受试药物中存在内毒素，即被洋葱伯克霍尔德菌污染的利多卡因和被肠球菌污染的胰岛素。多剂量瓶中至少某些注射用药物的意外微生物污染可能会导致患者接触到活的生物体。然而，负责制备和使用这些药物的人员应注意到，在特定情况下，诸如利多卡因之类的药物有支持生物体生长的可能性。在这些情况下，污染药物中的内毒素对患者的潜在危害尚未得到评估。应开展更多此类研究，以提供关于注射用产品微生物污染风险的更完整信息。
