Vojnosanitetski Pregled (Jan 2008)
Preparation and testing of solutions for organ perfusion and preservation in transplantation
Abstract
Background/Aim. Histidine-tryptophan-ketoglutarate (HTK) solution is the most frequently used solution for the preservation of abdominal organs by leading transplant centers worldwide. The aim of the study was to investigate whether it is possible to prepare this kind of perfusion solution in the hospital pharmacy. In the hospital pharmacy setting we prepared HTK preservation solution and tested its quality, and in accordance with the obtained results recommended its shelf-life. Methods. A multicomponent HTK solution was prepared following standardized aseptic procedures for sterile products. Components of HTK solution were dissolved in water for injection under aseptic conditions and the obtained solution was sterilized by bacteriological membrane filtration (0,22 μm). The quality of the produced solution was examined using physical and physico-chemical methods and biological tests. Following pharmacopoeial regulations, we examined clarity, pH value, sterility and performed testing on pyrogens. The content of the amino acids histidine and triptophan was determined by using high pressure liquid chromatography (HPLC) method. The concentrations of chloride ions were investigated by retitration method. Atomic absorption spectrometry and ion-exchange chromatography with conductometric detection were used for determining the level of magnesium and calcium ions and the concentrations of sodium and potassium ions in HTK solution, respectively. Results. It was shown that the quality of the prepared HTK solution complied with the regulation demands. Also, pH value of the solution as a function of storage temperature, remained in the physiological range (pH 7.4). Conclusion. According to the obtained results of physico-chemical and biological testing it can be concluded that in the hospital pharmacy setting with the applied technological procedure, we can produce HTK preservation solution of the required quality. Keeping of HTK preservation solution in a refrigerator at 4ºC warrants its shelf-life of six months. .
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