Calhoun D A, Juul S E, McBryde E V, Veerman M W, Christensen R D
Department of Pediatrics, College of Medicine, University of Florida, Gainesville 32610, USA.
Ann Pharmacother. 2000 Nov;34(11):1257-61. doi: 10.1345/aph.10105.
To determine the stability of recombinant granulocyte colony-stimulating factor (rG-CSF, filgrastim) and recombinant erythropoietin (rEpo, epoetin alfa) in a solution designed for enteral administration in the neonatal intensive care unit.
Filgrastim and epoetin alfa were added to a solution with NaCl 0.9%, sodium acetate, potassium chloride, and human albumin in concentrations designed to mimic human amniotic fluid. Additionally, the solution was dripped through polyvinyl chloride feeding tubes to simulate feedings, and aliquots were collected before, during, and after priming of the tube. Other aliquots were either frozen immediately, stored at room temperature, or refrigerated for 0, 6, 12, 18, and 24 hours.
Filgrastim and epoetin alfa concentrations in the various aliquots were compared with the concentrations in the original solution.
Filgrastim and epoetin alfa concentrations were stable for at least 24 hours when refrigerated and for at least three weeks when frozen. At room temperature, filgrastim was stable for 18 hours and epoetin alfa for 24 hours. Filgrastim concentrations did not vary significantly before, during, or after priming of the feeding tube, whereas epoetin alfa concentrations decreased significantly unless the feeding tube was primed with 10 mL of solution.
Filgrastim and epoetin alfa were stable in our amniotic fluid-like solution. In this respect, our solution is suitable for enteral administration to patients in the neonatal intensive care unit.
确定重组粒细胞集落刺激因子（rG-CSF，非格司亭）和重组促红细胞生成素（rEpo，阿法依泊汀）在一种为新生儿重症监护病房肠内给药设计的溶液中的稳定性。
将非格司亭和阿法依泊汀添加到一种含有0.9%氯化钠、醋酸钠、氯化钾和人白蛋白的溶液中，其浓度设计为模拟人羊水。此外，该溶液通过聚氯乙烯喂养管滴注以模拟喂养，并在管灌注前、期间和之后收集等分试样。其他等分试样要么立即冷冻，要么在室温下储存，要么冷藏0、6、12、18和24小时。
将各种等分试样中的非格司亭和阿法依泊汀浓度与原液中的浓度进行比较。
非格司亭和阿法依泊汀浓度在冷藏时至少24小时稳定，冷冻时至少三周稳定。在室温下，非格司亭稳定18小时，阿法依泊汀稳定24小时。喂养管灌注前、期间和之后非格司亭浓度无显著变化，而阿法依泊汀浓度显著下降，除非用10 mL溶液灌注喂养管。
非格司亭和阿法依泊汀在我们的羊水样溶液中稳定。在这方面，我们的溶液适用于新生儿重症监护病房患者的肠内给药。
