Parikh Mansi J, Dumas Greg, Silvestri Anthony, Bistrian Bruce R, Driscoll David F
Bristol-Myers Squibb, Wallingford, CT, USA.
Am J Health Syst Pharm. 2005 Jun 1;62(11):1177-83. doi: 10.1093/ajhp/62.11.1177.
The compatibility of calcium and phosphate salts in total parenteral nutrient (TPN) admixtures at the highest concentrations recommended for preterm and term infants was studied.
Particulate matter from eight different macronutrient combinations was measured and counted (range, 1.8-50 mum) by a laser-based, single-particle optical sensing technique. Measurements were performed at four intervals after compounding the formulations under aseptic conditions (within 1 hour of preparation and at 6, 24, and 30 hours) at 23-27 degrees C. The number of particles measuring >or=5, >or=10, and >or=25 microm per milliliter of TPN admixture was recorded. Detailed visual inspections were also performed at these intervals, and pH was measured at the beginning (time 0) and end of the study (30 hours). Precipitated material was characterized by polarized microscopy and infrared spectroscopy.
The TPN admixture with the lowest concentration of amino acids (0.5%), as well as the highest pH, resulted in significant growth of particulate matter over time. At 30 hours, the particle growth was accompanied by visible evidence of precipitation, which was confirmed to be dibasic calcium phosphate. Neither significant particle growth nor precipitation was noted in the remaining seven formulations, which had amino acid concentrations of 1-4%.
Commonly used organic calcium and inorganic phosphate salts in cysteine-added, lipid-free TPN formulations at the highest recommended amounts for neonates were compatible when the amino acid concentration was between 1% and 4% and the dextrose concentration was 5% or 10%. The salts remained compatible for up to 30 hours at a room temperature of up to 27 degrees C. Precipitation of dibasic calcium phosphate occurred with lower amino acid concentrations and higher pH values.
研究在早产和足月婴儿推荐的最高浓度全胃肠外营养（TPN）混合液中钙盐和磷酸盐的相容性。
通过基于激光的单颗粒光学传感技术测量并计数来自八种不同宏量营养素组合的颗粒物（范围为1.8 - 50微米）。在无菌条件下配制制剂后的四个时间点（制备后1小时内以及6、24和30小时），于23 - 27摄氏度进行测量。记录每毫升TPN混合液中尺寸大于或等于5、大于或等于10以及大于或等于25微米的颗粒数量。在这些时间点还进行了详细的目视检查，并在研究开始时（时间0）和结束时（30小时）测量pH值。通过偏光显微镜和红外光谱对沉淀物质进行表征。
氨基酸浓度最低（0.5%）且pH值最高的TPN混合液，随着时间推移颗粒物显著增加。在30小时时，颗粒增加伴有明显的沉淀迹象，经证实沉淀物质为磷酸氢钙。其余七种氨基酸浓度为1 - 4%的制剂，既未观察到显著的颗粒增加，也未出现沉淀。
在添加半胱氨酸、无脂的TPN制剂中，当氨基酸浓度在1%至4%之间且葡萄糖浓度为5%或10%时，按新生儿推荐的最高用量使用常用的有机钙盐和无机磷酸盐是相容的。在室温高达27摄氏度的条件下，这些盐在长达30小时内保持相容。氨基酸浓度较低且pH值较高时会出现磷酸氢钙沉淀。
