Huston Robert K, Christensen J Mark, Alshahrani Sultan M, Mohamed Sumeia M, Clark Sara M, Nason Jeffrey A, Wu Ying Xing
Northwest Newborn Specialists, PC and Pediatrix Medical Group, Portland, OR, United States of America.
Department of Pharmaceutical Sciences, College of Pharmacy, Oregon State University, Corvallis, OR, United States of America.
PLoS One. 2015 Aug 28;10(8):e0136894. doi: 10.1371/journal.pone.0136894. eCollection 2015.
Previous studies of compatibility of calcium chloride (CaCl2) and phosphates have not included particle counts in the range specified by the United States Pharmacopeia. Micro-flow imaging techniques have been shown to be comparable to light obscuration when determining particle count and size in pharmaceutical solutions.
The purpose of this study was to do compatibility testing for parenteral nutrition (PN) solutions containing CaCl2 using dynamic light scattering and micro-flow imaging techniques.
Solutions containing TrophAmine (Braun Medical Inc, Irvine, CA), CaCl2, and sodium phosphate (NaPhos) were compounded with and without cysteine. All solutions contained standard additives to neonatal PN solutions including dextrose, trace metals, and electrolytes. Control solutions contained no calcium or phosphate. Solutions were analyzed for particle size and particle count. Means of Z-average particle size and particle counts of controls were determined. Study solutions were compared to controls and United States Pharmacopeia (USP) Chapter 788 guidelines. The maximum amount of Phos that was compatible in solutions that contained at least 10 mmol/L of Ca in 2.5% amino acids (AA) was determined. Compatibility of these solutions was verified by performing analyses of 5 repeats of these solutions. Microscopic analyses of the repeats were also performed.
Amounts of CaCl2 and NaPhos that were compatible in solutions containing 1.5%, 2%, 2.5%, and 3% AA were determined. The maximum amount of NaPhos that could be added to TrophAmine solutions of > = 2.5% AA containing at least 10 mmol/L of CaCl2 was 7.5 mmol/L. Adding 50 mg/dL of cysteine increased the amount of NaPhos that could be added to solutions containing 10 mmol/L of CaCl2 to 10 mmol/L.
Calcium chloride can be added to neonatal PN solutions containing NaPhos in concentrations that can potentially provide an intravenous intake of adequate amounts of calcium and phosphorus.
先前关于氯化钙（CaCl2）与磷酸盐相容性的研究未涵盖美国药典规定范围内的颗粒计数。在测定药物溶液中的颗粒计数和大小时，微流成像技术已被证明与光阻法相当。
本研究的目的是使用动态光散射和微流成像技术对含CaCl2的肠外营养（PN）溶液进行相容性测试。
将含有小儿胺（布劳恩医疗公司，尔湾，加利福尼亚州）、CaCl2和磷酸钠（NaPhos）的溶液在有和没有半胱氨酸的情况下进行配制。所有溶液均含有新生儿PN溶液的标准添加剂，包括葡萄糖、微量元素和电解质。对照溶液不含钙或磷酸盐。对溶液进行粒度和颗粒计数分析。测定对照溶液的Z-平均粒度和颗粒计数的平均值。将研究溶液与对照溶液和美国药典（USP）第788章指南进行比较。确定在含2.5%氨基酸（AA）且至少含10 mmol/L钙的溶液中与CaCl2相容的最大磷酸盐量。通过对这些溶液进行5次重复分析来验证这些溶液的相容性。还对重复溶液进行了显微镜分析。
确定了在含1.5%、2%、2.5%和3% AA的溶液中与CaCl2和NaPhos相容的量。可添加到含至少10 mmol/L CaCl2的>=2.5% AA小儿胺溶液中的最大NaPhos量为7.5 mmol/L。添加50 mg/dL的半胱氨酸可将可添加到含10 mmol/L CaCl2溶液中的NaPhos量增加到10 mmol/L。
氯化钙可以添加到含NaPhos的新生儿PN溶液中，其浓度有可能提供足够量的钙和磷的静脉摄入量。
