Strom J G, Miller S W
Mercer University Southern School of Pharmacy, Atlanta, GA 30312.
DICP. 1990 Feb;24(2):130-4. doi: 10.1177/106002809002400202.
Experiments were performed to determine the chemical stability and compatibility of cephalexin, cimetidine, diazepam, or propranolol with full-strength and half-strength Isocal, Sustacal, and Sustacal HC (Mead Johnson). The enteral nutrient formulas (ENFs) containing the solid or liquid dosage forms were stored at 24 degrees C and samples were taken at times 0, 1.5, 3, 6, 8, 10, and 24 hours. At each sampling time, the mixtures were visually examined for signs of incompatibilities such as precipitation, viscosity changes, and phase separation. Samples from each time period were analyzed by a stability-indicating high-performance liquid chromatography (HPLC) method. The drugs mixed with half-strength ENFs were also passed through ultrafiltration membranes to separate complexed from uncomplexed drug. Neither visual changes nor variations in pH were observed in any formula. With the exception of cephalexin suspension in half-strength ENFs, none of the drug concentrations changed appreciably throughout the study period. The assays performed for undecomposed drug at each sampling time for the various full- or half-strength ENF-solid drug mixtures stored at 24 degrees C for 24 hours ranged from 92.3 to 103.4 percent for cephalexin, 96.2 to 103.0 percent for cimetidine, 93.9 to 106.2 percent for diazepam, and 95.5 to 102.2 percent for propranolol. For the liquid drugs, the concentration ranged from 86.5 to 102.0 percent for cephalexin, 97.0 to 101.1 percent for cimetidine, 98.2 to 103.0 percent for diazepam, and 97.4 to 104.8 percent for propranolol. Ultrafiltration studies showed varying percent binding dependent on the drug studied.
进行了多项实验，以确定头孢氨苄、西咪替丁、地西泮或普萘洛尔与全强度和半强度的益力佳、能全素及能全素HC（美赞臣公司）之间的化学稳定性和兼容性。含有固体或液体剂型的肠内营养配方（ENF）在24摄氏度下储存，并在0、1.5、3、6、8、10和24小时时取样。在每个取样时间，对混合物进行目视检查，以寻找不相容性迹象，如沉淀、粘度变化和相分离。每个时间段的样品通过稳定性指示高效液相色谱（HPLC）法进行分析。与半强度ENF混合的药物也通过超滤膜，以分离复合药物和未复合药物。在任何配方中均未观察到外观变化或pH值变化。除了头孢氨苄在半强度ENF中的混悬液外，在整个研究期间，没有一种药物浓度有明显变化。对在24摄氏度下储存24小时的各种全强度或半强度ENF - 固体药物混合物，在每个取样时间对未分解药物进行的测定中，头孢氨苄的含量范围为92.3%至103.4%，西咪替丁为96.2%至103.0%，地西泮为93.9%至106.2%，普萘洛尔为95.5%至102.2%。对于液体药物，头孢氨苄的浓度范围为86.5%至102.0%，西咪替丁为97.0%至101.1%，地西泮为98.2%至103.0%，普萘洛尔为97.4%至104.8%。超滤研究表明，结合百分比因所研究的药物而异。
