Clarke A J, Watkins R E
Am J Hosp Pharm. 1985 Jul;42(7):1542-6.
A method used by a hospital pharmacy department for manufacturing and testing a ready-to-administer i.v. nitroglycerin injection is described, and costs for this extemporaneously prepared injection are compared with costs for commercially available nitroglycerin products for i.v. use. A powder adsorbate containing one part nitroglycerin and nine parts lactose was used to prepare nitroglycerin injection in two strengths: 0.04 mg/mL (250-mL quantities) in 0.9% sodium chloride injection and 0.4 mg/mL (400-mL quantities) in 5% dextrose injection. Each batch was tested for sterility, for presence of pyrogens (endotoxin testing), and for nitroglycerin concentration (spectrophotometric assay). In one year, a total of 1217 bottles of nitroglycerin injection were prepared. This required 75 hours; preparation from commercial i.v. nitroglycerin products would have required approximately 200 hours (including admixture preparation). First-year costs for extemporaneous preparation (excluding costs of i.v. solutions and containers) were approximately $2200, far less than drug costs alone for the commercial i.v. nitroglycerin products. Nitroglycerin injection of high quality and confirmed potency was prepared extemporaneously in a hospital pharmacy department. Costs for this method were substantially less than those for use of commercial i.v. nitroglycerin products.
描述了一家医院药房部门用于制备和测试即用型静脉注射硝酸甘油注射液的方法，并将这种临时配制注射液的成本与市售静脉用硝酸甘油产品的成本进行了比较。使用一种含一份硝酸甘油和九份乳糖的粉末吸附剂来制备两种浓度的硝酸甘油注射液：0.9%氯化钠注射液中浓度为0.04mg/mL（250mL装量），5%葡萄糖注射液中浓度为0.4mg/mL（400mL装量）。每批产品都进行了无菌、热原（内毒素检测）和硝酸甘油浓度（分光光度法测定）检测。一年内共制备了1217瓶硝酸甘油注射液。这需要75小时；而从市售静脉用硝酸甘油产品制备则大约需要200小时（包括混合制剂的制备）。临时配制的第一年成本（不包括静脉注射液和容器的成本）约为2200美元，远低于仅市售静脉用硝酸甘油产品的药品成本。在医院药房部门临时配制出了高质量且效力得到确认的硝酸甘油注射液。这种方法的成本大大低于使用市售静脉用硝酸甘油产品的成本。
