Belson J J, Juhl Y H, Moyer E S, Page D P, Shroff A P
Am J Hosp Pharm. 1981 Dec;38(12):1903-7.
The stability of digoxin tablets that had been stored in hospitals across the United States was studied. All hospital pharmacies in the U.S. were contacted in February 1980 to inform them about the program, the reimbursement procedures, the sampling requirement, and the process by which laboratory results would be distributed. A response card was included for those who wanted to participate. Ninety-two samples, representing three manufacturers and an adequate cross-section of the country, as well as typical dosage forms and packaging variations, were selected for laboratory analyses of content uniformity, strength, dissolution, identification, and related fluorescing substances. Eighty-five samples met the current compendial standards and seven samples failed the dissolution specifications. All seven were manufactured before July 1975 when the UPS dissolution requirements were changed. The digoxin products studied were not adversely affected by the variable stresses of the marketplace.
对在美国各地医院储存的地高辛片剂的稳定性进行了研究。1980年2月联系了美国所有医院药房，告知他们该项目、报销程序、抽样要求以及实验室结果的分发流程。为那些想参与的人提供了一张回执卡。选取了代表三家制造商且能充分反映美国不同地区、典型剂型和包装差异的92个样品，进行含量均匀度、强度、溶出度、鉴别以及相关荧光物质的实验室分析。85个样品符合现行药典标准，7个样品溶出度规格不合格。所有7个不合格样品均是在1975年7月美国药典溶出度要求变更之前生产的。所研究的地高辛产品并未受到市场各种变化因素的不利影响。
