Allen L V, Stiles M L, Prince S J, McLaury H J, Sylvestri M F
Department of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Oklahoma Health Sciences Center (UOHSC), Oklahoma City 73117, USA.
Am J Health Syst Pharm. 1995 Nov 1;52(21):2433-6. doi: 10.1093/ajhp/52.21.2433.
The stability of ramipril in water, in apple juice, and in applesauce was studied. The contents of a single capsule each of ramipril 1.25, 2.5, and 5 mg were mixed in glass beakers with 120 mL of deionized and filtered water, apple juice, or applesauce. Each mixture was apportioned into 10 120-mL amber polyethylene terephthalate (PET) containers. Five of the containers in each set were stored at 23 degrees C, and samples were taken at 0, 1, 2, 6, 12, and 24 hours. The other five containers were stored at 3 degrees C, and samples were taken at 4, 8, 12, 24, and 48 hours. The samples were analyzed for ramipril concentration by stability-indicating high-performance liquid chromatography (HPLC). The quantity of drug remaining in the PET container after "administration" was determined by mixing the contents of single 5-mg ramipril capsules with 60 mL of apple juice, pouring the mixture into a waste receptacle, rinsing the PET container three separate times with 10 mL of water, and analyzing the pooled fluid from these rinses for ramipril concentration by HPLC. Under no condition did the percentage of ramipril remaining drop below 90%. No peaks for degradation products appeared in the chromatograms. The mean +/- S.D. quantity of ramipril remaining in the PET containers after draining was 0.3 +/- 0.3% for the apple juice. Ramipril from 1.25-, 2.5-, and 5-mg capsules mixed in water, in apple juice, and in applesauce was stable for 24 hours at 23 degrees C and for 48 hours at 3 degrees C.
研究了雷米普利在水、苹果汁和苹果酱中的稳定性。将1.25毫克、2.5毫克和5毫克的雷米普利单粒胶囊内容物分别与120毫升去离子并经过滤的水、苹果汁或苹果酱在玻璃烧杯中混合。每种混合物被分配到10个120毫升的琥珀色聚对苯二甲酸乙二酯（PET）容器中。每组中的5个容器在23摄氏度下储存，并在0、1、2、6、12和24小时取样。另外5个容器在3摄氏度下储存，并在4、8、12、24和48小时取样。通过稳定性指示高效液相色谱法（HPLC）分析样品中的雷米普利浓度。“给药”后PET容器中剩余的药物量通过将单粒5毫克雷米普利胶囊的内容物与60毫升苹果汁混合，将混合物倒入废物容器中，用10毫升水对PET容器进行三次单独冲洗，并通过HPLC分析这些冲洗液的合并液中的雷米普利浓度来确定。在任何情况下，雷米普利剩余的百分比均未降至90%以下。色谱图中未出现降解产物的峰。苹果汁冲洗后PET容器中剩余雷米普利的平均±标准差量为0.3±0.3%。在水、苹果汁和苹果酱中混合的1.25毫克、2.5毫克和5毫克胶囊中的雷米普利在23摄氏度下稳定24小时，在3摄氏度下稳定48小时。
